Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2214

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2214
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 threat.

The
intellectual property that we have in-licensed has been discovered through government funded programs and thus may be subject to federal
regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance
with such regulations may limit our exclusive rights, and limit our ability to contract with non-U.S. manufacturers.

All
of the intellectual property rights that we have in-licensed to date were discovered through the use of U.S. government funding and are
therefore subject to certain federal regulations. As a result, the U.S. government may have certain rights, pursuant to the Bayh-Dole
Act of 1980, or Bayh-Dole Act, and implementing regulations, to the intellectual property embodied in our current product candidates,
all of which are derived from our existing in-licensed intellectual property. These U.S. government rights in certain inventions developed
under a government-funded program include a nonexclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental
purpose. In addition, the U.S. government has the right to require us or our licensors to grant exclusive, partially exclusive, or nonexclusive
licenses to any of these inventions to a third party if it determines that: (i) adequate steps have not been taken to commercialize the
invention; (ii) government action is necessary to meet public health or safety needs; or (iii) government action is necessary to meet
requirements for public use under federal regulations (also referred to as “march-in rights”). All of our product candidates
pursuant to the license agreements are subject to such march-in rights. The U.S. government also has the right to take title to these
inventions if we, or the applicable licensor, fail to disclose the invention to the government and fail to file an application to register
the intellectual property within specified time limits. These time limits have recently been changed by regulation and may change in
the future. Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance
with which may require us or the applicable licensor to expend substantial resources. In addition, the U.S. government requires that
any products embodying the subject invention or produced through the use of the subject invention be manufactured substantially in the
United States. The manufacturing preference requirement can be waived if the owner of the intellectual property can show that reasonable
but unsuccessful efforts have been made to grant licenses on similar terms to potential