Company: OSRH
Filing Date: 2025-01-29
Form Type: S-4/A
Source: 0001213900-25-007923
Chunk: 147

Company: OSR Holdings, Inc.
Filing Date: 2025-01-29
Form: S-4/A
Chunk 147
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 the Veterans Administration, managed care providers, private health insurers, and other organizations. Patients who are provided medical treatment for their conditions generally rely on third -partypayors to reimburse all or part of the costs associated with their treatment. Coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors are critical to new product acceptance. Patients are unlikely to use our product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost. We cannot be sure that coverage and reimbursement will be available for, or accurately estimate the potential revenue from, our product candidates or assure that coverage and reimbursement will be available for any product that we may develop. Government authorities and other third -partypayors decide which drugs and treatments they will cover and the amount of reimbursement. Coverage and reimbursement by a third -partypayor may depend upon a number of factors, including the third -partypayor’s determination that use of a product is: •a covered benefit under its health plan; •safe, effective and medically necessary; •appropriate for the specific patient; •cost -effective; and •neither experimental nor investigational. 75 In the United States, no uniform policy of coverage and reimbursement for products exists among third -partypayors. As a result, obtaining coverage and reimbursement approval of a product from a government or other third -partypayor is a time -consumingand costly process that could require us to provide to each payor supporting scientific, clinical and cost -effectivenessdata for the use of our products, with no assurance that coverage and adequate reimbursement will be obtained. Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co -paymentsthat patients find unacceptably high. Additionally, third -partypayors may not cover, or provide adequate reimbursement for, long -termfollow -upevaluations required following the use of product candidates, once approved. It is difficult to predict what third -partypayors will decide with respect to the coverage and reimbursement for our product candidates, if approved. Additionally, our ability to obtain and maintain coverage for our products by certain government health care programs may depend on our participation in certain government pricing programs, such as the Medicaid Drug Rebate Program and the 340B program. These programs often include complex reporting and payment obligations, which are subject to frequent change. If we fail to provide timely and accurate information under these