Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 363

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 363
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clinical 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 not comply with the GCP or cGMP
requirements. Failure by us or by third parties we engage to comply with regulatory requirements can also result in fines, adverse publicity,
and civil and criminal sanctions.

65

Any third parties conducting aspects of our preclinical studies, clinical
trials or manufacturing process will not be our employees and, except for remedies that may be available to us under our agreements with
such third parties, we cannot control whether or not they devote sufficient time and resources to our preclinical studies and clinical
programs. These third parties may also have relationships with other commercial entities, including our competitors, for whom they may
also be conducting clinical trials or other product development activities, which could affect their performance on our behalf. If these
third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced
or if the quality or accuracy of the preclinical or clinical data they obtain is compromised due to the failure to adhere to our protocols
or regulatory requirements or for other reasons or if due to federal or state orders or absenteeism they are unable to meet their contractual
and regulatory obligations, our development timelines, including clinical development timelines, may be extended, delayed or terminated
and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our product candidates.
As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and
our ability to generate revenue could be delayed.

If