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Health Sector Goods - Section II. Bid Data Sheet

Section II. Bid Data Sheet
 
Notes on the Bid Data Sheet
 
Section II is intended to assist the Purchaser in providing the specific information in relation to corresponding clauses in the Instructions to Bidders included in Section I and has to be prepared for each specific procurement.
The Purchaser should specify in the Bid Data Sheet information and requirements specific to the circumstances of the Purchaser, the processing of the procurement, the applicable rules regarding bid price and currency, and the bid evaluation criteria that will apply to the bids. In preparing Section II, the following aspects should be checked:
  1. The correct version of the Bid Data Sheet must be used as a base, dependent upon the type of Goods being procured. For example, if changes or additions are made to the Bid Data Sheet it may require changes to the corresponding SCC.
  2. Information that specifies and complements provisions of Section I, ITB, must be incorporated.
  3. Amendments and/or supplements, if any, to provisions of Section I, ITB, as required by the circumstances of the specific procurement, must also be incorporated.

Bid Data Sheet

Pharmaceuticals (additional clauses)
Vaccines (additional clauses)

The following specific data for the Goods to be procured shall complement, supplement, or amend the provisions in the Instructions to Bidders (ITB). Whenever there is a conflict, the provisions in the Bid Data Sheet (BDS) shall prevail over those in the ITB.

A. General

ITB 1.1

Name of Purchaser: [ insert: name of Purchaser ].

Name of authorized Purchasing Agent: [ if appropriate, insert: name of the Purchasing Agent, otherwise state: "none" ].

Type of goods: [ insert pharmaceuticals, nutritional supplements, or injectable hormonal contraceptive ].

Name and identification number of the Contract: [ insert: name and identification number of the Contract ].

ITB 2.1

Name of the Borrower: [ insert: name of Borrower ].

Loan or credit number: [ insert: loan / credit number ].

Loan or credit amount: [ insert: loan / credit amount as stated in the Loan Agreement governing the project ].

Name of Project: [ insert: name of project ].

ITB 4.1 & 5.1

Applicable edition of the Guidelines: Procurement under IBRD Loans and IDA Credits: [ insert either: the date of latest edition, for example "January 1995, Revised January and August 1996, September 1997, and January 1999" or insert: the date of the edition specified in the Loan Agreement governing the project ].

ITB 6.3 (c)

Documentation requirements for eligibility of Goods. In addition to the documents stated in Clause 6.2 and 6.3 (a) and (b), the following documents should be included with the Bid:

[ Insert: any other eligibility documentation required ]

ITB 6.4

[Note: If the Purchaser¬タルs country does not require registration of the Goods, delete 6.4 (b) and 6.4.1 below and insert the following language:

ITB Sub-Clause 6.4 is inapplicable. The Applicable Law does not require registration of the Goods to be supplied under the Contract.]

Note: The Purchaser shall not annul award of a Contract on the basis of a Bidder¬タルs failure to successfully register the Goods, without first seeking and obtaining the World Bank¬タルs no objection. There shall be no forfeiture of a performance security based on the failure to obtain registration.

ITB 6.4 (b)

By the time of Contract signing, the successful Bidder shall have complied with the following documentary requirements in order to register the Goods to be supplied under the Contract: [ insert: specific documentary requirements or any other country specific requirement].

Note: Because of the potential for delay when various government agencies must intervene in the registration process, bidders are advised to start gathering the registration information as early as possible.

ITB 6.4.1

For the purpose of obtaining additional information about the requirements for registration, Bidders may contact [ insert: name of agency, contact person, phone/fax/email address ].

ITB 7.1 (a)

Qualification requirements for Bidders are:

[ insert, as appropriate: quantifiable qualification criteria for experience and / or financial viability ].

