GRANT NUMBER D802-GM GRANT NUMBER D597-GM (AMENDMENT) Financing Agreement (Second Additional Financing for The Gambia COVID-19 Vaccine Preparedness and Response Project) between REPUBLIC OF THE GAMBIA and INTERNATIONAL DEVELOPMENT ASSOCIATION GRANT NUMBER D802-GM GRANT NUMBER D597-GM (AMENDMENT) FINANCING AGREEMENT AGREEMENT dated as of the Signature Date between the REPUBLIC OF THE GAMBIA (“Recipient”) and INTERNATIONAL DEVELOPMENT ASSOCIATION (“Association”) for the purpose of: (i) providing additional financing for activities related to the Original Project; and (ii) amending specific provisions of the Original Financing Agreement (as defined in the Appendix to this Agreement). The Recipient and the Association hereby agree as follows: ARTICLE I — GENERAL CONDITIONS; DEFINITIONS 1.01. The General Conditions (as defined in the Appendix to this Agreement) apply to and form 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 General Conditions or in the Appendix to this Agreement. ARTICLE II — FINANCING 2.01. The Association agrees to extend to the Recipient a grant, which is deemed as Concessional Financing for purposes of the General Conditions, in an amount equivalent to five million six hundred thousand Special Drawing Rights (SDR 5,600,000) (“Financing”), to assist in financing the project described in Schedule 1 to this Agreement (“Project”). 2.02. The Recipient may withdraw the proceeds of the Financing in accordance with Section III of Schedule 2 to this Agreement. 2.03. The Maximum Commitment Charge Rate is one-half of one percent (1/2 of 1%) per annum on the Unwithdrawn Financing Balance. 2.04. The Payment Dates are September 15 and March 15in each year. 2.05. The Payment Currency is Dollar. ARTICLE III — PROJECT 3.01. The Recipient declares its commitment to the objectives of the Project and the MPA Program. To this end, the Recipient shall carry out the Project in accordance with the provisions of Article V of the General Conditions and Schedule 2 to this Agreement. -2- ARTICLE IV — EFFECTIVENESS; TERMINATION 4.01. The Additional Condition of Effectiveness consists of the following, namely that the Recipient has updated the ESMF and the SEP in a manner acceptable to the Association. 4.02. The Effectiveness Deadline is the date ninety (90) days after the Signature Date. 4.03. For purposes of Section 10.05(b) of the General Conditions, the date on which the obligations of the Recipient under this Agreement (other than those providing for payment obligations) shall terminate is twenty years after the Signature Date. ARTICLE V — REPRESENTATIVE; ADDRESSES 5.01. The Recipient’s Representative is the minister responsible for finance. 5.02. For purposes of Section 11.01 of the General Conditions: (a) the Recipient’s address is: Ministry of Finance and Economic Affairs The Quadrangle Banjul Republic of The Gambia; and (b) the Recipient’s Electronic Address is: Facsimile: +2204227954 5.03. For purposes of Section 11.01 of the General Conditions: (a) The Association’s address is: International Development Association 1818 H Street, N.W. Washington, D.C. 20433 United States of America; and (b) the Association’s Electronic Address is: Telex: Facsimile: 248423 (MCI) 1-202-477-6391 -3- AGREED as of the Signature Date. REPUBLIC OF THE GAMBIA By: _____________________________________ Authorized Representative Honorable Mambury Njie Name: _____________________________ Minister Title: ______________________________ 28-Apr-2021 Date: ______________________________ INTERNATIONAL DEVELOPMENT ASSOCIATION By: _____________________________________ Authorized Representative Nathan M. Belete Name: _____________________________ Country Director Title: ______________________________ 26-Apr-2021 Date: ______________________________ -4- SCHEDULE 1 Project Description The objectives of the Project are to prevent, detect and respond to the threat posed by COVID-19 and strengthen national system for public health preparedness. The Project is a part of the MPA Program and consists of the Original Project and the following Part 1(c): Part 1: Emergency COVID-19 Response Providing immediate support to prevent COVID-19 from arriving or limiting local transmission through containment strategies, including the following: (a) Enhancing case detection, confirmation, tracing, recording and reporting through inter alia: (i) strengthening disease surveillance systems; (ii) strengthening the capacity of the Public Health Emergency Operation Center; (iii) combining detection of new cases with active contact tracing locally and at various points of entry; (iv) providing on-time data and information for guiding decision-making, response and mitigation activities; (v) strengthening the health management information system to facilitate recording and on-time virtual sharing of information; (vi) developing a public health emergency plan; and (vii) implementing the Recipient’s health care waste management plan including, inter alia, medical waste management and establishing disposal systems such as non-incineration cluster treatment in health facilities. (b) Supporting the implementation of social distancing measures through inter alia: (i) developing and implementing guidelines related to social