1. PREAMBLE 

This is an Agreement between CRYO-SAVE SOUTH AFRICA (PTY) LIMITED (CRYO-SAVE) and the legal GUARDIAN, whether a parent or otherwise (GUARDIAN) of a child about to be born and relating to the collection of stem cells (SPECIMEN) obtained from the umbilical cord of the child at birth, with a view to the storage of the SPECIMEN in an approved cellular storage LABORATORY (LAB). Wherever the word LABORATORY or LAB is referred to in this agreement it shall be a laboratory either owned,
operated or approved by Cryo-Save. Any processing and storage of the SPECIMEN shall only take place in the LAB.

 2.  OBTAINING, TRANSPORTING AND PROCESSING OF SPECIMEN

• 2.1 CRYO-SAVE shall be responsible for :
  • 2.1.1 providing a kit for the collection of the SPECIMEN;
  • 2.1.2 collecting the SPECIMEN from the GUARDIAN or his representative;
  • 2.1.3 transporting the SPECIMEN to the LAB for storage;
  • 2.1.4 processing the SPECIMEN provided that it reserves the right to refuse to process the SPECIMEN if it has been incorrectly
    deposited, or contaminated or if any tests or reports on the mother are unfavourable;
  • 2.1.5 in the case of a multiple birth, collecting not more than one SPECIMEN unless otherwise agreed;
  • 2.1.6 payment to the GUARDIAN’S medical practitioner and/or antenatal clinic sister of an agreed fee for administrative work as required.
• 2.2 The GUARDIAN shall be responsible for :
  • 2.2.1 in the case of an expected multiple birth, advising CRYO-SAVE in writing and requesting the requisite number of kits;
  • 2.2.2 arranging for a medical practitioner to obtain the SPECIMEN from the umbilical cord and deposit same in the kit;
  • 2.2.3 ensuring that CRYO-SAVE is informed in good time to enable it to arrange for the collection of the SPECIMEN;
  • 2.2.4 providing, when reasonably requested by CRYO-SAVE, such medical or blood tests of the mother of the child before birth and up to four months thereafter, all at the expense of the GUARDIAN, completing such forms and supplying such information as shall be reasonably requested by CRYO-SAVE.

 3. STORAGE

• 3.1 After processing the SPECIMEN, CRYO-SAVE shall isolate the stem cells and shall store them in the LAB unless the number of stem cells available is insufficient or unless the SPECIMEN is in any way unsuitable. In either of the said events, CRYO-SAVE reserves the right to refuse to store the SPECIMEN.
• 3.2 CRYO-SAVE shall store the SPECIMEN in a Cryo-Save approved LAB in its sole discretion. CRYO-SAVE shall also be entitled to transfer the SPECIMEN to another LAB or to relocate the LAB at any time.
• 3.3 CRYO-SAVE shall store the SPECIMEN in good condition for a period of twenty years unless extended by agreement between the
  parties.
• 3.4 The onus shall be on the GUARDIAN to contract for the renewal of this Agreement prior to the expiry of the storage period and CRYO-SAVE shall have no further liability under this Agreement unless so renewed. If 30 days before the expiry of this Agreement the client has not renewed their contract the client relinquishes all rights in and waives all rights to the SPECIMEN. CRYO-SAVE shall have the right to dispose of the SPECIMEN.
• 3.5 During the period of storage, only the GUARDIAN shall be entitled to withdraw part or all of the SPECIMEN for the medical treatment of the child or any other person. During such period the GUARDIAN shall also have the right to withdraw the entire SPECIMEN for storage elsewhere. The GUARDIAN shall give reasonable notice of any such requirement and shall be responsible for the cost of transportation of such cells from the LAB at his own risk. The partial or total withdrawal of the SPECIMEN for any reason shall not entitle the GUARDIAN to a refund of any fees.
• 3.6 The GUARDIAN consents to the harvesting and storage of the SPECIMEN and consents to testing the umbilical cord sample for any infectious diseases (eg. HIV, CMV, Hepatitis B & C and Syphilis).
• 3.7 Ownership of the SPECIMEN shall vest solely in the GUARDIAN.

4. MEDICAL HEALTH HISTORY

As requested by Cryo-Save in clause 12, the parent shall undergo the Stem Cell Collection Blood Test at a registered pathology laboratory and hereby unconditionally consents to the test and gives permission to

Cryo-Save to collect and obtain the test results.

