Updated 30.1.25
1. Definitions
In these terms and conditions (“T&Cs”), the following definitions shall apply:
“Clinical Trial Products” means any products ordered from Us by You including without limitation pharmaceutical compounds and drugs, medical equipment and medical supplies which are ordered by You for use strictly in connection with any clinical trial;
“Clinigen Subsidiary” means any person that directly or indirectly is controlled by Clinigen Limited;
“Contract” means any contract between You and Us incorporating these “T&Cs” for the sale of Products and/or the provision of the Services;
“controlled by” means the power to direct or cause the direction of the management or policies of a person whether through the direct or indirect ownership of voting securities, by contract, resolution, regulation or otherwise;
“Field of Use” means the field of use and/or application for which You have engaged Us to perform the Services as stated in the “Quotation” where provided by Us and agreed by You or as otherwise agreed by Us and You in writing in an order placed by You and accepted by Us;
“General Products” means any products ordered from Us by You including without limitation pharmaceutical compounds and drugs, medical equipment and medical supplies and any ancillary Services required, but excluding the “Clinical Trial Products”;
“Liability” means liability for any and all damages, claims, proceedings, actions, awards, expenses, costs and any other losses and/or liabilities;
"Order" means Your purchase order form, or Your written acceptance of Our “Quotation”, as the case may be;
“Products” means “General Products” and “Clinical Trial Products”;
“Quotation” means, where provided by Us, the form, proposal or similar document completed and signed by Us and You, confirming the details and price for the “Products” and / or “Services” and other variable details specific to your "Order";
“Sanctions Laws” means any law, regulation or wider measure applicable to either You or Us relating to the adoption, implementation and enforcement of economic sanctions, export controls and trade embargos;
“Sanctioned Person” means any individual, entity or body (i) specifically designated under “Sanctions Laws”, or (ii) owned or controlled by any individual, entity or body specifically designated or listed under “Sanctions Laws”, or (iii) acting for or on behalf of any individual, entity or body specifically designated or listed under “Sanctions Laws”;
“Services” means without limitation: (i) the distribution, sourcing and/or procurement of medicinal products, comparator drugs, other health products, medical supplies; and equipment; and (ii) such other services as You may request from Us and We may agree to deliver including managed access, clinical trials, regulatory affairs, pharmacovigilance, clinical strategy, regulatory and medical writing, pharmaceutical, clinical consultancy and advisory services and/or work;
“We, Us, Our” means Clinigen Limited or any “Clinigen Subsidiary”;
“You, Your, Yourself” means the person, organisation or other business entity whose order for “Products” and/or “Services” is accepted by Us and to whom We subsequently supply the “Products” and/or “Services”.
2. Basis of Contract and Quotations
2.1 These T&Cs shall govern the agreement between You and Us to the exclusion of any other terms or conditions, including the exclusion of any terms or conditions which You may purport to apply under any purchase order, confirmation order or similar document, except that in the event of any conflict between these T&Cs and any signed agreement between You and Us the signed agreement shall take precedence.
2.2 No oral warranties or representations shall bind Us. No variation of these T&Cs shall be binding on Us unless agreed in writing between You and one of Our authorised representatives or contained in the relevant “Quotation” where provided by Us. Our employees, sub-contractors and/or agents are not authorised to make any representations or warranties concerning the “Products” and/or “Services” unless confirmed by Us in writing. You acknowledge that You do not rely on any representation and/or warranty that has not been made in accordance with these T&Cs.
2.3 “Quotations” will not form part of the Contract unless (i) accepted by signature by both You and Us within the time period specified on the “Quotation” (if any) ("Quotation Offer Period") or (ii) the Contract comes into effect in accordance with clause 2.3. “Quotations” may be withdrawn by Us at any time during the Quotation Offer Period by oral or written notice. Notwithstanding this, We shall have the right to refuse to accept any orders placed for “Products” and/or “Services” under the “Quotation”.
2.4 All of these T&Cs shall apply to the supply of both “Products” and “Services” except where application to one or the other is specified.