distancing measures; (ii) developing and production of risk communication and community engagement materials; (iii) community engagement and social mobilization of target audiences; (iv) operationalizing existing or new laws and regulations on social distancing measures; and (v) supporting preventative actions complementary to social distancing including the promotion of personal hygiene; the promotion of handwashing and proper cooking; the distribution and use of masks, and the promotion of community participation in slowing the spread of the pandemic. (c) Supporting Project COVID-19 Vaccine acquisition and deployment through inter alia: -5- (i) Providing planning and management support for the development and implementation of regional micro-plans to ensure proper distribution of the Project COVID-19 Vaccines. (ii) Strengthening the Recipient’s regulatory framework and standards on medicines/vaccines registration system, national pharmacovogilance system and adverse events following immunization (AEFI) system. (iii) Providing logistics and cold-chain support through: (A) facilitating advance acquisition mechanisms, procurement, transportation and storage of Project COVID-19 Vaccines, (B) procurement of requisite vaccination supplies and other COVID-related supplies including diagnostic tests and drugs for side-effects, (C) development and implementation of a Project COVID-19 Vaccine delivery and distribution plan, (D) development and dissemination of protocols and SOPs for monitoring purposes and (E ) improving the cold chain system, using energy efficient technologies. (iv) Facilitating program delivery by: (A) supporting community engagement and advocacy on COVID-19 and Project COVID-19 Vaccine; (B) supporting delivery and dissemination of the Project COVID-19 Vaccine to target population; (C) improving Project COVID-19 Vaccine safety and surveillance systems; and (D) supporting waste management of Project COVID-19 Vaccine waste through procurement of incinerators. (v) Supporting Monitoring and Performance Management by: (A) linking Project COVID-19 Vaccine vaccination registration with the establishment of an electronic civil registration and vital statistics system and produce vaccination registration dashboards for real-time progress monitoring of vaccine coverage and adverse events; and (B) improving the quality and completeness of Project COVID-19 Vaccine vaccination data. Part 2: Strengthening Multi-sector, National Institutions and Platforms for Policy Development and Coordination of Prevention and Preparedness using One Health Approach Strengthening national disease surveillance and diagnostic capacities for public health emergencies and other hazards and enhancing national diseases information and analytical systems. -6- Part 3: Supporting National and Subnational Prevention and Preparedness (a) Developing and implementing a costed plan for the collection, packaging, transportation and testing of COVID-19 samples to the WHO recommended laboratories, including, inter alia, preparation of associated standard operating procedures, guidelines and terms of reference and provision of containers for handling specimen. (b) Strengthening the capacities of laboratories in various health facilities for provision of full hematology, biochemistry, microbiology and other critical services and provision of critical consumables, reagents, personal protective equipment and other equipment stock for emergencies. (c) Provision of Training to medical and veterinary laboratory personnel on handling highly specialized personal protective equipment and testing of hazardous biological samples efficiently and effectively. (d) Acquisition of vehicles, motorcycles and ambulances for emergency operations and cold chain apparatus for transportation of biological surveillance samples and blood products. (e) Acquisition of emergency medical and non-medical supplies such as gloves, surgical masks, respirators, eye protection wear and isolation gowns as well as infection prevention and control materials for health workers and health facilities. (f) Supporting rehabilitation and upgrading of selected treatment and isolation centers, and construction of a designated public health emergency treatment center. (g) Supporting the provision of laboratory equipment and supplies to selected laboratories and the construction of new national public health laboratory and training center. Part 4: Implementation Management and Monitoring and Evaluation Strengthening the capacity of the Project Coordination Unit and the Ministry of Health for day to day implementation, coordination, supervision and overall management (including, fiduciary aspects, monitoring and evaluation, carrying out of audits and reporting) of Project activities and results all through the provision of technical advisory services, Training, Operating Costs, non-consulting services and acquisition of goods for the purpose. -7- SCHEDULE 2 Project Execution Section I. Implementation Arrangements A. Institutional Arrangements 1. National Health Emergency Committee The Recipient shall designate, at all times during the implementation of the Project, the National Health Emergency Committee (“NHEC”) to be responsible for, inter alia: (a) providing strategic and policy guidance on the implementation of the Project; (b) reviewing progress made towards achieving the Project’s objectives; and (c) facilitating coordination of Project activities and removal of any obstacle(s) to the implementation of the Project. 