Roche Diagnostics LimitedStandard Terms and Conditions for the Supply of Goods and Services
Roche Service Contract Document: the most recent published versionof the document entitled the ’Roche Diagnostics Limited Service
Contract’.
Services: includes, without limitation, Fully Comprehensive Service
Contracts and any other services provided by Roche to the Customer as
specified in the Quotation.
Terms: these Standard Terms and Conditions for the Supply of Goods
and Services.
Territory: the United Kingdom (“UK”) and the European Economic Area(“EEA”).

1. Definitions
Affiliates:● an organisation, which directly or indirectly controls a party
to the Contract;● an organisation, which is directly or indirectly controlled by aparty to the Contract;● an organisation, which is controlled, directly or indirectly, by
the ultimate parent company of a party to the Contract,

Working Day: Monday to Friday excluding weekends and bank holidays.

where ‘Control’ is defined as owning more than fifty percent of the voting
stock of a company or having otherwise the power to govern the financial
and the operating policies or to appoint the management of anorganisation. With respect to Roche the term “Affiliate” shall not include
Chugai Pharmaceutical Co. Ltd., 1-1, Nihonbashi-Muromachi 2-chome,
Chuo-ku Tokyo, 103-8324, Japan (“Chugai”) and its subsidiaries, unlessRoche opts for such inclusion of Chugai and its subsidiaries by giving
written notice to the Customer.
Contract: the contract between Roche and the Customer for the supply
of Goods and/or Services which includes these Terms, the Quotation
provided by Roche and, where applicable for the provision of Services,
the Roche Service Contract Document.
Customer: the person, firm, company or authority who purchases theGoods and/or Services from Roche.
Equipment: the systems specified in the Quotation.
Equipment Warranty Period: as defined in clause 7.1 of these Terms.
Force Majeure: any event or circumstance not within the reasonable
control of Roche including, without limitation, industrial action, war,governmental action or regulation, act of God, epidemic or pandemic,
riots or unavailability of stocks or materials.
Goods: any goods supplied by Roche to the Customer pursuant to theContract including, but not limited to, Equipment and Reagents.
Fully Comprehensive Service Contract: a contract in relation topreventative and corrective maintenance as further detailed in the Roche
Service Contract Document.
Lease Basis: Goods supplied on an operating lease or reagent rental
basis.
Medical Devices Legislation: the UK Medical Devices Regulations
2002 (“UK MDR”) and any UK legislation subsequently enacted whichamends, substitutes or replaces the UK MDR, the EU IVDD 98/79/EC, theEU Medical Devices Regulation 2017/745 (“EU MDR”), the EU In Vitro
Medical Devices Regulation 2017/746 (“EU IVDR”), and any national

2. General - Scope
2.1 These Terms shall apply to all Quotations and all Orders accepted by
Roche including, but not limited to, the following purchase types (whichshall be specified in the Quotation):- capital purchase- Lease Basis- Fully Comprehensive Service Contracts
2.2 Save for as specified in clause 2.3, these Terms apply to the Contract
to the exclusion of any other terms that the Customer seeks to impose orincorporate (including, without limitation, any terms which the Customer
purports to apply under any purchase order), or which are implied bytrade, custom, practice or course of dealing.
2.3 If Roche and the Customer have executed a formal, bespoke written
contract signed and dated by authorised signatories of both parties inrelation to the provision of goods and services specified in a quotation,
the terms of that contract shall apply.
2.4. Any amendments, cancellation or waiver of these Terms or theContract must be made in writing and signed by a duly authorised
representative of Roche. For the avoidance of doubt, Roche’s drivers or
warehouse staff are not duly authorised representatives.
2.5 Where there is a conflict between the documents which constitute theContract, they shall take precedence in the following order:- Quotation- these Terms- Roche Service Contract Document (if applicable)

legislation implementing the EU IVDD and/or EU IVDR, as applicable.
Operator’s Manual: the document that is supplied on the installation of
the Equipment. This document outlines the technical specification,
principles of operation and customer responsibilities.
Order: the Customer’s return of Roche’s Quotation signed by the
Customer.

3. Basis of Contract
3.1 Any Quotation provided by Roche to the Customer shall not constitutean offer and is only valid for a period of 90 days from the date of issue.
3.2 The Order constitutes an offer by the Customer to purchase goods
and/or services as detailed in the Quotation subject to these Terms.

Price: as defined in clause 11.1 of these Terms.
Product Information: the information that is supplied with the Goods,
including the product labelling, technical specifications, Instructions for

3.3 The Order shall only be deemed accepted when Roche issues written
acceptance of the Order, which may include email or facsimile or, if
earlier, where Roche supplies the Goods and/or Services to the Customer
at which point the Contract shall come into existence (the“Commencement Date”). Any Order shall be accepted entirely at thediscretion of Roche.

Use (“IFU”) and sales and packaging materials.
Quotation: the quotation or proposal provided by Roche to the Customer
for the provision of Goods and/or Services and to which these Terms
apply.
Reagents: the reagents specified in the Quotation.
Roche: Roche Diagnostics Limited, a company incorporated in Englandand Wales with registration number 00571546.

4. Goods

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4.1 The Goods are as described within the Quotation and the relevant
Operator’s Manual and Product Information.

7.1 The warranty period for the Equipment shall be 12 months from thedate of commissioning or 14 months from the date of delivery, whicheverdate is the sooner (the “Equipment Warranty Period”).

4.2 Roche reserves the right to amend the Operator’s Manual and/or
Product Information if required to do so by any applicable statutory or
regulatory requirement.

