Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2545

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2545
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Anti-Kickback Statute makes it illegal for any person or entity, including a prescription drug manufacturer (or a party acting on its
behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration (including any kickback, bribe, or rebate), directly
or indirectly, in cash or in kind, that is intended to induce or reward referrals, including the purchase, recommendation, order or prescription
of a particular drug, for which payment may be made, in whole or in part, under a federal healthcare program, such as Medicare or Medicaid.
Violations of this law are punishable by imprisonment, criminal fines, administrative civil money penalties and exclusion from participation
in federal healthcare programs. In addition, a person or entity does not need to have actual knowledge 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