125742 S1 M1 exclusivity claim

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COVID -19 Vaccine (BNT162; PF -07302048)
Module 1.3.5.3 Exclusivity Claim
PFIZER CONFIDENTIAL 
Page 1NOTICE OF CLAIMED EX CLUSIVITY
A.BioNTech Manufacturing GmbH hereb y requests a determination that the licensure of Pfizer -
BioNTech- COVID -19constitutes the “first licensure” of Pfizer -BioNTech -COVID -19and 
that BioNTech Manufacturing GmbH is entitled to exclusivity  from the date of licensure 
pursuant to section 351(k)(7) of the Public Health Service Act. 
B.There are no licensed biological products that are structurally  related to Pfize r-BioNTech-
COVID -19 for which BioNTech Manufacturing GmbH or one of its affiliates, licensors, 
predecessors in interest, or related entities are the current or previous license holders.
C.Accordingl y, consistent with Section 351(k)(7)(C) of the Public Health Service Act, FDA’s 
licensure of Pfizer -BioNTech- COVID -19under 351(a) will constitute the “first licensure” of 
Pfizer -BioNTech- COVID -19.  
1.Pursuant to Section 351(k)(7)(A), no approval of an application submitted under 
Section 351(k) for which Pfizer -BioNTech- COVID -19 is the reference product can 
be made effective until 12 y ears after the date of licensure of Pfizer -BioNTech-
COVID -19.  
2.Pursuant to Section 351(k)(7)(B), no application under Section 351(k) for which 
Pfizer -BioNTech- COVID -19is the ref erence product can be submitted until 4 y ears 
after the date of licensure of Pfizer -BioNTech- COVID -19.
090177e19501b0e9\Final\Final On: 24-Sep-2020 18:04 (GMT)
FDA-CBER-2021-5683-0013852