GRANT NUMBER D958-MZ Financing Agreement (Additional Financing for the COVID-19 Strategic Preparedness and Response Project) between REPUBLIC OF MOZAMBIQUE and INTERNATIONAL DEVELOPMENT ASSOCIATION GRANT NUMBER D958-MZ FINANCING AGREEMENT AGREEMENT dated as of the Signature Date between REPUBLIC OF MOZAMBIQUE ("Recipient") and INTERNATIONAL DEVELOPMENT ASSOCIATION ("Association") for the provision of additional financing to the Original Project and activities related to the Original Project (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, the Original Financing Agreement 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 seventy-one million four hundred thousand (Special Drawing Rights (SDR 71,400,000) ("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 February 15 and August 15 in each year. 2.05. The Payment Currency is Dollar. ARTICLE III - PROJECT 3.01. The Recipient declares its commitment to the objective of the Project and the MPA Program and to this end, the Recipient, through MISAU, 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 Effectiveness Deadline is the date ninety (90) days after the Signature Date. 4.02. 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 its Minister responsible for Economy and Finance or any successor thereof. The Recipient's National Director of Public Debt Management may, by him or herself, represents the Recipient to sign this Agreement, amendments and/or notices to this Agreement. 5.02. For purposes of Section 11.01 of the General Conditions: (a) the Recipient's address is: Minister of Economy and Finance Praga da Marinha Popular Av. 10 de Novembro no 929 Maputo Republic of Mozambique; and (b) the Recipient's Electronic Address is: Facsimile: (+258) 21313747 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 MOZAMBIQUE By Z111- Authorided 'Representative Name: 7fl4tfL Title: ' y/v ( C c1l li Date: INTERNATIONAL DEVELOPMENT ASSOCIATION By Authorized Representative Name: Title: DL. r Y Date: / v o ) -4- SCHEDULE 1 Project Description The objective of the Project is to support the Recipient to acquire, manage, and deploy Project COVID-19 Vaccines, and to strengthen its pandemic preparedness, response, and health systems' capacity. The Project constitutes a phase of the MPA Program and consists of the following parts: Part 1: Vaccines, Medical Supplies and Cold Chain Equipment Provision of support for Project COVID-19 Vaccine acquisition, planning and distribution, including: (a) the acquisition of Project COVID-19 Vaccines; (b) the acquisition of vaccination supplies needed for vaccine delivery and distribution including diluents, syringes, and medical supplies; (c) the acquisition of climate- friendly cold chain inputs, including LED lamps and refrigerators, (d) provision of maintenance of existing cold chain equipment, warehouses, vehicles and other logistics infrastructure, as well as refurbishment and maintenance of facilities to be resilient to climate shocks; (e) provision of equipment for infection prevention and waste management (including climate-friendly waste management and disposal supplies and maintenance); (f) Project COVID-19 Vaccine storage and transportation; and (g) other Project COVID-19 Vaccine related supplies, including diagnostic tests (i.e. polymerase chain reaction, rapid diagnostic tests). Part 2: Vaccine Administration, Follow-up and Community Engagement (a) Supporting implementation of prevention, detection and response activities in the National COVID- 19 Preparedness and Response Plan, the National Deployment and Vaccination Plan, and the National Plan for Vaccination Against COVID-19, and the continuity of essential health services, including: (i) strengthening the capacity of key institutions in the Recipient's immunization system, including capacities for planning, budgeting, and procurement, vaccine distribution, quality control and monitoring and related safeguards, regulation of vaccine safety and indemnification systems, development of contingency plans for safe vaccine delivery and availability in the case of climate emergencies. (ii) provision of assistance to the Recipient for: (A) closing the gaps identified in the vaccine readiness assessments for COVID-19- related systems; (B) assessing and enhancing policies, -5- institutional frameworks, and capacities around safe and effective Project COVID-19 Vaccine deployment; (C) support for the quantification and forecasting of supply needs, including vaccines, immunization-related supplies and human resources, to ensure no disruption in essential services while Project COVID- 19 Vaccines are being rolled out; and (D) training of front-line delivery workers for service delivery. (iii) Strengthening the overall national immunization budgeting and budget tracking capacity, including coordination mechanisms between national health and finance authorities and donors. (iv) Supporting and optimizing plans and processes for collection and transportation of used Project COVID-19 Vaccines' syringes and other