Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 334

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 334
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 product liability or
other product claim risks. We currently do not have product liability or other insurance for such claims and may not be able to obtain
such insurance on acceptable terms or that any insurance we do obtain will be sufficient to protect us against potential claims or that
insurance will be available in the future in amounts sufficient to protect us. A product liability claim or other claim, as well as any
claims for uninsured liabilities or in excess of insured liabilities, could have a material adverse effect on our business, financial
condition, results of operations and prospects.

50

Our relationships with healthcare providers and physicians and third-party payors
will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to
criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

The contracts and other arrangements that pharmaceutical manufacturers
have with third-party payors, health care providers and customers create risk that the pharmaceutical manufacturers 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