Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 69

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 69
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 financial arrangements. Such restrictions under applicable federal and state healthcare laws and
regulations, include the following:

    ●
    the federal Anti-Kickback Statute, which prohibits, among other things,
    persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback,
    bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the
    purchase, lease or order of, any good or service, for which payment may be made, in whole or in part, under a federal healthcare
    program such as Medicare and Medicaid;

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    ●
    the federal civil and criminal false claims laws, including the civil
    False Claims Act, and civil monetary penalties laws, which prohibit individuals or entities from, among other things, knowingly presenting,
    or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement
    to avoid, decrease or conceal an obligation to pay money to the federal government;

    ●
    the federal Health Insurance Portability and Accountability Act of
    1996, which created additional federal criminal laws that prohibit, among other things, knowingly and willingly executing, or attempting
    to execute, a scheme or making false statements in connection with the delivery of or payment for health care benefits, items, or
    services;

    ●
    HIPAA, as amended by the Health Information Technology for Economic
    and Clinical Health Act and its implementing regulations, which also imposes obligations, including mandatory contractual terms,
    with respect to safeguarding the privacy, security and transmission of individually identifiable health information on covered entities
    and their business associates that associates that perform certain functions or activities that involve the use or disclosure of
    protected health information on their behalf;

    ●
    the federal transparency requirements known as the federal Physician
    Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation
    Act (collectively the “ACA”), which requires 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 Centers for Medicare & Medicaid Services (“CMS”), within the U.S. Department of Health
    and Human Services, information related to payments and other transfers of value to physicians and teaching hospitals and