related medical waste to disposal sites, as well as developing and implementing guidelines and staff training to improve climate friendly medical waste management at the facility level. (v) strengthening the Recipient's existing AEFI monitoring system, including policies and structures for indemnification and compensation, including the provision of support to institutionalize traceability tools, skills and processes to: (A) improve distribution to end-users; (B) prevent diversion and elite capture; (C) contribute to regulatory efforts to identify false and sub-standard products; (D) strengthen relevant existing institutions; (E) monitor AEFI, with potential for broader application in the health system, including monitoring vaccines for climate-induced preventable diseases, including building capacity to manage communication following any AEFI; and (vi) strengthening MISAU, DPH, INS, and CMAM's capacity to improve effective data utilization, including: (A) development of harmonized procedures for surveillance, reporting, diagnosis and response to COVID-19 and other priority diseases; (B) improvement of the interoperability and better utilization of laboratory and other data systems, including the use of digital tools for data-driven decision-making; (C) expand sentinel surveillance sites; (D) support piloting of innovative digital surveillance approaches to improve monitoring and control of COVID-19 and infectious disease outbreaks; (E) reinforcing of the Recipient's network of high-quality laboratories, including possible support to enable genomic surveillance; and (F) supporting the undertaking of a baseline sero-surveillance study with representative samples of target populations in order to distinguish between infection and vaccine acquired immunity. -6- (b) Provision of support for building community trust and vaccine confidence, through: (i) improving the national risk-communication plan and activities to ensure community participation in COVID- 19 vaccination efforts, including accurate information sharing, efforts to create demand, and counter measures for addressing disinformation, as well as dissemination of educational materials to promote behavioral changes that prevent transmission and acquisition of COVID-19 and other climate induced water and vector-borne diseases; and (ii) supporting communications and community engagement efforts and targeting strategies that explicitly address restricted mobility and access to information and vaccinations by women, IDPs, and other disadvantaged groups, including: (A) introducing the use of interactive multi-media platforms, as well as the support of facility level outreach and accountability mechanisms to help monitor and promote the Project COVID-19 Vaccine rollout; (B) developing standard protocols and an integrated data management platform to triage, channel, and respond to complaints registered on these mechanisms; (C) support to the development of community-level mobilization efforts and vaccination points targeting women; (D) promoting the inclusion of informal sectors and community health workers, with special consideration to women, as part of prioritized groups; (E) provision of vaccines together with other RMNCAH-N services that target women and vulnerable groups to leverage the benefits of both; and (F) mobile brigades to reach vulnerable populations, including those in IDP and refugee camps, people living with disabilities, and prisoners. Part 3: Continuity of Essential Services Strengthening the resilience and performance of the Recipient's health system, specifically to address the disruptions of the COVID-19 pandemic in routine essential maternal, child and adolescent health services at the primary health care level, in addition to services for communicable diseases, through: (a) Provision of training and inputs to expand the new role of APEs in rolling out the COVID-19 vaccine campaign to rural areas, while promoting demand and access to essential health services and information, including: (i) training to support population sensitization to increase demand; (ii) preventive measures and recognition of symptoms of COVID- 19 and other key health concerns, particularly for mothers, children, and adolescents; (iii) technical assistance and provision of financing to CMAM for the forecasting, acquisition, and deployment of supply kits for APEs. -7- (b) Provision of support for improving coordination between EPI and CMAM, with a focus on streamlining delivery and institutionalizing last mile outsourcing of essential drug and vaccine distribution, including: (i) provision of support for a more efficient distribution of Project COVID- 19 Vaccines to rural areas, including to APEs; and (ii) provision of support for the implementation of the Pharmaceutical Logistics Strategic Plan, focused on centralizing the supply chain, improving its management, and outsourcing last mile distribution of drugs to more remote areas. (c) Provision of technical assistance and communications activities to