Prequalification Documents for Procurement of FMD...

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PRE-QUALIFICATION DOCUMENT Prequalification for Procurement of Foot and Mouth Disease Vaccine (Trivalent) GOVERNMENT OF THE PUNJAB LIVESTOCK& DAIRY DEVELOPMENT DEPARTMENT, PUNJAB LAHORE

Transcript of Prequalification Documents for Procurement of FMD...

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PRE-QUALIFICATION DOCUMENT

Prequalification for Procurement

of

Foot and Mouth Disease Vaccine (Trivalent)

GOVERNMENT OF THE PUNJABLIVESTOCK& DAIRY DEVELOPMENT

DEPARTMENT, PUNJABLAHORE

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Livestock & Dairy Development Department

Invitation for Prequalification of FirmsFor

Procurement of Foot and Mouth Disease Vaccine (Trivalent)

INVITATION FOR PREQUALIFICATION OF FIRMS FOR PROCUREMENT OFFOOT AND MOUTH DISEASE VACCINE (TRIVALENT)

Livestock and Dairy Development Department Punjab intends to procure Foot and MouthDisease Vaccine (FMDV) trivalent for its field formations during financial year, 2017-18.Manufacturers and Importers of FMDV will be prequalified according to the provisions ofPPRA Rules, 2014 (16) to ensure transparency, competitiveness and efficiency in theprocurement process. Applications for prequalification are invited from well-reputed,financially sound, income tax/sales tax registered firms having eligibility/ experience in thefield of FMDV on following lines:-

1. In case of manufacturer (hereafter called as Principal) directly participating for

prequalification, year of its establishment, full address, contact information of person

duly authorized by the Principal for further correspondence.

2. In case of an authorized firm (hereafter called as Representative), authorization from

Principal, full address, contact information of person duly authorized by the

Representative for further correspondence.

3. Proof of experience of yearly Production of FMDV by the principal, with details, since

its establishment.

4. Proof of registration of Principal with the Competent Authority in the respective

country of its origin.

5. Valid Manufacturing / Import License of Firm from the Competent Authority in the

respective country of its origin.

6. Details of staff and machinery owned by the Principal.

7. Financial statement issued by scheduled Banks in the name of authorized Firm,

preferably, for last three years.

8. Proof of present assets owned and held by the Firm.

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9. Detail of any arbitration / litigation or similar proceedings against any Govt. / Semi-

Govt. Department/Organization.

10. Undertaking on judicial paper that the Firm was never black listed by any of theGovernment / Semi Govt. Organization in the past.

11. Registration of Firm (local only) with the income tax Department along with acertificate of payment of income tax / sales tax and should be an active tax payer.

12. Detail of imports of FMDV (if any) by the Representative during last three years.13. In case of company/ limited Firm, partnership deed / article of association with power

of attorney.14. Any concealment about the information / details mentioned above will result in dis-

qualification of the Firm.15. The Representative, in case of import, should have certificate / proof of registration

with the Drug Registration Authority of Pakistan (DRAP).16. In case of incomplete information, the application will not be considered for

prequalification.17. The firm is required to give undertaking that it has carefully studied the prequalification

notice / documents and it will abide by the rules and regulations as detailed in the pre-qualification document.

18. The decision of prequalification committee will be final.

Interested Firms may apply for pre-qualification on prescribed forms / documents available in

the office of undersigned free of cost. These prescribed forms / documents can also be

downloaded from departmental website www.livestockpunjab.gov.pk and PPRA website

www.ppra.punjab.gov.pk. The prequalification documents completed in all respect may be

submitted within 30 days from the publication in International print media or latest by

27-7-2017 till 2:00 PM, and will be opened at 2:30 PM on the same day. Only prequalified

Firms will be eligible to participate in the subsequent procurement process.

Further information if desired, may be obtained from the office of undersigned during workinghours on any working day.

Convener / Director General (Res),Purchase Committee

Livestock & Dairy Development Department,Veterinary Research Institute,Zarar Shaheed Road, Lahore

Phone # 042-99220143Email: [email protected]

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Acronyms & Abbreviations

FMD Foot and Mouth Disease

FMDV Foot and Mouth Disease Vaccine

OIE Office International des Epizooties (World Organization for Animal Health)

FIDIC Federation International des Ingénieurs-Conseils; an association based in Switzerlandthat produces Conditions of Contract for different classes of works construction.

ICB International Competitive Bidding

IFB Invitation for Bids

IFP Invitation for Prequalification

ITA Instructions to Applicants

JV Joint Venture

NCB National Competitive Bidding

PDS Prequalification Data Sheet

PQ Prequalification

PQD Prequalification Document

SBD Standard Bidding Documents

SPD Standard Prequalification Document

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ContentsSection I: Instructions to Applicants (ITA) .................................................................................................. 1

A. General...............................................................................................................................................1

1. Scope of Application.......................................................................................................................1

2. Source of Funds ..............................................................................................................................1

3. Fraud and Corruption .....................................................................................................................1

5. Eligible Goods ................................................................................................................................. 2

B. Contents of the Prequalification Document ......................................................................................3

6. Sections of Prequalification Document ..........................................................................................3

7. Clarification of Prequalification Document ....................................................................................3

8. Amendment of Prequalification Document ...................................................................................3

C. Preparation of Applications................................................................................................................4

9. Cost of Applications........................................................................................................................4

