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Section II.

Bidding Forms
Table of Forms 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Bid / No Bid Confirmation Form Check-List Form Bidder Information Form Joint Venture Partner Information Form Bid Submission Form Price Schedule Form Technical Specification Form Bid Security (Bank Guarantee) Form Manufacturers Authorization Form Performance Statement Form No Adverse Action Confirmation Form

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1. Bid / No Bid Confirmation Form


[Complete this page and return it prior to bid opening if you do not intend to bid] Date: To: UNOPS Cambodia Phnom Penh Center, 6th Floor, Room 628, Sothearos Blvd, 12301 Phnom Penh, Cambodia Fax/email: youklint@unops.org

From: ITB, UNOPS case no.: UNOPS/KHOC/ITB RDT/2013/05 Project no. 00086135

Subject:

YES, we intend to submit an offer. NO, we are unable to submit a bid in response to the above mentioned invitation to bid due to the reason(s) listed below: () The requested products are not within our range of supply () We are unable to submit a competitive offer for the requested products at the moment () The requested products are not available at the moment () We cannot meet the requested specifications () We cannot offer the requested type of packing () We can only offer FCA prices () The information provided for quotation purposes is insufficient () Your ITB is too complicated () Insufficient time is allowed to prepare a quotation () We cannot meet the delivery requirements () We cannot adhere to your terms and conditions (please specify: payment terms, request for performance security,etc) () We do not export () Our production capacity is currently full () We are closed during the holiday season () We had to give priority to other clients requests () We do not sell directly but through distributors () We have no after-sales service available () The person handling the bids is away from the office () Others (please specify) () We would like to receive future ITBs for this type of goods () We dont want to receive ITBs for this type of goods If UNOPS has questions to the bidder concerning this NO BID, UNOPS should contact Mr./Ms._________________, phone/email ________________, who will be able to assist.

2. Check-ListForm
[Please fill in and include with your Bid] Activity Have you duly completed as all the Bidding Forms provided in Section II?; i.e.: - Bid / No bid Confirmation - Bidder Information - Joint Venture Partner Information and associated documents as per Instructions to Bidders Sub Clause 4.4 - Bid SubmissionForm - Price Schedule - Technical Specification Compliance Confirmation (Comparative Data Table) - Bid Security (in the correct form, andindicating the correct amount and correct validity period) - Manufacturer Authorization - Performance Statement - No Adverse Action Confirmation Form Have you provided the information as per Instructions to Bidders Clauses: - 18: Documents establishing the conformity of the Goods and Related Services - 38:Post-qualification of the Bidder - Financial capability related documents - Experience and technical capacity related documents Additional requirements - Authorization to sign the bid - Manufacturers valid ISO certificate-ISO 13485:2003 - WHO-FIND Malaria Rapid Diagnostic Test Performance Report Round 4 2012 - Thermal Stability Data from manufacturer - Packaging (Primary and Secondary): Documentary evidence that products have undergone and passed an appropriate and validated packaging test. i.e. leak proof details, integrity of sealing - Certificate of Analysis - Free Sale Certificate of the country of origin/Marketing Authorization in the territory of one of the founding members of the Global Harmonization Task Force must be Yes/No/NA Page No in your Bid Remark

Activity submitted together with the bidding documents. - Production Schedule - 10 Samples

Yes/No/NA

Page No in your Bid

Remark

3. Bidder Information Form


1. Expertise of Organization: Please fill in Organization structure (e.g. service provider, wholesaler, trader, manufacturer) Years of company experience Areas of expertise of organization Current Licenses if any, and Permits (with dates, numbers and expiration dates) Heath Authority Registration Information Production Capacity 2. Quality Assurance Certification:

International Quality Management System (QMS) List of other ISO certificates or equivalent certificates Presence and characteristics of in-house quality control laboratory 3. Expertise of Staff:

Total number of staff Number of staff involved in similar supply contracts 4. Client Reference List: Please provide references such as client details, commercial bank details, etc. Name of company: Contact person: Telephone: 1. 2. 3. 5. Contact details of persons that UNOPS may contact for requests for clarification during bid evaluation:

E-mail:

Name/Surname Tel Number (direct) Email address (direct): PS: This person must be available during the next two weeks following receipt of bid

