Terms and Conditions

Conditions

The following definitions are used in these Conditions:

1.1. These Conditions set out the rights and obligations of us and you under the Contract.

1.2. This Contract shall come into existence on the date of last of signature of the parties.

2.1. If you provide us with identification and contact details for more than one Parent, you agree that we can accept instructions from either of you, for example in cases of requests for Therapeutic Use or cancellation of the Services.

2.2. If you have a dispute with the other Parent of the Child, for example in connection with giving us instructions regarding a Sample, you agree to repay us for any loss that we may suffer as a result of the other Parent taking legal action against us in connection with the dispute, including our costs in connection with legal fees that we have to pay to defend a claim.

2.3. You understand that:
a) umbilical cord stem cell transplantation is a treatment that may offer possible future benefits;
b) cord blood and/or cord tissue offers a source of stem cells, but there are alternative sources of stem cells;
c) cryopreservation of the Sample is an accepted procedure, and tests and studies have indicated it is a successful method of preserving stem cells; and
d) the stem cells in a Sample may never be needed or used.

2.4. You acknowledge that no assurance or guarantee can be made about the benefits or utility derived from a Sample.

3.1. You will be provided with information about the Plan you have chosen and the Fees payable. You will pay the Fees in accordance with your Plan.

3.2. The Processing and Storage Fee is due 14 days after the Storage Date.

3.3. You will be notified by SCI once the Sample has been processed whether the Sample is suitable for Storage.

3.4. In the event that SCI processes the Sample and it is not stored for any reason:
a) the Booking Fee and Processing Fee are non-refundable; and
b) the Annual Fee will be refunded to you within 14 days if you have prepaid it.

3.5. If you have a Subscription Plan, we may increase the Fee with effect from each anniversary of the Commencement Date in line with the increase in the CPI during the period since the Commencement Date or the date of the last price increase. We will give you not less than one month’s prior written notice of the proposed price increase.
If you do not agree to the Fee increase in accordance with clause 3.5, you may terminate the Contract on written notice to us with effect from the next anniversary of the Commencement Date, provided that:
a) if you terminate in the first 10 years of the Term, you pay the Exit Fee; or
b) if you terminate after the first 10 years of the Term, no further Annual Fee shall be due.
You acknowledge and agree that the Exit Fee is a fair reflection of the work SCI has undertaken during the first half of the Term and if you decide to terminate before the end of the Term, it is fair and reasonable for SCI to recover its costs via the Exit Fee.

4.1. You acknowledge and agree that if the Sample is not collected in accordance with the Collection Procedure Protocol, that it may affect the viability of the Sample for Storage resulting in us having to destroy the Sample. You further understand that if the Sample is not collected by a trained and licensed person, such as a phlebotomist, SCI may be required to destroy the Sample by the HTA.

4.2. You understand that there may be additional considerations or unforeseeable circumstances during the delivery of your Child which may affect the collection of the Sample. The safety and care of the Child and mother are of primary concern. You therefore acknowledge and agree that a qualified medical professional may, for any reason and at their discretion, refuse to collect the Sample. This is outside the control of SCI. If the Sample is not collected for any reason, you may terminate this Contract within 30 days of your child’s birth by:
a) notifying SCI in writing; and
b) returning the Collection Kit intact and in good condition.

4.3. If you terminate the Contract in accordance with clause 4.2, you will be refunded the Fees that you have paid, less the Booking Fee. If the Collection Kit is not returned or returned in unusable condition, we may deduct the cost of the Collection Kit from any refund provided to you.

4.4. You understand that the volume of cord blood that can be collected depends on several factors including but not limited to the size of the placenta, the length of the umbilical cord, rate of clotting, blood flow rate to the baby and cord clamping time. Collection is the responsibility of the phlebotomist and SCI cannot guarantee that the Minimum Volume will be collected on the day of birth.

4.5. You are responsible for contacting SCI as soon as possible following the birth of your Child in accordance with the Collection Procedure Protocol to arrange transport of the Sample to SCI.

5.1. It is a regulatory requirement that a sample of maternal bloods is provided by you to SCI. The maternal blood must be taken at the time of delivery of your Child or no later than 7 days after the Child’s birth.

5.2. SCI will perform mandatory tests on the maternal blood as requested by HTA – including HIV, Syphilis, Hepatitis B and Hepatitis C, CMV and HTLV, any tests if indicated by the maternal health questionnaire and any other disease that may be specified by legislation or recommended and which may change from time to time.

5.3. We will notify you of any positive maternal blood test results as quickly as possible but cannot guarantee a time frame for this notification.

