Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 272

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 272
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, that require certain manufacturers of drugs, devices, biologics
    and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program,
    with specific exceptions, to report annually to the CMS information related to: (i) payments or other “transfers of
    value” made to physicians and teaching hospitals and (ii) ownership and investment interests held by physicians and
    their immediate family members;

48 

    ●
    state and foreign
    law equivalents of each of the above federal laws, state laws that require drug manufacturers to report information related
    to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and state
    laws governing the privacy and security of health information in certain circumstances, many of which differ from each other
    in significant ways and may not have the same effect, thus complicating compliance efforts in certain circumstances, such
    as specific disease states; and

    ●
    state and foreign
    laws that govern the privacy and security of health information in some circumstances, many of which differ from each other
    in significant ways and often are not enrollment by HIPAA, thus complicating compliance efforts.

Because
of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some
of our business activities could be subject to challenge under one or more of such laws. If our operations are found to be in
violation of any of the laws described above or any other government regulations that apply to us, we may be subject to penalties,
including civil and criminal penalties, damages, fines, exclusion from participation in government health care programs, such
as Medicare and Medicaid, imprisonment and the curtailment or restructuring of our operations, any of which could adversely affect
our ability to operate our business and our results of operations.

Efforts
to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve
substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with
current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us,
we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion of products
from government funded healthcare programs, such as Medicare and Medicaid, and the curtailment