2. Ministry of Health Without limitation upon the provisions of paragraph 1 of this Section I.A, the Recipient shall designate, at all times during the implementation of the Project, the Ministry of Health (“MOH”) to be responsible for prompt and efficient oversight and implementation of activities under the Project, and shall take all actions including the provision of funding, personnel and other resources necessary to enable said MOH to perform said functions. 3. Project Coordination Unit Without limitation upon the provisions of paragraphs 1 and 2 of this Section I.A, the Recipient, through the MOH, shall designate, at all times during the implementation of the Project, the Project Coordination Unit (“PCU”), to be responsible for day to day execution, coordination and implementation (including procurement, financial management, environmental and social safeguards, supervision, reporting and communication aspects) of activities under the Project. To this end, the Recipient shall take all actions, including the provision of funding, personnel (including a procurement specialist, a financial management specialist, an operations officer, an environmental specialist and a social development specialist), and other resources satisfactory to the Association, to enable the PCU to perform said functions. -8- B. Implementation Arrangements 1. National COVID-19 Preparedness and Response Plan and the National COVID-19 Vaccination Plan Without limitation to Section 3.01 of this Agreement, the Recipient shall ensure that the Project is carried out in accordance with the National COVID-19 Preparedness and Response Plan and the National COVID-19 Vaccination Plan as applicable; and shall maintain, at all times during the implementation of the Project, adequate public health emergency coordination and management arrangements, all in a manner acceptable to the Association. 2. Project Operations Manual (a) The Recipient shall, not later than thirty (30) days after the Effective Date update and adopt a Project operations manual containing detailed guidelines and procedures for the implementation of the Project, including with respect to: (i) administration and coordination, monitoring and evaluation, financial management, procurement and accounting procedures, environmental and social safeguards, corruption and fraud mitigation measures, a grievance redress mechanism, collection and processing of Personal Data in accordance with good international practice, roles and responsibilities for Project implementation; (ii) rules and procedures for prioritizing intra-country Project COVID-19 Vaccine allocation following principles established in the WHO Fair Allocation Framework, including an action plan setting out the timeline and steps for implementing such rules; (iii) rules and procedures establishing minimum standards for Project COVID-19 Vaccine management and monitoring, including medical and technical criteria, communications and outreach plan, cold chain infrastructure, and other related logistics infrastructure; and (iv) Project COVID-19 Vaccine distribution plan, including action plan setting out timeline and steps for immunization; and such other arrangements and procedures as shall be required for the effective implementation of the Project, in form and substance satisfactory to the Association (“Project Operations Manual”). (b) In case of any conflict between the provisions of the Project Operations Manual and the provisions of this Agreement, the provisions of this Agreement shall prevail, and except as the Association shall otherwise agree, the Recipient shall not amend, abrogate or waive any provision of the Project Operations Manual. -9- 3. Work Plan and Budget (a) The Recipient shall, not later than one (1) month after the Effective Date, prepare and furnish to the Association, a work plan and budget containing all activities proposed to be included in the Project and a proposed financing plan for expenditures required for such activities, setting forth the proposed amounts and sources of financing. (b) The proposed work plan and budget shall specify any Training activities that may be required under the Project, including: (i) the type of Training; (ii) the purpose of the Training; (iii) the personnel to be trained; (iv) the institution or individual who will conduct the Training; (v) the location and duration of the Training; and (vi) the cost of the Training. (c) The Recipient shall afford the Association a reasonable opportunity to exchange views with the Recipient on such proposed work plan and budget and thereafter ensure that the Project is implemented with due diligence in accordance with such work plan and budget as shall have been approved by the Association (“Work Plan and Budget”). (d) The Recipient shall not make or allow to be made any change to the approved Work Plan and Budget without prior approval in writing by the Association. C. Environmental and Social Standards 1. The Recipient shall ensure that the Project is carried out in accordance with the Environmental and Social Standards, in a manner acceptable to the Association. 