4. Joint Venture Partner Information Form


[The Bidder shall fill in this Form in accordance with the instructions indicated below]. Date: [insert date (as day, month and year) of Bid Submission] ITB No.: [insert number of bidding process] Page ________ of ______ pages 1. Bidders Legal Name: [insert Bidders legal name] 2. JVs Party legal name: [insert JVs Party legal name] 3. JVs Party Country of Registration: [insert JVs Party country of registration] 4. JVs Party Year of Registration: [insert JVs Part year of registration] 5. JVs Party Legal Address in Country of Registration: [insert JVs Party legal address in country of registration] 6. JVs Party Authorized Representative Information Name: [insert name of JVs Party authorized representative] Address: [insert address of JVs Party authorized representative] Telephone/Fax numbers: [insert telephone/fax numbers of JVs Party authorized representative] Email Address: [insert email address of JVs Party authorized representative] 7. Attached are copies of original documents of:[check the box(es) of the attached original documents] Articles of Incorporation or Registration of firm named in 2, above, in accordance with Instructions to Bidders Sub-Clauses 4.1 and 4.2.

JV Agreement, orletter of intent to enter into such an Agreement, signed by the legally authorized signatories of all the parties

5. Bid Submission Form


[The Bidder shall fill in this Form in accordance with the instructions indicated No alterations to its format shall be permitted and no substitutions shall be accepted.] Date: [insert date (as day, month and year) of Bid Submission] ITB No.: [insert number of bidding process] Invitation to Bid No.: [insert No of ITB] Alternative No.: [insert identification No if this is a Bid for an alternative] To:[insert complete name of Purchaser] We, the undersigned, declare that: (a) We have examined and have no reservations to the Bidding Documents, including Amendment No.: ______________[insert the number and issuing date of each Amendment]; We offer to supply in conformity with the Bidding Documents and in accordance with the Delivery Schedules specified in the Schedule of Requirements the following Goods and Related Services _______________________ [insert a brief description of the Goods and Related Services]; The total price of our Bid, excluding any discounts offered in item (d) below, is: ______________________________[insert the total bid price in words and figures, indicating the various amounts and the respective currencies];

(b)

(c)

(d) The discounts offered and the methodology for their application are: Discounts.If our bid is accepted, the following discounts shall apply._______[Specify in detail each discount offered and the specific item of the Schedule of Requirements to which it applies.] Methodology of Application of the Discounts.The discounts shall be applied using the following method:__________ [Specify in detail the method that shall be used to apply the discounts]; (e) Our bid shall be valid for the period of time specified in Instructions to BiddersSub-Clause 20.1, from the date fixed for the bid submission deadline in accordance with Instructions to BiddersSub-Clause 24.1, and it shall remain binding upon us and may be accepted at any time before the expiration of that period; If our bid is accepted, we commit to obtain a performance security in accordance with Instructions to BiddersClause 44 and GCC Clause 12for the due performance of the Contract; We, including any subcontractors or suppliers for any part of the contract, have nationality fromcountries________ [insert the nationality of the Bidder, including that of all parties that comprise the Bidder, if the Bidder is a JV, and the nationality each subcontractor and supplier] We have no conflict of interest in accordance with Instructions to BiddersSub-Clause 4.2; Our firm, its affiliates or subsidiariesincluding any subcontractors or suppliers for any part of the contracthas not been declared ineligible by UNOPS, in accordance with Instructions to BiddersSubClause 4.3;

(f)

(g)

(h) (i)

(j) We understand that you are not bound to accept the lowest evaluated bid or any other bid that you may receive. (k) Signed:_______________ [insert signature of person whose name and capacity are shown]

In the capacity of _______[insert legal capacity of person signing the Bid Submission Form]

Name:____________ [insert complete name of person signing the Bid Submission Form]

Duly authorized to sign the bid for and on behalf of:_____ [insert complete name of Bidder] Dated on ____________ day of __________________, _______ [insert date of signing]

6. Price Schedule Form


[The Bidder shall fill in these Price Schedule Forms in accordance with the instructions indicated. The list of line items in column 1 of the Price Schedules shall coincide with the List of Goods and Related Services specified by UNOPS in the Schedule of Requirements.] BIDDERS TOTAL PRICES (Price & Currency to be entered by Bidder) TOTAL FIRM FCA PRICE (Bidder to mentioned the place of FCA in their country) FCA. Country TOTAL FIRMCPTPRICE Currency:___________