10. Language of Application ...............................................................................................................4

11. Documents Comprising the Application.......................................................................................4

12.Application Submission Form........................................................................................................ 4

13. Documents Establishing the Eligibility of the Applicant...............................................................4

14. Documents Establishing the Qualifications of the Applicant .......................................................4

15. Signing of the Application and Number of Copies ....................................................................... 4

D. Submission of Applications ................................................................................................................5

16. Sealing and Identification of Applications....................................................................................5

17.Deadline for Submission of Applications.......................................................................................5

18. Late Applications ..........................................................................................................................5

19. Opening of Applications ...............................................................................................................5

E. Procedures for Evaluation of Applications .........................................................................................5

20. Confidentiality ..............................................................................................................................5

21. Clarification of Applications ......................................................................................................... 6

22. Responsiveness of Applications ................................................................................................... 6

23. Domestic Bidder Price Preference................................................................................................6

F. Evaluation of Applications and Prequalification of Applicants...........................................................6

24. Evaluation of Applications............................................................................................................6

25. Procuring Agency’s Right to Accept or Reject Applications .........................................................6

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26. Prequalification of Applicants ...................................................................................................... 6

27. Notification of Prequalification .................................................................................................... 6

28. Invitation to Bid ............................................................................................................................6

Section II: Prequalification Data Sheet (PDS) .............................................................................................7

A. General...............................................................................................................................................7

B. Contents of the Prequalification Document ......................................................................................7

D. Submission of Applications ................................................................................................................8

Section III: Qualification Criteria and Requirements..................................................................................9

Section IV: Application Forms ..................................................................................................................13

Section V: Scope of Products....................................................................................................................22

Prequalification Evaluation Flow Chart ....................................................................................................32

Glossary ....................................................................................................................................................33

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Section I: Instructions to Applicants (ITA)A. General

1. Scope ofApplication

1.1 In connection with the Invitation for Prequalification indicated inSection II, Prequalification Data Sheet (PDS), the Procuring Agency,as defined in the PDS, issues this Prequalification Document (PQD)to applicants interested in bidding for the supply of Foot and MouthDisease Vaccine (Trivalent) described in Section V.

2. Source of Funds2.1 Government of the Punjab, Pakistan

3. Fraud andCorruption

3.1 It is the Government of the Punjab’s {Rule 2(1) (p) of PPR 2014}policy to require that bidders, suppliers and manufacturers and theiragents observe the highest standard of ethics during the procurementand execution of such contracts.

(a) In pursuance of this policy, the following terms are defined:

(i) “corrupt practice” is the offering, giving, receiving orsoliciting, directly or indirectly, of anything of value toinfluence improperly the actions of another party;

(ii) “fraudulent practice” is any act or omission, including amisrepresentation, that knowingly or recklessly misleads, orattempts to mislead, a party to obtain a financial or otherbenefit or to avoid an obligation;

(iii) “collusive practice” is an arrangement between two ormore parties designed to achieve an improper purpose,including to influence improperly the actions of another party;

(iv) “coercive practice” is impairing or harming, or threateningto impair or harm, directly or indirectly, any party or theproperty of the party to influence improperly the actions of aparty;

(v) “obstructive practice” is deliberately destroying, falsifying,altering or concealing of evidence material to theinvestigation or making false statements to investigators inorder to materially impede a Bank investigation intoallegations of a corrupt, fraudulent, coercive or collusivepractice; and/or threatening, harassing or intimidating anyparty to prevent it from disclosing its knowledge of mattersrelevant to the investigation or from pursuing theinvestigation; or

(b) the Procuring Agency will reject a proposal for award if itdetermines that the bidder recommended for award has, directly orthrough an agent, engaged in corrupt, fraudulent, collusive, coerciveor obstructive practices in competing for the contract in question;

(c) the Procuring Agency will sanction a firm or individual, includingdeclaring ineligible, either indefinitely or for a stated period of time,to be awarded a contract if it, at any time, determines that the firm

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has, directly or through an agent, engaged in corrupt, fraudulent,collusive, coercive or obstructive practices in competing for, or inexecuting, the contract; and

(d) the Procuring Agency will have the right to require that a provisionbe included in bidding documents requiring bidders, suppliers andmanufacturers and their agents to permit the Procuring Agency toinspect their accounts and records and other documents relating tothe bid submission and contract performance and to have themaudited by auditors appointed by the Purchaser;

4. EligibleApplicants

4.1 An Applicant can be a private, or public entity, or any combination ofpublic or private entities including Joint Venture (JV), consortiumwith the formal intent, (substantiated with a letter of intent), to enterinto an agreement or under an existing agreement.

4.2 Firms of a country may be excluded from bidding if as a matter of lawor official regulation, the Government of Pakistan prohibitscommercial relations with that country;

4.3 A firm declared disqualified / blacklisted by any of the public sectororganization in Pakistan shall be ineligible to bid for a contract duringthe period of embargo.

4.4 Applicants and all parties constituting the Applicant shall not have aconflict of interest. Applicants shall be considered to have a conflictof interest, if they participated as a consultant in the preparation ofthe technical specifications of the goods that are the subject of thisprequalification. Where a firm, or a firm from the same economic orfinancial group, in addition to consulting, also has the capability tomanufacture or supply goods or to construct works, that firm, or a firmfrom the same economic or financial group, cannot normally be asupplier of goods or works, if it provided consulting services for thecontract corresponding to this prequalification, unless it can bedemonstrated that there is not a significant degree of commonownership, influence or control.

