Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 335

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 335
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, reputational harm, possible exclusion from participation in
federal and state funded healthcare programs, contractual damages and the curtailment or restricting of our operations, as well as additional
reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations
of non-compliance with these laws. Any action for violation of these laws, even if successfully defended, could cause a pharmaceutical
manufacturer to incur significant legal expenses and divert management’s attention from the operation of the business. Prohibitions
or restrictions on sales or withdrawal of future marketed products could materially affect business in an adverse way.

Even if we receive regulatory approval of any product candidates,
we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense
and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product
candidates.

If any of our product candidates are approved, they will be subject
to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping,
conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal
and state requirements in the United States and requirements of comparable foreign regulatory authorities, all of which will require
us to incur significant costs and expenses. In addition, we will be subject to continued compliance with the Current Good Manufacturing
Practices (“cGMP”) and Good Clinical Practices (“GCP”) requirements for any clinical trials that
we conduct post-approval.

If we do not comply with regulatory requirements and applicable standards
or if problems occur after a product reaches the market, the FDA or European Medicines Agency may impose consent decrees or withdraw approval.
Later discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity or frequency,
or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in,
among other things:

●restrictions on the marketing or manufacturing of our products,
withdrawal of the product from the market or voluntary or mandatory product recalls;

●manufacturing delays and supply disruptions where regulatory
inspections identify observations of noncompliance requiring remediation;

●revisions to the labeling, including limitation on approved
uses or the requirement of additional warnings, contraindications or other safety information, including boxed warnings;

●imposition of a Risk Evaluation and Mitigation Strategy (“REMS”),
which may include distribution or use