7.2 Subject to clause 7.3, Roche shall, at its sole option, repair or replace
the defective Equipment or refund the price of the defective Equipmentin full during the Equipment Warranty Period provided Roche is notified
in writing within a reasonable time of discovery that some or all of theEquipment do not comply with their published specification and that
Roche is given reasonable opportunity to examine the Equipment. Should
Roche elect to repair the defective Equipment, the Customer shall grant
Roche a reasonable period for repairing the defects and cooperate with
Roche, as appropriate. The repair or replacement of defective Equipment
shall not extend the Equipment Warranty Period.

5. Services
5.1 Fully Comprehensive Service Contracts and Services shall be
performed in line with the Quotation, these Terms and, where applicable,
the Roche Service Contract Document.
6. Delivery of the Goods and Services
6.1 Any dates quoted for delivery of Goods and Services by Roche are
estimates and the time of delivery is not of the essence. Roche will not beheld liable for any delay or non-delivery nor for, without limitation, any
resulting loss, expense, damage or fine. Any delay in delivery will notentitle the Customer to terminate the Contract.

7.3 Roche shall not be liable for the failure of the Equipment to comply
with its published specification where:
7.3.1 the defect has arisen due to the Customer’s failure tofollow Roche’s oral or written instructions as to the storage,
installation, commissioning, use or maintenance of theEquipment;
7.3.2 the Customer alters or repairs such Equipment without thewritten consent of Roche; and/or
7.3.3 the defect arises as a result of fair wear and tear, wilfuldamage, negligence, abnormal working conditions or any act
or omission not caused by Roche; and/or

6.2 Unless otherwise stated in the Quotation, delivery of the Goods shalltake place at the Customer’s premises when unloaded from the delivery
vehicle.
6.3 When signing for Goods from the carrier, the Customer agrees tocheck that the number of packages received is in accordance with thenumber on the delivery note and immediately to record any numerical
discrepancy or obvious external damage on the carrier’s delivery note.
6.4 Roche will consider claims for damaged Goods, shortages or incorrect
deliveries if notified within 14 days of the receipt of the Goods, after which
point the Goods will be deemed accepted.

7.3.4 the Customer uses, or has used, reagents or consumableson the Equipment that are manufactured by a third party thatis not Roche without the prior written authorisation of Roche.

6.5. Roche will not accept the return of unwanted Goods correctly
delivered against an Order accepted by Roche in accordance with theseTerms.

7.4 The warranty period for the Reagents shall be the shelf-life as
indicated on each relevant Reagent’s packaging or package insert(“Reagent Warranty Period”). Subject to clause 7.5, Roche shall at its
sole option, either replace or refund the price of the defective Reagentsduring the Reagent Warranty Period provided Roche is notified in writing
within a reasonable time of discovery that some or all of the Reagents do
not comply with their published specification and Roche is given

6.6 Where title to Goods has not passed to the Customer, Roche reserves
the right to withhold delivery of any Goods pursuant to a Contract where
the Customer goes or, in Roche’s reasonable opinion, seems likely to go
into liquidation, makes any composition or arrangement with its creditors
or has appointed an administrator or an administrative receiver.

reasonable opportunity to examine the Reagents.
7.5 Roche shall not be liable for the failure of the Reagents to comply with
its published specification where:

6.7 If the Customer fails to take delivery of the Goods and/or Services
when due in accordance with the Contract then, without limitation to
Roche’s right to terminate under clause 15, the Customer shall indemnify
Roche for all costs associated with performing the Contract up until thedate of failed delivery.

7.5.1 the defect has arisen due to the Customer’s failure tofollow Roche’s oral or written instructions as to the storage or
use of the Reagents; and/or
7.5.2 the defect arises as a result of wilful damage, negligence,
abnormal working conditions or any act or omission not causedby Roche.

6.8 Roche may deliver the Goods in instalments, which shall be invoiced
and paid for separately. Each instalment shall constitute a separate
Contract. Any delay or defect in an instalment shall not entitle theCustomer to cancel any other instalment.

7.6 The Customer shall inform Roche of any non-conformity where theCustomer considers or has reason to believe that any Goods are not in
conformity with the requirements of the Medical Devices Legislation, andshall not place such Goods on the market until they have been brought
into conformity.

6.9 Any order received on a Friday, which requires dry ice or other formof temperature control, will be dispatched the following Monday (or in thecase of an intervening bank holiday(/s)), the following Working Day). In
the event that the Customer requires a weekend delivery, which Roche
subsequently agrees to provide at its discretion, the Customer shall besolely responsible for any degradation of the Goods in the event theGoods cannot be delivered.

7.7 Roche warrants that the Services shall be performed with due careand skill.
7.8 Roche shall re-perform any Services which do not comply with clause
7.9. Except as provided within this clause 7.8, Roche shall have no liability
to the Customer in respect of the failure of the Services to comply withthe warranty set out in clause 7.7.

6.10 Orders below £100 or €120 shall be subject to a handling charge.
Roche reserves the right to make additional charges for including, but notlimited to, deliveries requiring dry ice, all special and urgent deliveries anddeliveries outside the United Kingdom and the Republic of Ireland.

7.10 Except as provided in this clause 7, Roche shall have no liability to
the Customer in respect of the failure of the Goods to comply with its
published specification. Roche does not give any representation or

7. Quality of the Goods and Services

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warranty or undertaking in relation to the Goods or Services other thanthose set out in these Terms and accordingly any representation, warranty
or condition that might be implied or incorporated into the Contract(including the terms implied by sections 13 to 15 of the UK Sale of Goods
Act 1979, by sections 3 to 5 of the Sale of Goods and Services Act 1982,
and by sections 13 to 15 of the Irish Sale of Goods and Supply of Services
Act 1980) are excluded to the fullest extent permitted by law.

