Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 125

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 125
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 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 preclinical studies and clinical trials than would be the case if we relied entirely upon our own staff. Nevertheless,
we are responsible for ensuring that each of our studies and trials are conducted in accordance with the applicable protocol, legal and
regulatory requirements and scientific standards, and our reliance on third parties does not relieve us of our regulatory responsibilities.
We and these third parties are required to comply with GCP and cGMP requirements, which are regulations and guidelines enforced by the
FDA and comparable foreign regulatory authorities for product candidates in clinical development. Regulatory authorities enforce these
GCP and cGMP requirements through periodic inspections of trial sponsors, clinical investigators, manufacturers and trial sites. If we
or any of these third parties fail to comply with applicable GCP or cGMP requirements, the clinical data generated in our clinical trials
may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to suspend or terminate these trials
or perform additional preclinical studies or clinical trials or determine that our clinical trials do