1. Interpretation and definitions

The following terms shall bear the following meaning:

1.1. “Agreement” means these terms and conditions as attached to the Client Registration Documentation, including the Informed Consent and such terms and conditions on the CryoSave website which relate hereto;

1.2. “Child” means the Child who is born and from whose umbilical cord the Umbilical Cord Blood (UCB) and/or Umbilical Cord Tissue (UCT) Stem Cells are taken;

1.3. “Client” means the Mother and/or the Father subject to, in the event:-

1.3.1. where the Mother is deceased, the Father of the Child shall automatically be deemed from the date immediately prior to the death of the Mother, to be the Client; or

1.3.2. where the Mother and Father of the Child are deceased, the legal guardian of the Child with effect from the date immediately prior to the date of the last deceased; or

1.3.3. where the Child attains the age of majority, the Child shall be the Client with effect from the date of attainment;

1.4. “Client Registration Documentation” means the CryoSave Client Registration Documentation required to be completed by the Client in order to register with CryoSave.

1.5. “CryoSave” means CryoSave South Africa (Pty) Limited (Registration Number 2010/009754/07), and its respective shareholders, directors, officers, employees and agents including marketing agents and other representatives. CryoSave is a company duly registered and incorporated according to the company laws of the Republic of South Africa;

1.6. “Father” means the:

1.6.1. biological father (conceived the Child); or

1.6.2. biological father (donated the sperm in respect of the Child); or

1.6.3. legal father (legal guardian of the Child);

1.7. “Informed Consent” means the informed consent that is required to be signed by the Client in terms of statute;

1.8. “Maternal Blood” means the blood to be taken from the birth Mother at birth and to be tested for transmissible diseases and/or any other factors as required in accordance with legislation and international standards;

1.9. “Healthcare Practitioner” means inter alia, an obstetrician, midwife or nurse;

1.10. “Mother” means the:

1.10.1. birth mother (gave birth to the Child); or

1.10.2. biological mother (donated the egg); or

1.10.3. legal mother (legal guardian of the Child).

1.11. “Processing/Process” means all operations involved in the preparation, isolation, extraction, and cryopreservation of the Stem Cells from the UCB and/or UCT;

1.12. “Stem Cells” mean cells that have the capability of differentiating into a specialised cell of the body and producing a daughter stem cell (i.e. capable of self-renewal);

1.13. “Storage/Storing/Store” means maintaining the Stem Cells under appropriate controlled conditions;

1.14. “Storage Period” means 20 (twenty) years.

1.15. “Testing/Test” means (subject to the context of use of such term), maternal blood tests performed on the birth Mother (and surrogate mother, if applicable) for transmissible diseases, and/or laboratory tests conducted on UCB and/or UCT;

1.16. “UCB” means umbilical cord blood which contains haematopoietic (blood-forming) stem cells

1.17. “UCT” means umbilical cord tissue which contains Mesenchymal (tissue-forming) stem cells

1.18. “The Laboratory” means the CryoSave South Africa Laboratory

1.19. Any reference to an enactment, regulation, rule or by-law is that enactment, regulation, rule or by-law as at the signature date, and as amended from time to time.

1.20. All amounts payable in terms of this Agreement are inclusive of VAT unless otherwise indicated.

1.21. This Agreement shall be governed by the laws of the Republic of South Africa

2. Preamble

2.1. This is an Agreement between CryoSave and the Client relating to the collection of UCB and/or UCT obtained from the umbilical cord of the Child, with the view to cryogenically store the extracted UCB and/or the UCT with CryoSave, private cryogenic storage laboratory.

2.2. The Client has requested and consented to the Collection, Processing, Testing and Storage of Stem Cells obtained from UCB and/or UCT collected from the umbilical cord at the time of the birth of the Child.

2.3. The Client intends to store the Stem Cells acquired from the UCB and/ or UCT, for the sole and exclusive benefit of the Child or any such family member that the Client expressly and in writing elects to donate the Stem Cells, if there is a suitable tissue match.

2.4. The Client authorises CryoSave to Process, Test and Store such Stem Cells in terms of this Agreement and the signed Informed Consent.

