Contract for cord blood stem cell storage IT

Transcription

1 Contract for cord blood stem cell storage IT Client code: 1) Introduction The purpose of this document is to explain the terms, conditions, limits, risks and costs of processing, testing and storing stem cells obtained from the umbilical cord (hereinafter: Sample) collected when a child (hereinafter: Baby) is born to the undersigned parents or those possessing parental authority (hereinafter: Parents/Guardians), meaning by Parent/Guardians those who have the right to dispose of the Baby s cord blood according to the relative laws and regulations in force and to exercise their rights on the sample stored until the Baby comes of age. This contract must be signed by at least the mother of the Baby, since her consent is necessary for some activities specified in the contract. This document also constitutes a binding contract between: A) BIO-VAULT Ltd., Tissue Bank based in Plymouth, 24 Brest Road, Derriford, PL6 5XP, United Kingdom, holder of HTA (Human Tissue Authority) licence n B) Nanog International s.r.l. (hereinafter: NI), based in Rome, via Vittorio Locchi Roma. C) the undersigned Parents/Guardians. NI is a procurement company under British law, that is a company providing information on cord blood collection, including commercial and logistic aspects, so that it can be suitably received, treated and stored in the tissue bank holding a specific HTA (Human Tissue Authority) licence according to approved Standard Operating Procedures. NI deals with the entire management of the contract, including certification of cryogenetic storage, in the name of and on behalf of Bio-Vault Ltd., under the terms of ISO 9001:2008 standards. With the signature of this contract, consisting of two originals of which one is kept by the Parents/Guardians and the other by NI, the undersigned Parents/Guardians agree to process and store the Sample with the tissue bank (hereinafter: Laboratory) and declare they accept the following. The Parents/Guardians are aware that the transplant of stem cells from the umbilical cord is a relatively new technique that can be beneficial for the Baby or for other possible beneficiaries (where permitted by the relative laws and regulations in force). The Parents/Guardians specifically acknowledge that NI and the Laboratory do not provide any guarantee of the therapeutic success of the Sample. 2) Purpose of contract The purpose of the contract is the private treatment and cryogenic storage of umbilical cord stem cells for the first 25 years from the date on which storage began as indicated on the certificate, as per art. 8 below; the Bio-Vault Ltd. Laboratory, based in Plymouth, 24 Brest Road, Derriford, PL6 5XP, United Kingdom, shall be responsible for the storage. The Laboratory undertakes to guarantee suitable storage standards and to respect all the scientific, quality or security provisions or any other matters imparted by the regulatory authority. The Sample in cryogenic storage can only be issued to a health unit licensed in the EU or to a certified transplant centre anywhere in the world. The introduction is an essential part of the contract, which takes effect after NI receives a copy signed by the Parents/Guardians who shall retain a copy for themselves. NI does not perform medical services, does not provide medical advice and does not carry out activities other than those specified in this contract. The Parents/Guardians are invited to consult with professionals chosen by them with the purpose of assessing the use and expediency of the purpose of this contract. 3) Cost of Kit and Storage Service The kit costs euro VAT inclusive which must be paid before receiving said kit. The kit can be requested by filling in the order form, by telephone or directly from the NI website. The order will be automatically sent to the address of the Parents/ Guardians with the bank account details for purchasing the kit. Once the payment has been made, the Parents/Guardians will be contacted for delivery. The cost of the cryogenic storage service is 2,000 euro VAT inclusive and shall preferably be paid before the birth, to the bank indicated in the order form. The price includes: information and logistic assistance in the preliminary stage, supply of a suitable kit for collecting and sending the Sample at the appropriate temperature, ordinary shipping costs by international express courier (usually DHL Express), processing of the blood and laboratory tests for cryogenetic storage, entering data in database, certification of the processing result, storage of the stem cells for the first 25 years and possible request to use the Sample for therapeutic purposes (art. 10). The price is invoiced by NI with application of Italian VAT, since Bio-Vault Ltd has delegated NI to manage the relationship with the Parents/Guardians. The Parents/Guardians who sign this contract are jointly liable for payment, irrespective of the parent/guardian to whom the invoice is made out. NI shall pay for the shipment of the Sample and, considering the fact the couriers do not operate on holidays and weekends as well as the time limits for pick-up, will make use, if appropriate and/or necessary, of the services of an alternative courier. 1