3. Orders
3.1 In respect of “Products”, the Contract shall come into effect on Our acceptance of Your "Order". No "Order" shall be deemed accepted by Us until confirmed in writing by Our authorised representatives.
3.2 In respect of “Services”, the Contract shall come into effect on Your written acceptance of the “Quotation”, or the parties agreeing a work order, statement of work or similar document, or we start the “Services” at your request.
3.3 You shall be responsible for the accuracy of an "Order" and for giving Us any information necessary to perform the Contract.
3.4 If You approve sample “Products” supplied by Us then You shall have no claim in respect of, nor any right to reject, the “Products”, provided those “Products” are of the same description, specification, quality and fitness for purpose as the sample.
4. Delivery of Products and Performance of Services
4.1 We shall deliver the “Products” to the location set out in the "Order" or such other location as the parties may agree ("Delivery Location"). We will use Our reasonable commercial endeavours to ensure delivery and/or performance on the dates specified in the "Order", but dates for delivery and/or performance are estimates only and are not guaranteed. Time is not of the essence in relation to such dates and late delivery or performance shall not entitle You to cancel the "Order". They are also subject to any matter beyond Our reasonable control.
4.2 Delivery shall be deemed to occur:
4.2.1 where “Products” are delivered by Us to You: at the time when the “Products” arrive at the Delivery Location; or
4.2.2 where “Products” are collected by You: on collection from the designated collection address and in any event, no later than 3 Working Days (defined below) after You have been notified that the “Products” are available for collection in accordance with clause 4.9.
4.3 Where we require the return of any packaging material, You shall make any such packaging materials available for collection at such times as We shall reasonably request. Returns of packaging materials shall be at Our expense.
4.4 If “Products” are to be delivered in instalments, each delivery shall constitute a separate and distinct contract. Failure by Us to deliver, or a claim by You regarding, any instalment under a separate and distinct contract shall not entitle You to repudiate and/or terminate the Contract as a whole or any other separate and distinct contract or "Order".
4.5 We shall not be required to fulfil "Orders" for “Products” and/or “Services” in the sequence in which they are placed.
4.6 You shall procure during normal working hours that We have free rights of access to the Delivery Location or the relevant location to perform the “Services”. You shall be responsible at Your own cost for all arrangements to unload the “Products” when delivered to You. Unless otherwise agreed in writing, delivery of “Products” and performance of “Services” will be made between 0800 hours and 1700 hours, Monday to Friday, excluding public holidays in the UK and the country of the Delivery Location (“Working Days”).
4.7 If You fail or refuse to take delivery of any “Products” and/or to allow performance of the “Services” then We shall be entitled to withhold delivery and/or performance of those “Products” and/or “Services” and to treat the Contract for that particular "Order" as repudiated by You. If any delay to take delivery of any “Products” is caused by You, We may store the “Products” for at least 7 Working Days in accordance with clause 4.9, and charge You for all related costs and expenses (including insurance).
4.8 If We agree that the “Products” are to be collected from Us by You then You shall collect the “Products” within 3 Working Days of being notified that the “Products” are ready for collection. If the “Products” are not collected by You within this time We may store the “Products” at Your expense and risk until collection.
4.9 If after 7 Working Days you do not rectify the failure or refusal to take delivery of “Products” or to allow performance of the “Services” under clause 4.9, or You do not collect the “Products” from Us within the time period specified in clause 4.9, We may in Our discretion sell or otherwise dispose of part or all of the “Products” and will no longer make the “Services” available to you.
4.10 Where the quantity of “Products” delivered is not in accordance with the "Order", You must notify Us within 3 Working Days of delivery or within 1 day of delivery in relation to cell therapy or gene therapy “Products”. We will remedy any shortfall in delivery where We consider an error in the "Order" has occurred solely by Us.
