CREDIT NUMBER 7028-NP Financing Agreement (Second Additional Financing for COVID-19 Emergency Response and Health Systems Preparedness Project) between NEPAL and INTERNATIONAL DEVELOPMENT ASSOCIATION CREDIT NUMBER 7028-NP FINANCING AGREEMENT AGREEMENT dated as of the Signature Date between NEPAL ("Recipient") and INTERNATIONAL DEVELOPMENT ASSOCIATION ("Association") for the purpose of providing additional financing for 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, Original Financing Agreement (as defined in the Appendix to this Agreement), the First Additional Financing Agreement (as defined in the Appendix to this Agreement) or in the Appendix to this Agreement. ARTICLE II - FINANCING 2.01. The Association agrees to extend to the Recipient a credit, which is deemed as Concessional Financing for purposes of the General Conditions, in an amount equivalent to twelve million nine hundred thousand Special Drawing Rights (SDR 12,900,000) (variously, "Credit" and "Financing"), to assist in financing the project described in Schedule I 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 The Service Charge is three-fourths of one percent (3/4 of 1%) per annum on the Withdrawn Credit Balance. 2.05. The Payment Dates are April 1 and October 1 in each year. 2.06. The principal amount of the Credit shall be repaid in accordance with the repayment schedule set forth in Schedule 3 to this Agreement. 2.07. 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. through MoHP. carry' out the Project in accordance with the provisions of Article V of the General Conditions and Schedule 2 to this Agreement. ARTICLE IV - 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 (20) years after the Signature Date. ARTICLE V - REPRESENTATIVE; ADDRESSES 5.01. The Recipient's Representative is its Secretary. Ministry of Finance, or its Joint Secretary of the International Economic Cooperation Coordination Division, Ministry of Finance. 5.02. For purposes of Section 11.01 of the General Conditions: (a) the Recipient's address is: Ministry of Finance Government of Nepal Singha Durbar Kathmandu Nepal; and (b) the Recipient's Electronic Address is: Facsimile: E-mail: (977-1) 4211-164 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 AGREED as of the Signature Date. NEPAL By Mko2w7 t- Authorized Representative Name: Madhu Kurnar Marasini Title: Finance Secretary Date: February 25, 2022 INTERNATIONAL DEVELOPMENT ASSOCIATION By Autho e eresentative Name: Faris H. Hadad-Zervos Title: Country Director for Maldives, Nepal and Sri Lanka Date: February 25. 2022 -4- SCHEDULE 1 Project Description The objective of the Project to prevent, detect and respond to the threat posed by COVID-19 and to strengthen national systems for public health preparedness in Nepal. The Project constitutes a phase of the MPA Program and consists of the Original Project. -5- SCHEDULE 2 Project Execution Section I. Implementation Arranaements A. Institutional Arrangements. 1. The Recipient shall vest responsibility for the overall implementation ofthe Project in MoHP with the Chief Specialist overseeing its Health Coordination Division as the Project Coordinator with the support from the HEOC. To this end the Recipient, through MoHP, shall maintain throughout the implementation of the Project, the Ministerial Level COVID-19 Coordination Committee within the MoHP, with a mandate, composition, and resources satisfactory to the Association, to be chaired by its Secretary, to be responsible for, inter alia, coordinating and monitoring the implementation of the Project in accordance with the provisions of this Agreement. 2. The Recipient, through MoHP, shall ensure based on the Data Protection Protocol that the collection, use, and processing (including transfers to third parties) of any personal data collected under this Project shall be done in accordance with national laws and best international practice ensuring legitimate, appropriate, and proportionate treatment of such data. B. Vaccine Delivery and Distribution Plan. 1. In order to ensure adequate implementation of Part 1(c) of the Project, the Recipient shall update and adopt, a plan for Project COVID-19 Vaccine delivery and distribution ("Vaccine Delivery and Distribution Plan"), in form and substance satisfactory to the Association, which shall include: (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, 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; -6- (d) vaccine distribution plan, including action plan setting out tieicline and steps for immunization; and (e) detailed guidelines and procedures for the purchase, delivery and distribution of the Project COVID-19 Vaccine, including, inter alia, with respect to: 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. roles and responsibilities for Project implementation, 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. 2. The Recipient shall carry out the Project in accordance with this Agreement and the Vaccine Delivery and Distribution Plan. Except as the Association shall otherwise agree, the Recipient shall not assign, amend, abrogate, or waive the provisions of the Vaccine Delivery and Distribution Plan without prior approval of the Association. In the event of any conflict between the provisions of the Vaccine Delivery and Distribution Plan and this Agreement, the provisions of this Agreement shall prevail. C. Use of Military and Security Actors 1. All activities carried out by MoIJA under the Project if any,. shall be under the coordination of MollP and shall be undertaken exclusively for the purposes related to the Project. All goods, works, services, Incremental Operating Costs, and Training financed by the Financing proceeds may be used by MolIA under the coordination of MoHP and strictly in accordance with the Vaccine Delivery and Distribution Plan and other arrangements or protocols that the Association may require for carrying out these activities. 