Social Marketing III and Yemen Reproductive

Health IV

Project Number: (BMZ Project No. 2017 6728.4)

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Contents

Social Marketing III and Yemen Reproductive Health IV .......................................................... 1 Project Number: (BMZ Project No. 2017 6728.4) .................................................................. 1 Contents ................................................................................................................................. 2 1.1 Section I. Invitation for Bids (IFB) .............................................................................. 4 1.2 Timeline ..................................................................................................................... 4 1.3 LIST OF ABBREVIATIONS ....................................................................................... 5 1.4 Section II. Instruction to Bidders ................................................................................ 6

1. Scope of Bid .......................................................................................................... 6 2. Source of funds ...................................................................................................... 6 3. Eligible bidders ...................................................................................................... 6 4. Cost of Bidding ...................................................................................................... 7 5. Documents Establishing Goods’ Eligibility and Conformity to Bidding Documents7 6. Content of the Bidding Document .......................................................................... 7 7. Clarification of Bidding Documents ........................................................................ 8 8. Amendment of the Bidding Documents ................................................................. 8 9. Language of Bids ................................................................................................... 9 10. Documents and Samples Constituting the Bid ...................................................... 9 11. Bid Prices ............................................................................................................... 9 12. Bid Currency .......................................................................................................... 9 13. Period of Validity of Bids ........................................................................................ 9 14. Format and signing of the Bids ............................................................................ 10 15. Format of Bid Submission, Sealing and Marking of Bids .................................... 10 16. Deadline for Submission of Bids .......................................................................... 11 17. Late Bids .............................................................................................................. 11 18. Modification and Withdrawal of Bids .................................................................... 12 19. Bid Opening and Prequalification ........................................................................ 12 20. Clarification of Bids .............................................................................................. 12 21. Preliminary Examination ...................................................................................... 13 22. Evaluation and Comparison of Bids .................................................................... 13 23. Confidentiality ...................................................................................................... 14 24. Evaluation and Scoring ........................................................................................ 14 25. Award Criteria ...................................................................................................... 14 26. Purchaser’s Right to Vary Quantities at Time of Award ...................................... 14 27. Purchaser’s Right to Accept Any bid and to Reject any or all bids ..................... 15 28. Notification of Award ............................................................................................ 15 29. Signing of Contract .............................................................................................. 15

Section III. General Conditions of Contract ......................................................................... 16 1. Definitions ............................................................................................................ 16 2. Applications ......................................................................................................... 16 3. Country of Origin .................................................................................................. 16 4. Standards ............................................................................................................ 16 5. Assignment .......................................................................................................... 17 6. Patent Rights ....................................................................................................... 17 7. Inspections and Tests .......................................................................................... 17 8. Packing ................................................................................................................ 17 9. Examination ......................................................................................................... 18 10. Delivery and Documents...................................................................................... 18 11. Insurance ............................................................................................................. 19 12. Expiry Dates ........................................................................................................ 19 13. Warranty .............................................................................................................. 19 14. Payment ............................................................................................................... 20 15. Price ..................................................................................................................... 20 16. Change Orders .................................................................................................... 20 17. Contract Amendments ......................................................................................... 21

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18. Subcontracts ........................................................................................................ 21 19. Delays in the Supplier’s Performance ................................................................. 21 20. Liquidated Damages ............................................................................................ 21 21. Termination for Default ........................................................................................ 21 22. Force Majeure ...................................................................................................... 22 23. Termination for Insolvency................................................................................... 22 24. Termination for Convenience .............................................................................. 22 25. Resolution of Disputes ......................................................................................... 23 26. Governing Language ........................................................................................... 23 27. Applicable Law ..................................................................................................... 23 28. Notices ................................................................................................................. 23 29. Taxes and Duties ................................................................................................. 23 30. Reimbursements and Similar payments by Supplier ........................................... 24

Section IV. GCC Data Sheet ................................................................................................ 25 Section V. Application for Prequalification ........................................................................... 26

A. General Company Information Sheet .................................................................. 26 B. Mandatory Criteria Checklist ............................................................................... 26

Section VI – Technical Specifications .................................................................................. 29 Male latex Condom in Protec™ primary packaging (foil packaging only) ........................ 29

Section VII. Delivery Schedule ............................................................................................. 31 Section VIII. Bid Score sheet (Clause 24 of the ITB) ........................................................... 32 Section IX. Schedule of Prices ............................................................................................. 34

Price schedule for quantities over full period of contract ................................................. 34 Section X. Bidding and Contract Forms ............................................................................... 35

1. Bid Form ....................................................................................................................... 35 2. Declaration of Undertaking .................................................................................. 36 3. Manufacturer’s Authorisation Form ..................................................................... 38 4. Standard Form of Performance Bond .................................................................. 39 5. Mandatory Criteria Checklist ............................................................................... 40

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1.1 Section I. Invitation for Bids (IFB)

Project Name: Project: Social Marketing III and Reproductive Health IV

Project Number: (BMZ Project No. 2017 6728.4)

IFB No: YF Male Latex Condom 2018

1. The Yamaan Foundation in Yemen, through the Ministry of Public Health and

Population, has received funding from KfW Development Bank for the Marketing of

Contraceptives through the Private Sector (Project Component: Social Marketing of

Contraceptives). It is intended that part of the proceeds of these funds will be used to

procure Male latex condoms.

2. Accordingly, Yamaan Foundation hereby invites sealed bids from manufacturers of

male latex condoms, or their duly recognised agents for the supply of around

12,420,000 pieces (86250 gross) of male latex condoms to be delivered to Yemen

over a period of 36 months and two shipments.

3. The bidding process and requirements are laid out in the Instruction to Bidders (ITB)

to follow (section II Instructions to Bidders)

1.2 Timeline

Event Date and Time

Tender launch Tuesday 6th November 2018

Request for clarification deadline Thursday 6th December 2018 17.00 GMT

Clarifications sent out to interested

bidders

Monday 10th December 2018 17.00 GMT

Deadline for bid submission Friday 21st December 12.00noon GMT

Deadline for submission of electronic

version

Friday 21st December 12:00 noon GMT –

Saturday 22nd December 12:00 noon GMT

Opening bids Saturday 22nd December 2018

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1.3 LIST OF ABBREVIATIONS

MPHP Ministry of Public Health and Population

KfW Kreditanstalt fur Wiederaufbau

YF Yamaan Foundation for Health and Social Development

IFB Invitation for Bids

ITB Instructions to Bidders

GCC General Conditions of Contract

EUR EURO

ICH International Conference on Harmonization of Technical

Requirements for Registration of Pharmaceuticals for Human Use

UNFPA United Nations Population Fund

CIF/CIP/FOB Trade Terms published by the International Chamber of Commerce,

Paris, commonly referred to as “INCOTERMS”

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1.4 Section II. Instruction to Bidders

1. Scope of Bid

1.1 Yamaan Foundation (hereafter referred to as the Purchaser) with technical assistance

from Marie Stopes International (MSI) hereby invites bids for the supply of Male Latex

Condom to be packaged in Yamaan Foundation own label branding.

1.2 Throughout these bidding documents, the terms “writing” means any handwritten, typed,

or printed communication, including email. And “day” means calendar day. Singular also

means plural.

2. Source of funds

2.1 The Yamaan Foundation for Health and Social Development has received funding from

the German government through KfW Development Bank (KfW) for the Project:

Reproductive Health and Support to Basic Health Services (BMZ Project No.

2017.6728.4) Project Component: Social Marketing of Contraceptives. It is intended that

part of the proceeds of these funds will be used to procure Male Latex Condom.

By contract no. BMZ Project No. 2017.6728.4, Purchaser has been funded by KfW to

procure the supply of around 12,420,000 pieces (86,250 gross) of condoms through an

open tender, to be delivered over a period of 36 months.

Payment will only be made at the request of the Purchaser in Yemen in accordance with

the terms and conditions of the funding agreement and will be subject in all respects to

the terms and conditions of that agreement

3. Eligible bidders

3.1 Bidders may submit bids if none of the following reasons for exclusion apply:

• Participation of a bidder is ruled out by sanctions issued by the UN Security Council

• The bidder is/or was involved as a consultant in the preparation or implementation of

the project. The same applies to an enterprise or an individual that is closely

connected to the bidder under a company group or similar business link, or to several

enterprises or individuals associated correspondingly.

