Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 349

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 349
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 EU and other companies have adopted legislation or regulations
that, much like the U.S. AKS, restricts the provision of benefits or advantages to physicians to induce or encourage the prescription,
recommendation, endorsement, purchase, supply, order or use of medicinal products. Violations of these laws could result in substantial
fines and imprisonment. Failure to comply with these requirements could also result in reputational risk, public reprimands, administrative
penalties, fines or imprisonment.

We may incur substantial costs in our efforts to comply with
evolving global data protection laws and regulations, and any failure or perceived failure by us to comply with such laws and regulations
may harm our business and operations.

The global data protection landscape is rapidly evolving, and we may
be or become subject to or affected by numerous federal, state and foreign laws and regulations, as well as regulatory guidance, governing
the collection, use, disclosure, transfer, security and processing of personal data, such as information that we collect 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