4.5 Applicants shall not be under execution of a Bid–Securing Declarationin the Procuring Agency’s Country

5. Eligible Goods5.1 All goods to be supplied under the Contract to be financed by the

Government of Punjab shall have as their origin in any country notrestricted by the Government of Pakistan (Notified from time to time)

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B. Contents of the Prequalification Document

6. Sections ofPrequalificationDocument

6.1 The document for the prequalification of Applicants (hereinafter -“prequalification document”) consists all the sections indicated below,and should be read in conjunction with any Addendum if issued.

Section I. Instructions to Applicants (ITA)

Section II. Prequalification Data Sheet (PDS)

Section III Qualification Criteria and Requirements

Section IV. Application Forms

Section V. Scope of Products

6.2 The “Invitation for Prequalification Applications” (IPA) issued by theProcuring Agency is not part of the prequalification document. Asample form is provided as an attachment to this PrequalificationDocument for information only.

6.3 The Procuring Agency, accepts no responsibility for the completenessof the prequalification document and its addenda unless they wereobtained directly from the Procuring Agency or downloaded fromdepartmental and PPRA Punjab websites.

6.4 The Applicant is expected to examine all instructions, forms, and termsin the Prequalification Document and to furnish all information ordocumentation required by the Prequalification Document.

7. Clarification ofPrequalificationDocument

7.1 A prospective Applicant requiring any clarification of thePrequalification Document shall contact the Procuring Agency inwriting at the Procuring Agency’s address indicated in the PDS. TheProcuring Agency will respond in writing to any request forclarification provided that such request is received no later than ten (10)days prior to the deadline for submission of applications. Should theProcuring Agency deem it necessary to amend the prequalificationdocument as a result of a clarification it shall do under intimation to allthe applicants who have obtained the prequalification documents.

8. Amendment ofPrequalificationDocument

8.1 At any time prior to the deadline for submission of applications, theProcuring Agency may amend the Prequalification Document byissuing addenda.

8.2 Any addendum issued shall be part of the Prequalification Documentand shall be communicated in writing to all who have obtained theprequalification document from the Procuring Agency.

8.3 To give prospective Applicants reasonable time to take an addenduminto account in preparing their applications, the Procuring Agencymay, at its discretion, extend the deadline for the submission ofapplications.

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C. Preparation of Applications

9. Cost ofApplications

9.1 The Applicant shall bear all costs associated with the preparation andsubmission of its application. The Procuring Agency will in no casebe responsible or liable for those costs, regardless of the conduct oroutcome of the prequalification process.

10. Language ofApplication

10.1 The application as well as all correspondence and documents relatingto the prequalification exchanged by the Applicant and the ProcuringAgency, shall be written in “ENGLISH”. Supporting documents andprinted literature that are part of the application may be in anotherlanguage, provided they are accompanied by an accurate translation ofthe relevant passages in “ENGLISH”.

11. DocumentsComprising theApplication

11.1 The application shall comprise the following:

(a) Application Submission Form, in accordance with ITA 12;

(b) documentary evidence establishing the Applicant’s eligibility toprequalify, in accordance with ITA 13;

(c) documentary evidence establishing the Applicant’squalifications, in accordance with ITA 14; and

(d) any other document required as specified in the PDS.

12. ApplicationSubmission Form

12.1 The Applicant shall prepare an Application Submission Sheet usingthe form provided in Section IV, Application Forms. This Form mustbe completed without any alteration to its format.

13. DocumentsEstablishing theEligibility of theApplicant

13.1 To establish its eligibility in accordance with ITA 4, the Applicantshall complete the eligibility declarations in the ApplicationSubmission Form and Forms ELI (eligibility) 1.1 and 1.2, included inSection IV, Application Forms.

14. DocumentsEstablishing theQualifications of theApplicant

14.1 To establish its qualifications to perform the contract(s) in accordancewith Section III, Qualification Criteria and Requirements, theApplicant shall provide the information requested in thecorresponding Information Sheets included in Section IV,Application Forms.

15. Signing of theApplication andNumber of Copies

15.1 The Applicant shall prepare one original of the documentscomprising the application as described in ITA 11 and clearly mark it“ORIGINAL”. The original of the application shall be typed orwritten in indelible ink and shall be signed by a person dulyauthorized to sign on behalf of the Applicant.

15.2 The Applicant shall submit copies of the signed original application,in the number specified in the PDS, and clearly mark them “COPY”.In the event of any discrepancy between the original and the copies, theoriginal shall prevail.

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D. Submission of Applications

16. Sealing andIdentification ofApplications

16.1 The Applicant shall enclose the original and the copies of the applicationin a sealed envelope that shall:

(a) bear the name and address of the Applicant;

(b) be addressed to the Procuring Agency, in accordance with ITA17.1; and

(c) bear the specific identification of this prequalification processindicated in the PDS 1.1

16.2 The Procuring Agency will accept no responsibility for notprocessing any envelope that was not identified as required.

17. Deadline forSubmission ofApplications

17.1 Applicants may always submit their applications by mail or byhand. Applications shall be received by the Procuring Agency at theaddress and no later than the deadline indicated in the PDS. Areceipt will be given for all applications submitted.

