S4Encrypt Covid-19 PCR and Antibody Testing Service Level Agreement

S4Encrypt will facilitate the provision of COVID-19 PCR and Antibody Testing services through Screen4, one of the world’s leading providers of testing services. This agreement refers to both S4Encrypt and Screen4, depending on the context of the reference.

Terms of Agreement:

1.            Definitions and Interpretation

1.1          In this Agreement, the following terms have the following meanings:

Antibody Test: qualitative detection of antibodies (including IgA, IgG, IgM) to SARS-CoV-2 in human serum and plasma for the determination of antibodies against SARS-CoV-2. The test is intended as an aid in the determination of the immune reaction to SARS-CoV-2.

Customer(s): The organisation who facilitates the collection of the Sample on behalf of the donor for delivery to Screen4 and its associated laboratories. Under the terms of this agreement, the employer is the Customer of S4Encrypt.

The Customer Consent Form: A consent form signed by each Customer authorising S4Encrypt to order the Antibody Test, a key part of the chain of custody for the sampling process.

Antibody Test Kit: the kit provided by Screen4 to the Customer will be provided / utilised by the clinician / phlebotomist and will be delivered by the phlebotomist attending the testing location.

Antibody Test  Request:  the Customer will provide a list of employees who they wish to have tested. This will cnclude first name, last name, email address and mobile phone number. This will be used by S4Encrypt to schedule the tests and to request the attendance of a clinician with the requisite number of test kits.

Antibody Test Result:  the result produced by the Antibody Test which will be either positive, negative or fail, or indicate the level of antibodies in the system – Assay dependant.

COVID Barcode: the barcode allocated by Screen4 to each Antibody Test Kit.

Data Protection Legislation: all applicable laws and regulations relating to the processing of personal data and privacy, including the General Data Protection Regulation 2018 and the Data Protection Act 2018 each as may be amended or replaced from time to time. 

Donor: the employee of the Customer from whom the blood sample for the Antibody Test or the swab for the PCR Test will be taken.

Fee: the fee due for the Antibody Test as set out initially in Clause 6.3 of this Agreement or as otherwise agreed in writing (for which purpose email will suffice) between S4Encrypt and the Customer. The fee for each test will be set out in the quotation issued by S4Encrypt for each Customer.

PCR Test: this is the Polymerase Chain Reaction Test, and uses a throat and a nasal swab to detect the presence of SARS-CoV-2.

PCR Test Result: the result of the test after analysis of the swab provided by the donor. This will be either positive, negative or inconclusive if the sample did not contain sufficient material for an effective test.

Personal Data: has the meaning given to it in the Data Protection Legislation.

Sample: a blood sample required to detect Covid19 antibodies in a manner approved by Public Health England (PHE) or Medicines and Healthacre Products Regulatory Agency (MHRA).

Scope of Services: the specific operational areas of service not detailed within these general terms and conditions. Please refer to the details provided in the Scope of Service.

Working Day(s): a day other than a Saturday, Sunday or public holiday in England.

1.2          Words in the singular include the plural and in the plural include the singular.

1.3          Headings shall not affect the interpretation of this Agreement.

1.4          References to Clauses are references to the conditions of this Agreement.

1.5          The word ‘including’ shall mean ‘including but not limited to’.

2.             Formation of the Contract

2.1          This Agreement governs the supply of the Covid-19 PCR or Antibody Test to the exclusion of all other terms and conditions of business, including any that the Customer may provide, and any terms implied by custom or practice to the maximum extent permitted by law.

2.2          The Customer acknowledges that it has not relied on any statement, promise, representation, assurance or warranty made or given by or on behalf of S4Encrypt which is not set out in this Agreement.

2.3          Each of the parties is an independent organisation and nothing in this Agreement shall be construed to imply that there is a relationship between the parties of the Customer and S4Encrypt, nor are the parties engaging in any joint venture. 

Please note the sections 3,4 and 5 of this agreement should be read in conjunction with the Scope of Service.

3.             Ordering

3.1          The Customer may from time to time complete the Antibody Test Request Form to order the service, or via other agreed method as part of the Scope of Service.

3.2          S4Encrypt shall facilitate to the Customer the PCR or Antibody Test Kits to be delivered by the phlebotomist after receipt of:

(a)           a list of the employees to be tested. The S4Encrypt Covid testing system will facilitate the allocation of employss to specific test events.

(b)           confirmation that each donor has completed the Antibody Consent Form.  The Customer acknowledges that S4Encrypt relies on this confirmation in order to complete the PCR or Antibody Test; and

(c)           online payment to S4Encrypt from the Customer of the total Fee due for the number of PCR or Antibody Tests as required under the agreed terms of payment. Normal terms are payment in advance of provision of services.

3.3          The Customer has no right to cancel an order for the PCR or Antibody Test Kit once payment has been received, and S4Encrypt will not offer a refund on any unused PCR or Antibody Test Kits.