9.2.2 Where the Goods are Equipment provided on a Lease
Basis, title in Equipment shall not pass and shall remain with
Roche at all times;
9.2.3 Where the Goods are reagents and/or consumables, title
in reagents and consumables shall pass at the point such
Goods are taken into use. For the avoidance of doubt, wheretitle passes in accordance with this clause 9.2.3 then the fullPrice for such Goods shall be recoverable by Roche from theCustomer as a debt if there is non-payment of an invoice issued
by Roche to the Customer in relation to such Goods.
9.2.4 Title in all other Goods shall pass at the point of full
payment of the Goods and all other sums owed by the
Customer to Roche.

8. Customer’s Obligations
8.1 The Customer shall:
8.1.1 ensure that the terms of the Order are complete andaccurate;
8.1.2 comply with the Operator’s Manual and Product9.3 Until title to the Goods has passed to the Customer, the Customer

Information;
8.1.3 act in full compliance with the applicable requirements of
the Medical Devices Legislation if selling, distributing orotherwise making the Goods available on the market in the UK
and/or the Republic of Ireland in the context of its activities;
8.1.4 fully cooperate and communicate with Roche and/or its
Affiliates in a timely manner in all matters relating toshall:
9.3.1 not remove, deface or obscure any identifying mark or
packaging on or relating to the Goods.
9.3.2 maintain the Goods in satisfactory condition and keepthem insured at its cost against all risks for their full Price fromthe date of delivery.
9.3.3 give Roche such information relating to the Goods as
Roche may reasonable require from time to time.
9.3.4 allow Roche reasonable access to its premises in order toexamine the Goods.
9.3.5 deliver the Goods up to Roche where requested by Roche
to do so.

compliance with the Medical Devices Legislation;
8.1.5 provide Roche, its employees, agents, consultants andsubcontractors, with access to the Customer’s premises, officeaccommodation and other facilities as reasonably required toprovide the Services;
8.1.6 while the Goods are under its responsibility, storage ortransport conditions comply with the conditions specified on
the Goods or otherwise notified by Roche, and its obligations

9.4 Subject to clause 9.6.1, the Customer may re-sell or use the Goods
purchased on a capital purchase basis in the ordinary course of its
business provided that all proceeds of sale are held on trust for Roche
pending full payment to Roche in relation to the Goods. For the avoidanceof doubt, Goods which are Equipment provided on a Lease Basis may not
be re-sold or otherwise dealt with resulting in the Customer parting
possession with the Equipment.

under the Medical Devices Legislation;
8.1.7 fully cooperate and communicate with Roche and/or its
Affiliates in a timely manner in all matters relating tocompliance with the Medical Devices Legislation;
8.1.8 notify Roche without delay of any incidents, complaints orreports concerning the Goods, and comply with any directionsof Roche in any issues, proceedings or negotiations relating to

9.5 Any sale by the Customer permitted by clause 9.4 shall be effected by
the Customer as principal and not as Roche’s agent.

such incidents, complaints and/or reports; and8.1.9 comply with any reasonable instructions of Roche in

9.6 If, before title to the Goods passes to the Customer, the Customer
becomes subject to any of the events listed in clause 15.1,

relation to the Goods and/or Services.
8.2 The Customer shall, at its own cost, obtain and maintain throughout
the term of the Contract any registrations, licences, authorisations andapprovals necessary or required in connection with the distribution ofGoods in the UK and/or the Republic of Ireland. Where any suchregistration, licence, authorisation or approval is required, the Customer
shall provide Roche with information and/or copies of such
documentation upon request.

9.6.1 the Customer’s right to re-sell Goods or use them in theordinary course of its business ceases immediately;
9.6.2 Roche may at any time:
9.6.2 (A) require the Customer to deliver up all Goods
in its possession which have not been resold; and9.6.2 (B) if the Customer fails to deliver up all Goods
promptly under clause 9.6.2(A), enter any premisesof the Customer where the Goods are stored in orderto recover them.

8.3 The Customer shall permit Roche on reasonable advance written
notice to inspect, during the term of this Contract, the Customer’s
premises and documents relevant to the distribution of Goods for the
purposes of performing an audit of the Customer’s conformity with thisContract.

10. Roche’s Obligations
10.1 Roche shall:
10.1.1 provide the Customer with all information, data anddocumentation required for the safe handling and use of theGoods, and to secure any registrations, licences, authorisations
or approvals that the Customer may be required to obtain
and/or retain by law;
10.1.2 provide the Customer with any updated versions of the
Product Information and other relevant documentation whenavailable; and10.1.3 notify the Customer of any safety alerts, notices
or other communications issued by the relevant regulatory
authorities or any similar communications issued by Roche
relating to the Goods.

9. Risk and Title
9.1 Risk in the Goods shall pass to the Customer at the point of delivery.
9.2 Title in the Goods shall not pass until the following:
9.2.1 Where Goods are Equipment provided on a capitalpurchase basis, title in Equipment shall pass at the point offull payment of the Equipment and all other sums owed by the
Customer to Roche under this Contract or any other Contract
between Roche and the Customer;3may in its sole discretion require full or partial payment prior to thedelivery of the Goods or Services. Roche will notify the Customer of thisrequirement where applicable.

11. Price and Payment
11.1 The price shall be as set out in the Quotation (the “Price”).
11.2 The Price is subject to variation without notice prior to delivery of therelevant Goods or Services.

12. Safety and Recall
12.1 The Customer should satisfy itself that the persons responsible forthe shipping, storage, handling and/or use of any Goods supplied by
Roche have all the information required on health and safety
requirements (as required by applicable law) and conditions of storage
and any health and material safety data sheets and/or Product
Information.

