Public procurement notice: Contract Notice
Published: 2025-02-17
Buyer: Helmholtz-Zentrum für Infektionsforschung GmbH
Country: DE
Region: DE911
Contract type: Services
Procedure: Open procedure
CPV classification: 33600000: Pharmaceutical products | 73100000
Submission deadline: 2025-03-18
Award criteria: price, quality

Technical requirements: When submitting the tender, the form "Self-declarations on exclusion grounds" relating to 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 sucessful 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.
Along with the offer, applicants should submit the completed form "Self-declaration EU sanctions" provided by the Contracting Authority. In the case of an applicant consortium, each member of the consortium should submit the form.
The headline objectives of the present manufacturing project are the use of the deliverables in GLP compliant preclinical toxicology and safety pharmacology studies as well as a phase 1 first-in-human clinical trial. The objective of the project is to manufacture two alternative pharmaceutical dosage forms, sterile liquid and semi-solid, to enable dosing as i.v. infusion and topical administration, respectively. This solely relates to current lack of clinical target validation and the requirement to ready the technology for proof-of-mechanism in systemic versus skin administration. We are targeting a virulence factor of S. aureus that may cause pulmonary or dermal infections.

HZI wishes to commission the following activities under Master Service Agreement to a suited contractor. A Go/ NoGo milestone is set after scope 1 while the tendering process and resulting contract shall comprise SCOPE1, SCOPE2, and SCOPE3 activities so as to assure these can be offered in the most economical way in terms of price and quality from one legal entity.

SCOPE1: process development and non-GMP manufacture of drug substance and injectable drug product to enable preclinical efficacy, pharmacokinetic and explora-tory tox/safety studies in preclinical animal models
SCOPE2: process scale up to GMP manufacturing of drug substance and drug product to perform regulatory preclinical tox and safety studies (GLP compliant) as well as a GCP-compliant phase 1 first-in-human clinical trial for the sterile liquid dosage form and infusion administration
SCOPE3: development of the semisolid dosage form for preclinical and phase 1 clinical administration via the topical route
The place of performance refers only to the delivery service. The place of manufacture shall be the bidder's place of business.
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 sating that - there are no grounds for exclusion within the meaning of §§ 123, 124 GWB respectively that successful self-remediation 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.

Eligibility requirements: 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 sating that - there are no grounds for exclusion within the meaning of §§ 123, 124 GWB respectively that successful self-remediation 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.
If possible, applicants should submit the following documents with their tender (in the case of applicant consortia with at least one member): #a) Confirmation that the applicant maintains professional indemnity/company liability insurance with cover of at least EUR 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.
Applicants should submit the following documents with the offer if possible (in the case of applicant consortia of at least one member): Informal self-declaration in which the applicant states whether and how it intends to  cooperate with other companies in the event of a contract. Applicant consortia are considered as a whole when assessing the suitability. In the event that an applicant / a consortium of applicants wishes to use individual companies as subcontractors, reference is made to the possibility of suitability lending and the requirements specified in § 47 VgV. If and insofar as the applicant / consortium of applicants relies on the suitability of the subcontractor, a declaration of commitment by the subcontractor that it will make its resources and capacities available to the applicant / consortium of applicants in the event of a contract must be submitted with the application. 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.
other
In addition, proof of suitability is required by written statement for the following project specific matters: referece for proving his competence and experience with formulation development in the research phase.
The contracting authority reserves the right to request missing documents. The contracting authority also reserves the right not to request missing documents in accordance with § 56(2) VgV.
In order to obtain the confidential document “A_05_AdditionalConfidentialInformation”, the signed CDA “A_01_CDA_small molecule manufacturing .doc” must be signed and submitted by 28 February at the latest. This is a prerequisite for submitting a valid offer. Subcontractors must also sign and submit the CDA. The main contractor is not allowed to pass on the confidential information.