Procurement under the Terms and Conditions of the Advance Market Commitment

1. Procurement under the Terms and Conditions of the Advance Market Commitment AMC Pre-tender meeting UNICEF SD, 26 August 2009 Tania Cernuschi and Ann Ottosen

2. Presentation Overview • AMC Procedures Memorandum • Request for Proposal (Call for Offers) • Supply Agreement Terms and Conditions

3. 1. AMC Procedures Memorandum

4. Overview of the AMC from a Supplier’s Perspective

5. 1. AMC Registered Manufacturer Registration Procedures • Only AMC Registered Manufacturers are eligible to make a supply offer in response to a UNICEF Call for Offers – and to forward a vaccine application for AMC eligibility • An AMC Registered Manufacturer Application Package may be forwarded to the AMC Secretariat at any time • UNICEF receives copy of info package and the AMC Registered Manufacturer Agreement between manufacturer and IBRD and GAVI when entered into

6. AMC Registered Manufacturer Application Package • Details of applicants legal status and corporate info • Particulars of manufacturing license and registration from NRA, if any • Info on vaccine production, supply/delivery activities, overview of existing portfolio, years of production, quantities supplied annually over past three years, number of countries where vaccine is licensed and marketed • Timeline for Application for vaccine Eligibility, if any No special template is required

7. AMC Registered Manufacturer Agreement • A manufacturer intending to participate in AMC Pneumo Initiative • Obligations in Agreement • To accept T&C of the AMC including Supply Agreement • To accept IAC determinations on AMC Eligibility • To provide an annual update on expected timing for application for Eligibility and WHO pre-qualification • To inform of Suspension Events, e.g. revoke of licensure, insolvency, material inquiry No obligation to make a Supply Offer

8. 2. Application for AMC Eligibility • To be submitted to the AMC Secretariat any time, but at the earliest upon WHO acceptance to review PSF • The AMC-Eligible Vaccine Information Package • PSF or written confirmation from WHO for acceptance of PSF for review • “Target Product Profile Eligibility Justification Document” of how the vaccine meets the TPP • Refer to information in PSF, or • Provide a clear explanation of how the vaccine meets the TPP Not a requirement in order to make a Supply Offer

9. Application for AMC Eligibility • IAC review no later than 30 days after receipt of application • Submit questions if any to WHO to clarify any aspects of the application • May request technical assistance from WHO in review and assessment of any criteria related to requirements of TPP which are not PQ requirements • Vaccine serotypes cover at least 60%, include 1, 5 and 14 • Documented in u/5’s and in particular effective in <2 years • Fit in national immunization programmes, no more than 3 doses in first year of life, first to be administered at 6 weeks • Liquid formulation, 0.5ml/dose • Administration: im/sc

10. Application for AMC Eligibility • IAC Eligibility Determination Meeting no later than 30 days of receipt of application for PQ’ed vaccine • Request a written report from WHO on how TPP criteria that are also PQ requirements are met • Immunogenicity, safety, co-administration, presentations, cold chain requirements, packaging and labeling, product registration and PQ, and post marketing surveillance • Review and consider if vaccine meets the non-PQ requirements of the TPP (serotypes composition, isolate coverage etc.) Outcome to be communicated to supplier within 15 days

11. To sum up • Manufacturers need to register in order to be eligible to make a supply offer • Manufacturers need to have their vaccine approved for AMC eligibility in order to supply

12. 2. Request for Proposal/Call for Offers

13. Timeline for Request for Proposal

14. Request for Proposal/Call for Offers • Triggers of a Call for Offers • (AMC Registered Manufacturers) • Release of GAVI Strategic Demand Forecast (6 August) • Call for Offers to be issued 20 days after release of any new GAVI SDF, provided • Increase in GAVI SDF by ≥ 10M doses annually for next 5 years, or • Unallocated quantities which exceed 10M doses annually • If conditions not met UNICEF will issue notification

15. The Pneumococcal AMC pilot • Overarching goal: reduce morbidity and mortality from pneumococcal diseases. Target: save more than 7 million lives by 2030 • Main objectives: • Bring forward the availability of effective pneumococcal vaccines - scale up of production capacity. • Accelerate development of second generation vaccines that meet developing country needs. • Accelerate vaccine uptake - predictable vaccine pricing for countries and manufacturers. • Test AMC concept • Pneumo AMC financial commitment: support pneumococcal vaccine market with US$ 1.5 billion 15

