Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 56

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 56
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 control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing or otherwise violating the licensor’s rights. In addition, certain of our agreements with third parties may provide that intellectual property arising under these agreements, such as data that could be valuable to our business, will be owned by the third party, in which case, we may not have adequate rights to use such data or have exclusivity with respect to the use of such data, which could result in third parties, including our competitors, being able to use such data to compete with us.

Third party intellectual property may prevent us from developing our potential products; our intellectual property may not prevent competition; and any intellectual property issues may be expensive and time consuming to resolve.

The manufacture, use or sale of our potential products may infringe the patent rights of others. If others obtain patents with conflicting claims, we may be required to obtain licenses to those patents or to develop or obtain alternative technology. We may not be able to obtain any such licenses on acceptable terms, or at all. Any failure to obtain such licenses could delay or prevent us from pursuing the development or commercialization of our potential products, platform and technology.

Generally, our success will depend on our and our licensors’ ability to obtain and maintain patents and other intellectual property rights for our potential products and technologies. our patent position is uncertain and involves complex legal and technical questions for which legal principles are unresolved. Even if we do obtain patents, such patents may not adequately protect the technology we own or have licensed.

The patents that cover our branded products
are listed in the Orange Book. If a third party submits a NDA or ANDA for a generic drug product that relies in whole or in part
on studies contained in the NDA for one of our branded products, the third party will have the option to certify to the FDA that,
in the opinion of that third party, the patents listed in the Orange Book for our branded product are invalid, unenforceable, or
will not be infringed by the manufacture, use or sale of the third party’s generic drug product. A third-party certification
that a new product will not infringe Orange Book-listed patents, or that such patents are invalid, is called a paragraph IV patent
certification. If the third party submits a paragraph IV patent certification to the FDA, a notice of the paragraph IV patent certification
must be sent to the NDA owner and the owner