Pandemic Influenza Vaccine

Statens Serum Institut

Statens Serum Institut (SSI) is a public enterprise under the Danish Ministry of Health. On behalf of the Ministry, SSI will conduct a procurement of a pandemic influenza vaccine. The purpose of this tender is to ensure the needed stock of influenza vaccines in the event of an influenza pandemic during the contract period. The contract (Advance Purchase Agreement) regards reservation of the supplier's production capacity and the contract will contain an option for delivery of pandemic influenza vaccine in the event of an influenza pandemic called by the WHO during the contract period. Denmark will need an option for delivery of up to 2 100 000 immunizations.

Deadline

Fristen for modtagelse af bud var på 2016-07-07. Indkøbet blev offentliggjort på 2016-06-06.

Leverandører

Følgende leverandører er nævnt i tildelingsbeslutninger eller andre indkøbsdokumenter:

Hvem? Hvad? Hvor?
Indkøbshistorik
Dato Dokument
2016-06-06 Udbudsbekendtgørelse
2017-01-13 Bekendtgørelse om indgåede kontrakter
Udbudsbekendtgørelse (2016-06-06)
Objekt
Omfanget af udbuddet
Titel: Vacciner
Kort beskrivelse:
Statens Serum Institut (SSI) is a public enterprise under the Danish Ministry of Health. On behalf of the Ministry, SSI will conduct a procurement of a pandemic influenza vaccine. The purpose of this tender is to ensure the needed stock of influenza vaccines in the event of an influenza pandemic during the contract period. The contract (Advance Purchase Agreement) regards reservation of the supplier's production capacity and the contract will contain an option for delivery of pandemic influenza vaccine in the event of an influenza pandemic called by the WHO during the contract period. Denmark will need an option for delivery of up to 2 100 000 immunizations.
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Bekendtgørelsens metadata
Originalsprog: engelsk 🗣️
Dokumenttype: Udbudsbekendtgørelse
Kontraktens art: Varer
Forordning: Den Europæiske Union, med deltagelse af GPA-lande
Fælles glossar for offentlige kontrakter (CPV)
Kode: Vacciner 📦
Yderligere CPV-kode: Influenzavacciner 📦
Sted for udførelsen
NUTS-region: Hovedstaden 🏙️

Procedure
Procedureform: Konkurrencepræget dialog
Bud-type: Indsendelse gældende for alle delaftaler
Kriterier for tildeling
Det økonomisk mest fordelagtige bud

Ordregivende myndighed
Identitet
Land: Danmark 🇩🇰
Type af ordregivende myndighed: Ministerium eller anden myndighed på nationalt plan eller forbundsplan
Navn på ordregivende myndighed: Statens Serum Institut
Postadresse: Artillerivej 5
Postnummer: 2300
Postby: København S
Kontakt
Internetadresse: http://ssi.dk 🌏
E-mail: nea@ssi.dk 📧
Telefon: +45 32683268 📞
URL til dokumenter: http://ssi.dk 🌏