11.3 The Price shall be exclusive of value added tax (VAT) which theCustomer shall additionally be liable to pay to Roche at the prevailing rate,
subject to the receipt of a valid VAT invoice.
11.4 Unless otherwise stated in the Quotation, Roche shall invoice:11.4.1 for Goods supplied on a capital purchase basis, at the
point of despatch of the Goods;
11.4.2 for Goods supplied on a Lease Basis, following supply;
11.4.3 for Fully Comprehensive Service Contracts, annually inadvance; and11.4.4 for reagents and consumables and for all other Goods,
at the point of despatch of the Goods.

12.2 Roche shall not be liable to the Customer in any civil proceedings
brought by the Customer against Roche in respect of a breach of theapplicable law, shipping, storage, handling or use instructions or any
other applicable health and safety legislation or any regulations, orders
or directions made pursuant to such health and safety legislation in force
from time to time or under any directive, regulation, order or other
instrument relating to health and safety, where such exclusion of liability

11.5 The Price shall be payable by the Customer within thirty (30) days ofthe date of invoice in full and in cleared funds payable to the accountnotified by Roche to the Customer in writing. Roche reserves the right towithdraw these credit terms at any time without notice.

is permitted by law.
12.3 Should the Customer re-sell any Goods in accordance with theseTerms:
12.3.1 the Customer shall at its own expense establish a systemthat enables it to track which Goods are delivered to whichcustomer and as such undertakes to maintain appropriate, upto-date and accurate records to enable the immediate recall of
any individual or batches of Goods for at least 10 years after
the last Good covered by the declaration of conformity has
been placed on the market. These records shall include (butare not limited to) records of deliveries to customers (including
identity of the product, UDI, batch/lot numbers, serial numbers,
quantity, delivery date, name and address of customer,
telephone number, fax number and e-mail address);
12.3.2 if there is a risk that serious deterioration in the state of
the health of a patient or user may occur in connection withany Goods, Roche may require that the re-sale of the Goods be
stopped immediately upon the Customer receiving notification
thereof in writing or by e-mail; and12.3.3 the Customer shall take such action and give suchinformation and assistance that Roche shall reasonably require
to recall Goods or investigate a potential issue relating to the11.6 The Customer shall notify Roche of any invoice discrepancy within
14 days of the date of invoice after which time, the invoice shall bedeemed accepted.
11.7 Time for payment by the Customer shall be of the essence.
11.8 Without limitation to Roche’s remedies under clauses 11.9, 12 and15, where the Customer is late paying any Roche invoice by a period
greater than or equal to 14 days from the point it was due, Roche reserves
the right, however is not obliged, to withhold a subsequent supply ofGoods and/or Services.
11.9 Without limitation to Roche’s remedies under clauses 11.8, 12 and15, where the Customer fails to make payment due to Roche by the duedate, the Customer shall pay interest on the overdue sum from the due
date until payment of the overdue sum. Interest under this clause 11.9
shall accrue each day at 8% a year above the Bank of England base ratefrom time to time.

Goods including, but not limited to, acknowledging receipt ofany safety, recall or other notification sent by Roche andreporting requested information and/or confirmations back to
Roche without delay. Roche shall inform the Customer
promptly about its intent to or the necessity of withdrawal of allor a part of Goods from trading.

11.10 Roche reserves the right to increase the Price of the Goods and/or
Services, by giving notice to the Customer at any time before delivery, toreflect any increase in the cost of the Goods to Roche which is due to:11.10.1 any factor beyond the control of Roche (including
foreign exchange fluctuation, increases in taxes and duties,
increases in labour, materials and other manufacturing costs);
11.10.2 any request by the Customer to change the delivery
date(s), quantities or type of Goods ordered or inaccurate
information in respect of the delivery of the Goods.

12.4 The Customer shall without delay take such action and give suchinformation and assistance that Roche shall reasonably require toinvestigate any potential issue relating to the Goods.
12.5 The Customer shall provide such assistance and provide suchinformation as Roche may reasonably require to enable Roche to comply
with its obligation in relation to complaints, reports and product recalls

11.11 Roche shall be entitled to increase the Price of any Fully
Comprehensive Service Contract on an annual basis in line with the Retail
Price Index.

in accordance with the Medical Devices Legislation.
13. Indemnity
13.1 The Customer agrees to indemnify and hold Roche harmless fromand against any losses, claims, costs, expenses, penalties, legal costs anddamage (whether direct, indirect or consequential) including, without
limitation, third party claims arising out of: (i) the abnormal or improperuse, misuse or neglect of the Goods; (ii) any act or omission in breach or
negligent performance of the Contract including, without limitation, any
breach of warranty.

11.12 Roche reserves the right to review the pricing for reagents and/or
consumables on an annual basis.
11.13 All amounts due under the Contract shall be paid in full without any
set-off, counterclaim, deduction or withholding (except for any deductionof tax as required by law).
11.14 If, in the reasonable opinion of Roche, the credit-worthiness of the
Customer deteriorates before delivery of the Goods or Services, Roche414. Limitation of Liability
14.1 Nothing in these terms shall limit or exclude Roche’s liability for:14.1.1 death or personal injury caused by its negligence.
14.1.2 fraud or fraudulent misrepresentation.
14.1.3 breach of the terms implied by section 2 of the UK Supply
of Goods and Services Act 1982.
14.1.4 breach of the terms implied by section 12 of the UK Saleof Goods Act 1979 or section 12 of the Irish Sale of Goods andSupply of Services Act 1980.
14.1.5 defective products under the Consumer Protection Act

15.2 Without affecting any other right or remedy available to it, Roche may
terminate the Contract on giving not less than 3 months' notice to theCustomer.
15.3 Notwithstanding any termination or suspension in accordance withthese Terms, the Customer shall pay Roche for all costs incurred by Rochein providing the Goods and Services up to and including the date ofsuspension or termination.

