Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 337

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 337
---
 Even if it is later determined
we were not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending our actions and
have to divert significant management resources from other matters. If we cannot successfully manage the promotion of our product candidates,
if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition.

The Affordable Care Act and the Inflation Reduction Act, as well
as other ongoing healthcare legislative and regulatory reform measures, may have a material adverse effect on our business and results
of operations.

Congress and regulatory agencies in the United States (and to
a lesser extent, state legislatures) have in recent years proposed and sometimes adopted substantial changes in laws and regulations
that affect the healthcare and pharmaceutical industry. These laws, including what is known as the Affordable Care Act (the “ACA”),
and the IRA, have substantially changed the way health care is financed by both governmental and private insurers, and significantly impacted
the U.S. biopharmaceutical industry, including permitting the Centers for Medicare and Medicaid Services (the “CMS”),
for the first time, to negotiate prices with pharmaceutical companies for selected drugs.

Many legislative and regulatory proposals have sought to reduce drug
prices, increase competition, lower out-of-pocket drug costs for patients, and increase patient access to lower-cost generic
and biosimilar drugs. These legislature and regulatory changes may significantly adversely impact our business and profitability.

The IRA was passed on August 16, 2022 and, among other things,
allows for CMS to negotiate prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D,
beginning with ten high-cost drugs paid for by Medicare Part D starting in 2026, followed by up to 15 Part D drugs in
2027, up to 15 Part B or Part D drugs in 2028, and up to 20 Part B or Part D drugs in 2029 and beyond. The legislation
subjects drug manufacturers to civil monetary penalties and a potential excise tax for failing to comply with the legislation by offering
a price that is not equal to or less than the negotiated “maximum fair price” under the law or for taking price increases
that exceed inflation. The legislation also caps Medicare beneficiaries’ annual out-of-pocket drug expenses at $2,000. The
effect of the IRA on our business and the healthcare industry in general is