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  1. Terms of this agreement
    1. This document aims to form an easily understood agreement between you, the person signing below, and Biovault Technical Ltd trading as Biovault Family (called here Biovault), whose registered address is at 24 Brest Road, Derriford, Plymouth, PL6 5XP. Biovault Family can be contacted on 01752 753723 and [email protected] This is an important document that you should read carefully.
    1. Biovault Family is a trading entity of Biovault Technical Ltd, a Licensed UK Tissue Bank regulated by the UK Human Tissue Authority. (Licence No: 11063)
    1. You have fully acquainted yourself with the risks and process for cord blood and/or cord tissue processing, storage and its likely uses and you wish Biovault to process and store cord blood and/or cord tissue.

2.        Definitions

The following are some simple definitions which need to be understood and are deemed agreed by you.

  • Autologous transplant – this is defined as cells or tissues removed from and applied to the same person.
    • Allogeneic transplant – this is defined as cells or tissues removed from one person and applied to another.
    • Umbilical Cord Blood – the blood passing through the umbilical cord from the placenta to the unborn baby and consequently the blood that was part of the baby’s circulatory system until the cord was cut. This is entirely separate from the blood in the mother’s circulatory system. Also known as Cord Blood and UCB.
    • Umbilical Cord Tissue – also known as the umbilical cord, the cord that connects the developing embryo or foetus with the placenta and through which run the umbilical arteries and vein. The matrix (the substance) of the umbilical cord is known as Wharton’s jelly and is a rich source of stem cells. At birth the umbilical cord measures about 20 inches (50 cm) in length but there are large variations. Also known as Cord Tissue or UCT.
    • Donor – defined in law as: the mother, or legal guardian, until the biological donor (the child) reaches 18 years of age.

The biological donor once past the age of 18 years.

  • Force Majeure – defined as a natural event of disastrous proportions that could not have reasonably been foreseen or protected against.
    • HLA Test – The Human Leukocyte Antigen test is commonly referred to as tissue typing and is required to assess if a donor and recipient are a suitable match.
    • Maternal Blood Sample – defined as the blood taken from the circulatory system of the mother.
    • Infectious Disease Testing – This can be undertaken using a PCR/NAT test. The Polymerase Chain Reaction (PCR) or Nucleic Acid Test (NAT) positively identifies viral DNA or RNA and is a method of identifying active viral infection. Or by Antibody testing which looks for antibodies in the blood which are produced as a result of exposure to a particular bacteria or virus.
    • Medical application – defined as clinically approved therapies or experimental therapies running as an approved clinical trial.

3.        Legal ownership

  • You warrant that you are legally permitted to act on behalf of the actual donor, the child, and are undertaking decisions and duties on behalf of the child in this matter and until child reaches the then prevailing age of legal ownership or consent. At that point decisions and duties relating to this agreement will pass to the actual donor, the child, unless a legal representative proves that they may legitimately continue in that role. If the legal representation of the child shall change, before the then prevailing age of legal ownership or consent, you will undertake to notify us and inform the new legal representative of the existence of this agreement. Should you be contemplating an imminent change of legal guardianship – for example you are a surrogate or are planning early adoption – you undertake to notify us and put us in direct contact with the proposed new guardians and we will try to conclude an agreement

in a bona fide manner to reflect as much as possible the wishes of all the parties.

  • As the legal donor, you are intending that the cord blood and/or cord tissue are stored privately for the sole use of your child (autologous use). You will have given consent to this process by signing a separate declaration. You understand that in the case of use for another family member (allogeneic use) additional testing and checks will be required.
    • If you die before the child reaches the age of 18, your rights under this agreement may be enforced by who has or is granted legal responsibility for the child. We may request supporting documentation as evidence of the change in responsibility. If the child dies before reaching the age of 18, your rights will remain in this agreement.

4.        Collection

  • If it is the case that your hospital trust can assist you with the collection of cord blood and/or cord tissue, you will arrange locally for these to be collected by a suitably trained, licensed and UK registered healthcare professional. Biovault will provide training and the documentation required to be signed by this individual. Alternatively, our partner phlebotomy company can provide this service for

you and you will need to ensure this is acceptable within the birthing suite. The collection needs to be made as soon as possible after the birth.

