Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2651

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2651
---
 exclusions from government funded healthcare
programs. Any action for violation of these laws, even if successfully defended, could cause a biopharmaceutical manufacturer to incur
significant legal expenses and divert management’s attention from the operation of the business. Prohibitions or restrictions on
sales or withdrawal of future marketed products could materially affect business in an adverse way.

Even
if we receive regulatory approval of any product candidates, we will be subject to ongoing regulatory obligations and continued regulatory
review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements
or experience unanticipated problems with our product candidates.

If
any of our product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging,
storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, efficacy and other
post-market information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory
authorities. In addition, we will be subject to continued compliance with cGMP and GCP requirements for any clinical trials that we conduct
post-approval.

Manufacturers
and their facilities are required to comply with extensive FDA and comparable foreign regulatory authority requirements, including ensuring
that quality control and manufacturing procedures conform to cGMP regulations. As such, we and our contract manufacturers will be subject
to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any marketing application, and
previous responses to inspection observations. Accordingly, we and others with whom we work must continue to expend time, money, and
effort in all areas of regulatory compliance, including manufacturing, production and quality control.

Any
regulatory approvals that we receive for our product candidates may be subject to limitations on the approved indicated uses for which
the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing,
including Phase 4 clinical trials and surveillance to monitor the safety and efficacy of the product candidate. The FDA may also require
a risk evaluation and mitigation strategy, or REMS, as a condition of approval of our product candidates, which could entail requirements
for long-term patient follow-up, a medication guide, physician communication plans or additional elements to ensure safe use, such as
restricted distribution methods, patient registries and other risk minimization tools.

113

The
FDA may impose consent decrees or withdraw approval if compliance with regulatory requirements and standards is not maintained or