2. Without limitation upon paragraph 1 above, the Recipient shall ensure that the Project is implemented in accordance with the Environmental and Social Commitment Plan (“ESCP”), in a manner acceptable to the Association. To this end, the Recipient shall ensure that: (a) the measures and actions specified in the ESCP are implemented with due diligence and efficiency, as provided in the ESCP; (b) sufficient funds are available to cover the costs of implementing the ESCP; (c) policies and procedures are maintained, and qualified and experienced staff in adequate numbers are retained to implement the ESCP, as provided in the ESCP; and - 10 - (d) the ESCP, or any provision thereof, is not amended, repealed, suspended or waived, except as the Association shall otherwise agree in writing, as specified in the ESCP, and ensure that the revised ESCP is disclosed promptly thereafter. 3. Without limitation upon the provisions of paragraph 2 above, if sixty (60) days prior to the Closing Date, the Association determines that there are measures and actions specified in the ESCP which will not be completed by the Closing Date, the Recipient shall: (a) not later than thirty (30) days before the Closing Date, prepare and present to the Association, an action plan satisfactory to the Association on the outstanding measures and actions, including a timetable and budget allocation for such measures and actions (which action plan shall deemed to be considered an amendment of the ESCP); and (b) thereafter, carry out said action plan in accordance with its terms and in a manner acceptable to the Association. 4. In case of any inconsistencies between the ESCP and the provisions of this Agreement, the provisions of this Agreement shall prevail. 5. The Recipient shall ensure that: (a) all measures necessary are taken to collect, compile, and furnish to the Association through regular reports, with the frequency specified in the ESCP, and promptly in a separate report or reports, if so requested by the Association, information on the status of compliance with the ESCP and the environmental and social instruments referred to therein, all such reports in form and substance acceptable to the Association, setting out, inter alia: (i) the status of implementation of the ESCP; (ii) conditions, if any, which interfere or threaten to interfere with the implementation of the ESCP; and (iii) corrective and preventive measures taken or required to be taken to address such conditions; and (b) the Association is promptly notified of any incident or accident related to or having an impact on the Project which has, or is likely to have, a significant adverse effect on the environment, the affected communities, the public or workers in accordance with the ESCP, the environmental and social instruments referenced therein and the Environmental and Social Standards. 6. The Recipient shall establish, publicize, maintain and operate an accessible grievance mechanism, to receive and facilitate resolution of concerns and grievances of Project-affected people, and take all measures necessary and appropriate to resolve, or facilitate the resolution of, such concerns and grievances, in a manner acceptable to the Association. - 11 - 7. The Recipient shall ensure that all bidding documents and contracts for civil works under the Project include the obligation of contractors , subcontractor and supervising entities to: (a) comply with the relevant aspects of ESCP and the environmental and social instruments referred to therein; and (b) adopt and enforce codes of conduct that should be provided to and signed by all workers, detailing measures to address environmental, social, health and safety risks, and the risks of sexual exploitation and abuse, sexual harassment and violence against children, all as applicable to such civil works commissioned or carried out pursuant to said contracts. D. Standards for Project COVID-19 Vaccine Approval All Project COVID-19 Vaccines shall satisfy the Vaccine Approval Criteria. Section II. Project Monitoring, Reporting and Evaluation The Recipient shall furnish to the Association each Project Report not later than one month after the end of each calendar semester, covering the calendar semester. Except as may otherwise be explicitly required or permitted under this Agreement or as may be explicitly requested by the Association, in sharing any information, report or document related to the activities described in Schedule 1 of this Agreement, the Recipient shall ensure that such information, report or document does not include Personal Data. Section III. Withdrawal of the Proceeds of the Financing A. General Without limitation upon the provisions of Article II of the General Conditions and in accordance with the Disbursement and Financial Information Letter, the Recipient may withdraw the proceeds of the Financing to finance Eligible Expenditures in the amount allocated and, if applicable, up to the percentage set forth against each Category of the following table: Percentage of Amount of the Grant Expenditures to be Allocated Financed Category (expressed in SDR) (inclusive of Taxes) (1) Goods, works, non-consulting 5,600,000 100% services, consulting services, Training and Operating Costs for Part 1(c) of the Project TOTAL AMOUNT 5,600,000 - 12 - B. Withdrawal Conditions; Withdrawal Period 1. Notwithstanding the provisions of Part A above, no withdrawal shall be made for payments made prior to the Signature Date, except that withdrawals up to an aggregate amount not to exceed SDR 1,120,000 may be made for payments made prior to this date but on or after January 1, 2021, for Eligible Expenditures under Category 1. 