17.2 The Procuring Agency may, at its discretion, extend the deadline forthe submission of applications by amending the PrequalificationDocument in which case all rights and obligations of the ProcuringAgency and the Applicants subject to the previous deadline shallthereafter be subject to the deadline as extended.

18. LateApplications

18.1 Any application received by the Procuring Agency after the deadline forsubmission of applications will not be entertained as indicated in thePDS.

19. Opening ofApplications

19.1 The Procuring Agency shall open all Applications at the date, timeand place specified in the PDS. Late Applications shall be treated inaccordance with ITA 18.1.

E. Procedures for Evaluation of Applications

20. Confidentiality20.1 Information relating to the evaluation of applications, and

recommendation for prequalification, shall not be disclosed toApplicants or any other persons not officially concerned with suchprocess until the notification of prequalification is made to allApplicants.

20.2 From the deadline for submission of applications to the time ofnotification of the results of the prequalification, any Applicant thatwishes to contact the Procuring Agency on any matter related to theprequalification process, may do so but only in writing.

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21. Clarification ofApplications

21.1 To assist in the evaluation of applications, the Procuring Agencymay, at its discretion, ask any Applicant for a clarification of itsapplication which shall be submitted within a stated reasonable periodof time. Any request for clarification and all clarifications shall be inwriting.

21.2 If an Applicant does not provide clarifications of the informationrequested by the deadline, the application shall be evaluated based onthe information and documents available at the time of evaluation ofthe application.

22. Responsivenessof Applications

22.1 All applications not responsive to the requirements of theprequalification document shall be rejected.

23. Domestic BidderPrice Preference

23.1 Unless otherwise specified in the PDS, a margin of preference fordomestic bidders shall not apply in the bidding process resulting fromthis prequalification.

F. Evaluation of Applications and Prequalification of Applicants

24. Evaluation ofApplications

24.1 The Procuring Agency shall use the factors, methods, criteria, andrequirements defined in Section III, Qualification Criteria andRequirements to evaluate the qualifications of the Applicants. Theuse of other methods, criteria, or requirements shall not be permitted.

25. ProcuringAgency’s Right toAccept or RejectApplications

25.1 The Procuring Agency reserves the right to accept or reject all theapplications, and to annul the prequalification process, as providedunder relevant section of PPRA rules.

26. Prequalificationof Applicants

26.1 All Applicants whose applications have met the specifiedrequirements will, to the exclusion of all others, be prequalified by theProcuring Agency.

27. Notification ofPrequalification

27.1 Once the Procuring Agency has completed the evaluation of theapplications it shall notify all Applicants in writing indicating theirstatus as to qualified or ineligible.

28. Invitation to Bid28.1 After the notification of the results of the prequalification the

Procuring Agency shall initiate the procurement process which shallonly be participated by the prequalified bidders.

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Section II: Prequalification Data Sheet (PDS)

A. General

ITA 1.1 Name of Procuring Agency: -Livestock & Dairy Development Department

ITA 1.1 PQD name and number are: -Pre-qualification of firms for Procurement of FMDVaccine, DG(Ext.)/L&DD/2017-18

ITA 4.7 Address for communication:

Director General (Res)/ Convener Purchase CommitteeLivestock & Dairy Development Department,

Veterinary Research Institute,Zarar Shaheed Road, Lahore

Phone # +9242-992010-3Email: [email protected]

B. Contents of the Prequalification Document

ITA 7.1 For clarification purposes, the Procuring Agency's address is:

“same as in 4.7 above”

C. Preparation of Applications

ITA 10.1 The language of the application as well as of all correspondence is: “English”

ITA 11.1 (d) The Applicant shall submit with its application, the following additional documents:

1. Articles of Incorporation or Documents of Constitution, and documents of registration ofthe legal entity named above. In case of JV, letter of intent to form JV or JV agreement.

2. Applicants signed affidavit on PKR 100.00 judicial paper confirming not having beendeclared disqualified/blacklisted by any of the public sector organization in Pakistan, asdescribed in ITA Sub-Clause 4.3

3. Applicants signed affidavit on PKR 100.00 judicial paper confirming not having beeninvolved in any litigation during last three years.

4. List of products manufactured / supplied5. Installed annual production capacity.6. Audited balance sheets, including all related notes, and income statements for the last 3 years7. Copy of product registration with DRAP8. Copy of latest Quality Assurance Certification9. Proof of raw material product and facility registrations with manufacturer’s country

regulatory authority and international agencies

ITA 15.2 In addition to the original, the number of copies to be submitted with the application is:[one copy]

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D. Submission of Applications

ITA 17.1 Applicants “shall not” have the option of submitting their applicationselectronically.

For application submission purposes only, the Procuring Agency's address isindicated in 4.7

The deadline for application submission is:Date: 27-07-2017Time: 14:00_ hours

ITA 18.1 Late applications shall not be entertained.

ITA 19.1 The opening of the Applications shall be at 14:30 hours on 27-07-2017 in the office ofDirector General (Res), L&DD, Veterinary Research Institute Zarar Shaheed road, Lahore

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Section III: Qualification Criteria and RequirementsThis Section contains all the methods, criteria, and requirements that the Procuring Agency shall use to evaluate applications. Theinformation to be provided in relation to each requirement and the definitions of the corresponding terms are included in the respectiveApplication Forms.