4.11 Where “Services” are to be performed in stages, each stage shall constitute a separate and distinct contract. Failure by Us to deliver, or any claim by You in respect of, any stage under a separate and distinct contract shall not entitle You to repudiate and/or terminate the Contract as a whole or any other separate and distinct contract or "Order".
4.12 If We accept that any “Services” we have supplied have not been supplied in accordance with the Contract, We will perform such “Services” again so that they are in accordance with the Contract.
5. Damaged and Defective Products
5.1 Any “Products” which are alleged to be defective or damaged must be notified to Us within 5 Working Days of delivery or collection, or within 1 day of delivery or collection in relation to cell therapy or gene therapy “Products”, with a written report of the alleged defect or damage, and where reasonable and if requested by Us be returned to Us within 10 Working Days of the date of delivery or collection in their original boxes and packaging for inspection. We will alert the Product manufacturer as quickly as reasonably possible and:
5.1.1. if the “Products” are confirmed as being defective then a credit for the price of the defective “Products” or replacement will only be issued by Us as authorised by the manufacturer concerned, and whichever option is provided is at the discretion of the manufacturer and/or Us; and
5.1.2. if the “Products” are confirmed as being damaged then either a refund or credit will be offered to You at Our discretion.
5.2 We will not accept Product returns except solely where agreed by Us in accordance with these T&Cs or in relation to a Product recall.
5.3 If, after the time periods referred to in clause 5.1 have passed and You have not raised any allegations of defective or damaged “Products”, You are deemed to have accepted the “Products”.
6. Postponement and Cancellation
6.1 We may comply with reasonable requests by You for postponement of delivery and/or performance but shall be under no obligation to do so. Where delivery and/or performance is postponed at Your request and We have agreed to that postponement, then We may require that You pay all Our costs and expenses incurred as a result including, but not limited to, reasonable charges for storage, transportation and insurance. In addition You shall be obliged to pay for the “Products” and/or “Services” in accordance with clause 7 as if delivery and/or performance had not been postponed.
6.2 If You wish to cancel an "Order" which has been accepted by Us, you must notify us immediately. Except where cancellation occurs in accordance with clause 8.1, in Our discretion, we may agree to the cancellation of the "Order" and termination of the relevant Contract. Our agreement to terminate the Contract for that "Order" will only be effective upon one of Our authorised representatives agreeing to it in writing. Notwithstanding our acceptance of a cancellation, We may require in Our discretion that You indemnify Us in full against all loss (including loss of profit), costs (including the cost of all labour and materials used), damages, charges and expenses incurred by Us as a result of cancellation.
6.3 If you purport to cancel an "Order" without our consent and/or refuse to accept delivery of ordered “Products” and/or the performance of any ordered “Services” You will:
6.3.1 have no further recourse against Us under the Contract; and
6.3.2 indemnify and keep Us indemnified against any and all lost profits, costs (including increased administration costs and legal costs on a full indemnity basis), expenses, damages and any other loss and/or Liability suffered by Us as a result.
7. Price, Payment and Credit Limit
7.1 The price of the “Products” and/or the “Services” shall be as specified in the “Quotation” or where no “Quotation” is signed by Us and You, as otherwise specified in writing by Our authorised representatives and confirmed in a written "Order". Except as otherwise stated, prices are exclusive of any transport, packaging, customs clearance charges and/or insurance costs, and any applicable taxes and duties for which You shall additionally be liable.
7.2 Where any taxable supply for Value Added Tax or similar tax purposes is made under the Contract by Us to You, You shall, on receipt of an invoice from Us, pay to Us such additional amounts in respect of such Value Added Tax or similar tax as are chargeable on the supply of the “Services” or “Products” at the same time as payment is due for the supply of the “Services” or “Products”.
7.3 We may increase Our prices where an increase in costs, expenses and/or materials is suffered by Us (including, without limitation, any factor outside of Our control such as any foreign exchange fluctuation, currency regulation and alteration of duties). You will be informed in advance and in writing by Us of any price increases for the “Products” and/or the “Services” as soon as practicable after we become aware of any changes. You may cancel without Liability any Contract in relation to which the price is to be increased, provided that the notice of cancellation is received by Us before the change becomes effective.
