Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 126

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 126
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 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 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