Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2544

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2544
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 licensure of (and a new period of exclusivity is not available for) a biological product if the licensure
is for a supplement for the biological product or for a subsequent application by the same sponsor or manufacturer of the biological
product (or licensor, predecessor in interest, or other related entity) for a change (not including a modification to the structure of
the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery
device or strength, or for a modification to the structure of the biological product that does not result in a change in safety, purity,
or potency. Therefore, one must determine whether a new product includes a modification to the structure of a previously licensed product
that results in a change in safety, 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