2 In the event in which the Parents/Guardians request a special service outside the days on which it is suitable and/or necessary, NI shall provide them with an estimate of the shipment costs; if accepted, this cost shall be charged to the Parents/Guardians without further fees while NI shall directly manage the shipment procedures. 4) Termination and Refunds 4.1 Refund of Kit: In the event that the Parents/Guardians intend to cancel the order of the kit/service, they must send to NI, within ten days of the compilation of the kit/service order form, a written request for cancellation by registered letter sent to NI s registered office or by to amministrazione@smartbank.it. Within ten days of the receipt of the request, NI shall provide for the refund of the kit, exclusively by bank transfer to the current account indicated by the Parents/Guardians after the intact kit has been returned by the Parents/ Guardians at their own expense, should they have already received it. 4.2 Refund of the Service Cost to Parents/Guardians The cost of the service paid to NI shall be refunded to the Parents/Guardians in the following cases: a. In the event the Sample blood is not collected and/or sent to the Laboratory for any reason. b. In the event it proves impossible to process or store the Sample for any reason (insufficient amount of blood, ongoing infection, etc.). c. In the event hepatitis B, hepatitis C antibodies and HIV 1 and 2 demonstrate that the mother has a virus infection. d. In the case described in art. 8 herein. 4.3 Parents/Guardians Right of Withdrawal and Partial Refund In the event that the Sample is insufficient, according to current scientific standards, in terms of quantity (<500,000 CD34+ cells) and/or quality (<60% of metabolically active cells) or because of a combination of said parameters, the Parents/Guardians have the right to withdraw from the storage contract within thirty days of receipt of the Statement of Withdrawal according to the formalities indicated herein; this statement was sent by NI with the cryogenic storage certificate. Should the Parents/Guardians exercise this right, NI shall refund them the cost of the service, net of euro 500,00 VAT inclusive, withheld as partial coverage of the processing and cryogenic storage expenses. 4.4 Termination by NI NI reserves the right not to accept a Sample unsuitable for storage because of, for example, insufficient volume, low metabolic vitality or non-treatable contaminating agents. In these cases, NI shall inform the Parents/Guardians of the impossibility of storing the Sample, also sending written notice of the cause(s) no later than thirty days after childbirth. NI, moreover, has the right to terminate this contract, and if necessary to destroy the Sample, in the event that the fee has not been settled (e.g. bank cheque rejected), totally or in part, without prejudice to NI s right to take legal steps to recover the debt. 5) Blood Tests and Export Licence To execute this contract it is essential that, during the thirty days before the expected date of childbirth the following tests be performed on the mother s serum: hepatitis B (all markers), hepatitis C antibodies, HIV 1 and 2 antibodies, syphilis, cytomegalovirus (Igg - Igm), HTLV 1 and 2. Should it be impossible to perform these tests in the allowable window, they must be performed no later than seven days after childbirth. In any event, the blood tests must be carried out in an accredited laboratory with the collection date indicated. The results of said tests must be sent to NI as soon as they are available, by to analisidelsangue@smartbank.it or by fax to 06/ or by mail. The stem cells cannot continue to be stored in the absence of the aforesaid test results and the Parents/Guardians shall have no right to refunds. It is understood that the Parents/ Guardians have sole responsibility for arranging said tests and their results, without NI having to send further communications or notices. NI thus disclaims all liability for the preservation of the Sample during the quarantine period or in the event it cannot be used because of the absence of these results. 6) Collection NI is not responsible for the cord blood collection, which must only be performed with the collection kit NI has provided. It is the responsibility of the Parents/Guardians to arrange the collection of the Sample with the hospital staff in accordance with the instructions delivered as part of the kit. Consequently, the Parents/Guardians have to ensure that those responsible for collecting the Sample have read the aforesaid collection instructions, that they are aware of said procedure and are duly authorized to exercise their profession (gynaecologists and obstetricians registered in the relative rolls). In no case, NI shall be held responsible for the medical procedures or the advice given to the Parents/ Guardians by the hospital staff the latter have chosen. The Parents/Guardians are aware that complications or circumstances beyond their control can occur during pregnancy or childbirth that could jeopardize the collection of the Sample. The Parties agree that the life and health of the mother and baby have the utmost priority, and therefore the collection of the Sample could be jeopardized because of said priority. In this event the Parents/Guardians have the right to cancel this contract under the conditions specified in art. 4.2 above, giving prompt notice of this to NI. 2