2. Except as the Association may otherwise agree, the Recipient shall ensure that the ownership of any assets generated, goods procured. and works constructed by any security or military unit out of the Financing proceeds shall be transferred to. or shall vest, with MoHP or any equivalent or appropriate line ministry or agency agreed with the Association. 3. The Recipient further undertakes that no Financing proceeds or resources may be used for security and military purposes or for any payments made to any security or military personnel without the Association's express approval. -7- D. Standards for COVID-19 Vaccine Approval. All Project COVID-19 Vaccines shall satisfy the Vaccine Approval Criteria. E. 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, and 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. In case of any inconsistencies between the ESCP and the provisions of this Agreement, the provisions of this Agreement shall prevail. 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 -8- 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. 4. 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. 5. The Recipient shall ensure that all bidding documents and contracts for civil works under the Project include the obligation of contractors, subcontractors 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. 6. The Recipient. through Mol IP. shall take the followx ing measures related to the use of security or military personnel. if any, in the implementation of Project activities and for provision of security to Project workers, sites and/or assets, in a manner satisfactory to the Association: (a) ensure standards, protocols and codes of conduct are followed for the selection and use of security or military personnel, and ensure that such personnel have not engaged in past unlawful or abusive behavior, including sexual exploitation and abuse ("SEA"). sexual harassment ("SI F") or excessive use of force: (b) ensure that such personnel are 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 if any. SEA and SH1. and other relevant areas), as set out in the Environmental and Social Management Framework. Security Management Plan: (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 -9- (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 fifteen (15) days after being received. F. Contingent Emergency Response 1 . In order to ensure the proper implementation of contingent emergency response activities under Part 4 of the Project ("Contingent Emergency Response Part"), the Recipient shall ensure that: (a) a manual ("CERC Manual") is prepared and adopted in form and substance acceptable to the Association, which shall set forth detailed implementation arrangements for the Contingent Emergency Response Part, including: (i) any structures or institutional arrangements for coordinating and implementing the Contingent Emergency Response Part; (ii) specific activities which may be included in the Contingent Emergency Response Part, Eligible Expenditures required therefor ("Emergency Expenditures"), and any procedures for such inclusion; (iii) financial management arrangements for the Contingent Emergency Response Part; (iv) procurement methods and procedures for the Contingent Emergency Response Part; (v) documentation required for withdrawals of Financing amounts to finance Emergency Expenditures; (vi) a description of the environmental and social assessment and management arrangements for the Contingent Emergency Response Part; and (vii) a template Emergency Action Plan; (b) the Emergency Action Plan is prepared and adopted in form and substance acceptable to the Association; (c) the Emergency Response Part is carried out in accordance with the CERC Manual and the Emergency Action Plan; provided, however, that in the event of any inconsistency between the provisions of the CERC Manual or the Emergency Action Plan and this Agreement, the provisions of this Agreement shall prevail; and (d) neither the CERC Manual or the Emergency Action Plan is amended, suspended, abrogated, repealed, or waived without the prior written approval by the Association. 2. The Recipient shall ensure that the structures and arrangements referred to in the CERC Manual are maintained throughout the implementation of the Contingent Emergency Response Part, with adequate staff and resources satisfactory to Association. -10- 3. The Recipient shall ensure that: (a) the environmental and social instruments required for the Contingent Emergency Response Part are prepared. disclosed and adopted in accordance with the CERC Manual and the ESCP. and in form and substance acceptable to the Association, and (b) the Contingent Emergency Response Part is carried out in accordance with the environmental and social instruments in a manner acceptable to the Association. 