1. Beschaffer
1.1.
Beschaffer
Offizielle Bezeichnung: Helmholtz-Zentrum für Infektionsforschung GmbH
Rechtsform des Erwerbers: Von einer zentralen Regierungsbehörde kontrollierte Einrichtung des öffentlichen Rechts
Tätigkeit des öffentlichen Auftraggebers: Gesundheit
2. Verfahren
2.1.
Verfahren
Titel: Preclinical Drug Discovery Services
Beschreibung: Non-GLP preclinical small molecule drug discovery services of the following kind and quantity, to be provided under Master Service Agreement.
Kennung des Verfahrens: ca16094d-a7a6-4edd-adf8-dcc2a19ffa76
Interne Kennung: 024/006/2024
Verfahrensart: Offenes Verfahren
Zentrale Elemente des Verfahrens: Requests to participate must be submitted electronically in text form (Section 126b BGB) via the procurement portal. Further information can be found on the homepage of the procurement portal. All communication between the contracting authority and the candidates will take place exclusively via the procurement portal. The contracting authority shall make all questions and answers available on the procurement portal in anonymized form. The formation of applicant/bidder consortia is only possible until the submission of the tender. The information on the composition of the bidding consortium is generally binding.
2.1.1.
Zweck
Art des Auftrags: Dienstleistungen
Haupteinstufung (cpv): 73000000 Forschungs- und Entwicklungsdienste und zugehörige Beratung
Zusätzliche Einstufung (cpv): 73111000 Forschungslabordienste
2.1.2.
Erfüllungsort
Land, Gliederung (NUTS): Braunschweig, Kreisfreie Stadt (DE911)
Land: Deutschland
2.1.3.
Wert
Geschätzter Wert ohne MwSt.: 500 000,00 EUR
Höchstwert der Rahmenvereinbarung: 500 000,00 EUR
2.1.4.
Allgemeine Informationen
Rechtsgrundlage:
Richtlinie 2014/24/EU
vgv -
Anzuwendende grenzübergreifende Rechtsvorschrift:
2.1.6.
Ausschlussgründe:
Rein innerstaatliche Ausschlussgründe: When submitting the tender, the form "Self-declarations on Sections 123 and 124 GWB" provided by the awarding authority must be submitted, in which it is declared that there are no grounds for exclusion within the meaning of Sections 123, 124 GWB or that successful self-cleaning measures within the meaning of Section 125 GWB have been carried out. In the case of bidding consortia, the form must be submitted by each member of the consortium.
Rein innerstaatliche Ausschlussgründe: Along with the offer, applicants shouldsubmit the completed form "Self-declaration on the EU sanctions package in connection with Russia's war of aggression on Ukraine" provided by theContracting Authority. In the case of an applicant consortium, each member of theconsortium should submit the form.
5. Los
5.1.
Los: LOT-0001
Titel: Preclinical Drug Discovery Services
Beschreibung: Preclinical Drug Discovery Services
Interne Kennung: 024/006/2024
5.1.1.
Zweck
Art des Auftrags: Dienstleistungen
Haupteinstufung (cpv): 73000000 Forschungs- und Entwicklungsdienste und zugehörige Beratung
Zusätzliche Einstufung (cpv): 73111000 Forschungslabordienste
Optionen:
Beschreibung der Optionen: The contract shall be concluded for a term of at least 3 years beginning with the award of the contract. The contract may be extended up to once by 1 year by unilateral declaration of the client. The maximum term of the contract is 4 years if the extension options are utilised.
5.1.2.
Erfüllungsort
Land, Gliederung (NUTS): Braunschweig, Kreisfreie Stadt (DE911)
Land: Deutschland
5.1.3.
Geschätzte Dauer
Laufzeit: 4 Jahr
5.1.4.
Verlängerung
Maximale Verlängerungen: 1
5.1.5.
Wert
Geschätzter Wert ohne MwSt.: 500 000,00 EUR
5.1.6.
Allgemeine Informationen
Vorbehaltene Teilnahme: Teilnahme ist nicht vorbehalten.
Auftragsvergabeprojekt nicht aus EU-Mitteln finanziert
Die Beschaffung fällt unter das Übereinkommen über das öffentliche Beschaffungswesen
5.1.7.
Strategische Auftragsvergabe
Ziel der strategischen Auftragsvergabe: Keine strategische Beschaffung
5.1.9.
