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 in connection with any clinical trial;
“Clinigen Affiliate” means any person that directly or indirectly through one or more intermediaries’ Controls, is controlled by or is under common control with Clinigen Group plc and any legal entity that is consolidated within the group annual accounts of Clinigen Group plc.
“Contract” means any contract between You and Us incorporating these T&Cs for the sale of Products and/or the provision of the Services;
“Control” and, with correlative meanings, the terms “controlled by” and “under common control with” 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 any Clinical Trial Products;
“Liability” means liability for any and all damages, claims, proceedings, actions, awards, expenses, costs and any other losses and/or liabilities;
“Products” means General Products and Clinical Trials Products;
“Quotation” means, where provided by Us, the form completed and signed by Us and You, confirming the price for the Products and Services and other variable details specific to your order;
“Services” means without limitation the sourcing, procurement and/or distribution of medicinal products, comparator drugs, other health products, medical supplies and equipment, and managed access, clinical trials, pharmaceutical, clinical consultancy and advisory services and/or work;
“We, Us, Our” means any one or more of the following companies: Clinigen Group plc (a company registered in England and Wales with company number 06771928); Clinigen Healthcare Limited (a company registered in England and Wales with company number 06252720); Clinigen Inc. (a company registered in the State of Delaware with company number 4477064); and any Clinigen Affiliate of Clinigen Group plc;
“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 Orders
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.
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 accepted by signature of both You and Us within the time period specified on the Quotation. Quotations may be withdrawn by Us at any time during this 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.
2.4 You shall be responsible for the accuracy of an order and for giving Us any information necessary to perform the Contract.
2.5 The Contract between You and Us 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.
2.6 No order which has been accepted by Us may be cancelled by You except with the agreement in writing of Us and on terms that You shall 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
2.7 If You approve sample Products supplied by Us then You shall have no claim in respect of, nor any right to reject, any Products provided those Products are of the same description, specification, quality and fitness for purpose as the sample.
3.1 We will use Our reasonable commercial endeavours to ensure delivery to the agreed delivery address and/or performance on the dates specified. 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 shall not entitle You to cancel the order. They are also subject to any matter beyond Our reasonable control.
3.2 If Products are to be delivered in instalments, each delivery shall constitute a separate and distinct contract and 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.
3.3 Where Services are to be performed in stages, each stage shall constitute a separate and distinct contract and 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.
3.4 We shall not be required to fulfil orders for Products and/or Services in the sequence in which they are placed.
3.5 You shall procure during normal working hours that We have free rights of access to the designated address to deliver Products or to perform 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 (“Working Days”).
3.6 If You 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 any other Products and/or Services and to treat the Contract as repudiated by You.
3.7 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 despatch the Products to You at Your expense and risk and/or store the Products at Your expense and risk until despatch and/or collection.
3.8 Products which are alleged to be damaged or defective must be notified to Us within 3 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 damage or defect, and if requested by Us must be returned to Us within 10 Working Days of the date of delivery or collection in their original boxes and packaging. In relation to Products which are alleged to be damaged either a refund or credit will be offered to You at Our discretion if we accept that they are damaged. In relation to Products which are alleged to be defective clause 9 below shall apply.
3.9 Products regarded by You as being short-delivered must be notified to 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.
3.10 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.
4. Postponement and Cancellation
4.1 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 then You shall 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 as if delivery and/or performance had not been postponed.
4.2 If you purport to cancel the Contract and/or refuse to accept delivery of ordered Products and/or the performance of any ordered Services You will:
4.2.1 have no further recourse against Us under the Contract; and
4.2.2 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.
5. Price, Payment and Credit Limit
5.1 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 and/or insurance costs and are exclusive of any applicable taxes and duties for which You shall additionally be liable.
5.2 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.
5.3 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.
5.4 Unless otherwise agreed in writing by Us or specified in the Quotation:
5.4.1 Our terms of payment are 30 days from the date of invoice;
5.4.2 time for payment shall be of the essence;
5.4.3 all invoices issued on a pro-forma basis are due for immediate payment.
5.5 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.
5.6 Any monies received by Us from You may be applied by Us at Our option against any additional administrative costs and/or interest charged on overdue sums prior to application against any principal sums due from You against which it may be applied in any order We decide.
5.7 We may invoice each delivery of Products and/or stage of the Services separately and render an invoice to You any time and/or at any stage during performance of the Contract.
5.8 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.
5.9 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.
5.10 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 immediately due for payment.
5.11 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.
6. Specification, Intellectual Property Rights and Confidentiality
6.1 Specifications supplied by Us to You shall only be approximate unless stated on the Quotation or otherwise agreed in writing.
6.2 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.
6.3 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. We shall have no Liability for errors in any specification or details supplied by You and You are solely responsible for their accuracy. 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.
6.4 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):
6.4.1 in the Products and/or their packaging shall be owned by Us or the relevant manufacturer (as appropriate) absolutely;
6.4.2 arising from the Services shall be owned by Us absolutely.
6.5 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 6.4 above and/or to assist Us in the application, registration, renewal and/or protection of such intellectual property rights.
6.6 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.
6.7 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.
6.8 We may terminate the licence granted under clause 6.7 at any time with immediate effect upon notice if any of the events in clause 8.1 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 6.4) arising from the Services otherwise than in accordance with the Contract.
