Product Requirements: Male condoms.
1. Description.
A. Condoms
1. In scope of this bidding male condoms of 2 types to be procured:
· condoms of thin-type (thickness NMT 0.7 mm);
· extra-strong (forced) type condoms.
2. Condoms made of natural latex only can be offered under these bidding conditions.
1. Each individual product to have smooth surface, having no cracks, beads and blisters.
2. Supplied condoms to be leak proof.
3. Condoms to contain no additional odour and colour other then natural.
4. Supplied condoms to contain no spermicide ingredients.
5. Condoms supplied under this bidding should be manufactured under supervision of appropriate quality management system linked at least to one of the following standards: standards of series ISO 9000, ISO 14971-1, ISO 13485, and ISO 13488.
6. Products quality control procedures to be obligatory undertaken in compliance with requirements of the following standards: ISO 4074 or/and EN 600.
7. Specific requirements to supplied condoms:
Parameter / Level1. Thickness
· thin-type / NMT 0.07mm
· extra-strong type / 0,07 – 0,09mm
2. Length / NLT 160mm
3. Width / 51 – 55mm
4. Total shelf-life / NLT 3 years, NMT 5 years
5. Remainder shelf-life / NMT 15% of total shelf-life to expire on the date of condoms arrival to place of destination
6. Airburst volume (unaged) / NLT 18 cubic dm
7. Airburst pressure (unaged) / NLT 1.0 kPa
B. Package
1. Each condom offered under this purchase description to be separately and air-tightly packed into individual package of sachet type.
2. One or more condoms in individual packs to be packed into 1 inner box (so-called gross), and several inner boxes to be put into 1 outer box (carton).
The company on its consideration to decide on package parameters. For instance it can be as follows:
· 1 carton comprises 50 inner boxes (grosses), and each inner box in its turn to contain 144 condoms. Totally 1 carton contains 7,200 condoms.
3. Number of individual packs in 1 outer box (carton): not more than 7,200 items.
4. All supplied outer boxes (cartons) to contain standard number of condoms only. E.g. if 1 standard carton comprises 7,200 condoms, all supplied cartons to include 7,200 condoms only – without exceptions.
5. Each individual pack to be opaque (non-transparent) and to keep quality and safeness conditions for the product stable during its whole shelf-life.
C. Individual pack marking and design
1. Face side of each individual pack to obligatory contain the following information:
· product name, manufacturer, batch (lot) No, month and year of manufacture, month and year of expire term.
2. Back side of each separate individual pack to be fully covered with ‘Not-for-sale’ block fully imitating the pattern presented in Annex #5 to the specification.
2. Quantity to be purchased. Purchase conditions.
1. Total number of condoms to be purchased: 19,100,000 units, including
· 17,500,000 condoms of thin-type;
· 1,600,000 condoms of extra-strong type.
2. Final quantity of condoms to be supplied is subject to possible + / - 30% change on Buyer’s option. It relates to ratio between condom types, too.
3. The contract to be awarded to not more than 2 suppliers.
4. Each bidder is allowed to submit as many bids as many separate trademarks and condoms varieties it offers. All offered condoms to fully comply the requirements of this specification.
3. Terms of delivery. Terms of payments.
1. Applicable terms of delivery: DDU (Delivery duty unpaid) Brovary, Kyiv region, Ukraine (Incoterms 2000).
2. All bids to be nominated in U.S. dollars only, and all relevant customs duties, tariffs and taxes to be included.
3. Supply contract to be nominated and disbursements to be made in:
· USD in case of the winning bidder is non-Ukrainian resident company;
· UAH in favour of Ukrainian resident supplier. Price to be fixed against the rate officially declared by the National Bank of Ukraine on the date of contract signature.
4. Condoms of both types (thin-type and extra-strong) can be supplied either with the only consignment, or with several consignments.
5. While making the delivery of the whole contract number of condoms in one only shipment, condoms to arrive to the place of destination not later than on August 15, 2010
6. In case the supplier chooses making several-consignments delivery, NLT 50% of contract number of condoms to arrive to the place of destination not later than on August 15, 2010. The remnant quantity to arrive to the place of destination not later than on November 01, 2010.
7. Terms of payments:
· 50 percent of the price of each separate consignment. To be paid to Ukrainian resident company - within 20 days of the contract signature; to non-resident – during 10 days upon receipt of copy of Bill of lading of the consignment.
