the experts in stem cell processing
Sample Transfer and Storage Agreement
Scan this QR code with your smartphone to view our Storage Agreement online.
Dear Parent or Donor, This is the Cells4Life Transfer of Sample Service Agreement and it is a legal document. We request that you read it very carefully as it sets out the entire agreement between us. All of your information will be held in strict confidence. For your reference, this document is divided into the following parts: Section 1 Donor information Section 2 Services and pricing information Section 3 Statement of consent Section 4 Sample transfer and storage agreement Section 5 Payment methods and Payment plans To transfer the storage of a sample to Cells4Life we require the Donor to provide consent to our Service and record it in Section 3 of this Agreement. Where the Donor is under the age of eighteen in the UK, sixteen in Scotland or is otherwise deemed legally incapable of providing consent, we require the Donor’s Parents or Legal Guardian to consent on their behalf. Please note we require one Agreement per Donor to be completed. If you have any questions please do not hesitate to contact us.
Yours faithfully
Wayne M Channon Chairman
Cells4Life | 2
Section 1 - Donor information Donor information
________________________________________________________________ _______________________________________ Postcode: _______________
Country: ________________________________________________________________ Home telephone: ________________________________________________________________ Mobile telephone: ________________________________________________________________ Work telephone: ________________________________________________________________ Fax: ________________________________________________________________ Email address: ________________________________________________________________ Note:
Please ensure the Parents’ information is provided where Donor is under the age of eighteen in the UK, sixteen in Scotland, or is otherwise deemed legally incapable of providing consent.
Parents’/Legal Guardian information Mother’s name: ______________________________________________________ (“Parent”) Father’s name: ______________________________________________________ (“Parent”) Address: ________________________________________________________________ (if different) ______________________________________ Postcode: ________________ Country: ________________________________________________________________ Home telephone: ________________________________________________________________ Mobile telephone: ________________________________________________________________ Work telephone: ________________________________________________________________ Fax: ________________________________________________________________ Email address: ________________________________________________________________
Sample details Name of current storage organisation: Contact name: Contact number: (if known) Patient ID or reference: Type of sample(s):
_______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________ _______________________________________________________
the experts in stem Pagecell 3 processing | 3
Donor information
Donor’s name: ______________________________________________________ (“Donor”) Date of birth: ________________________________________________________________ Reference number: __________________________________________________ (where known) Donor’s address: ________________________________________________________________
Section 2 - Services and pricing information
Services
and pricing information
The Cells4Life Sample Transfer and Storage Service provides:
HTA licensed storage facility
Temperature controlled shippers
Access to scientific and medical professionals
Dedicated courier service
Storage of your sample can be paid for using our Prepaid 25 Year Storage Plan or our Annual Storage Plan. For both Storage Plans, we offer 6 or 12 month payment plans. For further information, please contact our Customer Support Team on +44 (0) 1444 873 950.
Storage Plans Prepaid 25 Year Storage Plan £845 This includes an initial deposit of £195 for the activation of your account and storage setup and an administrative fee of £300 which is payable upon the successful transfer of your sample. This includes a prepaid 25 year Storage Fee of £350.
Annual Storage Plan £495 This includes an initial deposit of £195 for the activation of your account and storage setup and an administrative fee of £300 which is payable upon the successful transfer of your sample. An annual Storage Fee of £501 is payable after the first year of storage.
Options 6 month payment plan
£80
Payment of the initial deposit followed by 5 equal monthly instalments. 12 month payment plan Payment of the initial deposit followed by 11 equal monthly instalments.
£160
Total to pay: _______
Cost analysis Prepaid 25 Year Annual Payment Storage Plan Storage Plan
1. Initial deposit at time of booking 2. Administrative fee on successful transfer 3. Storage Fee on successful transfer Total to pay:
Notes:
Subject to annual review. All deposits are non-refundable. 1
Cells4Life | 4
£195 £300 £350 £845
£195 £300 £50 p.a. £495
Section 3 - Statement of consent Consent
If you change your mind you can withdraw your consent at any time. We encourage you to seek advice from other sources and to ask any questions you might have before committing to this Service.