Price:_______________ Currency:___________

Price:_______________ BIDDERS PRICES FOR GOODS (Price & Currency to be entered by Bidder): Schedule No. DESCRIPTION QTY (a). CURRENCY: UNIT PRICE UNIT PRICE TOTAL PRICE TOTAL PRICE FCA*.. CPT-Phnom FCA*.. CPT-Phnom (b) Penh (a)x(b) Penh International International Airport Airport (c) (a)x(c) 1. Malaria Rapid Diagnostic Test 1,085,325 Tests

(*Bidder to mentioned the place of FCA in their country) BIDDERS DISCOUNT FOR ACCELERATED PAYMENT
____________________________% of total firm price for each calendar day less than thirty (30) days BIDDERS DELIVERY DATA
Country of origin of offered products: FCA point(s) of delivery for offered products: Delivery time (FCA from date of order): Shipment dimensions of offered products (Including package): Schedule 1 Schedule 1 Schedule 1 Gross weight Schedule 1 Total Total volume Containers (if applicable): Number Size

In the event of an order where UNOPS utilizes its own freight forwarder, the awarded supplier is required to cover the difference in freight cost resulting from higher weight/volume than initially stated in the bid.

PROVIDED THAT A PURCHASE ORDER IS ISSUED BY UNOPS WITHIN THE REQUIRED BID VALIDITY PERIOD, THE UNDERSIGNED HEREBY COMMITS, SUBJECT TO THE TERMS OF SUCH PURCHASE ORDER, TO FURNISH ANY OR ALL ITEMS AT THE PRICES OFFERED AND TO DELIVER SAME TO THE DESIGNATED POINT(S) WITHIN THE DELIVERY TIME STATED ABOVE. Exact name and address of company
COMPANY NAME AUTHORIZED SIGNATURE ADDRESS NAME OF AUTHORIZED SIGNATORY (TYPE OR PRINT) DATE

PHONE NO.

FAX NO.

FUNCTIONAL TITLE OF SIGNATORY

EMAIL ADDRESS OF CONTACT PERSON

OTHER EMAIL ADDRESSES

WEB SITE

7. Technical Specification Form


(Comparative Data Table) Bidders must complete the right column of the table and the compliance confirmation statement as included in Section III, Schedule of Requirements; Technical Specifications.

8. Bid Security (Bank Guarantee) Form


[The Bank shall fill in this Bank Guarantee Form in accordance with the instructions indicated.] ________________________________ [Banks Name, and Address of Issuing Branch or Office] Beneficiary: UNOPS Cambodia, Phnom Penh Centre, 6th Floor, Room # 628, Corner of Sihanouk and SothearosBlvds., SangkatTonleBassac, Khan Chamkamon Blvd, Phnom Penh Date: ________________ BID GUARANTEE No.: _________________ We have been informed that [name of the Bidder] (hereinafter called "the Bidder") has submitted to you its bid dated (hereinafter called "the Bid") for the execution of [name of contract] under Invitation to Bid No. [ITB number] (the ITB). Furthermore, we understand that, according to your conditions, bids must be supported by a bid guarantee. At the request of the Bidder, we [name of Bank] hereby irrevocably undertake to pay you any sum or sums not exceeding in total an amount of [amount in figures] ([amount in words] ) upon receipt by us of your first demand in writing accompanied by a written statement stating that the Bidder is in breach of its obligation(s) under the bid conditions, because the Bidder: (a) has withdrawn its Bid during the period of bid validity specified by the Bidder in the Form of Bid; or (b) having been notified of the acceptance of its Bid by UNOPS during the period of bid validity, (i) fails or refuses to execute the Contract Form; or (ii) fails or refuses to furnish the performance security, if required, in accordance with the Instructions to Bidders. This guarantee will expire: (a) if the Bidder is the successful Bidder, upon our receipt of copies of the contract signed by the Bidder and the performance security issued to you upon the instruction of the Bidder; or (b) if the Bidder is not the successful Bidder, upon the earlier of (i) our receipt of a copy of your notification to the Bidder of the name of the successful Bidder; or (ii) twenty-eight days after the expiration of the Bidders Bid. Consequently, any demand for payment under this guarantee must be received by us at the office on or before that date. This guarantee is subject to the Uniform Rules for Demand Guarantees, ICC Publication No. 458. _____________________________ [signature(s)]

