Pologne – Appareils et instruments médicaux divers – DOSTARCZANIE ENDOPROTEZ STAWU KOLANOWEGO WRAZ Z NAJMEM SYSTEMU DO ENDOPROTEZOPLASTYKI STAWU KOLANOWEGO I BIODROWEGO ORAZ DOSTAWA MATERIAŁÓW ZUŻYWALNYCH

CONDITIONS OF PARTICIPATION IN THE PROCEDURE AND METHOD OF ASSESSING COMPLIANCE WITH THESE CONDITIONS

1. In the procedure for awarding the contract, only Contractors who meet the conditions specified in Article 57 of the Pzp Act and Article 112(2) of the Pzp Act may participate, namely:

1) are not subject to exclusion

2) meet the participation conditions, relating to:

a) the ability to operate in the economic market

The Buyer does not set a specific condition for participation in the Procedure.

b) the right to carry out a specific economic or professional activity

The Buyer does not set a specific condition for participation in the Procedure.

c) the economic or financial situation

The Buyer does not set a specific condition for participation in the Procedure.

d) the technical or professional capacity

The Buyer does not set a specific condition for participation in the Procedure.

LIST OF EVIDENCE OR DOCUMENTS THAT CONTRACTORS MUST PROVIDE TO CONFIRM COMPLIANCE WITH THE CONDITIONS OF PARTICIPATION IN THE PROCEDURE

1. In order to demonstrate that the Contractor meets the conditions referred to in Article 57 of the Pzp Act, the Contractor submits:

a) a declaration of compliance with the conditions of participation in the procedure – signed appropriately by the person(s) authorised to represent the Contractor. The relevant declaration is submitted by the Contractor in the form of a single document constituting Annex No. 4 to the Specification (form JEDZ).

2. In order to confirm the absence of grounds for exclusion from the Procedure in the circumstances referred to in Article 108 of the Pzp Act, Article 109(1)(1) and (4) of the Pzp Act, and Article 7(1) of the Act of 13 April 2022 on special solutions to counter the support of aggression against Ukraine and to protect national security (Journal of Laws of 2024, item 507) and Article 5k(1) 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 EU L 229 of 31.07.2014, p. 1, as amended), the Contractor submits:

a) a declaration of absence of grounds for exclusion from the procedure – completed and signed appropriately by the person(s) authorised to represent the Contractor. The relevant declaration is submitted by the Contractor in the form of a single document constituting Annex No. 4 to the Specification (form JEDZ);

b) a declaration that the Contractor is not subject to exclusion from the procedure under Article 7(1) of the Act of 13 April 2022 on special solutions to counter the support of aggression against Ukraine and to protect national security (Journal of Laws of 2025, item 514) and is not subject to a ban on the award or further execution of any public contracts under Article 5k(1) 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 EU L 229 of 31.07.2014, p. 1, as amended) – completed and signed appropriately by the person(s) authorised to represent the Contractor - Annex No. 2 to the Specification.

SELF-CLEANING PROCEDURE

1. The Contractor is not subject to exclusion in the circumstances set out in Article 108(1)(1), (2) and (5) of the Pzp Act or Article 109(1)(2) to (5) and (7) to (10) of the Pzp Act, if it proves to the Buyer that it has met the following cumulative conditions:

1) it has remedied or committed to remedying the damage caused by the offence, misdemeanour or its improper conduct, including by making monetary compensation;

2) it has fully explained the facts and circumstances related to the offence, misdemeanour or its improper conduct and the damage caused thereby, actively cooperating appropriately with the relevant authorities, including law enforcement agencies, or the Buyer;

3) it has taken specific technical, organisational and personnel measures to prevent further offences, misdemeanours or improper conduct, in particular:

a) it has severed all links with persons or entities responsible for the Contractor's improper conduct,

b) it has reorganised its staff,

c) it has introduced a reporting and control system,

d) it has created internal audit structures to monitor compliance with the rules, internal regulations or standards,

e) it has introduced internal regulations on responsibility and compensation for non-compliance with the rules, internal regulations or standards.

2. The Buyer assesses whether the actions taken by the Contractor, as referred to in paragraph 1, are sufficient to demonstrate its integrity, taking into account the seriousness and specific circumstances of the Contractor's conduct. If the actions taken by the Contractor, as referred to in paragraph 1, are not sufficient to demonstrate its integrity, the Buyer excludes the Contractor.

3. The Contractor may be excluded by the Buyer at any stage of the contract award procedure.

4. In order to benefit from the "self-cleaning" institution, the Contractor is required to complete the relevant information in the declaration constituting Annex No. 4 to the Specification.