Mutation detection



In these conditions of supply the following words will (unless the context otherwise requires) have the following meanings:
"Healthcare Customer Services Contact" means our customer services representatives on Tel: +44 (0)115 9739015.
"Conditions" the conditions set out below and overleaf.
"Contract" the contract between us and you for the supply of Services comprising these Conditions and any documents referred to in them.
"Data Protection Legislation" the Data Protection Act 1998 and all subordinate legislation;
"FFPE Block" means a formalin fixed paraffin embedded block;
"Favourable Test Outcome" means either of the following outcomes of the Mutation Analysis undertaken by us:

  • Activating mutation detected for the specific gene being analysed (KRAS, BRAF, NRAS, EGFR or PIK3CA as applicable to your Order);
  • No activating mutation detected for the specific gene being analysed (KRAS, BRAF, NRAS, EGFR or PIK3CA as applicable to your Order).

"Laboratory" Source BioScience UK Limited's laboratory at 1 Orchard Place, Nottingham Business Park, Nottingham NG8 6PX;

"Mutation Analysis" the laboratory testing for the purpose of the identification of specific activating mutations in a specific gene, including but not limited to, KRAS, BRAF, NRAS, EGFR and PIK3CA;

"Orders" as defined in term 4.1;
"Party" you or Source BioScience UK Limited ; "Parties" means you and Source BioScience UK Limited;
"Personal Data" any data compiled and/or processed by Source BioScience UK Limited pursuant to this Contract which identifies a living individual;
"Products" the extracted genomic DNA that is generated by Source BioScience UK Limited in preparing a Sample for Services;
"Results" means the narrative report and/or any data arising out of the results of the Services including the outcome of the Mutation Analysis undertaken by us which may be, Favourable Test Outcome or Unfavourable Test Outcome, as defined herein;
"Samples" the specimens supplied by you to us for use in respect of the Services;
"Services" means the services to be performed by us which includeMutation Analysis and involves a histopathology review of a specimen to ensure tumour tissue is present, analysis of data and the communication of all results related to Mutation Analysis to the referring clinician;
"Unfavourable Test Outcome" means the following outcome of the Mutation Analysis undertaken by us:

  • No Result for this specimen.

"we" / "us" / "our" Source BioScience UK Limited, a company registered in England and Wales with number 4078501 and whose registered office is 1 Orchard Place, Nottingham Business Park, Nottingham NG8 6PX.
"you" / "your" the company, academic institution, firm, body or any representative thereof or any other person who orders the Services.


Any reference in these Conditions to "writing" or cognate expressions includes a reference to facsimile transmission, email or comparable means of communication.


The headings are for reference only and will not affect the interpretation of these Conditions.


We reserve the right at any time without liability to correct any clerical, typographical or other similar errors or omissions made by us.


References to statutes or statutory instruments shall be deemed to be references to those statutes or statutory instruments as the same may be amended or re-enacted from time to time.





Subject to clause 2.4, these Conditions are the only conditions on which we are prepared to deal with you in relation to the Services and they will govern the provision of the Services.

These Conditions govern the Mutation Analysis services offered by Source BioScience for the KRAS, BRAF, NRAS, EGFR or PIK3CA genes;


These Conditions govern the Mutation Analysis services offered by Source BioScience for the KRAS, BRAF, NRAS, EGFR or PIK3CA genes


No terms, conditions or warranties endorsed upon, delivered with, referred to or stipulated or contained in any purchase order or other similar document delivered or sent by you to us will form part of the Contract.


No variation to, waiver of or addition to these Conditions or any representation about the Services will have any effect unless it is expressly agreed in writing and contains a specific reference to these Conditions.



You warrant that you shall comply with all applicable laws in respect of your possession of and/or use of the Samples and Results.


You shall supply us with the Samples in respect of each Order for Services in a timely manner and, in any event, in such a timescale as will allow us to meet our delivery obligations.


You shall be responsible for ensuring that the Samples are of appropriate quantity, quality and purity suitable for use by us in the performance of the Contract.


If the Sample is of human tissue origin or where relevant to any other Sample that is not of human tissue origin, you warrant that you have gained any required ethical permissions and/or consents for the work to be undertaken by us in respect of the Services and you accept that we shall have no liability if these permissions and approvals have not been properly granted.


You understand that a Favourable Test Outcome is dependant upon us receiving specimens containing sufficient viable DNA, suitable for use by us in conducting Mutation Analysis and you acknowledge that there is an inherent risk that a fraction of the Mutation Analysis performed by us under this Contract may deliver an Unfavourable Test Outcome. You agree that in all the circumstances and having regard to the nature of the testing that the limitation in 3.6 herein is reasonable.