1987 or the Irish Liability for Defective Products Act 1991.
14.1.6 any other liability of Roche which may not be lawfully
excluded or limited.

15.4 Termination of the Contract for any reason shall be without prejudice
to the rights and remedies of either party which have accrued up totermination.

14.2 Subject to clause 14.1, Roche shall not be liable to the Customer,
whether in contract, tort (including negligence), for breach of statutory
duty, or otherwise, arising under or in connection with the Contract for:14.2.1 loss of profit, business, revenue, anticipated savings or
goodwill, in each case whether direct or indirect or
14.2.2 any type of special, indirect or consequential loss.

16. Import and Export Control
16.1 The Customer shall not actively solicit orders for Goods for territories
outside of the UK and the Republic of Ireland that have been exclusively
reserved to Roche or any of its Affiliates or exclusively allocated by Rocheor any of its Affiliates to a third party.
16.2 If the Goods are being exported to the Customer outside the United
Kingdom the provisions of this clause 16 shall apply notwithstanding anyother provision of the Contract.

14.3 Subject to clause 14.1, Roche’s total liability to the Customer whether
arising in contract, tort (including negligence), breach of statutory duty orotherwise under or in connection with the Contract shall be limited to thePrice.

16.3 Unless the context otherwise requires, any term or expression which
is defined in or given a particular meaning by the provisions of Incoterms
2020 shall have the same meaning for the purposes of the Contract. In
the event of conflict between Incoterms 2020 and the Contract, theContract shall prevail.

14.4 The provisions of this clause 14 shall survive expiry or termination of
the Contract.
15. Termination
15.1 Without affecting any other right of remedy available to it, Roche may
immediately suspend performance of the Contract or terminate the16.4 Unless stated otherwise in the Contract any Goods being exported
to the Customer shall be delivered, “Delivered At Place” (DAP).

Contract without liability to the Customer if:
16.5 The Customer shall:
16.5.1 not actively supply any Goods to customers outside the
Territory without the prior written consent of Roche; and16.5.2 refer to Roche all enquiries it receives for Goods for saleor ultimate delivery outside of the Territory.

15.1.1 the Customer fails to make payment in accordance withclause 11.
15.1.2 the Customer fails to pay any other debt due and payable
to Roche by the relevant date.
15.1.3 the Customer commits a material breach of the Contract(and for the avoidance of doubt and without limitation, any
breach of clauses 11, 16, 17, 18, 20 and 23.1 will be considereda material breach).
15.1.4 the Customer fails to remedy a breach of its obligations
under the Contract within the timescale reasonably required by
Roche.
15.1.5 any sum payable under the Contract is not paid within
14 days of its due date.
15.1.6 any distress or execution is levied upon any of the
Customer’s goods.
15.1.7 the Customer enters into bankruptcy, individual
voluntary arrangement, liquidation, receivership, administration
or into a corporate voluntary arrangement as defined by the
Insolvency Act 1986 or the Irish Companies Act 2014.
15.1.8 the Customer ceases or threatens to cease to carry on all
or a material part of its business.
15.1.9 Roche reasonably believes that any of the events
specified in clause 15.1.7 is about to occur in relation to theCustomer.
15.1.10 the Customer stops or suspends or threatens tosuspend payment of all or a material part of its debts or isunable to pay its debts, or is deemed unable to do so under
section 123 of the Insolvency Act 1986 or section 570 of the

16.6 Nothing in these Terms shall prevent the Customer from meeting any
unsolicited or passive orders for Goods both within and outside of the
Territory, including territories that have been exclusively reserved to
Roche or any of its Affiliates or exclusively allocated by Roche or any of
its Affiliates to a third party.
16.7 The Customer shall be responsible for complying with any legislation,
regulations, guidelines, codes of practice or directions governing theexport, re-export, re-transfer or import of the Goods and the use or saleof the Goods in the country of destination.
16.8 Roche shall be under no obligation to give notice under section 3(2)of the Sale of Goods Act 1979.
16.9 The parties agree that all Goods, including software and technology,
delivered under the Contract may be subject to foreign trade controls. The
Customer is responsible for and shall strictly comply with all applicablenational and international laws and regulations for the control of import,
export or re-export, transfer, brokering and transit. Prior to any delivery ofGoods, the Customer shall guarantee that all necessary import and/or
export licences are obtained as may be required throughout the durationof the Contract.
16.10 Roche shall provide such information as the Customer reasonably
requires to ensure compliance with their obligations under applicable
export and customs regulations.

Irish Companies Act 2014.
15.1.11 there is a change of control of the Customer (within themeaning of section 1124 of the Corporation Act 2010 or section
432 of the Taxes Consolidation Act 1997).