Reference
Datoer
Afsendelsesdato: 2016-06-06 📅
Tilbudsfrist: 2016-07-07 📅
Offentliggørelsesdato: 2016-06-08 📅
Identifikatorer
Bekendtgørelsesnummer: 2016/S 109-194194
EUT-S-nummer: 109
Yderligere oplysninger
With regard to Section II.1.5) please note that SSI is not at present able to estimate the value of the contract. SSI will neither make a dialogue payment for the candidates as remuneration for their participation in the dialogue, nor a tender payment for each tender as remuneration for a compliant or successful tender.
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Objekt
Omfanget af udbuddet
Kort beskrivelse:
Reference is made to section II.1.4) above.
The procurement will be conducted as a competitive dialogue according to the Danish Act on Public Procurement (act no 1564 of 15.12.2015 — available at: www.retsinformation.dk) cf. § 55(4), cf. § 67. By documenting the fulfilment of the qualification criteria listed below, suppliers will be qualified and invited to further participation in the dialogue. The dialogue will be conducted with separate meetings with all qualified suppliers, in order to establish the solutions the market operators are able to provide and the terms of which they are able to fulfil an Advanced Purchase Agreement. The dialogue will be declared closed, when SSI is able to set the terms and conditions for the procurement and contract. Subsequent to the dialogue, SSI will conduct a tender competition between all qualified suppliers, based on the results of the dialogue and SSI's assessments.
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Before the dialogue, SSI conducted market consultations with a view to preparing the procurement and informing economic operators of the procurement plans and requirements.
All relevant documents regarding the market consultations as well as the dialogue can be found here: http://www.ssi.dk/Service/OmSSI/Juridisk%20information/Indkoeb/Vaccineudbud.aspx
Varighed: 48 måneder
Beskrivelse af fornyelser: Up to 72 months.
Beskrivelse af mulighederne:
The contract includes option for delivery of pandemic influenza vaccine of up to 2 100 000 immunizations to Denmark.
The tenderer shall commit to offering a contract to Iceland, Greenland and the Faroe islands on the same terms as Denmark, however variations in certain terms may be accepted in consequence of differences in number of doses, conditions of supply, etc.
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Yderligere oplysninger:
With regard to Section II.1.5) please note that SSI is not at present able to estimate the value of the contract. SSI will neither make a dialogue payment for the candidates as remuneration for their participation in the dialogue, nor a tender payment for each tender as remuneration for a compliant or successful tender.
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Juridiske, økonomiske, finansielle og tekniske oplysninger
Betingelser for deltagelse
Egnethed til at udøve det erhverv:
It is not required that the candidate is registered in a commercial register or a trade register.
Teknisk og faglig kompetence:
The candidate must use the European Single Procurement Document with the following information:
— A list of the applicant's principal deliveries of influenza vaccines effected within the last 3 years with indication of amounts, dates and recipient. Furthermore, the ESPD must include information about the applicant's principal deliveries of pandemic vaccines effected and delivered within the last 10 years.
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This is to be stated in the ESPD, Part IV, Section C, Technical and professional ability, under the item ‘For public supply and public services contracts: Delivery of the deliveries of the type specified’.
If the applicant relies on the ability of other entities, this must be stated in the ESPD, part II, section C, cf. section VI.3) The other entity/entities must each fill in a separate ESPD with the information required. If the applicant is part of a consortium, this must be stated in the ESPD, Part II, section A, and each of the participating economic operators must fill in a separate ESPD with the information required.
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In the selection phase, SSI will select the applicants with the best and most relevant references on the abovementioned supplies.
Kontraktens udførelse
Betingelser for opfyldelse af kontrakten:
The supplier/tenderer must have the necessary permits from the competent authorities in the EU to produce and engage in trade of medicinal products.
The supplier/tenderer must have a registered approval for a prototype pandemic influenza vaccine (mock up) in compliance with the CHMP Guideline on dossier structure and content for pandemic influenza vaccine marketing authorization application by the time of submitting the final tender.
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Procedure
Mindste antal ansøgere: 3
Sprog, på hvilke bud eller ansøgninger om deltagelse kan indgives: engelsk 🗣️
dansk 🗣️

Ordregivende myndighed
Kontakt
Enhed: Birgit Neale
URL til dokumenter: http://ssi.dk 🌏