• The bidder has previously been legally barred from any procurement process on the

grounds of previous violations of the regulations on fraud and corruption.

• The bidders are enterprises economically intertwined with the Purchaser in the host

country and/or are state-controlled enterprises that are not legally or financially

independent.

Only bids from manufacturers whose product meets one of the following criteria will be

accepted. The product must be manufactured in a GMP (Good manufacturing practice)

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compliant factory and meet the criteria set out by WHO/UNFPA Male latex condom.

Specification, prequalification and guidelines for procurement, 2010.

Supplier and product must be

• on the current UNFPA Prequalified Male Condom Manufacturing Sites

And/or

• Product is authorised for use by a stringent regulatory authority in ICH member

country.

3.2 Only bids from primary manufacturers, or an authorised agent, who is able to produce

an original manufacturer’s authorisation, for and on behalf of primary manufacturer will be

accepted.

A “primary manufacturer” is defined as a company that performs all the manufacturing

and fabricating operations needed to manufacture condoms in its appropriate form

including processing, filling, packing, labelling sterility and quality testing. Merchant

exporters, pre-packers, shippers and traders are not classified as primary manufacturers

and bids from them will not be considered.

4. Cost of Bidding

4.1 The Bidder shall bear all costs associated with the preparation and submission of its bid,

and the Purchaser, will in no case be responsible or liable for those costs, regardless of

the conduct or outcome of the bidding process.

5. Documents Establishing Goods’ Eligibility and

Conformity to Bidding Documents

5.1 If a firm is applying as an agent of a primary manufacturer, the firm must, as part of its

APPLICATION FOR PREQUALIFICATION supply an originally signed letter from a

primary manufacturer on the primary manufacturer’s letterhead and sealed with the

primary manufacturer’s official seal or stamp, stating that the agent has been granted

permission by the primary manufacturer to act as its agent for this bid.

6. Content of the Bidding Document

6.1 The Bidding Documents are those stated below and should be read in conjunction with

any addendum (amendment to Bidding Documents) issued in accordance with the ITB

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a) Instructions to Bidders (ITB).

b) Bid Data Sheet (BDS)

c) General Conditions of Contract

d) Technical Specifications

e) Delivery Schedule

f) Application for Prequalification

g) Sample forms (including Contract Agreement)

The “Invitation for Bids” does not form part of the Bidding Documents and is included as a

reference only. In case of discrepancies between the Invitation for Bid and the Bidding

Documents listed in 6.1 above, said Bidding Documents will take precedence.

The Bidder is expected to examine all instructions, forms, terms and specifications in the

Bidding Documents. Failure to furnish all information required by the Bidding Documents

or submission of a bid not substantially responsive to the Bidding Documents in every

respect will be at the Bidder’s risk and may result in the rejection of its bid.

7. Clarification of Bidding Documents

7.1 Bidder’s requiring any clarification of the Bidding Documents shall contact the Purchaser

and Technical Consultants in writing or by email at the Purchaser’s email address and

Technical Consultants indicated in the Bid Data Sheet. Requests for clarification must be

submitted at least fifteen (15) days prior to the bid submission deadline.

7.2 The Purchaser/Technical Consultants shall respond in writing to any request for

clarification of the Bidding documents no later than Ten (10) days prior to the deadline of

the submission of bids prescribed by the Purchaser. Copies of the Purchaser’s response

shall be sent to all prospective Bidders who have requested the Bidding Documents,

including a description of the inquiry but without identifying its source.

8. Amendment of the Bidding Documents

8.1 At any time prior to the deadline for the submission of bids, the Purchaser may amend the

Bidding Documents by issuing Addenda.

8.2 Any addendum thus issued shall be part of the Bidding Documents pursuant to ITB Sub-

Clause 6.1 (The content of all Bidding Documents) and will be communicated in writing to

all purchasers of the Bidding Documents and will be binding on them. Bidders are

required to immediately acknowledge receipt of any such amendment, and it will be

assumed that the information contained in the amendment will have been taken into

account by the Bidder in its Bid.

8.3 To give prospective Bidders reasonable time in which to take the amendment into

account in preparing the bid, the Purchaser shall extend, at its discretion, the deadline for

submission of bids, in which case, the Purchaser will notify all Bidders by email of the

extended deadline.

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9. Language of Bids

9.1 The bid, as well as all correspondence and documents relating to the bid exchanged by

the Bidder and Purchaser, shall be written in the English language. Supporting

documents and printed literature furnished by the Bidder may be in another language

provided they are accompanied by an accurate translation of the relevant passage in the

English language, in which case, for the purpose of interpretation of the Bid, the

translation shall govern.

10. Documents and Samples Constituting the

Bid

10.1 The bid submitted by the Bidder shall compromise the following components:

a) A completed Section V. Application for Prequalification and all relevant

documents requested.

b) A Bid Form and a Price Schedule completed on the form provided under Section IX.

Schedule of Prices and in accordance with ITB Clause 11 & 12 (Bid Prices and Bid

Currencies)

c) Data and Samples required under Section VIII. Bid Score sheet.

d) Written power of attorney authorising the signatory of the bid to commit the bidder

e) Completed forms 1- 5 under Section X.

f) Samples as per technical specification

11. Bid Prices

11.1 The Bidder shall indicate on the incremental Price Schedule, the Unit Prices FOB (at

port of departure).

11.2 The terms FOB shall be governed by the rules prescribed in the current edition of

Inco terms published by the International Chamber of Commerce, Paris.

11.3 Fixed Price. Prices quoted by the Bidder shall be fixed during the Bidder’s

performance of the Contract and not subject to variation on the contracted amount on any

account. A bid submitted with an adjustable price quotation will be treated as non-

responsive and rejected.

12. Bid Currency

12.1 All goods shall be quoted in Euro.

13. Period of Validity of Bids

13.1 Bids shall remain valid for 120 days after the date of the deadline for submission of

bids. A bid valid for a shorter period may be rejected by the Purchaser as non-responsive.

13.2 In exceptional circumstances, the Purchaser may solicit the Bidder’s consent to an

extension of the period of validity. The request and the response thereto shall be made in

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writing or by email. A Bidder granting the request will not be required nor permitted to

modify its bid, but will be required to extend the validity of its bid security for the period of

the extension

14. Format and signing of the Bids

14.1 The Bidder shall prepare the bid in both original hard copy and electronic soft copy.

Each electronic document must be the scanned, signed copy of the original, unless

otherwise requested. Electronic documents must be clearly marked and titled according

to the list in Clause 10 and include the bidder name. All original hard copies must be

clearly marked.

14.2 The original hard copies of the bid shall be typed or written in indelible ink and shall

be signed by a person or persons duly authorised to bind the Bidder to the contract.

Authorisation shall be indicated by written power-of-attorney accompanying the bid. Any

interlineations, erasures, or overwriting to correct errors made by the Bidder should be

initialled by the person or persons signing the bid. All electronic soft copies must match

the hard copies, in case of discrepancy, the hard copy will govern.

14.3 The Bidder shall furnish in the Bid information regarding commissions or gratuities, if

any, paid or to be paid to agents relating to this bid and to execution of the Contract if the

Bidder is awarded the Bid

15. Format of Bid Submission, Sealing and

Marking of Bids

15.1 The format for this tender will be a “hard and soft copy” format whereby the

prequalification and the bid are submitted at the same time in both original hard copies

and electronic soft copies. In addition, a total of 99 samples are required. 30 condoms (10

strips) shall be sent with the hard copies and a further 60 condoms (20 strips) shall be

sent to Yemen for subjective testing.

15.2 The submission deadline is the date the original hard copies must be received at the

address stated in clause 15.9.

15.3 Exact copies of the original hard copies must be submitted in electronic format via

email as outlined in clause 15.7 no earlier than 24 hours after the hard copy deadline, and

no later than 24 hours after the hard copy deadline, as per clause 1.2.

15.4 A separate sealed envelope or container shall contain 30 samples of Supplier’s Male

Latex Condoms as per Technical Specifications for the lot the bidder is bidding for as

requested under Clause 10 (f) and should be marked “SAMPLES + Bidder’s company

name”. This envelope or container shall be part of the bid.