Eligibility and Qualification Criteria Compliance Requirements Documentation

No. Subject Requirement Single

Entity

Joint Venture /Consortium Submission Requirements

1. Eligibility1.1 Nationality Nationality in accordance with ITA

Clause 4Must meetrequirement

Must meetrequirement

Forms ELI – 1.1 with attachments

1.2 Conflict ofInterest

No conflicts of interest in accordancewith ITA Sub-Clause 4.4

Must meetrequirement

Must meetrequirement

Application Submission Form

1.3 Ineligibility a)Not having been declareddisqualified/black listed by any of thepublic sector organization in Pakistan,as described in ITA Sub-Clause 4.3b) not having been involved in anylitigation during last three years. Incase yes, provide details

Must meetrequirement

Must meetrequirement

Form ELI – 1.2 (a) Affidavit(b) Affidavit

1.4 Applicant’sProductionCapacity

Installed production capacityMust meetrequirement

Must meetrequirement

Form ELI – 1.3

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Eligibility and Qualification Criteria Compliance Requirements Documentation

No. Subject Requirement Single

Entity

Joint Venture /Consortium Submission Requirements

2. Financial Situation2.1 Financial

PerformanceSubmission of balance sheets, forthe last 3 years to ascertain :

Must meetrequirement

Form FIN – 2.1 (a) with attachments

(a) the financial soundness andstability of the applicant’s positionand its prospective long termprofitability, and

(a) Mustmeetrequirement

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Eligibility and Qualification Criteria Compliance Requirements Documentation

No. Subject Requirement Single

Entity

Joint Venture /Consortium Submission Requirements

3. Experience

3.1 GeneralSuppliesExperience

Experience under supplies contractsin the role of supplier/manufactureror agent.

Supportinginformation Supporting

informationForm EXP – 3.1

3.2 SpecificSuppliesExperience

Participation as principal firm oragent in at least one or morecontracts within the last two years,that have been successfully andsubstantially completed and that aresimilar to the proposed goods.

Supportinginformation

Supportinginformation

Form EXP 3.2

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Eligibility and Qualification Criteria Compliance Requirements Documentation

No. Subject Requirement Single

Entity

Joint Venture /Consortium Submission Requirements

3.3 ManufacturingExperience

The Principal firm should havemanufactured(a) the specific goods subject ofbidding specified in the PDS for atleast 3 years.

Must meetrequirement

Must MeetRequirement

Certified Documents

3.4 ProductionCapacity

The Annual Production capacity ofthe Principal.

Must meetrequirement

Must MeetRequirement

Certified Documents

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Section IV: Application FormsApplication Submission Form

Date: _ _/_ _/2017PQD No. and title: DG(Ext.)/L&DD/2017-18

Procurement of FMD Vaccine

To

Livestock & Dairy Development Department,

Government of the Punjab, Lahore.

I/we, the undersigned, apply to be prequalified for the referenced procurement and declarethat:

(a) I/we have examined and have no reservations to the Prequalification Documents,including Addendum(s) No(s).(if any) issued in accordance with Instructions toApplicants (ITA) Clause 8: [insert the number and issuing date of each addendum].

(b) I/we have nationalities from eligible countries, in accordance with ITA Sub-Clause4.2: [insert the nationality of the Applicant, including that of all partners in case of aJoint Venture /Consortium if applicable];

(c) I/we, for any part of the contract resulting from this prequalification, do not have anyconflict of interest;

(d) I/we for any part of the contract resulting from this prequalification, have not been declareddisqualified / blacklisted by any of the public organization of the Procuring Agency's country

(e) I/we understand that you may cancel the prequalification process at any time; theprequalification does not bound the procuring agency to call for the bids from theprequalified firms.

(f) all information, statements and description contained in the Application are in all respecttrue, correct and complete to the best of our knowledge and belief.

Signed [insert signature(s) of an authorized representative(s) of the Applicant]

Name [insert full name of person signing the application]

In the Capacity of [insert capacity of person signing the application]

Duly authorized to sign the application for and on behalf of:Applicant’s Name [insert full name of Applicant]

Address [insert street number/town or city/country address]

Dated on _ _/_ _/2017

Official stamp: _______________________________________________

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14Prequalification Documents for Procurement of FMD vaccine (TrivalenT), Livestock& Dairy DevelopmentDepartment,

Form ELI -1.1Applicant Information Form

Date: _ _/_ _/2017PQD No. and title: DG(Ext.)/L&DD/2017- 18 ,

Procurement of FMD VaccinePage [insert page number] of[insert total number] pages

Name of the Firm

[insert full legal name]

In case of Joint Venture (JV), and consortium legal name of each partner:

[insert full legal name of each partner in JV]

Applicant’s / Firm’s country of constitution:

[indicate country of Constitution]

Applicant's/ Firm’s actual or Intended year of constitution:

[indicate year of Constitution]

Applicant's legal address in country of constitution:

[insert street/ number/ town or city/ country]

Applicant's authorized representative information

Name: [insert full legal name]

Address: [insert street/ number/ town or city/ country]

Telephone/ Mobile Phone / Fax numbers: [insert telephone/fax numbers, including countryand city codes]

E-mail address: [indicate e-mail address]

Attached are copies of original documents of

Articles of Incorporation or Documents of Constitution, and documents of registrationof the legal entity named above.

In case of JV, letter of intent to form JV or JV agreement.