Information about the law
Cells4Life is fully licensed to undertake the storage, distribution and import/export of human tissue and cells under HTA licence number 11083 as required by UK and European law. You currently have a sample containing stem cells in storage with another service provider and you want this to be transferred to Cells4Life for continued storage. Upon receipt of your completed Agreement we will arrange for your sample and all paperwork regarding the procurement, processing, testing and storage of your sample to be forwarded to Cells4Life. Your sample will be transported to us under the appropriate conditions, as required by law. It is a legal requirement that we hold full test results pertaining to your sample. In the event full test results are not available, we will advise you of this and request your sample and a maternal blood sample, where relevant, is retested. You acknowledge that until full test results are obtained, your sample will be stored with Cells4Life as noncompliant. Unless otherwise instructed, your sample will remain cryogenically preserved with Cells4Life for the term of this agreement.
Records and disposal Cells4Life will maintain a hard copy and electronic copy register of all information in confidence.
Disposal
Upon your request, Cells4Life will arrange for your sample to be destroyed. This will be done by autoclaving and incineration.
By signing this I confirm I have received sufficient information to make an informed
Signature of Mother, Legal Guardian or Donor Signature: ____________________________________________________________________________ Date: ______________________________________
Signature of Father, Legal Guardian or Donor Signature: ____________________________________________________________________________ Date: ______________________________________
the experts in stem cell processing | 5
of consent
Transfer of sample and paperwork
Statement
The transfer and storage of tissue and cells for human application is a procedure that requires your informed consent. As required by UK law, persons providing consent must be capable of understanding what the Service entails and all possible outcomes. If a person is not legally able to consent then this must be done by a Parent or Legal Guardian.
Section 4 - Sample transfer and storage agreement
Sample
transfer and storage agreement
This document is important and you will be legally bound by it. Please read it carefully, seek legal and medical advice and let us know if you have any questions before signing. This Agreement is between (insert full name of Parents, Legal Guardians or Donor): ________________________________________________________________________________________ and _________________________________________________________(referred to in this Agreement as “you”)
AND Cells4Life Group LLP (Company number OC357135), whose registered office is at Units 2 & 3 Oak House, Woodlands Office Park, Albert Drive, Burgess Hill, RH15 9TN (referred to in this Agreement as “Cells4Life”, “we” or “us”). The terms and conditions contained within this Agreement together with Section 7 (where relevant) form a legally binding agreement between us which relates to the collection, storage, distribution and import/export of a blood or saliva sample of you or your child(ren). In signing this Agreement, you acknowledge and agree that Cells4Life is in no way providing medical advice, care or treatment to you or anyone else.
1.
General terms
1.1. Definitions 1.1.1. “Sample” means the tissue sample(s) received by Cells4Life together with any stem cells. 1.1.2. “Child” means your child if your child is the Donor. 1.1.3. “Deposit” means the Deposit as detailed in the “Payment methods” section set out in Section 6 of this Agreement. 1.1.4. “Donor” refers to the person (either you or the Child) in relation to whose Sample we are to provide the Service. 1.1.5. “Service” means the transfer and storage of Sample(s). This does not include the procurement of the Sample(s). 1.1.6. “Service Level Agreement” means the agreement between Cells4Life and the current storage provider of your Sample in relation to the transfer of the Sample. 1.1.7. “Statement of consent” means Section 3 of this Agreement which details the Cells4Life service and which records your consent to the service particulars. 1.1.8. “Storage Fee” means the fees as detailed in the “Payment methods” section set out in Section 5 of this Agreement. 1.1.9. “Third Party Costs” means the cost of the Collection Kit, laboratory fees, any applicable courier fees and any applicable charges made by medical practitioners for procuring the Sample.
2.
Your instructions
2.1.
