Amendment No. 4 to the Administration Agreement between the Bill & Melinda Gates Foundation
         and the International Bank for Reconstruction and Development and the International
          Development Association regarding the Global Medicines Regulatory Harmonization
                                  Initiative (Trust Fund No. 071682)

1.      Reference is made to the Administration Agreement between the Bill & Melinda Gates Foundation
(the “Foundation”) and the International Bank for Reconstruction and Development and the International
Development Association (collectively, the “Bank”, and together with the Foundation, the “Parties”
and each a “Party”) regarding the Global Medicines Regulatory Harmonization Initiative (Trust Fund No.
071682) (the “Trust Fund”) effective as of July 20, 2011, as amended (the “Administration Agreement”).

2.        The Parties agree to amend the Administration Agreement as follows:

     (a) Paragraph 9.1 of Annex 2 shall be deleted and replaced with the following:

          “9.1 It is expected that the Contributions shall be fully disbursed by the Bank by
          December 31, 2021. The Bank shall only disburse Contributions for the purposes of this
          Agreement after such date with the written approval of the Donors.”

3.        All other terms of the Administration Agreement shall remain the same.

4.     Each of the Parties represents, by confirming its agreement below, that it is authorized to enter into
this Amendment and act in accordance with these terms and conditions. The Parties are requested to
sign and date this Amendment, and upon possession by the Bank of this fully signed Amendment
and respective amendment signed by the other donor to the Trust Fund, this Amendment shall
become effective as of the date of the last signature.

INTERNATIONAL BANK FOR RECONSTRUCTION AND DEVELOPMENT
INTERNATIONAL DEVELOPMENT ASSOCIATION


                                                                     23-Sep-2020
By:       _______________________________/s1/             Date:    _________________________/d1/
         Mamta Murthi
Name: _______________________________/n1/
             Vice President, Human Development
Title:    _______________________________/t1/
/d1/


BILL & MELINDA GATES FOUNDATION


                                                                     23-Sep-2020
By:       _______________________________/s2/             Date:    _________________________/d2/
         Murray Lumpkin
Name: _______________________________/n2/
             Deputy Director - Regulatory Affairs
Title:    _______________________________/t2/
/d2/