3.4 S4Encrypt may cancel an order for the PCR or Antibody Test Kit if:

          (a) it cannot facilitate the provision of the testing service to the testing location specified in the test event definition; and/or

        (b) it cannot obtain authorisation for payment and has not received payment in full from the customer. 

3.5          If S4Encrypt cancels an order for a PCR or Antibody Test under Clause 3.4, then its sole liability shall be to notify the Customer and refund any sums paid within 30 days. 

4.            Sample

4.1          Before providing a Sample, each donor must voluntarily complete the Consent Form. S4Encrypt shall be under no obligation to carry out a PCR or Antibody Test or refund all or part of the Fee in respect of any Customer unless the Customer provides written confirmation of compliance with this requirement in accordance with Clause 3.2(b).

4.2          S4Encrypt shall be under no obligation to carry out a PCR or Antibody Test or refund all or part of the Fee in respect of a Sample that has not been taken in accordance with the agreed process.

4.3          To enable the Sample to be tracked to help maintain validity of the Sample, Samples should be sent to Screen4 on the day that the Sample is collected and by courier or Royal Mail Special Delivery. This will be facilitated by the phlebotomist performing the extraction of blood samples or taking of throat and nasal swabs. The normal procedure is for the phlebotomist to arrange for the samples to be transferred to the laboratory for analysis.

4.4          The form provided to the client to allocate the COVID identity code number to the Donor must not be returned to the Lab with any Sample or otherwise and must be returned securely to S4Encrypt.

5.             PCR or Antibody Test

5.1          Screen4 shall use reasonable endeavours to carry out the PCR or Antibody Test and send the Antibody Test Results to the Customer within two (2) Working Days of receipt of the Sample at the laboratory premises. Delivery dates for the PCR or Antibody Test Results are approximate only and S4Encrypt will not be held liable for any delay in delivery or receipt.

5.2          S4Encrypt shall provide the PCR or Antibody Test Result to the Customer in electronic format.

                (Details of the format and mechanism to be agreed with S4Encrypt)

5.3          S4Encrypt will provide a method for the Customer to link the COVID identity code to a donor.

5.4          Screen4 will make every reasonable endeavour on behalf of S4Encrypt to analyse the Sample.  However, no PCR or Antibody Test Result shall be delivered, (or the Test Result shall be a fail) and no part of the Fee shall be refunded if the Sample cannot be analysed because:

(a)           the Customer has not obtained the Sample in accordance with the agreed process; and/or

(b)           the Sample has degraded for any reason including because of a delay in delivery or damage during delivery.

In such circumstances, at the request of the Customer, S4Encrypt shall arrange for the Customer to be provided with a new PCR or Antibody Test Kit at the Customer’s additional cost. 

6.             Fees and payment

6.1          All Fees payable by the Customer under the Contract are exclusive of value added tax. If any value added tax is due on the all or part of the Fees, the Customer shall pay such value added tax at the prevailing rate. 

6.2          S4Encrypt makes no warranty or representation that any third party, including any governmental healthcare programme, will pay for the PCR or Antibody Test.

6.3          The Customer shall pay to S4Encrypt a Fee for each PCR or Antibody Test Kit based on the numbered quotation provided by S4Encrypt and signed by the Customer.

6.4          S4Encrypt may only increase the Fees following at least one month’s prior written notice to the Customer and with the Customers written agreement (for which email will suffice) but only with respect to future Antibody Tests.

7.             Data Protection

7.1          The Customer shall only provide to S4Encrypt such Personal Data relating to a donor as is agreed and required to perform the Service.

7.2          COVID-19 is a new “Notifiable Disease” and all confirmed occurrences must be reported to the proper officer of the local authority, according to Public Health (Control of Disease) Act 1984 and the Health Protection (Notification) Regulations 2010. Accordingly, on receipt of a confirmed COVID-19 diagnosis, the Customer shall notify Public Health England in order to comply with its obligations under the Health Protection (Notification) Regulations 2010 for the purpose of informing PHE

8.             Liability

If the PCR or Antibody Test Kits are incomplete or damaged on delivery, the Customer shall notify S4Encrypt within 5 days of receipt.  The sole liability of S4Encrypt shall be to facilitate either the replacement of the Antibody Test Kits or the refund of the Fee paid at its discretion. 

8.2.         The COVID-19 rt-PCR CE-IVD assay used by Screen4 to perform the Antibody Test is highly sensitive and specific, with no known cross-reactivity. However, false-negative and false-positive results may occur due to, for example, improper Sample collection or degradation of viral RNA.

8.3.         A positive Antibody Test Result indicates a suspected COVID-19 infection. S4Encrypt recommends that the Customer should notify the donor immediately on receipt and the donor should discuss with their healthcare provider the Antibody Test Result along with all other available clinical information, to determine the best treatment decisions or actions required.

