Tender strategy Auto Disable (AD) Syringes and Safety Boxes 2013 SD, Copenhagen, 23 July 2013 1
Create Content Sales order of the presentation Purpose of the tender Forecast, tender and LTA time lines Invitee list Overview of the sections of the tender document Submission of relevant documentation (templates, bids, samples, QA documents) Other tender clauses Evaluation methodology New elements for the 2014-2015 tender exercise Forecast tool 2014-2015 tender quantities 2
Create Purpose Sales of order the tender strategy Obtain multiple supply arrangements, Long Term Arrangements (LTA) with manufacturers in order to ensure an uninterrupted sustainable supply of affordable quality AD syringes and Safety Boxes resulting in a smooth implementation on a country level. 3
Create Forecast, Sales tender order and LTA time lines Forecasting tool issued to countries August 2012 Closing of tender End August 2013 Clarifications and evaluation Sept- October 2013 Country forecasts submitted by Mid October 2012 Issuance of Tender End July/Beg Aug 2013 CRC approval Mid November 2013 Review/clarification of country forecasts Oct- Nov. 2012 Industry consultation 23 July 2013 Announcement of awards Beg/Mid Dec. 2013 Initial forecast data Mid November 2012 Reviewing procurement strategy Mid April 2013 Commencement of LTA s 1 st January 2014 4
Create Sales order Invitee list All suppliers having a PQS listed product by WHO All suppliers having expressed an interest in participating in UNICEF tenders for AD syringes and Safety Boxes. 5
Create Content Sales of order the tender document 1. PURPOSE 2. INSTRUCTIONS TO BIDDERS 3. TERMS AND CONDITIONS 4. FORECAST - Tender quantities 5. BID FORM 6. BID SHEET(s) 10. PACKING DETAILS SHEET(s) 14. MONTHLY OFFERED QUANTITIES 15. Annex A - UNICEF Generic Specifications 16. Annex B UNICEF General Terms and Conditions 6
Create Sales Response order format Each Bid MUST contain: A signed and completed BID FORM A completed BID SHEET for each product offered A completed MONTHLY OFFERED QUANTITY SHEET for each product offered A completed PACKING DETAILS SHEET for each product offered Explanations for any exceptions and/or deviations in the Bid. 7
Create Sample Sales order of the Bid Form 8
Create Sample Sales order of the Bid Sheet 9
Create Sales order Sample of the Monthly Offered Quantities Sheet 10
Create Sales order Sample of the Packing Detail Sheet 10. PACKING DETAILS SHEET The Bidder is requested to provide UNICEF with packing details for each product offered using this SHEET. a. Name and type of Product: b. Standard INNER CARTON Packing Dimensions and Weight: Product: Total No. of AD syringes per inner carton: Dimensions: Gross Weight: Net Weight: Length: Width: Height: Number of AD syringe per INNER CARTON: c. Standard EXPORT CARTON Packing Dimensions and Weight: Product: Total No. of AD syringes per EXPORT Packing: Dimensions: Gross Weight: Net Weight: Length: Width: Height: Number of inner cartons per EXPORT CARTON: Number of boxes/export cartons in 40 FCL: Number of boxes/export cartons in 20 FCL: d. Standard PALLET Packing Dimensions and Weight (For DAP shipments): Product: Total No. of AD syringes per PALLET: Dimensions: Gross Weight: Net Weight: Length: Width: Height: Number of EXPORT CARTONS per PALLET: Number of pallets in 40 FCL: Number of pallets in 20 FCL: 11
Required Create Sales Quality order assurance documents 1. PQS: A valid WHO letter confirming that the product is WHO prequalified under PQS 2. A Third Party type test certification of a level and content to demonstrate that the specifications are being achieved. 3. Certificate of Conformity (or Certificates of Quality) 4. A bidders' internal quality test results. 5. Certificate of sterility (AD syringes) 12
Create Required Sales Quality order system standards The production facility where the offered AD syringes and safety boxes will be (or are currently) produced must have GMP certification, or equivalent. Equivalent quality systems are the standards used by the founding members of the Global Harmonization Task Force (GHTF), or standards that are acknowledged by one of the founding members as equivalent. 13
Required Quality system standard Create Sales order documentation cont. Manufacturers shall either provide certification that they are compliant with one of the following standards or submit certification of a quality system that has been deemed equivalent by a founding member of the GHTF. The table lists the current quality systems in place with the five founding members. Country Quality system standard Australia ISO13485 or EN46001, ISO13488 or EN46002 Canada ISO13485, ISO13488 European Union ISO13485, ISO 13488, EN46001, EN46002 Japan GMP ( QS Standard for medical devices #1128) United States QS (21 CFR part 820) 14