16.11 Any costs incurred from the obligations in this clause 16 shall beborne by the Customer.

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17.5.2 ensure that all personnel who have access to and/or
process Personal Data are obliged to keep the Personal Data
confidential;
17.5.3 ensure that it has in place technical and organisational
measures to protect against any Personal Data Breachappropriate to the harm that might result from the Personal
Data Breach and the nature of the data to be protected, having
regard to the state of technological development and the costof implementing any measures (those measures may include,
where appropriate, pseudonymising and encrypting Personal
Data, ensuring confidentiality, integrity, availability andresilience of its systems and services, ensuring that availabilityof and access to Personal Data can be restored in a timely
manner after an incident, and regularly assessing andevaluating the effectiveness of the technical and organisational
measures adopted by Roche);17.5.4 save for the authorisation provided under clause 17.4 ofthese Terms by the Customer, not appoint any third party
processor of Personal Data under this Contract (a “Third Party
Processor”) unless:17.5.4 (A) the prior specific written consent of the
Customer has been obtained; and17.5.4 (B) the Third Party Processor is bound by terms
which are substantially similar to those set out in thisclause 16 under (i) a written agreement between
Roche and the Third Party Processor or (ii)
Applicable Data Laws.
As between the Customer and Roche, Roche shall remain fully
liable for all acts or omissions of any Third Party Processor
appointed pursuant to this clause 17.5.4;
17.5.5 assist the Customer, by appropriate technical andorganisational measures, in responding to any request from a
Data Subject and in ensuring compliance with its obligations
under the Data Protection Legislation with respect to requests
for exercising a Data Subject’s rights, security, breach
notifications, impact assessments and consultations withsupervisory authorities or regulators;
17.5.6 at the written direction of the Customer, delete or return
Personal Data and copies thereof to the Customer ontermination of the Contract unless required by Applicable Data
Law to store the Personal Data;
17.5.7 maintain and make available to the Customer all
information necessary to demonstrate its compliance with thisclause 17 and allow for and contribute to audits by the
Customer or the Customer’s designated auditor;
17.5.8 as soon as reasonably practical inform the Customer if,
in Roche’s opinion, an instruction infringes any Data Protection
Legislation or Applicable Data Law;

17. Data Protection
17.1 For the purposes of these Terms, the following terms shall have thefollowing meanings:
Data Protection Legislation means:(i) the UK General Data Protection Regulation (“UK GDPR”);(ii) the Data Protection Act 2018 (“DPA”);(iii) the Privacy and Electronic Communications (EC Directive)
Regulations 2003 (“PECR”);(iv) any successor legislation to the UK GDPR, the DPA or PECR;(v) the EU Data Protection Regulation 2016/679 (“EU GDPR”) and(vi) any national implementing laws, regulations and secondary legislation
relating to data protection as amended or updated from time to time, in
the UK and in the Republic of Ireland.
Personal Data Breach: means a breach of security leading to theaccidental or unlawful destruction, loss, alteration, unauthorised
disclosure of, or access to, Personal Data transmitted, stored or otherwise
processed.
Personal Data: shall have the meaning given to it in the applicable Data
Protection Legislation and shall include Special Categories of Personal
Data.
Special Categories of Personal Data: means Personal Data revealing
racial or ethnic origin, political opinions, religious or philosophical beliefs,
or trade union membership, and genetic data, biometric data, data
concerning health or data concerning a natural person’s sex life or sexual
orientation. ‘Genetic data’, ‘biometric data’ and ‘data concerning health’
shall have the meanings given to them in the UK and EU GDPR.
17.2. Both parties will comply with all applicable requirements of the Data
Protection Legislation. This clause 17 is in addition to, and does notrelieve, remove or replace, a party's obligations under the Data Protection
Legislation. In this clause 17, Controller, Processor, processing and Data
Subject shall have the meanings given to them in the applicable Data
Protection Legislation and process and processed shall be construed
accordingly.
17.3 In order to extinguish their respective obligations under the Contract,
Roche may be required to process Personal Data belonging to theCustomer. The duration of any such processing shall be equal to the termof the Contract, unless expressly stated otherwise. The parties
acknowledge that for the purposes of the Data Protection Legislation, theCustomer is the Controller and Roche is the Processor.
17.4 The Customer confirms its general authorisation to the appointmentof all sub-processors engaged by Roche to fulfil its obligation under theContract (the Existing Sub-Processors). Roche shall inform the Customerof any intended change(s) to the Existing Sub-Processors and theCustomer shall inform Roche in writing within seven (7) days of the dateof such notice if it has any objections to the proposed Existing SubProcessor change(s). If the Customer does not object to the Existing SubProcessor change(s) then the change(s) shall have effect no earlier thanthe eighth (8th) day after the date of the relevant notice from Roche. The
parties will discuss any objection to the Existing Sub-Processor change(s)in good faith to resolve the issue.

17.5.9 save for any specific authorisation provided under theseTerms by the Customer (including, but not limited to, clause
17.9), not transfer any Personal Data outside of the Territory
unless the prior written consent of the Customer has beenobtained and the following conditions are fulfilled:
17.5.9 (A) the Customer or Roche has provided
appropriate safeguards in relation to the transfer;17.5.9 (B) the Data Subject has enforceable rights
and effective legal remedies;17.5.9 (C) Roche complies with its obligations under
the Data Protection Legislation by providing anadequate level of protection to any Personal Data
that is transferred; and17.5.9 (D) Roche complies with reasonable
instructions notified to it in advance by the Customer
with respect to the processing of the Personal Data;and17.5.10 notify the Customer without undue delay on becoming
aware of a Personal Data Breach with sufficient detail to enable

17.5 Roche shall, in relation to any Personal Data processed in connection
with the performance by Roche of its obligations under the Contract:
17.5.1 save for any specific authorisation provided under theseTerms by the Customer, process that Personal Data only on thewritten instructions of the Customer (including, but not limited
to, with regard to the transfer of Personal Data outside of the
Territory ) unless Roche is required by the applicable laws of
any state in the Territory to process Personal Data(“Applicable Data Laws”). Where Roche is relying on
Applicable Data Laws as the basis for processing Personal
Data, Roche shall, to the extent legally permissible, promptly
notify the Customer of this before performing the processing
required by the Applicable Data Laws;

6the Customer to identify the facts relating to the Personal Data
Breach, its effects and Roche’s proposed remedial action.

19. Intellectual Property
19.1 All intellectual property rights in or arising out of or in connection
with the Goods and Services shall be owned by Roche.

17.6 The Customer confirms that it authorises all forms of data transfer
and processing as described in this clause 17 or elsewhere in the Contract
and warrants that:
17.6.1 it has received all requisite consent from the Data
Subjects (or is otherwise permitted by the Data Protection
Legislation) to disclose the Personal Data to Roche; and17.6.2 its disclosure of, and Roche’s subsequent use,
processing and/or transfer of, Personal Data under or in
relation to this Contract is permitted under the Data Protection
Legislation.