We shall not be held liable for any Unfavourable Test Outcome unless it can be demonstrated that such Unfavourable Test Outcome is attributable to our negligent acts or omissions or our breach of any of the warranties that we have provided under this Contract. Except as otherwise provided herein, you shall be liable for fees for Services including those with an Unfavourable Test Outcome,


Where a Sample gives rise to an Unfavourable Test Outcome, we will notify you. We will undertake a further test on a new Sample at your request and expense. All additional testing will be charged at the standard fee.


Where your Sample is an FFPE Block you understand that the number of sections cut and used by us for testing will be dependent upon the size and morphology of the specimen that has been embedded in the block. You accept that in some circumstances Samples submitted by you may be used up in the course of properly undertaking the testing.


Unless otherwise agreed between us, at the conclusion of the Services, we shall return all FFPE Blocks to the original sender.


You shall co-operate with us, as we may reasonably determine, in relation to the provision of the Services.



You shall provide us with an order (the "Order") for the Services in accordance with the following procedure:

4.1.1 Where you are able to submit the Sample and request form together: - by submitting a Sample together with a completed request form relevant to the Mutation Analysis to be performed (which can be downloaded from our website or can be obtained, by request, from our Healthcare Customer Services Contact) to Source BioScience Healthcare, 1 Orchard Place, Nottingham Business Park, Nottingham NG8 6PX; or

4.1.2 Where you require us to collect the Sample on your behalf:- by submitting a completed request form applicable to the Mutation Analysis to be undertaken byus, to, Source BioScience Healthcare, 1 Orchard Place, Nottingham Business Park, Nottingham NG8 6PX together with your letter of authorisation for collection of the Sample including all relevant Sample identifier and collection address information.


You must ensure that the content of your order for Services is complete and accurate.


Unless expressly agreed otherwise in writing by us, any times specified or agreed by us for the delivery of the Services are given in good faith but are an estimate only. If no time is specified or agreed by us delivery will take place within a reasonable time following our receipt of the Samples. We will not be liable for any loss, costs, damages, charges or expenses caused directly or indirectly by a delay in the delivery of the Services.



Fees for the Services shall be as agreed between us. Unless expressly agreed otherwise in writing by us, the fees for the Services shall be our standard fees as published by us from time to time (copies of which are available by request to our Healthcare Customer Services Contact).


You understand that in normal circumstances we shall seek payment from you in respect of the Services prior to the commencement of the Mutation Analysis. Notwithstanding the foregoing in certain circumstances we may agree to invoice you for the Services following completion of the Mutatoin Analysis in which case you shall pay the fees for the Services within 30 days of receipt of an invoice from us.


Subject to this clause 5.3, all fees are exclusive of VAT, which sum shall be added to your fee or the invoice as applicable and shall be payable by you. UK VAT is applicable to transactions within the European Union including the UK. For EU based organisations, registered outside the UK, supply of a valid VAT registration number is required, if you are to avoid UK VAT. Eligible bodies in the UK may qualify for zero rating under VATA 1994, Schedule 8, Group 15. Such organisations should check their eligibility status carefully and only supply a certificate where they are fully satisfied that zero-rating applies. We reserve the right to charge VAT to you where you do not provide a valid zero-rating certificate or where instructed to do so by HMRC.


In the event that we have agreed to invoice you the fees for the Services following completion of the Mutation Analysis, no payment will be deemed to have been received until we have received the payment in full in cleared funds. Time for payment will be of the essence of the Contract.


All payments payable to us under the Contract will become due immediately on termination of this Contract despite any other provision of these Conditions.


You will make all payments due under the Contract without any deduction whether by way of set-off, counterclaim, discount, abatement or otherwise.


Any defect in the Services which is due in whole or in part to defects in the Specimens submitted by you including but not limited to, inadequate viable DNA or non viable DNA will not entitle you to terminate the Contract, reject the Services, make any deductions from the fees or claim damages in respect of such defect.


If you fail to pay us any sum due pursuant to the Contract, then without prejudice to our other rights and remedies you shall pay interest to us at the rate of interest specified from time to time in the Late Payments of Commercial Debts (Interest) Act 1998, calculated daily on such sum from the due date for payment until payment is made in full (whether before or after any judgement).



Upon receipt of Samples we shall verify that the paperwork and the accompanying Sample concur.


We shall take reasonable care of any Sample whilst in our possession.


Provided that the Samples are not obviously of unsatisfactory quality, we shall proceed with the performance of the Services


We will not be liable for any loss or damage to Samples unless such loss or damage arises as a direct result of our negligence.



Unless otherwise expressly agreed retention or return of Samples will be at your cost and risk.


Unless otherwise expressly agreed between us, we shall supply the Results to you by one of the following mechanisms: printed paper copy by post or facsimile transmission to the referring clinician (or their named deputy) at the address or, where relevant, facsimile number as specified on the Order; email at an agreed email address to be provided by you prior to the commencement of the Services ; via a secure website or on a CD Rom.


We will not under any circumstances be liable for your use of the Results.