promote behavioral change for uptake of Project COVID- 19 Vaccines and for continuation of essential health services, including: (i) community- level interventions to promote utilization of antenatal care, routine EPI vaccinations, integrated gender-based violence services, and introduction of appointment making to promote and streamline antenatal care; (ii) support the linkage of a well-targeted communications campaign to generate demand and demystify issues around vaccine safety with efforts to boost other health promotion activities. Part 4: Project Implementation and Monitoring Provision of support for the strengthening of the existing PIU within MISAU, recruiting additional staff and covering operating costs, necessary training and equipment, support for procurement, financial management, environmental and social risk, impact management, monitoring and evaluation, and reporting activities. -8- SCHEDULE 2 Project Execution Section I. Implementation Arraneements A. Institutional Arrangements The Recipient, through MISAU shall implement the Project in close collaboration with CMAM, INS, and other institutions involved in the COVID-19 response. The National Coordinating Committee for the introduction of Vaccines Against COVID-19 will serve as the steering committee for this Project, under terms of reference acceptable to the Association. 1. National COVID-19 Preparedness and Response Plans Without limitation to the provisions of 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, the National Deployment and Vaccination Plan, and the National Plan for Vaccination Against COVID- 19, all in a manner acceptable to the Association. 2. Project Implementation Unit (a) The Recipient shall maintain at all times during the implementation of the Project, the existing Project Implementation Unit (PIU) within MISAU, with mandate, composition and resources acceptable to the Association and defined in the Project Implementation Manual. (b) Without limitation to the provisions of paragraph (a) immediately above, the PIU shall be responsible for day-to-day management of the Project, including: (i) managing the implementation of Project activities; (ii) managing the procurement, financial management, disbursements, and environmental and social aspects; (iii) coordinating the preparation, adjustments, and use of the Project management tools, including any updates to the PIM, Annual Work Plan, Procurement Plan, and disbursement projections; (iv) coordinating with key stakeholders on the technical aspects of all Parts of the Project; (v) monitoring the progress of the Project development objectives and intermediate indicators of the results framework; and (vi) preparing Project reports. (c) The PIU shall include, inter alia: (i) a Project coordinator; (ii) a Project manager; (iii) a procurement specialist; (iv) a financial management specialist; (v) a communications specialist; (vi) a monitoring and evaluation specialist; (vii) environmental and social specialists; and (viii) -9- other technical specialists as required in key MISAU directorates and provincial-level health offices, including for public health and communications, the regulatory authority, the directorate of pharmaceuticals, and INS, all recruited on the basis of terms of reference, qualifications, integrity and experience acceptable to the Association. 3. COVID-19 Committees The Recipient shall, for purposes of Project implementation, maintain throughout the period of COVID- 19 (as determined by the Recipient), the National COVID- 19 Coordinating Committee and a National Technical Consultative Group for Vaccination, to provide strategic and policy guidance for the COVID-19 response and for the introduction of COVID-19 vaccines, including: (i) planning and implementation; (ii) logistics and advocacy, and (iii) social mobilization and communication, all with terms of reference, composition and powers acceptable to the Association and described in the PIM. 4. Third Party Monitoring The Recipient shall, through MISAU continue working with the TPM Consultant to monitor the implementation of the Project (including the delivery and distribution of the Project COVID-19 Vaccine), require the TPM Consultant to prepare and submit monitoring reports, which shall be promptly made available and discussed with the Association; and promptly take any actions, as may be requested by the Association upon its review of the TPM Consultant's reports. B. Project Implementing Manual 1I The Recipient shall implement the Project in accordance with the Project Implementation Manual, setting out detailed guidelines, methods and procedures for the implementation of the Project, including: (i) the different roles and responsibilities in the implementation of the Project, including the various mechanisms for ensuring close coordination and collaboration between various Project stakeholders; (ii) budget and budgetary control; (iii) flow of funds, disbursement procedures and banking arrangements; (iv) financial, procurement and