5.  PARENT’S OBLIGATIONS

• 5.1  In terms of this agreement, it is the parent’s obligation to ensure that:
  • 5.1.1 the health care practitioner is provided with the specimen collection kit and the information provided by Cryo-Save;
  • 5.1.2 In the 2 (two) weeks prior to the projected birth date (due date) of the child, the mother of the child shall undergo screening tests for:
    • a) Human Immuno Deficiency Virus 1 & 2 plus the P24 Antigen
    • b) Hepatitis B Surface Antigenc) Hepatitis C Antibodies
    • d) VDRL – RPR
    • e) Cytomegalo Virus (CMV) IgG & IgM
• 5.2  The parent shall ensure that all the screening tests stated in clause 5.1 are performed.
• 5.3 The parent shall be liable for the cost of the screening tests.
• 5.4 The parent acknowledges that certain tests results may indicate that a specimen is not or will not be suitable for storage and that Cryo-Save’s Medical Director may, in his sole discretion, refuse to accepted, process or store the specimen.
• 5.5 the specimen is obtained by the health care practitioner and transported to the Lab.
• 5.6 It is the parents sole responsibility to contact Cryo-Save within 1 hour of birth to arrange collection of the specimen. If the birth is outside office hours (8 am- 5pm) the parent must make contact by 9am the following day.
• 5.7 The parent agrees to pay promptly all fees that are set out herein and agrees thereto that upon failure to fulfill this obligation Cryo-Save may terminate this agreement and, at its sole discretion, retain, use or dispose of the specimen.

6. FEES

• 6.1 The fees payable by the GUARDIAN to CRYO-SAVE for the services in this Agreement shall be as per the attached Acknowledgement of Indebtedness (Undertaking To Pay) and the GUARDIAN acknowledges that the failure to pay any fee timeously may result in the immediate cancellation of the Agreement by CRYO-SAVE. The services for which the GUARDIAN commits to pay CRYO-SAVE are:
  • 6.1.1 A Deposit which is charged for the initial direct costs incurred in rendering the services under this agreement; administration, a specimen collection kit, transport of the SPECIMEN to the LAB and processing of the SPECIMEN at the LAB to assess it’s viability for storage.
  • 6.1.2 A Storage Fee is charged for the services related to the  harvesting and the twenty year storage of the SPECIMEN. This storage fee will be payable upon written confirmation being given to the GUARDIAN that the SPECIMEN has been successfully stored.
  • 6.1.3 An Annual Fee is charged to cover the escalation of costs over the twenty year period thereby ensuring best practice is
    maintained in respect of the care of the SPECIMEN. Payment of the annual fee shall be made by means of a debit order in favour of
    Cryo-Save that is payable in the 11th (eleventh) month after the storage has commenced.
• 6.2 The GUARDIAN acknowledges that a breach of payment as contemplated in this clause 4, read in conjunction with the Acknowledgement of Indebtedness, shall constitute a fundamental breach of this agreement which shall entitle CRYO-SAVE to cancel this Agreement without notice to the GUARDIAN and without prejudice to any other claim that may be available. In the event of cancellation, CRYO-SAVE may destroy the SPECIMEN at CRYO-SAVE’s sole discretion.

7. LIMITATION OF LIABILITY

• 7.1 CRYO-SAVE shall not be obliged to give medical advice or provide any services other than those described in this Agreement.
• 7.2 CRYO-SAVE shall not be liable for loss or damage to the SPECIMEN caused by any event beyond its control, including force majeure. From the point where any stem cells are withdrawn from the child or from storage and delivered to a carrier for transportation to the LAB or the GUARDIAN, CRYO-SAVE shall have no liability for the stem cells withdrawn.
• 7.3 CRYO-SAVE shall also not be liable for any destruction of the SPECIMEN following cancellation of this Agreement.
• 7.4 In respect of any damage (other than that referred to above) to the SPECIMEN after collection or during transportation or during
  processing or whilst in storage, the maximum liability to the GUARDIAN shall be the refund of the fees paid other than the initial / subscription fee paid in terms of paragraph 4.1.1. in particular, CRYO-SAVE shall not be liable for any consequential loss or damage.

8.     CANCELLATION  

• 8.1 The GUARDIAN shall be entitled to cancel this Agreement upon written notice to CRYO-SAVE prior to the birth of the child but the initial / subscription fee, if paid, shall not be refundable.
• 8.2  In the event of the GUARDIAN being in breach of any payment or other obligation then CRYO-SAVE shall have the option to cancel this Agreement without notice to the GUARDIAN and without prejudice to any other claim that may be available. In the event of
  cancellation, CRYO-SAVE may destroy the SPECIMEN.

9. CESSION AND ASSIGNMENT

• 9.1 CRYO-SAVE shall be entitled to cede and assign its rights and obligations under this Agreement to a third party after prior written notice in writing to the GUARDIAN.
• 9.2 The GUARDIAN may, in writing, transfer to one or more persons his rights under this Agreement at any time and, in particular, upon his death or disablement. No transfer shall take effect until the transferee or successor consents in writing to the transfer and agrees to be bound by this Agreement. Should the GUARDIAN be deceased or disabled and should there be no transferee or successor to the GUARDIAN’s rights, CRYO-SAVE may, in its entire discretion, recognise the authority of any person to represent the child.

