1. DEFINITIONS AND INTERPRETATION
1.1 The definitions and rules of interpretation in this clause apply in these terms and conditions (Conditions).
Cells: means all those cells contained in the pulp area of the tooth treated by the BioEden process. Typically these might include mesenchymal stem cells, chondrocytes, osteoblasts and adipocytes among others;
Contract: your purchase order and our acceptance of it;
Services: the services to be provided by us to you under the Contract as set out overleaf;
VAT: value added tax chargeable under English law for the time being and any similar additional tax;
We or us: BioEden Limited (Company registration number 05968863) whose registered office is at 3M Buckley Innovation Centre, Firth Street, Huddersfield, West Yorkshire, HD1 3BD.
You: the person or people who purchase(s) Services from us.
1.2 Condition, schedule and paragraph headings shall not affect the interpretation of these conditions.
1.3 A person includes that person’s legal and personal representatives, successors and permitted assigns.
1.4 Words in the singular shall include the plural and vice versa.
1.5 A reference to a statute or statutory provision is a reference to it as it is in force for the time being, taking account of any amendment, extension, or re-enactment and includes any subordinate legislation for the time being in force made under it.
2.1 You agree to be responsible for the Cells until your child becomes 18 years old. At the age 18 ownership of the Cells legally passes automatically to your child. In any disagreement after this time your child’s requests are legally binding.
2.2 This agreement must be signed by at least one of the parents or legal guardians of the child. If both parents/guardians sign you will both be fully liable for your obligations under this agreement. We are entitled to act on the instructions of either parent/guardian, but in the event of both parents/guardians signing, the wishes of one specified parent/guardian will be followed in the event of a dispute. This person shall be known as the owner of the Cells until the child reaches the age of 18. If neither parent nor guardian is specified then the owner will be the signatory against section 1 of the contract.
2.3 Transplanting of stem Cells and other autologous Cells may well offer benefits to your child in the future. Tests indicate that the BioEden process can provide a successful means of preserving Cells, including mesenchymal stem Cells, for the future. However it is not possible to offer any guarantee about the effectiveness of any stored Cells for any treatments including those involving cell transplantation or that these Cells will provide any benefits to your child. By signing the Contract you confirm that you have given this point serious consideration before deciding to proceed.
2.4 It is your responsibility to ensure that the donor child provides a blood sample for serological testing within seven (7) days after the loss of the shed tooth. This sample must be taken by a health professional and forwarded by THEM to BioEden using the packaging which will be included in your collection kit. Any payment for this service will be your responsibility but BioEden will supply and pay for the carriage and the carriage materials for the sample.
2.5 Cells, including stem Cells, are available from alternative sources such as bone marrow and from the venous and arterial blood. By consenting to use the BioEden process you must have chosen to preserve tooth Cells in the knowledge of these points made in clauses 2.4 and
2.6 You also acknowledge that cryopreservation is a comparatively new procedure. You also understand that your child or any other family member may never need to use the stored Cells.
3. COSTS OF THE BIOEDEN PROCESS
3.1 BioEden Access Membership Plan
3.1.1 The BioEden Access membership includes a monthly fee payable from the point of membership until the plan is ended. Each BioEden Access membership is associated with a named child registered at the point of membership, benefits received under each individual membership are not transferrable and on early termination of the plan any payments made are non-refundable.
3.1.2 Regular payment of the agreed monthly fee is a condition of the ongoing BioEden Access membership. Failure to ensure the account is well maintained with regular payments being made in accordance with the membership to may result in it being terminated – this includes non-payment, unapproved payment holidays, irregular payment patterns, irregular or large sum payments.
3.1.3 It is the responsibility of the member to ensure that regular payments are being maintained.
3.1.4 The BioEden Access membership may at any time contain a range of different associated benefits provided by third parties and as a result the scope and content of these benefits will change over time. BioEden cannot therefore guarantee the future content of the BioEden Access membership but will endeavour to maintain a balanced range – at its complete discretion BioEden retains the right to vary the benefits offered, value, suppliers, volume, frequency and availability.
3.1.5 Payments made under the BioEden Access membership for an up to date and well maintained account will count towards ‘membership credits’ which can be applied towards the benefits available under the plan. For the avoidance of doubt, BioEden Access membership payments are non-refundable and can only be used against benefits under the plan.
