GMRHI GRANT NUMBER TF010846
GMRHI GRANT NUMBER TF0A2289
Global Medicines Regulatory Harmonization Initiative Trust
Fund Agreement Providing for the
Amendment and Restatement of the Grant Agreement
(East African Community for Medicines Regulatory Harmonization Project)
between
EAST AFRICAN COMMUNITY
and
INTERNATIONAL BANK FOR RECONSTRUCTION AND DEVELOPMENT
and INTERNATIONAL DEVELOPMENT ASSOCIATION
Acting as Administrator of the Global Medicines Regulatory Harmonization
Initiative Trust Fund
Dated March 21, 2012
As amended and restated on , 2016
GMRHI GRANT NUMBER TF010846
GMRHI GRANT NUMBER TF0A2289
GLOBAL MEDICINES REGULATORY HARMONIZATION INITIATIVE
GRANT AGREEMENT
AGREEMENT dated March 21, 2012, as amended and restated on
, 2016, entered into between EAST AFRICAN COMMUNITY
("Recipient" or "EAC") the regional intergovernmental organization of the Partner States (as
they are hereinafter defined in the Appendix to this Agreement) and INTERNATIONAL
BANK FOR RECONSTRUCTION AND DEVLOPMENT and INTERNATIONAL
DEVELOPMENT ASSOCIATION (collectively, the "World Bank"), acting as administrator
of the Global Medicines Regulatory Harmonization Initiative.
WHEREAS (A) under an agreement, dated March 21, 2012, between the Recipient
and the World Bank ("Original Grant Agreement") in an amount equal to five million five
hundred forty-nine thousand two hundred United States Dollars ($5,549,200) to assist in
financing the project described in Schedule I to the Original Grant Agreement ("Original
Project");
(B) the Recipient has requested the World Bank to provide additional financial
assistance in support of additional activities within the scope of the Original Project, by
making available to the Recipient an additional grant ("Additional Grant") in an amount equal
to three million four hundred thousand United States Dollars ($3,400,000); and
WHEREAS the World Bank has agreed, on the basis, inter alia, of the foregoing to
extend such additional assistance to the Recipient upon the terms and conditions set forth in
this Agreement;
NOW THEREFORE the Recipient and the World Bank hereby agree to amend and
restate the Original Grant Agreement, with effect as of the Effective Date of this Agreement,
to read as follows:
Article I
Standard Conditions; Definitions
1.01. The Standard Conditions for Grants Made by the World Bank Out of Various Funds,
dated July 31, 2010 ("Standard Conditions"), with the modifications set forth in
Section II of the Appendix to this Agreement, constitute an integral part of this
Agreement.
1.02. Unless the context requires otherwise, the capitalized terms used in this Agreement
have the meanings ascribed to them in the Standard Conditions or in this Agreement.
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Article II
The Project
2.01. The Recipient declares its commitment to the objectives of the Project. To this end,
the Recipient shall carry out the Project through the Secretariat and shall cause the
Partner States to carry out their respective activities to the Project in accordance with
the provisions of Article II of the Standard Conditions and in accordance with
pharmaceutical and ethical international best practices.
2.02. Without limitation upon the provisions of Section 2.01 of this Agreement, and except
as the Recipient and the World Bank shall otherwise agree, the Recipient shall ensure
that the Project is carried out in accordance with the provisions of Schedule 2 to this
Agreement.
Article III
The Grant
3.01. The World Bank agrees to extend to the Recipient, on the terms and conditions set
forth or referred to in this Agreement, a grant in an amount equal to eight million nine
hundred forty-nine thousand two hundred United States Dollars ($8,949,200)
("Grant") which consists of: (a) the Original Grant equal to five million five hundred
forty-nine thousand two hundred United States Dollars ($5,549,200); and (b) the
Additional Grant equal to three million four hundred thousand United States Dollars
($3,400,000), to assist in financing the project as described in Schedule I to this
Agreement ("Project").
3.02. The Recipient may withdraw the proceeds of the Grant in accordance with Section IV
of Schedule 2 to this Agreement.
3.03. The Grant is funded out of the abovementioned trust fund for which the World Bank
receives periodic contributions from the donors to the trust fund. In accordance with
Section 3.02 of the Standard Conditions, the World Bank's payment obligations in
connection with this Agreement are limited to the amount of funds made available to it
by the donors under the abovementioned trust fund, and the Recipient's right to withdraw
the Grant proceeds is subject to the availability of such funds. Accordingly, in the event
that any donor cancels or fails to pay any contributions under the trust fund to the World
Bank for any reason, or that as a result of currency exchange variations the amount of
funds available in the trust fund is insufficient for the purposes of the Grant, the Recipient
shall bear the risk of such funding shortfall and the World Bank shall not have any
liability whatsoever to the Recipient or to any third parties in respect of any expenditures
or liabilities incurred by the Recipient or any third parties in connection with this
Agreement which exceed the amount of funds made available to the World Bank by the
donors for the purposes of the Grant.