accounting procedures; (v) Personal Data collection and processing in accordance with applicable national law and good international practice; (vi) monitoring and evaluation arrangements; (vii) the Annual Work Plans and Budget for the first year of Project implementation; (viii) measures related to the use of security or military personnel in case the implementation of Project activities or for provision of security to Project workers requires it, sites and/or assets, in a manner satisfactory to the Association, including standards, protocols and codes of conduct for the selection and use of security or military personnel, and screen such personnel to verify that they have not engaged in past unlawful or abusive behavior, including sexual exploitation and abuse (SEA), sexual -10- harassment (SH) or excessive use of force; and (ix) such other arrangements and procedures as shall be required for the effective implementation of the Project. 2. For the purposes of adequate implementation of Part 1 of the Project, the Recipient shall continue referring to the separate annex to the PIM, and shall follow the necessary implementation rules and regulations for the vaccine delivery and distribution, in form and substance satisfactory to the Association, including: (a) rules and procedures for prioritizing intra-country 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; (b) rules and procedures establishing minimum standards for vaccine management and monitoring, including medical and technical criteria, communications and outreach plan, cold chain infrastructure, infection, prevention and control and other related logistics infrastructure; (c) rules and procedures for processing and collection of Personal Data in accordance with national law on Personal Data protection if it is deemed adequate and good international practice; and (d) vaccine distribution plan, including action plan setting out timeline and steps for immunization. 3. The Recipient shall carry out the Project in accordance with this Agreement and the PIM. Except as the Association shall otherwise agree, the Recipient shall not assign, amend, abrogate, or waive the provisions of the PIM without prior approval of the Association. In the event of any conflict between the provisions of the PIM and this Agreement, the provisions of this Agreement shall prevail. C. Standards for Project COVID-19 Vaccine Approval All Project COVID-19 Vaccines shall satisfy the Vaccine Approval Criteria. D. Use of Military and Security Actors 1 . If during Project implementation, the Recipient decides that the use of military or security forces is needed, the Recipient shall ensure that: (a) prior to any involvement of its military and/or security forces in the carrying out of Project activities, send a written notice to the Association communicating such decision, including the name of the military or security unit; and (b) all activities carried out by said military or security unit under the Project shall be under the control of MISAU and shall be undertaken exclusively for the purposes related to the Project. 2. All goods, services, Operating Costs, and Training financed by the Grant proceeds may be used by said military or security unit under the direction and control of MISAU and strictly in accordance with the PIM and other arrangements or protocols that the Association may require for carrying out these activities. All activities carried out under the Project shall be under the control of MISAU and shall be undertaken exclusively for the purposes related to the Project. All goods, -11- works and services financed by the Financing proceeds shall be used under the direction and control of MISAU and strictly in accordance with the PIM. E. Annual Plans and Budgets 1. The Recipient shall not later than November 30 of each year prepare and furnish to the Association, a work plan and budget ("Work Plan and Budget"), satisfactory to the Association, which shall include, inter alia:(a) the activities to be carried out under the Project and a financing plan for expenditures required for such activities, setting forth the amounts and sources of financing; and (b) thereafter carry out said Work Plan and Budget in accordance with its terms and in a manner acceptable to the Association. 2. 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. F. 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 I 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 (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 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 -12- outstanding measures and actions, including a timetable and budget allocation for such measures and actions (which action plan shall be deemed 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. 7. The Recipient shall ensure that all bidding documents and contracts for civil works under the Project include the obligation of contractors 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. 