The following documents must be included with the bid:

Documentary evidence of the Bidder¬タルs qualifications to perform the Contract if its bid is accepted:

(i) that, in the case of a Bidder offering to supply Goods under the Contract that the Bidder manufactures or otherwise produces (using ingredients supplied by primary manufacturers) that the Bidder:

    (a) is incorporated in the country of manufacture of the Goods;

    (b) has been licensed by the regulatory authority in the country of manufacture to supply the Goods;

    (c) has manufactured and marketed the specific goods covered by this Bidding Document, for at least two (2) years, and for similar Goods for at least five (5) years;

    (d) has received a satisfactory GMP inspection certificate in line with the WHO certification scheme on pharmaceuticals moving in International Commerce from the regulatory authority (RA) in the country of manufacture of the goods or has been certified by the competent authority of a member country of the Pharmaceuticals Inspection Convention (PIC), and has demonstrated compliance with the quality standards during the past two years prior to bid submission;

(ii) that, in the case of a Bidder offering to supply Goods under the Contract that the Bidder does not manufacture or otherwise produce,

    (a) that the Bidder has been duly authorized by a manufacturer of the Goods that meets the criteria under (i) above to supply the Goods in the Purchaser¬タルs country; and

The Bidder shall also submit the following additional information:

    (a) a statement of installed manufacturing capacity;

    (b) copies of its audited financial statements for the past three fiscal years;

    (c) details of on-site quality control laboratory facilities and services and range of tests conducted;

    (d) list of major supply contracts conducted within the last five years.

Note: In addition, guidance on what qualification requirements are reasonable is given in the Bank¬タルs PTN on the Procurement of Health Sector Goods. If bids for individual lots are permitted, the qualification criteria for each lot should be given separately.

In the case where a prequalification process has been undertaken, the qualification criteria stated here should mirror the criteria established in the prequalification.

B. The Bidding Documents

ITB 11.1

Purchaser¬タルs / duly authorized Purchasing Agent¬タルs address: [ insert: Purchaser¬タルs address, telephone, telex, and facsimile numbers; also specify a responsible contact person or officer to whom Bidder communications should be addressed ].

C. Preparation of Bids

ITB 13.1

The language of all correspondence and documents related to the bid is: [ select: English / French / Spanish ]. Moreover, the key passages of all accompanying printed literature in any other language must be translated into the above language.

ITB 14.1 (i)

In addition to the documents stated in Paragraphs 14.1 (a) through (h), the following documents must be included with the Bid [ insert: list of documents ]:

[Sample clause]

Bidders who are not primary manufacturers should provide evidence that their product conforms to the quality standards of the primary manufacturer and they have the capacity to supply the specified quantities. A "primary manufacturer" is defined as a company that performs all the manufacturing and formulating operations needed to produce pharmaceuticals or nutritional supplements in their appropriate dosage forms, including processing, blending, formulating, filling, packing, labeling, and quality testing. The Bidder shall furnish a certificate from the competent Regulatory Authority (RA) that the manufacturer is licensed to manufacture the Goods offered.

ITB 16.2 (a)(iii), (iv) (optional)

Prices for inland transportation, insurance, and other local costs incidental to delivery of the Goods offered from within the Purchaser¬タルs country shall be quoted as:

Price of other incidental services shall be quoted as:

[ specify EXW and whether prices for inland transportation and price of incidental services, must be quoted in addition to EXW ].

Note: If the price for inland transportation is not to be quoted separately, then estimated dimensions and shipping weight of each package should be requested in accordance with 32.5 (a). The related provisions shall be reflected accordingly in SCC and Price Schedules.

ITB 16.2 (b) (i)
(ii), (iii) (optional)
(iv), (v) (optional)

Prices for Goods offered from abroad shall be quoted as:

[ select, in accordance with the Schedule of Requirements, "CIP named place of destination or CIP border point or CIF named port of destination" ].

[ specify whether FOB or FCA prices (or other terms, CFR or CPT) are required pursuant to ITB Sub-Paragraph 16.2 (b) (ii) or (iii) ].

[ specify whether prices for inland transportation and prices of incidental services, pursuant to ITB Sub-Paragraph 16.2 (b) (iv) and (v), must be quoted in addition to the above CIF or CIP prices ].

Note: If the price for inland transportation is not to be quoted separately, then estimated dimensions and shipping weight of each package should be requested in accordance with 32.5 (a). The related provisions shall be reflected accordingly in SCC and Price Schedules.

ITB 16.5

Prices quoted by the Bidder shall be [ state: "fixed"; or, if a price adjustment mechanism is required, then specify the exact formula that will apply, including the nature of the indices that will be used ].