3.1.6 If a BioEden tooth collection kit is requested the member will select a BioEden activated plan from the range available (BioEden Active, BioEden Annual or BioEden Advance). At the company’s discretion, payments made under the BioEden Access membership for an up to date and well maintained account will be treated as ‘membership credits’ and allocated towards the cost of the selected BioEden activated plan at the rate ruling. In addition, a multiplier percentage applicable at the point of joining the BioEden Access membership will also be applied to membership credits to that date. The total value of this BioEden Access membership credit transfer will not exceed the lesser of £750 or the current value of a standard activation process under the BioEden Annual membership.
3.1.7 The company retains the right to close, restrict access to or introduce entry criteria for joining the membership scheme, at any point and for any reason.
3.2.1 BioEden Annual and BioEden Advance Memberships
188.8.131.52 The costs of the process to collect and test the Cells must be paid when the order for the collection kit is made. If a prepayment or a gift arrangement has already been made for the child in question then any balance outstanding must be paid at the time of ordering the collection kit. All charges are inclusive of VAT.
184.108.40.206 The first annual service fee must be paid at the time of ordering the collection kit. The subsequent service fee becomes payable one (1) year after the date of the initial successful storage of donor cells. Thereafter an annual membership payment is due on this date.
220.127.116.11 Annual membership fee packages of multiple years may be offered, these may be varied in duration and availability.
18.104.22.168 At the company’s discretion, approved ‘membership credits’ under the BioEden Access membership for an up to date and well maintained account will be accepted towards settlement of the costs of a BioEden Annual or BioEden Advance membership.
22.214.171.124 If a BioEden Annual or Advance membership cannot be completed due to insufficient remaining viable teeth the membership is deemed to have ceased and the conditions of clause 3.12 will apply.
126.96.36.199 A BioEden Active membership may not be transferred or converted to any other BioEden membership plan. A BioEden Annual or Advanced plan may not be transferred or converted into a BioEden Active membership.
3.2.2 BioEden Active Membership
188.8.131.52 BioEden Active is a long term plan including a single one off initial fee followed by a regular BioEden Active membership fee, as agreed at the point of becoming a member. For BioEden Access members converting to the BioEden Active plan the monthly membership fee ruling at the point of initial membership will be guaranteed and honoured.
184.108.40.206 Regular payment of the agreed monthly fee is a condition of the ongoing membership of BioEden Active. Failure to ensure the account is well maintained with regular payments being made in accordance with the plan may result in the plan being terminated in accordance with clause 220.127.116.11 – this includes non-payment, unapproved payment holidays, irregular payment patterns, irregular or large sum payments.
18.104.22.168 It is the responsibility of the BioEden Active member to ensure that regular payments are being maintained.
22.214.171.124 If a BioEden Active membership cannot be completed due to insufficient remaining viable teeth the membership is deemed to have ceased and the conditions of clause 3.12 will apply.
126.96.36.199 A BioEden Active membership may not be transferred or converted to any other BioEden membership plan. A BioEden Annual or Advanced plan may not be transferred or converted into a BioEden Active membership.
188.8.131.52 At the company’s discretion, approved ‘membership credits’ under the BioEden Access membership from an up to date and well maintained account will be accepted towards settlement of the costs of a BioEden Active membership.
184.108.40.206 If a BioEden Active member requests to transfer their cells out of or to end the membership for any reason, other than for a medical procedure/ treatment, the plan is deemed to have been closed early. Both parties agree that in the event of early closure the long term nature of the plan cannot be achieved and the plan will be re-calculated as a BioEden Annual plan at the standard rates effective from the date of tooth processing up to the date of closing early. Payments received under a BioEden Active membership plan which is closed early will be re-allocated against the BioEden Annual plan costs, any difference owed will be payable by the member.
3.3 Costs for the taking of the blood sample demanded by statutory HTA regulations will be the responsibility of the parent or guardian of the donor.
3.4 We do not collect or transport the tooth containing the Cells, and we have no responsibility for the transportation of the tooth and Cells. It is your responsibility to keep the shed tooth clean and safe according to the instructions, and to arrange the transportation in such a way that the tooth will reach us within 24 hours of being shed. Our responsibility begins when the tooth and Cells arrive at our laboratory. See clause 2.1.
3.5 You understand that the tooth is normally discarded or saved as a souvenir. The decision to collect, process and store the Cells is a voluntary act on the part of the parent or guardian that may allow you to protect your child’s right to the specimen Cells.
3.6 It is your responsibility to ensure that accurate labelling of the tooth is made, and that you have signed the appropriate documentation in the collection kit to confirm that the kit contains the specified tooth. Do not put a tooth or teeth from more than one child in the same collection kit.
3.7 It is important that you complete the Parental/Guardian Consent Form, sign it and return it with the Tooth. The BioEden Process cannot start without the signed consent form.