  • On receipt and acceptance of your completed application pack and non-refundable deposit you will be provided with a collection kit to collect the mothers blood, cord blood and/or cord tissue. The collection kit must be stored at room temperature in accordance with the instructions on the side of the kit.
    • You will be responsible for calling Biovault Family on 01752 753 723 (our dedicated courier line, open 7 days a week 8am – 8pm) when

the kit is ready for collection at the hospital. The courier needs to be booked as soon as possible; we will then arrange for the courier to pick up the kit from you. The appropriate documentation, known as the air waybill if required, will be contained in the envelope which is attached to the outside of the courier bag into which the courier box is placed and which will need to be given to the courier on collection.

  • It is important to follow the instructions, as non-compliance may render the cord blood and/or cord tissue unsuitable for processing, storage and medical application.

5.         Infectious disease testing

  • Biovault requires three samples of maternal blood for infectious disease testing. These are normally taken at the time of birth by the attending phlebotomist, midwife or suitably qualified healthcare professional, or up to 7 days after birth by a suitably qualified phlebotomist or healthcare professional.
    • Biovault will provide the materials for collecting the maternal blood samples with the collection kit. Biovault will test the maternal blood for mandated infectious diseases; these are listed on the consent form.
    • The purpose of the maternal blood sample is to enable us to test for the presence of infectious diseases in the mother that may also be present in the cord blood and/or cord tissue. If positive results are found it allows us to store the cord blood and/or cord tissue suitably and to inform the requesting clinician ahead of release for medical application. Positive results for infectious diseases do not render the cord blood and/or cord tissue unusable, however, they are relevant and need to be assessed ahead of release for medical application.

Please note that:

  • If a positive infectious disease is found you will be confidentially informed and should seek the advice of your GP regarding its

relevance to you.

  • The infectious disease testing is undertaken by an independent accredited facility.
    • The list of tests conducted is included on your consent form.
    • If the maternal blood sample cannot be collected and a repeat phlebotomist visit is required to obtain the maternal blood sample, there may be an additional charge of £100 to cover this visit. However, this will be discussed with you in advance.

6.        Storage of the cord blood and/or cord tissue

  • If the cord blood and/or cord tissue are suitable for processing, they will be stored and we will communicate confirmation of the successful

processing and storage.

  • If the cord blood and/or cord tissue are deemed unsuitable for processing or storage for reasons such as those detailed below, you will be

notified and the reason discussed.

  • Extended transit time to the Biovault facility.
    • Insufficient cord blood and/or cord tissue to process.
    • Heavy microbiological contamination of the cord blood and/or cord tissue with an antibiotic resistant microorganism or where the

viability of the stem cells contained within the cord blood is affected.

  • Lack of completed maternal health questionnaire, signed consent form or collection documentation.
    • If the cord blood and/or cord tissue marginally fails to reach the standards set for processing and storage, you will be notified and the

prospects discussed in full; where possible guidance will be given.

  • If the cord blood and/or cord tissue is deemed unsuitable for processing and/or storage the individual, hospital or phlebotomist performing the collection will be in no way liable.
    • Biovault will use appropriately small quantities of the collected cord blood and/ or cord tissue for the essential quality assessment tests.
    • Microbiological testing of a sample of your cord blood and/or cord tissue will be performed on behalf of Biovault by an independent accredited facility. If found to be contaminated with micro-organisms, these micro-organisms will be tested to determine their sensitivity to antibiotics. In cases such as this Biovault will make a recommendation on suitability for storage but you will be given the choice of whether you wish to continue storing the contaminated cord blood and/or cord tissue. Where the contaminating micro-organism is found to be sensitive to antibiotics you will be charged in full even if you decide not to continue with storage.
  • Biovault will store the cord blood and/ or cord tissue in fully compliant conditions and will handle them in accordance with best practice. Biovault cannot be held responsible for the results of force majeure.

7.    Release of the cord blood and/or cord tissue for medical application

  • If you, or your child once reaching 18 years of age require the release of the cord blood and/or cord tissue for medical application we will need written notice including the name and address of the hospital and clinician where the treatment will take place.
    • If the destination for release is a facility licensed by the competent authority for that country, we will ask the clinician requesting the release to sign an end user agreement with ourselves which specifies the responsibilities for both Biovault and the clinician. Once this has been signed the cord blood and/or cord tissue can be released.
    • If there is no regulatory framework in the country for licensing or the facility is not licensed in a country that does have a regulatory framework we would consult with the UK Human Tissue Authority to seek advice. We would also take into consideration the type of treatment to be undertaken, the recipient and the attributes of the product stored at Biovault, and based on this provide advice to yourself. As above if the release is progressed we will ask the clinician to sign an end user agreement with ourselves.
    • In cases of positive infectious diseases testing results from the mother’s blood or contamination of the cord blood and/or cord tissue with micro-organisms there may be limitations to the suitability for use for the recipient or required medical application. Ahead of the release copies of all records and results will be given to the requesting clinician for their assessment, alongside advice from Biovault’s medical and processing team.

