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BioNTech Manufacturing GmbH
An der Goldgrube 12 55131 Mainz
Germany
Tel.: +49 (0) 6131 -90 84 0
Fax: +49 (0) 6131 -90 84 390
[email protected]
Managing Director :
Dr. Sierk Poetting
Dr. Oliver Hennig
Martin Lang
Jan Kürschner
Commercial Register
District court Mainz
HRB 47548
VAT: DE 313150544
Tax ref. no:
DE263241058695198
Deutsche Bank
IBAN: DE94 5507 0040 0070 1441 00
SWIFT: DEUTDE5MXXX
Date: September 9, 2021
Ref: Letter of Authorization to Appoint US Agent
Dear Dr. Gruber ,
This letter will serve to advise your office that BioNTech Manufacturing GmbH hereby appoint
the following contact s as our U.S. Agent s:
Company name: Pfizer Inc.
Contact person: Adrienne Stafford
Title: Director, GCMC Vaccines
Telephone number:
Address: Pfizer Inc., 4300 Oak Park, Sanford, NC 27410
E-mail address: [email protected]
Company name: Pfizer Inc.
Contact person: Rich Pelt
Title: Senior Director, GCMC Vaccines
BioNTech Manufacturing GmbH
An der Goldgrube 12 · 55131 Mainz Germany
Dr. Gruber - Director of Office of Vaccines Research &
Review / CBER
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review 10903 New
Hampshire Avenue
Silver Spring, MD 20993
UNITED STATES
Contact: Ruben Rizzi
Department: Global Reg ulatory Affairs
Tel.: +49 (0) 6131 9084 -7593
Fax: +49 (0) 6131 9084 -390
Email: ruben.rizzi @biontech.de
Website: www.biontech.de
Te : + ) 8
4
(b) (6)
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FDA-CBER-2021-5683-1149932
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BioNTech Manufacturing GmbH
An der Goldgrube 12 55131 Mainz
Germany
Tel.: +49 (0) 6131 -90 84 0
Fax: +49 (0) 6131 -90 84 390
[email protected]
Managing Director :
Dr. Sierk Poetting
Dr. Oliver Hennig
Martin Lang
Jan Kürschner
Commercial Register
District court Mainz
HRB 47548
VAT: DE 313150544
Tax ref. no:
DE263241058695198
Deutsche Bank
IBAN: DE94 5507 0040 0070 1441 00
SWIFT: DEUTDE5MXXX
The previously appointed U.S. Agents as communicated on March 22, 2021 remain valid, as
follows:
Company name: Pfizer Inc.
Contact person: Amit P atel
Title: Director, Global Regulatory Affairs - Vaccines
Telephone number: 214-918-5262
Address: Pfizer Inc., 235 East 42nd Street, 219/9/69, New York, NY 10017
E-mail address: [email protected]
Company name: Pfizer Inc.
Contact person: Paul Rohlfing
Title: Executive Director, GCMC Vaccines
Telephone number: (919) 566 -4927
Address: Pfizer Inc., 4300 Oak Park , Sanford, NC 27410
E-mail address: [email protected]
Company name: Pfizer Inc.
Contact person: Elisa Harkins
Title: Global Regulatory Lead
Telephone number: 215-280-5503
Address: Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426
E-mail address: [email protected]
The appointed U.S. Agents will be responsible for all communication with, and regulatory
submissions to the US Food and Drug Administra tion on our behalf in regard to:
• BLA 125742
• EUA 027034
This authorization is valid until written retraction.
Sincerely,
Dr. Ruben Rizzi
Vice President Global Regulatory Affairs
FDA-CBER-2021-5683-1149933