Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 117

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 117
---
Boards, or ethics committees may require that we or our investigators, suspend or terminate clinical research or trials for various reasons,
including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;

●we may not have the financial resources available to begin and
complete the planned trials, or the cost of clinical trials of any product candidates may be greater than we anticipate;

●the supply or quality of our product candidates or other
materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate to initiate or complete a
given clinical trial; and

●the FDA or other comparable foreign regulatory authorities
may require us to submit additional data such as long-term toxicology studies, or impose other requirements before permitting us
to initiate a clinical trial.

We could also encounter delays if a clinical trial is suspended or
terminated by us, by the IRBs or ethics committees of the institutions in which such clinical trials are being conducted, or by the FDA
or other regulatory authorities. Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure
to conduct the clinical trial in accordance with regulatory requirements or our clinical trial protocols, inspection of the clinical trial
operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety
issues or adverse side effects, failure to demonstrate a benefit from the product candidates, changes in governmental regulations or administrative
actions or lack of adequate funding to continue the clinical trial.

Moreover, principal investigators for our clinical trials may serve
as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain
circumstances, we may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities. The
FDA or comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator has
created a conflict of interest or otherwise affected interpretation of the study. The FDA or comparable foreign regulatory authority
may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial
itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable
foreign regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our product
candidates.

Our product development costs will increase if we experience additional
delays in preclinical or clinical testing or in obtaining marketing