7.4 If You do not cancel the Contract for the provision of the “Products” and/or “Services” before the price increase becomes effective then the price increase shall take effect for the “Products” and/or “Services” ordered by You.
7.5 Unless otherwise agreed in writing by Us or specified in the “Quotation”:
7.5.1 Our terms of payment are 30 days from the date of invoice;
7.5.2 time for payment shall be of the essence;
7.5.3 all invoices issued on a pro-forma basis are due for immediate payment; and
7.5.4 payment of an invoice shall be in full and in cleared funds to a bank account nominated in writing by Us.
7.6 If You fail to make any payment in full on the due date then, without prejudice to any other right or remedy available, We may charge You any reasonable additional administration costs and/or interest (both before and after judgment) on the amount unpaid at the rate of 4% per annum above the base rate from time to time of Our bank.
7.7 We may invoice each delivery of “Products” and/or stage of the “Services” separately. We will render an invoice to You at any time and/or at any stage during performance of the Contract unless alternative invoicing arrangements are agreed in writing.
7.8 You shall pay all sums due to Us without any set-off, deduction, counterclaim and/or any other withholding. Payment shall not be deemed to be made until We have received either cash or cleared funds in respect of the full amount outstanding.
7.9 If payment in full is not made to Us when due then We may withhold or suspend future or current deliveries of the “Products” and/or performance of the “Services” and delivery and/or performance under any other agreement with You and/or cancel the Contract.
7.10 If any “Services” are cancelled, the Contract is terminated, or delivery and/or performance is suspended before completion of the “Services”, We are entitled to be paid on a quantum meruit basis for that part of the “Services” performed. We may invoice You accordingly and such monies shall be due for payment in accordance with clause 7.5.
7.11 We may set a reasonable credit limit for You. We may refuse to accept orders for “Products” and/or “Services” and/or suspend or withhold delivery of “Products” and/or “Services” if such “Products” and/or “Services” would result in You exceeding or you have exceeded Your credit limit.
8. Specification, Intellectual Property Rights and Confidentiality
8.1 Specifications supplied by Us to You shall only be approximate unless stated on the “Quotation” or otherwise agreed in writing. If there is an error in the specification made by Us in the “Quotation” or as otherwise agreed in writing by Us, where that error is material and it has been relied upon by You, You may cancel that part of the Contract only which is affected by the error without Liability due to the cancellation in respect of that part cancelled.
8.2 The quantity, quality, description and/or specification for the “Products” and/or the “Services” shall be that set out in Your "Order". You are responsible for checking the "Order" and satisfying Yourself that any specification given is accurate and adequate for the “Products” and/or “Services”.
8.3 We shall have no Liability for errors in any specification or details supplied by You. We will use all reasonable endeavours to provide final products to the same specification as proofs or samples, however, no guarantee is expressed or implied that the entire consignment of “Products” will have the same specification as the sample.
8.4 We warrant that, where “Products” are supplied by description and not sample, on delivery the “Products” will comply with their description in the "Order" in all material respects. We shall supply the “Services” in accordance with the "Order" in all material respects. We warrant that the “Services” will be provided using reasonable care and skill.
8.5 We shall use reasonable endeavours to meet any performance dates for the “Services” specified in the "Order", but any such dates shall be estimates only and time shall not be of the essence for the performance of the “Services”. We reserve the right to amend the “Services” if necessary to comply with any applicable law or regulatory requirement, or if the amendment will not materially affect the nature or quality of the “Services”, and We shall notify You in any such event.
8.6 You shall not make any modification to the “Products” or their packaging, nor alter, remove, or tamper with any trade marks used on or in relation to the “Products” and/or “Services”. All intellectual property rights (including without limitation all patents, copyright, design rights (whether registered or unregistered), trade marks (whether registered or unregistered) skill and/or know-how and other similar rights, whether existing now and/or in the future, wherever existing in the world together with the right to apply for protection of the same):
8.6.1 in the “Products” and/or their packaging shall be owned by Us or the relevant manufacturer or Product intellectual property owner (as appropriate) absolutely;
8.6.2 arising from the “Services” shall be owned by Us absolutely (excluding materials provided by You to Us in order to perform the “Services”).
