Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 365

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 365
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 technology to another third-party and a feasible alternative may not exist. These factors would increase our reliance
on such manufacturer or require us to obtain a license from such manufacturer in order to have another third-party manufacture our
product candidates. If we are required to change manufacturers for any reason, we will be required to verify that the new manufacturer
maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines. We will also
need to verify, such as through a manufacturing comparability or bridging study, that any new manufacturing process will produce our product
candidate according to the specifications previously submitted to the FDA or another regulatory authority. The delays associated with
the verification of a new manufacturer could negatively affect our ability to develop product candidates in a timely manner or within
budget.

To the extent that we enter into future manufacturing arrangements
with third parties, we will depend on these third parties to perform their obligations in a timely manner consistent with contractual
and regulatory requirements, including those related to quality control and assurance. If we are unable to obtain or maintain third-party manufacturing
for product candidates, or to do so on commercially reasonable terms, we may not be able to develop and commercialize our product candidates
successfully. Our or a third-party’s failure to execute on our manufacturing requirements and comply with cGMPs could adversely
affect our business in a number of ways, including:

●an inability to initiate or continue clinical trials of product
candidates under development;

●delay in submitting regulatory applications, or receiving
regulatory approvals, for product candidates;

●loss of the cooperation of an existing or future collaborator;

●subjecting third-party manufacturing facilities or our
manufacturing facilities to additional inspections by regulatory authorities;

66

●requirements to cease distribution or to recall batches of
our product candidates; and

●in the event of approval to market and commercialize a product
candidate, an inability to meet commercial demands for our products.

Changes in methods of product candidate manufacturing or formulation
may result in additional costs or delay.

As product candidates progress through preclinical to late stage clinical
trials to marketing approval and commercialization, it is common that various aspects of the development program, such as manufacturing
methods and formulation, are optimized along the way in an effort to improve yield, manufacturing batch size, minimize costs and achieve
consistent quality and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes
could cause our product candidates to perform