bd1114cb-644b-4adb-9c0b-10f13c274db8-01 Frist zur Einreichung von Aufklärungsfragen: 19.07.2024 Angebotsabgabefrist: 29.07.2024, 23:59 Uhr Öffnung der Angebote: 30.07.2024, 09:00 Uhr false update-add 16 ORG-0001 Universitätsklinikum Bonn AöR Venusberg-Campus 1 Bonn 53127 DEA22 DEU DE 811 917 555 GB4-Abteilung Einkauf +49 228 287-14798 einkauf@ukbonn.de ORG-0002 Vergabekammer Rheinland bei der Bezirksregierung Köln, Spruchkörper Köln Köln 50606 DEA23 DEU 05315-03002-81 +49 2211473116 VKRheinland@bezreg-koeln.nrw.de ORG-0003Datenservice Öffentlicher Einkauf (in Verantwortung des Beschaffungsamts des BMI)Bonn53119DEA22DEU0204:994-DOEVD-83+49228996100noreply.esender_hub@bescha.bund.de 00417660-2024135/20242024-07-12Z 2.3 eforms-sdk-1.7 93e7cee5-7806-4101-a859-0a9b9f2bc664 573259bd-daf8-49d4-a786-25877f6afd2e 2024-07-10+02:00 18:18:42+02:00 01 2024-07-10+02:00 32014L0024 cn-standard DEU body-pl-ra health ORG-0001 ted-esenORG-0003 no-eu-funds false vgv SomeTenderDocID1 non-restricted-document ENG bankr-nat Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB bankruptcy Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB corruption Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB cred-arran Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB crime-org Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB distorsion Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB envir-law Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB finan-laund Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB fraud Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB human-traffic Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB insolvency Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB labour-law Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB liq-admin Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB misrepresent Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB partic-confl Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB prep-confl Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB prof-misconduct Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB sanction Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB socsec-law Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB socsec-pay Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB susp-act Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB tax-pay Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB terr-offence Zwingende bzw. fakultative Ausschlussgründe nach §§ 123 bis 126 GWB no not-allowed https://www.evergabe.nrw.de/VMPSatellite/notice/CXPNY5YD37L 2 Competition Act (Gesetz gegen Wettbewerbsbeschränkungen - GWB) Section 160 Initiation of the Proceedings, Application (1) The public procurement tribunal shall initiate review proceedings only upon application. (2) Every undertaking that has an interest in the public contract or the concession and claims that its rights under Section 97(6) have been violated by non-compliance with the provisions governing the awarding of public contracts has the right to file an application. In doing so, the undertaking must show that it has been or risks being harmed by the alleged violation of public procurement provisions. (3) The application is inadmissible if 1. the applicant became aware of the claimed violation of public procurement provisions before filing the application for review, but did not complain to the contracting authority within a time limit of 10 calendar days; the expiry of the time limit under Section 134(2) remains unaffected, 2. violations of public procurement provisions which become apparent from the tender notice are not notified to the contracting authority by the end of the time limit for the application or the submission of a tender specified in the notice, 3. violations of public procurement provisions which only become apparent from the procurement documents are not notified to the contracting authority by the end of the time limit for the application or the submission of a tender specified in the notice, 4. more than 15 calendar days have expired since receipt of notification from the contracting entity that it is unwilling to redress the objection. Sentence 1 shall not apply to an application under Section 135(1) no 2 to have the contract declared ineffective. Section 134(1) sentence 2 shall remain unaffected. ORG-0002 DEU ENG open required https://www.evergabe.nrw.de/VMPSatellite/notice/CXPNY5YD37L false false 2024-09 CorA Drug Product + Phase 1 The procurement, published by means of the contract notice in the relevant EU-wide publications, concerns the manufacturing and regulatory support for a First in Human assessment of Corallopyronin A (CorA). services Bekanntmachungs-ID: CXPNY5YD37L false 73000000 73100000 73110000 DEA22 anyw-cou DEU Phase 2 is subject to the reservation of financing, i.e. the corresponding services will only be called off by the client if the client for their part receives the corresponding funds and orders phase 2 separately from the contractor in writing. Until then, the contractor is bound by the conditions offered for phase 2 if the client calls off phase 2 not later than 12 months after completion of phase 1. If this call-off-period turns out to be insufficient, the parties will negotiate a sufficient period and, if required, adjustments to the contractor's conditions for phase 2 (within the scope of applicable public procurement laws). The contractor is not entitled to the services for phase 2, and without a separate order for phase 2 also has no right to payment for phase 2. LOT-0001 other Self-declaration Self-declaration of the applicant (form C01). other Self-declarations on exclusion grounds Self-declarations on exclusion grounds sections 123 and 124 GWB: Declaration on taxes and social security contributions, as well as existing or impending bankruptcy proceedings (form C02). other Self-declaration EU Sanctions Self-declaration EU Sanctions Art 5k (form C03). sui-act Registration in a public register Proof of registration in a public register (e.g. commercial or trade central register; not older than three months) or comparable. ef-stand Business/professional liability insurance policy Proof of an existing business/professional liability insurance policy. ef-stand Clinical trials insurance policy Proof of an existing clinical trials insurance policy. tp-abil Availability of procedures and test systems By written statement: availability of standard operating procedures and regular validation for test systems requested by the Contracting Authority. tp-abil GMP and GCP By certificate: Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). Proof of compliance with local legal requirements for handling an Investigational Medicinal Product under GMP to be used in clinical