Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3439

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3439
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, purity, or potency to assess whether the licensure of the new product is a first licensure that triggers
its own period of exclusivity. Whether a subsequent application, if approved, warrants exclusivity as the “first licensure”
of a biological product is determined on a case-by-case basis with data submitted by the sponsor.

Other
Regulatory Matters

Manufacturing,
sales, promotion and other activities following product approval are also subject to regulation by numerous regulatory authorities in
the United States in addition to the FDA, including the Centers for Medicare & Medicaid Services, or CMS, the Office of Inspector
General and the Office for Civil Rights, as well as other divisions of the U.S. Department of Health & Human Services, the Department
of Justice, the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational
Safety & Health Administration, the Environmental Protection Agency and state and local governments.

Other
Healthcare Laws in the United States

Healthcare
providers, and third party payors will play a primary role in the recommendation and prescription of any products for which we obtain
marketing approval. Our current and future arrangements with healthcare providers and physicians and any future arrangements with third
party payers, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business
or financial arrangements and relationships through which we market, sell and distribute any drugs for which we obtain marketing approval.
In the United States, these laws include: the federal Anti-Kickback Statute, the False Claims Act, and the federal Health Insurance Portability
and Accountability Act, or HIPPA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH. The
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