Create Sales order All bidders must submit reference samples AD syringes minimum 100 pcs per offered product Safety Boxes minimum 10 safety boxes per offered product For all bidders 1 empty export carton 15
Different Create Sales addresses order for bids and samples Bid Attention: BID SECTION ITB- DAN-2013- Sample Attention : Ms. Aileen Bien Selorio - Quality Inspection Unit (ITB-DAN-2013-.. 16
Create Submission Sales of order Bids to the Bid Section SEALED BIDS MUST be securely closed in a suitable envelope, clearly MARKED on the outside with the BID NUMBER ITB and MUST be dispatched to arrive at the UNICEF office NO LATER THAN the indicated CLOSING TIME Sealed Bids shall be sent to: UNITED NATIONS CHILDREN'S FUND (UNICEF) Attention: BID SECTION ITB-DAN-2013- Oceanvej 10-12 2100 Copenhagen Ø Denmark Bids received in any other manner will be INVALIDATED. 17
Create Submission Sales order of samples to QIU The samples should be clearly labelled as follows: UNICEF ITB number (ITB-DAN-2013-.); b) The item number stated in the Bid; c) Supplier's product reference; d) Supplier's name and address. The samples should be addressed to: UNICEF Oceanvej 10-12 2100 Copenhagen Ø Denmark Attn : Ms. Aileen Bien Selorio - Quality Inspection Unit (ITB-DAN-2013-.) 18
Create Sales order Offered lead times have to be realistic DAP deliveries = the manufacturing period + the projected period for shipment FCA deliveries = the manufacturing period until goods are available for dispatch from the offered FCA location. 19
Create Liquidated Sales order damages clause For late delivery of items or items which do not meet UNICEFs specifications and therefore rejected by UNICEF UNICEF shall be entitled to claim liquidated damages from the successful Bidder. Deduction of -0.5% of the value of the items pursuant to the Purchase Order per additional day of delay, up to a maximum of 10% of the value of the Purchase Order. 20
Create Most Sales Favored order Customer Clause By submitting an offer the bidder certifies that UNICEF, for Long Term Arrangements / Purchase Orders / Contracts resulting from this Invitation to Bid, is not being charged more than other clients for similar goods (products) or services and similar quantities and within similar circumstances. 21
Create Sales Unethical order Behavior UNICEF strictly enforces a policy of zero tolerance concerning unethical, unprofessional or fraudulent acts of UNICEF bidders. Accordingly, any registered bidder that is found to have undertaken unethical, unprofessional or fraudulent activities will be suspended or forbidden from continuing business relations with UNICEF. 22
Create Corrupt Sales and order Fraudulent Practices UNICEF requires that all bidders associated with this Invitation to Bid observe the highest standard of ethics during procurement and execution of the work. In pursuance of this policy UNICEF: (a) Defines for the purpose of this provision the terms set forth as follows: (i) corrupt practice means the offering, giving, receiving or soliciting of any thing of value to influence the action of a public official in the procurement process or in the execution of a contract, and (ii) fraudulent practice means a misrepresentation of facts in order to influence a procurement process or the execution of a contract to the detriment of the client, and includes collusive practice among bidders (prior to or after bid submission) designed to establish bid prices at artificial non-competitive levels and to deprive the client of the benefits of free and open competition; (b) Will reject a proposal for award if it determines that the selected supplier / contractor have engaged in any corrupt or fraudulent practices in competing for the contract in question; (c) Will declare a bidder ineligible, either indefinitely or for a stated period of time, to be awarded a UNICEF-financed contract if at any time it determines that it has engaged in any corrupt or fraudulent practices in competing for, or in executing a UNICEF-financed contract. 23
Create Sales Officials order not to benefit The bidder warrants that no official of UNICEF or the United Nations has received or will be offered by the bidder any direct or indirect benefit arising from this Invitation to Bid or the award thereof. The bidder agrees that breach of this provision is a breach of an essential term of the Invitation to Bid. 24