8.7 You will at Our cost and request, do all acts and/or things and execute all documents and/or deeds to give effect to clause 8.5 above and/or to assist Us in the application, registration, renewal and/or protection of such intellectual property rights.
8.8 We reserve absolutely all rights to be identified as the authors of any works arising and/or generated from the “Services” in accordance with s78(2) of the Copyright Designs and Patent Act 1988 together with any right We may have to object to the alteration and/or derogatory treatment of the copyright granted by s80 of that Act. We may utilise for the benefit of Our other customers any skill and/or know-how developed and/or acquired in the performance of the “Services”.
8.9 We grant to You a non-exclusive royalty-free licence to use within the Field of Use all intellectual property rights owned by Us which arise solely from the “Services” except that We shall be entitled to use such intellectual property rights inside and outside of the Field of Use for ourselves and for conducting other research and/or projects for Our other customers. All rights and licences not specifically and expressly granted to and conferred upon You by the Contract are for all purposes reserved to Us.
8.10 We may terminate the licence granted under clause 8.8 at any time with immediate effect upon notice if any of the events in clause 10.2 occur in relation to You and/or if You use, attempt to use and/or We reasonably suspect that you intend to use the intellectual property rights (specified in clause 8.5) arising from the “Services” otherwise than in accordance with the Contract.
8.11 You grant to Us a fully paid-up, non-exclusive, royalty-free licence to copy and modify any materials provided by You to Us for the term of the Contract for the purpose of providing the “Services”.
8.12 Each party undertakes that it shall not at any time during the Contract, and for a period of five years after termination or expiry of the Contract, disclose to any person any confidential information concerning the business, affairs, customers, clients or suppliers of the other party, except as permitted by clause 8.12.
8.13 Each party may disclose the other party's confidential information:
8.13.1 to its employees, officers, representatives, contractors or subcontracts or advisers who need to know such information for the purposes of exercising the party's rights or carrying out its obligations under or in connection with the Contract. Each party shall ensure that its employees, officers, representatives or advisers to whom it discloses the other party's confidential information comply with this Clause 8; and
8.13.2 as may be required by law, a court of competent jurisdiction or any governmental or regulatory authority.
8.14 No party shall use any other party's confidential information for any purpose other than to exercise its rights and perform its obligations under or in connection with the Contract.
9. Risk and Title in Products
9.1 Risk in the “General Products” under an "Order" shall pass to You at the time of delivery as identified in clause 4.2.
9.2 Title to the “General Products” passes to You when risk passes according to clause 9.1, except that we shall retain title to the “General Products” under an "Order" until We have received payment in full in cash or cleared funds for all sums that are or that become due in relation to those “General Products”. At any time before title to the “General Products” passes to You, We may still sue You for any sums that are due.
9.3 Until title to the “General Products” passes to You, You shall:
9.3.1 store them separately from any products or goods belonging to You or any third party and they must be clearly identified as being Our property. You agree that Our employees and/or agents shall be entitled to enter Your premises to check compliance with this clause, and You agree to provide them with access;
9.3.2 not destroy, deface or change in any way any identifying mark or packaging of those “General Products”;
9.3.3 maintain them in satisfactory condition and keep them insured on Our behalf for their price against all insurable risks with an insurer that is reasonably acceptable to Us. You shall hold any proceeds of such policy of insurance on trust for Us and account to Us for any proceeds upon receipt of the same. Any monies received from You by Us in accordance with this clause shall not discharge Your liability to pay the price for the “General Products” plus interest accrued in accordance with clause 7.6 but shall be set off against such liability; and
9.3.4 give Us such information as We may reasonably require from time to time relating to the “General Products” and Your ongoing financial position.