9. ManufacturersAuthorization Form
[The Bidder shall require the Manufacturer to fill in this Form in accordance with the instructions indicated. Thisletter of authorization should be on the letterhead of the Manufacturer and should be signed by a person with the proper authority to sign documents that are binding on the Manufacturer.The Bidder shall include it in its bid, if so indicated in the Instructions to Bidders] Date: [insert date (as day, month and year) of Bid Submission] ITB No.: [insert number of bidding process] Alternative No.: [insert identification No if this is a Bid for an alternative] To:[insert complete name of UNOPS] WHEREAS We [insert complete name of Manufacturer], who are official manufacturers of [insert type of goods manufactured], having factories at [insert full address of Manufacturers factories], do hereby authorize [insert complete name of Bidder] to submit a bid the purpose of which is to provide the following Goods, manufactured by us [insert name and or brief description of the Goods], and to subsequently negotiate and sign the Contract. We hereby extend our full guarantee and warranty in accordance with Clause 13 of the General Conditions for Goods, with respect to the Goods offered by the above firm. Signed: [insert signature(s) of authorized representative(s) of the Manufacturer]

Name: [insert complete name(s) of authorized representative(s) of the Manufacturer] Title: [insert title]

Dated on ____________ day of __________________, _______ [insert date of signing]

10. Performance Statement Form


(for the period of the last five years) Bid no:_________

Name of the Firm ________________________________

Order placed Order no by (Full & date address of purchaser)

Description & quantity of ordered items

Value of Order

Date of completion of Delivery As per Actual Contract

Remarks indicating reasons of late delivery, if any

Was the supplies of goods satisfactory

Signature and seal of the Bidder

__________________________

Countersigned by and seal of Chartered Accountant

__________________________ To be attached: Documentary evidence (Clients certificate) in support of satisfactory completion of above orders.

11. No Adverse Action Confirmation Form


This is to certify that[delete unwanted option]: a. No adverse action has been taken against the Bidder[insert Bidders name]and the manufacturers [insert manufacturers name] )whose products are being offered by the Bidder against this Invitation to Bid, in the last 5 (Five) years. b. The following instances of previous past performance have resulted in adverse actions taken against the Bidder[insert Bidders name]) and the manufacturers [insert manufacturers name] whose products are being offered by the Bidder, in the last 5 (Five) years. Such adverse actions included: (indicatedate and reasons for adverse actions and result of adverse actions; i.e. suspension or cancellation of manufacturing license by regulatory authorities, product recalls,blacklisting, debarment from bidding etc.) Signature_____________ Name__________________ Designation with stamp____ Date_______

Section III. Schedule of Requirements


5) Comparative Data Table
Bidders must complete the right column of the below table and the compliance confirmation statement: Schedule No. 1 : Malaria Rapid Diagnostic Test (A) Technical Specifications and Required Documents for CNM and PSI PARAMETER REQUIREMENTS PLEASE FILL IN YOUR OFFER

Technology and malaria parasite species Technology Kit type Immunochromatographic test. Detection of P. falciparum (HRP2 or pLDH) and P. vivax (pLDH). Other species (P.malariaeand P.ovale) are desirable, but not mandatory. Sample type Shelf-life Whole blood. At least 24 months from date of manufacture. Guaranteed minimum remaining shelf life at time of delivery must be 80%. At least 40C Results in 20 minutes or less. Wild types (200 parasites/ l). >90% by Panel Detection Score. Wild types (200 parasites/ l). >90% by Panel Detection Score. Against clean negative samples/samples containing non Plasmodium species and immunological factors. <3.5%

Thermal Stability Assay time Sensitivity - P. falciparum Sensitivity - P. vivax

False Positive Rate

Kit Contents Test Format

Ancillary items

The RDT must be individually packed. Each pack must contain a complete set of all the items required to carry out one test (test device + all ancillary items). A laminated foil pouch contains: 1 plastic test device composed of: - A sample well (for blood). - A buffer well (for buffer). - A results window. - 1 colour change desiccant. An additional pack contains: - 1 alcohol swab.