ITB 16.6

Bids are being invited for [ indicate "one or more items," or "individual contracts (lots)" ]

ITB 17.1 (b)

The currency to be used for quoting prices of the Goods and Services components of the Goods offered from within the Purchaser¬タルs country, as well as local currency expenditures for local technical support, training, maintenance, transportation, insurance, and other local costs incidental to delivery, is: [ select: currency of Purchaser¬タルs country / other currency, as specified by the Purchaser ].

Note: Bid prices are usually lower if Bidders are allowed to quote and be paid in either the currency of expenditure or another internationally traded currency of their choice.

Normally the currency of bid and payment for locally supplied Health Sector Goods and Services is the currency of the Purchaser¬タルs country. However, Borrowers may allow domestic Bidders to bid in a stable foreign currency for their local costs. Alternatively, they may allow those prices to be adjusted. If payments must be made in the local currency to conform to local law or regulation, any such payments due to a domestic Supplier are converted from the currency of bid to local currency at the exchange rate prevailing at the time of payment.

The presence of such restriction on the currency of payment for locally supplied Health Sector Goods and Services, as well as the precise method of selecting the exchange rate to use in such a case (i.e., the date/time and source of the exchange rate), must be specified in the SCC regarding payment, along with the presence of such restrictions on the currency of payment for locally supplied Health Sector Goods and Services.

ITB 18.1

The bid validity period shall be [ insert: number (X) ] days after the deadline for bid submission, as specified below in reference to ITB Clause 23. Accordingly, each bid shall be valid through [ insert: the actual date of the expiration of the bid validity period (i.e., X days after the date of bid opening) ].

Note: The bid validity period should be sufficient to permit completion of the evaluation, review of the recommended award by the management of the implementing agency and the Bank, the receipt of all necessary approvals, including the Bank¬タルs no objection, and issuance of the notification of award. In most cases ninety (90) days should be adequate, but whatever period is selected, it should be realistic so that requests for extensions are kept to the minimum.

Bid security must be valid twenty-eight (28) days after the end of the bid validity period. Accordingly, a bid with a bid security that expires before [ insert: the actual date of the expiration of the bid security, i.e., twenty-eight (28) days after the end of the bid validity period ] shall be rejected as nonresponsive.

Note: Bank experience also shows that many bids are rejected on the basis of simple errors in calculating the bid security validity period. Accordingly, the Purchaser should explicitly state above the date through which bid security must be valid.

ITB 19.1

The amount of bid security required is: [ insert: fixed amount and currency ].

Note: The amount may be expressed as either a fixed amount or an amount "not less than" a specified percentage of the Bidder¬タルs bid price. To avoid premature disclosure of bid prices by commercial bank personnel or others, a fixed amount of not less than 2 percent to no more than 3 percent of the budget estimate for the contract (estimated) bid amount is strongly recommended. (Requiring higher bid security risks driving away potentially qualified Bidders.) Asking for smaller, or even no bid security at all, however, is acceptable for simple contracts where the market is relatively stable and mature.

Also, in the case of Bidding Documents covering multiple lots, a bid security should be specified as representing not less than "x" percent of the total Bid Price for all lots covered by the bid.

ITB 20.1

Alternative bids [ indicate: will or will not ] be accepted.

Note: When Bidders are permitted to submit alternative bids, only the alternative submitted by the Bidder whose basic bid is the lowest evaluated bid will be considered. Such alternatives will be evaluated in accordance with the evaluation criteria and methods specified in this BDS. An alternative bid can be selected for award only if it was submitted by the Bidder whose basic bid is the lowest evaluated bid. The alternative bid must be fully responsive to the requirements specified in the Bid Data Sheet, the SCC, and the Specifications of the Bidding Documents and the lowest evaluated bid when compared with the basic bid submitted by the bidder.

The evaluation criteria are [ insert: criteria ].

Requirements for responsive bids are [ insert: requirements ].

ITB 21.1

Required number of copies of the bid: [ insert: number (X) of

copies ].

D. Submission of Bids

ITB 22.2 (b)

The address for bid submission is: [ insert: address adequate for mail, courier, or physical delivery, including responsible officer or person ].

Note: Do not use a postal box or similar address.

ITB 22.2 (c) & (d)

See the above data for ITB 1.1 for the name of the Contract.

