Terms and Conditions

1. Interpretation

1.1. Definitions. In these Conditions, the following definitions apply:

Contract: the contract between MADx and the Customer for the sale and purchase of the Products in accordance with these Conditions.

Conditions: these terms and conditions as amended from time to time in accordance with clause 10.2.

Customer: any person who purchases Products from MADx.

DAP: Delivered at Place pursuant to the Incoterms 2020 published by the International Chamber of Commerce.

GDPR: The UK General Data Protection Regulation and the EU General Data Protection Regulation (Regulation (EU) 2016/679), as applicable.

Intellectual Property Rights: patents, rights to inventions, copyright and related rights, trade marks, business names and domain names, rights in get-up, goodwill and the right to sue for passing off, rights in designs, database rights, rights to use, and protect the confidentiality of, confidential information (including know-how), and all other intellectual property rights, in each case whether registered or unregistered and including all applications and rights to apply for and be granted, renewals or extensions of, and rights to claim priority from, such rights and all similar or equivalent rights or forms of protection which subsist or will subsist now or in the future in any part of the world.

MADx: MacroArray Diagnostics UK Ltd, a private limited company incorporated under the laws of England and Wales (Reg. No. 16937521) having a registered place of business at 71 Queen Victoria Street, London, United Kingdom, EC4V 4BE.

MADx Group: (1) MADx, any subsidiaries, its holding company (MADx GmbH) and (2) any entity over which from time to time any of the entities defined in part (1) of this definition either directly or indirectly exercises management control.

MADx GmbH: MacroArray Diagnostics GmbH, a company incorporated under the laws of Austria, having a registered place of business at Lemböckgasse 59, 1230 Vienna, Austria.

Order: the Customer’s order for Products as notified to MADx (in a form reasonably acceptable).

Products: The tests and devices provided by MADx as set out in the Order.

1.2. Construction. In these Conditions, the following rules apply:

(a) a person includes a natural person, corporate or unincorporated body (whether or not having separate legal personality);

(b) a reference to a party includes its personal representatives, successors or permitted assigns;

(c) a reference to a statute or statutory provision is a reference to such statute or statutory provision as amended or re-enacted. A reference to a statute or statutory provision includes any subordinate legislation made under that statute or statutory provision, as amended or re-enacted;

(d) any phrase introduced by the terms including, include, in particular or any similar expression, shall be construed as illustrative and shall not limit the sense of the words preceding those terms; and

(e) a reference to writing or written includes e-mail.

2. General

2.1. These Conditions shall apply to the sale and global supply of Products by MADx.

2.2. Contracts for the purchase of MADx Products shall be brought about by the Customer’s acceptance of a quotation furnished by MADx. Quotations shall be furnished to the Customer in writing. The quotation may be accepted by the Customer in writing, at which point the Contract shall come into existence. The Customer is responsible for ensuring that the terms of the Order are complete and accurate. Unilateral Orders furnished (in whatever manner) to MADx shall be dealt with as enquiries (invitations to treat) only and shall not trigger any obligations on the part of MADx.

2.3. Notwithstanding clause 2.2., Contracts with an already existing Customer for Products, which the Customer has already purchased at least once, can be concluded without a separate quotation from MADx. In this case, unilateral Orders by the Customer represent an offer by the Customer to conclude a Contract under the Conditions of the Contract for the same Products that preceded the Order. The Contract is concluded by the transmission of the Order confirmation by MADx. With regard to Products that the existing Customer has not yet purchased, the Order is treated as an enquiry of the Customer (see clause 2.2.).

2.4. The Products shall be intended solely for the use in the Customer’s health care facilities. Where a Product carries a use-by date the Customer shall not use or pass on to a third party such Product after its use-by date. The Customer shall, as a rule, not be permitted to pass on for free or for a consideration any Products bought from MADx (for exceptions see clause 8 below).

2.5. General terms and conditions as well as provisions of the Customer in other documents that regulate the liability of the contractual parties shall not be part of the Contracts concluded between MADx and the Customer.

3. Delivery

3.1. The Products shall be delivered DAP pursuant to the Incoterms 2020 except as otherwise provided in these Conditions. Delivery is completed on the completion of unloading the Products at the location set out in the Order or such other location as the parties may agree, within a reasonable time of its acceptance of any Order.

3.2. The cost of delivery shall be charged to and paid by the Customer at cost.

3.3. The Products may be delivered and invoiced as partial deliveries. Any delays in delivery or defect in a partial delivery shall not entitle the Customer to cancel any other partial delivery.