Create Guidelines Sales on order Gifts and hospitality Bidders shall not offer gifts or hospitality to UNICEF staff members. Recreational trips to sporting or cultural events, theme parks or offers of holidays, transportation, or invitations to extravagant lunches or dinners are also prohibited. 25
Create Sales order Disclosure of Sanctions or Temporary Suspension Only suppliers found to be responsible or conditionally responsible are eligible to be awarded UNICEF contracts and/or to bid on UNICEF solicitations. To be deemed a responsible supplier with whom UNICEF will conduct business, a supplier should not be suspended, debarred, or otherwise identified as ineligible by any organization within the World Bank Group or any other International or UN Organization. Suppliers are therefore required to disclose to UNICEF whether they are subject to any sanction or temporary suspension imposed by the World Bank Group or any other International or UN Organisation. 26
Create Sales Financial order evaluation SUPPLIER REGISTRATION AND EVALUATION Supplier must pass the financial evaluation conducted by UNICEF Supplier Evaluation Unit. If a supplier has not undergone this review, an application must be submitted through United Nations Global Marketplace (UNGM) website at http://www.ungm.org, under http://www.ungm.org/newsupplierregistration.aspx. Instructions are provided on the website. Bidders are requested to submit the UNGM application number, along with the documentation listed below, to UNICEF Supply Division, attention Supplier Evaluation Unit, A copy of company's legal registration A complete copy of company's latest audited financial statements, with comparative figures for the previous year. This includes, but is not limited to, the following: The report from the auditor (signed by the auditors) The balance sheet, The income statements, and notes thereto 27
Create Field Trial Sales Applicable order for AD syringes UNICEF requires demonstration of a successful user-friendliness field trial of production-run syringes. The purpose of the field trials will be to receive feedback from the actual target user group prior to widespread distribution of products not supplied by UNICEF before. The field trial protocols and results will be evaluated by UNICEF Supply Division and UNICEF program staff for acceptability. Any award will be made contingent upon successful results of such field trial, and no deliveries to UNICEF will be accepted prior to completion of the trial. Hence, following a successful field trial the resultant LTA award would therefore be considered for the remaining time of the tendered period i.e. 2015. Suppliers having undertaken their own trial would need to submit these as part of their bid for UNICEF review. 28
Create Main points Sales for order a UNICEF led Field trial Supplier to offer 100,000 pcs free of charge Minimum four (4) health centers/institutions should be included Minimum 25 and maximum 50 syringes used per user The number of users should be at least 40-80 users Questionnaires will be filled after using each syringe (up to 50 = quantitative) and at the end of the exercise (1 = qualitative). Forms will be collected by the ministry focal point and handed to the UNICEF Program Officer The study and analysis will commence once the surveys reach UNICEF Supply Division and is expected to last 4-6 weeks. UNICEF Supply Division will be responsible for data analysis, inference and report writing. The report will be shared with the Country Office, with due acknowledgement of their contributions. 29
Create Sales order DO request information from UNICEF during the tender process if need be Send all queries to the attention of Ms. Seba Ismaiel (e-mail: sismaiel@unicef.org), with specific reference to the tender. Inquiries received less than seven (7) calendar days prior to the Bid closing date cannot be guaranteed any response. A response to written queries will be provided to all Bidders in writing. 30
Award Create Notification Sales order in the public domain Information regarding awards, advising product, awarded supplier and total value of award is published on a monthly basis on the following site: http://www.unicef.org/supply/index_27009.html. UNICEF reserves also the right to make publicly available the awarded prices by manufacturer / supplier. 31
Create Sales order Evaluation methodology - two main reviews A. Review of Mandatory Requirements: Identify the minimum requirements to be considered for further review. Mandatory requirements will be indicated throughout the ITB by the words mandatory, shall, must or will in regard to obligations on the part of the Bidder. Bids that do not meet the mandatory requirements may not be eligible for award. B. Evaluation of Quantitative and Qualitative Data 32
