Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 63

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 63
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    state
    laws comparable to each of the above federal laws, such as, for example, anti-kickback and false claims laws applicable to commercial
    insurers and other non-federal payors, requirements for mandatory corporate regulatory compliance programs, and laws relating to
    patient data privacy and security.

If
our operations are found to be in violation of any such requirements, we may be subject to penalties, including civil or criminal penalties,
monetary damages, the curtailment or restructuring of our operations, loss of eligibility to obtain approvals from the FDA, or exclusion
from participation in government contracting, healthcare reimbursement or other government programs, including Medicare and Medicaid,
any of which could adversely our financial results. Although effective compliance programs can mitigate the risk of investigation and
prosecution for violations of these laws, these risks cannot be entirely eliminated. Any action against us for an alleged or suspected
violation could cause us to incur significant legal expenses and could divert our management’s attention from the operation of
our business, even if our defense is successful. In addition, achieving and sustaining compliance with applicable laws and regulations
may be costly to us in terms of money, time, and resources.

If
we or our collaborators, manufacturers or service providers fail to comply with applicable federal, state, or foreign laws or regulations,
we could be subject to enforcement actions, which could affect our ability to develop, market and sell our products successfully and
could harm our reputation and lead to reduced acceptance of our products by the market. These enforcement actions include, among others:

    ●
    adverse
    regulatory inspection findings;

    ●
    warning
    letters;

    ●
    voluntary
    or mandatory product recalls or public notification or medical product safety alerts to healthcare professionals;

    ●
    restrictions
    on, or prohibitions against, marketing our products;

39

    ●
    restrictions
    on, or prohibitions against, importation or exportation of our products;

    ●
    suspension
    of review or refusal to approve pending applications or supplements to approved applications;

    ●
    exclusion
    from participation in government-funded healthcare programs;

    ●
    exclusion
    from eligibility for the award of government contracts for our products;

    ●
    suspension
    or withdrawal of product approvals;

    ●
    product
    seizures;

    ●
    injunctions;
    and

    ●
    civil
    and criminal penalties and fines.

Any
drugs we develop may become subject