15.5 All envelopes shall be labelled with the bidder’s name, address and contact details,

and the words “Bid: Contract Number: (BMZ Project No. 2017 6728.4). In addition, all

envelopes must also bear the name, address and contact details given under ITB Clause

15.7.

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15.6 Electronic copies shall be sent to LSOTenders@mariestopes.org clearly stating in the

subject of the email the tender reference (BMZ Project No. 2017 6728.4), bidders name

and “DO NOT OPEN BEFORE 21 DEC 12:00 GMT”.

15.7 The original hard copy bid and samples (30 pieces of condoms) should be

submitted to the following address:

Marie Stopes – Jordan

Swaifiya, Abdulraheem Alhaj St.

Oasis2, building no57, Office no307

Tel: +962 6 581 5027

Amman, Jordan

Email: LSOTenders@mariestopes.org

And should be marked with the words “DO NOT OPEN BEFORE 21 DEC 2018 12:00 GMT”.

15.8 Samples for subjective testing (60 pieces of condoms) should be send to the

following address using only DHL:

Yamaan Foundation for Health and Social Development

Hadda Zone, Johar Street

P.O Box: 7335

Tel: 009671411684

Attn: Maha Alnajjar, Mob: 00967735287117

Sana’a – Yemen

15.9 If the envelopes are not sealed and marked as required by this clause, the Purchaser

will assume no responsibility for the bid’s misplacement or premature opening.

15.10 Bids should be hand delivered or sent by courier mail to ensure timely arrival

16. Deadline for Submission of Bids

16.1 Hard copies of the bids must be received at the address specified under ITB Clause

15.8, not later than 21/12/2018 12h00 noon GMT. Soft copies of the bids must be

received via email as specified in clause 15.7 between 21/12/2018 12h00 noon GMT and

22/12/2018 12h00 noon GMT.

16.2 The Purchaser may, at its discretion, extend this deadline for the submission of bids

by amending the Bidding Documents in accordance with ITB Clause 7, in which case all

rights and obligations of the Purchaser and the Bidders previously subject to the deadline

will thereafter be subject to the deadline as extended.

17. Late Bids

17.1 Any bids received by the Purchaser after the deadline for submission of bids given in

ITB Clause 16 (Deadline for Submission of Bids) will be rejected.

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18. Modification and Withdrawal of Bids

18.1 The Bidder may modify or withdraw its bid after the bid’s submission, provided that

written notice of the modification, or withdrawal of the bids duly signed by an authorised

representative, is received by the Purchaser prior to the deadline prescribed for the

submission of bids.

18.2 The Bidder’s modification or withdrawal notice shall be prepared, sealed, marked and

dispatched as follows:

a) The Bidder shall provide an original and electronic copy of any modifications to its

bid, envelopes duly marked “BID MODIFICATION “.

b) Other provisions concerning the marking and dispatch of bid modifications shall be in

accordance with ITB clauses 15 (sealing and marking of bids) & 16 (submission of

bids.)

18.3 A bidder wishing to withdraw its bid shall notify the Purchaser in writing prior to the

deadlines prescribed for bid submission. A withdrawal notice shall be received prior to the

deadline for submission of bids. The notice of withdrawal shall:

a) Be addressed to the Marie Stopes International at the address given under Clause

15.7 of the ITB and submitted electronically to LSOTenders@mariestopes.org

b) Bear the bidder’s name, address and contact details, and the words “BID

WITHDRAWAL NOTICE: BMZ Nr. 2017 6728.4 be accompanied by a written power

of attorney authorizing the signatory of the withdrawal notice to withdraw the bid.

18.4 Bids requested to be withdrawn in accordance with ITB Clause 18.3, above, shall be

returned unopened to the Bidders.

18.5 No bid may be withdrawn in the interval between the submission deadline and the

expiration of the bid validity as specified in ITB clause 13 (Period of Validity for Bids)

19. Bid Opening and Prequalification

19.1 The Purchaser will open all bids at the time, on the date and at the place specified in

the Bid Data Sheet.

19.2 Bids shall be opened one at a time, reading out: the name of the Bidder and whether

there is a modification. This process shall be repeated for every bid received. The result

of the prequalification process for each bid will be read out and recorded in writing.

19.3 The prequalification stage shall be deemed to be closed and the Purchaser shall

proceed to open and examine the remaining submitted documents of each prequalified

bid

20. Clarification of Bids

20.1 During the evaluation of bids, the Purchaser may, at its discretion, ask the Bidder for

a clarification of its bid. The request for clarification and the response shall be in writing,

and no change in the prices or substance of the bid shall be sought, offered, or permitted.

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21. Preliminary Examination

21.1 The Purchaser will examine the bids to determine whether they are complete,

whether any computational errors have been made, whether sureties have been

furnished, whether the documents have been properly signed, and whether the bids are

generally in order. Arithmetical errors will be rectified as follows.

21.2 If there is a discrepancy between the unit price and the total price that is obtained by

multiplying the unit price and the quantity, the unit price shall prevail, and the total price

shall be corrected. If there is a discrepancy between subtotals and the total price, the total

price shall be corrected. If there is a discrepancy between words and figures, the amount

in words shall prevail. If the Bidder does not accept the correction of the errors, its bid will

be rejected.

21.3 Prior to the detailed evaluation, The Purchaser will determine whether each bid is of

acceptable quality, is complete and is substantially responsive to the Bidding Documents.

For purposes of this determination, a substantially responsive bid is one which conforms

to all terms, specifications and conditions of the Bidding Documents without material

deviations, exceptions, objections, conditionality, or reservation:

a) That limits in any substantial way the scope, quality, or performance of Goods and

related Services;

b) That limits, in any substantial way that which is inconsistent with the Bidding

Documents, the Purchaser’s rights or successful Bidder’s obligations under the

Contract; and

c) That the acceptance of which would unfairly affect the competitive position of other

Bidders who have submitted substantially responsive bids

The Purchaser’s determination of bid responsiveness is to be based on the contents of

the bid itself without recourse to extrinsic evidence.

21.4 A bid determined as not substantially responsive will be rejected by the Purchaser

and may not subsequently be made responsive by the Bidder by correction of the non-

conformity.

21.5 The Purchaser may waive a minor informality or non-conformity or irregularity in a bid

which does not constitute a material deviation, provided such waiver does not prejudice

or affect the relative ranking of any Bidder

22. Evaluation and Comparison of Bids

22.1 The Purchaser’s evaluation of bid will exclude and not take into account:

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a) In the case of Goods manufactured in Yemen or of Goods of foreign origin already

located in Yemen, sales and other similar taxes, which will be payable on the Goods

if the Contract is awarded to the Bidder,

b) In the case of Goods of foreign origin offered from abroad, customs duties and other

similar import taxes which will be payable on the Goods if the Contract is awarded to

the Bidder, and

c) Any allowance for price adjustment during the period of execution of the Contract, if

provided in the bid.

23. Confidentiality

23.1 Information relating to the examination, clarification, evaluation and comparison of

bids, recommendations for the award of a Contract shall not be disclosed to bidders or

any other persons not officially concerned with such process until the notification of

Contract award is made to all Bidders.

23.2 Any effort by a Bidder to influence the Purchaser in the Purchaser’s bid evaluation,

bid comparison or Contract award decisions may result in the rejection of the Bidder’s bid.

23.3 From the time of bid opening to the time of Contract award, if any Bidder wishes to

contact the Purchaser on any matter related to its bid, it should do so in writing.

24. Evaluation and Scoring

24.1 Bids from prequalified bidders will be evaluated and scored on the criteria given by

the Bid Score sheet (section VIII). All instructions for completing the Bid Score sheet, the

scoring system and the maximum points for each criterion are given on the Bid Score

sheet.

24.2 Total scores will be submitted to KfW along with the description of the process and a

recommendation of the winner. On approval from KfW, Bidders shall immediately be

notified of the final outcome.

25. Award Criteria

25.1 The Purchaser will award the Contract to the Bidder whose bid is awarded the

highest total points on Bid Score sheet (Section VIII) attached. Purchaser reserves the

right to reject any bid.

