Company: PTHS
Filing Date: 2025-05-09
Form Type: PREM14C
Source: 0001140361-25-018219
Chunk: 326

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-09
Form: PREM14C
Chunk 326
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 allow a firm to enter into supply contracts, including government contracts. Any claim or action against Channel for violation of these laws, even if Channel successfully defends against it, could cause it to incur significant legal expenses and divert its management’s attention from the operation of its business. Prohibitions or restrictions on marketing, sales or withdrawal of future products marketed by Channel could materially affect its business in an adverse way.

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

**Government Regulation of Drugs Outside of the United States**

To market any product outside of the United States, Channel 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 its products. These regulatory requirements may be similarly complex and even more stringent in certain regards than those described above. If Channel fails to comply with applicable regulatory requirements in the jurisdiction where Channel conducts clinical trials or seek regulatory approvals, Channel may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

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For instance, in the European Economic Area (the “EEA”) (comprising the 27 European Union member states plus Iceland, Liechtenstein and Norway), medicinal products must be authorized for marketing by using either the centralized authorization procedure or national authorization procedures.

| • | Centralized procedure—The centralized procedure provides for the grant of a single marketing authorization by the European Commission that is valid throughout the EEA. Pursuant to Regulation (EC) No. 726/2004, the centralized procedure is compulsory for specific products, including for medicines produced by certain biotechnological processes, products designated as orphan medicinal products, advanced therapy products (gene therapy, somatic cell therapy and tissue engineered products) and products with a new active substance indicated for the treatment of certain diseases, which includes products for the treatment of cancer. For medicines that do not fall within one of the mandatory categories, an applicant still has the option of submitting an application for a centralized marketing authorization to the European