The Invitation for Bids title and number are: [ if applicable, insert: Invitation for Bids Title and Invitation for Bids Number (if any); otherwise, state "none" ].

See the below data for ITB 23.1 for the deadline for bid submission.

Note: The Purchaser should establish a clear and recognizable numbering system for its Contracts. Failure to do so typically results in misunderstandings in routine communications, review delays, and inadequate monitoring of overall project progress.

ITB 23.1

See the above data for ITB Sub-Clause 22.2 (b) for the address and deadline for bid submission.

Deadline for bid submission is: [ insert: date and time ].

Note: The bid submission date is generally six to twelve weeks from the date of issuance of the Bidding Documents, depending on the value, scope, and/or complexity of the Health Sector Goods being purchased.

ITB 24.1

See the above data for ITB Sub-Clause 23.1 for the deadline for bid submission.

ITB 25.2 (a)

The required number of copies of bid modifications is the same as the number of copies of the original bid specified above in the data for ITB Sub-Clause 21.1.

ITB 25.3 (a)

See the above data for ITB Paragraph 22.2 (b) for the address to use for submission of a bid withdrawal notice.

E. Bid Opening and Evaluation

ITB 26.1

Time, date, and place for bid opening are: [ insert: time, date, and place ].

Note: The date for the bid opening should be the same as specified for the bid submission deadline, and the time should be shortly thereafter, to minimize possible complaints regarding insecure storage arrangements. If the address for bid submission and the place of bid opening are not the same, adequate time between bid submission deadline and bid opening times should be allowed, to accommodate physically moving the bids from one site to the other. However, this delay must be kept to a minimum and reflect only the requirements of logistics, say, no more than two hours.

ITB 31.2

The currency chosen for the purpose of converting to a common currency is: [ specify either: the local currency, or a convertible currency commonly used for procurement of Health Sector Goods, for example, U.S. dollars ].

The source of exchange rate is: [insert: publication, name of bank, etc. ].

Note: If the common currency is other than the local currency, for example, U.S. dollars, indicate the name of an internationally circulated newspaper that lists daily currency selling exchange rates, which will be used for converting prices in foreign currencies. For prices in local currency and if the common currency selected above is the local currency, specify either the Central Bank or a commercial bank in the Purchaser¬タルs country, and identify the publication where the specified rates are published.

The date of exchange rate determination is: [ select: a date that shall not be earlier than four (4) weeks prior to the original deadline for the receipt of bids as specified for ITB Sub-Clause 23.1, and no later than the expiration of the original bid validity period ].

ITB 32.4 (d)

The evaluation will take into account [ insert: factors and other specific criteria ].

ITB 32.5

The factors retained pursuant to ITB Sub-Clause 32.4 and the quantification methods are: [ insert: factors ].

ITB 32.5 (a)

Inland transportation from EXW/port of entry/border point to
[insert: name of project site(s) ], insurance and incidentals.

Bidder shall furnish:

[ state: estimated dimensions and shipping weight of each package and approximate EXW/CIF/CIP value of each package ].

Note: This information is not required when the Bidders are invited to submit a bid in accordance with ITB Sub-Paragraph 16.2 (a) (iii) or ITB Sub-Paragraph 16.2 (b) (iv).

ITB 32.5 (b) (i) (ii) & (iii)

Delivery schedule [ specify: relevant parameters in accordance with option selected ].

The adjustment per week for delivery delays beyond the time specified in the Schedule of Requirements is [ specify: adjustment in percentage ].

Or

The adjustment per week for delivery delays beyond the range of weeks specified in the Schedule of Requirements is [ specify: adjustment in percentage ].

Or

The adjustment for partial shipments is [ specify: adjustments for early and late deliveries ].

Note: For evaluation purposes, a rate of one-half (0.5) percent per week is a reasonable figure.

ITB 32.5 (c) (ii)

The Purchaser [ select: will / will not ] accept deviations in the payment schedule in the SCC.

Note: If deviations are accepted, add the following text.

The percentage adjustment for payment schedule deviations is:
[ insert: percentage ] % per week.

Note: If inflation expectations widely diverge between local and foreign currencies, and Bidders are expected to quote significant amounts in local currencies, different adjustment rates for local and foreign currency prices should be provided.