8.         Duration and fees

  • The agreement commences from the day you sign this document or submit a marked as read version of this document via the online platform: www.biovaultfamily.com. However, you can withdraw your consent at any time. If consent is withdrawn prior to collection of the cord blood and/or cord tissue no further payment will be required. If consent is withdrawn at a later point the service will be charged in accordance with Clause 6.
    • Included in this agreement and the charges payable, are the following items and services;
      • A single point of contact for all matters relating to the stored cord blood and/or cord tissue, known as the client advisor.
      • Complete collection kits for the collection and transport of the cord blood and/or cord tissue and maternal blood samples.
      • Courier fees for the transport to Biovault for processing and storage.
      • Processing of the cord blood and/or cord tissue in preparation for storage.
      • Cryopreservation and long term cryogenic storage (if you selected Biovault’s fully inclusive 25 year storage plan). A proportion of your fees paid, sufficient to pay for the long term storage of your cord blood and/or cord tissue, will be transferred to our Escrow company and each year an amount to cover that years storage will be transferred back to Biovault. Therefore if anything happens to Biovault in

the future you can be assured that your cord blood and/or cord tissue will continue to be looked after for the remaining storage period. If you have selected the annual storage option the price includes the first years storage. You will be invoiced yearly in advance for the subsequent years storage and the cord blood and/ or cord tissue sample will be stored for a further year on payment of that invoice.

  • All testing applicable to autologous use for the donor child, and testing associated for allogeneic use for a sibling of the donor child or additional infectious disease testing required due to maternal health questionnaire answers.
    • A certificate of storage detailing the results of the testing performed.
    • Preparation and shipping of the cord blood and/or cord tissue for autologous use for the donor child and allogeneic use for a sibling of the donor child.
    • Disposal of the cord blood and/or cord tissue at the end of the storage period.
    • If the cord blood fails to reach the minimum acceptance criteria for processing and storage, and you decide not to store the cord blood, but the cord tissue is successfully processed and stored, you will still be charged for the processing and storage of the cord tissue.
    • In the extremely unlikely event that Biovault deem both the cord blood and cord tissue to be totally unsuitable for processing and/or storage, Biovault will contact you immediately and when agreed proceed with their disposal. There will be no further charges. If you decide to continue to store your child’s cord blood and/or cord tissue you will be required to complete a storage continuation form. This form documents your consent to continue to store the cord blood and/or cord tissue even though it has not met Biovault’s criteria. You understand that if this form is not received within 8 weeks of the cord blood and/or cord tissue being stored then it will be deemed that you do wish to continue to store and you will be invoiced accordingly.
    • If you do require the cord blood for medical application then a HLA test and any additional quality tests (based on maternal health questionnaire answers) must be carried out on sub-samples of the stored cord blood prior to release. If this is for autologous use (for the donor child) or a sibling (allogeneic use) of that child the cost for this and any further testing required is covered in the fees paid. However, for other family members (allogeneic use) these tests will be charged at an extra cost. The costs will be discussed with you prior to sending any samples for testing.
    • For the avoidance of doubt the following are the only additional charges that can be applied under this agreement:
      • Storage beyond agreed storage period (or annual storage if selected).
  • Any currently unforeseen payment required by law; this is not considered to be likely.
    • Costs incurred to rebook a phlebotomist to procure maternal blood samples (£100), it is rare that this is required and will not be done without prior correspondence.
    • Costs incurred for an allogeneic transplant such as HLA and quality testing for family members that are not siblings of the donor child.
    • Biovault will only dispose of the cord blood and/or cord tissue:
      • On completion of the storage period.
      • If any payment is not made within the period defined in this agreement.
      • If the cord blood and/or cord tissue are completely unsuitable for storage.
    • All prices are VAT inclusive. For the avoidance of doubt:
      • Should the cord blood and/or cord tissue be deemed by Biovault unsuitable for processing and/or storage there will be no second invoice if you choose to dispose.
      • There are no hidden charges.
      • There are no refunds of fees paid.
      • There is a legal requirement for traceability of every element of the service, and collection kits are provided specifically for your use

and are not transferrable to any other person.