16. Procurement Objectives • 1. Bring forward the availability of effective pneumococcal vaccines - ensuring supply for the actual demand as approved • 2. Selecting products and presentations that best meet the country preferences • 3. Continued vaccine supply and contributing to the creation of a healthy vaccine market including multiple suppliers To ensure access to sustainable supply of PV from AMC Registered Manufacturers to meet demand from 2014-2024

17. From 2009 to 2011, 13 GAVI-supported countries are approved to introduce PCV • 2 countries have introduced PCV7 in 2009 through a donation • 11 countries to introduce vaccines with more serotypes by 2010 and 2011, covering a birth cohort of ~7.3M children • Demand based on current GAVI approvals in 2010: ~19M doses • 15 countries are expected to apply in September 2009 for introduction in 2H 2010 Approved for intro Conditional approval

18. First Strategic Demand Forecast

19. First Strategic Demand Forecast ~ UNICEF forecast

20. Uncertainties related to the first SDF • Early forecasts tend to be more optimistic in terms of starting date of uptake • First time to base procurement on the SDF model – validation of model assumptions on country applications following Sept applications • Refinement of model ongoing e.g. with regards to coverage, to be included in 2nd CFO

21. Uncertainties related to the first SDF • Lessons learned from HepB and Hib forecasting – vaccine volumes highly dependant on actual year of intro from a small number of very large countries • Review of eligibility of GAVI countries and co-financing levels in 2010 and 2011

22. Request for Proposal/Call for Offers • Technical and Financial Mandatory Requirements • For vaccines not yet approved by IAC, written confirmation from WHO of acceptance of PSF, IF APPLICABLE • Most recent Audited Financial Statement • Quality System Certificate • UNGM code • The Supplier’s Vaccine Production Plan…. All Registered Manufacturers may offer irrespective of status of PSF

23. The Supplier’s Vaccine Production Plan • Product and production capacity development • Status and plans, sourcing of bulk, planned presentations and packaging, capacity • Description of sites and timelines for development • Clinical trials conducted and planned, timelines • Post marketing surveillance strategy • NRA status and plans for registration, and release NRA • WHO pre-qualification timelines, if applicable • Timeline for forwarding application for Eligibility • Status and timelines for submission to NRA and WHO for approval of manufacturing site, if applicable • Expected date for providing Vaccine Purchase Period Trigger Notice (at the latest 3 months before Vaccine Purchase Period) • Expected date for commencement of the Vaccine Purchase Period

24. Request for Proposal/Call for Offers • Qualitative Requirements • Product, schedule, standard shelf life, vial size and presentation, weight and volume • Number of years the manufacturer has produced and delivered the offered product(s) • Impact on production of other products • Experience in vaccine production and delivery of similar scale to that offered • Quality aspects, including quality control and any past non-compliance or irregularities • Account management information standard

25. Request for Proposal/Call for Offers • Quantitative Requirements • Supply Commitment Quantities on an annual basis for the Vaccine Purchase Period • Commencement date of 10 year Purchase Period • Price quotation for the Tail Price in US$ • Production and availability forecasts new Manufacturers may make several proposals with different commencement dates if within SDF and for alternative presentations

26. Illustration of alternative offers from a manufacturer in response to 1st Call for Offers

27. Request for Proposal/Call for Offers • Assessment of Supply Offer and determining award quantities to a supplier • Ability to meet Objectives including quantities offered and timelines for availability • Feasibility of the Supplier’s Vaccine Production Plan • The offered Tail Price including waiver or modifications of the inflation adjustment provisions • Experience in vaccine production and delivery of similar scale • Past performance record with UNICEF, if applicable

28. Award recommendation • UNICEF • Will base award recommendation on assessment of the offer and the WHO technical review, to be presented to PRG for advise and to be approved in accordance to UNICEF standard processes • May enter into a Supply Agreement with an AMC Eligible Manufacturer and a Provisional Supply Agreement for vaccines which have been accepted for review by WHO • May decide to award less than the total quantity forecasted if it is considered that vaccines in pipeline could reach the market within the next 5 years to meet objectives of multiple suppliers

29. Request for Proposal/Call for Offers • Confidentiality • All information provided by a supplier as part of the offer is considered confidential. Both PRG and WHO technical assessor sign confidentiality agreements with UNICEF • Due to the strategic nature related to which suppliers are making supply offers for vaccines in development, there will be no public opening

