Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 28

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 28
---
 regulatory requirements, may
result in revisions to the approved labeling to add new safety information, requirements for post-market studies or clinical trials
to assess new safety risks, or imposition of distribution or other restrictions under a REMS. Other potential consequences include,
among other things:

    ●
    restrictions on
    the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

    ●
    the issuance of
    safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety
    information about the product;

    ●
    fines, warning letters
    or holds on post-approval clinical trials;

    ●
    refusal of the FDA
    to approve applications or supplements to approved applications, or suspension or revocation of product approvals;

    ●
    product seizure
    or detention, or refusal to permit the import or export of products; 

    ●
    injunctions or the
    imposition of civil or criminal penalties; and

    ●
    consent decrees,
    corporate integrity agreements, debarment or exclusion from federal healthcare programs; or mandated modification of promotional
    materials and labeling and issuance of corrective information.

16 

United
States Patent Term Restoration and Marketing Exclusivity

Depending
upon the timing, duration and specifics of FDA approval of future compounds, some of our United States patents may be eligible
for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman
Amendments”). The Hatch-Waxman Amendments permit restoration of the patent term of up to five years as compensation for
patent term lost during the FDA regulatory review process for a drug that has not been previously approved for commercial marketing.
Patent-term restoration, however, cannot extend the remaining term of a patent beyond a total of 14 years from the product’s
approval date and only those claims covering such approved drug product, a method for using it or a method for manufacturing it
may be extended. The patent-term restoration period is generally one-half the time between the effective date of an IND and the
submission date of an NDA plus the time between the submission date of an NDA and the approval of that application, except that
the review period is reduced by any time during which the applicant failed to exercise due diligence. Only one patent applicable
to an approved drug is eligible for the extension and the application for the extension must be submitted prior to the expiration
of the