7. Property and Risk
7.1 Risk in the General Products shall pass to You at the time of delivery.
7.2 Delivery shall be deemed to occur:
7.2.1 where Products are delivered by Us to You: at the time when the Products arrive at the designated delivery address; or
7.2.2 where Products are collected by You: on collection from the designated collection address and in any event, no later than 3 Working Days after You have been notified that the Products are available for collection in accordance with clause 3.7.
7.3 We shall retain title of the General Products until We have received payment in full in cash or cleared funds of all sums due and/or owing in relation to the General Product.
7.4 Until We have received full payment for General Products supplied to You, You shall store the General Products separately from any products or goods belonging to You or any third party and the General Products 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.
7.5 In the event that there is to be 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 7.2.
7.6 Until title in the General Products has passed to You, You shall properly store and protect the General Products and keep the General Products insured for the price at which the General Products were sold to You against all insurable risks and shall hold any proceeds of such policy of insurance relating to the General Products on trust for Us and account to Us for any proceeds of such policy of insurance relating to the General Products 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 5.5 but shall be set off against such liability
7.7 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.
8.1 If You:-
8.1.1 fail to make payment to Us when due;
8.1.2 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;
8.1.3 persistently breach any one or more terms of the Contract;
8.1.4 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;
8.1.5 appear from Your credit rating to be financially unable to meet Your obligations under the contract; and/or
8.1.6 appear reasonably to Us to be about to suffer any of the above events; then We shall have the right, without prejudice to any other remedies, to exercise any or all of the rights set out in clause 8.2.
8.2 If any of the events in clause 8.1 occur in relation to You then:-
8.2.1 We may enter, without prior notice, any of Your premises (or premises of third parties) 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;
8.2.2 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;
8.2.3 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;
8.2.4 We may cancel, terminate and/or suspend without Liability to You any agreement with You; and/or
8.2.5 All monies owed by You to Us shall become due and payable immediately.
8.3 Additionally, if any of the events in clause 8.1 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 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).
9. Replacement of Defective Products.
9.1 Any Products which are alleged to be defective must be notified to Us within 3 Working Days of the delivery or collection of such Products, 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, and where reasonable and if requested by Us be returned to Us for inspection. We will alert the Product manufacturer as quickly as reasonably possible and 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..
9.2 We will not accept Product returns except solely where agreed by Us in accordance with these T&Cs or in relation to a Product or batch recall carried out by Us.
10. Limitations On Liability
10.1 We shall have no Liability:
10.1.1 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;
10.1.2 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;
10.1.3 for defective Products and/or Services where the defect has been caused or contributed to by You to the extent so contributed;
10.1.4 to You if the price for the Products and/or the Services has not been paid in full by the due date for payment;
10.1.5 to You for defective Products and/or Services, Products not despatched or Products damaged or lost in transit unless the event is notified to Us within the appropriate time limit set out in the Contract;
10.1.6 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;
10.1.7 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;
10.1.8 for any consequential losses, including but not limited to: loss of profits and/or damage to goodwill; economic and/or other similar losses; special damages and indirect losses; and/or business interruption, loss of business, contracts, opportunity and/or production.
10.2 You shall:
10.2.1 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. If You do not do so We shall have no Liability to You;
10.2.2 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 before We have any Liability to You;
10.2.3 be under a duty to mitigate any loss, damage, costs or expenses that You may suffer (including by maintaining an adequate stock of Products).
10.3 Our total Liability to You shall not exceed:
10.3.1 in respect of any claims relating to Clinical Trials Products, an amount equal to 10 (ten) per cent. of the value of the Clinical Trials Products to which the relevant claim relates; or
10.3.2 in respect of any other claims, £250,000.
10.4 Each of the limitations and/or exclusions in the Contract shall be deemed to be applicable for each of:
10.4.1 Liability for breach of contract;
10.4.2 Liability in tort (including negligence);
10.4.3 Liability for breach of statutory duty;
10.4.4 Liability for breach of Common Law, except clause 10.3 above which shall apply once only in respect of all the said types of Liability; and
10.4.5 All warranties, terms, conditions and duties implied by law relating to fitness, quality or adequacy are excluded to the fullest extent permitted by law.
10.5 Nothing in the Contract shall exclude or limit Our Liability for death or personal injury due to Our negligence or any Liability which is due to Our fraud or any other liability which it is not permitted to exclude or limit as a matter of law.
10.6 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:
10.6.1 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;
10.6.2 any breach of contract, any tortious act and/or omission and/or any breach of statutory duty by You; and/or
10.6.3 Our use of specifications, details and/or stipulations supplied by You.
11. Data Privacy
11.1 Where We process your personal data in relation to the purchase of Products or Services under the Contract We will comply with any applicable data protection legislation currently in force, including but not limited to (i) the Data Protection Act 2018, the General Data Protection Regulation ((EU) 2016/679) and any national implementing laws, regulations and secondary legislation, as amended or updated from time to time and (ii) any successor legislation to the GDPR or the Data Protection Act 2018.
12. Anti-Bribery and Corruption
12.1 Both We and You shall not, and shall procure that Our and Your 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.
13. Modern Slavery
13.1 We shall and We shall procure that our directors and employees shall at all relevant times (a) comply with the provisions of the Modern Slavery Act 2015; (b) 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.
14.1 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.
14.2 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.
14.3 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.
14.4 All third party rights are excluded and no third party shall have any right to enforce the Contract. Any right of a third party to enforce the Contract may be varied and/or extinguished by agreement between the parties to the Contract without the consent of such third party.
14.5 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