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Article IV
Additional Remedies
4.01. The Additional Events of Suspension referred to in Section 4.02 (k) of the Standard
Conditions consist of the following:
(a) The Treaty or the Protocol has been amended, suspended, abrogated, repealed
or waived so as to affect materially and adversely the ability of the Recipient
to carry out the Project.
(b) Any action has been taken for the dissolution, disestablishment or suspension
of the operation of the Recipient.
(c) A Partner State has failed to: (i) meet the commitments towards the Project as
set forth in the Letter of Comfort and/or pursuant to the
decisions/instructions/resolutions made by the Recipient to ensure the
effective implementation of their part of the Project; or (ii) make payment
(notwithstanding the fact that such payment may have been made by a third
party) of principal, interest, service charges or any other amount due to the
Association or the World Bank: (A) under any agreement between such
Partner State and the Association; or (B) under any agreement between such
Partner State and the World Bank; or (C) in consequence of any guarantee
extended or other financial obligation of any kind assumed by the Association
or the World Bank to any third party with the agreement of such Partner State.
(d) (i) Subject to subparagraph (ii) of this paragraph, the right of the
Recipient to withdraw the proceeds of any grant made to the Recipient for the
financing of Part 2 of the Project shall have been suspended, canceled or
terminated in whole or in part, pursuant to the terms of the WHO Co-financing
Agreement.
(ii) Subparagraph (i) of this paragraph shall not apply if the Recipient
establishes to the satisfaction of the World Bank that: (A) such suspension,
cancellation or termination is not caused by the failure of the Recipient to
perform any of its obligations under such agreement; and (B) adequate funds
for Part 2 of the Project are available to the Recipient from other sources on
terms and conditions consistent with the obligations of the Recipient under
this Agreement.
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AGREED at A r PL , svi2-VTVMA , as of the day
and year first above written.
EAST AFRICAN COMMUNITY
By
Au rize Representative
Name: .I PatT FU yK4(o
Title: S C
INTERNATIONAL BANK FOR
RECONSTRUCTION AND DEVELOPMENT AND
INTERNATIONAL DEVELOPMENT ASSOCIATION
acting as administrator of the
Global Medicines Regulatory Harmonization Initiative
By
Authorized Representative
Name:44a,74~O ffmIC114k. pok-11Cy
Title: $',It I(CA-Y1
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Article V
Effectiveness; Termination
5.01. The Conditions of Effectiveness consist of the following, namely the Recipient has
provided a legal opinion in form and substance satisfactory to the World Bank, of
counsel acceptable to the World Bank, showing the following matters, namely, on
behalf of the Recipient, that this Agreement has been duly authorized by, executed
and delivered on behalf of, and is legally binding upon, the Recipient, in accordance
with its terms.
Article VI
Recipient's Representative; Addresses
6.01. The Recipient's Representative referred to in Section 7.02 of the Standard Conditions
is the Recipient's Secretary General.
6.02. The Recipient's Address referred to in Section 7.01 of the Standard Conditions is:
East African Community
EAC Close, Afrika Mashariki Road
P.0 Box 1096
Arusha
United Republic of Tanzania
Facsimile:
+255 27 2162190
6.03. The World Bank's Address referred to in Section 7.01 of the Standard Conditions is:
International Bank for Reconstruction and Development and
International Development Association
1818 H Street, N.W.
Washington, D.C. 20433
United States of America
Facsimile:
1-202-477-6391
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SCHEDULE 1
Project Description
The objective of the Project is to harmonize medicines registration systems and to
improve efficiency and enhance transparency in medicines registration among the East
African Community Partner States.
The Project consists of the following parts:
Part 1. Regional coordination and capacity building for medicines regulatory
harmonization
1. Provision of support to develop regional harmonized protocols including standard
operating procedures and manuals by the Regional Technical Working Groups and
capacity building for medicine regulation.
