Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 330

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 330
---
pages and disruptions in delivery systems;

●limitations on employee resources that would otherwise be focused
on the conduct of our preclinical studies and clinical trials, including because of sickness of employees or their families or the desire
of employees to avoid contact with large groups of people;

●interruption or delays to outsourced research and discovery
and clinical activities;

●delays in receiving authorizations from regulatory authorities
to initiate our planned clinical trials;

●delays or difficulties in commencing enrollment of patients
in our clinical trials, enrolling and retaining patients in our clinical trials in adequate numbers and difficulties in clinical site
initiation, including difficulties in recruiting clinical site investigators and clinical site staff;

●diversion of healthcare resources away from the conduct of clinical
trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical
trials;

●interruption of key clinical trial activities, such as clinical
trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others
or interruption of clinical trial participant visits and study procedures that are deemed nonessential, which may impact the integrity
of participant data and clinical trial endpoints; and

●interruption or delays in the operations of the FDA, European
Medicines Agency or other regulatory authorities, which may impact review and approval timelines.

48

The extent to which an outbreak impacts our business will depend on
future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of any
disease, the duration of any pandemic, travel restrictions and social distancing in the United States and other countries, business
closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat
the disease.

Shareholder litigation and regulatory inquiries and investigations
are expensive and could harm the Company’s business, financial condition and operating results and could divert management attention.

Since securities class action litigation and/or stockholder derivative
litigation and inquiries or investigations by regulatory authorities often follows significant business transactions, such as the sale
of a company or announcement of any other strategic transaction, such as the Business Combination, we may become subject to those types
of lawsuits or investigations. Shareholder activism, which could take many forms or arise in a variety of situations, has been increasing
recently. Any stockholder litigation, stockholder activism, including potential proxy contests, and/or regulatory investigations against
the Company, whether