3.8 By signing the Consent Form you also agree to a Serological Test on your child’s blood for HIV1, HIV2, HEP B sAg (Hepatitis B surface Antigen), HEP B Anti HBc core, HEP C, Syphilis, and HTLV-1 (as required). This is to preserve quality control of all stored stem Cells and in keeping with Human Tissue Authority guidelines. If your child’s blood sample tests positive to any of these infections, we will notify your named GP in writing. You have the right to receive confirmed results of the Serological Test. These test results remain confidential as in all the medical history and notes retained by BioEden.
3.9 In the event of a positive result from your child’s blood sample, our contract with you is voided. We will be unable to store the cells from the donor and we will re-imburse all monies paid less laboratory processing and transportation costs of £250.
3.10 We understand that there is a risk of contamination or infection in a shed tooth. This is likely to happen in less than 10% of teeth. Consequently we immediately on receipt check the Cells for health and viability. In the unlikely event that the Cells are not considered healthy enough to store properly we will inform you immediately, and ask you to supply another replacement tooth when possible. There will be NO further charge for handling the replacement tooth.
3.11 If we are unable to process healthy cells from your child’s tooth and if your child has no more viable teeth for processing, then we will re-imburse all monies paid less laboratory processing and transportation costs of £250.
3.12 It is your responsibility to carefully follow all the instructions with regard to the saving, keeping and transporting of the tooth. Please arrange for the collection kit to be sent to you in good time once you realise that the tooth in question is loose, and will soon be shed – don’t leave ordering the collection kit until the last minute. This way you will have the kit in good time, and also have a good opportunity to familiarise yourself with the procedures.
4. PROCESSING AND WITHDRAWAL
4.1 We will put in place a contact arrangement for you with an experienced courier, and will transfer your carriage payment to this courier. You are however responsible for communicating with the courier to pick up the collection kit at the earliest opportunity and the courier is responsible for the transport of the kit. We are responsible for the tooth and Cells as soon as it arrives at our laboratory.
4.2 As soon as the collection kit is opened the Cells will be carefully removed from the tooth. They will be examined to check their health and condition. They will then be processed to confirm that they are viable Cells, and will be tested and observed for a set period to confirm their welfare. They will remain in isolation until the Serological Test has confirmed they are free from any of the listed infections detailed in clause 3.9. After this they will be immediately stored cryogenically. You will be able to check confidentially via our website or by telephone which stage in the process your Cells are at. If we are unhappy with any significant part of the condition of your Cells we will inform you immediately, and ask you to supply a replacement tooth. There will be no further charges to collect or process a replacement tooth.
4.3 Our laboratory process uses Penicillin and Streptomycin at this present time and any presence of these within Cells after processing could be minimal. Should your child be allergic to any antibiotics, then it is your responsibility to seek professional medical advice in relation to the application or treatments using stems cells and their possible side-effects and/or allergic reactions. No guarantee is given that the presence of Penicillin and Streptomycin is minimal.
4.4 All the Cells in the tooth will be stored – not just the stem Cells. The other Cells MAY be suitable to use in medical treatments in the future, so it is best to save them all. Our responsibility is to store the Cells in the most professional way possible, and when requested, make them available to medical professionals who may, or may not, be able to make use of them. No guarantee is given that any of the Cells can or will be used in the future or that any future use of the Cells will be effective.
4.5 All the work involved in opening the collection package, extracting, checking, processing and storing the Cells will be performed by our authorised employees who are trained, qualified and supervised to the standards specified under the auspices of the Human Tissue Authority regulations applying in the UK and Europe. Processing and storage will take place in England. Only tooth cell specimens will be stored in our unit – each specimen individually identified and contained.
4.6 The Cells will be owned and controlled exclusively or jointly, as requested, by the parent(s) or guardian(s) of the child. However once the child reaches the age of 18 the child shall automatically take over all control and ownership immediately.
4.7 You agree to keep us informed at all times of a current address and telephone number for contact with yourself.
4.8 In the event that you request the return of the preserved specimen from storage the request must be made in writing and signed by the owner of the Cells. The Cells will be made available under these circumstances to the care of a named medical doctor or named hospital manager only. The named health professional will be responsible for arranging a suitable courier to attend our premises to collect the Cells, and it is their responsibility to provide a suitable vessel to transport cryogenically stored Cells. It is important to note that the Cells are cryogenically frozen and maintained at a temperature of minus 150 degrees Centigrade. Any contact with any part of the human body could result in serious or fatal injury. We will NOT be responsible for assessing the suitability of the presented container. We shall require evidence in writing of the appropriate qualifications of both the health professional and the carrier before releasing the Cells. As soon as the Cells are placed in the provided container we have no further responsibility for the Cells. The responsibility for the Cells passes back at that point to the owner, or depending on the arrangements they have made the carrier/ health professional concerned.