8.1 Each Party shall keep strictly confidential all information concerning the business and affairs of the other together with any information disclosed under this Contract (including, without limitation, the Samples) obtained from the other either pursuant to this Contract or prior to and in contemplation of it, shall use the same exclusively for the purposes of this Contract, and shall disclose the same only to those of its directors, Consultants and employees to whom and to the extent that such disclosure is reasonably necessary for the purposes of this Contract.
8.2 The obligations of clause 8.1 above shall survive the termination of this Contract but shall not apply to any information which:
  8.2.1 the recipient can demonstrate was already in its possession and at its free disposal prior to receipt under the circumstances mentioned at clause 8.1 above;
  8.2.2 is subsequently disclosed to the recipient without any obligation of confidence by a third party who has not derived it directly or indirectly from the disclosing party; or
  8.2.3 enters the public domain through no act or default of the recipient, its agents or employees.


You will ensure that the Sample you provide is in good condition and suitable for our use in the performance of the Contract and while we will use reasonable endeavours to verify any relevant aspects of the Sample, we accept no responsibility for its suitability for our use in the performance of the Contract.


Any defect in the Services which is due in whole or in part to defects in the Sampple will not entitle you to terminate the Contract, reject the Services, make any deductions from the Contract price or claim damages in respect of such defect.


You will keep us indemnified in full against all liability, loss, damage, injury, claim, action, demand, expense or proceeding awarded against or incurred by us as a result of or in connection with our use of the Sample.



We warrant that we shall perform the Services using reasonable skill and care and in accordance with all applicable laws.


10.1 Save for the warranties given by us at clause 9, all warranties, conditions and other terms (whether implied by statute or otherwise) are, to the fullest extent permitted by law, excluded from the Contract.
10.2 Nothing in these Conditions excludes or limits our liability for fraudulent misrepresentation or for any death or personal injury caused by our negligence.
10.3 Subject to clause 10.2, we will not be liable to you in contract, tort (including, without limitation, negligence), misrepresentation or otherwise for any:
  10.3.1 economic loss of any kind (including, without limitation, loss of use, profit, anticipated profit, business, contracts, overhead recovery, revenue or anticipated savings);
  10.3.2 any damage to your reputation or goodwill: or
  10.3.3 any other special, indirect or consequential loss or damage
(even if we have been advised of such loss or damage) arising out of or in connection with the Contract.


Subject to the provisions of clause 9 and clause 10.2, our total liability in contract, tort (including, without limitation, negligence), misrepresentation or otherwise arising out of or in connection with this Contract (a "Default") will be limited to the price paid or payable in respect of the Services to which the Default relates.


The provisions of this clause 10 shall survive the termination or expiry (for whatever reason) of this Contract.


11.1 We may terminate the Contract immediately if:
  11.1.1 you fail to pay the price on the due date;
  11.1.2 you are in breach of any term of the Contract and have failed to remedy such breach within 28 days of receipt of written notice specifying the breach and requiring it to be remedied;


there is a material change in the ownership or control of you; or
  11.1.4 you are wound up or become insolvent or have a receiver or administrative receiver appointed or suffer the appointment or the presentation of a petition for the appointment of an administration or any equivalent or analogous event occurs in any other jurisdiction.


The termination of the Contract (howsoever arising) will be without prejudice to any rights and remedies which may have accrued to either party.


Any Conditions which impliedly have effect after termination or expiry will continue to be enforceable notwithstanding termination or expiry.



We will not be liable to you or be deemed to be in breach of these Conditions by reason of any delay in performing or failure to perform any of its obligations under these Conditions if such delay or failure was beyond our reasonable control including, without limitation, fire, flood, strike or other industrial action of whatever nature. If we are unable to perform our obligations under these Conditions we will promptly notify you of the nature and extent of the circumstances in question.



You shall not without our prior written consent assign or transfer the Contract or any part of it to any other person.


We may without your prior written consent assign, transfer or subcontract the Contract or any part of it to any other person.


Each of rights or remedies under these Conditions are without prejudice to any other right or remedy which we may have under these Conditions or otherwise.


Any notice or other document to be served under the Contract must be in writing and may be delivered or sent by prepaid first class post or facsimile transmission. Any notice or document shall be deemed served, if delivered at the time of delivery, if posted, 48 hours after posting and if sent by facsimile transmission, at the time of transmission.


If any provision of the Contract is found by any court, tribunal or administrative body of competent jurisdiction to be wholly or partly illegal, invalid, void, unenforceable or unreasonable it will, to the extent of such illegality, invalidity, voidness, unenforceability or unreasonableness, be deemed severable and the remaining provisions of the Contract and the remainder of such provision shall continue in full force and effect.


Failure or delay by either party in exercising any right or remedy provided by the Contract or by law will not be construed as a waiver of such right or remedy or a waiver of any other right or remedy.


A person who is not a party to the Contract will have no right under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of the Contract.


The Contract will be governed by English law and the parties submit to the exclusive jurisdiction of the English courts.