357140-2024 - Competition Competition Denmark: Vaccines Advance purchase agreement for the reservation and supply of pandemic influenza vaccine Denmark, Byen København (DK011) København S Type of procedure: Negotiated with prior publication of a call for competition / competitive with negotiation Buyer Buyer: Statens Serum Institut Denmark, Byen København (DK011), København S LOT-0000: Advance purchase agreement for the reservation and supply of pandemic influenza vaccine Vaccines Denmark, Byen København (DK011) København S Duration: 24 Months Deadline for receipt of requests to participate: 04/07/2024 - 21:59:00 (UTC) 357140-2024 - Competition Denmark – Vaccines – Advance purchase agreement for the reservation and supply of pandemic influenza vaccine OJ S 116/2024 17/06/2024 Contract or concession notice – standard regime - Change notice Supplies 1. Buyer 1.1. Buyer Official name: Statens Serum Institut Legal type of the buyer: Body governed by public law, controlled by a central government authority Activity of the contracting authority: Health 2. Procedure 2.1. Procedure Title: Advance purchase agreement for the reservation and supply of pandemic influenza vaccine Description: The purpose of this tender is to ensure fast delivery of pandemic 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 purchase of pandemic influenza vaccine in the event of an influenza pandemic called by the WHO during the contract period. The reserved volume of pandemic vaccine is expected to be 7.6 million doses; however, the number of doses may be reduced by SSI as described in the tender documents. SSI expects that the Agreement cannot be awarded without prior negotiations with potential suppliers due to the specific circumstances related to the nature and the complexity of the Agreement and the legal and financial aspects and the associated risks. In essence, the procedure encompasses a complex advance purchase agreement, and SSI is dependent on further information from potential suppliers in order to establish a complete and adequate set of terms and conditions in accordance with what the market operators are able to meet. This makes it necessary for SSI to be able to negotiate various as-pects of both the tender documents and the tenders received and potentially make various changes to the tender documents. Hence, the procurement will be conducted as a negotiated procedure pursuant to the Danish Procurement Act (udbudsloven). All terms and requirements that are not minimum requirements may be subject to negotiation and may be changed or withdrawn during the tender procedure according to SSI’s decision. Thus, SSI encourages all economic operators who comply with the minimum requirements (stated in the Tender Specification, paragraph 5) to apply for prequalification, even if the economic operator cannot comply with other terms and requirements. Procedure identifier: 8ed75d6b-04fe-446e-8ba8-0c9dd0bee67c Internal identifier: 4033881 Type of procedure: Negotiated with prior publication of a call for competition / competitive with negotiation The procedure is accelerated: no Main features of the procedure: After receipt of Indicative Offers (INDO1), SSI will conduct individual negotiation meetings with all tenderers who have submitted an INDO within the deadline stated. The negotiations will be conducted in accordance with the principle of equal treatment, and all tenderers will be given the same amount of time for negotiations with SSI. After the negotiations, SSI may choose to issue revised tender documents for further Indicative Offers or Best and Final Offer (BAFO). The tenderers will be informed thereof at the same time with an invitation to submit an INDO or BAFO. SSI will not pay a participation fee to the tenderers. For further information on the process of the negotiations, reference is made to the tender specifications, paragraph 11. 2.1.1. Purpose Main nature of the contract: Supplies Main classification (cpv): 33651600 Vaccines 2.1.2. Place of performance Postal address: Artellerivej 5 Town: København S Postcode: 2300 Country subdivision (NUTS): Byen København (DK011) Country: Denmark 2.1.4. General information Additional information: GENERAL INFORMATION: Participation in the tender procedure may only take place by electronic means via the electronic tendering system used by SSI. For access to the procurement documents, the candidate must be registered or register as a user. If the application contains several versions of the same document, the latest uploaded version will apply. All communication in connection with the tender procedure, including questions and answers, must take place through the electronic tendering system. The deadlines for the submission of questions are stated in the Tender Specifications. Questions asked after this date will be