2. The Closing Date is March 31, 2023. Section IV. Other Undertakings 1. The Recipient shall, no later than three (3) months after the Effective Date, or such later date as agreed by the Association, customize the Project’s accounting software, in form and substance satisfactory to the Association. 2. The Recipient shall, no later than three (3) months after the Effective Date, or such later date as agreed by the Association, sign an addendum to the Project auditor’s contract, in form and substance satisfactory to the Association. - 13 - APPENDIX Section I. Definitions 1. “Additional Financing for the Original Project” means the Project descried in Annex 1 of the Grant Agreement. 2. “Anti-Corruption Guidelines” means, for purposes of paragraph 5 of the Appendix to the General Conditions, 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 and as of July 1, 2016. 3. “Category” means a category set forth in the table in Section III.A of Schedule 2 to this Agreement. 4. “COVID-19” means the coronavirus disease caused by the 2019 novel coronavirus (SARS-CoV-2). 5. “Environmental and Social Management Framework” or “ESMF” means the same plan prepared for the Original Project, referred to in Article IV, Section 4.01 to this Agreement, and to be updated, consulted upon, disclosed and adopted for the Project, as set out in the ESCP, in accordance with the Environmental and Social Standards”. 6. “Environmental and Social Commitment Plan” or “ESCP” means the environmental and social commitment plan for the Project, dated March 17, 2021, as the same may be amended from time to time in accordance with the provisions thereof, which sets out the material measures and actions that the Recipient shall carry out or cause to be carried out to address the potential environmental and social risks and impacts of the Project, including the timeframes of the actions and measures, institutional, staffing, Training, monitoring and reporting arrangements, and any environmental and social instruments to be prepared thereunder. 7. “Environmental and Social Standards” or “ESSs” means, collectively: (a) “Environmental and Social Standard 1: Assessment and Management of Environmental and Social Risks and Impacts”; (b) “Environmental and Social Standard 2: Labor and Working Conditions”; (c) “Environmental and Social Standard 3: Resource Efficiency and Pollution Prevention and Management”; (d) “Environmental and Social Standard 4: Community Health and Safety”; (e) “Environmental and Social Standard 5: Land Acquisition, Restrictions on Land Use and Involuntary Resettlement”; (f) “Environmental and Social Standard 6: Biodiversity Conservation and Sustainable Management of Living Natural Resources”; (g) “Environmental and Social Standard 7: Indigenous - 14 - Peoples/Sub-Saharan Historically Underserved Traditional Local Communities”; (h) “Environmental and Social Standard 8: Cultural Heritage”; (i) “Environmental and Social Standard 9: Financial Intermediaries”; (j) “Environmental and Social Standard 10: Stakeholder Engagement and Information Disclosure”; effective on October 1, 2018, as published by the Association. 8. “General Conditions” means the “International Development Association General Conditions for IDA Financing, Investment Project Financing”, dated December 14, 2018 (revised on August 1, 2020). 9. “Ministry of Health” or “MOH” means the Recipient’s ministry responsible for health, and any successor thereto. 10. “MPA Program” means the global emergency multiphase programmatic approach program designed to assist countries to prevent, detect and respond to the threat posed by COVID-19 and strengthen national systems for public health preparedness. 11. “National COVID-19 Preparedness and Response Plan” means the Recipient’s emergency preparedness and response plan for COVID-19, dated March 6, 2020, and acceptable to the Association, as said document may be modified from time to time during the Emergency, and such term includes all schedules and annexes to said document. 12. “National COVID-19 Vaccination Plan” means the Recipient’s vaccination plan for COVID-19, dated February 2021, and acceptable to the Association, as said document may be modified from time to time, and such term includes all schedules and annexes to said document. 13. “National Health Emergency Committee” means the Recipient’s committee referred to in Section I.A.1 of Schedule 2 to this Agreement. 14. “Operating Costs” means the reasonable incremental expenses arising under the Project, and based on the Work Plan and Budget, on account of vehicle operation and maintenance, maintenance of equipment, communication and insurance costs, office administration costs, utilities, rentals, accommodation, banking charges, advertising expenses, travel and per diem, but excluding the salaries of the Recipient’s civil servants. 