SMALL MOLECULE CONTRACT MANUFACTURING SERVICES | Helmholtz-Zentrum für Infektionsforschung GmbH | Öffentliches Auftragswesen in Deutschland

Datum	Dokument
2025-02-14	Auftragsbekanntmachung
2025-02-17	Auftragsbekanntmachung

Kurze Beschreibung

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

Zusätzliche Informationen

Beschreibung der Optionen

Minimum contract term: 1 year (with the completion of SCOPE 1)***Optional contract terms: 2 extensions (1,5 years/1,5 years; max. 4 years in total)***End: With the completion of SCOPE 2 and 3 (expected end: 12/2028)
If the contract is not cancelled at least three months before its expiry date, it will be automatically renewed for a further year. The contract ends automatically when the maximum term of 4 years is reached without prior cancellation.

Liste und kurze Beschreibung der Bedingungen

Suitability to practice the profession including conditions relating to entry in a professional or commercial register: 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.

Liste und kurze Beschreibung der Auswahlkriterien

Economic and financial standing: 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.

Liste und kurze Beschreibung der Auswahlkriterien

Technical and professional ability: 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.

Liste und kurze Beschreibung der Regeln und Kriterien

Minimum requirements: 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.

In order to obtain the confidential document “A_05_AdditionalConfidentialInformation”, the signed CDA “A_01_CDA_small molecule manufacturing .doc” must be submitted. 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.

Documents that become part oft he contract and must be completed, signed and enclosed with the offer:
1. A_01_CDA_small molecule manufacturing
2. A_03_Price Schedule
3. A_04_Catalogue A_cirtiera
4. A_05_(AFTER CDA)_AdditionalConfidentialInformation
5. B_01_Data protection
6. C_00_Declaration on Exclusion Grounds
7. C_01_Self-declaration
8. C_02_Declaration_EU sanctions
9. C_03_Questions by applicants
10. D_01_Submission of Tender
11. D_02_Terms and Conditions
12. Project Schedule (according to B_02_Submission of a Project Schedule)
13. manufacturing quality concept (according to B_03_Submission of a manufacturing quality concept)

Documents that become part oft he contract and remain with the bidder:
14. B_00_Cover Letter
15. A_02_Performance description
16. Additional Contractual Conditions

Further documents that must be enclosed with the offer:
17. D_00_Master Service Agreement-Template_20231127 (for information only)

Genaue Informationen über Fristen für Überprüfungsverfahren

1) A review procedure before the Public Procurement Tribunal is inadmissible pursuant to Section 160 (3) Sentence 1 No. 4 ARC if more than 15 calendar days have elapsed since receipt of the contracting authority's notification that it does not intend to remedy a complaint.

2) In particular, Section 160 (3) Sentence 1 Nos. 1, 2 and 3 of the ARC and Section 134 (2) of the ARC shall be observed.

3) The period for asserting the invalidity of the contract pursuant to Section 135 of the ARC ends no later than 30 calendar days after publication of the notice of award procedures in the Official Journal of the European Union; see Section 135(2), second sentence, of the ARC.

Zusätzliche Informationen

The following A-criteria (minimum requirements) must be met and explicitly confirmed by the bidder with a 'Yes'. Failure to meet at least one of these A Criteria will result in the exclusion of the tender from further consideration:

> Compliant with the principles of Good Manufacturing Practices? (certificate(s) of GMP compliance for drug substance, injectable products and semi-solids have to be handed in)
> Regulatory Release of IMPs in the European Union? (By certificate)
> Qualified to manufacture the following IMPs: sterile liquids (injectable dosage form) and semi-solids (topical dosage form)? (please provide authorizations as applicable)
> Existing business liability insurance policy with minimum coverage of EUR 5m per occurence and policy year? (please answer yes or no)
> Competence and Experience with formulation development in the research phase available (one references has to be handed in)

***

A valid tender cannot be submitted without a CDA.
To obtain the confidential document ' A_05_(AFTER CDA)_AdditionalConfidentialInformation', the signed CDA must be submitted by 28 February
at the latest. It is possible to submit the CDA later, but this is the bidder's responsibility. If a bidder submits the CDA after 28 February, the bidder runs the risk that the remaining time may not be sufficient to prepare a complete and timely bid. The contracting authority is under no obligation to extend the tender deadline as a result of a late submission.
The CDA can be requested up to five days before the tender deadline. Subcontractors must also sign and submit the CDA. Disclosure of confidential information by the main contractor is not permitted.

***

In order to verify the information provided in the tender (in particular the concepts), the contracting authority reserves the right to invite the two best bidders to a verification tender presentation.
The purpose of the tender submission is the verification of the information provided by the tenderer. No negotiations will take place and no changes can be made to the offer. The offer presentation is expected to take place on 3 April 2025. The exact time and any
change of the date will be communicated via the Tender Platform by 1 April 2025.
The contracting authority reserves the right to correct the evaluation of the concept in case of non-performance or insufficient performance.