answered if they are received in time for SSI to provide the information required and communicate the answers not later than six days before expiry of the application deadline. Questions received later than six days before expiry of the deadline cannot expect to be answered unless the deadline is also postponed. Interested operators are requested to keep updated via the electronic tendering system. If the tenderer encounters problems with the system, please contact support by e-mail, dksupport@eu-supply.com, or telephone (+45) 70 20 80 14. ESPD: The tenderer must submit an ESPD with the tender as preliminary documentation of the circumstances set out in section 148(1), paras (1)-(3) of the Danish Public Procurement Act (udbudsloven). It is not necessary for the tenderer to sign the ESPD document. For groups of operators (e.g., a consortium), a separate ESPD must be submitted for each participating operator. Where the tenderer is a group of operators, the ESPD document of each participant in the group must be signed by the participant in question. The tenderer heading the group and submitting the tender is not required to sign its ESPD document. The tenderer will be excluded from participation in the tender procedure if the tenderer is covered by the mandatory grounds for exclusion, cf. sections 134a, 135 and 136 of the Danish Public Procurement Act unless the tenderer has provided sufficient documentation of its reliability in accordance with section 138 of the Danish Public Procurement Act (not applicable to section 134a). Before the award decision is made, the tenderer to whom SSI intends to award the contract must provide documentation of the information submitted in the ESPD pursuant to sections 151-152, cf. section 153 of the Danish Public Procurement Act. As an alternative to the documentation mentioned in sections 153-155, 157 and 158 of the Danish Public Procurement Act, the tenderer may submit to SSI a certificate of registration in an official list of approved economic operators, see section 156 of the Danish Public Procurement Act, issued by the competent authority. SSI only accepts certificates of registration in an official list from tenderers established in the country holding the official list. SELECTION OF CANDIDATES: SSI will select 3 candidates by applying the objective criteria stated in this contract notice, cf. the section 5.1.9, unless SSI receives no more than 3 compliant requests for participation. SSI will continue the tender procedure if SSI receives less than 3 compliant requests (i.e. the “minimum number of candidates” is not a prerequisite for continuing the procedure) ADDITIONAL INFORMATION: SSI may use the procedure of section 159(5) of the Danish Public Procurement Act in the event that applications or tenders do not comply with the formal requirements of the tender documents. Attention is drawn to Article 5k in Regulation (EU) No 833/2014, as amended, which applies to the tender procedure. The provision contains a prohibition against award of contracts to Russian companies and Russian-controlled companies etc. (reference is made to Article 5k, section 1, for the precise definition of the operators that are subject to the prohibition). SSI reserves the right to require at any time during the tender process that the economic operators prove that they are not subject to the prohibition, for example by requiring a declaration to this effect and/or documentation regarding the place of establishment and ownership of the economic operators and any sub-contractors. Legal basis: Directive 2014/24/EU http://data.europa.eu/eli/dir/2014/24/oj - Directive 2014/24/EU. https://www.retsinformation.dk/eli/lta/2015/1564 - The tender procedure is covered by the Danish Public Procurement Act (Act No. 1564 of 15 December 2015 as amended), which implements the Public Procurement Directive (Directive 2014/24/EU). 2.1.6. Grounds for exclusion: Corruption: see section 135(1), para (2) of the Danish Public Procurement Act. Participation in a criminal organisation: see section 135(1), para (1) of the Danish Public Procurement Act. Money laundering or terrorist financing: see section 135(1), para (5) of the Danish Public Procurement Act. Fraud: see section 135(1), para (3) of the Danish Public Procurement Act. Child labour and other forms of trafficking in human beings: see section 135(1), para (6) of the Danish Public Procurement Act. Guilty of misrepresentation, withheld information, unable to provide required documents and obtained confidential information of this procedure: see section 136, para (3) of the Danish Public Procurement Act. Conflict of interest due to its participation in the procurement procedure: see section 136, para (1) of the Danish Public Procurement Act. Direct or indirect involvement in the preparation of this procurement