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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 P
oetting
Dr. Oliver Hennig
Martin Lang
Jan Kürschner Commercial Register
District court M
ainz
HRB 47548
VAT: DE 313150544
Tax ref. no:
DE263241058695198 Deutsche Bank
IBAN: DE94 5507 0040 00
70 1441 00
SWIFT: DEUTDE5MXXX Date: August 3, 2021
Ref: Letter of Authorization to Appoint US Agent
Dear Dr. Gruber,
Th
is letter will serve to advise your office that BioNTech M anufacturing GmbH hereby appoint
the following contact as our U.S. Agent:
Company name: Pf
izer Inc.
Contact person: Amit Patel
Title: Director, Global Regulatory Affairs - Vaccines
Telephone number: 214-918-5262
Address: Pfizer Inc., 235 E ast 42nd Street, New York, NY 10017
E-mail address: [email protected]
The following cont
act will no longer operate on behalf of BioNTech Ma nufacturing GmbH as
U.S. Agent:
Company name: Pfizer Inc.
Contact person: Neda Aghajani Memar
Title: Senior Manager, Global Regulatory Affairs – Vaccines
Telephone number: 212-733-2613
Address: Pfizer Inc., 235 East 42nd Street, 219/9/69, New York, NY 10017 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 Regulatory Affairs
Tel.: +49 (0) 6131 9084 -7593
Fax: +49 (0) 6131 9084 -390
Email: ruben.rizzi @biontech.de
Website: www.biontech.de
FDA-CBER-2021-5683-0950393
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BioNTech Manufacturing GmbH
An der Goldgrube 12 55131 Mainz
Germany Tel.: +49 (0) 6131- 90 84 0
Fax: +49 (0) 61 31
-90 84 390
[email protected] Managing Director :
Dr. Sierk Poe t
ting
Dr. Oliver Hennig
Martin Lang
Jan Kürschner Commercial Register
District court Main
z
HRB 47548
VAT: DE 313150544
Tax ref. no:
DE263241058695198 Deutsche Bank
IBAN: DE94 5507 0040 0070 1441 00
S
WIFT: DEUTDE5MXXX E-mail address: [email protected]
The previously appointed U
.S. Agents as communicated on March 22, 2021 remain valid, as
follows:
Company name: Pfizer In
c.
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 In
c.
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 Administration on our behalf in regard to:
•BLA 125742
•EUA 027034
This authorization is v
alid until written retraction.
Sincerely,
Dr. Ruben Rizzi
Vice Presi dent Global Regulatory Affairs
FDA-CBER-2021-5683-0950394