4. Activities under the Contingency Emergency Response Part shall be undertaken only after an Eligible Crisis or Emergency has occurred. Section II. Project Monitorinl, Reportinl and Evaluation The Recipient shall furnish to the Association each Project Report not later than forty-five (45) days after the end of each Fiscal Quadrimester. covering the Fiscal Quadrimester. 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 I to this Agreement, the Recipient shall ensure that such information report or document does not include Personal Data. Section Ill. Withdrawal of the Proceeds of the Financing A. General Without limitation upon the provisions of Article 11 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: Amount of the Percentage of Category Credit Allocated Expenditures to be (expressed in SDR) Financed (inclusive of Taxes) I) Goods (including associated 12.900,000 100% freight/shipping and handling charges) for the purchase of Project COVID-19 Vaccines under Part 1(c) of the Project (2) Emergency Expenditures 0 100% TOTAL AMOUNT 12,900,000 -11- B. Withdrawal Conditions; Withdrawal Period 1. Notwithstanding the provisions of Part A above, no withdrawal shall be made: (a) for payments made prior to the Signature Date, except that withdrawals up to an aggregate amount not to exceed SDR 2,580,000 may be made for payments made prior to this date but on or after September 1, 2021, for Eligible Expenditures under Category (1) (and for the avoidance of doubt, consistent with the requirements set out in the ESCP); and (b) for Emergency Expenditures under Category (2), unless and until all of the following conditions have been met in respect of said expenditures: (i) (A) the Recipient has determined that an Eligible Crisis or Emergency has occurred, and has furnished to the Association a request to withdraw Financing amounts under Category (2): and (B) the Association has agreed with such determination, accepted said request and notified the Recipient thereof; and (ii) the Recipient has adopted the CERC Manual and Emergency Action Plan, in form and substance acceptable to the Association. 2. The Closing Date is July 15, 2024. -12- SCHEDULE 3 Repayment Schedule Principal Amount of the Credit repayable Date Payment Due (expressed as a percentage) * On each April I and October 1, 1.5625% commencing April 1, 2028 to and including October 1, 2059 * The percentages represent the percentage of the principal amount of the Credit to be repaid, except as the Association may otherwise specify pursuant to Section 3.05 (b) of the General Conditions. -13- APPENDIX Definitions 1. -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. 2. "Category" means a category set forth in the table in Section Ill.A of Schedule 2 to this Agreement. 3. "CERC Manual" means the manual referred to in Section I.F of Schedule 2 to this Agreement, as such manual may be updated from time to time with the agreement of the Association, and which is an integral part of the Operational Manual. 4. "Contingent Emergency Response Part" means any activity or activities to be carried out under Part 4 of the Project to respond to an Eligible Crisis or Emergency. 5. "COVID-19" means the coronavirus disease caused by the 2019 novel coronavirus (SARS-CoV-2). 6. "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 economnies, and which is coordinated by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), and the WHO. 7. "Eligible Crisis or Emergency" means an event that has caused, or is likely to imminently cause, a major adverse economic and/or social impact to the Recipient, associated with a natural or man-made crisis or disaster. 8. "Emergency Expenditures" means any of the eligible expenditures set forth in the CERC Manual referred to in Section I.F of Schedule 2 to this Agreement and required for the Contingent Emergency Response Part. 9. "Data Protection Protocol" means the personal data protection protocol dated April 26, 2020 submitted by the Recipient to the Association in connection with the Original Project. 10. "Environmental and Social Commitment Plan" or -ESCP" means the environmental and social commitment plan for the Project, dated November 13, 2021, and to be updated pursuant to Section 4.01 of this Agreement, 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 -14- 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. 11. "Environmental and Social Management Framework" means the environmental and social management framework for the Original Project. dated August 31, 2020 prepared and adopted by the Recipient. and to be updated. disclosed, consulted upon and adopted for the Project in a manner and substance acceptable to the Association and in accordance with the relevant ESSs. setting out the principles. rules. uidelines and procedures to screen and assess the potential adverse environmental and social risks and impacts (including health and safety issues) of Project activities, including the risks of gender-based violence and sexual exploitation and abuse, adopt measures to avoid, reduce, mitigate or offset environmental and social adverse risks and impacts. including measures that endeavor to prevent and respond to gender-based violence and sexual exploitation and abuse, procedural, budget and institutional arrangements and actions needed to implement these measures, and information on the agency or agencies responsible for addressing the Project's risks and impacts: as well as for the preparation of any environmental and social instruments referred to therein. as such framework may be amended by the Recipient from time to time, with the prior written agreement of the Association. 