3 7) Transport Once the Sample has been collected, the Parents/Guardians are responsible for ensuring that the kit contains their Baby s Sample and that the bag containing the Sample is correctly labelled as indicated in the packing and shipping instructions delivered as part of the kit. In the case of twins or multiple births, each Sample has to be correctly labelled. The Parents/Guardians shall be responsible for treating the Sample according to the aforesaid packing instructions and for contacting the Courier for the Sample collection and shipping to the Laboratory, accordingly with the packaging instruction in the kit. NI shall entrust the shipment, on behalf and in the interests of the Parents/Guardians, to a certified shipper respecting biological sample transport regulations and operating with the maximum diligence. NI shall be responsible for the Sample arriving in a suitable condition in the Laboratory within the timeframe specified in international standards. Nonetheless, NI, albeit offering the Parents/Guardians its experience and assistance for collecting and shipping the Sample, cannot be held responsible for its damage, loss or delay in delivery by the courier, which has sole liability for transport. In these cases, where it is impossible to process the cord blood or preserve the Sample, the Parents/ Guardians are entitled to a refund in accordance with art. 4.2 herein. 8) Treatment, Storage and Certification of the Sample With this agreement the Parents/Guardians expressly give their consent for the Laboratory designated by NI - Bio-Vault Ltd. to carry out all the appropriate tests on the cord blood necessary for the best preservation of the Sample and the respect of the relative laws and regulations in force. The Sample will thus be tested by assessing the volume of blood collected. Should the total initial volume of blood be less than 40 ml, the Sample will not be able to be treated/processed and shall therefore be eliminated. NI shall be responsible for communicating the aforesaid result to the Parents/Guardians who have the right to be refunded for the amount paid, as described in art. 4. In a BL3, grade A cleanroom, the Laboratory isolates the stem cells in the cord blood, checking that they meet quality and quality standards. The Sample is stored in a special bag divided into two communicating parts that can be separated so that either all or part of the Sample can be used. Once the Sample is placed in storage, NI shall certify it by forwarding the cryogenic storage certificate with the results of the tests, in terms of quantity (mononuclear cells and CD34+ haemopoietic cells) and quality (degree of cellular vitality) of stem cells, including amount of blood collected, date of cryogenic storage and laboratory details. After payment has been settled for the service, the aforesaid cryogenic storage certificate shall be sent to the address indicated by the Parents/Guardians no later than thirty days after the date of childbirth by post, with notice sent by if provided. To ensure the best storage conditions, in the event of attested need or by order of the regulatory authority, NI is expressly authorized to transfer the Sample to another laboratory or to another suitable unit, promptly informing the Parents/Guardians by means of registered letter with acknowledgement of receipt. Under no circumstances can the Sample be divided up among several laboratories, since centralized storage is considered essential, nor can it be used, wholly or in part, for scientific research. 9) Rights on Sample and Therapeutic Use The Sample shall be legally owned by the Parents/Guardians and shall remain under their exclusive control. The Parents/Guardians therefore undertake to inform NI, in writing or by , of any change in their address. They shall be able to take any decision involving the Sample (use, public donation, destruction) with the sole limit of observance of the relative laws and regulations in force, the provisions of the regulatory authority, of GMP (Good Manufacture Practice) and of every reasonable prudent practice. These rights shall be automatically transferred to the Baby from whose umbilical cord the Sample has been extracted, at the time he/she comes of age, in accordance with the laws of his/her citizenship. The Parents/Guardians therefore undertake to inform promptly the Baby of his/her rights with regards to the Sample that he/she will acquire when he/she comes of age, including the right to renew the contract upon its natural expiration date (twenty-five years). NI is expressly exonerated from every responsibility for the failure of the Parents/Guardians to observe the provisions given above. For the entire duration of the contract, the Parents/Guardians or the Baby, after he/she has reached 18 years of age, have the