2. Provision of support for the establishment and operation of: (a) the Regional Steering
Committee providing direction and oversight for the Project, (b) a Project
Coordination Team for the day to day operational support and reporting; and (c) six
Regional Expert Working Groups which will respectively take technical lead in:
(i) medicines registration, (ii) good manufacturing practices inspection,
(iii) information management systems, (iv) pharmaceutical policy, legal and
regulatory reforms; (v) pharmacovigilance; and (vi) quality management system.
3. Provision of support to undertake a comprehensive systems requirement study for on-
line registration and to develop a national and regional web-based data information
management system for the work sharing and sharing of medicines regulatory
information across the East Africa region.
4. Provision of support to enhance pharmacovigilance capacity of the Recipient and the
Partner States National Medicines Regulatory Agencies, by developing a strategic
plan to monitor patient safety and strengthen management of adverse events following
administration of medicines and vaccines.
Part 2. Institutional development and strengthening of national medicines regulatory
authorities
I. Carrying out of capacity building activities to the Partner States' NMRAs, including
support to: (i) additional staff training in areas of project management; (ii) quality
assessment and safety of medicines; and (iii) goods manufacturing practices
inspections.
2. Provision of support for the twinning/mentoring of NMRAs in the region and
implementation of quality management systems including internal and external audits.
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SCHEDULE2
Project Execution
Section I. Implementation Arraneements
A. Institutional Arrangements
1. Secretariat
The Secretariat of the East African Community shall be responsible for the overall
implementation of the Project, in collaboration, as needed, with the structures within
the Council of Ministers. For such purposes, the Recipient shall ensure the Secretariat
is provided at all times the financial and human resources suitable to enable it to carry
out its responsibilities under the Project. In particular, the Secretariat shall: (i) act as
the operational link between the World Bank and each of the Partner States; (ii) be
responsible for the procurement and financial management of the Project; and
(iii) prepare and implement the AWP&Bs in accordance with the provisions of
paragraph D of this Section I.
2. Project Coordination Team
The Recipient shall maintain, throughout the implementation of the Project, the
Project Coordination Team (PCT) within the Health Department of the Secretariat,
including financial management, procurement, accounting, and monitoring and
evaluation and informatics specialists to assist the Secretariat to carry out its tasks in
the Project, all with terms of reference and experience satisfactory to the World Bank.
3. Steering Committee
The Recipient shall maintain, throughout the implementation of the Project, the
Steering Committee vested with the responsibility to provide overall guidance and
oversight over Project preparation and implementation and to approve the AWP&Bs.
The Steering Committee shall be composed of senior representatives from the
Secretariat and from the Partner States' ministries responsible for health, finance and
East African cooperation.
4. Council of Ministers
Following the approval of the AWP&Bs by the Steering Committee and prior to their
implementation, the Recipient shall ensure that said plans are endorsed by the Council
of Ministers.
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(b) not later than April 30 immediately prior to each such Fiscal Year, furnish to
the World Bank for its comments and approval, the draft AWP&B for such
Fiscal Year and, promptly thereafter, finalize the AWP&B taking into account
the World Bank's views and recommendations thereon; and
(c) adopt and sign the final version of the AWP&B in the form approved by the
World Bank not later than June 30 immediately prior to each such Fiscal Year.
E. Training under the Project
For the purposes of the Training to be financed under the Project, the Recipient shall:
(a) furnish to the World Bank for its approval, not later than April 30 of each
year, a training or workshop program including an explanation of how such
training or workshop is consistent and conducive to the objectives of the
Project and whether it offers the best price/quality ratio, as well as the
schedule for its implementation;
(b) select the trainees or attendees in accordance with a transparent process and
criteria satisfactory to the World Bank; and
(c) furnish to the World Bank a report of such scope and detail as the World Bank
shall reasonably request, on the results of each training and workshop and the
benefits to be derived there from.
F. Donor Visibility and Visit
1 . The Recipient shall take or cause to be taken all such measures as the World Bank
may reasonably request to identify publicly the Donor's support for the Project.
2. For the purposes of Section 2.09 of the Standard Conditions, the Recipient shall, upon
the World Bank's request, take all measures required on its part to enable the
representatives of the Donor(s) to visit any part of the Recipient's Partner States'
territory for purposes related to the Project.
Section II. Project Monitoring, Reporting and Evaluation
A. Project Reports
1. The Recipient shall monitor and evaluate the progress of the Project and prepare
Project Reports in accordance with the provisions of Section 2.06 of the Standard
Conditions and on the basis of the Monitoring and Evaluation Indicators acceptable
to the World Bank. Each Project Report shall cover the period of one calendar
semester, and shall be furnished to the World Bank not later than one (1) month after
the end of the period covered by such report.