12. "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. 13. "First Additional Financing Agreement" means the financing agreement for the COVID 19 Emergency Response and Health Systems Preparedness Project between the Recipient and the Association, dated April 2. 2021. as amended from time to time (Credit No. 6847-NP) -15- 14. "General Conditions" means the "International Development Association General Conditions for IDA Financing, Investment Project Financing", dated December 14, 2018 (revised on August 1, 2020, April 1, 2021, and January 1, 2022). 15. "HEOC" means the Recipient's Health Emergency Operation Center, established within the MoHP premises, through the decision by its Secretary on January 12, 2012, or any successor thereto. 16. "Incremental Operating Costs" means the reasonable costs required for the day-to-day coordination, administration and supervision of Project activities, including leasing and/or routine repair and maintenance of vehicles, equipment, facilities and office premises; office rent; office supplies; utilities; consumables; communication expenses; translation; printing, photocopying and postal expenses; bank charges; advertising expenses; insurance; costs of clearing, forwarding, inspection, survey and transportation of goods; Project-related meeting expenses; Project-related travel, subsistence and lodging expenses; and salaries and allowances of contractual staff (other than consultants) but excluding salaries and salary top ups of the Recipient's civil servants and those items included in the Compensation Benefits. 17. "Ministerial Level COVID-19 Coordination Committee" means the committee established through the decision by the Minister, MoHP on March 25, 2020. 18. "MoHP" means the Recipient's Ministry of Health and Population, or any successor thereto. 19. "MoHA" means the Recipient's Ministry of Home Affairs, or any successor thereto. 20. "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. 21. "National Immunization Committee" means the Recipient's committee, established through the Recipient's Immunization Act (Act No, 2072), dated January 26, 2016, for the Recipient's national immunization program's policy development, exploration, and management of necessary resources for its financial sustainability, monitoring and evaluation, and multi-sectoral coordination for its expansion and development. 22. "Original Financing Agreement" means the agreement between the Recipient and the Association for the financing of the Original Project, dated April 7, 2020 (Credit No.6604-NP), as amended from time to time. -16- 23. "Original Project" means the Project described in Schedule I to the Original Financing Agreement. 24. 'Personal Data" means any infornation 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. "Procurement Regulations" means. for purposes of paragraph 87 of the Appendix to the General Conditions. the "World Bank Procurement Regulations for IPF Borrow. ers", dated November 2020. 26. "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. 27. "SEA" means any sexual exploitation and abuse. 28. 'Security Management Plan" means the security management plan to be adopted by the Recipient, satisfactory to the Association, and to be disclosed on the Recipient's website, as said instrument may be updated from time to time with the prior written agreement of the Association. 29. "SI " means any sexual harassment. 30. "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. 31. "Stringent Regulatory Authority" means a national regulatory authority ("NRA") that is classified by WHO as a Stringent Regulatory Authority. 32. "Training" means the reasonable costs required for the participation of personnel involved in training activities, workshops, seminars, conferences and study tours under the Project. which have been approved by the Association in writing on a bi-annual basis, including: (a) travel, hotel, and subsistence costs associated to training, workshops, seminars. conferences and study tours provided that such costs are paid directly to the eligible recipient using the banking system: (b) costs associated with rental of training and wNorkshop facilities: preparation and -17- reproduction of training, workshop, seminar and conference materials; and other costs directly related to preparation and implementation of any training course, workshop, seminar, conference or study tour; and (c) tuition fees, travel, accommodation and per diem of trainer and trainees 33. "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. 34. "Vaccine Delivery and Distribution Plan" means the Recipient's National Deployment and Vaccination Plan 2021 for COVID- 19, approved by the National Immunization Committee on November 26, 2021, referred to in Section I.B. of Schedule 2 to this Agreement, as the same may be amended from time to time with the Association's prior written approval. 35. "WHO" means the World Health Organization. 36. "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. 37. "WHO Fair Allocation Framework" means the rules which governs the allocation of vaccines to participants in the COVAX Facility, as developed by WHO, subject to periodic review by the COVAX Facility. 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.