H.6 Regulatory Rights
This contract involves supply of a product that requires FDA pre–market approval or clearance before commercial authorization. Contractor is seeking FDA authorization or clearance for the commercialization of mRNA–1273, Moderna vaccine for SARS–CoV–2 Corona virus (the “Technology”). The Contractor is the Sponsor of the Regulatory Application (an investigational new drug application (IND), investigational device exemption (IDE), emergency use authorization (EUA), new drug application (NDA), biologics license application (BLA), premarket approval application (PMA), or 510(k) pre–market notification filing (510(k)) or another regulatory filing submitted to FDA) for the technology. As the Sponsor of the Regulatory Application to FDA (as the terms “sponsor” and “applicant” are defined or used in al 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20), the Contractor has certain standing before the FDA that entitles it to exclusive communications related to the Regulatory Application.
Accordingly, the Contractor and the Government agree to the following:
- DoD Medical Product Priority. PL 115–92 allows the DoD to request, and FDA to provide, assistance to expedite development of products to diagnose, treat, or prevent serious or life–threatening diseases or conditions facing American military personnel. The contractor recognizes that only the DoD can utilize PL 115–92. As such, the contractor will work proactively with the Government to leverage this law to its maximum potential under this contract. The contractor shall submit Public Law 115–92 Sponsor Authorization Letter that will be delivered to the designated OWS POC(s) within 30 days of award.