Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 30

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 30
---
 right of reference
to all of the preclinical studies and adequate and well-controlled clinical trials necessary to evaluate maximum tolerated dose
and effectiveness.

Other
Regulatory Matters

Manufacturing,
sales, promotion and other activities of products following product approval, where applicable, or commercialization are also
subject to regulation by numerous regulatory authorities in the United States in addition to the FDA, which may include the Centers
for Medicare & Medicaid Services (“CMS”), other divisions of the U.S. Department of Health and Human Services
(“HHS”), the Department of Justice, the Drug Enforcement Administration, the Consumer Product Safety Commission, the
Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency and state and
local governments and governmental agencies.

17 

Healthcare
Laws

Healthcare
providers, physicians, and third-party payors will play a primary role in the recommendation and prescription of any products
for which we obtain marketing approval. Our business operations and any current or future arrangements with third-party payors,
healthcare providers, and physicians may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations
that may constrain the business or financial arrangements and relationships through which we develop, market, sell and distribute
any drugs for which we obtain marketing approval. In the United States, these laws include federal and state anti-kickback, false
claims, physician transparency, and patient data privacy and security laws and regulations, including those described below.

    ●
    The federal Anti-Kickback
    Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying
    any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind,
    to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any
    good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such
    as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the statute or specific
    intent to violate it in order to have committed a violation. Violations are subject to civil and criminal fines and penalties
    for each violation, plus up to three times the remuneration involved, imprisonment, and exclusion from federal health care
    programs. In addition, the government may assert that a