Eignungskriterien
Kriterium:
Art: Eignung zur Berufsausübung
Bezeichnung: Suitability to practice the profession, including conditionsrelating to entry in a professional or commercial register
Beschreibung: Applicants should submit the following documents with the offer if possible (from each member in the case of consortia): # a) Informal company presentation stating the name, registered office, contact details, VAT identification number and entry in the commercial register/professional register. # b) Informal self-declaration stating that - that there are no grounds for exclusion within the meaning of §§ 123, 124 GWB respectively that successful selfremediation measures within the meaning of § 125 GWB have been carried out; - that they comply with the provisions of Art. 5k of the Regulation (EU) 833/2014 in the version of Art. 1 point 22 of Council Regulation (EU) 2023/1214 of June 23, 2023 as part of the EU sanctions package related to Russia's war of aggression on Ukraine. # c) Applicant consortia should also submit a declaration stating that there has been no breach of antitrust law and that no unlawful agreements restricting competition have been made. Applicants should use the forms provided by the Contracting Authority. The Contracting Authority reserves the right to request additional documents in accordance with § 56 (2) VgV. There is no legal entitlement to this.
Kriterium:
Art: Wirtschaftliche und finanzielle Leistungsfähigkeit
Bezeichnung: Economic and financial standing
Beschreibung: If possible, applicants should submit the following documents with their tender (in the case of applicant consortia with at least one member): #a) Details of total turnover for the last three completed financial years, if possible including annual financial statements and audit reports, as well as details of turnover for the last three financial years with services comparable to the subject of this contract. #b) Confirmation that the applicant maintains professional indemnity/company liability insurance with cover of at least EUR 1.5 million per claim, 2 times maximum, or will take out such insurance if the contract is awarded. In the event that a candidate wishes to use individual companies as subcontractors, reference is made to the possibility of suitability lending and the requirements specified in Section 47 VgV. If and insofar as the applicant relies on the suitability of the subcontractor, a declaration of commitment from the subcontractor that it will make its resources and capacities available to the applicant in the event of a contract being awarded must be submitted with the tender. Applicants should use the forms provided by the contracting authority. The contracting authority reserves the right to request additional documents in accordance with Section 56 (2) VgV; there is no legal entitlement to this.
Kriterium:
Art: Technische und berufliche Leistungsfähigkeit
Bezeichnung: Technical and professional ability
Beschreibung: Applicants should submit the following documents with the offer if possible (in the case of applicant consortia of atleast one member): #a) references for contracts from the last up to 3completed financial years that are comparable to the present subject matterof the contract in terms of performance, including the name of a contactperson at the respective client of the contracts named as references. If, forreasons of confidentiality, applicants are not permitted to name the clients,this must be indicated. In this case, it is sufficient to state the sector forwhich the order was performed. #b)Information on the total average number of staff employed annually over thelast three completed financial years and, separately, the number of managers.#c) With the application to participate, applicants should prove that theyhave an environmental management system in place. #d) The applicantshould prove by certificate that he fulfills local legal requirements formanufacture of an API for an Investigational Medicinal Product to be usedin clinical trials phase I-III according to current EU legislation (Regulation(EU) No 536/2014), e.g. Manufacturing Authorization according to § 13 (1)AMG. Applicants are also accepted that comply with cGMP standards andcommit to obtain the required manufacturing authorization on a timelineacceptable for the clinical trial material production. There is the regulatoryrequirement that the material used in preclinical studies should not varymuch from the subsequent IMP material for clinical studies. #e) Informalself-declaration in which the applicant states whether and how it intends tocooperate with other companies in the event of a contract. Applicantconsortia are considered as a whole when assessing the suitability. In theevent that an applicant / a consortium of applicants wishes to use individualcompanies as subcontractors, reference is made to the possibility ofsuitability lending and the requirements specified in § 47 VgV. If and insofaras the applicant / consortium of applicants relies on the suitability of thesubcontractor, a declaration of commitment by the subcontractor that it willmake its resources and capacities available to the applicant / consortium ofapplicants in the event of a contract must be submitted with the applicationto participate. Applicants should use the forms provided by the ContractingAuthority. The Contracting Authority reserves the right to request additionaldocuments in accordance with § 56 (2) VgV. There is no legal entitlement tothis.
Kriterium:
Art: Sonstiges
Bezeichnung: Minimum requirements
Beschreibung: In addition, proof of suitability is required by certificate or written statement for the following project specific matters: #a) By certificate: In vivo experiments are performed in AAALAC-I accredited State-of-the-Art animal facility (BSL2) with competent and skilled veterinary doctors, veterinary technicians and hygiene personnel holding training certificates equivalent to FELASA, categories A to D. #b)The successful bidder must be AAALAC accredited for animal work and co-locate at one site vivarium and analytical lab functions without involvement of third parties. #c) By written statement: (i) availability of standard operating procedures and regular validation for test systems requested by the Contracting Authority; (ii) declaration that the tests are performed in-house (if required, which part is subject to subcontracting).
