Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2136

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2136
---
 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 using
it or a method for manufacturing it may be extended. The patent-term restoration period is generally one-half the time between the effective
date of an IND and the submission date of an NDA or BLA plus the time between the submission date of an NDA or BLA and the approval of
that application, except that the review period is reduced by any time during which the applicant failed to exercise due diligence. Only
one patent applicable to an approved drug is eligible for the extension and the application for the extension must be submitted prior
to the expiration of the patent. The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension
or restoration. In the future, we may apply for restoration of patent term for our currently owned or licensed