Changes and clarifications to the content of the RVUs and other procurement documents directly related to the procurement procedure will be made available on the following website: https://platformazakupowa.pl/transaction/1072427 1.The subject of the order is the successive supply of medicinal products in 2 packages: Package 1- Supply of a medicinal product containing the active substance Andexanet alfa for a non-commercial clinical trial: ‘Multicenter, randomised, parallel-group, double-blind, placebo-controlled phase II study evaluating the efficacy and safety of intravenous recombinant tissue plasminogen activator (rtPA) reperfusion thrombolytic therapy in ischaemic stroke in patients receiving oral anticoagulants not belonging to the vitamin K antagonist group and after reversal of anticoagulant activity with a specific antidote’ Package 2-supply of medicinal products containing the active substance alteplaze (rtPA Actilyse 10, 10 mg powder and solvent for solution for infusion, rtPA Actilyse 20, 20 mg powder and solvent for solution for infusion, and rtPA Actilyse 50, 50 mg powder and solvent for solution for infusion and rtPA Actilyse for non-commercial clinical study: ‘A multicenter, randomised, parallel-group, double-blind, placebo-controlled phase II study evaluating the efficacy and safety of intravenous recombinant tissue plasminogen activator (rtPA) reperfusion thrombolytic therapy in ischaemic stroke in patients receiving oral anticoagulants not belonging to the vitamin K antagonist group and after reversal of anticoagulant activity with a specific antidote’ 2. Detailed Description of the Subject of the Contract is attached as Annex 3 and 3.1 to the SWZ. 3. The number of packages of Investigated Medicinal Products specified in Annexes 3 and 3.1 to the SPC is an estimate and may be reduced depending on the needs of the Ordering Party, but not by more than 50% of the contract value, without the need to change the terms of the Agreement. 4. Package 1-2 - shelf life of the medicinal product - minimum 24 months from the date of delivery of the goods to the Ordering Party. 5. Deliveries of products with a shorter period of validity may be allowed in exceptional situations and must always be agreed to by an authorized representative of the Ordering Party. 6. Detailed provisions for the performance of the obligations relating to this contract are set out in the draft contract – Annexes 4 and 4.1 to the SWZ. 9. Medicinal products must be authorised for marketing in the Republic of Poland. The procurement of medicinal products intended for use in a non-commercial clinical trial from EU or non-EU markets is allowed. In such a situation, the contractor is obliged to prepare documentation required by law enabling the use of the Medicinal Product in a Non-Commercial Clinical Trial. 10. The contracting authority does not allow variants to be submitted. 11. The Contracting Authority accepts the possibility of submitting partial tenders in the scope of the described packages from 1 to 2. Each Contractor shall be entitled to submit a tender for the package or packages of partial tenders of his choice. 12. The ordering party does not require a deposit. 13. The contracting authority does not provide for the possibility of awarding contracts directly referred to in Art. 1 point 7 and 8. 14. The Contracting Authority does not require the Contractor to carry out an on-site inspection or check the documents necessary for the performance of the contract. 15. The Ordering Party does not reserve the obligation to personally perform key tasks by the Contractor. 16. The contracting authority does not require the provision of a performance bond. 17. The Contracting Authority does not provide for a method of communication with the Contractors other than using the means of electronic communication indicated in the SWZ. 18. In connection with 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, p. 1) as amended by Council Regulation (EU) 2022/576 of 8 April 2022 amending Regulation (EU) No 833/2014 concerning restrictive measures in view of Russia's actions destabilising the situation in Ukraine (OJ Urz. EU No L 111, p. 1), the Contracting Authority informs that it will not award a public contract falling within the scope of the Public Procurement Directives, as well as within the scope of Art. 1, 3, mouth. 6(a) to (e), paragraph 8, 9 and 10, Articles 11, 12, 13 and 14 of Directive 2014/23/EU, Articles 7 and 8, points (b) to (f) and points (h) to (j) of Article 10 of Directive 2014/24/EU, Article 18, points (b) to (e) and points (g) to (i) of Article 21, Articles 29 and 30 of Directive 2014/25/EU and points (a) to (d), (f) to (h) and (j) of Article 13 of Directive 2009/81/EC for or with: Russian nationals or natural or legal persons, entities or bodies established in Russia; legal persons, entities or bodies whose proprietary rights are directly or indirectly owned for more than 50 % by an entity referred to in point (a) of this paragraph; natural or legal persons, entities or bodies acting on behalf or at the direction of an entity referred to in points (a) or (b) of this paragraph, including subcontractors, suppliers or entities whose capacities are relied on within the meaning of the Public Procurement Directives, where they account for more than 10 % of the value of the contract. 20. In order to confirm that the Contractor is not subject to any of the transmissions specified in para. 19 above, the tender must be accompanied by a declaration – Annex 5 to the CVT – in electronic form with a qualified electronic signature.
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