Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 44

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 44
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 requirements
can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties.
Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from
those tested by us and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe that such
off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians
in their choice of treatments. The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of
their products.

Other Healthcare Laws and Compliance Requirements

Our sales, promotion, medical
education, clinical research and other activities following product approval will be subject to regulation by numerous regulatory and
law enforcement authorities in the United States in addition to FDA, including potentially the Federal Trade Commission, the Department
of Justice, the Centers for Medicare and Medicaid Services, or CMS, other divisions of the U.S. Department of Health and Human Services
and state and local governments. Our promotional and scientific/educational programs must comply with the federal Anti-Kickback Statute,
the civil False Claims Act, physician payment transparency laws, privacy laws, security laws, and additional federal and state laws similar
to the foregoing.

The federal Anti-Kickback
Statute prohibits, among other things, the knowing and willing, direct or indirect offer, receipt, solicitation or payment of remuneration
in exchange for or to induce the referral of patients, including the purchase, order or lease of any good, facility, item or service that
would be paid for in whole or part by Medicare, Medicaid or other federal health care programs. Remuneration has been broadly defined
to include anything of value, including cash, improper discounts, and free or reduced-price items and services. The federal Anti-Kickback
Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, formulary
managers, and beneficiaries on the other. Although there are a number of statutory exceptions and regulatory safe harbors protecting some
common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Practices that involve remuneration that may be
alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception
or safe harbor. Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does
not make