5.1.10.
Zuschlagskriterien
Kriterium:
Art: Preis
Bezeichnung: Price - siehe Vergabeunterlagen
Gewichtung (Prozentanteil, genau): 55
Kriterium:
Art: Qualität
Bezeichnung: Quality - siehe Vergabeunterlagen
Gewichtung (Prozentanteil, genau): 45
5.1.11.
Auftragsunterlagen
Sprachen, in denen die Auftragsunterlagen offiziell verfügbar sind:
5.1.12.
Bedingungen für die Auftragsvergabe
Bedingungen für die Einreichung:
Elektronische Einreichung: Erforderlich
Sprachen, in denen Angebote oder Teilnahmeanträge eingereicht werden können: Deutsch, Englisch
Elektronischer Katalog: Nicht zulässig
Varianten: Nicht zulässig
Frist für den Eingang der Angebote: 04/04/2024 10:00:00 (UTC+2)
Frist, bis zu der das Angebot gültig sein muss: 2 Monat
Informationen, die nach Ablauf der Einreichungsfrist ergänzt werden können:
Nach Ermessen des Käufers können alle fehlenden Bieterunterlagen nach Fristablauf nachgereicht werden.
Zusätzliche Informationen: The Contracting Authority reserves the right torequest additional documents in accordance with § 56 (2) VgV. There is nolegal entitlement to this.
Informationen über die öffentliche Angebotsöffnung:
Eröffnungsdatum: 04/04/2024 10:00:00 (UTC+2)
Auftragsbedingungen:
Elektronische Rechnungsstellung: Erforderlich
Informationen über die Überprüfungsfristen: The procedure for violations ofthis award is governed by the provisions of §§ 160 ff. of the Act against Restraintsof Competition (GWB). With regard to compliance with the time limits, referenceis made to §§ 160 ff. GWB. In particular, we would like to point out that theapplication for review pursuant to § 160 (3) sentence 1 no. 4 GWB must besubmitted no later than 15 calendar days after receipt of the notification from theContracting Authority that it does not intend to remedy a complaint. Pursuant to §160 (3) sentence 1 no. 1 GWB, the Contracting Authority must be notified ofbreaches of public procurement rules within 10 calendar days after the applicantbecomes aware of the violation before submitting the application for review.Pursuant to § 160 (3) sentence 1 no. 2 GWB, violations of contract awardregulations that are recognizable on the basis of the contract notice must bereported to the Contracting Authority by the end of the application period at thelatest.
5.1.15.
Techniken
Rahmenvereinbarung: Rahmenvereinbarung ohne erneuten Aufruf zum Wettbewerb
Informationen über das dynamische Beschaffungssystem: Kein dynamisches Beschaffungssystem
5.1.16.
Weitere Informationen, Schlichtung und Nachprüfung
Überprüfungsstelle: Helmholtz-Zentrum für Infektionsforschung GmbH
8. Organisationen
8.1.
ORG-0001
Offizielle Bezeichnung: Helmholtz-Zentrum für Infektionsforschung GmbH
Registrierungsnummer: Leitweg-ID 992-80177-07
Stadt: Braunschweig
Postleitzahl: 38124
Land, Gliederung (NUTS): Braunschweig, Kreisfreie Stadt (DE911)
Land: Deutschland
Telefon: 053161812301
Rollen dieser Organisation:
Beschaffer
Überprüfungsstelle
8.1.
ORG-0002
Offizielle Bezeichnung: Beschaffungsamt des BMI
Registrierungsnummer: 994-DOEVD-83
Stadt: Bonn
Postleitzahl: 53119
Land, Gliederung (NUTS): Bonn, Kreisfreie Stadt (DEA22)
Land: Deutschland
Telefon: +49228996100
Rollen dieser Organisation:
TED eSender
11. Informationen zur Bekanntmachung
11.1.
Informationen zur Bekanntmachung
Kennung/Fassung der Bekanntmachung: ec25ecc5-6913-40ee-a16a-78ef1333c9ac - 01
Formulartyp: Wettbewerb
Art der Bekanntmachung: Auftrags- oder Konzessionsbekanntmachung – Standardregelung
Datum der Übermittlung der Bekanntmachung: 29/02/2024 00:00:00 (UTC+1)
Sprachen, in denen diese Bekanntmachung offiziell verfügbar ist: Deutsch
11.2.
Informationen zur Veröffentlichung
Veröffentlichungsnummer der Bekanntmachung: 129748-2024
ABl. S – Nummer der Ausgabe: 44/2024
Datum der Veröffentlichung: 01/03/2024