Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2604

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2604
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, lot consistency and timely availability of raw materials. Even if we obtain marketing approval for any of our current product
candidates or any future product candidates, there is no assurance that our manufacturers will be able to manufacture the approved product
to specifications acceptable to the FDA or other comparable foreign regulatory authorities, to produce it in sufficient quantities to
meet the requirements for the potential commercial launch of the product or to meet potential future demand. If our manufacturers are
unable to produce sufficient quantities for clinical trials or for commercialization, our development and commercialization efforts would
be impaired, which would have an adverse effect on our business, financial condition, results of operations and growth prospects

88

Risks Related to Commercialization

Even
if a product candidate we develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians,
patients, third-party payors and others in the medical community necessary for commercial success.

Even
if a product candidate we develop receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians,
patients, third-party payors, such as Medicare and Medicaid programs and managed care organizations, and others in the medical community.
In addition, the availability of coverage by third-party payors may be affected by existing and future health care reform measures designed
to reduce the cost of health care. If the product candidates we develop do not achieve an adequate level of acceptance, we may not generate
significant product revenues and we may not become profitable.

The
degree of market acceptance of any product candidate, if approved for commercial sale, will depend on a number of factors, including:

    ●
    the
    efficacy and potential advantages compared to alternative treatments;

    ●
    the
    ability to offer our products, if approved, for sale at competitive prices;

    ●
    the
    convenience and ease of administration compared to alternative treatments;

    ●
    the
    willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

    ●
    the
    price we pay or any of our future collaborators charge for our products;

    ●
    the
    recommendations with respect to our product candidates in guidelines published by various scientific organizations applicable to
    us and our product candidates;

    ●
    the
    strength of marketing and distribution support;

    ●
    the
    ability to obtain sufficient third-party coverage and adequate reimbursement;

    ●
    the
    prevalence and severity of any side effects; and

    ●
    The