NTN # :____________________________

G.S.T No # _________________________

Signature :_________________________ Stamp:______________________

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15Prequalification Documents for Procurement of FMD vaccine (TrivalenT), Livestock& Dairy DevelopmentDepartment,

Form ELI -1.2Applicant Affidavit

a) Applicants signed affidavit on PKR 100.00 judicial paper confirming not having been declaredineligible by any of the public sector organization in Pakistan, as described in ITA Sub-Clause 4.3

b) Applicants signed affidavit on PKR 100.00 judicial paper confirming not having been involved inany litigation during last three years.

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16Prequalification Documents for Procurement of FMD vaccine (TrivalenT), Livestock& Dairy DevelopmentDepartment,

Form ELI -1.3Applicant's Information Form1

Date: [insert day, month, year]PQD No. and title: DG(Ext.)/L&DD/2017-18, Procurement of FMD Vaccine

Page [insert page number]of [insert total number]pages

1 Applicant's PrimaryBusiness Details

1

2

3

4

2 List of Products / Services

1

2

3

4

3 List of Authorization fromthe principals

1

2

3

4

5 Warranty Details

6 Return/Replacement Policy

7 Installed annual productioncapacity

8 Any Other Information thatsupplier may like toprovide

Signature: _________________________ Stamp:__________________________

1 For local manufacturers, the Procuring Agency reserves the right to physically verify theinformation provided by the applicant in the prequalification documents.

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17Prequalification Documents for Procurement of FMD vaccine (TrivalenT), Livestock& Dairy DevelopmentDepartment,

Form FIN – 2.1 (a)Financial Situation

[The following table shall be filled in for the Applicant and for each partner of a Joint Venture /Consortium]

Applicant’s Legal Name: [insert full name]Date: [insert day, month, year]Applicant’s Party Legal Name:[insert full name]PQD No. and title: DG(Ext.)/L&DD/2017-18,Procurement ofFMD VaccinePage [insert page number] of [insert total number] pages

1. Financial dataFinancial information in

(PKR/US$ equivalent in 000s)previous _[insert number] years,

years information [insert in words]

(PKR/US$ equivalent in 000s)

2013 2014 2015 Year…. Year….

Information from Balance Sheet

Total Assets (TA)

Total Liabilities (TL)

Net Worth (NW)2

(TA – TL)

Curent Assets (CA)

Curent Liabilities (CL)

Working Capital3

(CA – CL)

Information from Income Statement

Total Revenue (TR)

Profits Before Taxes (PBT)

Signature: _________________________ Stamp:__________________________

2Net worth is the difference between total assets and total liabilities. The net worth measures a firm’s ability toproduce profits over the long run as well as its ability to sustain losses.3Working capital is the difference between current assets and current liabilities, and measures the firm’s abilityto generate cash in the short term.

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18Prequalification Documents for Procurement of FMD vaccine (TrivalenT), Livestock& Dairy DevelopmentDepartment,

2. Financial documents

The Applicant and its parties shall provide copies of the balance sheets and/or financialstatements for [number] years pursuant Section III, Qualifications Criteria and Requirements,Sub-factor 3.1. The financial statements shall:

(a) Reflect the financial situation of the Applicant or partner to a JV/Consortium, and notsister or parent companies.

(b) Be complete, including all notes to the financial statements.

(c) Correspond to accounting periods already completed and audited (no statements forpartial periods shall be requested or accepted).

Attached are copies of financial statements (balance sheets, including all related notes, andincome statements) for the [number] years required above; and complying with therequirements

Signature: _________________________ Stamp:__________________________

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19Prequalification Documents for Procurement of FMD vaccine (TrivalenT), Livestock& Dairy DevelopmentDepartment,

Form EXP - 3.1General Experience

[The following table shall be filled in for the Applicant]

Applicant's Legal Name: [insert full name]Date: [insert day, month, year]

Applicant Party Legal Name: [insert full name]PQD No. and title: DG(Ext.)/L&DD/2017-18,Procurement of FMD Vaccine

Page [insert page number]of [insert total number]pages

[Identify contracts that demonstrate continuous supplies over the past [number] years pursuant to SectionIII, Qualification Criteria and Requirements, Sub-Factor 3.1.List contracts chronologically, according totheir commencement (starting) dates. Attach documentary proof with proper reference for thecompanies / organizations mentioned above.]StartingMonth /

Year

EndingMonth /

Year

Contract Identification Role ofApplicant

[indicatemonth/year]

[indicatemonth/year]

Contract name: [insert full name]Brief Description of the supplies by theApplicant: [describe goods supplied briefly]Amount of contract: [insert amount in PKRequivalent]Name of Procuring Agency: [indicate full name]

Address: [indicate street/number/town orcity/country ]

[insert"Supplier/Manufact

urer or Agent”]

Contract name: [insert full name]Brief Description of the supplies by theApplicant: [describe goods supplied briefly]Amount of contract: [insert amount in PKRequivalent]Name of Procuring Agency: [indicate full name]

Address: [indicate street/number/town orcity/country]

[insert“Supplier/Manufact

urer or Agent”]

Contract name: [insert full name]Brief Description of the supplies by theApplicant: [describe goods supplied briefly]Amount of contract: [insert amount in PKRequivalent]Name of Procuring Agency: [indicate full name]

Address: [indicate street/number/town orcity/country]

[insert"Supplier/Manufact

urer or Agent”]