19.2 No right or licence is granted under the Contract to the Customer
under any patent, trade mark, copyright, registered design or otherintellectual property right, except the right to use or re-sell the Goods.
19.3 The Customer shall not sub-licence, assign or otherwise transfer therights granted under clause 19.2.
19.4 All Goods may be sold or re-sold by the Customer only in the
packages and packaging in which the Goods were supplied by Rocheand in no case may any trademark other than the trademark carried by
the Goods at the time of delivery be marked or applied in relation to theGoods by the Customer.

17.7 Roche may, at any time on not less than 30 days’ notice, revise thisclause 17 by replacing it with any applicable controller to processor
standard clauses or similar terms forming part of an applicablecertification scheme (which shall apply when replaced by attachment tothis Contract).

20. Confidentiality
20.1 A party (“Receiving Party”) shall keep in strict confidence: (i) all
technical or commercial know-how, specifications, inventions, processes
or initiatives which are of a confidential nature and have been disclosed
to the Receiving Party by the other party (“Disclosing Party”), its
Affiliates, employees, subcontractors, permitted assigns or agents, (ii) any
other confidential information concerning the Disclosing Party’s business,
its products and services which the Receiving Party may obtain as part of
the Contract, (iii) any information that is marked or has been otherwise
indicated to be confidential and (iv) all information in whatever form
which would be regarded as confidential by a reasonable business person(together, the “Confidential Information”).

17.8 Roche is hereby authorised by the Customer to download and use
data which does not constitute Personal Data (such as performance data)
via a secure gateway system for purposes including but not limited to
optimisation of the Roche service, anticipation and preparation forpotential epidemics and analysis of regional testing behaviour.
17.9 The Customer acknowledges and agrees that:
17.9.1 in order to provide technical support including, but notlimited to, remote technical support, Roche will need to view,
store and/or transfer (including outside of the Territory) data
which may contain Personal Data. When the data has been
evaluated and the technical support case has been closed, any
data stored will be deleted; and17.9.2 the majority of technical support will be offered from the
UK and Republic of Ireland by Roche, however where second
and third line escalations are required, Roche may utilise global
expertise by safely and securely transferring data (which may
include Personal Data), employing infrastructure that has been
specially implemented for this purpose and which is fully
certified against ISO 27001.

20.2 The Disclosing Party warrants that it has the full and unconditionalright to disclose the Confidential Information to the Receiving Party.
20.3 The Receiving Party shall:
20.3.1 only use the Confidential Information to discharge its
obligations under the Contract;
20.3.2 disclose the Confidential Information only to those of its
Affiliates, employees, subcontractors, permitted assigns oragents who need to know it for the purpose of discharging theReceiving Party’s obligations under the Contract; and20.3.3 ensure that all Affiliates, employees, subcontractors,
permitted assigns or agents who receive Confidential
Information under Condition 20.3.2 comply with the obligationsof confidentiality set out in this clause 20 as if they were a party
to the Contract.

17.10 The Customer shall indemnify Roche in full against all liabilities,
costs, expenses, damages or losses (including, but not limited to, any
direct, indirect or consequential losses, loss of profit, loss of reputation
and all interest, penalties and legal costs (calculated on a full indemnity
basis) and all other reasonable professional costs and expenses) suffered
or incurred by Roche arising out of or in connection with any act oromission by or on behalf of the Customer resulting in a breach of the Data
Protection Legislation by Roche. Liability under this indemnity isunlimited.

20.4. The obligations of confidentiality in this clause 20 shall not extend
to any information which the Receiving Party can demonstrate:
20.4.1 is publicly available or becomes publicly available
through no act or omission of the Receiving Party;
20.4.2 was independently disclosed to the Receiving Party by athird party entitled to disclose the same;
20.4.3 is required to be disclosed by the Receiving Party under
any applicable law, or by legal order of a court or governmental
body or authority of competent jurisdiction.

18. Anti-bribery, anti-slavery and human trafficking
18.1 The Customer will, and will procure that any of its Affiliates,
employees, subcontractors, permitted assigns, agents or any otherpersons who perform any obligations under the Contract will fully comply
with, and not commit any act or omission which causes or could cause
the Customer or Roche or any of its or their Affiliates to breach or commit
an offence under, all laws, statutes, regulations and codes of practicerelating to:
18.1.1 anti-bribery and/or anti-corruption, including the Bribery
Act 2010-and the Irish Criminal Justice (Corruption Offences)
Act 2018; or
18.1.2 anti-slavery and human trafficking in the UK andelsewhere, including the Modern Slavery Act 2015 and the Irish
Criminal Law (Human Trafficking) Act 2008 as amended or
updated from time to time.

20.5. Upon termination or expiration of the Contract for any reason, unlessotherwise agreed in writing between the parties, the Receiving Party shallcease all use and make no further use of the Confidential Information andshall upon receipt of a written request from the Disclosing Party and at
the Receiving Party’s sole cost and expense promptly deliver up to theDisclosing Party or destroy (at the Disclosing Party’s sole option) all
Confidential Information, including any documents, materials and records
in any medium containing or reflecting the Confidential Information.
Notwithstanding the obligations set out in this clause 20.5, the Receiving
Party may retain one copy of the Confidential Information to the extent it

7

is required to do so to comply with any law or regulation provided always
that any retained Confidential Information is kept always in fullcompliance with the provisions of this clause 20.

23.4 Nothing in the Contract is intended to, or shall be deemed to,establish any partnership or joint venture between the parties, constitute
either party the agent of the other, or authorise either party to make orenter commitments for or on behalf of the other party.

