1. PREMISES
a) “Purchaser” means any business, public or privately owned company, or person, who purchases any type of Product from Infra Srl (the Seller)
b) “Orders” means the orders placed by the Purchaser and accepted by the Seller that are subject to these General Conditions
c) “Products” refers to all items sold by the Seller
2. PURPOSE AND SCOPE OF THE GENERAL CONDITIONS OF SALE
2.1 Unless otherwise agreed in writing, with a specific contract, all orders, offers, quotations and the consequent purchase and sale agreements entered into between the Seller and the Purchaser are governed by these general terms and conditions of sale and replace and exclude any terms or condition proposed, entered into or communicated to the Purchaser.
2.2 The previous point 2.1 may be waived only when there are specific changes or regulations governing the sale of Products to government agencies or other public bodies or if there are binding statutory provisions at a local level.
2.3 The Order is considered confirmed only after the Seller has provided written confirmation or, in the absence of said written confirmation, the Order is considered accepted at the time of shipment of the Products by the Seller.
2.4 In the event that Infra Srl sends the Purchaser a supply offer by means of a proforma invoice or other equivalent document, the conditions and terms of supply indicated therein must be considered an integration of these General Terms and Conditions of Sale. In the event of a discrepancy, the provisions of the supply offer take precedence over the provisions of the General Terms and Conditions of Sale.
2.5 In the case of continuous supplies, over time, any changes or communications during the course of the supply do not constitute novation of the contract
3. PRODUCTS AND DELIVERY
3.1 The descriptions, specifications and illustrations in catalogues, price lists, advertising publications and on the Seller’s website or otherwise forwarded to the Purchaser, are only intended to provide a general idea of the Products described and are not to be considered as contractually binding.
3.2 The Products may be modified at the sole discretion of the Seller, if necessary in order to comply with statutory obligations or with European requirements or at the request of the Purchaser as long as, at the sole discretion of the Seller, such modifications will not materially affect the quality or performance of the Products.
3.3 Delivery terms are indicative and not binding for the purposes of the contract. The Seller is therefore not liable for any direct and/or indirect damages due to delay in delivery caused by the Purchaser, by third parties or force majeure. This clause also applies in the case of partial or split deliveries or continuous supplies.
4. PRICE AND PAYMENT
4.1 Unless otherwise specified, all prices quoted are exclusive of VAT and any other applicable taxes or charges. They are also exclusive of packing, transport or insurance costs. In order to avoid any doubt, the Seller reserves the right to charge the Purchaser for any additional costs that the Seller may incur
as a result a request from a Purchaser for a special shipment or for a particular type of packaging.
4.2 “Prices” means the prices quoted by the Seller or, in the absence of a quotation (or if the quoted prices have become invalid), the prices included in the Seller’s price list on the date of acceptance of the Order and anyway indicated in commercial documents (invoice, order confirmation, proforma invoice etc.).
4.3 Unless otherwise agreed between the parties, payment for the goods must be made by the Purchaser, within the deadline and in the manner indicated in the supply offer, where present, or by advance payment or by letter of credit confirmed by a leading European bank.
4.4 Payment is due in full even in the event of late delivery, and even if the Products are made available by the Seller to the Purchaser at his/her factory or any other agreed place and are not collected by the Purchaser.
4.5 In the event of late payment, the Purchaser is required to pay the Seller default interest according to the provisions of the law, in particular to the provisions of Italian Legislative Decree n. 231 of 9 October 2002 and subsequent amendments, which will take effect from the day following the deadline, without the Seller having to provide prior formal notice to the Purchaser.
4.6 This is without prejudice to the provisions of articles 1453 (termination for breach of contract), 1455 (severity of the non-performance), 1461 (change in the financial conditions of the contracting parties) and art. 1467 (termination on the grounds of excessive costs) of the Italian Civil Code
4.7 In any case of force majeure that totally or partially prevents the Seller from carrying out contractual obligations or from meeting the agreed conditions, the Seller will be entitled to choose between terminating the contract or accepting the Purchaser’s offer of different terms and methods of performance.
4.8 The parties agree that the contract is automatically terminated in the event of even partial breach of contract or late payment by the Purchaser, the ownership of the Products involved in the transaction is not transferred and the Seller regains possession of them as soon as possible, retaining what has already been received as compensation, without prejudice to compensation for the greater damage suffered.
4.9 The Purchaser does not have the right to withhold or postpone the payment of any sums due to the Seller as an advance for a dispute, claim or as compensation that may be requested to the Seller.
5. PRODUCT CONFORMITY
5.1 The Seller guarantees that the Products are manufactured in accordance with the strictest European Regulations in force and that in compliance with them, the production process is subject to regular inspections. At the time of delivery, the Products made are therefore free from defects in materials and workmanship and are perfectly suitable for the purposes and indications described in the specific instructions.
5.2 in the absence of alternative agreements or of mandatory regulations established for purchases, in the form of a tender or otherwise, from government agencies or other public bodies, any non-conformities that are immediately apparent, or defects in terms of quantity or type of product, must be notified in writing and comprehensively documented within 8 days of receipt of the Products.
5.3 The purchaser’s failure to submit a claim constitutes the unconditional acceptance of the products and the waiver by the Purchaser to make any further claims in relation to them. It will also be taken as confirmation that the Purchaser has examined the products and has determined that they are compliant and suitable for use. Any guarantee will anyway expire on the expiry date of the Products.
