Company: OSRH
Filing Date: 2025-01-24
Form Type: S-4/A
Source: 0001213900-25-006139
Chunk: 146

Company: OSR Holdings, Inc.
Filing Date: 2025-01-24
Form: S-4/A
Chunk 146
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 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 programs or comply with any rebate or discount pricing requirements, we may have reimbursement obligations or be subject to penalties or other sanctions. Changes to currently applicable laws and state and federal healthcare reform measures that may be adopted in the future may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used. Because we have multiple programs and product candidates under development and are pursuing a variety of target indications and treatment modalities, we may expend our limited resources to pursue a particular product candidate and fail to capitalize on development opportunities or