right to request the use of the Sample for therapeutic purposes. The service includes retrieval of the cells, as well as any tests or treatments requested when the Sample is removed or specified by the protocols of the country of destination and its delivery to the chosen accredited transplant centre. The request to use the Sample must be forwarded, by those so entitled, to NI s registered office by registered letter or by to: info@smartbank.it. Following the request for use, NI shall send to the applicant (s) and to the doctor who will perform the transplant the appropriate forms/documents to be filled in and sent back to NI by to info@smartbank.it or by fax to N.06/ At least three months before the natural expiration date of the contract, as specified in art. 2 above, NI shall send a communication to the Baby or his/her legal representative regarding the expiry of the contract, as well as the possibility for its renewal in accordance with the terms and conditions indicated by NI. Should this contract not be renewed at its natural expiration date, the Sample shall be kept at the Baby s disposition for a period of ninety days after expiry. During this period the Baby can take a decision with regards to the Sample (continue storage, public donation, destruction) informing NI promptly in writing. Should this not occur, the Sample shall be donated, if possible, to a public donation bank or otherwise destroyed without the need to obtain further consent, and excluding the possibility of offering the Sample, wholly or in part, for the purpose of scientific research. 3

4 10) Warranties NI guarantees that the kit provided corresponds to legal requisites and is of satisfactory quality for the purpose of collecting and transporting the Sample, insofar as it is used in accordance with the collection protocol and instructions provided. NI guarantees that the transport of the Sample shall be carried out respecting the regulations governing the shipping of biological samples and of international standards. NI guarantees that the Sample will be tested, treated and stored in the laboratory NI has chosen in full respect of the scientific provisions for quality and safety, in accordance with the approved Standard Operating Procedures, the GMP and the provisions of the regulatory authority. NI guarantees that the Sample will be cryogenically stored for the entire duration of this contract (twenty-five years), ready to be used in any authorized health unit in the EU or in a certified transplant centre anywhere in the world, albeit NI shall not be held responsible for the success of the treatment/processing. NI and the laboratory jointly and severally undertake to respect the clauses of this contract and, in the event of attested need, reserve the right to transfer the Sample to another laboratory with equivalent quality certificates and standards. 11) Limited Responsibilities The Parents/Guardians acknowledge that NI shall not be held responsible in the event that, due to factors or circumstances beyond its control, it proves impossible to collect the Sample or the quantity of blood collected is insufficient. The Parents/Guardians expressly acknowledge and accept that NI shall not be held responsible for any failure with regards to this contract caused by delays or errors in its execution, where such delays or errors are due to actions or omissions of the Parents/ Guardians or to any other cause beyond its reasonable control. NI shall be liable to the Parents/Guardians for reimbursing any losses or damages due exclusively to its fault or negligence, or to the fault or negligence of its employees, collaborators or suppliers; therefore NI shall reimburse only the losses or damages that could have been reasonably foreseen at the date of this contract. In any event, the damages payable by NI are expressly limited to the total amount pertaining to this contract. The tissue bank s activities are adequately insured up to 10,000,000 pounds sterling. The Parents/Guardians, acknowledging that NI cannot be considered responsible for the loss or damage of the Sample during transport, accept that in this case the only possible reimbursement would be the cost of the service paid, excepting the responsibility of the courier. The Parents/Guardians acknowledge that NI and the laboratory do not provide any guarantee with regards to the suitability of the Sample for future processing and/or the successful treatment of diseases. 12) Data Treatment Under this agreement, the Parents/Guardians authorize NI, in accordance with the following, to handle all the data in question. In the event of a medical emergency, NI shall have the right to provide said data in writing to doctors or medical bodies. In other cases, NI shall not either show or provide any such data without previous specific authorization in writing. NI shall take every reasonable measure to maintain the confidential nature of the information pertaining to the Parents/Guardians and to the Baby. All samples to be tested shall be marked with an exclusive reference number and a bar code. Personal information shall be kept on a secure database and/or on a backup copy. Within the limits of the general authorization of the Guarantor of Privacy n. 2/2004 for the handling of data liable to reveal state of health and sexual habits, the possibility of divulging anonymous data, also aggregated, and of including such data, in particular, in scientific or educational publications or publications aimed at health prevention and information remains unaltered. 