Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 375

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 375
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 use of the product, or a method of manufacturing the product. However, the applicable authorities, including the
FDA and the USPTO in the United States, and any equivalent regulatory authority in other countries, may refuse to grant extensions
to our patents, or may grant more limited extensions than we request. We may not be granted an extension because of, for example, failing
to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable
requirements. Moreover, the applicable time-period or the scope of patent protection afforded could be less than we request. Even
if we are able to obtain an extension, the patent term may still expire before or shortly after we receive FDA marketing approval.

If we are unable to extend the expiration date of our existing patents
or obtain new patents with longer expiry dates, our competitors may be able to take advantage of our investment in development and clinical
trials by referencing our clinical and pre-clinical data to obtain approval of competing product candidates following our patent
expiration and launch their product earlier than might otherwise be the case.

Obtaining and maintaining our patent protection depends on compliance
with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent
protection could be reduced or eliminated as a result of non-compliance with these requirements.

Periodic maintenance fees on any issued patent are due to be paid to
the USPTO and other patent agencies in other jurisdictions in several stages over the lifetime of the patent. The USPTO and various national
or international patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions
during the patent application process. In certain circumstances, we rely on our licensing partners to pay these fees due to U.S. and non-U.S. patent
agencies and to take the necessary action to comply with these requirements with respect to our licensed intellectual property. While
an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there
are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or
complete loss of patent rights in the relevant jurisdiction(s). Non-compliance events that could result in abandonment or lapse
of patent rights include, but are not limited to, failure to timely file national and regional stage patent applications based on our
international patent applications