procedure: see section 136, para (2) of the Danish Public Procurement Act. Guilty of grave professional misconduct: see section 136, para (4) of the Danish Public Procurement Act. Payment of social security contributions: see section 135(3) of the Danish Public Procurement Act. Payment of taxes: see section 135(3) of the Danish Public Procurement Act. Terrorist offences or offences linked to terrorist activities: see section 135(1), para (4) of the Danish Public Procurement Act. 5. Lot 5.1. Lot: LOT-0000 Title: Advance purchase agreement for the reservation and supply of pandemic influenza vaccine Description: The purpose of this tender is to ensure fast delivery of pandemic 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 purchase of pandemic influenza vaccine in the event of an influenza pandemic called by the WHO during the contract period. The reserved volume of pandemic vaccine is expected to be 7.6 million doses; however, the number of doses may be reduced by SSI as described in the tender documents. SSI expects that the Agreement cannot be awarded without prior negotiations with potential suppliers due to the specific circumstances related to the nature and the complexity of the Agreement and the legal and financial aspects and the associated risks. In essence, the procedure encompasses a complex advance purchase agreement, and SSI is dependent on further information from potential suppliers in order to establish a complete and adequate set of terms and conditions in accordance with what the market operators are able to meet. This makes it necessary for SSI to be able to negotiate various as-pects of both the tender documents and the tenders received and potentially make various changes to the tender documents. Hence, the procurement will be conducted as a negotiated procedure pursuant to the Danish Procurement Act (udbudsloven). All terms and requirements that are not minimum requirements may be subject to negotiation and may be changed or withdrawn during the tender procedure according to SSI’s decision. Thus, SSI encourages all economic operators who comply with the minimum requirements (stated in the Tender Specification, paragraph 5) to apply for prequalification, even if the economic operator cannot comply with other terms and requirements. Internal identifier: 4033881 5.1.1. Purpose Main nature of the contract: Supplies Main classification (cpv): 33651600 Vaccines 5.1.2. Place of performance Postal address: Artellerivej 5 Town: København S Postcode: 2300 Country subdivision (NUTS): Byen København (DK011) Country: Denmark 5.1.3. Estimated duration Duration: 24 Months 5.1.4. Renewal Maximum renewals: 3 The buyer reserves the right for additional purchases from the contractor, as described here: The duration of 24 months is including potential extensions of the Agreement. The Initial Term of the Agreement is from the signature of the Agreement (expected to be 1 November 2024) until 31 March 2025. SSI is entitled to extend the term of the agreement one or more times up to a total duration of 24 months. 5.1.6. General information Reserved participation: Participation is not reserved. Procurement Project not financed with EU Funds. The procurement is covered by the Government Procurement Agreement (GPA) Additional information: GENERAL INFORMATION: Participation in the tender procedure may only take place by electronic means via the electronic tendering system used by SSI. For access to the procurement documents, the candidate must be registered or register as a user. If the application contains several versions of the same document, the latest uploaded version will apply. All communication in connection with the tender procedure, including questions and answers, must take place through the electronic tendering system. The deadlines for the submission of questions are stated in the Tender Specifications. Questions asked after this date will be answered if they are received in time for SSI to provide the information required and communicate the answers not later than six days before expiry of the application deadline. Questions received later than six days before expiry of the deadline cannot expect to be answered unless the deadline is also postponed. Interested operators are requested to keep updated via the electronic tendering system. If the tenderer encounters problems with the system, please contact support by e-mail, dksupport@eu-supply.com, or telephone (+45) 70 20 80 14. ESPD: The tenderer must submit an ESPD with the tender as preliminary documentation of the circumstances set out in section 148(1), paras (1)-(3) of the Danish Public Procurement Act (udbudsloven). It is not necessary for the tenderer to sign the ESPD document. For groups of operators (e.g., a consortium), a separate ESPD must be submitted for each participating