13) Information and Consent for Handling Sensitive Data The Parties take note of the following information: Dear Sir/Madam, Legislative Decree 196 of 30 June 2003 ( referring to personal data protection ) and subsequent integrations and amendments, specifies the protection for the handling of personal data. In accordance with the regulations indicated, this data processing shall be based on the principles of correctness, lawfulness and transparency and of the protection of your privacy and your rights. Therefore, pursuant to article 13 of Legislative Decree 196/2003, we hereby provide the following information: The data you provide, including your and your baby s sensitive data, shall be handled, within the limits of the general authorization of the Guarantor of Privacy n. 2 and subsequent integrations and amendments for the purposes indicated in this contract, with both paper and electronic instruments. The processing of genetic data can also reveal information not relevant to our services but functional for the execution of the contract. This information shall remain confidential and shall not be processed by SmartBank S.r.l. or Bio- Vault Ltd. The processing of data is necessary for the execution of this contract and is compulsory for carrying out the operations required by law. If permission is not given it will be impossible to execute said contract. With the sole purpose of executing the contract, the data can be communicated to: - healthcare professionals; - Tissue Bank in Plymouth, 24 Brest Road, Derriford, PL6 5XP, United Kingdom; - companies who deal with shipments on our behalf (excluding sensitive data); - medical units providing cryogenic storage (see article 14 herein). 4

5 In case of medical emergencies NI shall have the right to provide the data (including sensitive data) in writing to doctors or medical units. Outside these cases NI shall not show or provide this data to anyone, unless previously authorized in writing. It is understood that data revealing state of health and sensitive data may not be divulged. The duration of the storage of biological samples is 25 years from the start of the cryogenic storage as indicated on the relevant certificate, as per art. 8 herein, with the possibility of extending the period. To this end the genetic data shall be preserved for a period of time no longer than that strictly necessary to fulfil the obligations or duties deriving from the contract and once this term has elapsed they shall be destroyed. Data subjects shall be recognised the rights under article 7 of the cited code and in particular the right to access their personal data, to request its correction, updating or cancellation, if incomplete, erroneous or collected in violation of the law, as well as oppose its processing for legitimate reasons, addressing their requests to the data controller: SmartBank S.r.l., based in Rome, Via Panama, n. 68, in the person of its legal representative Alessandro Maria Lerro, lawyer, c/o the company. Privacy Statement and Consent to Use of Data The undersigned, have reviewed the information provided by the data controller and being aware, in particular, that the processing will involve sensitive data pertaining to both me and my baby, agree that the data may be processed for the purposes and with the procedures indicated in the information. Surname. Name... Surname. Name... Place..... Date. 14) Statement of Consent With the signature of this contract the Mother of the Baby declares she has been adequately informed (in her language or a language which she understands ) of the purpose of the contract and of that specified by the following operations and therefore gives her express consent to the following operations: a) collection of cord blood; e) storage of stem cell Sample; b) transport of cord blood to laboratory; f) transfer of Sample to an authorized transplant centre; c) laboratory tests on cord blood; d) processing of cord blood; e) cord blood storage; f) eventual distribution to a duly authorized transplant centre; g) destruction of Sample if not suitable for preservation with regards to that specified in this contract or should the contract not be renewed. 15) Correspondence and Relevant Information For the purposes of this contract the Parents/Guardians request that all correspondence be sent to: Parents/Guardians..... Tax code... Address... Telephone..... Fax Place and date.. 5

6 Paul Giles HTA Designated Individual Bio-Vault ltd Alessandro M. Lerro Presidente SmartBank s.r.l. Genitori/Guardiani Genitori/Guardiani The following articles are specifically approved: 4) Termination and refunds 6) Collection 7) Transport 8) Treatment, Storage and Certification of the Sample 9) Rights on Sample and Therapeutic Use 10) Warranties Parents/Guardians Parents/Guardians 6