Unless the Donor is deemed competent by law, we will act upon the written instructions of you or such other person as authorised by law in relation to the storage and use of the Sample. Otherwise we are required to act upon the instructions of the Donor in relation to the further storage and use of the Sample. However, please note that this Agreement is between you and us and you remain liable for the payment of any fees which arise under the terms of this Agreement for the duration of the term of this Agreement. Except where this Agreement is terminated in accordance with clause 9.2 the Sample shall at all times remain the absolute and sole property of the Donor and Cells4Life holds the Sample on the terms set out in this Agreement.
2.2.
3.
Delivery of Sample to Cells4Life
3.1. 3.2.
The Sample will be delivered to Cells4Life in accordance with current legislation. We will notify you that we have received the Sample within 48 hours of receipt.
Cells4Life | 6
4. Warranties 4.1. 4.2.
Limit of Cells4Life’s liability
IMPORTANT Subject to the terms set out in this Clause our liability to you under the Terms of this Agreement is as follows: OUR LIABILITY TO YOU IN RESPECT OF ANY FAULT RELATING TO THE Service is limited to the cost of reimbursing any Storage Fee paid by you. Our liability to you in respect of ANY LOSS OR DAMAGE DUE TO OUR NEGLIGENCE, OR THE NEGLIGENCE OF ANY OF OUR EMPLOYEES, shall be limited to DIRECT LOSSES YOU SUFFER WHICH WE COULD HAVE REASONABLY FORESEEN AT THE DATE OF THIS AGREEMENT UP TO THE MAXIMUM AMOUNT of one million pounds (£1million). Nothing in this Agreement seeks to exclude our liability for the following: 5.3.1. ANY DEATH OR PERSONAL INJURY CAUSED AS A DIRECT RESULT OF OUR NEGLIGENCE, OR THE NEGLIGENCE OF OUR EMPLOYEES 5.3.2. Fraud or fraudulent misrepresentation. We shall in no way be liable to you for any loss or damage suffered by you as a result of your failure to comply with the terms of this Agreement. Subject to Clauses 5.1, 5.2 and 5.3 we exclude all other liability for damage or loss suffered in connection with this Agreement whether direct or indirect to the maximum extent permitted by law. You acknowledge and understand that we shall not be liable to you, or be considered to be in breach of this Agreement, because of any delay in performing, or any failure to perform, any of our obligations if the delay or failure was due to your acts or omissions or to any other cause beyond our reasonable control. Should there be loss of the Sample whilst in the care of Cells4Life, which was beyond our control, we will reimburse a proportion of the Storage Fee prepaid (on a pro rata basis for the remaining storage term paid for.
5.1. 5.2.
5.3.
5.4. 5.5. 5.6.
5.7.
6. Fees 6.1. 6.2.
6.3.
6.4.
The Storage Fee is detailed in Section 6 and is payable by you to Cells4Life in accordance with the terms of Payment methods. The Fees are intended to cover the costs of administration, transportation and secure storage for the relevant period as detailed therein. Any further fees which may be chargeable to you will be notified to you at the time, if applicable. This may include courier service charges which will be charged to you in the event that you withdraw the Sample in accordance with section 13. We may also charge for our costs incurred in transferring the Sample to another service provider if you wish us to do so in accordance with section 12. If any payment due under this Agreement remains unpaid for a period of more than 14 days after the date on which it fell due, Cells4Life shall be entitled to be paid an additional fee of £50 to cover the administration costs incurred in dealing with a late payment. For the avoidance of doubt the figure of £50 is a genuine attempt by Cells4Life to estimate the costs it would incur in those circumstances. All of our fees are quoted to include any applicable VAT.
the experts in stem cell processing | 7
transfer and storage agreement
5.
Sample
4.3.
