Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 364

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 364
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 any of our relationships with these third-party CROs, CMOs
or others terminate, we may not be able to enter into arrangements with alternative CROs, CMOs or other third parties in a timely manner
or to do so on commercially reasonable terms. Switching or adding additional CROs or CMOs involves additional cost and requires extensive
time and focus of our management. As a result, delays may occur, which can materially impact our ability to meet our desired development
timelines which may have a material adverse impact on our business, financial condition and prospects.

Because we rely on third-party manufacturing and supply
vendors, our supply of research and development, preclinical and clinical development materials may become limited or interrupted or may
not be of satisfactory quantity or quality.

We rely on third-party contract manufacturers to manufacture our
product candidates for preclinical studies and clinical trials. We do not own manufacturing facilities for producing any commercial product
supplies. There 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