PARAMETER

REQUIREMENTS 1 sterile lancet (easy to use with minimal discomfort to patient, e.g. twist top 23 G). 1 pipette indicating correct blood volume. 1 vial of buffer (for 1 test)

PLEASE FILL IN YOUR OFFER

Instructions for Correct Use Package Insert The instructions for use should comply with the Global Harmonization Task Force (SG1N070: 2011: Label and Instructions for Use for Medical Devices). Instructions for use in Khmer are to be included in each dispenser and in each individually wrapped test (text in Khmer will be provided by the Purchaser to the winning bidder at the time of contract award). The test procedure should consist of a few simple steps as noted below. No additional steps are acceptable.

Open the pouch and remove the device. Collect the correct volume of whole blood using the micropipette provided. Blot the blood on the pad in the sample well. Dispense the clearing buffer into the buffer well. Read the result after 20 minutes or less. In sum, the instructions need to clearly lay out: 1. How the test works. 2. The target antigens and malaria species that the test can identify. 3. How the test is done, with all the steps involved. 4. Interpretation of the results with pictures.5. Reading time 6. Instructions on the safe use of all items, blood safety and test reliability.7. Recommendations for storage. 8.List of contents.
Results

Negative: One red line appears in a result window under the C (Control) mark. Positive: P. falciparum: One red line appears in a result window under a C (control) Mark and one red line under the P.f (or '1) mark. Positive: P. vivax: One red line

PARAMETER

REQUIREMENTS

PLEASE FILL IN YOUR OFFER

appears in a result window under a C (control) Mark and one red line under the P.v (or 2) mark. Positive: P.falciparum and P. vivax: One red line appears in a result window under a C (control) Mark and red lines appear under the P.f/1 and P.v/2 marks Invalid: No red line appears in result window, under the C(control) mark.
Labelling Labelling standards The labelling should comply with the Global Harmonization Task Force (SG1-N070: 2011: Label and Instructions for Use for Medical Devices). English language should be used by default.

Documentations ISO Certified Manufacturer Recipients shall procure only diagnostic products that have been manufactured at a site, which complies with the requirements of ISO13485:2003in general and specifically for in vitro diagnostic product. The valid ISO certificate must be submitted together with the bidding documents. WHO-FIND Malaria Rapid Diagnostic Test Performance Report

The RDT must be listed in the WHOFIND RDT Performance Report-Round 4 2012. WHO-FIND Malaria Rapid Diagnostic Test Performance Report Round 4 2012 must be submitted together with the bidding documents.

Heat Stability Data

Production schedule

Two months stability must be demonstrated on all criteria. Manufacturer stability data must be submitted together with the bidding documents. Production schedule from data order is placed, to arrival at final Center Medical Stores. The production schedule must be submitted together with the bidding documents. Documentary evidence that products have undergone and passed an appropriate and validated packaging test E.g. Leak proof details / Integrity of sealing must be submitted together with the bidding

Packaging (Primary & secondary)

PARAMETER

REQUIREMENTS

PLEASE FILL IN YOUR OFFER

documents. (Visual inspection, a bubble test and a vacuum leak test to ensure no weaknesses in the sealed areas of the pouch. Adequate protection from humidity and other contaminants, from the manufacturing plant through transport, storage and the entire shelflife, up to the moment of use is paramount).
Quality Control and Testing

Marketing Authorization

Certificate of Analysis of the product (Malaria RDT) being sent as sample with this bid must be submitted together with the bidding documents. Free Sale Certificate of the country of origin/marketing authorization in the territory of one of the founding members of the Global Harmonization Task Force (GHTF) must be submitted together with the bidding documents.. 10 samples of the offered RDTs must be submitted together with the bidding documents.

Sample Number of sample required

(B) Packaging for CNM Packaging Pack Size Requirements The RDT must be individually packed. Each pack must contain a complete set of all the items required to carry out one test (test device + all ancillary items) (Refer to the above section-Kit Contents); and 25 individually packed RDTs to be packed in a single dispenser/pack. Please fill in your offer

(C) Packaging and Branding for PSI Packaging & Branding Pack Size Requirements The RDT must be individually packed. Each pack must contain a complete set of all the items required to carry out one test (test device + all ancillary items) (Refer to the above section-Kit Content); and 10 individually packed RDTs to be packed in a single dispenser/pack. Branding Over branding is required for the offered RDTs for PSI. Artwork must be designed Please fill in your offer

Packaging & Branding

Requirements by the supplier by strictly following the artwork and requirements provided as sample enclosed with this bidding document.

