Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2122

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2122
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 preclinical testing, as well as for clinical testing and commercial manufacturing if
our product candidates receive marketing approval.

Our
product candidates include small molecules, vaccines, and monoclonal and bispecific antibodies. Several contract manufacturing facilities
exist that have expertise in each product type and we anticipate that our product candidates can be produced by them at scale and in
a cost-effective manner. As needed, we also expect to rely on CMOs for the manufacturing of companion diagnostics, which are assays or
tests to identify an appropriate patient population. Depending on the technology solutions we choose, we may rely on multiple third parties
to manufacture and sell a single test.

Commercialization

We
will objectively assess and choose each program’s commercialization option that maximizes potential value for patients and for
our shareholders. We anticipate optimizing its commercial value through various options, including internal advancement, partnerships
with established companies, and spin-outs or IPOs. If we opt to commercialize a particular candidate ourselves, we anticipate assembling
a focused sales and marketing organization to sell our products. We will aim for such organization to address the community of relevant
medical practitioners who are the key specialists in treating the patient populations for which our product candidates are being developed.
We may also enter into distribution and other marketing arrangements with third parties for any of our product candidates that obtain
marketing approval.

We
also plan to build a marketing and sales management organization to create and implement marketing strategies for any products that we
market through our own sales organization and to oversee and support our sales force. The responsibilities of the marketing organization
would include developing educational initiatives with respect to approved products and establishing relationships with researchers and
practitioners in relevant fields of medicine.

47

Government
Regulation

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