Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2647

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2647
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 approval or the frequency with which any such product candidate is prescribed or used.

Our
relationships with healthcare providers and physicians and third-party payors will be subject to applicable anti-kickback, fraud and
abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational
harm and diminished profits and future earnings.

Healthcare
providers, physicians and third-party payors in the United States and elsewhere play a primary role in the recommendation and prescription
of biopharmaceutical products. Arrangements with third-party payors, health care providers and customers can expose biopharmaceutical
manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal
Anti-Kickback Statute, 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