Combined vaccine against: diphtheria, tetanus, and pertussis (acellular, combined), adsorbed, with reduced antigen content, inj. 0.5 ml (dtap) for children at 14 years of age – for mandatory booster vaccinations and for reserve. Part: 1

I. DEFINITION OF THE SUBJECT OF THE ORDER: 1. Combined vaccine against: diphtheria, tetanus, and pertussis (acellular, combined), adsorbed, with reduced antigen content, inj. 0.5 ml (dtap) for children at 14 years of age – for mandatory booster vaccinations and for reserve. Part 1: in the amount of 100,000 doses. 2. When selecting the most advantageous offer, the contracting authority reserves the right to reduce the purchase of medicinal products, but by no more than 20% of the total subject of the order (in each of the aforementioned parts) in case of: exceeding the amount allocated for the execution of the order or arising objective and justified needs, particularly changes in patient demand. 3. The order must be executed in accordance with the requirements specified in the SWZ and PPU. II. SUBJECT EVIDENCE: 2.1. Based on Art. 105 and Art. 106 of the Pzp Act, in order to confirm the compliance of the offered supplies with the requirements, characteristics, or criteria specified in the description of the subject of the order or the offer evaluation criteria or requirements related to the execution of the order, the Contracting Authority requests the Contractors to submit the following documents: A valid, current marketing authorization for the medicinal product in the Republic of Poland issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, or A valid, current marketing authorization for the medicinal product issued by the Council of the European Union or the European Commission, 2.2. Pursuant to Art. 107 (1) of the Pzp Act, the Contractor is obliged to submit the aforementioned subject evidence with the offer and should exercise all due diligence to ensure that these documents are complete and contain all necessary information enabling the Contracting Authority to verify their correctness. 2.3. The marketing authorization for the medicinal product must be valid on the day of submitting the offers. 2.4. The composition of the preparation and packaging must comply with the content of the documents referred to in point 2.1. 2.5. In the event that the validity of the document expires, the Contractor is obliged to provide the Contracting Authority, along with the documents referred to in point 2.1., with an additional document declaring the timely submission of an application for extension of the marketing authorization for the medicinal product or, if obtained, a valid marketing authorization for the medicinal product. 2.6. The Contractor is obliged to inform the Contracting Authority about the transfer of rights and obligations of the responsible entity resulting from the marketing authorization for the medicinal product to another entity. 2.7. The aforementioned documents must have an expiry date covering the entire period of order execution. 2.8. The documents referred to above are submitted in the manner provided for in the regulations issued pursuant to Art. 70 of the Pzp Act, i.e., in the Regulation of the President of the Council of Ministers of December 30, 2020, on the method of preparing and transmitting information and technical requirements for electronic documents and electronic communication methods in public procurement proceedings or competitions. 2.9. Pursuant to Art. 107 (2) of the Pzp Act, the Contracting Authority provides for the possibility of supplementing the aforementioned subject evidence once within the deadline set by the Contracting Authority. 2.10. Documents prepared in a foreign language must be submitted with a Polish translation.