operator. Where the tenderer is a group of operators, the ESPD document of each participant in the group must be signed by the participant in question. The tenderer heading the group and submitting the tender is not required to sign its ESPD document. The tenderer will be excluded from participation in the tender procedure if the tenderer is covered by the mandatory grounds for exclusion, cf. sections 134a, 135 and 136 of the Danish Public Procurement Act unless the tenderer has provided sufficient documentation of its reliability in accordance with section 138 of the Danish Public Procurement Act (not applicable to section 134a). Before the award decision is made, the tenderer to whom SSI intends to award the contract must provide documentation of the information submitted in the ESPD pursuant to sections 151-152, cf. section 153 of the Danish Public Procurement Act. As an alternative to the documentation mentioned in sections 153-155, 157 and 158 of the Danish Public Procurement Act, the tenderer may submit to SSI a certificate of registration in an official list of approved economic operators, see section 156 of the Danish Public Procurement Act, issued by the competent authority. SSI only accepts certificates of registration in an official list from tenderers established in the country holding the official list. SELECTION OF CANDIDATES: SSI will select 3 candidates by applying the objective criteria stated in this contract notice, cf. the section 5.1.9, unless SSI receives no more than 3 compliant requests for participation. SSI will continue the tender procedure if SSI receives less than 3 compliant requests (i.e. the “minimum number of candidates” is not a prerequisite for continuing the procedure) ADDITIONAL INFORMATION: SSI may use the procedure of section 159(5) of the Danish Public Procurement Act in the event that applications or tenders do not comply with the formal requirements of the tender documents. Attention is drawn to Article 5k in Regulation (EU) No 833/2014, as amended, which applies to the tender procedure. The provision contains a prohibition against award of contracts to Russian companies and Russian-controlled companies etc. (reference is made to Article 5k, section 1, for the precise definition of the operators that are subject to the prohibition). SSI reserves the right to require at any time during the tender process that the economic operators prove that they are not subject to the prohibition, for example by requiring a declaration to this effect and/or documentation regarding the place of establishment and ownership of the economic operators and any sub-contractors. 5.1.9. Selection criteria Criterion: Type: Economic and financial standing Use of this criterion: Not used Criterion: Type: Suitability to pursue the professional activity Use of this criterion: Not used Criterion: Type: Technical and professional ability Description: The candidate must submit the European Single Procurement Document with the following information: 1) A list of the applicant's principal deliveries of influenza vaccines effected within the last 3 years with indication of amounts, dates, and recipient. 2) Information about the applicant's principal deliveries of pandemic vaccines effected and delivered within the last 10 years. 3) Information about Advanced Purchase Agreements that the applicant has entered into within the last 10 years. 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. Before the award decision is made, the tenderer to whom the contracting entity intends to award the contract must submit documentation that the information stated in the ESPD is accurate. No additional documentation of technical and professional capacity will be required from the tenderer. However, SSI reserves the right to contact the tenderer, or the customer stated in the reference for verification of the information stated in the reference, including the dates of the reference indicated. If the tenderer relies on the technical capacity of other operators with the operator making their technical capacity available to the tenderer must sign a letter of commitment, the commitment letter must be submitted in connection with submission of documentation for the information stated in the ESPD, see tender specification paragraph 15. If SSI receives more than 3 compliant requests for participation SSI will select the 3 applicants with the best and most relevant references on the abovementioned supplies and contracts. Use of this criterion: Used Information about the second stage of a two-stage procedure: Minimum number of candidates to be invited for the second stage of the procedure: 3 Maximum number of candidates to be invited for the second stage of the procedure: 3 5.1.10. Award criteria Criterion: Type: Price Name: Price Description: Reference is made to the Tender Specifications, Appendix A, section 1.1. Weight (percentage, exact): 50 Criterion: Type: Quality Name: Delivery Description: Reference is made to the Tender Specifications, Appendix A, section 1.2. Weight (percentage, exact): 20 Criterion: Type: Quality Name: Liability Description: Reference is made to the Tender Specifications, Appendix A, section 1.3. Weight (percentage, exact): 15 Criterion: Type: Quality Name: Flexibility Description: Reference is made to the Tender Specifications, Appendix A, section 1.4. Weight (percentage, exact): 15 5.1.11. Procurement documents Address of the procurement documents: https://eu.