Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2540

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2540
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 uses may be subject to significant liability, including investigation by federal and state authorities. Prescription drug promotional
materials must be submitted to the FDA in conjunction with their first use or first publication.

53

Further,
if there are any modifications to the drug or biologic, including changes in indications, labeling or manufacturing processes or facilities,
the applicant may be required to submit and obtain FDA approval of a new NDA/BLA or NDA/BLA supplement, which may require the development
of additional data or preclinical studies and clinical trials. The FDA may also place other conditions on approvals including the requirement
for a REMS, to assure the safe use of the product. If the FDA concludes a REMS is needed, the sponsor of the NDA or BLA must submit a
proposed REMS. The FDA will not approve the NDA or BLA without an approved REMS, if required. A REMS could include medication guides,
physician communication plans or elements to assure safe use, such as restricted distribution methods, patient registries and other risk
minimization tools. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription
or dispensing of products. Product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following
initial marketing.

FDA
regulations require that products be manufactured in specific approved facilities and in accordance with cGMP regulations. We rely, and
expect to continue to rely, on third parties for the production of clinical and commercial quantities of our products in accordance with
cGMP regulations. These manufacturers must comply with cGMP regulations that require, among other things, quality control and quality
assurance, the maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP. Manufacturers
and other entities involved in the manufacture and distribution of approved drugs or biologics are required to register their establishments
with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for
compliance with cGMP requirements and other laws. Accordingly, manufacturers must continue to expend time, money and effort in the area
of production and quality control to maintain cGMP compliance. The discovery of violative conditions, including failure to conform to
cGMP regulations, could result in enforcement actions, and the discovery of problems with a product after approval may result in restrictions
on a product, manufacturer or holder of an approved NDA or BLA, including recall