26. Purchaser’s Right to Vary Quantities at Time

of Award

26.1 The Purchaser reserves the right at the time of award of Contract to increase or

decrease by up to Twenty-five (25) percent the quantity of ordered as given in the

Schedule of requirements without any change in unit price or other terms and conditions.

In this case the total price will be calculated by multiplying the adjusted quantity by the bid

unit price.

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27. Purchaser’s Right to Accept Any bid and to

Reject any or all bids

27.1 The Purchaser reserves the right to score the bids and accept and reject any/all bids

at any time prior to award of Contract without thereby incurring any liability to the affected

Bidder or Bidders or any obligations to inform the Bidder or Bidders of the grounds for the

Purchaser’s action.

28. Notification of Award

28.1 Prior to the expiration of the period of bid validity, the Purchaser will notify the

successful Bidder in writing by email, to be confirmed in writing by registered letter, that

its bid has been accepted.

28.2 The notification of award will constitute the formation of the Contract.

28.3 Upon the successful Bidder’s furnishing of performance security, pursuant to ITB

Clause 30 (Performance Security), the Purchaser will promptly notify each unsuccessful

Bidder by writing.

29. Signing of Contract

29.1 At the same time as the Purchaser notifies the successful bidder that its bid has been

accepted, the Purchaser will send the bidder the Contract Form provided in the Bidding

Documents, incorporating all agreements between the parties.

29.2 Within fourteen (14) days of the receipt of the Contract Form, the successful Bidder

shall sign and date the Contract and return it to the Purchaser.

29.3 Purchaser reserves the right to make the award of the bid pending on a successful

“passed” inspection of the Bidders’ manufacturing plant by the Purchaser or Purchaser’s

agent. In this case, the 14-day period stated in 29.2 shall begin on the day that the

Purchaser notifies the successful Bidder that its plant audit was “successful/passed”.

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Section III. General Conditions of Contract

1. Definitions

1.1 In this contract, the following terms shall be interpreted as indicated:

1.2 “The Contract” means the agreement entered into between the Purchaser and the

Supplier, as recorded in the Contract Form signed by the parties, including all

attachments and appendices thereto and all documents incorporated by reference therein

1.3 “The Contract Price” means the price payable to the Supplier under the Contract for the

full and proper performance of its contractual obligation.

1.4 “The Goods” means YF Male Latex Condom, which the supplier is required to supply in

various quantities to the Purchaser under the contract.

1.5 “Services” means services ancillary to the supply of Goods, such as transportation and

insurance.

1.6 “The Purchaser” means the organisation purchasing the Goods defined on Line 1 on the

GCC Data Sheet; and

1.7 “The Supplier” means the individual or firm supplying these Goods

2. Applications

2.1 These general Conditions shall apply to the extent that they are not superseded by

provision of others of the Contract.

3. Country of Origin

3.3 For purpose of this Clause “origin” means the place where the Goods were produced or

manufactured. Goods are produced when, through manufacturing, processing, a

commercially recognised new product results that is substantially different in basic

characteristics or utility from its component.

3.4 The origin of Goods and Services is distinct from the nationality of the Supplier.

4. Standards

4.1 The Goods supplied under this contract shall be manufactured in accordance with the

standards of Good Manufacturing Practice (GMP) applicable to medical devices. The

manufacturing standards shall have been accredited by one or more of the following

regulatory bodies:

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a) Manufacturer/Product is accepted under WHO/ UNFPA prequalification scheme for

Reproductive Health products.

b) Product has been registered by a stringent regulatory authority in ICH.

4.2 All ingredients used, and finished Goods shall be manufactured in accordance with

WHO/UNFPA Male latex condom. Specification, prequalification and guidelines for

procurement, 2010 and the relevant ISO standards that apply to different aspects of the

manufacture.

4.3 All premises used for the manufacture of Goods must hold a current Licence to operate

as a Medical Device Manufacturer in their regulatory setting, and suitable ISO 9001 and

13485 certifications as evidence that the site and equipment used respect the conditions

stipulated in an international quality certification system. The relevant certificates must be

issued by the relevant Ministry of Health or suitable certifying organisation, and the

premises must be open to visits from Inspectors appointed by the Purchaser.

5. Assignment

5.1 The Supplier shall not assign, in whole or in part, its obligations to perform under the

Contract, except with the Purchaser’s prior written consent.

6. Patent Rights

6.1 The Supplier shall indemnify the Purchaser against all third-party claims of infringement

of patent or trademark rights arising from use of the Goods or any part thereof in the

Purchaser’s country.

7. Inspections and Tests

7.1 The Purchaser’s right to inspect, test and, where necessary, reject the goods before

shipment of the goods shall in no way be limited or waived by reason of the Goods having

previously been inspected, tested and passed by the Purchaser or any representative of

these prior to the Good’s shipment from their country of origin.

7.2 In the event that the independent testing laboratory, and/or Purchaser, and/or an agent of

the Purchaser’s fail any batch supplied by the Supplier, Supplier shall immediately

remove and replace the failed batch so as not to cause delay in the continuous supply of

goods to Purchaser. This shall be regardless of Supplier’s intention to contest the testing

or refer the issue to an arbitrator or umpire.

7.3 Nothing in this GCC Clause 8 (Inspections and Tests) shall in anyway release the

Supplier from any warranty or other obligations under the Contract.

8. Packing

8.1 The Supplier shall provide such packing of Goods as is required to prevent their damage

or deterioration during transit to their final destination as indicated in the Contract. The

packing shall be sufficient to withstand, without limitation, rough handling during transit

and exposure to extreme temperatures, sunlight, humidity, salt and precipitation during

transit and storage. Packing case size and weights shall take into consideration, when

18

appropriate, the remoteness of the Goods’ final destination. The primary package that

comes in contact with the product should be properly sealed and leak proof and should

strictly conform to technical specifications.

8.2 The outer cases should be of a reasonable size to allow them to be handled by the end

users who may not have access to handling equipment.

8.3 The packing, marking, and documentation within and outside the packages shall comply

strictly with such special requirements as shall be expressly provided for in the Contract,

including additional requirements, if any specified in the Technical Specifications, and in

any subsequent instructions ordered by the Purchaser.

9. Examination

9.1 The Purchaser reserves the right to examine all Goods in course of manufacturing and

packaging and to take samples for independent analysis.

9.2 Upon handover to the freight agent, the goods will be inspected to confirm quantity, expiry

dates and packaging is undamaged. This must be documented, signed by both supplier

and freight agent.

10. Delivery and Documents

10.1 Delivery of the Goods and Documents shall be made by the Supplier to the port

specified in Line 3 of the GCC Data Sheet in accordance with the schedule and terms

specified by the Purchaser in its Schedule of Requirements and this GCC Clause 11.

10.2 The Supplier will immediately dispatch to the Purchaser a set of the following

documents by courier service and another set through attached to goods:

a) Three Certified commercial invoices showing the FOB price of goods and three

copies.

b) Three Certificates of Origin

c) Three Certificates of in-house analysis.

d) Three original copies of certificate of weight issued by the port authority/licensed

authority.

e) Three original copies of packing list

f) Three original copies of Insurance Certificate showing a value of 110% of the FOB

value of the consignment to departure port

g) Supplier’s/manufacturers certificate of quality (annex III)

h) Quality testing certificate by independent laboratory (see 8.1) where applicable

i) Copy of Advanced Shipping Notice (ASN) or written confirmation that goods have

been inspected by and handed over to freight agent as per clause 9.2

10.3 For purpose of the contract, “FOB”, “CFR”, “CIF, “CIP”, and other trade terms used to

describe the obligations of the parties shall have the meanings assigned to them by the

current edition of the International Rules for Interpretation of the Trade Terms published

by the International Chamber of Commerce, Paris, commonly referred to as

“INCOTERMS.”

19

10.4 The description of Goods shown on the Supplier’s invoices and packing notes will

have to include (unless inapplicable) the pharmacopoeia title and initial letters of the

pharmacopoeia standard, e.g. BP, as shown on the label. The expiry date must be

indicated for all Goods being supplied.

11. Insurance

11.1 The Goods supplied under the Contract shall be fully insured in a freely convertible

currency against loss or damage incidental to manufacture or acquisition, transportation,

storage and delivery.