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5. Regional Expert Working Group
(a) The Recipient shall maintain, throughout the implementation of the Project,
six Regional Expert Working Groups, in form and substance and qualified
staff satisfactory to the World Bank, to respectively develop harmonized
medicines related guidelines and supporting standard operating procedures in
the following four areas: (i) medicines registration; (ii) good manufacturing
practices inspection; (iii) information management systems,
(iv) pharmaceutical policy; legal and regulatory reforms;
(v) pharmacovigilance; and (vi) quality management system.
(b) Each Regional Expert Working Group shall comprise representatives of the
national medicines regulatory authority of two or more Partner States and will
function under the leadership of the national medicine regulatory authority of
one of the Partner States, all as set forth in the Project Operations Manual.
B. Anti-Corruption
The Recipient shall ensure that the Project is carried out in accordance with the
provisions of the Anti-Corruption Guidelines.
C. Project Operational Manual
The Recipient shall: (i) take all action required to carry out the Project in accordance
with the provisions and requirements set forth or referred to in the Project Operational
Manual; (ii) submit recommendations to the World Bank for its consideration for
changes and updates of the Project Operational Manual as they may become necessary
or advisable during the operation of the Project in order to achieve the objective of the
Project; and (iii) not assign, amend, abrogate or waive the Project Operational Manual
or any of its provisions without the World Bank's prior agreement. Notwithstanding
the foregoing, if any of the provisions of the Project Operation Manual is inconsistent
with the provisions of this Agreement, the provisions of this Agreement shall prevail
and govern.
D. Annual Work Program and Budget (AWP&B)
The Recipient shall:
(a) prepare a draft AWP&B for each Fiscal Year, setting forth, inter alia: (i) a
detailed description of planned activities for Parts I and H of the Project for
the Fiscal Year; (ii) the sources and uses of funds therefore; and
(iii) responsibility for execution of said Project activities, budgets, start and
completion date, outputs, and monitoring indicators to track progress of each
activity;
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2. The Recipient shall prepare the Completion Report in accordance with the provisions
of Section 2.06 of the Standard Conditions. The Completion Report shall be furnished
to the World Bank not later than six (6) months after the Closing Date.
B. Mid-Term Review
The Recipient, through the Project Coordination Team, shall:
(a) maintain policies and procedures adequate to enable it to monitor and evaluate
on an ongoing basis, in accordance with the Monitoring and Evaluation
Indicators, the carrying out of the Project and the achievement of the objective
thereof;
(b) prepare, under terms of reference satisfactory to the World Bank, and furnish
to the World Bank, by May 2014, a report integrating the results of the
monitoring and evaluation activities and setting out the measures
recommended to ensure the efficient carrying out of the Project and
achievement of the objective thereof during the period following such date;
and
(c) review with the World Bank, by June 2014, or such later date as the World
Bank shall request, the report referred to in the preceding paragraph (b), and,
thereafter, take all measures required to ensure the efficient completion of the
Project and the achievement of the objective thereof, based on the conclusions
and recommendations of the said report and the World Bank's views on the
matter.
C. Financial Management, Financial Reports and Audits
1 . The Recipient shall ensure that a financial management system is maintained in
accordance with the provisions of Section 2.07 of the Standard Conditions.
2. The Recipient shall ensure that interim unaudited financial reports for the Project are
prepared and furnished to the World Bank not later than forty-five (45) days after the
end of each calendar quarter, covering the quarter, in form and substance satisfactory
to the World Bank.
3. The Recipient shall have its Financial Statements for the Project audited in accordance
with the provisions of Section 2.07(b) of the Standard Conditions. Each such audit of
the Financial Statements shall cover the period of one (1) fiscal year of the Recipient.
The audited Financial Statements for each such period shall be furnished to the World
Bank not later than six (6) months after the end of such period.
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Section HI. Procurement
A. General
1. Procurement and Consultant Guidelines. All goods, non-consulting-services and
consultants' services required for the Project and to be financed out of the proceeds
of the Grant shall be procured in accordance with the requirements set forth or referred
to in:
(a) Section I of the Procurement Guidelines in the case of goods and non-
consulting services, and Sections I and IV of the Consultant Guidelines in the
case of consultants' services; and
(b) the provisions of this Section III, as the same shall be elaborated in the
procurement plan prepared and updated from time to time by the Recipient
for the Project in accordance with paragraph 1.18 of the Procurement
Guidelines and paragraph 1.25 of the Consultant Guidelines ("Procurement
Plan").
