Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 362

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 362
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 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 upon and we have less control over our operations
due to our reliance on third parties. While we believe our business model significantly reduces overhead cost, we may not realize the
efficiencies of this arrangement if we are unable to effectively manage third parties or if our employees are unable to manage the operations
of each of our subsidiaries, including the development of their programs and product candidates. The failure to successfully and efficiently
outsource operational functions or appropriately manage the operations of our subsidiaries could materially adversely affect our business,
results of operations, and financial condition.

We rely on third parties to conduct important aspects of our
preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, meet expected
deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any potential product
candidates.

We depend upon third parties to conduct important aspects of our preclinical
studies and clinical trials, under agreements with CROs, CMOs, strategic collaborators and others. We expect to continue to negotiate
budgets and contracts with such third parties, which may result in delays to our development timelines and increased costs.

We will rely heavily on third parties over the course of our preclinical
studies and clinical trials, and, as a result, we control only certain aspects of their activities. When working with third parties, we
have less direct control over the conduct, timing and completion of our preclinical studies and clinical trials and the management of
data developed through pre