3.4. MADx shall use its best efforts to comply with the anticipated dates of dispatch which are approximate only. Except as expressly agreed otherwise, such periods and dates shall not be of the essence, are non-binding and shall be understood to mean the expected date and time of delivery and handing-over to the carrier. The Customer may rescind the Contract if the date of dispatch is exceeded by at least one week and a reasonable respite of at least four weeks is set. Respite and rescission shall require a notification by registered letter. The right to rescind the contract shall apply only to such part of the shipment which is at fault. Possible delays in delivery after dispatch by MADx shall not entitle the Customer to rescind the contract.

3.5. MADx shall not be liable for any delay in the delivery of the Products that is caused by a Force Majeure Event (as defined in clause 11).

3.6. In the event that MADx rescinds the contract due to the Customer’s default in accepting the shipment the Customer shall pay a penalty of 50% (fifty percent) of the pre-tax invoiced amount.

4. Payment

4.1. MADx may invoice the Customer for the Products on or at any time after the completion of delivery and always in the same month of delivery. Invoices shall be due and payable in full not later than 30 days after their receipt (time for payment is of the essence). In the event of payment default the Customer shall pay default interest at a rate of [8 (eight) percent] p.a. above the Bank of England base rate from time to time. Such interest shall accrue on a daily basis from the due date until actual payment of the overdue amount, whether before or after judgement. The Customer shall pay the interest together with the overdue amount.

4.2. All amounts payable by the Customer under the Contract are exclusive of amounts in respect of value added tax chargeable for the time being (VAT) if applicable. Where any taxable supply for VAT purposes is made under the Contract by MADx to the Customer, the Customer shall, on receipt of a valid VAT invoice from MADx, pay to MADx such additional amounts in respect of VAT as are chargeable on the supply of the Products at the same time as payment is due for the supply of the Products.

4.3. If partial payments have been agreed, the Customer shall be in default of payment if a single partial payment is not made in good time and to the full amount.

5. Warranty and damages

5.1. The warranty period shall be six months after the delivery of the Products by the Customer (Warranty Period). MADx warrants that on delivery the Products shall conform in all material aspects with their description.

5.2. It shall be the Customer’s responsibility to furnish evidence of a defect. To the extent permitted by law, the parties agree that the presumption under Section 19(14) of the Consumer Rights Act 2015 and any implied terms under the Sale of Goods Act 1979 shall not apply.

5.3. The Customer shall promptly and specifically notify any defect in writing to MADx during the Warranty Period within a reasonable time of discovery that some or all of the Products are defective and including reasonable details of the same (Warranty Notice). In case of Warranty Notice, MADx shall be given a reasonable opportunity of examining such Products and shall, acting reasonably, be entitled to determine the appropriate remedy (including, but not limited to, repair, replacement, price reduction, cancellation of the contract), if any.

5.4. With the exception of death or personal injuries and fraud or fraudulent misrepresentation, MADx shall be liable for any loss or damage only when caused intentionally or by gross negligence. Subject to statutory provisions, MADx’s liability shall be limited to the amount of the purchase price and becomes time-barred six months after the Customer becomes aware of the damage and the damaging party. No compensation shall be made for any consequential damage (from the defect), other property damage, pecuniary loss, breach of statutory duty or loss from third-party claims against the Customer.

6. Data protection

6.1. MADx processes the following data of the Customer as the controller: Customer number, name, Company Register number or other register or ID number (like VAT and tax number), if any, address, contact information (such as telephone number, fax number, e-mail address), data on order management and invoicing (such as date of order, Products, quantities, prices, shipping and invoicing data), product details (such as LOT, batch or serial number, production and use-by date, UDI, etc.), errors, damage, accidents or complaints in connection with the product as well as name and data of contacts at the Customer’s.

6.2. This data is processed for the following purposes: • execution of contracts (Art 6 (1) (b) GDPR); • preservation of evidence (legitimate interest within the meaning of Art 6 (1) (f) GDPR); • compliance with obligations under the applicable medical device law or related regulations, in particular the Medical Device Regulation. This concerns, for example, processing for the purposes of market surveillance, traceability and risk management after placing on the market (legal obligation as defined in Art 6 (1) lit (c) GDPR); • contact data for the purpose of establishing promotional contact by e-mail, mail, fax or telephone (consent in accordance with Art 6 (1) (a) GDPR (Section 6.7.) and legitimate interest within the meaning of Art 6 (1) (f) GDPR)

6.3. MADx receives this data either from the Customer or from a Distributor through whom Products are purchased.

6.4. The mentioned data will be processed for the duration of the contractual relationship and will be erased, due to statutory obligations to preserve commercial records, not later than seven years after termination of the contractual relationship, except when more extensive obligations for preservation apply. Contact data will be used for advertising purposes until such time as consent is revoked or for a maximum of three years after termination of the contractual relationship or the last Customer contact. Data for compliance with the obligations of medical device law and related regulations will be processed for the duration of the life cycle of the Products or, if necessary, beyond that, if this is necessary for the above-mentioned purposes.