trials phase I-III. false not-allowed no-eu-funds allowed false vgv SomeTenderDocID1 non-restricted-document ENG https://www.evergabe.nrw.de/VMPSatellite/notice/CXPNY5YD37L/documents false late-some Ordinance on the Award of Public Contracts (Procurement Ordinance (Vergabeverordnung - VgV)) Section 56 (2) The contracting entity may, in compliance with the principles of transparency and equal treatment, ask the candidate or tenderer to complete, send on or correct any incomplete, missing or incorrect business-related documents, particularly selfdeclarations, statements, certificates or other means of proof, or to complete or send on any incomplete or missing documents related to the performance. The contracting entity is entitled to state in the contract notice or procurement documents that it will not follow up with requests for documents. (3) Follow-up requests for performance-related documents concerning the economic evaluation of the tenders using the award criteria are excluded. This shall not apply to pricing, provided only non-essential individual entries are involved, the individual prices of which do not change the overall price or adversely affect the evaluation sequence and the competition. (4) Following the contracting entity"s request, the documents shall be submitted by the candidate or tenderer within a reasonable time limit to be set by the contracting entity according to a calendar date. no not-allowed required performance Specifications of the required services are set out in the document "B01 Service Specifications". The services shall be governed by the enclosed Standard Terms and Conditions of Purchase (document B02) and the Master Contract Services Agreement (document B03). ORG-0001 https://www.evergabe.nrw.de/VMPSatellite/notice/CXPNY5YD37L 2 Competition Act (Gesetz gegen Wettbewerbsbeschränkungen - GWB) Section 160 Initiation of the Proceedings, Application (1) The public procurement tribunal shall initiate review proceedings only upon application. (2) Every undertaking that has an interest in the public contract or the concession and claims that its rights under Section 97(6) have been violated by non-compliance with the provisions governing the awarding of public contracts has the right to file an application. In doing so, the undertaking must show that it has been or risks being harmed by the alleged violation of public procurement provisions. (3) The application is inadmissible if 1. the applicant became aware of the claimed violation of public procurement provisions before filing the application for review, but did not complain to the contracting authority within a time limit of 10 calendar days; the expiry of the time limit under Section 134(2) remains unaffected, 2. violations of public procurement provisions which become apparent from the tender notice are not notified to the contracting authority by the end of the time limit for the application or the submission of a tender specified in the notice, 3. violations of public procurement provisions which only become apparent from the procurement documents are not notified to the contracting authority by the end of the time limit for the application or the submission of a tender specified in the notice, 4. more than 15 calendar days have expired since receipt of notification from the contracting entity that it is unwilling to redress the objection. Sentence 1 shall not apply to an application under Section 135(1) no 2 to have the contract declared ineffective. Section 134(1) sentence 2 shall remain unaffected. ORG-0002 DEU ENG true false required false https://www.evergabe.nrw.de/VMPSatellite/notice/CXPNY5YD37L 2024-07-29+02:00 23:59:00+02:00 2024-07-19+02:00 00:00:00+02:00 2024-07-30+02:00 09:00:00+02:00 false none none 2024-09 CorA Drug Product + Phase 1 Specifications of the required services are set out in the document "B01 Service Specifications". The services shall be governed by the enclosed Standard Terms and Conditions of Purchase (document B02) and the Master Contract Services Agreement (document B03). The expected services of the CorA-DP project are divided into two phases that will be awarded simultaneously to the same bidder. The call-off of the services for phase 2 is subject to financing until further notice. Phase I: The University Hospital Bonn aims to progress with the natural product Corallopyronin A (CorA) into a Phase I clinical trial. Therefore, the University Hospital Bonn is looking for a service provider that can fulfill the technical transfer of a spray drying process of CorA (formation of an amorphous solid dispersion) followed by implementation and development of downstream processes such as dry granulation, capsule filling and tableting (ER matrix). The manufacturing of chemistry, manufacturing, and controls (CMC) batches is required and stability data should be generated to support early regulatory activities and to enable the preparation of necessary regulatory documentation to facilitate a first in human study. The service should continue with Clinical Trial Materials (CTM) batch manufacturing, testing, and certification. Phase II: In order to save drug substance resources by minimizing required stability studies and offer high flexibility in adapting phase I clinical studies, an ideal partner would offer immediate access to the clinical trial unit and conduct clinical phase I. Thus, the period between manufacturing of CTS and first patient in would not be more than 2 weeks. The entire process will be awarded to the CMO as a phased contract and should run sequentially after successful completion of each work package. A Master Service Agreement (MSA) or framework agreement is preferred to facilitate the commission of the required work packages in form of Statements of Work (SoWs). There will be a commercial agreement and an additional quality assurance agreement. services false inn-pur rd-act 73000000 73100000 73110000 DEA22 anyw-cou DEU See contract extension as described above. Phase 2 is subject to the reservation of financing, i.e. the corresponding services will only be called off by the client if the client for their part receives the corresponding funds and orders phase 2 separately from the contractor in writing. Until then, the contractor is bound by the conditions offered for phase 2 if the client calls off phase 2 not later than 12 months after completion of phase 1. If this call-off-period turns out to be insufficient, the parties will negotiate a sufficient period and, if required, adjustments to the contractor's conditions for phase 2 (within the scope of applicable public procurement laws). The contractor is not entitled to the services for phase 2, and without a separate order for phase 2 also has no right to payment for phase 2.