8. The Recipient, through MISAU, shall take the following measures if they are planning the use of security or military personnel in the implementation of Project -13- activities for provision of security to Project workers, sites and/or assets, in a manner satisfactory to the Association: (a) Adopt and enforce standards, protocols and codes of conduct for the selection and use of security or military personnel, and screen such personnel to verify that they have not engaged in past unlawful or abusive behavior, including sexual exploitation and abuse (SEA), sexual harassment (SH) or excessive use of force; (b) ensure that such personnel is deployed in accordance with the relevant requirements of ESSs and the ESCP; (c) ensure that such personnel is adequately instructed and trained, prior to deployment and on a regular basis, on the use of force and appropriate conduct (including in relation to civilian-military engagement, SEA and SH, and other relevant areas), as set out in the PIM; (d) ensure that the stakeholder engagement activities under the Stakeholder Engagement Plan include a communication strategy on the involvement of security or military personnel under the Project; and (e) ensure that any concerns or grievances regarding the conduct of such personnel are received, monitored, documented (taking into account the need to protect confidentiality), resolved through the Project's grievance mechanism; and reported to the Association no later than three days after being received. Section II. Project Monitoring, Reporting and Evaluation 1. The Recipient shall furnish to the Association each Project Report not later than one (1) month after the end of each calendar semester, covering the calendar semester. 2. 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 -14- forth against each Category of the following table: Amount of the Percentage of Category Grant Allocated Expenditures to be (expressed in SDR) Financed (inclusive of Taxes) (1) Goods, works, non- consulting services, consulting services, Operating Costs and Training for Parts 2 and 4 of the Project (2) Goods (including Project COVID-19 Vaccines), works, non-consulting services, consulting 42,126,000 100% services, Operating Costs and Training for Part 1 of the Project TOTAL AMOUNT 71,400,000 B. Withdrawal Conditions; Withdrawal Period 1. Notwithstanding the provisions of Part A above, no withdrawal shall be made for: (a) payments made prior to the Signature Date, except that withdrawals up to an aggregate amount not to exceed SDR 31,416,000 of the Financing, may be made for payments made prior to this date but on or after twelve (12) months prior to the Signature Date, for Eligible Expenditures under Category (2); and (b) payments under Category (1) unless and until the Environmental and Social specialist under the PIU and referred to in Section I.A.2(c) of Schedule 2 to this Agreement is hired in a manner satisfactory to the Association. 2. The Closing Date is June 30, 2024. -15- APPENDIX Definitions 1. "AEFI" means adverse event following immunization. 2. "Annual Work Plan and Budget" means the work plan and budget acceptable to the Association referred to in Section I.E 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. 3. "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. 4. "APEs" means Agentes Polivalentes Elementares, community health workers. 5. "Category" means a category set forth in the table in Section III.A of Schedule 2 to this Agreement. 6. "CMAM" means Central de Medicamentos e Artigos Midicos, the Recipient's central medical storage. 7. "COVAX Facility" means the COVID-19 Vaccine Global Access Facility, a mechanism through which demand and resources are pooled to support the availability of, and equitable access to, COVID-19 vaccines for all economies, and which is coordinated by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), and the WHO. 8. "COVID-19" means the coronavirus disease caused by the 2019 novel coronavirus (SARS-CoV-2). 9. "DPH" means the Recipient's directorate of public health, within MISAU. 10. "Environmental and Social Commitment Plan" or "ESCP" means the environmental and social commitment plan for the Project, dated December 1, 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. -16- 11. "Environmental and Social Standards" or "ESSs" means, collectively: (i) "Environmental and Social Standard 1: Assessment and Management of Environmental and Social Risks and Impacts"; (ii) "Environmental and Social Standard 2: Labor and Working Conditions"; (iii) "Environmental and Social Standard 3: Resource Efficiency and Pollution Prevention and Management"; (iv) "Environmental and Social Standard 4: Community Health and Safety"; (v) "Environmental and Social Standard 5: Land Acquisition, Restrictions on Land Use and Involuntary Resettlement"; (vi) "Environmental and Social Standard 6: Biodiversity Conservation and Sustainable Management of Living Natural Resources"; (vii) "Environmental and Social Standard 7: Indigenous Peoples/Sub- Saharan Historically Underserved Traditional Local Communities"; (viii) "Environmental and Social Standard 8: Cultural Heritage"; (ix) "Environmental and Social Standard 9: Financial Intermediaries"; (x) "Environmental and Social Standard 10: Stakeholder Engagement and Information Disclosure"; effective on October 1, 2018, as published by the Association. 