Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2619

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2619
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 develop may be covered by third parties’ patents or other exclusive
    rights;

    ●
    the
    patents of others may have an adverse effect on our business; or

    ●
    given
    that all of the preclinical developments of our oncology, fibrosis and malaria programs have, to date, been funded through grants
    totaling more than $110 million (prior to in-licensing our product candidates), which include grants from the federal government,
    it is possible that the federal government could invoke its march-in rights under 35 U.S.C. § 203 if it deems that it is necessary
    for it, or for third parties it designates, to practice our patent rights in order to address a national public safety or national
    security 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