Verfahrensangaben

The procurement, published by means of the contract notice in the relevant world-wide publications, concerns the conduct of a toxicology and safety pharmacology studies, GLP in vitro and in vivo study for an anti-parasitic drug of DNDi.

The University Hospital Bonn aims to progress the investigational compound E4095372 for treatment of helminth infections in humans. For this, the University Hospital Bonn is looking for a contract research organization (CRO) to conduct GLP safety and toxicology studies in rats. The maximum treatment time will be 28 days.

The entire process will be awarded to the CRO as a single-phase contract. 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.

Competition Act (Gesetz gegen Wettbewerbsbeschränkungen - GWB), Section 160:
(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.

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.

Specifications of the required services are set out in the document "B01 Service Specifications". The services shall be governed by the enclosed Master Contract Services Agreement (document B02).