  • Payment terms:
    • You are required to pay a non-refundable deposit on registration for the issue of the collection kit. Collection kits will not be issued prior to receipt of this payment.
    • An additional fee will be payable for the phlebotomist collection service if you choose this option. Our partner phlebotomy company will provide this service and Biovault will facilitate the booking of this for you.
    • When the cord blood and/or cord tissue are stored successfully you will be notified and only then a second and final invoice will be issued on 14-day payment terms. On payment of this invoice or the first instalment via a payment plan a certificate of storage will be issued. If you require to take advantage of one of our payment plans of up to 12 months you will need to apply and be accepted prior to the cord blood and/or cord tissue being stored. There is no option to apply for a payment plan after storage has taken place.

9.      Biovault liability

  • Biovault will provide the services outlined in this contract in accordance with the appropriate regulations, standards and guidelines, using procedures developed by Biovault.
    • Given the nature of the service Biovault makes no claims for the success or effectiveness of future medical application of the stored cord

blood and/or cord tissue. Biovault will, however, make recommendations regarding the cord blood’s suitability for storage and for future use based on currently recognised standards. However, no guarantees can be given and the medical application outcomes depend on the circumstances of each individual case. Accordingly, you release Biovault from any liability for any loss or damage arising from:

  • Failure of the cord blood and/or cord tissue to meet a medical condition.
    • Delay, loss, damage or deterioration in the cord blood and/or cord tissue during transport from you to Biovault.
    • Deterioration in the cord blood and/or cord tissue caused by deficiencies in the services offered, except the liability arising from any

breach by Biovault in the procedures outlined in point 9.1. Any liability is limited to the amount paid for the service.

10.        Personal information

  1. Biovault will request personal information regarding you, your family and your child such as names, dates of birth, addresses such as physical, email, telephone number and IP address. We will use this information to contact you and discuss our products and services and/or to perform a specific engagement. We use your IP address to track the geolocation of individuals that view our website.
    1. We collect and use personal data and data concerning health in the provision of our products and services. You are responsible for the accuracy and completeness of this information. In certain instances, we may ask for further information of a personal nature, this is for the purpose of providing the services offered only.
    1. You must notify Biovault of any changes to your personal information at the earliest opportunity and are responsible for notifying us of any changes in contact details, such as address.
    1. We may also use your personal information, namely your contact details, to transmit promotional email communications of some of our services that you may be interested in. You agree that we may send or correspond with you regarding further services and other relevant information that we believe may be of interest to you. If you do not wish to receive communications of this nature you may inform us by writing to us.
    1. All information will be held, handled and internally transmitted securely and in full compliance with the General Data Protection Regulation. Personal information will only be passed on to organisations working under instruction and agreements with Biovault such as licensed testing facilities, courier companies and our partner phlebotomy company who are directly involved in offering the service.

Information will only be passed to another party with your permission, for example in the case of release of the cord blood and/or cord tissue for medical application.

  1. We may also share your personal information with third parties such as the Human Tissue Authority (HTA) where we are required to do so by law.
    1. We will store your personal information for up to 10 years after disposal of the cord blood and/or cord tissue. You understand that if the cord blood stem cells are required for medical application the data including your personal data will, in accordance with the law, be held for 30 years post use and that even if you withdraw your consent Biovault must continue to hold that data.
    1. You have the right to request copies of the personal information we hold about you at any time. You have the right to request that we correct any inaccurate personal information we hold about you. You have the right to request that we delete your personal information from our records. However, this cannot contravene the particulars of point 10.7. You have the right to restrict how we use your personal information but understand this may limit the services that can be offered to you. You have the right to object to the collection and use of your personal information at any time. You have the right to obtain a copy of your personal information in a legible and compatible form such as Excel or Word. To exercise your rights you can contact us at any of the contact details in Section 1.
    1. You warrant that you are the legal guardian and are acting in the best interests of the donor and that you understand that the cord blood and/or cord tissue will become the property of the donor when the donor turns 18 or as the law shall then apply.
    1. You agree that no one except a party to this agreement has any right to prevent the amendment of this agreement or its termination and no one except a party to this agreement may enforce it.
    1. To lodge a complaint about the use of your personal information please contact us at any of the contact details in Section 1. You also have the right to lodge a complaint directly with the Information Commissioner’s Office (ICO). The ICO are a regulator who makes sure that we use your personal information in a lawful way. You can lodge a complaint with the ICO by following this link https://ico.org.uk/concerns or calling the ICO on +44(0)303 123 1113.

