“Field” means the development of anti-pathogen assets to treat, diagnose or prevent emerging infectious diseases.
7.0 Patent Rights; Data Rights; PREP Act and Transparency
7.2 Patent Rights
h. Compulsory Licensing Rights
Regeneron agrees that, with respect to any Subject Invention in which it has retained title, the Government has the right to require Regeneron, an assignee, or exclusive licensee of a Subject Invention to grant a non-exclusive license to a responsible applicant or applicants, upon terms that are reasonable under the circumstances, and if Regeneron, assignee, or exclusive licensee refuses such a request, the Government has the right to grant such a license within the Field itself only if the Government determines that:
i. Action is necessary to alleviate the following health or safety needs that may affect the United States and Regeneron (itself or through its assignee, subcontractor or licensee) is unwilling or unable to manufacture or supply the Subject Invention to address such needs:
a. Declaration for Public Health Emergency by the Secretary of HHS;
b. Determination that there is a significant potential for a public Health emergency that has a significant potential to affect a national or health security of U.S. citizens as determined by the Secretary of HHS; or
c. Declaration by WHO Director General of a public health emergency of international concern.