Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 367

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 367
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 process, we may be required to provide preclinical and clinical data showing the comparable identity, strength,
quality, purity or potency of the products before and after such changes. If microbial, viral or other contaminations are discovered
at the facilities of our manufacturers, such facilities may need to be closed for an extended period of time to investigate and
remedy the contamination, which could delay clinical trials and adversely harm our business.

In addition, there are risks associated with large scale manufacturing
for clinical trials or commercial scale including, among others, cost overruns, potential problems with process scale-up, process reproducibility,
stability issues, compliance with good manufacturing practices, lot consistency and timely availability of raw materials. Even if we obtain
marketing approval for any of our current product candidates or any future product candidates, there is no assurance that our manufacturers
will be able to manufacture the approved product to specifications acceptable to the FDA or other comparable foreign regulatory authorities,
to produce it in sufficient quantities to meet the requirements for the potential commercial launch of the product or to meet potential
future demand. If our manufacturers are unable to produce sufficient quantities for clinical trials or for commercialization, our development
and commercialization efforts would be impaired, which would have an adverse effect on our business, financial condition, results of operations
and growth prospects.

67

Risks Related to the Company’s Intellectual Property

The following risk factors reference the risks and uncertainties
relating to the intellectual property of OSR, which, following the closing of the Business Combination, will be the intellectual property
of 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.

If we are unable to obtain and maintain patent and other intellectual
property protection for our technology and product candidates or if the scope of the intellectual property protection obtained is not
sufficiently broad, we may not be able to compete effectively in our markets.

We rely upon a combination of patents, trademarks, trade secret protection
and confidentiality agreements with employees, consultants, collaborators, advisors and other third parties to protect the intellectual
property related to our product candidates. Our success depends in large part on our ability to obtain and maintain patent protection
in the United States and other countries with respect to our product candidates and any future product candidates. We also seek to
protect our proprietary position by in-licensing or acquiring intellectual property and filing patent applications in the United States