Reference
Yderligere oplysninger
Concerning ESPD:
Applicants must complete and submit the ESPD together with the application as a temporary proof of the conditions mentioned in s. 148, para 1, (3) of the Procurement Act. See the website of the Danish Competition and Consumer Authority, which contains more specific instructions for completing the European single procurement document. SSI is obliged to exclude a tenderer from participation in the tendering procedure if the tenderer is subject to the mandatory grounds for exclusion set out in ss.135 and 136 of the Procurement Act. Information on exclusion grounds must be stated in the ESPD, Part III ‘exclusion grounds’ in section A, B and C. Attention is drawn to the fact that certain optional grounds for exclusion in the Directive on Public Procurement (Directive 2014/24/EU of the European Parliament and of the Council) is made mandatory in s. 136 of the Procurement Act. Reference is furthermore made to the Danish Competition and Consumer Authority's guide to the European single procurement document regarding correct completion of the form.
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SSI reserves the right to initiate a ‘self-cleaning’ procedure if relevant, see s.138 of the Procurement Act.
Before SSI makes its decision regarding award of the contract, supporting evidence of the information stated in the European single procurement document must be provided, see ss.151 and 152 of the Procurement Act. Further information about this is to be found in the procurement documents.
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The contract will be valid for minimum 4 years from the date of signing. The option for renewal for up to 72 months (Section II.2.7)) will be a topic for the dialogue with the suppliers. The contract will be valid throughout the contract period regardless of whether a pandemic occurs within the contract period. Should a pandemic occur before the end of the contract period, the contract may be extended with the time necessary in order to complete the vaccination and meet a possible 2
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Supplerende oplysninger
Gennemgå organ
Navn: Klagenævnet for udbud (The Complaints Board for Public Procurement)
Postadresse: Dahlerups Pakhus, Langelinie Allé 17
Postby: Copenhagen Ø
Land: Danmark 🇩🇰
Telefon: +45 35291095 📞
E-mail: klfu@erst.dk 📧
Oplysninger om frister for klageprocedurer:
Pursuant to Danish Act on The Complaints Board for Public Procurement (act No 492 of 12.5.2010 with subsequent amendments — available at: www.retsinformation.dk), the following time limits for filing a complaint apply.
Complaints regarding a candidate not being pre-qualified must be filed with The Complaints Board for Public Procurement within 20 calendar days starting the day after the contracting authority has sent notification to the candidates involved, cf. § 171(2) of the Danish Act on Public Procurement (act No 1564 of 15.12.2015 — available at: www.retsinformation.dk) or § 2(1) of the Danish Act on The Complaints Board for Public Procurement, provided that the notification includes a short account of the relevant reasons for the decision.
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Other complaints must be filed with The Complaints Board for Public Procurement within 45 calendar days after the contracting authority has published a contract award notice in the Official Journal of the European Union (with effect from the day following the publication date).
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The complainant must inform the contracting authority of the complaint in writing at the latest simultaneously with the lodge of the complaint to The Complaints Board for Public Procurement stating whether the complaint has been lodged in the standstill period, cf. § 6(4) of the Act on The Complaints Board for Public Procurement. If the complaint has not been lodged in the standstill period, the complainant must also state whether it is requested that the appeal is granted delaying effect, cf. § 12(1) of the said Act.
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Tjeneste, hvorfra der kan indhentes oplysninger om klageproceduren
Navn: Konkurrence- og Forbrugerstyrelsen
Postadresse: Carl Jacobsens Vej 35
Postby: Valby
Postnummer: 2500
Telefon: +45 41715000 📞
E-mail: kfst@kfst.dk 📧
Internetadresse: http://www.kfst.dk 🌏
Kilde: OJS 2016/S 109-194194 (2016-06-06)
Bekendtgørelse om indgåede kontrakter (2017-01-13)
Objekt
Omfanget af udbuddet
Kort beskrivelse:
Statens Serum Institut (SSI) is a public enterprise under the Danish Ministry of Health. On behalf of the Ministry, SSI has conducted a procurement of a pandemic influenza vaccine. The purpose of this tender is to ensure the needed stock of influenza vaccines in the event of an influenza pandemic during the contract period. The contract (Advance Purchase Agreement) regards reservation of the supplier's production capacity and the contract will contain an option for delivery of pandemic influenza vaccine in the event of an influenza pandemic called by the WHO during the contract period.
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Den samlede værdi af udbuddet: 1 EUR 💰
Bekendtgørelsens metadata
Dokumenttype: Bekendtgørelse om indgåede kontrakter