Signature: _________________________ Stamp:__________________________

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20Prequalification Documents for Procurement of FMD vaccine (TrivalenT), Livestock& Dairy DevelopmentDepartment,

Form EXP - 3.2Specific Experience

[The following table shall be filled in for contracts performed by the Applicant. Attach documentaryproof with proper reference for the companies / organizations mentioned.]Applicant's Legal Name: [insert full name]

Date: [insert day, month, year]Party Name: [insert full name]

PQD No. and title: DG(Ext.)/L&DD/2017-18,Procurement of FMD VaccinePage [insert page number]of [insert total number]pages

Similar Contract No.1[insert number]of [insert numberof similar contracts required]

Information

Contract Identification [insert contract name and number, if applicable]

Award date [insert day, month, year, i. e., _ _/ -/, 201_]

Completion date [insert day, month, year, i.e., / - /, 201_]

Role in Contract

Total Contract Amount [insert total contract amount in localcurrency]

PKR/US$[inserttotal contractamount inPKR/US$equivalent]

If partner in a JV/Consortium, orsubcontractor, specify participationin total contract amount

[insert apercentageamount]

[insert totalcontract amount inlocal currency]

[insert totalcontract amountin PKR/US$equivalent]

Procuring Agency's Name: [insert full name]Address:

Telephone/fax number

E-mail:

[indicate street / number / town or city / country]

[insert telephone/fax numbers, including country andcity area codes]

[insert e-mail address, if available]

Signature: _________________________ Stamp:__________________________

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21Prequalification Documents for Procurement of FMD vaccine (TrivalenT), Livestock& Dairy DevelopmentDepartment,

Form EXP - 3.2 (cont.)Specific Experience (cont.)

Similar Contract No.2[insert number]of [insert numberof similar contract s required]

Information

Description of the similarity inaccordance with Sub-Factor 4.2ofSection III:

1. Amount[insert amount in PKR/US$ in words and inFigures]

2. Products[insert type and description of product]

Similar Contract No.3[insert number]of [insert numberof similar contracts required]

Information

Description of the similarity inaccordance with Sub-Factor 3.2ofSection III:

1. Amount[insert amount in PKR/US$ in words and inFigures]

2. Products[insert type and description of product]

Similar Contract No.4[insert number]of [insert numberof similar contracts required]

Information

Description of the similarity inaccordance with Sub-Factor 3.2ofSection III:

1. Amount[insert amount in PKR/US$ in words and inFigures]

2. Products[insert type and description of product]

Signature: _________________________ Stamp:__________________________

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22Prequalification Documents for Procurement of FMD vaccine (TrivalenT), Livestock& Dairy Development Department,

Section V: Scope of Product

Sr.No Specifications Required Offered

1 Vaccine type. Polyvalent Foot-and-Mouth Disease Vaccine (from the virusgrown in BHK-21 cells) liquid, inactivated, containing the antigens(inactivated by BEI /BEI+ formaldehyde) of:

1. Type O: PanAsia-22. Type A: A Iran 05 strains3. Type Asia-1:Sind 08The vaccine should fulfill the OIE standards and therequirements of the European Pharmacopoeia monographs

2 Species The FMD vaccine must have been shown to be efficacious inBuffalo/cattle./Sheep/Goat

3 Route: Vaccine intended for administration via subcutaneous orintramuscular injection

4 Adjuvant Aluminium hydroxide and Saponin (able to produce protection forat least 6 months post vaccination)

5Potency

The concentration of serotype O PanAsia-2 and serotype Asia-1Sind 08 strains in the vaccine should be > 6 PD50. Theconcentration of serotype A Iran 05 strains in the vaccine should be> 16 PD50.

6 Expiry The expiry of the vaccine batch shall be guaranteed for at leastTwelve months period after date of manufacturing.

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23Prequalification Documents for Procurement of FMD vaccine (TrivalenT), Livestock& Dairy Development Department,

7 Expiry date / Stability The stability of the vaccine should be at least 80 % of the shelf lifeand shall be guaranteed for at least twelve months at the time ofdelivery.

8 Packaging 1. The vaccine should be in plastic vials (Foodgrade/medicinal grade) opaque / Ambered colored glass(food grade /medicinal grade vials containing 25 doses forBuffalo/cattle and transported in thermopore boxescontaining 100 vials each with at least 4 ice gel packs ofapproximately 4x8 inches and a temperature monitoringcard in each thermopore box. A user's notice, in English, isto be included in each package.The vaccine shall bepacked, dispatched, stored, inspected and tested inaccordance with the stipulations and instructions stated in“Guidelines on the International Packaging and Shippingof Vaccines WHO/IVB/05.23” (or those currently inforce).

2. Embossed on bottle with words “ Property of L&DDGoPb”

3. Green Flip Top

9 Storage and cold chainmonitoring

2-8oC. The vaccine must be delivered to a designated cold storagein Punjab (Islamic Republic of Pakistan) with cold chainmonitoring cards or electronic devices. Verification will berequired of continuity of appropriate 2–8oC storage of the vaccinefrom production to delivery. Each individual package shouldcontain a temperature control card.

Vaccine must be delivered in cold storage facilities in thedestination country with cold chain monitoring cards / temperaturerecorders for verification of continuity of appropriate storage of thevaccine from production to delivery.