11.2 Loss proceeds shall be payable in EUR to KfW at the account specified in GCC

clause 32.1

12. Expiry Dates

12.1 All bids submitted must details the maximum shelf life available against all Goods

offered.

All goods offered must be of fresh manufacture and thus have maximum possible shelf

life. All goods offered must arrive at FOB port no more than 3 months into the shelf life of

the product. No goods will be accepted which do not comply with this strict requirement

unless there has been a prior written agreement issued by Yamaan Foundation. The

expiry date must be shown on the invoice and (where despatch by post is impractical or

prohibited) on the application for shipping, or airfreight dispatch.

13. Warranty

13.1 The Supplier warrants that all Goods supplied under the Contract

a) will be of fresh manufacture

b) shall arrive at FOB port of departure with no more than three months into the shelf life

of the product

c) are not subject to recall by the applicable regulatory authority due to unacceptable

quality or an adverse drug reaction

d) that the goods fully comply in all respects with the Technical Specifications and with

the conditions laid down in the Contract in every respect

In the event, any of the Goods are recalled, the Supplier shall notify the Purchaser within

fourteen (14) days and promptly replace the items covered by the recall at its own cost.

13.2 Warranty shall be valid for the shelf life of the products provided the products are

stored in accordance with Manufacturer’s storage instructions.

13.3 The Purchaser shall promptly notify the Supplier in writing of any claims arising under

this warranty.

13.4 Upon receipt of such notice, the Supplier shall, with all reasonable speed, replace the

defective Goods without cost to the Purchaser. The Supplier will be required to remove or

20

destroy, at his own risk and cost, the defective Goods once the replacement Goods have

been delivered.

13.5 If the Supplier, having been notified, fails to replace the defective Goods within a

reasonable period, the Purchaser may proceed to take such remedial action as may be

necessary, at the Supplier’s risk and expense and without prejudice to any other rights

which the Purchaser may have against the Supplier under the Contract.

14. Payment

14.1 Payment shall be made to the Supplier by KfW on behalf of the Yamaan Foundation

in accordance with KfW direct payment procedures. Payment will be made in one single

payment following hand over to the freight agent at the port of departure, provision of a

signed handover and inspection document (see clause 9.2) and upon receipt of the

invoice.

14.2 The Supplier’s requests for payment shall be made to the Purchaser in writing,

accompanied by an invoice describing, as appropriate the Goods delivered and Services

performed, and by shipping documents, submitted pursuant to GCC Clause 10 (Delivery

and Documents), and upon fulfilment of other obligations stipulated in the Contract.

14.3 Payments will be made promptly by KfW within sixty (60) days of submission of an

invoice, Advance Shipping Notice (ASN) or written confirmation that goods have been

handed over to and inspected by freight agent, by the Supplier.

15. Price

15.1 Prices charged by the Supplier for Goods delivered and Services performed under

the Contract shall not vary from the prices quoted by the Supplier.

16. Change Orders

16.1 The Purchaser may at any time, by a written order given to the Supplier pursuant to

GCC Clause 29(Applicable Law), make changes within the general scope of the Contract

in any or more of the following aspects.

a) The method of shipment or packing

b) The packaging

c) The place of delivery

d) The Services to be provided by the Supplier

e) The timing of shipments

16.2 If any such changes cause an increase or decrease in the cost of, or the time

required for, the Supplier’s performance of any part of the Contract, whether changed by

the order, an equitable adjustment shall be made in the Contract Price or delivery

schedule, or both, and the Contract shall accordingly be amended. Any claims by the

Supplier for adjustment under this clause must be asserted within thirty (30) days from

the date of the Supplier’s receipt of the Purchaser’s changed order.

21

17. Contract Amendments

17.1 Subject to GCC clause 18, no variation in or modification of the terms of Contract

shall be made except by written amendment signed by the parties.

18. Subcontracts

18.1 The Supplier shall notify the Purchaser in writing of all Subcontracts awarded under

the Contract if not already specified in his bid. Such notification, in his original bid or later,

shall not relieve the Supplier from any liability or obligation under the Contract.

19. Delays in the Supplier’s Performance

19.1 Delivery of the Goods and performance of services shall be made by the Supplier in

accordance with the time schedule specified by the Purchaser in its Delivery Schedule.

19.2 An unexpected delay by the Supplier in the performance of its delivery obligations

shall render the Supplier liable to any or all of the following sanctions: forfeiture of its

performance security, imposition of a penalty, imposition of liquidated damages, and/or

termination of the Contract for default.

19.3 If at any time during the performance of the Contract, the Supplier or its

subcontractor(s) should encounter conditions impending timely delivery of the Goods and

performance of Services, the Supplier shall promptly notify the Purchaser in writing of the

fact of the delay, its likely duration and cause(s). As soon as practicable after receipt of

the Supplier’s notice, the Purchaser shall evaluate the situation and may at its discretion

extend the Supplier’s time for performance, in which case the extension shall be ratified

by the parties by amendments of the Contract.

20. Liquidated Damages

20.1 Subject to GCC Clause 21(Delays in Supplier’s Performance), if the Supplier fails to

deliver any or all of the Goods or perform the Services within the time period(s) specified

in the Schedule of Requirements, the Purchaser shall, without prejudice to its other

remedies under the Contract, deduct from the Contract price as liquidated damages, a

sum equivalent to 4% percent of the delivered contract Price of the delayed Goods or

unperformed Services for each week of delay until actual delivery or performance, up to a

maximum deduction of 10 percent of the delayed Goods or Services Contract Price.

When the maximum is reached, the Purchaser may terminate the Contract.

21. Termination for Default

21.1 The Purchaser may, without prejudice to any other remedy for breach of contract, by

written notice of default sent to Supplier, terminate the Contract in whole or in part:

22

a) If the Supplier fails to deliver any or all of the Goods within the time period(s)

specified in the Contract, or any extension thereof granted by the Purchaser pursuant

to GCC Clause 21;

b) If the Supplier fails to promptly replace any Goods rejected when submitted for testing

or subject to recall ordered by the applicable regulatory authority in the country of

manufacture due to unacceptable quality after giving prompt notice of recall

c) If the Supplier fails to perform any other obligation(s) under the contract

21.2 In the event the Purchaser terminates the Contract in the whole or part, pursuant to

GCC sub clause 21.1 above, the Purchaser may produce, upon such terms and such

manner as it deems appropriate goods similar to those undelivered, and the Supplier

shall be liable to the Purchaser for any excess costs for such similar Goods. If the

Supplier fails to reimburse the Purchaser for such excess costs within a reasonable

period, the Purchaser may have resource to the performance security. However, the

Supplier shall continue performance of the Contract to the extent not terminated.

22. Force Majeure

22.1 Notwithstanding the provisions of GCC Clauses 21, 22 and 23, the Supplier shall not

be liable for the forfeiture of its performance security, liquidated damages or termination

by default, if and to the extent that its delay is performance or other failure to perform its

obligations under the Contract is the result of an event of Force Majeure.

22.2 For the purpose of this clause, “Force Majeure” means an event beyond the control of

the Supplier and not involving the Supplier’s fault or negligence and not foreseeable.

Such event may include, but are not restricted to, act of the Purchaser in its sovereign

capacity, wars or revolutions, fires, floods, epidemic, quarantine restrictions and freight

embargoes.

22.3 If a Force Majeure situation should arise, the Supplier shall promptly notify the

Purchaser in writing of such condition and the clause thereof. Unless otherwise directed

by the Purchaser in writing the Supplier shall continue to perform its obligations under the

Contract as far as is reasonable alternative means for performance not prevented by the

Force Majeure event.

23. Termination for Insolvency

23.1 The Purchaser may at any time terminate the Contract by giving written notice to the

Supplier, without compensation to the Supplier, if the Supplier becomes bankrupt or

otherwise affects any right of action or remedy which has accrued or will accuse

thereafter to the Purchaser.

24. Termination for Convenience

24.1 The Purchaser by written notice sent to the Supplier may, terminate the Contract, in

whole or in part, at any time for convenience. The notice of termination shall specify that

termination if for the Purchaser’s convenience, the extent to which performance of the

Contract is terminated, and the date upon which such termination becomes effective.