12. "General Conditions" means the "International Development Association General Conditions for IDA Financing, Investment Project Financing", dated December 14, 2018 (revised on August 1, 2020 and April 1, 2021). 13. "IDP" means internally displaced people. 14. "INS" means Instituto Nacional de Sa4de, the Recipient's national institute of health. 15. "MISAU" means Minist&io de Sa4de, the Recipient's ministry of health. 16. "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. 17. "National COVID-19 Coordinating Committee" means Comitg Nacional de Peritos de Imunizaqdo, one of the two committees referred to in Section I.A.3 of Schedule 2 to this Agreement. 18. "National COVID-19 Preparedness and Response Plan" means the Recipient's plan to address COVID-19, dated April 2020, 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. 19. "National Deployment and Vaccination Plan" and the "National Plan for Vaccination Against COVID-19" means the Recipient's immunization plans for COVID-19, dated February 17, 2021 and March 5, 2021 respectively, and -17- 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. 20. "National Technical Consultative Group for Vaccination" means Comissdo T6cnico Cientificapara a resposta a Covid 19, one of the Recipient's committees referred to in Section I.A.3 of Schedule 2 to this Agreement. 21. "Operating Costs" means the reasonable incremental operating costs, based on Annual Work Plans and Budgets, incurred by the Recipient on account of Project implementation including: office equipment and supplies, maintenance of equipment, insurance costs, office administration costs, rental, consumables, accommodation, vehicle operation and maintenance costs, utilities, communication charges, per diems, travel allowances, and salaries of the Recipient's locally contracted staff, but excluding salaries, fees, honoraria, bonuses, and any other salary supplements of members of the Recipient's civil service. 22. "Original Financing Agreement" means the financing agreement for the COVID- 19 Strategic Preparedness and Response Project, dated June 17, 2021 (Credit No. D825-MZ). 23. "Original Project" means the Project described in Schedule 1 to the Original Financing Agreement. 24. "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. 25. "Pharmaceutical Logistics Strategic Plan" means the plan prepared by the Recipient for its Central de Medicamentos e Artigos Mdicos. 26. "PIU" means the Project implementation unit within MISAU referred to in Section I.A.2 of Schedule 2 to this Agreement. 27. "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. -18- 28. "Project Implementation Manual" and "PIM" means the manual dated December 2, 2021, prepared by the Recipient for the implementation of the Original Project and referred to in Section I.A.2 of Schedule 2 to this Agreement. 29. "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. 30. "RINCAH-N" means Reproductive, Maternal, Newborn, Child, and Adolescent Health and Nutrition. 31. "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. 32. "TPM Consultant" means the third-party monitoring consultant referred to in Section I.A.5 of Schedule 2 to this Agreement, responsible for monitoring Project activities undertaken by MISAU and compliance with applicable laws and regulations in accordance with the relevant terms of reference approved by the Association. 33. "Training Costs" means the reasonable costs associated with training under the Project, based on the relevant Annual Work Plan and Budget, and attributable to study tours, training courses, seminars, workshops and other training activities, not included under service providers' contracts, including costs of training materials, space and equipment rental, travel, accommodation and per diem costs of trainees and trainers, trainers' fees, and other training related miscellaneous costs. 34. "Vaccine Approval Criteria" means that the Project COVID-19 Vaccine: (a) has received regular or emergency licensure or authorization from at least one of the Stringent Regulatory Authorities identified by WHO for vaccines procured and/or supplied under the COVAX Facility, as may be amended from time to time by WHO; (b) has received the WHO Prequalification or WHO Emergency Use Listing; or (c) has met such other criteria as may be agreed in writing between the Recipient and the Association. 35. "WHO" means the World Health Organization. 36. "WHO Fair Allocation Framework" means the rules which govern the allocation of vaccines to participants in the COVAX Facility, as developed by WHO, subject to periodic review by the COVAX Facility. -19- 37. "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. 38. "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.