Master Alliance Provisions Guide (MAPGuide)

US Department of Defense – Moderna, COVID-19 Vaccine Supply Agreement

  • Business model | Regulatory strategy

<p><b><i>H.6 Regulatory Rightsi>b>p>
<p><span style=”fontweight: 400;”>This contract involves supply of a product that requires FDA premarket approval or clearance before commercial authorization. Contractor is seeking FDA authorization or clearance for the commercialization of mRNA1273, Moderna vaccine for SARSCoV2 Corona virus (thespan><b><i>Technologyi>b><span style=”fontweight: 400;”>”). 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) premarket notification filing (510(k)) or another regulatory filing submitted span><span style=”fontweight: 400;”>to FDA) for the technology. As the Sponsor of the Regulatory Application to FDA (as the termssponsorandapplicantare 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.span>p>
<p><span style=”fontweight: 400;”>Accordingly, the Contractor and the Government agree to the following:span>p>
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<li><span style=”fontweight: 400;”><span style=”textdecoration: underline;”> DoD Medical Product Priority.span> PL 11592 allows the DoD to request, and FDA to provide, assistance to expedite development of products to diagnose, treat, or prevent serious or lifethreatening diseases or conditions facing American military personnel. The contractor recognizes that only the DoD can utilize PL 11592. 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 11592 Sponsor Authorization Letter that will be delivered to the designated OWS POC(s) within 30 days of award.span>li>
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