8.4          S4Encrypt shall have no liability for any use made of the information provided in the PCR or Antibody Test  Result, any decisions taken, or for any costs incurred by Customer and/or the donor or physician or any third party  in consequence of such use, advice or decisions that do not form part of the process agreed with S4Encrypt for the use of the result by a donor within a digital wallet.

8.5          The PCR or Antibody Test should be used as a convenient and confidential way of getting tested quickly for a COVID-19 infection. The Test Results are not intended to replace medical advice, nor should they be used as a full diagnosis, or to prescribe medication without consulting an appropriate medical professional.

8.6          Subject to Clause 8.8, S4Encrypt shall not be liable to the Customer or the donor whether in contract, tort (including negligence and breach of statutory duty), or otherwise for any:

(a)           error or defect in the PCR or Antibody Test Result as a result of any inaccurate or incomplete information supplied by the Customer;

(b)           loss of data or materials, including the Sample and/or the Test Result arising as a result of the acts or omissions of the postal or courier service or any other delivery service used by the Customer to transport the Sample to Screen4;

(c)           indirect or consequential loss (including lost profits, loss of revenue or sales, loss of use, diminution of goodwill, business interruption or the like) arising whether or not S4Encrypt has been informed or advised of the possibility of such losses.

8.7          Subject to the provisions of this Clause 8, the total liability of S4Encrypt to the Customer in respect of all losses arising under or in connection with this Agreement, whether in contract, tort, or otherwise, shall in no circumstances exceed the Fees paid for the single PCR or Antibody Test  by the Customer that is the subject of the claim.

8.8          Nothing in the Agreement limits or excludes the liability of S4Encrypt for breach of its obligations under section 12 of the Sale of Goods Act 1979 and/or section 2 of the Supply of Goods and Services Act 1982; death or personal injury resulting from negligence; or fraud or fraudulent misrepresentation.

8.9          If at any time S4Encrypt is prevented or hindered from carrying out its obligations under this Agreement for reasons beyond its control, including strikes, lock-outs or other industrial disputes (whether involving the workforce of Screen4 or any other party), failure of a utility service or transport network, act of God, war, riot, civil commotion, malicious damage, compliance with any law or governmental order, rule, regulation or direction, accident, breakdown of plant or machinery, fire, flood, storm or default of suppliers or subcontractors, including shortage of supplies from suppliers required by S4Encrypt to perform the PCR or Antibody Test, it  shall notify the Customer accordingly and, save for the obligations of S4Encrypt set out in Clauses 3.5, 9, 10, 11 and 12, the obligations of S4Encrypt under this Agreement shall be suspended until the obligations can be performed.

9.            Compliance

9.1          Each party shall comply with its obligations under the Bribery Act 2010 and under its own bribery policies in relation to its rights and obligations under this Agreement

9.2          Each party, by itself or through others, must not engage, participate or otherwise become involved in any activity or course of action that is illegal, deceptive, misleading or unethical.

10           Confidential Information

10.1        Subject to Clause 7, S4Encrypt agrees to keep confidential the existence of this Agreement, PCR or Antibody Test Results, and any Personal Data shared with it under this Agreement. However, nothing in this Clause 10 shall prevent S4Encrypt from using the PCR or Antibody Test Results on a completely anonymised basis for the purpose of research and analysis and as evidence of clinical practice.

11           Term and Termination

11.1        This Agreement shall commence on the date on which he S4Encrypt quotation was signed and dated by the customer and shall continue unless terminated by either party giving the other party one month’s prior notice in writing.

11.2        S4Encrypt shall continue to provide the PCR or Antibody Test in respect of any Sample received from the Customer using the Antibody Test Kit, notwithstanding termination of this Agreement. 

12           General

12.1        No amendment or variation of this Agreement shall be effective unless it is in writing and signed by the duly authorised representative of each of the parties.

12.2        The Customer shall not be entitled to assign or otherwise deal with its rights or obligations under this Agreement except with the prior written consent of S4Encrypt.

12.3        If any part of this Agreement shall be found by any court of competent jurisdiction to be invalid or unenforceable but would be valid and enforceable if certain words were deleted or added, such provisions shall apply with such amendments as required to make them valid and enforceable.  In any event, any invalidity or unenforceability shall not affect the other provisions of this Agreement which shall remain in full.

12.4        Any notice given under this Agreement shall be in writing and shall be served by delivering the notice personally, or by pre-paid mail to the address for each party set out in this Agreement (or such other address as either party notifies to the other from time to time) and with respect to the Customer with a copy via email  (delivery of such copy shall not itself constitute valid notice). Any such notice shall be deemed to have been received if delivered personally at the time of delivery or if delivered by mail 2 Working Days from the date of posting.

12.5        This Agreement shall be governed by and construed in accordance with the laws of England and Wales and each party hereby irrevocably submits to the exclusive Jurisdiction of the English Courts.