23

24.2 The Goods that are complete and ready for shipment with 30 days after the Supplier’s

receipt of notice of termination shall be purchased by the Purchaser at the Contract terms

and prices. For the remaining Goods, the Purchaser may elect:

a) To have portion completed and delivered at the Contract terms and prices; and/or

b) To cancel the reminder and pay to the Supplier the agreed amount for the partially

completed Goods and for materials previously procured by the Supplier

25. Resolution of Disputes

25.1 The Purchaser and the Supplier shall make every effort to resolve amicably by direct

informal negotiation any disagreement or dispute arising between them under or in

connection with the Contract.

25.2 If after thirty (30) days from the commencement of such informal negotiations, the

Purchaser and the Supplier have been unable to resolve amicably a Contract dispute;

either party may require that the dispute be referred for settlement by arbitration in

accordance with the provisions of the UNCITRA Arbitration Rules.

26. Governing Language

26.1 The Contract shall be written, and its interpretation governed by the English

Language. All correspondence and other documents pertaining to the Contract which are

exchanged by the parties shall be written in the same language

27. Applicable Law

29.1 The Contract shall be interpreted in accordance with the laws of Germany.

28. Notices

28.1 Any notice given by the Supplier to the Purchaser pursuant to the Contract shall be

sent in writing or by fax/email and confirmed in writing to the address specified for that

purpose on line 7 of the GCC Data Sheet. The Supplier’s address for notice purpose shall

be given on line 8 of the GCC Data Sheet.

29. Taxes and Duties

29.1 A foreign Supplier shall be entirely responsible for all taxes, stamp duties, licence

fees and other such levies imposed outside the Purchaser’s country.

29.2 A local Supplier shall be entirely responsible for all taxes, duties, and licence fees etc,

incurred until delivery of the contracted Goods to the Purchaser.

24

30. Reimbursements and Similar payments by

Supplier

30.1 Any reimbursements guarantee, or similar claimable payments and any insurance

payments shall be made for account of the Yamaan Foundation for Health and Social

Development to account at KfW, Frankfurt am Main, IBAN: DE53 5002 0400 3800 0000

00, BIC: KFWIDEFF, with KfW crediting such payments to the account of the Yamaan

Foundation for Health and Social Development. If such payments are made in local

currency they shall be remitted to a special account of the Yamaan Foundation for Health

and Social Development in the country of the Yamaan Foundation for Health and Social

Development, which may be drawn on only with the consent of KfW.

25

Section IV. GCC Data Sheet

Clause reference A. Listed information in the GCC

1.1 (e) The Purchaser is:

Yamaan Foundation for Health and Social Development

1.1(f) The Supplier is:

11.1 The place of destination is FOB port of departure

15 The currency of payment shall be EURO

27 The language of the Contract shall be: English

29 The Purchaser’s address for notice purpose is:

ATT: Maha Alnajjar; Mobile: 00967735287117

Yamaan Foundation for Health & Social Development

Hadda Zone, Johar St., Sana'a, Yemen

Tel: 009671411684

Email: maha.alnajjar@yamaan.org

Signed by Ashraf Badr on behalf of Yamaan Foundation

___________________

Date:

29 The Supplier address for notice purpose is:

ATT:

Address:

Tel:

Email

Signed by___________ on behalf of ____________

Date:

26

Section V. Application for Prequalification

A. General Company Information Sheet

Must be competed in FULL

1. Name of Firm

2. Name of Directors

3. Full registered Street Address:

4. Factory Address if different to HQ address

6. Telephone number:

7. Email Address

8. Contact Person

9. Statement of the capacity in which the

supplier is applying e.g. as a primary

manufacturer, an agent of a manufacturer etc

10. If a firm is applying as an agent of a

primary manufacturer, state the name and

address of the primary manufacturer.

11. Company Registration Number

12. VAT Registration Number if applicable

A “primary manufacturer” is defined as a company that performs all the manufacturing and

fabricating operations needed to manufacture Male Latex Condom as per technical

specification (Section VI) in its appropriate form including processing, filling, packing,

sterilising, labelling and quality testing. Merchant exporters, pre-packers, shippers and traders

are not classified as primary manufacturers and bids from them will not be considered

The documentary evidence of the eligibility of the goods and services shall consist of a

statement of the country of origin of the Goods offered that shall be confirmed by a

Certification of Origin issued at the time of the dispatch

B. Mandatory Criteria Checklist

All information provided must be relevant to this specific procurement and all requirements

must be fulfilled in order to qualify for the tender. Each requirement must be supported by one

or more supporting documents, either in the form of a registration certificate, or an official

27

written statement by the firm. Supporting documentation must be submitted in their original

form or as a notarised copy. Documents in a language other than the English language must

be accompanied by a full certified translation into the English language. The Purchaser will

not return any document to the bidder.

The Purchaser reserves the right to immediately terminate the contract without notice and to

take legal action against the bidder if any documentation submitted by a bidder is

subsequently discovered to be false or misleading, and the bidder has been awarded a

contract.

This Prequalification check sheet must be completed by the primary manufacturer. Where the

applying firm is not the primary manufacturer, the applying firm should also submit a letter

indicating its exact role in the manufacturing process. In this case the Purchaser may at its

discretion, request the applying firm to provide additional information.

The following points are mandatory. Failure to meet or complete any of these requirements

will result in disqualification.

1. Provide proof of registration as a legal entity with relevant local authority

permission to manufacture medical devices including Male Latex Condom.

Proof must be certified document of regulatory certificate, or applicable

national regulatory code

2. Provide evidence that they are a primary manufacturer

(i.e. one that undertakes the processes of moulding, assembly, sterilization

and packaging, as specified by UNFPA in the call for an EOI, one or more

of these processes may be carried out on a contract basis, but the

manufacturer retains overall responsibility for product quality)

3. Provide a Valid GMP Certificate or similar relevant quality management

certification issued by National Regulatory Body

4. Provide Proof of current ISO:13485 certificate

5. Provide proof of one of the followings

Product is WHO Prequalified under the WHO/UNFPA prequalification

programme (letter from WHO/UNFPA will be accepted). A list of suppliers

who are prequalified is available on the UNFPA website.

OR Product is authorised for use by a stringent regulatory authority in ICH member country

6. Provide a copy of a test report of a recently produced batch

7. Provide a declaration on company letterhead that product supplied under

this contract will be in full compliance with the UNFPA/WHO specification

for Male latex Condom as laid out in: WHO/UNFPA Male latex condom.

Specification, prequalification and guidelines for procurement, 2010.

28

8. Provide a list of countries where your Male Latex Condom are legally

registered with the local national drug regulatory authorities. Name

countries and state number/reference. Also include countries where

registration is pending

9. Provide a Statement (on company letterhead and signed and dated) that

you can supply the products in Yamaan Foundation “own label branding”

under the brand name “Protec” in primary (foil) packing only.

10. Provide a summary of Male latex Condom manufacturing history of the

last three years to similar specification to the ‘Technical Specifications’

11. Provide a statement (on company letterhead and signed and dated) of

ability to comply with the technical specification

12. Provide an overview of your production capacity of the factory, available

production capacity for this order and standard LOT size.

13. Provide a statement on company letterhead that primary contact person

is fluent in both written and spoken English

14. Provide the Signed Declaration Understanding (see form 3 Declaration

of Understanding)

15. Provide a declaration of company letterhead that you have registration

or have documentation to lodge a regulatory dossier to export condoms into

Yemen

16. Provide a Full set of signed audited financial accounts for the past three

fiscal years, demonstrating that the firm is in a healthy financial condition

and that it has followed proper and transparent accounting procedures.

Please include:

Name of Bankers:

Address of Bankers:

Payment Address if different from Head Office or Main Base address

already entered here

29

Section VI – Technical Specifications

Male latex Condom in Protec™ primary packaging (foil

packaging only)

General and performance requirements

Manufactured as per the specifications in the WHO/UNFPA Male latex condom.

Specification, prequalification and guidelines for procurement, 2010.

The performance requirements specified in the WHO/UNFPA Specification are based on the

requirements of ISO 4074:2014 Natural rubber latex male condoms -- Requirements and

test methods.