9.4 If any amount payable by You under the "Order" becomes overdue or You enter into bankruptcy, liquidation or administration, We may terminate Your right to possession and use of the “General Products”, and We may enter Your premises or those of a third party where the “General Products” are stored in order to recover them. Title to the “General Products” shall revert to Us when You exercise any right to reject the “Products”, cancel the "Order" or otherwise return the “Products” to us.
9.5 In the event that there is no payment due for the “General Products” provided by Us to You, title shall pass to You at the time of delivery as defined in clause 4.2.
9.6 Title to the “Clinical Trial Products” and liability for risk of loss or damage shall pass from Us to You immediately after We have purchased and ourselves acquired title to the relevant “Clinical Trial Products”. You shall be responsible for arranging insurance in respect of the “Clinical Trial Products” immediately after We have purchased the relevant “Clinical Trial Products”. We shall only be liable for any damage caused to the “Clinical Trial Products”, on a contractual or non-contractual basis, to the extent that such damage is caused by Our wilful misconduct or recklessness. In the event, however, that the You have not pre-paid for the “Clinical Trial Products”, and subsequently fail to pay in accordance with the terms of the Contract, We have the right to take title back and We may enter Your premises or those of a third party where the “Clinical Trial Products” are stored in order to recover them.
10. Termination and Default
10.1 Without affecting any other right or remedy available to it, either party may terminate a Contract by giving the other party not less than 12 months' written notice.
10.2 If You:-
10.2.1 fail to make payment to Us when due;
10.2.2 breach the terms of the Contract and, if capable of remedy, have not remedied the breach within 10 Working Days of receiving notice requiring it to be remedied;
10.2.3 persistently breach any one or more terms of the Contract;
10.2.4 pledge or charge any “Products” which remain Our property, or cease or threaten to cease to carry on business, or propose to compound with Your creditors, apply for an interim order under Section 252 Insolvency Act 1986 or have a Bankruptcy Petition presented against You, enter into voluntary or compulsory liquidation, have a receiver, administrator or administrative receiver appointed over all or any of Your assets, or take or suffer any similar action in any jurisdiction;
10.2.5 appear from Your credit rating to be financially unable to meet Your obligations under the contract; and/or
10.2.6 appear reasonably to Us to be about to suffer any of the events described in 10.2.4 and 10.2.5;
then We shall have the right, without prejudice to any other remedies, to exercise any or all of the rights set out in clause 10.3.
10.3 If any of the events in clause 10.2 occur in relation to You then:-
10.3.1 We may enter, without prior notice, and You shall give us access to, any of Your premises (or premises of third parties, of which You shall procure that We are given access to) where “Products” owned by Us may be and repossess and dispose of or sell any “Products” found which are owned by Us so as to discharge any sums due to Us under this Contract or any other agreement with You;
10.3.2 We may require You not to re-sell or part with the possession of any “Products” owned by Us until You have paid in full all sums due to Us under the Contract or any other agreement;
10.3.3 We may withhold delivery of any undelivered “Products” and/or performance of any “Services” and stop any “Products” in transit and/or cease any “Services” in progress;
10.3.4 We may cancel, terminate and/or suspend without Liability to You any agreement with You; and/or
10.3.5 All monies owed by You to Us shall become due and payable immediately.
10.4 Additionally, if any of the events in clauses 10.2.4 – 10.2.6 occurs in relation to You, We shall have a lien over all property or goods belonging to You in Our possession in respect of all sums due from You to Us, and upon the termination of the Contract if monies due to Us from You have not been paid within 7 Working Days of termination We may sell any property or goods over which We have a lien (and You agree that We may give good title for such property and/or goods) and shall apply the proceeds of sale firstly in discharging any costs or expenses of sale, secondly in repaying any interest or expenses owed by You to Us, thirdly in payment of any principal sums owed to Us and fourthly We shall account to You for the remainder (if any).