6.5. The above data will not be disclosed to any third party. Excluded from this are: • Distributors who are entrusted with the execution of the contract, for this purpose as well as for establishing contact or for purposes of market surveillance and traceability of the goods in accordance with medical device law and related regulations; • competent authorities in enforcement of medical device law and related regulations, in particular in the context of vigilance; • service providers of MADx who process Customer data as processors within the meaning of the GDPR exclusively under the instructions of MADx (e.g. for hosting purposes or for sending newsletters etc.).

6.6. The Customer shall promptly inform MADx of any changes in the data required for the Contract. The Customer has the right to information about the data processed by MADx concerning him or her and – to the extent defined by law – to demand rectification or erasure or restriction of their processing or to object to processing and the right to data portability. Moreover the Customer shall be entitled to file a complaint with the Information Commissioner Office.

6.7. The Customer consents to being informed by MADx of Products and other offers by e-mail or by telephone and to having MADx process the requisite e-mail address and telephone number for this purpose. Such consent is not necessary for rendering the contractual works and services and may be revoked at any time without stating any reasons by sending an e-mail tooffice.uk@madx.com. 6.8. Data processing within the scope of providing other services or using MADx software and Products is regulated in the respective special agreements or conditions concerning these.

7. Special provisions for Distributors

7.1. The following provisions shall only apply to contracts between MADx and Customers contractually purchasing Products for the purpose of reselling them (“Distributors”):

7.2. The restriction on reselling as provided in clause 2.4. above shall not apply.

7.3. Such Products shall be delivered DAP pursuant to the Incoterms 2020, except as otherwise provided in these Conditions.

7.4.Until complete payment has been effected, the Distributor shall assign, on account of payment, to MADx any and all claims and security interests due to the Distributor from the resale. In the event of a default of payment, MADx shall be entitled to inform the Customer of the Distributor of the assignment and demand the payment to be made to MADx.

7.5. Distributors shall ensure that the resale of the Products takes place exclusively under contractual basis and acceptance of the these Conditions, or other conditions of MADx applicable to the respective Products or their use.

7.6. Distributors shall also ensure that Customer data in the sense of the above clause 6.3. is passed on to MADx, that this passing on is permitted and that Customers are informed in accordance with Art 13 and 14 GDPR about the processing of their personal data by MADx in accordance with clause 6. of these General Terms and Conditions.

7.7. Distributors shall be liable without limitation for any damages, including indirect and consequential damages, that MADx incurs due to a violation of clauses 7.5. and 7.6.

8. Applicable law and venue

8.1. Any and all legal transactions entered into under these Conditions shall be governed by and construed in accordance with the law of England and Wales.

8.2. The sole place of jurisdiction for all disputes arising directly or indirectly out of or in connection with a contractual relationship governed by these Terms and Conditions shall be the courts of England and Wales.

9. Intellectual Property Rights

9.1 All Intellectual Property Rights in or arising out of or in connection with the Products, shall be owned by the MADx Group.

9.2 The Customer acknowledges that the MADx Group is the proprietor or exclusive licensee of certain Intellectual Property Rights regarding the Products. The Customer acknowledges that any attempt by it or a third party with whom it conducts business to use the MADx Group’s Intellectual Property Rights may infringe the MADx Group’s Intellectual Property Rights.

10. Miscellaneous

10.1. In the event that any provision(s) of these Conditions should be or become legally ineffective or unenforceable this shall not affect the legal effectiveness of the remaining provisions. The contracting parties shall replace such legally ineffective or unenforceable provision(s) by a legally effective and enforceable provision which is as close as possible in content and purpose to the legally ineffective and unenforceable provision.

10.2. No agreement to deviate from these Conditions nor any change of or addition to a contract shall be valid except when made in writing. The same shall apply to any deviation from the above requirement for the written form. 10.3. Claims by MADx shall not be offset by counterclaims of any kind whatsoever.

11. Force Majeure

11.1. For the purposes of this Contract, Force Majeure Event means an event beyond the reasonable control of MADx including but not limited to strikes, lock-outs or other industrial disputes (whether involving the workforce of MADx or any other party), failure of a utility service or transport network, act of God, war, riot, civil commotion, malicious damage, compliance with any law or governmental order, rule, regulation or direction, accident, breakdown of plant or machinery, fire, flood, storm or default of suppliers or subcontractors.

11.2. MADx shall not be liable to the Customer as a result of any delay or failure to perform its obligations under this Contract as a result of a Force Majeure Event.