Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 168

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 168
---
 off -labeluses and a company that is found to have improperly promoted off -labeluses may be subject to significant liability. The federal government has levied large civil and criminal fines against companies for alleged improper promotion of off -labeluse and has enjoined several companies from engaging in off -labelpromotion. Violation of the Federal Food, Drug, and Cosmetic Act and other statutes, including the FCA, and equivalent legislation in other countries relating to the promotion and advertising of prescription products may also lead to investigations or allegations of violations of federal and state and other countries’ health care fraud and abuse laws and state consumer protection laws. 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 89 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 -pocketdrug costs for patients, and increase patient access to lower -costgeneric 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 -sourcedrugs and biologics reimbursed under Medicare Part B and Part D, beginning with ten high -costdrugs 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