11. Limitation Of Liability: Your attention is drawn particularly to this clause
11.1 We have obtained insurance cover in respect of Our legal liability. The limits and exclusions in this clause reflect that insurance cover and an appropriate allocation of risk between the parties. You are responsible for making Your own arrangements for the insurance of any excess loss.
11.2 We shall have no Liability:
11.2.1 for any loss arising from the use of the “Product” by an end user unless such Liability can be demonstrated to have arisen as a direct result of our wilful misconduct or recklessness in handling the supply of the “Product”;
11.2.2 for any defect in the “Products” caused or contributed to as a result of the “Products” being used for display or demonstration purposes or being handled by You or Your customers;
11.2.3 for defective “Products” and/or “Services” where (i) the defect has been caused or contributed to by You to the extent so contributed; (ii) You continue to use the “Products” or “Services” after giving notice of defect under clause 5; (iii) the defect arises because You failed to follow Our oral or written instructions as to the storage, installation, commissioning, use or maintenance of the “Products”; (iv) the defect arises as a result of Our following instructions from You to alter or amend the “Products”; (v) You alter or repair the “Products” without Our consent; or (vi) the defect arises as a result of wilful damage or negligence by You;
11.2.4 to You for breach of warranty where the “Products” differ from their description as a result of changes made to ensure they comply with applicable statutory or regulatory standards;
11.2.5 to You if the price for the “Products” and/or the “Services” has not been paid in full by the due date for payment;
11.2.6 to You for defective or damaged “Products” and/or “Services” and incorrect quantity of “Products” delivered unless the event is notified to Us within the appropriate time limit set out in the Contract;
11.2.7 to You for “Products” not despatched or “Products” lost in transit unless the event is notified to Us within 3 Working Days of such event occurring;
11.2.8 for damage, loss, liability, claims, costs or expenses caused or contributed to by the continued use of defective “Products” and/or “Services” after a defect has become apparent or suspected or should reasonably have become apparent to You;
11.2.9 to You to the extent that You are covered by any insurance policy and You shall ensure that Your insurers waive any and all rights of subrogation they have against Us;
11.3 You shall:
11.3.1 give Us an opportunity to remedy any matter for which We are liable before You incur any costs and/or expenses in remedying the matter Yourself;
11.3.2 produce to Us written evidence of any claims you allege that We are liable together with written details of how the loss was caused and the steps taken by You to mitigate the loss;
11.3.3 be under a duty to mitigate any loss, damage, costs or expenses that You may suffer (including by maintaining an adequate stock of “Products”).
11.4 Nothing in the Contract or any "Order" shall exclude or limit Our Liability for: (i) death or personal injury caused to Our negligence; (ii) fraud or fraudulent misrepresentation; or (iii) any matter in respect of which it would be unlawful for Us to exclude or restrict Liability.
11.5 We shall have no Liability for any: (i) loss of profits; (ii) loss of sales or business; (iii) loss of or damage to goodwill; (iv) business interruption; (v) loss of business, contracts or opportunity; (vi) loss of production; or (vi) special, indirect or consequential loss or damage whether in contract, tort (including negligence) breach of statutory duty, misrepresentation or otherwise.
11.6 Subject to clause 11.5, Our maximum aggregate Liability to You arising under or in connection with the Contract, whether in contract, tort (including negligence), breach of statutory duty, misrepresentation, restitution or otherwise, will be limited to:
11.6.1 in respect of any claims relating to “Clinical Trials Products” an amount equal to ten (10) per cent of the value of the “Clinical Trials Products” to which the relevant claim relates;
11.6.2 in respect of any claims relating to the “Services” a sum equivalent to the aggregate of all fees paid by You to Us in the previous 12 (twelve) months prior to the date of the claim for “Services” provided under the particular "Order" to which the “Services” relate; and
11.6.3 in respect of any other claims £250,000 (two hundred and fifty thousand pounds Sterling).
11.7 All warranties, terms, conditions and duties implied by law relating to fitness, quality or adequacy are excluded to the fullest extent permitted by law.