5.4 Products subject to dispute must be kept at the disposal of the Seller and may be returned to the Seller only with the prior written authorisation of the latter, within 7 (seven) days from the date of receipt of said authorisation. Modified, non-sterile, opened, damaged or deteriorated Products cannot be returned. All returned products must have the original packing slip and the reason for their return must be indicated.
5.5 In the event that the complaint is justified, it is at the sole discretion of the Seller as to whether to replace the Products or refund the purchase price after the return of the Products.
5.6 The Seller’s liability, with regard to claims relating to loss, damage or expenses of any kind in relation to the Products, may not in any case exceed a total purchase price of the Products in question. Under no circumstances shall the Seller be liable for any indirect damage caused to the Seller and/or to third parties.
5.7 Hidden defects or malfunctions that occur subsequently must be treated according to the specific indications provided by the Medical Device Regulation (MDR) 2017/745.
5.8 Any alteration due to improper handling, storage and use relieves the Seller of any liability. Likewise, any modifications made to the Product by the Seller or by third parties relieve the Seller of any liability. Correct use is defined exclusively as what is written in the Instructions for Use, provided by the Seller.
5.9 Any complaints regarding a single delivery of Products do not release the Purchaser from the obligation to receive any subsequent contractually agreed deliveries.
6. PRODUCT STORAGE AND MANAGEMENT
6.1 The premises in which the products are stored and handled must:
a) be suitably designed and have sufficient space for storage, cleaning, maintenance and other necessary operations;
b) provide sufficient protection against factors that could affect the quality of the Products e.g. lighting, temperature, humidity, airborne particles, microbial contamination;
c) ensure there are areas separate from the Products suitable for carrying out operations that could produce impurities and contamination.
6.2 The purchaser should have the following systems in place:
a) preventive and regular sanitization of rooms and de-infestation treatments, including the positioning and control of baits and their regular replacement and/or the use of targeted insecticides. This treatment must be carried out to prevent contamination of the products;
b) an effective stock rotation model; a “first in/first out” system is recommended, especially for sterile Products and for all Products for that have an expiry date.
7. TRACEABILITY AND COMPLIANCE WITH REGULATIONS
7.1 As a manufacturer of Medical Devices, the Seller must comply with the traceability requirements of the Products mentioned in Directive 93/42/EC, as amended by Directive 47/2007/EC.
7.2 The Purchaser must ensure the traceability of the Products purchased through suitable documentary records, using the same criterion adopted by the manufacturer (batch and/or serial number registration). These records must be kept for a minimum of 5 years.
7.3 In the event of an inspection by the competent authorities or the need to recall a Product, the Purchaser must make the above-mentioned traceability records immediately available to the Seller.
7.4 The Purchaser must notify the Seller immediately of any recalls due to non-compliance, accident or malfunction of the Product he has become aware of directly, or has been notified of by a user. In particular, if either a situation of immediate risk or an accident occurs pursuant to art. 9 of the Italian Legislative Decree no. 46/1997 and subsequent amendments, the Purchaser must immediately notify the Seller, in accordance with the law and provide him/her with all the necessary documentation and support, in accordance with the provisions of the relevant legislation, for the purpose of communication to the national authorities responsible for health protection.
7.5 The Purchaser undertakes to comply with all the rules and regulations of the country in which he/she is based, as well as any other applicable jurisdiction relating to the marketing, distribution, supply, sale, labelling and installation of the Products in each country and/or territory in which he carries out activities with the Products supplied by the Seller
7.6 The Purchaser must not modify the Product purchased from the Seller in any way, including the label, the packaging and the instructions for use, not even in the event of resale or transfer of the Product or for any other reason.
7.7 The Purchaser undertakes to comply with anti-corruption legislation in the country in which he/she has his/her residence or domicile and in particular:
a) undertakes not to make payments or offer anything of value, either directly or indirectly, to government officials or government agencies for the purpose of influencing the actions and decisions taken by said individuals or for the purpose of inducing officials to use their influence to obtain or retain business and to obtain favourable treatment or any other special concession.
b) declares to have never used funds to make illicit contributions, in any form, related to political activities and/or to have never made payments to officials, government employees, or political parties.
8. INTELLECTUAL PROPERTY RIGHTS
8.1 The Purchaser acknowledges that the Seller has full ownership of the Trademarks and
of the Industrial and Intellectual Property rights relating to any Product or materials in written form or reproduced on other media and undertakes without reserve to provide the Seller with all assistance necessary in any matters relating to the protection of the aforementioned intellectual property and to promptly report any infringement, counterfeiting or illegal use of Trademarks and intellectual property rights.
8.2 The specifications, plans, drawings, process information, models, designs, formulas and processes created, calculated and designed by the Seller in order to meet the requirements and comply with the specific and customized instructions of the Buyer in relation to the supply of the Products, do not authorise the Purchaser to make any registration or claim ownership in his/her own name. The parties agree that intellectual property in all its forms remains the exclusive property of the Seller and this implies confidential treatment of the information by the Purchaser, which must be maintained indefinitely over time.
9. DISPUTE RESOLUTION AND JURISDICTION
9.1 All supply contracts governed by these general terms and conditions of sale are governed by Italian law.
9.2 For disputes concerning the performance, interpretation, validity, resolution and termination of supply contracts between the parties in which the action is brought by the Purchaser, the Court of Reggio Emilia has exclusive jurisdiction. Were instead the action is brought by Infra Srl, in addition to the Court of Reggio Emilia, any other Court of law, including the Court in the place where the Purchaser has its place of business, has jurisdiction.