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=404456&B= 5.1.12. Terms of procurement Terms of submission: Electronic submission: Required Address for submission: https://eu.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=404456&B= Languages in which tenders or requests to participate may be submitted: English Electronic catalogue: Not allowed Variants: Not allowed Deadline for receipt of requests to participate: 04/07/2024 21:59:00 (UTC) Terms of contract: Conditions relating to the performance of the contract: The Supplier must have the necessary permits from the competent authorities in the EU to produce and engage in trade of medicinal products. The Supplier or an Affiliate (as defined in the tender documents) must have an EU Authorisation for a Pandemic Preparedness Vaccine. Electronic invoicing: Required Electronic ordering will be used: yes Electronic payment will be used: yes Information about review deadlines: Pursuant to the Danish Act on the Complaints Board for Public Procurement, etc. (lov om Klagenævnet for Udbud m.v.) (the Act is available (in Danish) at www.retsinformation.dk), the following deadlines apply to the lodging of complaints: Complaints of not having been selected must be submitted to the Danish Complaints Board for Public Procurement before the expiry of 20 calendar days, see section 7(1) of the Act, from the day after submission of notification to the candidates concerned of the identity of the successful tenderer where the notification is accompanied by an explanation of the grounds for the decision in accordance with section 2(1), para (1) of the Act and section 171(2) of the Danish Public Procurement Act. In other situations, complaints of award procedures, see section 7(2) of the Act, must be lodged with the Danish Complaints Board for Public Procurement before the expiry of: 45 calendar days after the contracting entity has published a notice in the Official Journal of the European Union that the contracting entity has entered into a contract. The deadline is calculated from the day after the day when the notice was published. Not later than at the time of lodging a complaint with the Danish Complaints Board for Public Procurement, the complainant must notify the contracting entity in writing that a complaint has been lodged with the Danish Complaints Board for Public Procurement and whether the complaint was lodged during the standstill period, see section 6(4) of the Act. In cases where the complaint was not lodged within the standstill period, the complainant must furthermore indicate whether a suspensory effect of the complaint has been requested, see section 12(1) of the Act. The e-mail address of the Complaints Board for Public Procurement is klfu@naevneneshus.dk. The Complaints Board’s own complaints procedure is available at https://naevneneshus.dk/start-din-klage/klagenaevnet-for-udbud/vejledning/. 5.1.15. Techniques Framework agreement: No framework agreement Information about the dynamic purchasing system: No dynamic purchase system 5.1.16. Further information, mediation and review Review organisation: Klagenævnet for Udbud Organisation providing more information on the review procedures: Konkurrence- og Forbrugerstyrelsen Organisation receiving requests to participate: Statens Serum Institut Organisation processing tenders: Statens Serum Institut 8. Organisations 8.1. ORG-0001 Official name: Statens Serum Institut Registration number: 46 83 74 28 Postal address: Artellerivej 5 Town: København S Postcode: 2300 Country subdivision (NUTS): Byen København (DK011) Country: Denmark Contact point: Birgit Neale Email: nea@ssi.dk Telephone: +4532683978 Internet address: https://www.ssi.dk Buyer profile: https://eu.eu-supply.com/ctm/company/companyinformation/index/281426 Roles of this organisation: Buyer Organisation receiving requests to participate Organisation processing tenders 8.1. ORG-0002 Official name: Klagenævnet for Udbud Registration number: 37795526 Postal address: Nævnenes Hus, Toldboden 2 Town: Viborg Postcode: 8800 Country subdivision (NUTS): Vestjylland (DK041) Country: Denmark Email: klfu@naevneneshus.dk Telephone: +45 72405600 Internet address: