Recombinant human insulin-like growth factor-1 (mecasermin) for administration in generally available small-capacity, high-precision syringes: - vial/ampoule with a capacity of < 50 mg

1. The total basic order quantity is: 136,810 mg. 2. The contracting authority reserves the right to increase the quantity of the subject of the order, but by no more than 15% of the basic order, in the amount of 20,250 mg. 3. The contracting authority anticipates a change in the quantity of the subject of the order during the contract period, i.e., the possibility of reducing the ordered volume is allowed - by 20% of the basic order quantity, in case of objective and justified needs, particularly changes in demand among patients - this change depends on the internal needs of direct recipients that may arise during the execution of the order and is left solely to its discretion. The contractor, by submitting an offer, acknowledges the possibility of various circumstances affecting changes in demand. 4. The offered drug is registered and reimbursed for the treatment of short-statured patients with severe primary IGF-1 deficiency with recombinant IGF-1. 5. The offered preparation must meet the conditions for use in the aforementioned indication in patients covered by drug program B.20, "Treatment of short-statured children with severe primary insulin-like growth factor 1 deficiency" with recombinant human insulin-like growth factor-1. 6. Pursuant to art. 255 point 3 of the Pzp Act, the Contracting Authority may annul the public procurement procedure if the price or cost of the most advantageous offer or the offer with the lowest price for the basic order exceeds the amount that the Contracting Authority intends to allocate for financing the order. 7. Pursuant to art. 256 of the Pzp Act, the Contracting Authority may annul the procurement procedure before the deadline for submitting offers if circumstances arise that make further proceedings unjustified. 8. Pursuant to art. 257 of the Pzp Act. The Contracting Authority anticipates the possibility of annulling the public procurement procedure if the funds intended for financing all or part of the order have not been granted to it. 9. The order must be executed in accordance with the requirements specified in the SWZ and the Draft Contract Provisions. The detailed description of the subject of the order is specified in the Specification of the Order Conditions (SWZ). Relevant evidence: Pursuant to 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 criteria for evaluating offers or requirements related to the execution of the order, the Contracting Authority requests the Contractors to submit the following documents: • A valid 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 marketing authorization for the medicinal product issued by the Council of the European Union or the European Commission. 2.2. In case of failure to attach the relevant evidence referred to in point 2.1. to the offer, the Contracting Authority, pursuant to art. 107 para. 2 of the Pzp Act, anticipates the possibility of a single supplementation of the aforementioned relevant evidence within the deadline set by the Contracting Authority. 2.3. The marketing authorization for the medicinal product must be valid and current on the date of offer submission. 2.4. The composition of the preparation and packaging must be consistent 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, in case of its obtaining, 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 to another entity, which...