5.4. We do not routinely notify positive IgG CMV maternal blood results unless IgM CMV is also found to be positive or equivocal, as IgG CMV antibodies are typically present in most adults. If you wish to receive your IgG CMV test result, this can be provided on request.

5.5. We do not automatically notify negative results, but if you wish to receive a copy of negative maternal blood test results, this can be provided on request.

6.1. Cord blood and cord tissue Samples shall be processed and stored at an authorised Facility located in the
United Kingdom.

6.2. The Sample, shall at all times be owned by the Child and shall be subject to your exclusive control until the Child reaches the age of 18, when ownership and control over the Sample shall automatically transfer to the Child.

6.3. No additional costs will be incurred for the transportation of the Sample during the Term if required for Therapeutic Use.

6.4. If before the Child reaches the age of 18 another person is granted parental responsibility for that Child, that person may enforce your rights under this Contract. We reserve the right to request supporting evidence of legal guardianship, including documents issued by a court of law, before acting on the instructions of any person purporting to have parental responsibility for your Child.

6.5. SCI will only accept written requests for release of stored Samples:
a) from you, if the Child is under 18 when the request is made; or
b) from the Child, if he or she has reached the age of 18 when the request is made.

6.6. Once the Child reaches 18, in the event of any conflict between your request and the requests of your Child, we will be bound by the requests of your Child.
If a Sample is required for Therapeutic Use, SCI will arrange release of the Sample according to SCI’s procedure and current regulatory requirements.

7.1. SCI will provide the Services for the Term.

7.2. SCI may refuse to process and/or store the Sample if:
a) the Sample has been unlawfully procured;
b) the volume of cord blood collected is less than the Minimum Volume;
c) the Sample, in SCI’s reasonable and professional opinion, is determined to be unsuitable for Storage;
d) the Sample has been incorrectly packaged in accordance with the requirements provided with the Collection Kit;
c) any part of the Collection Kit has been replaced;
f) the maternal blood donor has tested positive for HIV or no maternal blood sample has been provided to SCI in accordance with clause 5; or
g) you have not made payment of the Fees after we have sent you reasonable notice of the Fees being overdue.

7.3. In the event that SCI refuses to process or store the Sample pursuant to paragraph 7.2
a) you will be provided with a refund of the Fee, less the (i) Booking Fee, (ii) Processing Fee of £465 if the Sample has been processed and (iii) any fee for phlebotomy services where this has been arranged by SCI; and
b) SCI may destroy the Sample or use it for internal quality control purposes.

7.4. SCI sets a minimum cell count(s) for storing cord blood units based on current transplant science/technology. In the event your cord blood unit is below these criteria, you will be notified and given the option to terminate the Contract or continue with the Storage Services. If you wish to continue to store the Sample, the agreed Fees will apply.

7.5. For our Services bought online or over the telephone, you have 14 days after the date the Contract is formed (see clause 1.4) to change your mind about a purchase of the Services.

7.6. If you change your mind, please contact us:
a) using the contact details on Contact Us page of the website here;
b) by emailing us at uk@smartcells.com;
c) telephoning us on 01895 424430.

7.7. We refund you as soon as possible and within 14 days of you telling us you’ve changed your mind in accordance with clause 7.7. We refund you by the method you used for payment. We don’t charge a fee for the refund.

7.8. If 14 days have elapsed since the date the Contract is formed (see clause 1.2) but the Sample has not yet been collected, you can cancel by contacting us in accordance with clause 7.8. In this case, you will be charged the Booking Fee only and SCI will refund you any portion of the Fee in excess of the Booking Fee that you have prepaid.

7.9. In the event that full payment of any outstanding Fees has not been received within thirty days of an invoice being sent to you, we may terminate this Contract on reasonable notice after we have sent reminder notices of overdue payment to you. SCI reserves the right to destroy the stored Sample on termination of the Contract.

7.10. At least six months before the end of the Term, SCI will notify the Child by letter (at the last address you have provided us with) and/or by email or telephone, that the Term is due to expire. If we do not receive a response to our communication within 3 months of the end of the Term, we reserve the right to dispose of and destroy the stored Sample without sending any further notice to you.

8.1. We guarantee to you that:
a) the Collection Kit is of satisfactory quality and fit for the purpose of collecting the Sample and is, at the date supplied, compliant with the HTA requirements.
b) the Services will be provided using reasonable care and skill.