2. Definitions. The capitalized terms used below in this Section to describe particular
procurement methods or methods of review by the World Bank of particular contracts,
refer to the corresponding method described in Sections II and Ill of the Procurement
Guidelines, or Sections II, III, IV and V of the Consultant Guidelines, as the case may
be.
B. Particular Methods of Procurement of Goods and Non-consulting Services
1 . International Competitive Bidding. Except as otherwise provided in paragraph 2
below, goods and non-consulting services shall be procured under contracts awarded
on the basis of International Competitive Bidding.
2. Other Methods of Procurement of Goods and Non-consulting Services. The
following methods, other than International Competitive Bidding, may be used for
procurement of goods and non-consulting services for those contracts specified in the
Procurement Plan: (a) National Competitive Bidding; (b) Shopping; and (c) Direct
Contracting.
3. Additional Provisions Governing National Competitive Bidding referred to in
paragraph B.2 (a) of this Section.
National Competitive Bidding for goods and Non-consulting Services shall be subject
to the following:
(a) In accordance with paragraph 1.16(e) of the Procurement Guidelines, each
bidding document and contract financed out of the proceeds of the Grant shall
provide that: (i) the bidders, suppliers, contractors and subcontractors shall
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permit the World Bank, at its request, to inspect their accounts and records
relating to the bid submission and performance of the contract, and to have
said accounts and records audited by auditors appointed by the World Bank;
and (ii) the deliberate and material violation by the bidder, supplier, contractor
or subcontractor of such provision may amount to an obstructive practice as
defined in paragraph 1.1 6(a)(v) of the Procurement Guidelines.
(b) There shall be no preference accorded to domestic suppliers and contractors.
C. Particular Methods of Procurement of Consultants' Services
1 . Quality- and Cost-based Selection. Except as otherwise provided in paragraph 2
below, consultants' services shall be procured under contracts awarded on the basis
of Quality- and Cost-based Selection.
2. Other Methods of Procurement of Consultants' Services. The following methods,
other than Quality- and Cost-based Selection, may be used for procurement of
consultants' services for those assignments which are specified in the Procurement
Plan: (a) Quality-based Selection; (b) Selection under a Fixed Budget; (c) Least Cost
Selection; (d) Selection based on Consultants' Qualifications; (e) Single-source
Selection of consulting firms; (f) Selection of Individual Consultants; and (g) Single-
source procedures for the Selection of Individual Consultants.
D. Review by the World Bank of Procurement Decisions
The Procurement Plan shall set forth those contracts which shall be subject to the
World Bank's Prior Review. All other contracts shall be subject to Post Review by
the World Bank.
Section IV. Withdrawal of Grant Proceeds
A. General
1I The Recipient may withdraw the proceeds of the Grant in accordance with the
provisions of: (a) Article III of the Standard Conditions; (b) this Section; and (c) such
additional instructions as the World Bank may specify by notice to the Recipient
(including the "World Bank Disbursement Guidelines for Projects" dated May 2006,
as revised from time to time by the World Bank and as made applicable to this
Agreement pursuant to such instructions), to finance Eligible Expenditures as set forth
in the table in paragraph 2 below.
2. The following table specifies the categories of Eligible Expenditures that may be
financed out of the proceeds of the Grant ("Category"), the allocations of the amounts
of the Grant to each Category, and the percentage of expenditures to be financed for
Eligible Expenditures in each Category:
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Amount of the Percentage of Amount of the Percentage of
Grant Expenditures to Grant Expenditures
Allocated be Financed Allocated to be Financed
(expressed in (inclusive of (expressed in (inclusive of
USD) Taxes) USD) Taxes)
Category TF010846 TF010846 TF0A2289 TF0A2289
(1) Goods, non-consulting 2,409,700 100% 1,924,936 100%
services, and
consultants' services,
Operating Costs and
Training under Part I of
the Project
(2) Goods, non-consulting 3,139,500 100% 1,475,064 100%
services, and
consultants' services,
Operating Costs and
Training under Part 2 of
the Project
TOTAL AMOUNT 5,549,200 3,400,000
B. Withdrawal Conditions; Withdrawal Period
1. Notwithstanding the provisions of Part A of this Section no withdrawal shall be made
for payments made prior to the date of this Agreement, except that withdrawals up to
an aggregate amount not to exceed $150,000 equivalent may be made for payments
made prior to this date on or after March 11, 2016, for Eligible Expenditures.
2. The Closing Date referred to in Section 3.06(c) of the Standard Conditions is
June 30, 2017.
