Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 37

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 37
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 Services
Administration, additional laws and requirements apply. Products must meet applicable child-resistant packaging requirements under
the U.S. Poison Prevention Packaging Act. Manufacturing, labeling, packaging, distribution, sales, promotion and other activities
also are potentially subject to federal and state consumer protection and unfair competition laws, among other requirements to
which we may be subject. The distribution of pharmaceutical products is subject to additional requirements and regulations, including
extensive recordkeeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical
products, and state licensure.

The
failure to comply with any of these laws or regulatory requirements may subject firms to legal or regulatory action. Depending
on the circumstances, failure to meet applicable regulatory requirements can result in criminal prosecution, fines or other penalties,
injunctions, exclusion from federal healthcare programs, requests for recall, seizure of products, total or partial suspension
of production, denial or withdrawal of product approvals, relabeling or repackaging, or refusal to allow a firm to enter into
supply contracts, including government contracts. Any claim or action against us for violation of these laws, even if we successfully
defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation
of our business. Prohibitions or restrictions on marketing, sales or withdrawal of future products marketed by us could materially
affect our business in an adverse way.

Changes
in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for
example: (1) changes to our manufacturing arrangements; (2) additions or modifications to product labeling or packaging; (3) the
recall or discontinuation of our products; or (4) additional recordkeeping requirements. If any such changes were to be imposed,
they could adversely affect the operation of our business.

21 

Government
Regulation of Drugs Outside of the United States

To
market any product outside of the United States, we would need to comply with numerous and varying regulatory requirements of
other countries regarding safety and efficacy and governing, among other things, clinical trials, marketing authorization, manufacturing,
commercial sales and distribution of our products. These regulatory requirements may be similarly complex and even more stringent
in certain regards than those described above. If we fail to comply with applicable regulatory requirements in the jurisdiction
where we conduct clinical trials or seek regulatory approvals, we may be subject to, among other things, fines, suspension or
withdrawal of regulatory approvals, product recalls, seizure