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BNT162b2
Module 1.3.1.4 Transfer of Obligations
Pfizer Confidential
1
TRANSFER OF OBLIGATIONS
In compliance with 21 CFR 312.52, Table 1 below lists the Spons or responsibilities* that were
transferred from BioNTech SE to Pfizer Inc. in the conduct of t he C4591001 clinical study, with
the specific obligations that we re transferred. Any obligation not provided in the written
description below shall be deemed not to have been transferred.
Table 1. Sponsor Obligations Transferred to Pfizer Related to the Conduct of Study
C4591001
NAME AND
ADDRESS STUDY(S)
CONTRACTEDOBLIGATIONS ASSUMED /
TRANSFERRED
Pfizer Inc.
445 Eastern Point Road, Groton, CT 06340 United States
C4591001
21 CFR 312.50 Ensuring that the investigation is conducted in accordance with the approved investigational plan, the approved protocol and Good Clinical Practice (GCP)
21 CFR 312.53(a) Selecting investigators with qualified training and Experience 21 CFR 312.53(c) Obtaining information from investigators, including a signed investigator statement
(Form FDA 1572); curriculum vitae; financial disclosure
information required under 21 CFR 54 21 CFR 312.53(d) Selecting monitors qualified by training and experience
21 CFR 312.55(a) Providing investigators with the information they need to conduct the investigation properly 21 CFR 312.55(b) Informing investigators of new
observations with respect to adverse events and safe use
21 CFR 312.56(a) Ensuring proper monitoring of the clinical trial 21 CFR 312.56(b) Secure compliance or discontinue
shipments from investigators found not to comply with
signed agreement (FDA 1572), the general investigational plan, or other requirements under 21 CFR 312
21 CFR 312.56(c) Review and evaluate evidence of safety
and effectiveness of drug
FDA-CBER-2022-5812-0220820
BNT162b2
Module 1.3.1.4 Transfer of Obligations
Pfizer Confidential
2 Table 1. Sponsor Obligations Transferred to Pfizer Related to the Conduct of Study
C4591001
NAME AND
ADDRESS STUDY(S)
CONTRACTEDOBLIGATIONS ASSUMED /
TRANSFERRED
21 CFR 312.56(d) Ensure discontinuation of the study if the drug presents an unreasonable and significant risk to
study subjects; notification to FDA and IRB of
discontinuation 21 CFR 312.57 Maintenance of records and reports
21 CFR 312.59 Drug accountab ility (e.g. record of
shipment, receipt, method of disposal); ensuring all
unused drug is returned or properly disposed of Responsible for maintaining an effective IND and ensuring that FDA is promptly informed of: 1) reportable
adverse effects or risks with respect to the drug; 2)
significant changes to the protocol; 3) addition(s) of new investigators; 4) annual reviews
*Where applicable, contractors who performed clinical supplies manufacturing, packaging, labeling and/or testing
are noted in Module 3 Section P.3.1 of the IND and are, therefo re, not included in Table 1.
FDA-CBER-2022-5812-0220821