· 50 percent of the price of each separate consignment to be paid within 20 days upon its acceptance completion.
4. Special requirements to the product. Content of bids.
A. Raw materials.
Condoms offered under this purchase description shall be produced of validated raw materials obtained from a licensed manufacturer or its authorized distributor. This applies to all ingredients including package.
B. Registration requirements
Bidders offering condoms under this purchase description are obliged to have valid registration for the product marketing in Ukraine.
If registration certificate allowing condoms use in Ukraine expires before December 31, 2012 the bidder to ensure its further prolongation. In such case the bidder should submit an official letter as part of the bid stating such obligation.
C. Lots per order
The supplier shall fill the order using the fewest number of manufacturing lots possible.
D. Test Data
Chemical and physical test data for the product testing must be on record for each lot shipped, and must be available to Buyer's when requested.
E. Shelf life
At the time of arrival to the point of destination not more than 15 percent of product shelf life shall have expired since the date of manufacture shown on the batch release or Certificate of analysis (conformance).
Thereby in case if total shelf-life is 5 years (60 months), condoms should arrive to Brovary, Kyiv region, Ukraine not later than in 9 months since their production completion. In case of 4 years total shelf-life such period to be 7.2 months, and for 3 years it is 5.4 months.
F. Bid contents
Participants are required to submit the following documentation as participant’s bid:
1. Copy of documentation on bidder’s state registration in accordance to legislation of country of origin.
2. Copy of valid documentation issued by the regulatory authority of Ukraine allowing marketing of the product on the territory of Ukraine.
If the registration certificate expires before December 31, 2012, the bidder to accompany it with official letter fixing bidder’s obligation to prolong its force.
3. Copy of valid certificates proving condoms manufacturing plant to undergo certification of production cycle and/or quality management system in accordance to clause 1.A.7-8 of the specification.
4. Copy of 5 certificates of analysis (conformance) on the product offered in scope of this bidding. Certificates to be issued not earlier then January 01, 2010, and to contain actual data on the following parameters of product quality:
· Thickness.
· Length.
· Width.
· Airburst volume (unaged).
· Airburst pressure (unaged).
In case when certificates do not contain data on any of afore-mentioned parameters, the bidder to attach any other documentation (manufacture standards, specifications etc.) proving measures of such parameters.
5. Non-Ukrainian participants to provide Bid organizer with photos (in paper or electronic form) of proposed condoms. Photos to describe individual pack and separately not-packed condoms.
A Ukrainian applicant to include not less than 3 samples of proposed condoms into one’s bid.
6. Fill in and submit Annexes ##1-4 to this specification.
Requirements to compiling the bid:
If the bidder decides to offer several products for this bidding, as much separate bids to be submitted.
Each document or its copy if not originally issued in English/Russian/Ukrainian should be accompanied with translation into any of named languages.
Please note that bid application should be structured in a way that single sheet of paper shall entitle the following document (set of documents on the same theme). For instance, if bidder submits the Copy of registration certificate, there should be a paper with the title ‘Copy of registration certificate’ in the dossier prior to the document per se.
All submitted copies to be attested with bidder’s official stamp or authorities’ signature.
Annex 1 to the specification ‘Product Requirements: Male condoms’.
Please review this form and submit it properly filled in.
To: ICF “The International HIV/AIDS Alliance in Ukraine”
Gentlemen and/or Ladies:
Having examined the bidding documents the receipt of which is hereby duly acknowledged, we, the undersigned, offer to supply and deliver male condoms in conformity with the said bidding documents at the prices as mentioned in attached quotation and made part of this Bid.
We undertake, if our Bid is accepted, to deliver the goods in accordance with the delivery schedule specified in the draft-contract (as part of Bidding Documents).
If our bid is accepted, we undertake to provide a performance security in the form, in the amounts, and within the times specified in the Bidding Documents.
We agree to abide by this Bid for the Bid Validity Period specified in the Bidding announcement and it shall remain binding upon us and may be accepted at any time before the expiration of that period.
Until a formal Contract is prepared and executed, this Bid, together with your written acceptance thereof and your notification of award, shall constitute a binding Contract between us.
We understand that you are not bound to accept the lowest or any bid you may receive.
