Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2528

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2528
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Government
authorities in the United States at the federal, state and local level and in other countries regulate, among other things, the research,
development, manufacture, testing, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution,
post-approval monitoring and reporting, marketing and export and import of drug and biological products, as well as diagnostics. Generally,
before a new drug, biologic or diagnostic can be marketed, considerable data demonstrating its quality, safety and efficacy must be obtained,
organized into a format specific for each regulatory authority, submitted for review and approved, authorized, or cleared by the applicable
regulatory authority.

United
States Government Regulation of Drug and Biological Products

In
the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FD&C Act, and its implementing regulations
and biologics under the FD&C Act and the Public Health Service Act, or PHSA, and their implementing regulations. Both drugs and biologics
also are subject to other federal, state and local statutes and regulations, such as those related to competition. The process of obtaining
regulatory approvals and the subsequent compliance with appropriate federal, state, and local statutes and regulations requires the expenditure
of substantial time and financial resources. Failure to comply with the applicable United States requirements at any time during the
product development process, approval process or following approval may subject an applicant to administrative actions or judicial sanctions.
These actions and sanctions could include, among other actions, the FDA’s refusal to approve pending applications, withdrawal of
an approval, license revocation, a clinical hold, untitled or warning letters, voluntary or mandatory product recalls or market withdrawals,
product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution,
disgorgement and civil or criminal fines or penalties. Any agency or judicial enforcement action could have a material adverse effect
on our business, the market acceptance of our products and our reputation.

Our
product candidates must be approved by the FDA through either an NDA or a BLA before they may be legally marketed in the United States.
The process generally involves the following:

    ●
    completion
    of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with GLP requirements;

    ●
    submission
    to the FDA of an IND application, which must become effective before human clinical trials may begin;

    ●
    approval