https://klfu.naevneneshus.dk/ Roles of this organisation: Review organisation 8.1. ORG-0003 Official name: Konkurrence- og Forbrugerstyrelsen Registration number: 10294819 Postal address: Carl Jacobsens Vej 35 Town: Valby Postcode: 2500 Country subdivision (NUTS): Byen København (DK011) Country: Denmark Email: kfst@kfst.dk Telephone: +45 41715000 Internet address: http://www.kfst.dk Roles of this organisation: Organisation providing more information on the review procedures 8.1. ORG-0004 Official name: Mercell Holding ASA Registration number: 980921565 Postal address: Askekroken 11 Town: Oslo Postcode: 0277 Country subdivision (NUTS): Oslo (NO081) Country: Norway Contact point: eSender Email: publication@mercell.com Telephone: +47 21018800 Fax: +47 21018801 Internet address: http://mercell.com/ Roles of this organisation: TED eSender 10. Change Version of the previous notice to be changed: 453c35b7-7c51-4816-97ed-947263b20e07-01 Main reason for change: Buyer correction Description: Due to a technical error in tendering system text appears regarding the Danish Public Procurement Act section 137(1), para 1-6 under section 2.1.6 Grounds for exclusion. It is not possible to change the content of the contract notice. The selected grounds for exclusion are described in the sections 2.1.4 and 5.1.6 General information, where the following is stated: "The tenderer will be excluded from participation in the tender procedure if the tenderer is covered by the mandatory grounds for exclusion, cf. sections 134a, 135 and 136 of the Danish Public Procurement Act unless the tenderer has provided sufficient documentation of its reliability in accordance with section 138 of the Danish Public Procurement Act (not applicable to section 134a)." These are the sole grounds for exclusion that apply for this tender, as described in the Tender Specification para. 7. The non-compulsory grounds for exclusion as stated in the Danish Public Procurement Act section 137(1), para 1-6 have not been selected for this tender, regardless of what else may appear from contract notice 335850-2024. In the ESPD only the compulsory grounds for exclusion appear. It should also be noted that the application deadline is stated as "04/07/2024 21:59:00 (UTC)" in section 5.1.12 Terms of procurement. This is also due to a technical error in the tendering system, and it is not possible to change in the contract notice. It is therefore emphasized that the application deadline is 4 July 2024 at 23:59:00 (CET), see Tender Specifications para. 3. 11. Notice information 11.1. Notice information Notice identifier/version: 991da097-b923-4f9e-8a5b-997bd5d5fdd9 - 01 Form type: Competition Notice type: Contract or concession notice – standard regime Notice dispatch date: 14/06/2024 09:18:55 (UTC) Notice dispatch date (eSender): 14/06/2024 09:30:34 (UTC) Languages in which this notice is officially available: English 11.2. Publication information Notice publication number: 357140-2024 OJ S issue number: 116/2024 Publication date: 17/06/2024 Czech document download: https://ted.europa.eu/cs/notice/357140-2024/pdf Danish document download: https://ted.europa.eu/da/notice/357140-2024/pdf German document download: https://ted.europa.eu/de/notice/357140-2024/pdf Greek document download: https://ted.europa.eu/el/notice/357140-2024/pdf Spanish document download: https://ted.europa.eu/es/notice/357140-2024/pdf English document download: https://ted.europa.eu/en/notice/357140-2024/pdf Estonian document download: https://ted.europa.eu/et/notice/357140-2024/pdf Finnish document download: https://ted.europa.eu/fi/notice/357140-2024/pdf French document download: https://ted.europa.eu/fr/notice/357140-2024/pdf Irish document download: https://ted.europa.eu/ga/notice/357140-2024/pdf Croatian document download: https://ted.europa.eu/hr/notice/357140-2024/pdf Hungarian document download: https://ted.europa.eu/hu/notice/357140-2024/pdf Italian document download: https://ted.europa.eu/it/notice/357140-2024/pdf Lithuanian document download: https://ted.europa.eu/lt/notice/357140-2024/pdf Latvian document download: https://ted.europa.eu/lv/notice/357140-2024/pdf Maltese document download: https://ted.europa.eu/mt/notice/357140-2024/pdf Dutch document download: https://ted.europa.eu/nl/notice/357140-2024/pdf Polska document download: https://ted.europa.eu/pl/notice/357140-2024/pdf Portuguese document download: https://ted.europa.eu/pt/notice/357140-2024/pdf Romanian document download: https://ted.europa.eu/ro/notice/357140-2024/pdf Slovak document download: https://ted.europa.eu/sk/notice/357140-2024/pdf Slovenian document download: https://ted.europa.eu/sl/notice/357140-2024/pdf Swedish document download: https://ted.europa.eu/sv/notice/357140-2024/pdf Bulgarian document download: https://ted.europa.eu/bg/notice/357140-2024/pdf