Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2541

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2541
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Once
an approval is granted, the FDA may issue enforcement letters or withdraw the approval of the product if compliance with regulatory requirements
and standards is not maintained or if problems occur after the drug or biologic reaches the market. Corrective action could delay drug
or biologic distribution and require significant time and financial expenditures. Later discovery of previously unknown problems with
a drug or biologic, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply
with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market
studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a REMS program. Other
potential consequences include, among other things:

    ●
    restrictions
    on the marketing or manufacturing of the drug or biologic, suspension of the approval, complete withdrawal of the drug from the market
    or product recalls;

    ●
    fines,
    warning letters, untitled letters or holds on post-approval clinical trials;

    ●
    refusal
    of the FDA to approve applications or supplements to approved applications, or suspension or revocation of drug or biologic approvals;

    ●
    safety
    alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information
    about the product;

    ●
    mandated
    modification of promotional materials and labeling and issuance of corrective information;

    ●
    drug
    or biologic seizure or detention, or refusal to permit the import or export of products;

    ●
    consent
    decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs; or

    ●
    injunctions
    or the imposition of civil or criminal penalties.

54

United
States Patent Term Restoration and Marketing Exclusivity

Depending
upon the timing, duration and specifics of FDA approval of our future product candidates, some of our United States patents may be eligible
for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the
Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit restoration of the patent term of up to five years as compensation for patent
term lost during the FDA regulatory review process. Patent-term restoration, however, cannot extend the remaining term of a patent beyond
a total of 14 years from the product’s approval date and only those claims covering such approved drug product, a method for