Poland – Medical equipments – Dostawa aparatury medycznej oraz części zużywalnych do badania klinicznego

The subject of the procedure is the supply of medical equipment and consumable parts for a clinical trial. The project is financed from the state budget by the Medical Research Agency, Project Number 2025/ABM/01/00044 "Non-commercial, randomized, controlled Phase III head-to-head clinical trial evaluating the effectiveness and safety of tirzepatide and/or intensive insulin therapy in a continuous subcutaneous insulin infusion model using an automatic, advanced hybrid closed-loop system in patients with chronic, poorly controlled type 1 diabetes and coexisting overweight or obesity and accompanying neuropsychiatric disorders." The parties, in accordance with Article 455(1)(1) of the Public Procurement Act, establish that the contract may be changed according to the rules and conditions set out below: 1) a change in the VAT rate and/or excise duty rate has occurred - for the parties, the VAT rate applicable on the date of invoice issuance will be binding, and the change in the gross price amount for this reason is accepted by the parties without the need to submit additional statements; 2) in the case of a change in the product name, catalogue number – with the product and producer remaining unchanged (the change may only affect the name given by the producer); 3) in the case of a change in the packaging method – the quantity will be recalculated to the appropriate number of packages or the number of items in the package and the unit price will be proportionally recalculated for the new package size; 4) in the event of a medical incident – the possibility of introducing an equivalent product, with no lower quality and functional parameters and no higher price than the price of the product to which the incident relates; 5) a shortage of products on the market due to reasons independent of the Supplier (e.g. cessation of production, withdrawal from circulation or shortage on the market) – there is the possibility of replacing with an equivalent product, but at a price no higher than the price of the withdrawn or missing product or termination of the contract without the application of the penalty referred to in paragraph 3; 6) the parties may extend this contract, but not for more than a period of 4 months, in the event of: a) failure to exhaust the quantity of the assortment covered by the contract within the term of its validity - until the quantity of the subject of the contract is exhausted, b) increase in the value of the contract in the manner of Article 455(2) of the Public Procurement Act; 7) in the case of a change in the amount of the minimum remuneration for work or the minimum hourly rate, set on the basis of the Act on the minimum remuneration for work and/or in the case of a change in the rules of contribution to social insurance or health insurance or the rate of contribution to social or health insurance and/or in the case of a change in the rules of accumulation and the amount of contributions to employee capital plans (specified in separate regulations) - the contract may be changed no earlier than after the expiry of 12 months from the date of conclusion of the contract, and each of the parties may approach the other party to conduct negotiations on the appropriate change in remuneration – provided that the aforementioned changes listed above affect the costs of the Supplier's performance of the contract conditions.