ITB 32.5 (d)

[ insert: other factors to be used in the evaluation and their evaluation method or reference to the Technical Specifications ]

Evaluation criteria for items/lots

[Select one of the two sample clauses below]

If bids have been invited for items only, the BDS should state the following:

Bidders may bid for any one or more items. Bids will be evaluated for each item and the Contract will comprise the item(s) awarded to the successful Bidder.

If lots will be accepted, the BDS should state the following:

Bidders can bid for one or more lots. Bids will be evaluated lot by lot. Bidders must quote for the entire quantity of each item and at least eighty percent (80%) of the number of items in the lot to be treated as substantially responsive.

Bid evaluation of such bids will be carried out as per the following procedures. The average price of an item quoted by substantially responsive bidders will be added to the bid price of those who did not quote for that item and the equivalent total cost of the bid so determined will be used for bid comparison, evaluation, and award.

ITB 33.1

A margin of domestic preference [specify: will or will not ] apply.

F. Postqualification and Award of Contract

ITB 34.1

Postqualification

[ insert: Any specific postqualification requirements, such as the required number of years of manufacturing experience. ]

ITB 37.1

Percentage for increase or decrease of quantity of Goods and Services originally specified: [ insert: percentage not more than 20% ].


Bid Data Sheet

Pharmaceuticals
(Additional Clauses)

[Note: The below data should be included in the Bid Data Sheet used in Bidding Documents for the procurement of pharmaceuticals.]

ITB 6.3 (c)

[ Sample clauses ]

The Goods offered should meet the specified pharmacopoeial standards as stated in the Technical Specification. If the Goods offered are not included in one of the specified pharmacopoeias (e.g., the case of a new drug), the Bidder will provide testing protocols and alternative reference standards.

ITB 7.1 (a) & (d)

Documentary evidence of the Bidder¬タルs qualifications to perform the Contract if its bid is accepted:

(ii) (d) has a Good Distribution Practice (GDP) Certificate where appropriate.

The Bidder will submit the following additional information:

    (e) list of pharmaceuticals being manufactured by the Bidder with product registration/license number and date.

    (f) a Certificate of Pharmaceutical Product as recommended by the WHO for each item offered.


Bid Data Sheet

Vaccines
(Additional Clauses)

[Note: The below data should be included in the Bid Data Sheet used in Bidding Documents for the procurement of vaccines.]

The following specific data for the Goods to be procured shall complement, supplement, or amend the provisions in the Instructions to Bidders (ITB). Whenever there is a conflict, the provisions in the Bid Data Sheet (BDS) shall prevail over those in the ITB.

A. General

ITB 6.3 (c)

[ Sample clauses ]

1. The Goods to be supplied under the Contract must be licensed both in the country of manufacture and in the Purchaser¬タルs country by the time of Contract signing by a recognized NCA. An NCA is an organization that performs all six critical functions for control of biological products as defined by the World Health Organization, namely: licensing based on published set of requirements; surveillance of vaccine field performance; system of lot release for vaccines; use of laboratory when needed; regular inspections for good manufacturing practice and evaluation of clinical performance. The license from country of manufacture must state that the Bidder is licensed to manufacture the Goods by the NCA in the manufacturing country. Documentary evidence in the form of a certified copy of the license and a copy of the vaccine license/registration that the offered vaccine has been licensed by the NCAs of the manufacturer¬タルs country shall accompany the bid and a copy of the license issued by an NCA in the Purchaser¬タルs country must be submitted by Contract signing. If there is no NCA with specific biologics expertise in the Purchaser¬タルs country, the Bidder shall furnish evidence that the Goods meet the qualification criteria in the Technical Specifications.

2. If the Goods offered do not meet the specified pharmacopoeial standards as stated in the Technical Specification, the Bidder will provide testing protocols and alternative reference standards.

ITB 7.1 (a) & (d)

Documentary evidence of the Bidder¬タルs qualifications to perform the Contract if its bid is accepted:

    (e) is certified by a competent authority in the country of manufacture according to resolution WHA 28 65 (2) of the World Health Organization¬タルs Certificate Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.

The Bidder will submit the following additional information:

    (f) list of vaccines being manufactured by the Bidder with product registration/license number and date.




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