20.6 The provisions of this clause 20 shall survive expiry or termination of
the Contract.

23.5 A waiver of any right or remedy under the Contract or by law is only
effective if given in writing and shall not be deemed a waiver of any
subsequent breach or default. A failure or delay by a party to exercise any
right or remedy provided under the Contract or by law shall not constitutea waiver of that or any other right or remedy, nor shall it prevent or restrict
any further exercise of that or any other right or remedy. No single orpartial exercise of any right or remedy provided under the Contract or bylaw shall prevent or restrict the further exercise of that or any other rightor remedy.

20.7 Roche acknowledges that the Customer may be subject to theFreedom of Information Act 2000 and/or the Irish Freedom of Information
Acts 1997 and 2014 (“FOIA”), and the Customer acknowledges that any
information disclosed to the Customer which relates to financial issues ortechnical specifications not in the public domain should be held in thestrictest of confidence. The Customer acknowledges that suchinformation is exempt from disclosure under the FOIA as it has been
provided in confidence and disclosure would constitute an actionablebreach of confidence and/or that the information provided is a trade
secret and in all the circumstances the public interest in maintaining the
exemption outweighs the public interest in disclosure. If the Customer
receives a request under FOIA relating to the Goods or the Services, it
shall notify Roche and give Roche a reasonable opportunity to make any
submissions in relation to disclosure before responding to the applicant.
Roche’s submissions shall be taken into account by the Customer before
a final decision on disclosure is made. If the Customer decides to disclose
information relating to the Goods or the Services contrary to any
submissions by Roche, it will notify Roche of its decision at least three (3)days prior to such disclosure being given to the applicant.

23.6 If any provision or part-provision of the Contract is or becomes
invalid, illegal or unenforceable, it shall be deemed modified to theminimum extent necessary to make it valid, legal and enforceable. If suchmodification is not possible, the relevant provision or part-provision shallbe deemed deleted. Any modification to or deletion of a provision or partprovision under this clause 23.6 shall not affect the validity andenforceability of the rest of the Contract.
23.7 Any notice or other communication given to a party under or inconnection with the Contract shall be in writing, addressed to that party
at its registered office (if it is a company) or its principal place of business(in any other case) or such other address as that party may have specified
to the other party in writing in accordance with this clause, and shall bedelivered personally, sent by pre-paid first class post or other next
working day delivery service, commercial courier, or email. A notice orother communication shall be deemed to have been received: if delivered
personally, when left at the address referred to in this clause; if sent by
pre-paid first class post or other next working day delivery service, at 9.00
am on the second Working Day after posting; if delivered by commercial
courier, on the date and at the time that the courier's delivery receipt issigned; or, if sent by email, one Working Day after transmission. The
provisions of this clause shall not apply to the service of any proceedings
or other documents in any legal action.

21. Force Majeure21.1 If Roche is prevented from or delayed in delivering any Goods orServices by an event of Force Majeure, Roche shall be entitled to cancel
or suspend deliveries of such Goods or Services without prejudice to its
right to payment for any Goods or Services already delivered. Roche shallnot be liable for any loss or damage arising directly or indirectly as a resultof an event of Force Majeure.
21.2 Either party may terminate a Contract if an event of Force Majeurecontinues for a period of 6 months.
22. Assignment and other dealings
22.1 Roche may at any time assign, mortgage, charge, subcontract,
delegate, declare a trust over or deal in any other manner with any or allof its rights and obligations under the Contract.

23.8 All Contracts shall be non-exclusive and shall not confer any
distribution or agency rights unless otherwise specifically agreed inwriting.
23.9 A person who is not a party to this Contract has no right under the22.2 The Customer shall not assign, transfer, mortgage, charge,
subcontract, declare a trust over or deal in any other manner with any of
its rights and obligations under the Contract.

UK Contracts (Rights of Third Parties) Act 1999 to enforce any terms of
the Contract.
23.10 The parties agree that electronic signatures as defined inRegulation (EU) 910/2014 on electronic identification and trust services
for electronic transactions in the internal market (“EU eIDAS”), and in EU
eIDAS to the extent that it was retained in UK law under the European
Union (Withdrawal) Act 2018 and amended by The Electronic
Identification and Trust Services for Electronic Transactions (Amendmentetc.) (EU Exit) Regulations 2019 (“UK eIDAS”) shall have the same legal
force and effect as original signatures.

23. General
23.1 The parties agree to comply with all applicable laws, regulations andguidelines in relation to the provision of Goods and/or Services under theContract including, but not limited to the Medical Devices Legislationand the MedTech Europe Code of Ethical Business Practice.
23.2 The rights and remedies of Roche under these Terms are cumulativeand not exclusive of any other rights or remedies that may be available toRoche under applicable law.

23.11 The Contract and any dispute or claim (including non-contractual
disputes or claims) arising out of or in connection with it or its subject
matter or formation shall be governed by and construed in accordancewith the laws of England and Wales.

23.3 Without prejudice to clause 2.3, each Contract constitutes the entire
agreement between the parties and supersedes and extinguishes any
previous drafts, agreements, undertakings, representations, warranties
and arrangements of any nature, whether in writing or oral relating to therelevant supply of Goods and/or Services. By making an offer inaccordance with clause 3.2, the Customer acknowledges that it has notbeen induced to enter into a Contract by any representation or warranty
other than those contained in the Contract and agrees that it shall haveno remedy in respect of any other such representation or warranty except
in the case of fraud.

23.12 Each party irrevocably agrees that the Courts of England and Wales
shall have exclusive jurisdiction to settle any dispute or claim (including
non-contractual disputes or claims) arising out of or in connection with
the Contract or its subject matter or formation.
Version: December 20228