Section V. Other Undertakings
I . (a) To facilitate the carrying out of the Project, the Recipient shall make a portion
of the Grant proceeds available on a grant basis to the Partner States under
terms and conditions approved by the World Bank, which shall include, inter
alia: (a) the principal amount of the funds which will benefit each Partner
State denominated in Dollars; (b) the Recipient's right to suspend, terminate
or obtain refund, of the funds that benefitted the Partner States individually or
collectively, in the event a Partner State fails to perform its obligations under
the Project pursuant to the instructions/decisions/resolution made by the
Recipient to ensure the implementation of the Project; and (c) the obligation
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of Partner States to abide by the terms of the Project Operations Manual and
the Anti-Corruption Guidelines.
(b) The Recipient shall exercise its rights and carry out its obligations in such a
manner as to protect the interests of the Recipient and the World Bank and to
accomplish the purposes of the Grant.
2. The Recipient shall cause each Partner State to provide a Comfort Letter to the World
Bank confirming the Partner State's commitment to the objectives of the Project, and,
that to this end each Partner State shall:
(a) respectively carry out the activities of Project at the local level with due
diligence and efficiency and in conformity with appropriate administrative,
financial, educational, technical, social, medical, ethical and environmental
practices in collaboration with the Recipient;
(b) provide, promptly as needed, facilities, services and other resources required
for the Project; and
(c) take all measures required on its part to enable the representatives of the
World Bank and Donor(s) to visit any part of the Partner State's territory for
purposes related to the Project and provide any information as the World Bank
shall reasonably request regarding the administration and operation of the
activities carried out by said Partner State under the Project.
3. The Recipient shall have recruited, by July 1, 2013, the additional staff for the
Secretariat and the National Focal Points in the National Medicines Regulatory
Authorities of respective East African Community Partner States under terms of
reference and with qualifications and experience satisfactory to the World Bank.
4. The Recipient and WHO shall, by July 19, 2012, enter into the WHO Co-financing
Agreement.
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APPENDIX
Section I. Definitions
1. "Annual Work Plan and Budget" and "AWP&B" mean the annual work plan and
budget to be prepared on an annual basis by the Secretariat (as hereinafter defined).
2. "Anti-Corruption Guidelines" means the "Guidelines on Preventing and Combating
Fraud and Corruption in Projects Financed by IBRD Loans and IDA Credits and
Grants", dated October 15, 2006 and revised in January 2011.
3. "Category" means a category set forth in the table in Section IV of Schedule 2 to this
Agreement.
4. "Co-financier" means the World Health Organization or WHO.
5. "Co-financing" means an amount of funds to be provided by the Co-financier to assist
in financing the Project.
6. "Comfort Letter" means the letters referred to in Section V.2 of Schedule 2 of this
Agreement provided by the Partner States to the World Bank.
7. "Consultant Guidelines" means the "Guidelines: Selection and Employment of
Consultants under IBRD Loans and IDA Credits and Grants by World Bank
Borrowers", dated January 2011, revised in July 2014.
8. "Council of Ministers" means the Recipient's Council of Ministers referred to in
paragraph 4 of Section L.A of Schedule 2 to this Agreement, which is the policy organ
of the Recipient established and functioning pursuant to the provisions, respectively,
of Articles 9. 1(b) and 14 of the Treaty (as hereinafter defined).
9. "Fiscal Year" means the twelve (12) month period corresponding to any of the
Recipient's fiscal years, which period commences on July 1 and ends on June 30 in
each calendar year.
10. "Global Medicines Regulatory Harmonization Initiative Trust Fund" means the trust
fund established pursuant to the Administration Agreement between the Bill and
Melinda Gates Foundation and the World Bank on July 11, 2011, as amended.
11. "Monitoring and Evaluation Indicators" means the agreed monitoring and evaluation
indicators set forth in the Project Operation Manual (as hereinafter defined) to be
utilized by the Recipient to measure the progress in the implementation of the Project
and the degree to which the objectives thereof is being achieved.
12. "National Medicines Regulatory Agencies" and "NMRAs", each means the agencies
responsible for the regulation and control of medical products.
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13. "Operating Costs" means the expenditures incurred to finance the cost of the
administrative support to be provided under the Project, including: (i) office furniture
and equipment; (ii) equipment maintenance and insurance; (iii) public utilities and
communication technology (including, without limitation, internet and telephone);
(iv) building security and maintenance; (v) translation services, photocopies and
publications; and (vi) office supplies.
