General Terms & Conditions

1.1 These general conditions of sale (the "General Conditions") apply to the sale and supply of products (the "Products") by ISE S.r.l. ("ISE") to the customer (the "Purchaser"). ISE and the Purchaser are jointly referred to as the "Parties" and each of them as a "Party".1.2 Unless otherwise agreed in writing, by entering into any sale or supply agreement with ISE, the Purchaser accepts these General Conditions.1.3 The order sent by the Purchaser and accepted by ISE (the "Order"), any special conditions agreed in writing by the Parties (the "Special Conditions") and these General Conditions constitute the entire agreement between the Parties (the "Agreement").1.4 In case of discrepancy or conflict, the Order prevails over the Special Conditions and the General Conditions, and the Special Conditions prevail over the General Conditions.

2.1 The Agreement is entered into upon ISE's acceptance of the Order or upon ISE's performance of the Order, whichever occurs first.2.2 Unless otherwise set out in the Agreement, any Order that ISE has not accepted within 15 (fifteen) days of receipt is deemed rejected. ISE is not bound to accept any Order.2.3 Offers or quotations made by ISE (the "Offers") that the Purchaser has not accepted within 15 (fifteen) days of receipt, or within the term stated in the Offer, are null and void.2.4 Offers made by agents and/or representatives of ISE are not binding on ISE until accepted by ISE.2.5 The delivery or publication of these General Conditions by ISE is not a contractual offer and does not imply acceptance of any offer or order made by the Purchaser. These General Conditions supersede and replace any general conditions previously proposed by either Party.2.6 Where an export or import licence, a foreign exchange control authorisation or a similar authorisation is required for the performance of the Agreement, the Party responsible for obtaining it shall act with due diligence to obtain it in due course. If the required licence or authorisation cannot be obtained within 3 (three) months, either Party may terminate the Agreement by written notice to the other Party, without any duty to indemnify the other Party (only restitution obligations apply).

3.1 Weights, dimensions, capacities, prices, performance ratings and other data included in catalogues, advertisements, manuals, price lists or other documents, or appearing on ISE's website or any other website, are not binding unless expressly included in the Agreement by reference.3.2 ISE provides the Purchaser, free of charge, with the instruction manuals for the use and maintenance of the Products.3.3 All pre-shipment inspection, audit and verification costs charged by the inspecting body or third party, and all costs related to the legalisation of documents, are borne by the Purchaser.

4.1 Unless otherwise expressly provided, all prices indicated in the Offers or in the Agreement, as well as in ISE's price lists and catalogues, are in Euro (EUR) and include the costs of packing required for air transport to prevent damage to or deterioration of the Products before they reach the destination stated in the Order. Prices do not include VAT, taxes, levies, duties, insurance or any other cost not expressly indicated as included.4.2 Any payment made by bank/wire transfer shall be without expenses for ISE.

5.1 Unless otherwise set out in the Agreement, ISE delivers the Products Ex Works (Incoterms 2020: EXW).5.2 Risk in the Products passes as indicated by Incoterms 2020. Notwithstanding the foregoing, title and ownership in the Products transfer to the Purchaser only upon full payment of any amount due to ISE in respect of such Products.

6.1 Unless otherwise expressly indicated, delivery terms are not binding.6.2 Delivery terms are calculated from the date of ISE's acceptance of the relevant Order or, where the Agreement provides for advance payment, from the date of payment by the Purchaser.6.3 If ISE fails to deliver the Products within a binding delivery term, the Purchaser may terminate the Agreement by written notice to ISE in respect of all undelivered Products and of delivered Products that cannot be properly used without the undelivered Products. In that case, the Purchaser is entitled, excluding any other remedy:•        to recover any payment made in respect of such Products;•        to reject the delivered Products that cannot be properly used.6.4 If the Purchaser fails to receive the Products at the place and time indicated in the Agreement for any reason other than an act or omission of ISE, the Purchaser shall make any payment provided in the Agreement as if the Products had been delivered. In such case, ISE may arrange for storage of the Products at the Purchaser's risk and cost, without prejudice to ISE's right to recover any costs incurred or damages suffered.6.5 Upon written request of the Purchaser, ISE may (but is not obliged to) agree to restock Products sold and/or delivered to the Purchaser. In case of restocking, ISE will charge the Purchaser 20% of the amount stated in the invoice and may also charge any additional costs for repairing, updating, etc. the restocked Products. The Purchaser shall pay such amounts within the payment terms originally specified in the Agreement.6.6 ISE ships reagents with a minimum shelf life of 10 (ten) months at the moment of shipping. Where the expiry is below 10 (ten) months, ISE will advise the Purchaser in advance, and the Purchaser shall accept or refuse such shelf life in writing/by e-mail in a timely manner.

7.1 Payment terms are indicated in the Agreement. In the absence of such indication, the Purchaser shall pay within 30 (thirty) days of ISE's notification that the Products have been dispatched.7.2 Any delay in payment entitles ISE:•        to suspend performance of the Agreement (including, without limitation, deliveries of any Products) until payment is made;•        to claim interest at the rate indicated by law (Italian Decree 231/2002, enacting Directive 2000/35/EC on combating late payment in commercial transactions) or at 18% (eighteen percent) per annum, whichever is higher; and•        to terminate the Agreement by written notice to the Purchaser if the delay in any payment exceeds 30 (thirty) days.7.3 Complaints made by the Purchaser or disputes between the Parties do not entitle the Purchaser to delay or suspend any payment.7.4 Where payments are made in instalments, failure to pay any instalment on time entitles ISE to claim immediate payment of the entire consideration.7.5 Payments made to ISE's agents and/or representatives are not deemed received by ISE until the relevant amounts have been credited to ISE.

