Purchase and successive delivery of oncological drug : Osimertinibum and immunoglobulins under the drug program together with the lease of pumps and other devices (if required).

… with the Pharmaceutical Law Act of 6 September 2001 (Journal of Laws No. of Laws 2026, item 612, as amended). The contracting authority shall not allow medicinal products authorised pursuant to Article 4(1)(b) CTMR to be offered. 1 and 2 of the Pharmaceutical Law Act of 6 September 2001 (Journal of Laws 2026, item 612, as amended). 3.3. in Parts 1 and 2 - to the extent that the subject of the contract are medical devices (devices necessary for the administration of a medicinal product / infusion kit) - were medical devices in accordance with the Act of 7 April 2022 on medical devices (Journal of Laws No. Journal of Laws 2024, item 1620, as amended) and meet the requirements laid down in this Act and in the applicable provisions of European Union law, in particular as regards placing on the market and putting into service, classification, conformity assessment, packaging and marking. The Ordering Party reserves the right to require the Contractor, at any stage of the procedure, to present documents confirming compliance with the requirements set out in points 3.2 and 3.3 of ,, in particular documents confirming the admission of the offered medicinal products to the market in the territory of the Republic of Poland and documents confirming the compliance of the offered medical devices with the requirements of applicable law. 3.4. in the case of medicinal products subject to reimbursement – meet the requirements set out in the Act of 12 May 2011 on the reimbursement of medicines, foodstuffs intended for particular nutritional uses and medical devices (Journal of Laws No. of Laws 2026, item 253, as amended), to the extent applicable to the subject-matter of the contract. Note to point 3.4: If it is found that the chemical substance in the dose and form indicated in the tender specification is included in the current Notice of the Minister for Health on the list of reimbursed medicines, foodstuffs intended for particular nutritional uses and medical devices - Annex B and/or C, and the medicinal product offered is not indicated there, the tender will be rejected. The offer will also be rejected if the price of the offered medicinal product is higher than the official price indicated in the current announcement of the Minister of Health on the list of reimbursed medicines, foodstuffs for particular nutritional uses and medical devices, if the official price applies to the given medicinal product. 4 . The scope of the contract includes the delivery of the items of the order in the quantities specified in the Price and Offer Forms for the period of: - for Parts 1 to 5, 12 months from the date of conclusion of the contract. 5. DATE OF COMPLETION OF THE CONTRACT: 5.1 The subject of the order within the scope of Parts No. 1 to No. 5 will be carried out in the form of successive deliveries for a period of 12 months from the date of conclusion of the contract. 5.2 If, during the term of the contract, the subject of the order is not fully realized in relation to Lots No. 1 to No. 5, the Ordering Party reserves the right to extend the term of the contract. The change of the term of the contract will take place by means of a written annex signed by the Parties. The Ordering Party will inform Wyk