Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 279

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 279
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 certain developing countries, do not favor the
enforcement of patents, trade secrets and other intellectual property protections, particularly those relating to biotechnology
products and those of foreign entities. Such challenges in enforcing rights in these countries could make it difficult for us
to stop the infringement of our patents, if pursued and obtained, or marketing of competing products in violation of our proprietary
rights generally. Proceedings to enforce our current and future patent rights in foreign jurisdictions could result in substantial
costs and may divert our efforts and attention from other aspects of our business; could put our asserted patents at risk of being
invalidated or interpreted narrowly; could put any future patent applications, including continuation and divisional applications,
at risk of not issuing; and could provoke third parties to assert their own patent claims against us or to attack the validity
of our other patents. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any,
may not be commercially meaningful. Accordingly, our efforts to enforce any intellectual property rights around the world stemming
from intellectual property that we develop may be inadequate to obtain a significant commercial advantage in these foreign jurisdictions.

52 

Third
parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which
would be uncertain and could have a material adverse effect on the success of our business. 

Our
commercial success depends upon our ability (and the ability of any potential future collaborators) to develop, manufacture, market
and sell CC8464, CT2000, CT3000 and future new compounds, and to freely use our proprietary technologies (e.g., without
infringing the intellectual property rights of others). Many companies and institutions have filed, and continue to file, patent
applications related to various aspects of pain management and opioid sparing technology. Because patent applications can take
many years to issue, may be confidential for 18 months or more after filing, and can be revised before and after issuance, there
may be issued patents and patent applications now pending which may later result in issued patents that third-party asserts are
infringed by the manufacture, use, sale, or importation of our products. The biotechnology and pharmaceutical industries are characterized
by extensive and complex litigation regarding patents and other intellectual property rights. Our competitors or other third parties
may assert infringement claims against us, alleging that our therapeutics, manufacturing methods, formulations or administration
methods are covered by their patents. Moreover, we may face patent infringement claims from non