Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2140

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2140
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 of the statute or specific intent
to violate it. Moreover, the Patient Protection and Affordable Care Act, as amended by the Healthcare and Education Reconciliation Act
of 2010, or collectively the ACA provides that 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 federal civil False Claims Act.

Although
we would not submit claims directly to payors, drug manufacturers can be held liable under the federal civil False Claims Act, which
imposes civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities (including manufacturers)
for, among other things, knowingly presenting, or causing to be presented to federal programs (including Medicare and Medicaid) claims
for items or services, including drugs, that are false or fraudulent, claims for items or services not provided as claimed, or claims
for medically unnecessary items or services. Penalties for a False Claims Act violation include three times the actual damages sustained
by the government, plus mandatory civil penalties for each separate false claim, the potential for exclusion from participation in federal
healthcare programs and, although the federal False Claims Act is a civil statute, conduct that results in a False Claims Act violation
may also implicate various federal criminal statutes. The government may deem manufacturers to have “caused” the submission
of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting a product
off-label. Our operations, including the future marketing and activities relating to the reporting of wholesaler or estimated retail
prices for our products, if approved, the reporting of prices used to calculate Medicaid rebate information and other information affecting
federal, state and third-party reimbursement for our products, and the sale and marketing of our product candidates, are subject to scrutiny
under this law.

56

HIPAA
created new federal criminal statutes that prohibit among other things, knowingly and willfully executing, or attempting to execute,
a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any money or property owned
by, or under the control or custody of, any healthcare benefit program, including private third party payors, knowingly and willfully
embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and
knowingly and willfully falsifying, concealing or covering up by trick, scheme or device, a material fact