Procedure
Bud-type: Finder ikke anvendelse

Ordregivende myndighed
Kontakt
Internetadresse: https://www.ssi.dk 🌏

Reference
Datoer
Afsendelsesdato: 2017-01-13 📅
Offentliggørelsesdato: 2017-01-17 📅
Identifikatorer
Bekendtgørelsesnummer: 2017/S 011-015927
Henviser til bekendtgørelse: 2016/S 109-194194
EUT-S-nummer: 11
Yderligere oplysninger
With regard to the mandatory sections II.1.7) Total value of the procurement as well as V.2.4) Information on value of the contract/lot, SSI has stated ‘1.00’. Please note that this is not the correct or estimated value. SSI cannot inform about the value due to confidentiality.
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Objekt
Omfanget af udbuddet
Kort beskrivelse:
The procurement was conducted as a competitive dialogue according to the Danish Act on Public Procurement (act No 1564 of 15.12.2015 — available at www.retsinformation.dk) cf. § 55(4), cf. § 67. By documenting the fulfilment of the qualification criteria, suppliers were qualified and invited to further participation in the dialogue. The dialogue was conducted with separate meetings with all qualified suppliers, in order to establish the solutions the market operators were able to provide and the terms of which they were able to fulfil an Advanced Purchase Agreement. The dialogue was declared closed when SSI was able to set the terms and conditions for the procurement and contract. Subsequent to the dialogue, SSI conducted a tender competition between the qualified suppliers, based on the results of the dialogue and SSI's assessments.
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Beskrivelse af mulighederne:
The contract includes an option for delivery of pandemic influenza vaccine of up to 2 100 000 immunizations to Denmark.
The tenderer shall commit to offering a contract to Iceland, Greenland and the Faroe Islands on the same terms as Denmark, however variations in certain terms may be accepted in consequence of differences in number of doses, conditions of supply etc.
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Yderligere oplysninger:
With regard to the mandatory sections II.1.7) Total value of the procurement as well as V.2.4) Information on value of the contract/lot, SSI has stated ‘1.00’. Please note that this is not the correct or estimated value. SSI cannot inform about the value due to confidentiality.
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Procedure
Kriterier for tildeling
Kvalitetskriterium (navn): Quality
Kvalitetskriterium (vægtning): 40
Kvalitetskriterium (navn): Delivery
Kvalitetskriterium (vægtning): 20
Kvalitetskriterium (navn): Flexibility
Kvalitetskriterium (vægtning): 15
Kvalitetskriterium (navn): Product liability
Kvalitetskriterium (vægtning): 5
Vægtning af pris: 20

Tildeling af kontrakt
Dato for kontraktindgåelse: 2016-12-21 📅

Supplerende oplysninger
Gennemgå organ
Postadresse: Nævnenes Hus, Toldboden 2
Postby: Viborg
Postnummer: 8800
Internetadresse: www.erhvervsstyrelsen.dk/klagenaevnet-for-udbud 🌏
Oplysninger om frister for klageprocedurer:
Pursuant to Danish Act on The Complaints Board for Public Procurement (act No 492 of 12.5.2010 with subsequent amendments — available at www.retsinformation.dk), the following time limits for filing a complaint apply:
Complaints regarding a candidate not being pre-qualified must be filed with The Complaints Board for Public Procurement within 20 calendar days starting the day after the contracting authority has sent notification to the candidates involved, cf. § 171(2) of the Danish act on Public Procurement (act No 1564 of 15.12.2015 – available at www.retsinformation.dk) or § 2(1) of the Danish Act on The Complaints Board for Public Procurement, provided that the notification includes a short account of the relevant reasons for the decision.
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The complainant must inform the contracting authority of the complaint in writing at the latest simultaneously with the lodge of the complaint to The Complaints Board for Public Procurement stating whether the complaint has been lodged in the stand-still period, cf. § 6(4) of the Act on The Complaints Board for Public Procurement. If the complaint has not been lodged in the stand-still period, the complainant must also state whether it is requested that the appeal is granted delaying effect, cf. § 12(1) of the said Act.
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Tjeneste, hvorfra der kan indhentes oplysninger om klageproceduren
Postadresse: Carl Jacobsens Vej, 35
Kilde: OJS 2017/S 011-015927 (2017-01-13)
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