4.9 Cells in storage will only normally be released with the approval of a medical professional for use in medical treatment. BioEden will cooperate with the arrangements made for the transfer of the cells to the selected medical professional.
4.10 Release of Cells will only be possible to an alternative approved cryogenic storage provider if the account is fully up to date and the account balance is zero – all liabilities, arrangements and costs of the transfer will be at the risk and the responsibility of the cell owner.
4.11 The owner must pay an annual fee at the appropriate dates each year for service (see 3.2.1) or adhere to a pre-arranged payment plan (see 3.2.2). If the fee is unpaid we will contact the owner and remind them that payment is due. If payment has still not been made, or if no contact has been possible, after 28 days following the due date of payment we reserve the right to remove the Cells from storage. In this event we will again try to contact the owner both before and after removal. If the owner has made no arrangement to collect the Cells after removal from storage they will subsequently be dealt with as we see fit, and the owner informed at the last recorded address that we have for them.
5.1 We must reserve the right to refuse to process or store any particular sample without explanation but this will only be in exceptional circumstances and we will use our reasonable endeavours to consult with you if we feel this necessary.
5.2 You may cancel this agreement at any time before the tooth has arrived for processing. In that event you will only be liable for any transport and administrative costs, plus a cancellation fee, making a total of £250.
5.3 Cancellation must be made in writing, and received at our office before any processing of the tooth and Cells has begun.
6. LIMITATION OF LIABILITY – THE CUSTOMER’S ATTENTION IS PARTICULARLY DRAWN TO THE PROVISIONS OF THIS CONDITION
6.1 This condition 6 sets out our entire financial liability (including any liability for the acts or omissions of our employees, agents and sub- contractors) to you in respect of:
6.1.1 any breach of the Contract;
6.1.2 any use made by you of our Services; and
6.1.3 any representation, statement or negligent act or omission arising under or in connection with the Contract.
6.2 All warranties, conditions and other terms implied by statute or common law are, to the fullest extent permitted by law, excluded from the Contract.
6.3 Nothing in these Conditions limits or excludes our liability:
6.3.1 for death or personal injury resulting from negligence; or
6.3.2 for any damage or liability incurred by you as a result of fraud or fraudulent misrepresentation by us.
6.4 Subject to condition 6.2 and condition 6.3, we shall not be liable for:
6.4.1 loss of use; or
6.4.2 loss of corruption of data or information; or
6.4.3 any special, indirect, consequential or pure economic loss, costs, damages, charges or expenses.
6.5 OUR TOTAL LIABILITY IN CONTRACT, TORT (INCLUDING NEGLIGENCE OR BREACH OF STATUTORY DUTY), MISREPRESENTATION, RESTITUTION OR OTHERWISE ARISING IN CONNECTION WITH THE PERFORMANCE OR CONTEMPLATED PERFORMANCE OF THE CONTRACT SHALL BE LIMITED TO THE PRICE PAID FOR THE SERVICES.
6.6 You are responsible for the safe keeping of the tooth prior to transportation, organising the transportation at a suitable time, packaging the tooth and preparing it for transportation.
6.7 The carrier is responsible for the carriage of the tooth in accordance with their standard terms and conditions.
6.8 We are responsible for the tooth and Cells once it has been delivered to our laboratory.
6.9 There is no liability to you if we are unable to isolate or store a reasonable cell specimen when the Cells are examined.
6.10 In the event of the loss of a cell specimen while in our care during processing, which was caused by an act or omission by us, our employees or agents, we will reimburse all service costs incurred up to that point – even if we are not responsible for the loss of the specimen. In the event that both Cell samples placed in storage in our facility and our remote facility are lost which was by an act or omission by ourselves, our employees or agents, we will reimburse all service costs incurred up to that point- even if we are not responsible for the loss of the specimen.
6.11 We shall have no liability to you under the Contract if we are prevented from or delayed in performing our obligations under the Contract or from carrying on our business by acts, events, omissions or accidents beyond our reasonable control, including strikes, lock-outs or other industrial disputes (whether involving our workforce or any other party’s), 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 sub-contractors.
7. DATA PROTECTION
7.1 Your personal data will be stored both in hard copy and electronic format for the duration of the contact for service or a minimum of 30 years, whichever is the greater.
