Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 57

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 57
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 of the patents that are subject to the paragraph IV patent certification notice once
the third-party’s NDA or ANDA is accepted for filing by the FDA. A lawsuit may then be initiated to defend the patents identified
in the notice. The filing of a patent infringement lawsuit within 45 days of the receipt of notice of a paragraph IV patent certification
automatically prevents the FDA from approving the generic NDA or ANDA until the earlier of the expiration of a 30-month period,
the expiration of the patents, the entry of a settlement order stating that the patents are invalid or not infringed, a decision
in the infringement case that is favorable to the NDA or ANDA applicant, or such shorter or longer period as the court may order.
If a patent infringement lawsuit is not initiated within the required 45-day period, the third-party’s NDA or ANDA will not
be subject to the 30-month stay. Third parties may challenge the patents covering our branded products. We may from time to time
become party to litigation or other proceedings as a result of paragraph IV patent certifications.

In addition, we cannot assure you that
all of the potentially relevant prior art information that was or is deemed available to a person of skill in the relevant art
prior to the priority date of the claimed invention-relating to our patents and patent applications has been found. If such prior
art exists, it can invalidate a patent or prevent a patent from issuing from a pending patent application (whether owned by us
or in-licensed from Ligand or another third party), and we may be subject to a third-party pre-issuance submission of prior art
to the USPTO. Even if our patent applications (whether owned by us or in-licensed from Ligand or another third party) do successfully
issue and even if such patents cover our products or potential products, third parties may initiate litigation or opposition, interference,
re-examination, post-grant review, inter partes review, nullification or derivation action in court or before patent offices, or
similar proceedings challenging the validity, enforceability or scope of such patents, which may result in the patent claims being
narrowed or invalidated and may allow third parties to commercialize our products and compete directly with us, without payment
to us, or limit the duration of the patent protection of our technology and products.

In addition, similar to what other companies in our industry have experienced, we expect our competitors and others may have patents or may in the future obtain