Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 124

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 124
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 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, which, following the closing of the Business Combination, will be the reliance on third
parties by the Company. References in this section to “we,” “us,” and “our” refer to OSR prior to
the closing of the Business Combination and to the Company after closing.

We currently outsource, and intend to continue to outsource,
much of our discovery, clinical development, and manufacturing functions to third-party providers or consultants. Outsourcing
these functions has significant risks, and our failure to manage these risks successfully could materially adversely affect our business,
results of operations, and financial condition.

Our business model relies upon the use of third parties, such as vendors
and consultants, to conduct our drug discovery, preclinical testing, clinical trials, manufacturing, and all other aspects of clinical
development. While our reliance on third parties allows us to purposely employ a small number of full-time employees, we may not
be able to effectively manage and oversee the third parties that our business depends