We warrant to you that the Service will be provided using reasonable care and skill and, provided that you comply with your obligations, in accordance with this Agreement. If the Donor is the Child, you warrant to us that: 4.2.1. you are the Parent/Legal Guardian of the Child with legal responsibility for the Child; 4.2.2. you have the right to enter into this Agreement on behalf of the Child; and 4.2.3. entering into this Agreement does not violate any local laws or regulations. IMPORTANT – You acknowledge and accept that we cannot give any guarantees with respect to any: 4.3.1. suitability of Sample for the future treatment of diseases; 4.3.2. successful treatment of diseases through Sample transplantation; 4.3.3. advantages of Sample transplantation over other types of treatment using stem cells; or 4.3.4. successful transplantation of the Sample; and you enter this Agreement with this understanding.
7. Term
Sample
transfer and storage agreement
7.1. 7.2.
Subject to the rights of termination set out in this Agreement the term of this Agreement shall commence on the date Cells4Life receives this signed Agreement and the Storage Fee and shall continue for an initial period (“the Initial Term”) of ten (10) years. Upon expiry of the Initial Term, and subsequently the anniversary thereof, this Agreement may be repeatedly renewed for further periods of one (1) year (“the Renewal Period”) upon payment of the appropriate Storage Fee which shall be notified to you at the time.
8.
Your cancellation and termination rights
8.1.
You may cancel this Agreement upon notifying us in writing as follows: 8.1.1. for any reason, within seven (7) working days of Cells4Life receiving your signed consent; or 8.1.2. in the event that: (a) a resolution is passed or a winding up order is made for the winding up of Cells4Life; or (b) an order is made for the appointment of an administrator; or (c) Cells4Life enters into a voluntary arrangement with any of its creditors; or 8.1.3. at any time after the expiry of the Initial Term by giving us not less than thirty (30) days’ notice. In the event that you terminate this Agreement under Clauses 8.1.1 we shall refund the Storage Fee that you have paid to us less any Third Party Costs which have been incurred. In the event that you decide to terminate the Agreement under Clause 8.1.3 we shall refund the Storage Fee that you have paid or that is due to us under the terms of this Agreement on a pro rata basis for the balance of any storage term remaining as detailed in Section 6 less any Third Party Costs which have been incurred. In the event that you decide to terminate the Agreement under clause 8.1.2. or 8.1.3. we shall at your written request (or that of the Donor in the event that the Donor is 18 or over at the time), upon payment of all sums due to Cells4Life under this Agreement and at your cost use our reasonable endeavours to transfer the Sample to an alternative storage provider of your choice, provided that transfer to such a storage provider is in compliance with applicable legislation.
8.2. 8.3.
8.4.
9.
Our cancellation and termination rights
9.1.
We may terminate this Agreement and stop providing the Services to you at any time in the event that we are unable to continue to perform the services for any reason beyond our reasonable control including (but not limited to) an Act of God, fire, flood or other natural disaster, war, riot, insurrection or other civil commotion, strike lock-out or other industrial action, embargoes, shortage of labour, unavailability of raw materials or a change in the law. In such circumstances, we will endeavour to notify you and, if you request us to do so and if we are able to do so, we will transfer the Sample to your alternative nominated storage provider at your risk and cost. We shall refund the balance of any Storage Fee you have paid on a pro rata basis for the balance of any storage term remaining as detailed in Payment methods. We may terminate this Agreement if you fail to make any payment in respect of the Storage Fee within thirty (30) days after such payment falls due. If this Agreement is terminated in accordance with this clause 9.2 ownership of the blood will pass to us and we may then dispose of or otherwise deal with the Sample as we see fit including, but not limited to, allogeneic use (i.e. for use on a person other than the Child) without any further reference to you. In those circumstances clause 10 shall not apply. We may (without limiting any other remedy available) at any time terminate this Agreement by giving notice to you if you do not comply with any of your obligations under this Agreement and (if possible) fail to resolve the issue within thirty (30) days after being required to do so. Upon the termination of this Agreement for any reason (except where indicated that there is no requirement of further reference to you) we will, at your request, transfer the Sample to another storage provider at your risk and cost. Such transfer to another storage provider will only be effected where we are legally permitted to do so and once any sums due to Cells4Life from you in respect of the Storage Fee has been paid. If you do not request the Sample to be transferred to another storage provider within thirty (30) days of the termination of this Agreement, or you fail to make all due payments within thirty
9.2.