11.8 You will indemnify and keep indemnified Us against any and all losses, proceedings, lost profits, damages, awards, expenses, costs (including increased administration costs and legal costs on a full indemnity basis), claims, actions and any other losses and/or liabilities suffered by Us and arising directly or indirectly from or due to:
11.8.1 any loss arising from the use of the “Product” by an end user unless such Liability can be demonstrated to have arisen as a direct result of Our actions in handling the supply of the “Product”;
11.8.2 any breach of contract, any tortious act and/or omission and/or any breach of statutory duty by You;
11.8.3 any breach by You of “Sanctions Laws”; and/or
11.8.4 Our use of specifications, details and/or stipulations supplied by You.
12. Data Privacy
12.1 Both parties will comply with all applicable requirements of data protection legislation in force from time to time, including the Data Protection Act 2018, the UK GDPR, Privacy and Electronic Communications Regulations 2003 (SI 2003/2426)and the EU GDPR (if directly applicable). If required for the “Services” the parties will enter into a separate data processing agreement.
13. Anti-Bribery and Anti-Corruption
13.1 Both parties shall not, and shall procure that its respective directors, employees, agents, representatives, contractors or sub-contractors shall not, engage in any activity, practice or conduct which would constitute an offence under any anti-bribery and anti-corruption laws, regulations and codes in any jurisdiction, including but not limited to the Bribery Act 2010 and, where applicable, the Foreign Corrupt Practices Act 1977.
14. Modern Slavery
14.1 Both parties shall and shall procure that its directors and employees shall at all relevant times (i) comply with the provisions of the Modern Slavery Act 2015; and (ii) not engage in any activity, practice or conduct that would constitute an offence under the Modern Slavery Act 2015 if such activity, practice or conduct were carried out in the UK.
15. Sanctions
15.1 Both parties acknowledge the existence of “Sanctions Laws”. Each party shall ensure that it complies with all applicable “Sanctions Laws” to which it is subject, including those of any jurisdiction where that party is located or incorporated.
15.2 Neither party shall take any action or refrain from taking any action which would, or would in the reasonable opinion of the party subject to “Sanctions Laws”, cause such party to breach such “Sanctions Laws”.
15.3 You shall carry out appropriate due diligence with regards to any third party to whom the “Products” or “Services” are re-sold, re-supplied, re-exported, or re-transferred. You shall ensure that You have no knowledge or reasonable cause to suspect that any activities related to the “Products” or “Services” will, either directly or indirectly, involve any “Sanctioned Person” or will otherwise be in breach of “Sanctions Laws”.
15.4 In the event of either party becoming a “Sanctioned Person”, the other party may terminate any Contracts with immediate effect and without payment of compensation.
16. General
16.1 No waiver by Us of any breach of the Contract shall be considered as a waiver of any subsequent breach of the same provision or any other provision. If any provision of the Contract is held by any competent authority to be invalid or unenforceable in whole or in part the validity of the other provisions of the Contract and the remainder of the affected provision shall be unaffected and shall remain in full force and effect. Any provision of the Contract that expressly or by implication is intended to come into or continue in force on or after termination of the Contract shall remain in full force and effect.
16.2 Either party shall have no Liability to the other for any delay in performance of the Contract (other than in relation to payment) where such delay is due to events outside the affected party's reasonable control including without limitation to acts of God, war, flood, fire, labour disputes, subcontractor delays, strikes, lock-outs, riots, civil commotion, malicious damage, explosion, governmental actions and any other similar events. If a party is affected by such events then time for performance shall be extended for a period equal to the period that such events delayed performance.
16.3 You shall not assign Your interest in the Contract (or any part) without Our written consent. We may assign, transfer or sub-contract all or any part of our obligations and/or interest in the Contract to any third party without notice.
16.4 The Contract does not give rise to any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of the Contract.
16.5 The Contract is governed by and interpreted in accordance with English law and the parties agree to submit to the exclusive jurisdiction of the English courts.