The subject of the contract is the purchase of coagulation factor VIII concentrate (plasma-derived or recombinant) together with an administration kit, in accordance with the description of the subject matter of the contract specified in the Terms of Reference and under the conditions set out in the Draft Provisions of the Agreement (PPU), which constitute an appendix to the Terms of Reference.

The purchase is carried out as part of the health policy program of the Minister of Health entitled "National Program for the Treatment of Patients with Haemophilia and Related Haemorrhagic Disorders for the years 2024-2028".

I. Determination of the object of the order:

1. The subject of the contract is the purchase of coagulation factor VIII concentrate (plasma-derived or recombinant)

2. Total quantity (purchase quantity): 20,000,000 IU

3. Dose ratios: according to SWZ.

4. The coagulation factor concentrate must be supplied with an administration kit.

5. In accordance with Article 257 of the Pzp Act. The Contracting Authority may invalidate the procurement procedure if the public funds which the Contracting Authority intended to allocate to the financing of all or part of the contract have not been granted to it.

6. The Contracting Authority reserves the possibility of reducing the purchase of a medicinal product, but not more than 20% of the total object of the order, in the event of exceeding the amount spent on the execution of the order, or objective and legitimate needs arise, in particular the modification demand among patients.

7. The order must be executed in accordance with the requirements of the description of the subject of the contract set out in the Specification of the Order Terms and Conditions (SWZ) and under the conditions set out in the Designed Agreement Provisions (PPU), which are annexed to the SWZ.

II. Measures of evidence in question:

1. Pursuant to Article 105 and Article 106 of the Pzp. Act, in order to confirm the conformity of the supply offered with the requirements, characteristics or criteria specified in the description of the subject of the contract or the criteria for the evaluation of tenders or the requirements related to the execution of the contract, the Contracting Authority shall request from the Contractors submission of the following documents:

• A valid marketing authorization for a 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 marketing authorisation of a medicinal product issued by the Council of the European Union or the European Commission.

2. In accordance with Article 107 (1) of the Pzp Act, the Contractor is obliged to submit the abovementioned evidence measures in question together with the offer and should exercise every diligence to ensure that these documents are complete and contain all the necessary information enabling the Contracting Authority to them verification for correctness.

3. The marketing authorisation of the medicinal product must be valid and up-to-date at the date of submission of tenders.

4. The composition of the preparation and packaging must be in accordance with the contents of the documents referred to in point 1.

5. Where the validity of the document expires, the Contractor shall be obliged to transmit to the Contracting Authority, together with the documents referred to in point 1, an additional document declaring the submission of an application in due time for renewal of the marketing authorisation of the medicinal product or in a timely manner when it is obtained, a valid marketing authorisation of the medicinal product.

6. The Contractor shall be obliged to inform the Contracting Authority of the transfer to another entity of the rights and obligations of the responsible entity arising from the marketing authorisation of the medicinal product.

7. The documents must have an expiry date covering the entire period of execution of the contract.

8. The documents referred to above are submitted as provided for in the provisions issued pursuant to Article 70 of the Law Pzp., i.e. in the Regulation of the President of the Council of Ministers of 30 December 2020 on the method of preparation and transmission of information and technical requirements for documents electronic communications and means of electronic communication in the procedure for the award of a public contract or competition.

9. According to Article 107 (2) of the Law Pzp. The Contracting Authority provides for the possibility of supplementing the above-mentioned evidence measures within the time limit set by the Contracting Authority.

10. Documents drawn up in a foreign language are submitted together with translation into Polish.

I. Determination of the object of the order:

1. The subject of the contract is the purchase of coagulation factor VIII concentrate (plasma-derived or recombinant)

2. Total number (volume of purchase): 40,000,000 IU

3. Dose ratios: according to SWZ.

4. The coagulation factor concentrate must be supplied with an administration kit.

5. In accordance with Article 257 of the Pzp Act. The Contracting Authority may invalidate the procurement procedure if the public funds which the Contracting Authority intended to allocate to the financing of all or part of the contract have not been granted to it.

6. The Contracting Authority reserves the possibility of reducing the purchase of a medicinal product, but not more than 20% of the total object of the order, in the event of exceeding the amount spent on the execution of the order, or objective and legitimate needs arise, in particular the modification demand among patients.

7. The order must be executed in accordance with the requirements of the description of the subject of the contract set out in the Specification of the Order Terms and Conditions (SWZ) and under the conditions set out in the Designed Agreement Provisions (PPU), which are annexed to the SWZ.

II. Measures of evidence in question:

1. Pursuant to Article 105 and Article 106 of the Pzp. Act, in order to confirm the conformity of the supply offered with the requirements, characteristics or criteria specified in the description of the subject of the contract or the criteria for the evaluation of tenders or the requirements related to the execution of the contract, the Contracting Authority shall request from the Contractors submission of the following documents:

• A valid marketing authorization for a 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 marketing authorisation of a medicinal product issued by the Council of the European Union or the European Commission.