9.3. 9.4.
Cells4Life | 8
9.5.
Release of the Sample
This clause 10 shall apply except where this Agreement has been terminated in accordance with clause 9.2, in which case it will cease to be of any effect. IMPORTANT – We will only release the Sample in accordance with legislation prevailing at the time, and on the written request of you (or your Child if over eighteen (18)) and the treating medical practitioner provided that the request gives the Child’s unique reference number, or if release is required by any Court Order. We will only release the Sample to a designated hospital address, or an alternative storage provider, and provided all Fees due having been paid. IMPORTANT – We will not release the Sample where to do so would contravene any law. Any notice, from you or a physician, must state the name of the individual and the address to which the Sample should be delivered and the date upon which it is required. We shall arrange for our courier to deliver the Sample to that address and on that date if reasonably possible. You agree that the costs of delivery are at your sole expense and we may invoice you for any such costs incurred which you agree to pay by return upon receipt. We shall use all reasonable endeavours to deliver the Sample on any requested date but you must give us as much notice as possible and you acknowledge and agree that we will not be responsible for any delays in delivery beyond our reasonable control. The authorised person who receives the Sample will be required to sign an acknowledgement of receipt form to confirm that the Sample has been received at the named address in good order. You will be solely responsible for the Sample as soon as it is delivered and you accept that we will no longer be responsible. Permitted use: Unless the test results received comply with current legislation, a Sample stored under the terms of this Agreement shall be released for autologous use only, i.e. for use directly for the Child.
10.1.
10.2.
10.3. 10.4.
10.5
11.
Confidentiality and data protection
11.1.
Cells4Life will use all reasonable endeavours to keep confidential all information relating to you and your Child. All samples to be tested will be labelled with unique reference numbers and bar coded. Personal information will only be held on our secure database and/or database backup. Information held by Cells4Life will only be released if required by your or your Child’s medical practitioner for their internal confidential records or otherwise as requested by you. None of the information held on our database will be disclosed or released to Third Parties other than as required by law. Cells4Life is registered under the Data Protection Act 1998 and will process all personal data in accordance with its obligations under that Act. By signing this Agreement, you consent to our holding and processing your and your Child’s personal data (including sensitive personal data) for the purposes of performing our obligations under this Agreement and you also acknowledge and agree that we may disclose any such personal data to your or your Child’s medical practitioner on request or as otherwise required by law. Otherwise we will not disclose personal data to any other party without your consent. All requests must be made in writing to Cells4Life.
11.2.
12. Miscellaneous 12.1. 12.2.
You understand that this Agreement is binding upon you and your respective successors and assigns. No variations to this Agreement shall be made unless agreed in writing by us.
the experts in stem cell processing | 9
transfer and storage agreement
10.
Sample
9.6.
(30) days of termination of this Agreement, you acknowledge and agree that we may dispose of the Sample at our sole discretion. It is your responsibility to ensure that we have a current contact address for you and also for the Child once the Child has reached the age of 18. It is also your responsibility to advise the Child of any rights it may have in relation to the Sample. You agree to indemnify Cells4Life against any loss or damage it may suffer as a result of failure to do this. In the event of corporate failure the samples will be moved to an HTA licensed storage premises in accordance with the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
12.3.
12.5. 12.6. 12.7.
By signing this agreement, you agree that you understand and accept the above terms:
Signature of Mother, Legal Guardian or Donor Signature: ____________________________________________________________________________ Date: ______________________________________
Signature of Father, Legal Guardian or Donor Signature: ____________________________________________________________________________ Date: ______________________________________
Sample
transfer and storage agreement
12.4.