We certify/confirm that we have the legal capacity to enter into the contract.
Dated this ______day of ______2010.
[signature] [in the capacity of]
Duly authorized to sign Bid for and on behalf of
Annex 2 to the specification ‘Product Requirements: Male condoms’.
General information
1. / Full company name2. / Company legal address
3. / Company location address
4. / Head of the company: position, name
5. / Contact phone number of the head of the company
6. / Contact person on this bidding
7. / Contact phone number of the contact person
8. / Fax number of the contact person
9. / Condoms offered under this bidding: please state trademark(s) and their varieties (e.g. trademark ‘ABC’ and ‘Comfort’ as variety of the product)
10. / Country of condoms origin and name of the factory of manufacture
Dated this ______day of ______2010.
[signature] [in the capacity of]
Duly authorized to sign Bid for and on behalf of
Annex 4 to the specification ‘Product Requirements: Male condoms’.
Please fill in the table below as confirmation on meeting requirements of the specification.
№ / Specification criteria / Confirmation on meeting criteria or declaration of discrepancy to the criteria. Comments1. / Full compliance of condoms with criteria described in clause 1. A. of the specification
2. / Condoms package in full compliance with clause 1. B. of the specification
3. / Agree to fully meet the requirements of clause 1. C. on condoms marking, including technical ability to mark ‘Not-for-sale’ block in compliance with 1. C. 2.
4. / Ability of your company to deliver 17,500,000 ultra-thin condoms and 1,600,000 extra-strong condoms within terms described in 3.5 and 3.6.
5. / Agree to follow payment terms defined in 3.7.
6. / Products raw materials in compliance with 4. A.
7. / Offered condoms do have current registration for marketing in Ukraine.
8. / Agree to ensure the fewest possible number of manufactured lots in compliance with 4. C.
9. / Test data for each shipped lot in compliance with 4.D.
10. / Agree on products shelf-life in compliance with 4.E.
11. / Agree in case of awarding a contract to conclude supply contract on the grounds of the draft included into bidding documents (in terms of requirements of this specification)
Dated this ______day of ______2010.
[signature] [in the capacity of]
Duly authorized to sign Bid for and on behalf of
Требования к закупаемой продукции: Презерватив мужской.
1. Общее описание и технические характеристики.
A. Изделие
1. В рамках данного тендера будут закуплены 2 вида мужских презервативов:
o изделия с тонкой толщиной стенки (толщина не более 0,07 мм; тип «ultra-thin»);
o изделия с повышенной прочностью (тип «extra-strong»).
2. Презервативы должны быть изготовлены исключительно из натурального латекса.
3. Поверхность презерватива должна бать гладкой, на ней не должно быть трещин, пузырьков или вздутий.
4. Презервативы должны быть герметичными (непроницаемыми).
5. Презервативы не должны содержать дополнительные кроме естественных запах (отдушку) и цвет. Т.е. исключаются изделия с запахами фруктов, не присущим натуральному латексу цвету и т.д.
6. Смазка презервативов не должна содержать спермицидных веществ.
7. Поставляемые презервативы и их упаковка должны быть изготовлены обязательно под надзором системы управления качеством, сертифицированной в соответствии с как минимум с одним из следующих стандартов: стандарты серии ISO 9000, ISO 14971-1, ISO 13485, ISO 13488.
8. Контроль качества произведенных изделий должен осуществляться обязательно с соблюдением требований следующих международных стандартов: ISO 4074 и/или EN 600.
9. Особые требования к изделию в рамках данного тендера:
Параметр / Значение1. Толщина
· для изделия с тонкой толщиной стенки / не более 0,07 мм
· для изделия с повышенной прочностью (тип “extra-strong”) / 0,07 – 0,09 мм
2. Длина / не менее 160 мм
3. Ширина / 51 – 55 мм
4. Общий срок годности / не менее 3 лет, не более 5 лет
5. Остаточный срок годности / на момент осуществления поставки должно истечь не более 15% от общего срока годности
6. Объём на разрыв (необработанные презервативы) / не менее 18 дм ³
7. Давление на разрыв (необработанные презервативы) / не менее 1,0 кПа
B. Упаковка
1. Каждый презерватив должен быть отдельно и герметично упакован в индивидуальный пакет типа саше (sachet).