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24Prequalification Documents for Procurement of FMD vaccine (TrivalenT), Livestock& Dairy Development Department,

COLD CHAIN MONITORING:

1. Each individual package to be delivered with cold chainmonitoring cards and ice gel packs.

Monitoring cards accepted are:

Type WHO PISE6/16or UNICEF/11.830-17 (French)or UNICEF 11.830-18 (English)or 3MION/34AA (Monitor)or equivalent

These cards are available from;A) Messrs. Berlinger & Co. Ag, Postfach 9608, Ganterschwil,SwitzerlandB) Unicef (Supply Division), Procurement And Assembly Centre,Unicef Plads, Freeport, Dk-2100 Copenhagen, Denmark

2. “Temperature Recorders” supervising the temperature during thevarious transport links will be delivered to the suppliers address bycourier with full operational instructions (start up of temperaturerecorder).One (1) temperature recorder to be loaded separately in apolystyrene box but additionally it should be highlighted with alabel mentioning:“Temperature recorder inside this box to be released / collected byInspection Company upon arrival. “

Supplier to immediately liaise with the Inspection Company toprovide the necessary information in order for this latter to decideon the number of temperature recorders to be placed in the boxesPlease note – You are kindly requested to provide the inner sidedimensions of the polysterene box i.e. length x width x height(space available for the installation of eventual recorder separately

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25Prequalification Documents for Procurement of FMD vaccine (TrivalenT), Livestock& Dairy Development Department,

from the vaccines. – one polystyrene box with one temperaturerecorder.

10 Delivery Place The vaccine must be delivered at the following cold chain storagesas required by the department;

1. Cold chain Storage of Director ADRS, at VeterinaryResearch Institute, Zarrar Shaheed Road, Lahore.

2. Cold chain Store of District livestock Office Rawalpindi3. Cold chain Store of District livestock Office Sargodha4. Cold chain Store of District livestock Office Multan5. Cold chain Store of District livestock Office Bahawalpur6. Cold chain Store of Buffalo Research Institute Pattoki

District Kasur

11 Delivery Period Part supply part payment. Consignment will have to be deliveredwithin the delivery period as mentioned in the bidding documentby the department.

12 Literature Original literature of the product is required to be attached.(In case original literature is not in English certified Englishtranslation is to be attached

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26Prequalification Documents for Procurement of FMD vaccine (TrivalenT), Livestock& Dairy DevelopmentDepartment,

General requirements

1. Vaccine manufacture and quality control testing on the each batch and the finishedproduct must be conducted in accordance with OIE Guidelines (Manual ofDiagnostic Tests and Vaccines).

2. Documentation is to be furnished to validate quality assurance practices and theproduction details for each vaccine batch as per OIE standards

3. The vaccine must be registered / licensed by the recipient government of the IslamicRepublic of Pakistan.

4. Documentation: Documentation should be in English and must indicate thefollowing:

4.1. Type of vaccine, name of strains along with PD50 value of each strain5.2 Quality control test results of the vaccine batch(s) with associated

standard operating procedures to demonstrate compliance with OIEstandards including sterility, safety, and innocuity and potency tests.

5.3 Provide data showing that the vaccine does not induce antibodies to the3ABC Non Structural Proteins (NSP). For proof of the later, the resultsand information on the test used, especially on the NSP used, shall beprovided. The evidence should show that NSP antibodies are notinduced even after repeated immunization.

5.4 The data should also provide evidence of the duration of immunityfollowing a single vaccination and after booster vaccination.

5.5 Provide available data on the expected onset and duration of immunityof each serotype/strain

5.6 Provide available correlation data between protection and antibodytitre, and specify test used for such correlation (type of ELISA andvirus neutralization test). These data will be valuable in determininglevel of post vaccination herd immunity and the evaluation of thevaccination program.

5.7 Proof should be given of QA system that is applied and of recent auditsby the international or national accreditation body.

5.8 Cutting /erasing on the document must be avoided.5.9 Evaluation committee can demand any clarification, information or

document during the scrutiny process5.10 Evaluation committee has the right to reject any firm prior to its

acceptance under the provision of PARA rules 2014.

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27Prequalification Documents for Procurement of FMD vaccine (TrivalenT), Livestock& Dairy DevelopmentDepartment,

Glossary

Bid SecuringDeclaration

Procuring Agency

An undertaking by a prospective bidder, committing to pay thecorresponding fine and be suspended for a period of time from beingqualified to participate in any government procurement activity in theevent it violates any of the conditions stated in the bidding documents.

One of the two parties to a supplies contract, the other party being the“Supplier.”

Supplier The legal entity that is party to and performs a supplies contract, theother party to the contract being the “Procuring Agency.”

Post-qualification An assessment made by the Procuring Agency after the evaluation ofbids and immediately prior to award of contract, to ensure that thelowest-evaluated, responsive, eligible Bidder is qualified to performthe contract in accordance with previously specified prequalificationrequirements.

Pre-qualification An assessment made by the Procuring Agency before inviting bids, ofthe appropriate level of experience and capacity of firms expressinginterest in undertaking a particular contract, before inviting them tobid.

turnover The gross earnings of a firm, defined as the billings for supplies inprogress and/or completed, normally expressed on an annual basis, andexcluding income from other sources.

In writing For the purpose of this document, means authenticated handwritten,typed, or printed; a document prepared in writing can be transmittedby telex, electronic mail, facsimile, with proof of receipt; and in theform requested by the sender.