Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2552

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2552
---
 among other things, bring more transparency
to drug pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement
methodologies for drugs. At the federal level, the Trump administration used several means to propose or implement drug pricing reform,
including through federal budget proposals, executive orders and policy initiatives. On September 24, 2020, HHS and FDA issued a final
rule under Section 804 of the Food, Drug, and Cosmetic Act allowing commercial importation of certain prescription drugs from Canada
without the manufacturer’s authorization. The validity of the final rule has been challenged in federal court by the Pharmaceutical
Research and Manufacturers of America, the Partnership for Safe Medicines and the Council for Affordable Health Coverage. Further, on
November 30, 2020, HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers
to plan sponsors under Medicare Part D, either directly or through pharmacy benefit managers, unless the price reduction is required
by law. The implementation of the rule has been delayed by the Infrastructure Investment and Jobs Act to January 2026. The rule also
creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a new safe harbor for certain fixed fee arrangements
between pharmacy benefit managers and manufacturers, the implementation of which have also been delayed. On November 20, 2020, CMS issued
an interim final rule implementing a new payment model, the Most Favored Nation Model, which would have tied Medicare Part B payments
for certain physician-administered drugs to the lowest price paid in other economically advanced countries, effective January 1, 2021.
On December 28, 2020, the United States District Court in Northern California issued a nationwide preliminary injunction against implementation
of the interim final rule. CMS withdrew the rule on December 27, 2021.

Packaging
and Distribution in the United States

If
our products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional
laws and requirements apply. Further, products must meet applicable child-resistant packaging requirements under the United States Poison
Prevention Packaging Act. Manufacturing, sales, promotion and other activities also are potentially subject to federal and state consumer
protection and unfair competition laws.

The
distribution of pharmaceutical products is subject to additional federal and state requirements and regulations, including extensive
record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products.

The
failure to comply with any of these