8.2. You acknowledge and accept that we cannot give any guarantees with respect to any:
a) suitability of the Sample for the future treatment of diseases or Therapeutic Use as this will be dependent on the circumstances of each individual case;
b) successful treatment of diseases through Sample transplantation or Therapeutic Use;
c) advantages of Sample stem cell transplantation over other types of treatment, whether using stem cells or otherwise;
d) tests we carry out which cannot be exhaustive and we cannot guarantee that the Sample is not contaminated due to circumstances beyond our reasonable control (for example contamination by the mother of the Child) before we accept it for storage;
e) cell count, volume or quality of cord blood/tissue collected.

9.1. We’re not responsible for losses you suffer caused by us breaking this Contract if the loss is:
a) Unexpected. It was not obvious that it would happen and nothing you said to us before we accepted your Order meant we should have expected it (so, in the law, the loss was unforeseeable).
b) Caused by a delaying event outside our control. As long as we have taken steps to minimize any losses or delays outside of our control, we’re not responsible for such losses or delays.
c) Avoidable. Something you could have avoided by taking reasonable action, including following our reasonable instructions regarding use, storage or processing of the Sample.

9.2. If you suffer foreseeable or expected losses caused by us breaking this Contract, our total liability to you for the loss will be limited to two times the Fees.

10.1. SCI will keep confidential all information relating to you, your Child and the Sample.

10.2. How we use any personal data you give us is set out in our Privacy Policy.

If you have selected the Neuro-Assistance Package as part of your Plan, the following additional terms shall apply:

11.1. The Neuro-Assistance Package is an optional service facilitating the potential autologous administration of stem cells derived from the umbilical cord blood (“Sample”) to the Child, where the Child is diagnosed with cerebral palsy or an autism spectrum disorder, as part of non-standard, experimental medical applications (the “Procedure”). This service is distinct from Therapeutic Use and relates solely to experimental treatment pathways coordinated through third-party healthcare providers.

2.1. The fees for the Neuro-Assistance Package shall only be payable where the Sample is successfully collected and meets the qualification criteria for Storage in accordance with clauses 7.2 and 7.3 of this Contract.

2.2. If the Sample is not collected or does not meet the criteria for Storage, no fees shall be charged for the Neuro-Assistance Package.

3.1. Subject to clause 4 below, SCI shall provide coordination services where Parents wish to pursue the Procedure for the Child.

3.2. These coordination services may include:
a) facilitating the Child’s application for eligibility assessment for autologous administration of stem cells derived from the Sample;
b) arranging or coordinating required testing, where applicable;
c) arranging transportation of an aliquot of the Sample to the relevant treatment centre; and
d) covering or reimbursing reasonable costs associated with the Child’s stay at the treatment centre for up to two (2) days in connection with the Procedure.

3.3. Where the Neuro-Assistance Package is in place and the Child is accepted for the Procedure in accordance with clause 4, the cost of the medical treatment forming part of the Procedure shall be included within the Programme and no additional fees shall be payable by you for such treatment.

3.4. Any payments referred to in clauses 3.2(d) and 3.3 shall be made directly to the relevant centre or reimbursed to you upon provision of valid invoices or cost statements.

4.1. SCI shall only provide the services described in clause 3 where all of the following conditions are satisfied:
a) the Sample has been successfully processed and stored in accordance with this Contract;
b) the Sample is deemed suitable for use by the SCI Chief Medical Officer, including meeting minimum cell count thresholds (currently at least 1 x 10⁷ TNC/kg of the Child’s weight at qualification);
c) the Child is independently qualified for the Procedure by an appropriately authorised treating physician; and
d) all required consents for participation in experimental medical treatment have been obtained.

5.1. You acknowledge and agree that:
a) the Procedure constitutes a non-standard, experimental medical treatment;
b) any such treatment is performed by independent healthcare providers not controlled by SCI; and
c) SCI does not provide medical advice, treatment, or clinical services in connection with the Procedure.

5.2. SCI’s role is limited to coordination and administrative support. All decisions regarding eligibility, treatment, and clinical care are the sole responsibility of the relevant healthcare provider.

6.1. SCI does not guarantee:
a) that the Child will qualify for the Procedure;
b) that the Procedure will be available at any specific time or location; or
c) any clinical outcome, benefit, or effectiveness arising from the Procedure.

6.2. If the Child is deemed ineligible for the Procedure by the relevant healthcare provider, SCI may, at its discretion, provide a waiver of the Annual Fee for a period of up to one (1) year.

7.1. Except as expressly set out in clause 3, all costs associated with:
a) additional travel or accommodation; and
b) any related healthcare services,
shall remain your responsibility.

7.2. Where the Neuro-Assistance Package has not been selected, all services described in this section shall be excluded and any associated costs shall be borne entirely by you.