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
Circled activities – new activities to manufacturers to be undertaken once for each vaccine. Yellow activities: activities to be undertaken at regular intervals
The AMC Procedures Memorandum explains the processes for a manufacturer to follow for AMC Manufacturer Registration, AMC Eligibility and Supply offers and Supply Agreements.

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
RFP to be shared with all vaccine manufacturers, as a manufacturer could apply and become registered during the 20 days from issuance to closing.
Not a requirement to sign up to have a vaccine in development.
IBRD = International Bank for Reconstruction and Development

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 expectation on timing of making a supply offer -
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
AMC eligibility meaning that the product meets the specifications of the Target Product Profile and can therefore be funded and supplied under the AMC.
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
Member ship IAC
At least 60% of invasive disease isolates in the target region

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.)
30 days means 30 business days, that is 6 weeks
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
20 IBRD working days from issuance of CFO to offers to be received, 40 days for evaluation, 20 days for agreement in principle of SA, 20 days for signing.

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 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
With other new vaccines the duration between first global introductions to vaccines reaching developing countries have been years. Under the AMC PV will hopefully be supplied with a much shorter interval.
To ensure access to sustainable supply of PV from AMC Registered Manufacturers to meet demand from

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
Nigeria and Benin conditional approval.
CAR, Cameroun, Congo, DRC, Gambia, Guyana, Honduras, Kenya, Mali, Nicaragua, Rwanda, Sierra Leone, Yemen.
Approved for intro
Conditional approval

18. First Strategic Demand Forecast
52 countries makes up the demand of 89M doses by 2014.
AMC much focused on assuring future capacity to meet future demand by 2014 to allow capacity and product development, however, the procurement will aim at assuring also short term supply availability to meet demand.

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
To base procurement on SDF for future demand is a new concept and it is a learning process for all of us, we acknowledge that we may not get the quantities right in the first go, but hope to rectify over the next procurement rounds. In the past we have seen too optimistic forecasts based on needs rather than funded demand, this has been disappointing to industry with the consequence that some manufacturers decided to exit the UNICEF market – and partners have been criticised.
To include demand from large countries in awards following first calls for offers will be based on certainty of demand – e.g. India and Indonesia not to included:
India: Based on past experience with India and the challenges with vaccines introduction, e.g. HepB in 11 states, challenges with polio, now approved to introduce penta but to take over full funding in two years – and given the fact that India has used its cap with GAVI for funding support
Indonesia: likely to introduce only when local production is in place
Award levels will also take into consideration the offers received for pipeline products. Also to protect manufacturers, a conservative approach initially should be appreciated so that capacity investments are not made which will not be utilised.

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
WHO will assess the feasibility of the VPP and potentially to undertake audits with suppliers on progress.

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
Offer Agreement, AMC Terms and Conditions 6.6, with reference to Procedures memorandum 4.2, 4.3, 4.4 (eligibility to make supply offers – all Registered, contents and requirements: technical, financial mandatory, quantitative and qualitative requirements, assessment of offer)

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
Publication in accordance to Offer agreement AMC Terms and Conditions 6.7

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
Also, SA part of the RFP and suppliers will need to confirm acceptance to all terms and conditions of the RFP including the SA.

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
Max annual supply commitment – UNICEF Annual Demand Forecast-more info on forecast processes….

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
Check up on consequences for AMC share ….

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
UNICEF can not sign until the GAVI Board has approved the budget

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