14. "Operational Manual" means the Recipient's set of guidelines and procedures dated
January 31, 2012, by the Recipient through the Secretariat (as hereinafter defined), as
revised, applicable for the purpose of implementing the Project, including in the areas
of monitoring and evaluation, coordination, financial management (including
financial, administrative and accounting procedures, procurement, internal controls
and audits), and other provisions related to the institutional organization of the Project,
as such guidelines and procedures may be amended from time to time with the prior
written agreement of the World Bank.
15. "Partner States" means the states of the Republic of Burundi, Republic of Kenya,
Republic of Rwanda, United Republic of Tanzania and Republic of Uganda and with
the prior agreement of the World Bank, any other state that might become a party to
the Treaty following the date of this Agreement.
16. "Procurement Guidelines" means the "Guidelines: Procurement of Goods, Works and
Non-consulting Services under IBRD Loans and IDA Credits and Grants by World
Bank Borrowers", dated January 2011, revised in July 2014.
17. "Procurement Plan" means the Recipient's procurement plan for the Project, dated
February 13, 2012, and referred to in paragraph 1.18 of the Procurement Guidelines
and paragraph 1.25 of the Consultant Guidelines, as the same shall be updated from
time to time in accordance with the provisions of said paragraphs.
18. "Program" means the program designed to support countries increase the rapid
availability of safe and effective medicines of assured quality, including life saving
treatments for priority diseases ("ARMH").
19. "Project Coordination Team" and "PCT" mean the group responsible for coordinating
implementation of the Project activities and referred to in paragraph 2 of Section I.A
of Schedule 2 to this Agreement.
20. "Protocol" means the "Protocol on the Establishment of the East African Community
Common Market" signed by the EAC Heads of State on November 20, 2009, and
entered into force on July 1, 2010.
21. "Regional Expert Working Groups" means a group of technical experts in a
specialized functional/thematic area in medicines regulation nominated from the
Partner States' NMRAs.
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22. "Secretariat" means the executive organ of the Recipient established pursuant to the
provisions of Articles 9.1(g) and 66 of the Treaty (as hereinafter defined).
23. "Steering Committee" means the committee referred to in paragraph 3 of Section L.A
of Schedule 2 to this Agreement.
24. "Training" means the expenditures incurred to finance the cost of the meetings and
the training and workshops to be provided and/or received under the Project, and
including: (i) per diem and travel expenses of the attendees, training instructors
(trainers) and/or training participants (trainees); (ii) educational equipment and
materials for display (including, without limitation, television, projector); (iii) training
and/or workshop fees and other reasonable and ancillary costs for attending the
meetings, training and/or workshop; and (iv) organization and coordination, training
facilities, and communication and marketing costs related to the meetings, training
and/or workshop events.
25. "Treaty" means Arusha Treaty for the Establishment of the East African Community
(1999) (as amended on December 14, 2006 and August 20, 2007).
26. "WHO" means the World Health Organization.
27. "WHO Co-financing Agreement" (Memorandum of Understanding between the East
African Community and World Health Organization) means an amount of
approximately one million Dollars ($1,000,000) provided in kind by the WHO to
assist in financing the Project out of the portion of the Global Medicines Regulatory
Harmonization Initiative Trust Fund which the WHO shall receive from the Bank to
support selected activities of the Project in accordance with the WHO's own
procedures and guidelines, including procurement guidelines.
Section II. Modifications to the Standard Conditions
The Standard Conditions are modified as follows:
1. (a) Paragraph 17 of the Appendix (Definitions) is modified to read as follows:
"17. "Member Country" means a member of the World Bank in whose
territory the Project is carried out or any of such member's political or
administrative subdivisions, and refers separately to each such member."
(b) A new definition 27 is added to read as follows:
"27. "Partner States" means collectively the states-parties signatories of
the Arusha Treaty for the Establishment of the East African Community
(1999), namely the Republic of Burundi, the Republic of Kenya, the United
Republic of Tanzania, the Republic of Rwanda, and the Republic of Uganda,
and in whose territories the Project is carried out; and "Partner State" refers
separately and individually to each and any of such Partner States."
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2. Section 3.07 is modified to read as follows:
"Section 3.07. Financing Taxes
(a) The Grant Agreement may specify that the proceeds of the Grant may not be
withdrawn to pay for Taxes levied by, or in the territory of, a Member Country on or
in respect of Eligible Expenditures, or on their importation, manufacture,
procurement or supply. In such case, if the amount of any such Taxes decreases or
increases, the World Bank may, by notice to the Recipient, adjust the percentage of
such Eligible Expenditures to be financed out of the proceeds of the Grant specified
in the Grant Agreement, as required to ensure consistency with such limitation on
withdrawals."