15. “Original Financing Agreement” means the financing agreement for the Original Project between The Republic of The Gambia and the International Development Association dated April 3, 2020 (Grant No. D597-GM). - 15 - 16. “Original Project” means the Project described in Schedule 1 to the Original Financing Agreement. 17. “Personal Data” means any information relating to an identified or identifiable individual. An identifiable individual is one who can be identified by reasonable means, directly or indirectly, by reference to an attribute or combination of attributes within the data, or combination of the data with other available information. Attributes that can be used to identify an identifiable individual include, but are not limited to, name, identification number, location data, online identifier, metadata and factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of an individual. 18. “Procurement Regulations” means, for purposes of paragraph 87 of the Appendix to the General Conditions, the “World Bank Procurement Regulations for IPF Borrowers”, dated November 2020. 19. “Project Coordination Unit” means the Recipient’s unit referred to in Section I.A.3 of Schedule 2 to this Agreement. 20. “Project COVID-19 Vaccine” means a vaccine for the prevention of COVID-19, authorized by the Recipient’s national regulatory authority for distribu tion, marketing and administration within the territory of the Recipient , and acquired or deployed under the Project; “Project COVID-19 Vaccines” means the plural thereof. 21. “Project Operations Manual” means the Recipient’s manual referred to in Section I.B.2 of Schedule 2 to this Agreement. 22. “Public Health Emergency Operation Center” means the Recipient’s center established and operating within the Ministry of Health. 23. “Regions” mean the regional areas of the North America, South America, Europe, Asia, Asia Pacific, and Africa. 24. “Stakeholder Engagement Plan” means the same plan prepared for the Original Project, referred to in Article IV, Section 4.01 to this Agreement, and to be updated, consulted upon, disclosed and adopted for the Project, as set out in the ESCP, in accordance with the Environmental and Social Standards”. 25. “Signature Date” means the later of the two dates on which the Recipient and the Association signed this Agreement and such definition applies to all references to “the date of the Financing Agreement” in the General Conditions. 26. “Stringent Regulatory Authority” means a National Regulatory Authority (“NRA”) that is classified by WHO as a Stringent Regulatory Authority. - 16 - 27. “Training” means the costs associated with training, workshops and study tours provided under the Project, based on the Work Plan and Budget, consisting of reasonable expenditures (other than expenditures for consultants’ services) for: (a) travel, room, board and per diem expenditures incurred by trainers and trainees in connection with their training and by non-consultant training facilitators; (b) course fees; (c) training facility rentals; and (d) training material preparation, acquisition, reproduction and distribution expenses. 28. “Vaccine Approval Criteria” means that the vaccine: (a) has been approved by three (3) Stringent Regulatory Authorities (including by Emergency Use Authorization) in two (2) Regions; or (b) has received the WHO Emergency Use Listing and has been produced with a licensing or similar arrangement from a manufacturer of a parent/bioequivalent vaccine that has received a prior Stringent Regulatory Authority approval (including Emergency Use Authorization); or (c) has met such other criteria as may be agreed in writing between the Recipient and the Association. 29. “Work Plan and Budget” means the work plan and budget approved by the Association and adopted by the Recipient in accordance with the provisions of Section I.B.3 of Schedule 2 to this Agreement, as said work plan and budget may be modified from time to time with the written agreement of the Association. 30. “World Health Organization” or the acronym “WHO” means the United Nations World Health Organization. 31. “WHO Emergency Use Listing” means a risk-based procedure for assessing and listing by WHO of unlicensed vaccines, therapeutics, and in vitro diagnostics with the aim of expediting the availability of these products to people affected by a declared public health emergency. 32. “WHO Fair Allocation Framework” means the WHO’s allocation framework as elaborated in its working paper on “Fair allocation mechanism for COVID -19 vaccines through the COVAX Facility” dated September 9, 2020, for prioritizing: (a) frontline workers in health and social care settings; (b) the elderly; and (c) and people who have underlying conditions that put them at a higher risk of death. 