2. In accordance with Article 107 (1) of the Pzp Act, the Contractor is obliged to submit the abovementioned evidence measures in question together with the offer and should exercise every diligence to ensure that these documents are complete and contain all the necessary information enabling the Contracting Authority to them verification for correctness.

3. The marketing authorisation of the medicinal product must be valid and up-to-date at the date of submission of tenders.

4. The composition of the preparation and packaging must be in accordance with the contents of the documents referred to in point 1.

5. Where the validity of the document expires, the Contractor shall be obliged to transmit to the Contracting Authority, together with the documents referred to in point 1, an additional document declaring the submission of an application in due time for renewal of the marketing authorisation of the medicinal product or in a timely manner when it is obtained, a valid marketing authorisation of the medicinal product.

6. The Contractor shall be obliged to inform the Contracting Authority of the transfer to another entity of the rights and obligations of the responsible entity arising from the marketing authorisation of the medicinal product.

7. The documents must have an expiry date covering the entire period of execution of the contract.

8. The documents referred to above are submitted as provided for in the provisions issued pursuant to Article 70 of the Law Pzp., i.e. in the Regulation of the President of the Council of Ministers of 30 December 2020 on the method of preparation and transmission of information and technical requirements for documents electronic communications and means of electronic communication in the procedure for the award of a public contract or competition.

9. According to Article 107 (2) of the Law Pzp. The Contracting Authority provides for the possibility of supplementing the above-mentioned evidence measures within the time limit set by the Contracting Authority.

10. Documents drawn up in a foreign language are submitted together with translation into Polish.

I. Determination of the object of the order:

1. The subject of the contract is the purchase of coagulation factor VIII concentrate (plasma-derived or recombinant)

2. Total number (volume of purchase): 40,000,000 IU

3. Dose ratios: according to SWZ.

4. The coagulation factor concentrate must be supplied with an administration kit.

5. In accordance with Article 257 of the Pzp Act. The Contracting Authority may invalidate the procurement procedure if the public funds which the Contracting Authority intended to allocate to the financing of all or part of the contract have not been granted to it.

6. The Contracting Authority reserves the possibility of reducing the purchase of a medicinal product, but not more than 20% of the total object of the order, in the event of exceeding the amount spent on the execution of the order, or objective and legitimate needs arise, in particular the modification demand among patients.

7. The order must be executed in accordance with the requirements of the description of the subject of the contract set out in the Specification of the Order Terms and Conditions (SWZ) and under the conditions set out in the Designed Agreement Provisions (PPU), which are annexed to the SWZ.

II. Measures of evidence in question:

1. Pursuant to Article 105 and Article 106 of the Pzp. Act, in order to confirm the conformity of the supply offered with the requirements, characteristics or criteria specified in the description of the subject of the contract or the criteria for the evaluation of tenders or the requirements related to the execution of the contract, the Contracting Authority shall request from the Contractors submission of the following documents:

• A valid marketing authorization for a 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 marketing authorisation of a medicinal product issued by the Council of the European Union or the European Commission.

2. In accordance with Article 107 (1) of the Pzp Act, the Contractor is obliged to submit the abovementioned evidence measures in question together with the offer and should exercise every diligence to ensure that these documents are complete and contain all the necessary information enabling the Contracting Authority to them verification for correctness.

3. The marketing authorisation of the medicinal product must be valid and up-to-date at the date of submission of tenders.

4. The composition of the preparation and packaging must be in accordance with the contents of the documents referred to in point 1.

5. Where the validity of the document expires, the Contractor shall be obliged to transmit to the Contracting Authority, together with the documents referred to in point 1, an additional document declaring the submission of an application in due time for renewal of the marketing authorisation of the medicinal product or in a timely manner when it is obtained, a valid marketing authorisation of the medicinal product.

6. The Contractor shall be obliged to inform the Contracting Authority of the transfer to another entity of the rights and obligations of the responsible entity arising from the marketing authorisation of the medicinal product.

7. The documents must have an expiry date covering the entire period of execution of the contract.

8. The documents referred to above are submitted as provided for in the provisions issued pursuant to Article 70 of the Law Pzp., i.e. in the Regulation of the President of the Council of Ministers of 30 December 2020 on the method of preparation and transmission of information and technical requirements for documents electronic communications and means of electronic communication in the procedure for the award of a public contract or competition.

9. According to Article 107 (2) of the Law Pzp. The Contracting Authority provides for the possibility of supplementing the above-mentioned evidence measures within the time limit set by the Contracting Authority.

10. Documents drawn up in a foreign language are submitted together with translation into Polish.