3. Section 4.02 is amended as follows:
(i) Paragraph (a) is amended to read as follows:
"(a) Interference. If the Grant has been made to a Recipient which is not the
Member Country, a Member Country has: (i) taken or permitted to be taken any action
which would prevent or interfere with the execution of the Project or the performance
by the Recipient of its obligations under the Grant Agreement; or (ii) failed to afford
a reasonable opportunity for representatives of the World Bank to visit any part of its
territory for purposes related to the Grant or the Project."
(ii) Paragraphs (c) and (d) are amended to read as follows:
"(c) Fraud and Corruption. At any time, the World Bank determines that any
representative of the Recipient (or any Member Country, if the Recipient is not the
Member Country, or any other recipient of any of the proceeds of the Grant) has
engaged in corrupt, fraudulent, coercive or collusive practices in connection with the
use of the proceeds of the Grant, without the Recipient (or any such Member Country
or any other such recipient) having taken timely and appropriate action satisfactory to
the World Bank to address such practices when they occur.
(d) Cross Suspension. IBRD or IDA has suspended in whole or in part the
right of the Recipient (or of any Member Country, if the Recipient is not the Member
Country) to make withdrawals under any agreement with IBRD or with IDA because
of a failure by the Recipient (or by any such Member Country) to perform any of its
obligations under such agreement or any other agreement with IBRD or IDA."
(iii) Paragraph (h) is amended to read as follows:
"(h) Membership. A Member Country: (i) has been suspended from
membership in or ceased to be a member of IBRD or of IDA; or (ii) has ceased to be
a member of the International Monetary Fund."
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(iv) The first sentence of paragraph (i) is amended to read as follows:
"(i) Condition of Recipient. If the Grant has been made to a Recipient which
is not a Member Country:"
(v) Paragraph (j) is amended to read as follows:
"(j) Ineligibility. IBRD or IDA has declared the Recipient (other than a
Member Country) ineligible to receive proceeds of any financing made by IBRD or
IDA or otherwise to participate in the preparation or implementation of any project
financed in whole or in part by IBRD or IDA, as a result of: (i) a determination by
IBRD or IDA that the Recipient has engaged in fraudulent, corrupt, coercive or
collusive practices in connection with the use of the proceeds of any financing made
by IBRD or IDA; and/or (ii) a declaration by another financier that the Recipient is
ineligible to receive proceeds of any financing made by such financier or otherwise to
participate in the preparation or implementation of any project financed in whole or
in part by such financier as a result of a determination by such financier that the
Recipient has engaged in fraudulent, corrupt, coercive or collusive practices in
connection with the use of the proceeds of any financing made by such financier."
4. Paragraph (c) of Section 4.03 is modified to read as follows:
"(c) Fraud and Corruption. At any time, the World Bank determines, with
respect to any amount of the proceeds of the Grant, that corrupt, fraudulent, collusive
or coercive practices were engaged in by representatives of the Recipient (or any
Member Country, if the Recipient is not a Member Country, or any other recipient of
the proceeds of the Grant), without the Recipient (or any such Member Country or
other recipient of the proceeds of the Grant) having taken timely and appropriate
action satisfactory to the World Bank to address such practices when they occur."
5. Paragraph (a)(ii) of Section 4.05 is modified to read as follows:
"(ii) (A) engaging in corrupt, fraudulent, collusive or coercive practices in
connection with the use of such amount, or (B) use of such amount to finance a
contract during the procurement or execution of which such practices were engaged
in by representatives of the Recipient (or any Member Country, if the Recipient is not
a Member Country, or other recipient of such amount of the Grant), in either case
without the Recipient (or any such Member Country, or other such recipient) having
taken timely and appropriate action satisfactory to the World Bank to address such
practices when they occur."
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6. Paragraph (j) of Section 5.03 is modified to read as follows:
"(j) If, within thirty days after counterparts of the award have been delivered
to the parties, the award has not been complied with, any party may: (i) enter judgment
upon, or institute a proceeding to enforce, the award in any court of competent
jurisdiction against any other party; (ii) enforce such judgment by execution; or
(iii) pursue any other appropriate remedy against such other party for the enforcement
of the award and the provisions of the Grant Agreement. Notwithstanding the
foregoing, if the Recipient is the Member Country, this Section shall not authorize any
entry of judgment or enforcement of the award against the Recipient except as such
procedure may be available otherwise than by reason of the provisions of this
Section."