11.   Notices

  1. This agreement is governed by the laws of England and Wales. Any disputes between parties shall be heard in English Courts.
    1. We reserve the right to assign this agreement to any person or company. We will give you notice of any such assignment, and they will be bound by the terms of this agreement.
    1. If any part of this agreement is not clear please discuss with your Biovault client advisor prior to signing. A signed agreement or marked as read version of this agreement via our online platform at: www.biovaultfamily.com assumes you have full understanding of the contents.
    1. If we need to communicate with you regarding this agreement we will do so in writing. If you change address please notify us as soon as possible.

In signing this document or submitting a marked as read version of this document via our online platform at www.biovaultfamily.com you acknowledge that you have given full consent for the aspects listed below based on a full understanding of the implications of this decision and the usefulness of the stored cord blood and/or cord tissue in future medical application.

You are giving your consent voluntarily and this will be evidenced by signing this document or submitting a marked as read version via our online platform at: www.biovaultfamily.com.

You also understand that the cord blood, cord tissue and maternal blood samples have to be collected by a healthcare professional who is trained and suitably licensed. Biovault can provide a suitably trained phlebotomist or provide licensing agreements and training to a healthcare professional of your choice.

You understand that there is no guarantee or assurance of the success of the collection process and understand that the collection should not interfere with the birth or cause any discomfort.

Consent is given for:

  1. Collection of the cord blood once mother and child are deemed to be in a suitable condition to allow the process, (it may not, for medical rea- sons, be possible to collect the cord blood and it is up to the attending healthcare professional to decide if it is safe to do so).
  2. If selected, collection of a section of the umbilical cord (cord tissue) once mother and child are deemed to be in a suitable condition to allow the process. (It may not, for medical reasons, be possible to collect the cord tissue and it is up to the healthcare professional to decide if it is safe to do so).
  3. The taking of a minimum of three 10ml samples of maternal blood for mandatory infectious disease testing. You understand that the taking of the maternal blood samples may cause some pain and discomfort.
  4. Transport of cord blood, cord tissue and maternal blood samples by courier to Biovault Technical Ltd in Plymouth, UK. You understand it is your responsibility to notify Biovault when they are ready to be transported using the instructions provided.
  5. The processing of the cord blood for cryopreservation and cryogenic storage.
  • If selected, the processing of the cord tissue for cryopreservation and cryogenic storage. The cord tissue will be stored under the same conditions as the cord blood. Currently, there are no medical treatments available using stem cells extracted from cord tissue. The cord tissue is, consequently, stored with a full understanding of this and solely at your request.
  • Directly associated testing of the cord blood and/ or cord tissue. These tests are required to determine suitability for storage and any subsequent therapeutic use.
  • Mandatory testing of the maternal blood for the following infectious diseases:
  • HIV I & II
  • HTLV I & II
  • Hepatitis B
  • Hepatitis C
  • CMV
  • Syphilis

You understand that you will be notified of the results of these tests and that they may reveal current or past infections affecting your health and or the health of your child that you may not be presently aware of. The discovery of these infections may be distressing for you and your child and may indicate that you should seek further medical advice and treatment.

  • Review of your medical and processing records by the clinical team, if your child’s cord blood and/or cord tissue is required to be used for medical application.

And finally

You understand that you have the right and upon reaching 18 years of age, your child has the right to withdraw consent at any time. To withdraw consent, you understand that you will be required to complete a consent form to dispose of the cord blood and/or cord tissue. Once this has been received at Biovault the cord blood and/or cord tissue will be disposed of in accordance with the company’s procedures.

You understand that you have the right and upon reaching 18 years of age, your child has the right to withdraw consent at any time to the processing, transfer and holding of any personal data. However, if you withdraw your consent Biovault will not be able to provide the services and the cord blood and/or cord tissue will have to be disposed of.

You understand that on receipt of a request for disposal Biovault may ahead of the disposal perform additional tests on the cord blood and/ or cord tissue as part of its ongoing quality assessment processes. The results of these tests will be for Biovault use only and will not be communicated to you.

You understand that if the cord blood stem cells are required for medical application the data including your personal data will, in accordance with the law, be held for 30 years post use and even if you withdraw your consent Biovault must continue to hold that data.

In signing this form or submitting a marked as read version via our online platform at www.biovaultfamily.com you acknowledge:

  • That you have been provided with the Biovault Family educational information on cord stem cell banking.
  • You have also been provided with the opportunity to access donor education and advocacy services such as independent websites (Parents Guide to Cord Blood and the Cord Blood Association) and had the opportunity to ask questions regarding cord stem cell banking, the use, risks and potential benefits of storing your child’s cord stem cells.
  • You have been given a copy of contact information for future questions on the service.