Create Mandatory Sales order requirements Compliance with Instructions to Bidders UNICEF General Terms and Conditions Declaration of Country of Origin Compliance with shelf life requirement Compliance with Financial Requirement WHO prequalification status Compliance with required Quality System Standards 33
Create Additional Sales mandatory order requirements Currency of offer (EURO or USD) Compliance with packing and shipping marking requirements Submission of samples to the Quality Inspection Unit (QIU) Compliance with requirements for fixed needle and blister packing (AD syringes) Fixed and firm pricing Compliance with inspection requirements Successful sample review and approval by QIU 34
Create Sales order Review of quantitative and qualitative requirements Price: DAP and FCA price Payment Terms Responsiveness to the tender document Delivery times Offered production quantity Acceptance to keep a rolling buffer stock (min 10% of awarded quantities) Account management abilities Past performance on account management and on-time delivery. On-time delivery is measured by a) ability to meet agreed upon delivery dates; and b) ability to meet stated monthly allocations 35
Review of quantitative and qualitative Create Sales order requirements cont. Proven experience, including information on conducted field trials of the offered product Country feed back/customer acceptance Other information required and included in the evaluation: Bidders relationship with the manufacturer of the offered products Validity of Bid minimum 120 days Country of origin Gross weight and volume Point of activation of disabling mechanism of offered product. In line with the objective to reduce the risk of reuse, UNICEF has a preference for Auto-Disable Syringes with activation of the autodisabling feature commencing prior to delivery of the fixed full dose. (AD syringes) 36
Create The Sales Evaluation order process in stages Phase 1 WHO PQS status Responsiveness of the bid complete documentation Review of mandatory requirements Phase 2 QIU successful review and testing of samples Commercial evaluation (price, production, lead times, acceptance of buffer stock, INCO terms, currency of offer etc) Supplier evaluation unit (SEU) acceptance Phase 3 Field trial (AD syringes) Successful Quality Assurance Inspection (QIU)Plant inspection 37
Create Sales order New elements for the 2013 tender exercise Change to full calendar years: The LTA will be valid 2014-2015. Basis of award will be made on a landed cost scenario. 38
Create Sales Full order calendar years Better for planning, forecasting and reporting purposes Allows better allocation of quantities In line with the UNICEF annual forecasting exercise 39
Create Sales order 90 % of the demand will be based on a Landed cost scenario Top 10 ports based on number of deliveries. Based on an analysis of a combination of: Top 10 countries based on volume. 40
Create Landed Sales order cost components FCA price nearest international port Freight component by the UNICEF FF Landed cost 41
Create Sales order A total of 7 ports have been selected out of which 5 from the African continent and 2 from the Asian continent. Dar Es Salaam Djibouti East Africa Matadi Douala Apapa West Africa Karachi Bandar Abbas Asia 42
Create Sales order Forecasted tender volumes - Result of a review and analysis of several data sources; UNICEF annual forecast for devices Updated programmatic data for vaccines (notably new vaccines) Updated vaccine data from the Measles and Rubella Initiative Past forecast accuracy Wastage (vaccines and devices) Past historical procurement 43
Create AD 0.5 Sales ML order 23 G Tender volumes 2014 550,000,000 pieces 2015 608,000,000 pieces Total 1,158,000,000 pieces 44
Create AD 0.5 Sales ML order 24 G Tender volumes 2014 28,000,000 pieces 2015 25,000,000 pieces Total 53,000,000 pieces 45
Create AD Sales 0.05 ML order Tender volumes 2014 41,000,000 pieces 2015 43,000,000 pieces Total 84,000,000 pieces 46
Create AD Sales 0.1 ML order Tender volumes 2014 220,000 pieces 2015 220,000 pieces Total 440,000 pieces 47
Create Safety Sales Boxes order 5L Tender volumes 2014 7,000,000 pieces 2015 7,400,000 pieces Total 14,400,000 pieces 48
Create Upcoming Sales order tender volumes Product 2014 2015 Total AD syringe 0.5ml 23 G 550,000,000 608,000,000 1,158,000,000 AD syringe 0.5ml 24 G 28,000,000 25,000,000 53,000,000 BCG AD Syringe, 0.05 ml 41,000,000 43,000,000 84,000,000 BCG AD Syringe, 0.1 ml 220,000 220,000 440,000 Safety box 7,000,000 7,400,000 14,400,000 49
Thank you SD, Copenhagen, 23 July 2013 50