Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2242

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2242
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, or AKS, and the federal False Claims Act, or FCA, which may constrain the business or financial arrangements and
relationships through which such companies sell, market and distribute biopharmaceutical products. In particular, the research of our
product candidates, as well as the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements
in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices.
These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s),
certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper
use of information obtained in the course of patient recruitment for clinical trials. The applicable federal, state and foreign healthcare
laws and regulations laws that may affect our ability to operate include, but are not limited to:

    ●
    the
    federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying
    any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to
    induce or reward, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any
    good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the
    Medicare and Medicaid programs. A person or entity can be found guilty of violating the statute without actual knowledge of the statute
    or specific intent to violate it. In addition, a claim submitted for payment to any federal health care program that includes items
    or services that were made as a result of a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim
    for purposes of the FCA. The Anti-Kickback Statute has been interpreted to apply to arrangements between biopharmaceutical manufacturers
    on the one hand and prescribers, purchasers, and formulary managers, among others, on the other. There are a number of statutory
    exceptions and regulatory safe harbors protecting some common activities from prosecution;

111

    ●
    the
    federal civil and criminal false claims laws, including the FCA, and civil monetary penalty laws which prohibit, among other things,
    individuals or entities