English law shall apply to this Agreement and the English Courts shall have the non-exclusive jurisdiction to resolve any disputes arising out of this Agreement. If any provision of this Agreement is decided by any Court or other competent authority to be wholly or partially invalid or unenforceable, the other provisions of this Agreement and the remainder of the provision in question shall not be affected and shall remain valid and enforceable. This Agreement is solely for your benefit and, cannot be transferred to any other party. No express term of this Agreement or any term implied under it is enforceable pursuant to the Contracts (Rights of Third Parties) Act 1999 by any person who is not a party to it. If you change your address or any other details, you must promptly notify us in writing. You are responsible for ensuring that we have an up to date address for you and the Child once the Child reaches the age of 18 so that we may contact you and/or the Child if necessary. This agreement embodies the entire agreement and understanding between us and supersedes all prior oral or written agreements, understandings or arrangements. Neither party shall be entitled to rely on any agreement, understanding or arrangement not expressly set out in this agreement save for any representation made fraudulently.
Cells4Life | 10
Section 5 - Payment methods
By cheque
By bank transfer Account name: Bank:
Cells4Life Group LLP NatWest Bank PLC South Kensington Station Branch PO Box No 592 18 Cromwell Place London SW7 2LB
UK account number: UK sort code: IBAN: BIC:
64907376 51-50-01 GB33 NWBK 5150 0164 907376 NWBK GB 2L
Reference:
Donor’s last name or where known, customer number.
By card Please note due to the UK Credit Act we are unable to accept the Storage Fee on any card. Debit or Credit
Name on card: _____________________________________________________________ Card number: _____________________________________________________________ Valid from (mm/yy): _______________/_______________ Expires end (mm/yy): _______________/_______________ Card security code (CV2): _______________ (The rightmost 3 digit number on the signature strip) Note:
All fees and international bank charges will be payable by you, including receipt fees. American Express attracts a handling fee of 1.5%.
the experts in stem cell processing | 11
methods
Please make cheques payable to Cells4Life Group LLP and send to: Cells4Life Group LLP Units 2 & 3 Oak House Woodlands Office Park Albert Drive Burgess Hill RH15 9TN
Payment
We accept payment by cheque, bank transfer, credit card, debit card or cash. If you are paying by cash, cheque or bank transfer please ensure the Donor’s last name of customer number, where known is provided as the payment reference.
Payment
plans
Payment Plans Please only complete this form if you have opted for one of our Payment Plans and/or our Annual Payment Storage Plan. If you are creating a standing order electronically, please ensure the Donor’s last name or customer number, where known, is provided as the payment reference and send proof to us.
To the bank manager Details
Account to be debited
Beneficiary details
Bank name: ______________________________________ NatWest Bank PLC Bank address: ______________________________________ South Kensington Station Branch ______________________________________ PO Box No 592 ______________________________________ 18 Cromwell Place ______________________________________ London Postcode: ______________________________________ SW7 2LB Sort code: ____________-____________-____________ 51-50-01 Account number: ______________________________________ 64907376 Account name: ______________________________________ Cells4Life Group LLP
Payment Plan standing order details
Payment reference (office use): ________________________________________________ Amount of payment (office use): £_______________________________________________ Amount of payment in words (office use): ________________________________________________ Date of first payment: ________________________________________________ Frequency of payment: Monthly Number of payments: Five (5) / Eleven (11) Customer name: ________________________________________________ Customer signature: ________________________________________________ Customer contact number: ________________________________________________
Annual Payment Storage Plan standing order details
Payment reference (office use): ________________________________________________ Amount of payment (office use): £_______________________________________________ Amount of payment in words (office use): ________________________________________________ Date of first payment: ________________________________________________ Frequency of payment: Yearly Number of payments: Twenty four (24) Customer name: ________________________________________________ Customer signature: ________________________________________________ Customer contact number: ________________________________________________ Please note banks require an original signature so scanned and printed copies can not be used. We will send the original Standing Order to your bank. Cells4Life | 12