Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 446

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 446
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 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. 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 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. 280 The failure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension or debarment from government contracting. The SEC also may suspend or bar issuers from trading securities on United States exchanges for violations of the FCPA’s accounting provisions. Coverage and Reimbursement Successful commercialization of new drug products depends, in part, on the extent to which reimbursement for those drug products will be available from government health administration authorities, private health insurers, and other organizations. Government authorities and third -partypayors, such as private health insurers and health maintenance organizations, decide which drug products they will pay for and establish reimbursement levels. The availability and extent of reimbursement by governmental and private payors is essential for most patients to be able to afford a drug product. Sales of drug products depend substantially, both domestically and abroad, on the extent to which the costs of drugs products are paid for by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers and other third -partypayors. A primary trend in the United States healthcare industry and elsewhere is cost containment. Government authorities and third -partypayors have attempted to control costs by limiting coverage and the amount of reimbursement for particular drug products. For example, in order to have our products covered by Medicaid, we must offer rebates to state Medicaid programs on purchases of certain of our pharmaceutical products under the Medicaid Drug Rebate program, based on pricing data reported by us on a monthly and quarterly basis. Any company that participates in the Medicaid Drug Rebate program also must participate in the 340B drug pricing program, and the Federal Supply Schedule (“ FSS”) pricing program. The 340B program, which is administered by the Health Resources and Services