Presentation

Condom features

• Material: Natural Latex Rubber

• Texture: Non textured / Smooth

• Shape: Parallel Sided, Reservoir Tip

• Length: Minimum 180mm

• Single Wall Thickness: 0.065 +/- 0.015mm; Laid Flat Width 53mm +/- 2mm

• Colour: Translucent

• Lubricant quantity (including powder): 550mg +/- 150mg

• Lubrication: Silicon Oil

• Scent: Non-scented / non-Flavoured

• Batch size: 3,000 gross per batch

• Shelf Life: Male latex condoms shall be supplied with 7/8 of shelf life remaining

Each mounting shall have the following information: (Yamaan will provide Brand name)

• Brand name: Protec

• Manufacturer's name

• Country of manufacture

• Batch or lot identification code

• Manufacturing date (month, year)

• Expiration date (month, year)

1. Packaging (Foil packaging only)

Primary foil

• Primary/Foil dimensions: Square not to exceed (5.5cm x 5.5cm) and should be in

strips of 3 condoms

30

• Primary/Foil Material: Poly aluminium foil consisting of a laminate of cellophane/PET

layers and aluminium layer of at least 8 micro-meters thick. Packaging must be

hermetically sealed and impervious to light and air. Foil should be pre-printed using

artwork of 4 colours.

• Artwork: is supplied with these documents and samples should be printed in Protec

Artwork

Secondary packaging – Bulk Carton

Outer carton

Quantity of inner cartons/dispensers per outer carton

As per manufacturers standard Please provide how many condoms will fit in each carton

Markings required on outer box • Delivery Address: Yamaan Foundation for Health & Social development. Sana'a – Yemen

• Brand: Protec Condom

• Batch/Lot No.:

• Man. date:

• Expiry date:

• Quantity:

• STORE IN A COOL DRY PLACE AWAY FROM HEAT AND DIRECT SUNLIGHT

Burst strength of carton (as per WHO/UNFPA specs) >1900 kPa

Maximum gross weight of carton: 25kg

All other properties, including packaging and labelling, shall be in accordance with ISO 4074

Standard and WHO/UNFPA specification and shall be verified as per ISO 4074:2014 Natural

rubber latex male condoms -- Requirements and test methods.

All manufacturing, sampling and independent testing shall be carried out in strict accordance

with the requirements of ISO 4047:2014.

Purchaser reserves the right to amend these specifications or testing requirements at any

time.

Workmanship

Products and packaging shall be free of defects that impair their serviceability, affect their

durability, or detract from their appearance

Shelf Life

The shelf life of the product provided under this contract shall be at least five (5) years from

the date of manufacture. The supplier shall be able to provide Manufacturer's stability test

data substantiating this five-year shelf life at ambient temperatures or above 32°C and

relative humidity of 85% in the proposed package.

31

Quality Assurance

The supplier shall guarantee that the products as packed for shipment comply with all the

provisions of the specifications and related documents. MSI reserves the right to perform or

cause to be performed inspections and tests of the products where such inspections are

deemed necessary to assure that the goods conform to the foregoing prescribed requirement

Section VII. Delivery Schedule

To be finalised and subject to change.

The date for the first delivery will be given to the successful bidder, taking into account lead

times for artwork approvals, printing, packaging, production, sampling testing and transit.

This must not exceed 16 weeks from issuing of contract and confirmation of final

artwork

The total quantity will be between 75,000-90,000 gross of condoms and shall be delivered in

two- three shipments over 36 months.

Below is an indication of delivery dates. Exact delivery dates to be confirmed later.

PRODUCT QUANTITY DELIVEY TIMINGS

Male latex Condom pieces

25,000-30,000 1st delivery no later than 16

weeks after contract signing

25,000-30,000 Approximately 12 months

after 1st delivery

25,000-30,000 Approximately 12 months

after 2nd delivery

Total 75,000-90,000

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Section VIII. Bid Score sheet (Clause 24 of the ITB)

For each item on the score sheet the highest points will be awarded to the bidder that best

fulfils the requirements. The bid shall be scored so that the best bid for each criterion is

awarded maximum points for those criteria and all other bids will be evaluated and scored in

accordance with how they compare to the best bid for that criteria.

Bidders should indicate clearly on their response, the criteria to which that response

corresponds. For example, the bidder’s response to the first criteria should be clearly labelled:

“Criteria 1”. Bidders must tailor their response to each criterion. Unspecific information or

information that is not clearly labelled as being in response to specific criteria may result in

the bidder being penalised.

No Description Points

1 References:

Please provide details of all customers to whom you have supplied Male

Latex Condom to over the last two years. Provide the customer’s name,

the date supplied, and the quantity supplied.

Separately, provide the company/organisation/government department

name, contact person’s name and contact details (telephone and email)

of three of your most recent customers so that Purchaser may approach

them to obtain references.

Please do not include Marie Stopes International (MSI) or any

partner/affiliate of Marie Stopes International as a reference due to MSI’s

involvement as a technical consultant in the opening and review of the

bids.

10

2 Subjective Quality Evaluation on Packaging

Perceived quality is different to the actual quality in that it is subjective

and cannot be measured quantifiably. MSI recognises the importance of

perceived quality. Yamaan Foundation has therefore designed a “blind

test” whereby a sample of health professionals shall score samples of YF

Male Latex Condom from each bidder.

Bidder must provide 99 pieces of Male Latex Condom in strips of three.

Samples must have equivalent packaging (material, printing quality) to

those that the supplier if awarded this (samples should be in Protec™

packaging or similar standard of branding). 60 pieces must be sent by

DHL to Sana’a, Yemen and 30 pieces must be sent to the MSI Amman

Office.

The purchaser will organise a subjective test among a health

providers/pharmacies/shop keeper. Before the test is carried out, the

Purchaser will black-out all marking identifying the manufacturer so that

none of the examiners will be able to identify the YF Male Latex Condom

20

33

by anything other than a code.

The examiners will evaluate and score the samples based on subjective

evaluation of the quality of the packaging and labelling and perceived

quality of condom pieces. The maximum score (20) points will be awarded

to the sample that is perceived to be the best quality. Scores will be

collected and averaged to give an overall test score for each sample.

Please note that this test is not a substitute for independent quantitative

empirical quality testing and formal packaging inspections.

3 Lead time:

Please state the maximum lead time from receiving purchase order to

goods being available for hand-over to freight agent at named port (FOB

incoterms).

20

4 Price:

Price to be filled in on the schedule of Prices. The bid offering the lowest

price shall be awarded the maximum points. Other bids shall have two (2)

points deducted for every 1% above the price of the lowest bid. Fill in

Schedule of prices (Section IX).

Price points will be weighted as follows based on prices provided in

Section IX. Schedule of Prices

Quantity Weighting

25,000-45,000 0.4

45,001-65,000 0.3

65,001-85,000 0.2

85,001 and above 0.1

50

Total Points 100

34

Section IX. Schedule of Prices

Bidders should clearly indicate prices in European Euros under the headings “UNIT PRICE

FOB”. Where FOB is as per the current INCOTERMS.

The unit pack size quoted shall be for one piece of Male Latex Condom packed in primary

foil packaging in the Purchaser’s own label. All packaging costs including the cost of labour

shall be included.

Price schedule for quantities over full period of

contract

Quantity Unit price FOB

25,000-45,000

45,001-65,000

65,001-85,000

85,001 and above

Signature of Bidder: __________________

Date: ___________________

35

Section X. Bidding and Contract Forms

1. Bid Form

Date: ________________________________

IFB No: ______________________________

Dear Sir or Madam:

Having examined the Bidding Documents, including Addenda the receipt of which is hereby

duly acknowledged; we, the undersigned, offer to supply and deliver the Goods under the

above-named Contract in full conformity with the said Bidding Documents for the sum given

under Section IX. Schedule of Prices, attached herewith and made part of the bid.

We undertake, if our bid is accepted to commence delivery according to Section VII. Delivery

Schedule attached herewith and made part of the bid.

Until a formal contract is prepared and executed, this bid, together with your written

acceptance thereof and your notification of award shall constitute a binding contract between

us.

We understand that you are not bound to accept the lowest or any bid you may receive.

