Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 96

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 96
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2018, North Korea held a series
of bilateral summit meetings with South Korea and the United States to discuss peace and denuclearization of the Korean peninsula.
However, those discussions have ended and North Korea has since resumed its missile testing and bellicose statements, heightening tensions,
and increasing uncertainty.

Further tensions in North Korean relations could develop due to a leadership
crisis, breakdown in high-level inter-Korea contacts or military hostilities. Alternatively, tensions may be resolved through
reconciliatory efforts, which may include peace talks, alleviation of sanctions or reunification. We cannot assure that future negotiations
will even occur and, if they do, result in any lasting resolution of key issues, such as North Korea’s nuclear program, or that
the level of tensions between South Korea and North Korea will not escalate. Any increase in the level of tension between South Korea
and North Korea, an outbreak in military hostilities or other actions or occurrences, could adversely affect our business, prospects,
financial condition, and results of operations and could lead to a decline in the price per share of our common stock.

Except with respect to RMC, our Korean subsidiary engaged in
the sale and distribution of medical products in Korea, we do not expect to carry any business interruption insurance or any other insurance
(except for director and officer liability insurance). As a result, we may incur uninsured losses, increasing the possibility that you
would lose your entire investment in the Company.

Our pharmaceutical products may expose us to 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