Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 112

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 112
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 about participants
and healthcare providers (including information relating to their representatives) in connection with clinical trials. Processing of personal
data, including health related information, is increasingly subject to legislation and regulations in numerous jurisdictions around the
world, including General Data Protection Regulation (“GDPR”) and each of the California Consumer Privacy Act of 2018
and HIPAA in the United States, among many others. The application and enforcement of data protection laws and regulations
may create uncertainty in our business, affect our or our service providers’ ability to operate in certain jurisdictions or to collect,
store, transfer use and share personal data, result in liability or impose additional compliance or other costs on us. Any failure or
perceived failure by us to comply with federal, state, or foreign laws or self-regulatory standards could result in negative publicity,
diversion of management time and effort and proceedings against us by governmental entities or others, including potential significant
penalties. We expect the data protection laws will increase our compliance costs and potential liability.

58

Additional laws and regulations governing international operations
could negatively impact or restrict our operations.

We must dedicate additional resources to comply with numerous laws
and regulations in each jurisdiction in which we plan to operate. The U.S. Foreign Corrupt Practices Act (“FCPA”)
prohibits any U.S. individual or business entity from paying, offering, authorizing payment or offering of anything of value, directly
or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign
entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities
are listed in the United States to comply with certain accounting provisions requiring the company to maintain books and records
that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain
an adequate system of internal accounting controls for international operations.

Compliance with the FCPA is expensive and difficult, particularly in
countries in which corruption is a recognized problem. In addition, the FCPA presents particular challenges in the pharmaceutical industry,
because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign
officials. Certain payments to hospitals and healthcare providers in connection with clinical trials and other work have been deemed to
be improper payments to government officials and have led to FCPA enforcement actions.

Apart from the FCPA, we are