8.1 If the Purchaser deems that the delivered Products do not conform to the Agreement, it shall notify ISE in writing within 5 (five) days of receipt. If the Purchaser does not notify ISE within this term, the Products are deemed accepted and may not be rejected, without prejudice to clause 9 (Warranty).8.2 The Purchaser cannot reject the Products for any defect, damage or non-conformity occurring after the passing of risk.8.3 Upon ISE's written request, the Purchaser shall return the rejected Products to ISE at ISE's risk and expense. In the absence of such request, the Purchaser shall not return the Products and, after 30 (thirty) days from their receipt, shall dispose of them at its own cost and expense.

9.1 ISE warrants the Products against defects in material or workmanship, when used with due care and in accordance with the operating procedures and manuals supplied by ISE and with the authorised reagents and consumables supplied by ISE, for a period of 12 (twelve) months from the invoice date (the "Warranty Period").9.2 During the Warranty Period, the Purchaser shall notify ISE in writing of any defect within 8 (eight) days of discovery. Upon such notice, ISE shall, at its option:•        have the defective Product or parts returned for repair; or•        replace the defective Product; or•        replace the defective parts to enable the Purchaser to carry out the necessary repairs.9.3 The Purchaser shall return the defective Product or part at its own cost. ISE will send the replacement part to the Purchaser at its own cost; where ISE can consolidate the replacement part in a planned shipment to the Purchaser, this shall prevail. After the Warranty Period, replacement Products or parts are delivered Ex Works (Incoterms 2020: EXW) by ISE.9.4 This warranty does not cover:•        consumable parts, such as lamps, cuvettes, plastic and glass parts, syringes, etc., as well as semiconductors, labour and/or labour costs in any form;•        Products modified without ISE's written consent and/or on which non-ISE-approved spare parts have been used;•        Products stored, handled, installed, used or operated without due care and/or in a manner inconsistent with ISE's operating instructions;•        damage occurring after the passing of risk;•        Products operated with reagents and/or consumables not supplied by ISE.9.5 Unauthorised use of an instrument, use for a purpose for which it is not intended, or operation, repair, maintenance, servicing, moving, replacement or cleaning by non-certified users, specialists or technicians or by unauthorised staff, may result in immediate termination of the instrument warranty. ISE provides application and service training, against a fee, at the ISE Training Centre in Guidonia, Italy.9.6 ISE shall not be liable for any consequential, indirect or incidental damages resulting from economic loss or property damage sustained by the Purchaser from wrongful use of the Products or otherwise, or from inaccurate test results when using the Products.9.7 Except in cases of wilful misconduct or gross negligence, ISE's liability arising under the Agreement in relation to each Product shall not exceed the purchase price of such Product.

10.1 Unless otherwise set out in the Agreement, any tacit renewal of the Agreement is excluded.10.2 Unless otherwise set out in the Agreement, where the term of the Agreement exceeds 30 (thirty) days, ISE may terminate the Agreement at any time by giving the Purchaser 15 (fifteen) days' prior written notice.

11.1 Either Party's temporary inability to fulfil its contractual obligations due to force majeure entails the suspension of the Agreement until the cause of such inability ceases to exist. For the purpose of this clause, "force majeure" includes any event beyond the Parties' control, such as events limiting or preventing normal manufacturing, delivery or distribution of the Products, including without limitation discontinuation of supplies by suppliers, difficulty in obtaining supplies, strikes, third-party activities, plant breakdown, onset of technical problems, and measures of state or local authorities.

12.1 The Purchaser acknowledges that ISE's name, trademark and logo, as well as the Products' names, trademarks and logos, are the sole and exclusive property of ISE. The Purchaser shall not use such names, trademarks and logos without ISE's prior written approval.

13.1 In accordance with the vigilance procedure described in Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), the Purchaser shall immediately inform ISE of any issue with a Product (e.g. where the Product causes an incident that could harm the user). ISE will immediately start the process to identify and resolve the issue as soon as possible, in accordance with its internal procedures.

14.1 Neither Party shall disclose to third parties confidential information concerning the other Party of which it became aware in the performance of the Agreement. The Purchaser shall not disclose to third parties any information concerning the Products.

15.1 In relation to activities related to the execution of the Agreement, the Parties shall comply, each within its own competence, with Italian Legislative Decree 196/2003, Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data (General Data Protection Regulation), any other applicable law or regulation, and the provisions of the Italian Data Protection Authority applicable to the activities covered by the Agreement.

16.1 Recitals and schedules form an integral and essential part of the Agreement. Any reference to price lists, to these General Conditions or to any other ISE material is deemed made to the documents in force at the time the reference is made, unless otherwise specified; texts previously in force between the Parties are deemed superseded. ISE may amend its price lists, General Conditions and other material without prior notice. All terms are in calendar days/months unless otherwise expressly provided.

17.1 The Agreement is governed by the laws of Italy, excluding the Vienna Convention of 11 April 1980 on Contracts for the International Sale of Goods.17.2 Any dispute arising out of or in connection with the Agreement shall be submitted to the exclusive jurisdiction of the Court of Milan (Italy). Pursuant to Articles 1341 and 1342 of the Italian Civil Code, the Purchaser expressly accepts clauses 2.6, 7.2, 7.3, 8.1, 8.2, 9, 10, 11 and 17.2.