Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2241

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2241
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 amount of reimbursement. Coverage
and reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that
use of a product is:

    ●
    a
    covered benefit under its health plan;

    ●
    safe,
    effective and medically necessary;

    ●
    appropriate
    for the specific patient;

    ●
    cost-effective;
    and

    ●
    neither
    experimental nor investigational.

In
the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. As a result, obtaining
coverage and reimbursement approval of a product from a government or other third-party payor is a time-consuming and costly process
that could require us to provide to each payor supporting scientific, clinical and cost-effectiveness data for the use of our products
on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained. Even if we obtain coverage for
a given product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require
co-payments that patients find unacceptably high. Additionally, third-party payors may not cover, or provide adequate reimbursement for,
long-term follow-up evaluations required following the use of product candidates, once approved. It is difficult to predict what third-party
payors will decide with respect to the coverage and reimbursement for our product candidates, if approved.

Changes
to currently applicable laws and state and federal healthcare reform measures that may be adopted in the future may result in additional
reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any product candidates for which
we may obtain regulatory 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