10. CONFIRMATION OF COMPREHENSION

The parent hereby confirms that he comprehends the following:

• 10.1 The decision on whether to perform the cord blood collection is subject to the sole discretion of the health care practitioner and Cryo-Save has no control over the decisions made by the health care practitioner in this regard.
• 10.2 Cord blood collection is a relatively new and experimental technique. Stem cells that are harvested from the child’s cord blood may assist in the treatment of future diseases that the child may suffer, but such assistance cannot be guaranteed.
• 10.3 The future therapeutic use of the child’s specimen may entail risks and complications that are as yet unknown. The parent or the
  major child, whichever is applicable, shall at the appropriate time make decisions regarding the use of the specimen and the inherent benefits and risks of this treatment.
• 10.4 There are alternative sources of stem cells, such as bone marrow, peripheral blood or adipose tissue.
• 10.5 The collection of the specimen may be unsuccessful for several reasons, including the following:
  • 10.5.1 The health care practitioner may be unable to perform the collection;
  • 10.5.2 it may not be possible to collect a sufficient quantity of the specimen for processing and storage;
  • 10.5.3 after collection, the specimen may be found to be unsuitable for storage;
  • 10.5.4 the specimen may become contaminated or may be damaged, lost or destroyed during the process of collection, temporary storage, transportation, processing, cryogenic freezing or final storage.
• 10.6 The parent bears the responsibility for ensuring that:
  • 10.6.1 The health care practitioner communicates timeously with Cryo-Save, or the relevant medical courier nominated by Cryo-Save, to arrange for the collection of the specimen;
  • 10.6.2 arrangements have been made for PathCare, or a similar organisation nominated by Cryo-Save, to transport the specimen as soon as possible to its final destination, which process should not take more than 48 (forty eight) hours; and that
  • 10.6.3 Cryo-Save is notified of the birth of the baby no later than one hour after the birth.
• 10.7 A delay in the above-mentioned process may affect the viability of the specimen for storage and Cryo-Save cannot be held
  responsible for such delay or its consequences.
• 10.8 Cryo-Save may, if it is considered necessary, test the child’s specimen and require further tests to be performed on the maternal blood.
• 10.9 There is no guarantee regarding the success of the collection, processing or storage of the specimen and Cryo-Save shall not be liable for any loss or damage sustained by the parent as a result of any act or omission on the part of any party, irrespective of whether such act or omission is negligent, grossly negligent or intentional.
• 10.10  It is recorded that Cryo-Save provides no warranty in terms of this agreement. However, it is noted that:
  • 10.10.1  Cryo-Save commits itself to ensuring that all legal requirements are fulfilled and all processes relevant to its actions and activities are followed at all times;
  • 10.10.2 the extraction, processing, storage and use of the specimen currently falls into a statutory or regulatory lacuna as there is no clear statutory provision or regulation in terms of which an applicable license may be granted;
  • 10.10.3 Cryo-Save has taken all possible and reasonable steps to ascertain whether a license is necessary and, if so, to obtain such license. No such obligation appears to exist and, accordingly, no license has been obtained;
  • 10.10.4 should any government, regulatory body or person in the future deem the collection, processing, storage and use of the specimen in terms of this agreement to be unlawful, or that a license was in fact required, the parent, in his personal capacity and on behalf of the child, hereby indemnifies Cryo-Save against any resultant failure to perform its obligations or duties in terms of this agreement as well as against any loss or damage that may be suffered as a consequence.

 11. JURISDICTION

This Agreement shall be governed and interpreted according to South African law.

12. DOMICILE/NOTICES

• 12.1 The GUARDIAN shall appoint an address for receiving communications during the period of storage and shall be responsible for advising CRYO-SAVE in writing of any change.
• 12.2 CRYO-SAVE chooses as its address for the receipt of all notices: PO Box 39660, Garsfontein East, 0060, Pretoria, Republic of South Africa; alternatively, E‑mail : info@cryo-save.co.za ; alternatively, fax number +27 86 219-9157
• 12.3 Either party shall be entitled to vary the addresses set out above on written notice to the other.
• 12.4 Notices may be sent by E-mail, fax or airpost. E-mail and fax shall be deemed to have been received on the following transmission and if sent by airpost, on the tenth day after posting, provided that any change of address sent to CRYO-SAVE shall only be deemed to have been received after written acknowledgment is sent to the GUARDIAN.

13. WHOLE AGREEMENT

This Agreement constitutes the entire agreement between the parties and no warranties, representations, guarantees or other terms and conditions not contained or recorded herein shall be of any force or effect. No variation shall be of any force or effect unless reduced to writing and signed by the parties.

11. INDULGENCES

No indulgence which either party may grant to the other shall constitute a waiver of any rights.