7.2 Your child’s medical data will be preserved in a secure area and protected from external access in accordance with the Data Protection Act.
7.3 Medical information will only be released to the named medical professional nominated in writing by the legal owner of the cells as specified in 4.7.
7.4 You acknowledge and agree that details of your name, address and payment record may be submitted to a credit reference agency, and personal data will be processed by and on our behalf in connection with the Services.
8.1 We guarantee:
8.1.1 the suitability and quality of the collection kit. We also guarantee the accuracy of the instructions to save and pack the tooth;
8.1.2 that the BioEden process will be provided using all reasonable skill and attention, and that ongoing checks will be constantly made on the quality of the process and the quality of the storage in line with the demands of the Human Tissue Authority regulations;
8.1.3 that all processes and equipment are constantly monitored. Our laboratory and storage staff will receive continuing professional training in the appropriate processes and techniques;
8.1.4 that once we have received your cells and personal data they will be in our care. We maintain very high standards of security for the protection of specimens and data. (We reserve the right to store your sample at the facility we feel is most suitable. This facility may or may not be owned by us);
8.2 We guarantee:
8.2.1 that full professional confidentiality will apply at all times to all records and information which we hold.
8.3 We cannot guarantee:
8.3.1 that the stored Cells will be suitable for any future treatment of injury or disease;
8.3.2 that successful treatment of any injury or disease will be performed with stem Cells or any of the other types of stored tooth Cells;
8.3.3 that stored tooth Cells may be any more suitable for treatments in future than any other kind of autologous Cells.
9.1 You warrant:
9.1.1 that you are the person (or people) legally entitled to own and be responsible for the tooth and Cells defined in this contract;
9.2.2 that you have read all parts of the Contract including these terms and conditions, and given them due consideration before signing – thereby accepting them.
No variation of the Contract or these Conditions or of any of the documents referred to in them shall be valid unless it is in writing and signed by or on behalf of each of the parties.
11.1 A waiver of any right under the Contract is only effective if it is in writing and it applies only to the party to whom the waiver is addressed and the circumstances for which it is given.
11.2 Unless specifically provided otherwise, rights arising under the Contract are cumulative and do not exclude rights provided by law.
12.1 If any provision (or part of a provision) of the Contract is found by any court or administrative body of competent jurisdiction to be invalid, unenforceable or illegal, the other provisions will remain in force.
12.2 If any invalid, unenforceable or illegal provision would be valid, enforceable or legal if some part of it were deleted, that provision will apply with whatever modification is necessary to make it valid, enforceable and legal.
13. STATUS OF PRE-CONTRACTUAL STATEMENTS
Each of the parties acknowledges and agrees that, in entering into the Contract it does not rely on any undertaking, promise, assurance, statement, representation, warranty or understanding (whether in writing or not) of any person (whether party to these terms and conditions or not) relating to the subject matter of the Contract, other than as expressly set out in the Contract.
14.1 The Customer shall not, without our prior written consent, assign, transfer, charge, sub-contract or deal in any other manner with all or any of its rights or obligations under the Contract.
14.2 We may at any time assign, transfer, charge, sub-contract or deal in any other manner with all or any of our rights or obligations under the Contract.
15. RIGHTS OF THIRD PARTIES
The Contract is made for the benefit of the parties to it and (where applicable) their successors and permitted assigns and is not intended to benefit, or be enforceable by, anyone else.
Notice given under the Contract shall be in writing, sent for the attention of the person, and to the address or fax number, given in the Contract (or such other address, fax number or person as the relevant party may notify to the other party) and shall be delivered personally, sent by fax or sent by pre-paid, first-class post or recorded delivery. A notice is deemed to have been received, if delivered personally, at the time of delivery, in the case of fax, at the time of transmission, in the case of pre-paid first class post or recorded delivery, 48 hours from the date of posting and, if deemed receipt under this condition 16 is not within business hours (meaning 9.00 am to 5.30 pm Monday to Friday on a day that is a business day), at 9.00 am on the first business day following delivery. To prove service, it is sufficient to prove that the notice was transmitted by fax, to the fax number of the party or, in the case of post, that the envelope containing the notice was properly addressed and posted.
17. GOVERNING LAW AND JURISDICTION
17.1 The Contract and any dispute or claim arising out of or in connection with it or its subject matter, shall be governed by, and construed in accordance with, the law of England and Wales.
17.2 The parties irrevocably agree that the courts of England and Wales shall have exclusive jurisdiction to settle any dispute or claim that arises out of or in connection with the Contract or its subject matter.