Dated this____________________ day of _____________________2018

_____________________________

Signature

(In the capacity of duly authorised to sign bid for and on behalf of)

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2. Declaration of Undertaking

We underscore the importance of a free, fair and competitive procurement process that

precludes abusive practices. In this respect, we have neither offered nor granted directly or

indirectly any inadmissible advantages to any public servant or other person nor accepted

such advantages in connection with our bid, nor will we offer or grant or accept any such

incentives or conditions in the present procurement process or, in the event that we are

awarded the contract, in the subsequent execution of the contract. We also declare that no

conflict of interest exists in the meaning of the kind described in the corresponding

Guidelines.

We also underscore the importance of adhering to environmental and social standards in the

implementation of the project. We undertake to comply with applicable labour laws and the

Core Labour Standards of the International Labour Organization (ILO) as well as national and

applicable international standards of environmental protection and health and safety

standards.

We will inform our staff about their respective obligations and about their obligation to fulfil this

declaration of undertaking and to obey the laws of the country of Yemen.

We also declare that our company/all members of the consortium has/have not been included

in the list of sanctions of the United Nations, nor of the EU, nor of the German Government,

nor in any other list of sanctions and affirm that our company/all members of the consortium

will immediately inform the client and KfW if this situation should occur at a later stage.

We acknowledge that, in the event that our company (or a member of the consortium) is

added to a list of sanctions that is legally binding on the client and/or KfW, the client is entitled

to exclude our company/the consortium from the procurement procedure and, if the contract

is awarded to our company/the consortium, to terminate the contract immediately if the

statements made in the Declaration of Undertaking were objectively false or the reason for

exclusion occurs after the Declaration of Undertaking has been issued.

.............................. ................... .......................................................

(Place) (Date) (Name of company)

......................................................

(Signature(s))

37

Manufacturer’s certificate of quality

[Supplier’s Letterhead]

Yamaan Foundation,

Hadda Zone, Johar St.

Sana’a, Yemen

Manufacturer’s Letter of Quality

[Date]

We hereby certify that all batches of Male Latex Condom included in our Commercial Invoice

No. [insert] were manufactured according to : The Male latex Condom Technical

Specification and Prequalification Guidance 2016 and were found to fully confirm to the

technical specifications and standards of : The Male latex Condom Technical Specification

and Prequalification Guidance 2016 as well as the Certificate of Analysis issued with each

batch and were found to fully conform to the Technical Specifications and Standards set forth

in VI of the Contract for the International Purchase and Supply of Goods Between Yamaan

foundation and [insert company name] effective as of [insert date]

The shipping lot numbers supplied and shipped are listed below:

[Insert lot numbers] [Insert quantity] cycles

For [insert Supplier’s full legal name]

(Supplier)

[Signature]

Authorized Signature

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3. Manufacturer’s Authorisation Form

(Manufacturer’s or Producer’s letterhead)

To: (Insert name of Purchaser)

WHEREAS [insert: name of the manufacturer or producer] (hereinafter, “we” or “us”) who

are established and reputable manufacturer’s or producer’s of [insert: name and/or

description of the Goods requiring this authorisation] (hereinafter, “Goods”] having

production facilities at [insert: address of factory] do hereby authorise [insert: name and

address of Bidder] (hereinafter, the “Bidder”) to submit a bid, and subsequently negotiate

and sign the Contract with you against IFB [insert: title and reference number of the

Invitation for Bids] including the above Goods produced by us.

We hereby extend our full guarantee and warranty for the above specified Goods against

these Bidding Documents.

For and on behalf of the Manufacturer or Producer

Signed: _______________________________________

Date: _________________________________________

In the capacity of [insert: title, position, or other appropriate designation] and duly authorise to

sign this Authorisation on behalf of [insert: name of manufacturer or producer]

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4. Standard Form of Performance Bond

Address of guarantor bank

Address of beneficiary (contracting agency):

On you concluded with ("Contractor") a contract for the supply of

Male Latex Condom) (Reproductive Health Project II) at a price of

In accordance with the provisions of the contract the Contractor is obligated to provide a

performance bond for … % of the contract price.

We, the undersigned (Guarantor), waiving all objections and defences under the

aforementioned contract, hereby irrevocably and independently guarantee to pay on your first

written demand an amount up to a total of (in words: )

against your written declaration that the Contractor has failed to duly perform the

aforementioned contract.

In the event of any claim under this guarantee, payment shall be effected to KfW, Frankfurt

am Main (BIC: KFWIDEFF, BLZ 500 204 00), account no. 38 000 000 00 (IBAN:

DE53 5002 0400 3800 0000 00) for account of (Yamaan

Foundation, Yemen).

This guarantee shall expire no later than .

By this date we must have received any claims for payment by letter or encoded

telecommunication.

It is understood that you will return this guarantee to us on expiry or after payment of the total

amount to be claimed hereunder.

This guarantee is governed by the laws of Federal Republic of Germany

Place, date

Guarantor

40

5. Mandatory Criteria Checklist

All information provided must be relevant to this specific procurement and all requirements

must be fulfilled in order to qualify for the tender. Each requirement must be supported by one

or more supporting documents, either in the form of a registration certificate, or an official

written statement by the firm. Supporting documentation must be submitted in their original

form or as a notarised copy. Documents in a language other than the English language must

be accompanied by a full certified translation into the English language. The Purchaser will

not return any document to the bidder.

The Purchaser reserves the right to immediately terminate the contract without notice and to

take legal action against the bidder if any documentation submitted by a bidder is

subsequently discovered to be false or misleading, and the bidder has been awarded a

contract.

This Prequalification check sheet must be completed by the primary manufacturer. Where the

applying firm is not the primary manufacturer, the applying firm should also submit a letter

indicating its exact role in the manufacturing process. In this case the Purchaser may at its

discretion, request the applying firm to provide additional information.

The following points are mandatory. Failure to meet or complete any of these requirements

will result in disqualification.

1. Provide proof of registration as a legal entity with relevant local

authority permission to manufacture medical devices including Male

Latex Condom. Proof must be certified document of regulatory

certificate, or applicable national regulatory code

2. Provide evidence that they are a primary manufacturer

(i.e. one that undertakes the processes of moulding, assembly,

sterilization and packaging, as specified by UNFPA in the call for an

EOI, one or more of these processes may be carried out on a

contract basis, but the manufacturer retains overall responsibility for

product quality)

3. Provide a Valid GMP Certificate or similar relevant quality

management certification issued by National Regulatory Body

4. Provide Proof of current ISO:13485 certificate

5. Provide proof of one of the followings

Product is WHO Prequalified under the WHO prequalification

programme (letter from WHO/UNFPA will be accepted) A list of

supplier who are prequalified is available at

https://www.unfpa.org/resources/prequalification-programme-

condom

OR

41

Product is authorised for use by a stringent regulatory authority in

ICH member country

6. Provide a copy of a test report of a recently produced batch

7. Provide a declaration on company letterhead that product

supplied under this contract will be in full compliance with the

UNFPA/WHO specification for Male latex Condom as laid out in :

The Male latex Condom Technical Specification and

Prequalification Guidance 2016

Available at https://www.unfpa.org/resources/prequalification-

programme-condom

8. Provide a list of countries where your Male Latex Condom are

legally registered with the local national drug regulatory authorities.

Name countries and state number/reference. Also include countries

where registration is pending

9. Provide a Statement (on company letterhead and signed and

dated) that you can supply the products in Yamaan Foundation

“own label branding” under the brand name “Protec” in primary

packing.

10. Provide a summary of Male latex Condom manufacturing

history of the last three years to similar specification to the

‘Technical Specifications’

11. Provide a statement (on company letterhead and signed and

dated) of ability to comply with the technical specification

12. Provide an overview of your production capacity of the factory,

available production capacity for this order and standard LOT size.

13. Provide a statement on company letterhead that primary

contact person is fluent in both written and spoken English

14. Provide the Signed Declaration Understanding (see form 3

Declaration of Understanding)

15. Provide a declaration of company letterhead that you have

registration or have documentation to lodge a regulatory dossier to

export condoms into Yemen

16. Provide a Full set of signed audited financial accounts for the

past three fiscal years, demonstrating that the firm is in a healthy

financial condition and that it has followed proper and transparent

accounting procedures. Please include:

Name of Bankers:

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Address of Bankers:

Payment Address if different from Head Office or Main Base

address already entered here