33. “WHO Prequalification” means a service provided by WHO to assess the quality, safety, and efficacy of medical products for priority diseases, and which are intended for United Nations and international procurement to developing countries. - 17 - Section II. Amendments to the Original Financing Agreement The Original Financing Agreement is amended as follows: 1. The Original Project description under Part 1 of Schedule 1 to the Original Financing Agreement is amended by adding sub-component (c) as follows: (c) Supporting Project COVID-19 Vaccine acquisition and deployment through inter alia: (i) Providing planning and management support for the development and implementation of regional micro-plans to ensure proper distribution of the Project COVID-19 Vaccines. (ii) Strengthening the Recipient’s regulatory framework and standards on medicines/vaccines registration system, national pharmacovogilance system and adverse events following immunization (AEFI) system (iii) Providing logistics and cold-chain support through: (A) facilitating advance acquisition mechanisms, procurement, transportation and storage of Project COVID-19 Vaccines; (B) procurement of requisite vaccination supplies and other COVID-related supplies including diagnostic tests and drugs for side-effects; (C) development and implementation of a Project COVID-19 Vaccine delivery and distribution plan; (D) development and dissemination of protocols and SOPs for monitoring purposes; and (E ) improving the cold chain system, using energy efficient technologies (iv) Facilitating program delivery by: (A) supporting community engagement and advocacy on COVID-19 and Project COVID-19 Vaccine; (B) supporting delivery and dissemination of the Project COVID-19 Vaccine to target population; (C) improving Project COVID-19 Vaccine safety and surveillance systems; (D) supporting waste management of Project COVID-19 Vaccine waste through procurement of incinerators. (v) Supporting Monitoring and Performance Management by: (A) linking Project COVID-19 Vaccine vaccination registration with the establishment of an electronic civil registration and vital statistics system and produce vaccination registration dashboards for real-time progress monitoring of vaccine coverage and adverse events; and (B) improving the quality and completeness of Project COVID-19 Vaccine vaccination data. - 18 - 2. The Implementation Arrangements set forth in Sections I.B.1 and I.B.2 of Schedule 2 to the Original Financing Agreement are hereby amended and restated as set forth in Sections I.B.1 and I.B.2 of Schedule 2 to this Agreement, and a new Section I.D (Standards for Project COVID-19 Vaccine Approval) is added as set forth in Section I.D of Schedule 2 to this Agreement. 3. Schedule 2 to the Original Financing Agreement is amended by adding a new Section IV (Other Undertakings) as set forth in Section IV of Schedule 2 to this Agreement. 4. The Closing Date set forth in Section III.B.2 of Schedule 2 to the Original Financing Agreement shall be the date March 31, 2023. 5. The Appendix to the Original Financing Agreement is amended by adding the following definitions in alphabetical order, and the rest of the definitions renumbered accordingly: “National COVID-19 Vaccination Plan” means the Recipient’s vaccination plan for COVID-19, dated February 2021, and acceptable to the Association, as said document may be modified from time to time, and such term includes all schedules and annexes to said document. “Project COVID-19 Vaccine” means a vaccine for the prevention of COVID-19, authorized by the Recipient’s national regulatory authority for distribution, marketing and administration within the territory of the Recipient , and acquired or deployed under the Project; “Project COVID- 19 Vaccines” means the plural thereof “Regions” mean the regional areas of the North America, South America, Europe, Asia, Asia Pacific, and Africa. “Stringent Regulatory Authority” means a National Regulatory Authority (“NRA”) that is classified by WHO as a Stringent Regulatory Authority “Vaccine Approval Criteria” means that the vaccine: (a) has been approved by three (3) Stringent Regulatory Authorities (including by Emergency Use Authorization) in two (2) Regions; or (b) has received the WHO Emergency Use Listing and has been produced with a licensing or similar arrangement from a manufacturer of a parent/bioequivalent vaccine that has received a prior Stringent Regulatory Authority approval (including Emergency Use Authorization); or (c) has met such other criteria as may be agreed in writing between the Recipient and the Association. - 19 - “WHO Emergency Use Listing” means a risk-based procedure for assessing and listing by WHO of unlicensed vaccines, therapeutics, and in vitro diagnostics with the aim of expediting the availability of these products to people affected by a declared public health emergency. “WHO Fair Allocation Framework” means the WHO’s allocation framework as elaborated in its working paper on “Fair allocation mechanism for COVID-19 vaccines through the COVAX Facility” dated September 9, 2020, for prioritizing: (a) frontline workers in health and social care settings; (b) the elderly; and (c) and people who have underlying conditions that put them at a higher risk of death. “WHO Prequalification” means a service provided by WHO to assess the quality, safety, and efficacy of medical products for priority diseases, and which are intended for United Nations and international procurement to developing countries.