Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 127

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 127
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 can be no assurance that our preclinical and clinical development product supplies will not be limited, interrupted, or
of satisfactory quality or continue to be available at acceptable prices. For example, the COVID-19 pandemic would have significantly
impacted our ability to procure sufficient supplies for the development of our product candidates. Any future pandemic or similar public
health crisis may create delays or gaps in supply of materials driven by the response to any pandemic or similar public health crisis.
In particular, any replacement of a contract manufacturer could require significant effort and expertise because there may be a limited
number of qualified replacements.

The manufacturing process for a product candidate is subject to FDA
and foreign regulatory authority review. Suppliers and manufacturers must meet applicable manufacturing requirements and undergo rigorous
facility and process validation tests required by regulatory authorities in order to comply with regulatory standards, such as cGMPs.
In the event that any of our manufacturers fails to comply with such requirements or to perform its obligations to us in relation to quality,
timing or otherwise, or if our supply of components or other materials become limited or interrupted for other reasons, we may be forced
to manufacture the materials ourselves, for which we currently do not have the capabilities or resources, or enter into an agreement with
another third-party, which we may not be able to do on reasonable terms, if at all. In some cases, the technical skills or technology
required to manufacture our product candidates may be unique or proprietary to the original manufacturer and we may have difficulty transferring
such skills or technology to another third-party and a feasible alternative may not exist. These factors would increase our reliance
on such manufacturer or require us to obtain a license from such manufacturer in order to have another third-party manufacture our
product candidates. If we are required to change manufacturers for any reason, we will be required to verify that the new manufacturer
maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines. We will also
need to verify, such as through a manufacturing comparability or bridging study, that any new manufacturing process will produce our product
candidate according to the specifications previously submitted to the FDA or another regulatory authority. The delays associated with
the verification of a new manufacturer could negatively affect our ability to develop product candidates in a timely manner or within
budget.

To the extent that we enter into future manufacturing arrangements
with third parties, we will depend on these third parties to perform their obligations in a timely manner consistent with contractual
and regulatory requirements, including those