Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 45

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 45
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 the conduct per se illegal under the federal Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated
on a case-by-case basis based on a cumulative review of all its facts and circumstances. Several courts have interpreted the statute’s
intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare
covered business, the federal Anti-Kickback Statute has been violated. The government has enforced the federal Anti-Kickback Statute to
reach large settlements with healthcare companies based on sham research or consulting and other financial arrangements with physicians.
Further, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a
violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback
Statute constitutes a false or fraudulent claim for purposes of the False Claims Act. Many states have similar laws that apply to their
state health care programs as well as private payors.

26

Federal false claims and false
statement laws, including the federal civil False Claims Act, or FCA, imposes liability on persons or entities that, among other things,
knowingly present or cause to be presented claims that are false or fraudulent or not provided as claimed for payment or approval by a
federal health care program. The FCA has been used to prosecute persons or entities that “cause” the submission of claims
for payment that are inaccurate or fraudulent, by, for example, providing inaccurate billing or coding information to customers, promoting
a product off-label, submitting claims for services not provided as claimed, or submitting claims for services that were provided but
not medically necessary. Actions under the FCA may be brought by the Attorney General or as a qui tam action by a private individual in
the name of the government. Violations of the FCA can result in significant monetary penalties and treble damages. The federal government
is using the FCA, and the accompanying threat of significant liability, in its investigation and prosecution of pharmaceutical and biotechnology
companies throughout the country, for example, in connection with the promotion of products for unapproved uses and other illegal sales
and marketing practices. The government has obtained multi-million and multibillion dollar settlements under the FCA in addition to individual
criminal convictions under applicable criminal statutes. In addition, certain companies that were found to be in violation of the FCA
have been forced to implement extensive corrective