Please fill in your offer

THE OFFERED PRODUCTS ARE IN ACCORDANCE WITH THE REQUIRED SPECIFICATIONS AND TECHNICAL REQUIREMENTS: YES NO

ANY DEVIATIONS MUST BE LISTED BELOW:

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Section VI. Contract Forms


Table of Forms

1. 2.

Contract Form Performance Security

1.
Purchase Order No.: P.O. DATE : SHIP BY: CONSIGNEE: Attn.: Tel.: Fax: DELIVERY TERMS (INCOTERMS 2010): PAYMENT TERMS: ITEM DESCRIPTION

Contract Form
Project No. :

In the event of a Contract, the successful Bidder shall receive this form duly filled.

IMPORTANT: All shipments, invoices and correspondence must show PURCHASE ORDER and PROJECT NUMBERS. VENDOR No: Attn.: Tel.: Fax:

QTY

U/M

UNIT PRICE

TOTAL PRICE

1 2 Special Terms and Conditions A. This purchase order is subject to our Invitation to Bid, Ref. No.: XXXXX dated XXXXX and according to your offer dated .; B. Notify Party; C. Final Destination; D. Other information, if any:; E: Attachments: General Conditions for Goods, Packing and Shipping Instructions, others if any. CURRENCY : Date: Queries should be addressed to: Buyer: Name, Title, Tel. ON BEHALF OF UNOPS: Name of Procurement Authority, Title, Business Unit ACKNOWLEDGEMENT COPY: Vendor's Signature: UNOPS, Office, Address, Country, Tel, Fax GRAND TOTAL:

Date:

This Purchase Order may only be accepted by the Vendor's signing and returning the Acknowledgement Copy.Acceptance of this Purchase Order shall effect aContract between the Parties under which the rights and obligations of the Partiesshall be governed solely by the Conditions of this Purchase Order, including theGeneral Conditions for Goods of the United Nations Office for Project Services (UNOPS) and any UNOPS attachments (hereinafter collectively referred to as "This Contract"). No additional or inconsistent provisions proposed by the Vendorshall bind UNOPS unless agreed to in writing by a duly authorised official of UNOPS. UNOPS General Conditions for Goods are available at UNOPS website at http://www.unops.org/english/whatweneed/Pages/Guidelinesforsuppliers.aspx under General conditions of contract. If your company is unable to access the document, Please send an e-mail or fax request to: insert e-mail address and fax number of contact person and the UNOPS General Conditions for Goods will be sent to you electronically or by fax.

2.

Performance Security

The bank, as requested by the successful Bidder, shall fill in this form in accordance with the instructions indicated.
Date: [insert date (as day, month, and year) of Bid Submission] ITB No. and title: [insert no. and title of bidding process] Banks Branch or Office: [insert complete name of Guarantor] Beneficiary: UNOPS, Phnom Penh Center, 6th floor, Room # 628, Corner of Sihanouk and SothearosBlvds, SangkatTonleBassac, Khan Chamkamon, 12301 Phnom Penh, Cambodia PERFORMANCE GUARANTEE No.: [insert Performance Guarantee number]

We have been informed that [insert complete name of Supplier] (hereinafter called "the Supplier") has entered into Contract No. [insert number] dated [insert day and month], [insert year] with you, for the supply of [description of Goods and related Services] (hereinafter called "the Contract"). Furthermore, we understand that, according to the conditions of the Contract, a Performance Guarantee is required. At the request of the Supplier, we hereby irrevocably undertake to pay you any sum(s) not exceeding [insert amount(si) in figures and words] upon receipt by us of your first demand in writing declaring the Supplier to be in default under the Contract, without cavil or argument, or your needing to prove or to show grounds or reasons for your demand or the sum specified therein. This Guarantee shall expire no later than the [insert number] day of [insert month][insert year] ,iiand any demand for payment under it must be received by us at this office on or before that date. This guarantee is subject to the Uniform Rules for Demand Guarantees, ICC Publication No. 458, except that subparagraph (ii) of Sub-article 20(a) is hereby excluded. [signatures of authorized representatives of the bank and the Supplier]