Poland – Laboratory reagents – Sukcesywna dostawa specjalistycznych odczynników do analizy cfDNA w ramach badania klinicznego N-BRAVE (PLRG-HL05)

Changes and explanations of the content of the SWZ and other documents related to the procurement procedure will be made available on the website: https://platformazakupowa.pl/transakcja/1397981

1. The subject of the procurement is the successive supply of specialist reagents for cfDNA analysis as part of the clinical trial N-BRAVE (PLRG-HL05) entitled: "Assessment of the efficacy and tolerance of the N-AVD scheme compared to the BrE-CADD scheme in patients with advanced Hodgkin's lymphoma" carried out by the Medical University of Gdańsk based on the co-financing agreement no. 2024/ABM/02/00001 concluded with the Medical Research Agency.

2. The subject of the procurement consists of an assortment detailed in Annex 3 to the SWZ (itemised price list).

3. This concerns item 5 of Annex 3 – priced by the Contractor, the value of this item will not change after the probe is designed by the user.

4. The quantities of individual products have been estimated for a period of 12 months from the date of signing the Contract.

5. The Purchaser reserves the right not to implement 50% of the value of the order, without the need to change the terms of the Contract.

6. The subject of the procurement is detailed in Annex 3 to this SWZ – description of the subject of the procurement.

7. Detailed provisions regarding the performance of obligations related to this procurement are contained in the draft contract – Annex 4 to the SWZ.

8. The Purchaser does not require subject-specific evidence in this procurement procedure. Pursuant to Article 5k of Council Regulation (EU) No 833/2014 of 31 July 2014 concerning restrictive measures in view of Russia's actions destabilising the situation in Ukraine (OJ L 229, 31.7.2014, p. 1) as amended by Council Regulation (EU) 2022/576 of 8 April 2022 and as amended by Council Regulation (EU) 2025/2033 of 23 October 2025 amending Regulation (EU) No 833/2014 concerning restrictive measures in view of Russia's actions destabilising the situation in Ukraine (OJ L 111, 8.4.2022, p. 1 and OJ L 2033, 23.10.2025, p. 1, as amended), the Purchaser informs that it will not award a public contract covered by the scope of the directives on public procurement, as well as the scope of Article 10(1), (3), (6)(a)–(e), Article 10(8), (9) and (10), Article 11, 12, 13 and 14 of Directive 2014/23/EU, Article 7(a)–(d), Article 8, Article 10(b)–(f) and (h)–(j) of Directive 2014/24/EU, Article 18, Article 21(b)–(e) and (g)–(i), Article 29 and 30 of Directive 2014/25/EU and Article 13(a)–(d), (f)–(h) and (j) of Directive 2009/81/EC to or with the participation of: a) Russian citizens residing in Russia or legal entities, bodies or organisations based in Russia; b) legal entities, bodies or organisations, to which more than 50% of the ownership rights belong directly or indirectly to a natural or legal person, body or organisation referred to in point (a) above; or c) natural or legal persons, bodies or organisations acting on behalf of or under the direction of a natural or legal person, body or organisation referred to in point (a) or (b) above, including subcontractors, suppliers or entities on whose capabilities reliance is placed in accordance with the directives on public procurement, where this exceeds 10% of the value of the procurement. To confirm that none of the above-mentioned circumstances apply to the Contractor, a declaration – Annex 5 to the SWZ – in electronic form with a qualified electronic signature must be attached to the offer. In the case of joint tendering by Contractors, the declaration referred to above shall be submitted by each of the Contractors jointly tendering for the procurement. The Purchaser informs that it allows the submission of subject-specific evidence by presenting a valid certificate of the Contractor issued by an authorised certifying body within the scope covered by the certificate, in accordance with the provisions of the Act of 5 August 2025 on the certification of public procurement contractors (Journal of Laws 2025, item 1235, as amended). In accordance with the provisions of SWZ Sections V – VIII.