30. 3. Supply Agreement Terms and Conditions

31. Supply Agreement Terms and Conditions • Few input fields (art II, para 1, 3 and 9, art VII, para 3) • Suppliers Annual Vaccine Supply Commitment Quantity in doses to be supplied for 10 years • Vaccine Purchase Period commencement date • Tail Price offered in US$ (max US$3.50) • FCA Named airport • The terms and conditions of Supply Agreement are non-negotiable – Registered Manufacturers acknowledged and agreed by signing Registered Manufacturer Agreement

32. Suppliers’ commitments • To make available annually for 10 years the quantities at a Tail Price • To issue Vaccine Purchase Period Trigger Notice at the latest 3 months before commencement of Vaccine Purchase Period • To deliver an update every 6 months on the implementation of Supplier’s Vaccine production Plan until Trigger Notice • To notify UNICEF immediately if becoming aware of factors indicating a delay in the issuance of Vaccine Purchase Period Trigger Notice • Make the annual quantities available, distributed reasonably throughout any 12 months period as per procurement forecast • From first supply availability to provide six monthly forecasts indicating monthly availability for upcoming 12 months, and quarterly for the period thereafter

33. Suppliers’ access • Access to the AMC subsidy and demand in GAVI countries • Firm contracts for 20%,15%, and 10% of annual quantities in each Supply Agreement in year 1-3 of the Vaccine Purchase Period • To supply prior to the commencement of Vaccine Purchase Period provided there is demand • To reduce the duration of agreement through early supply • To increase quantities under agreement through early supply (require agreement with UNICEF and GAVI Board approval)

34. Supply Agreement Terms and Conditions • Automatic termination (art II para 3+5, art VIII para 9) • If a supplier fails to deliver the Vaccine Purchase Period Trigger Notice 3 months prior to Vaccine Purchase Period • Supplier shall within 30 days repay the total amount of AMC-Funded Price paid prior to termination • Should the Supplier advice UNICEF in advance, then the Parties may review and negotiate in good faith new applicable conditions and timing • UNICEF may agree to extend commencement date by up to a total of 60 months from date of agreement

35. Supply Agreement Terms and Conditions • Possible adjustments to Total Vaccine Supply Quantity (Art IV para 3): • If UNICEF’s Annual Demand Forecast for any 12 month period is lower than the Supply Commitment Quantity • Supplier may decide to make lesser amounts of vaccines available without penalty, to inform UNICEF in writing • Supplier may propose to reduce Commitment Quantity for next 12 month period, to be agreed by UNICEF and GAVI

36. Supply Agreement Terms and Conditions • Possible adjustments to Total Vaccine Supply Quantity (art IV para 4+5) - continued: • If the GAVI SDF projects a reduced demand for a period of no less than 3x12 months during the Vaccine Purchase Period, and supply on all SA exceeds demand – Commitments may be reduced, to be agreed between UNICEF and Supplier • At any time upon request by Supplier, UNICEF may reduce Commitment Quantity by such amount and for such period and on terms as UNICEF may determine in consultation with GAVI without compromising AMC objectives

37. Supply Agreement Terms and Conditions • UNICEF change or amendments to standard PO and General Terms and Conditions (art VI para 3) • To notify the Supplier of changes material to the SA • Supplier has 30 days notice to give UNICEF 90 days written notice of withdrawal from Agreement without penalty, but also without claims

38. Supply Agreement Terms and Conditions • Effectiveness of agreement the later of • a) signing by both parties, • (b) notice from GAVI to UNICEF that the SA is consistent with AMC T&C • Awards for Supply Agreements will be published on the UNICEF website with regards to supplier name, date of entry into SA, total award value, duration of SA and Tail Price

39. In conclusion….

40. Procurement under the AMC Terms and Conditions • First Request for Proposal/Call for Offers under AMC planned to be issued 2nd September • Any manufacturer expecting to be able to have supply availability to UNICEF within 60 months should register and make an offer • AMC Provisional Supply Agreements and/or Supply Agreements following this Call for Offers provided valid offers to be in place January 2010 • First supplies with countries as soon as possible, and best case late Q1 • Next RFP/CFO to be issued following GAVI Board approval of new applications and update of SDF, expected January 2010

41. UNICEF VACCINES • Thank You