Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 312

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 312
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upon a number of factors, including the third-party payor’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.

In the United States, no uniform policy of coverage and reimbursement
for products exists among third-party payors. As a result, obtaining coverage and reimbursement approval of a product from a government
or other third-party payor is a time-consuming and costly process that could require us to provide to each payor supporting
scientific, clinical and cost-effectiveness data 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-payments that patients find unacceptably high. Additionally, third-party payors
may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of product
candidates, once approved. It is difficult to predict what third-party payors 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 product candidates that may be more profitable or
for which there is a greater likelihood of success.

We have two subsidiaries and expect to have multiple subsidiaries with