Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 361

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 361
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 clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,
more convenient, or less expensive than any products that we may develop. Furthermore, products currently approved for other indications
could be discovered to be effective treatments as well, which could give such products significant regulatory and market timing advantages
over our product candidates. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we
may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter
the market. Additionally, products or technologies developed by our competitors may render our potential product candidates uneconomical
or obsolete and we may not be successful in marketing any product candidates we may develop against competitors. The availability of competitive
products could limit the demand, and the price we are able to charge, for any products that we may develop and commercialize.

Product liability lawsuits against us could cause us to incur
substantial liabilities and could limit commercialization of any product candidates that we may develop.

We face an inherent risk of product liability exposure related to the
testing of product candidates in human clinical trials. If we cannot successfully defend ourselves against claims that our product candidates
or medicines caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result
in:

●decreased demand for any product candidates or medicines
that we may develop;

●injury to our reputation and significant negative media attention;

●withdrawal of clinical trial participants;

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●significant costs to defend the related litigation;

●substantial monetary awards to trial participants or patients;

●loss of revenue; and

●the inability to out-license our product candidates.

Although we intend to maintain product liability insurance, including
coverage for clinical trials that we sponsor, it may not be adequate to cover all liabilities that we may incur. We anticipate that we
will need to increase our insurance coverage as we commence additional clinical trials. The market for insurance coverage is increasingly
expensive, and the costs of insurance coverage will increase as our clinical programs increase in size. We may not be able to maintain
insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Risks Related to the Company’s Reliance on Third Parties

The following risk factors reference the risks and uncertainties
relating to the reliance on third parties by OSR,