2.5. Subject to the order of any court of competent jurisdiction, and to the terms and conditions of this Agreement, all right, title and interest in and to the UCB and/or UCT and Stem Cells derived therefrom shall, vest exclusively with the Client. All such right, title and interest shall cede to the Child, at the date at which the Child attains the age of majority (in terms of the Children’s Act, 38 of 2005 as amended.

3. Collection, transport, processing and storage of umbilical cord blood and/or umbilical cord tissue

3.1. The Client undertakes to:

3.1.1. consult with CryoSave, and make the necessary arrangements to ensure that UCB and/or UCT is collected and properly packaged in the kit, in accordance with the instructions provided therein;

3.1.2. contact CryoSave within 1 (one) hour of birth of the Child, or as soon as reasonably possible after the collection of the UCB and/or UCT, to ensure that a reasonable time is afforded to CryoSave to arrange for a courier to transport the UCB and/or UCT to the CryoSave laboratory.

3.2. CryoSave shall not be responsible for any compromise to the integrity of the UCB and/or UCT before, during or after collection or transportation (which is beyond the control of CryoSave).

3.3. CryoSave shall Process the UCB and/or UCT and Store the Stem Cells, provided that it reserves the right to refuse to Process and Store the UCB and/or UCT if the UCB and/or UCT was incorrectly collected and/or deposited, and/or contaminated and/or the collection volume falls below the minimum requirements, and/or if any tests or reports on the Mother are deemed unfavourable, and/or the requisite Informed Consent has not been completed and/or not been signed, and/or the collection fee has not been paid, and/or testing of the UCB and/or UCT is deemed to be Sub-Optimal, and/or once Processed, the number and/or viability of the Stem Cells falls below the minimal requirements as defined by CryoSave as being suitable for Storage:

3.3.1. Optimal (a UCB and/or UCT that contains stem cells that have been extracted from either the UCB, UCT (or either of or both) and which CryoSave has determined as being suitable for storage);

3.3.2. Sub-Optimal (a UCB and/or UCT that notwithstanding that it contains stem cells that have been extracted from either the UCB and/or, UCT which, in the opinion of CryoSave (due to factors that may include, but not be limited to the number or quality of the stem cells contained therein) the future potential usefulness of such cells is in doubt and in respect to which the election to store such is left to the Client in accordance with clause 5.1.2; or

3.3.3. Not Viable (a UCB and/or UCT that, irrespective as to whether such UCB and/or UCT contain any stem cells or not, in the discretion of CryoSave as per clause 10.1.2, has been rejected for storage.)

3.4. In the case of a multiple birth, CryoSave will only be providing services in regard to one UCB and/or UCT, unless CryoSave and the Client have agreed to the provision of services in respect to more or all of the born children, in which event, an Agreement shall be required to be completed for each respective Child.

3.5. CryoSave shall Store the Stem Cells in good condition for the Storage Period, or such other continued period of Storage as agreed between the Client and CryoSave from time to time.

3.6. CryoSave undertakes to contact the Client 4 (four) months prior to the expiration of the Storage Period, and the Client will have the option to elect to:

3.6.1. continue Storing the Stem Cells, in which case CryoSave shall invoice the Client for the Storage thereof at its then current rates, which will be market related; or

3.6.2. terminate this Agreement in accordance with clause 10.1.5;

3.6.3. If, CryoSave elects to terminate the Agreement in accordance with clause 10.1.5, all rights in and to the UCB and/or UCT shall be deemed to have been waived in favour of CryoSave and Cryo- Save shall have the right to dispose of the UCB and/or UCT.

3.7. The Client (or Child obtaining the age of majority), in consultation with a Healthcare Practitioner who by qualification is competent to extract the UCB and/or UCT and/or administer a Stem Cell transplant, may elect to retrieve the Stem Cells from Storage in accordance with clause 4, as and when deemed necessary.

3.8. CryoSave shall be entitled to transfer the stored Stem Cells to an authorised organisation, institution or person (authorised in terms of the South African National Health Act 2003, Regulation 183 on Stem Cells Banks to conduct the activities referred to in paragraph 2 Regulation 183 (and which are amended from time to time) or any other internationally accredited establishment, or relocate its own storage facility at any time and furnish the Client with written notice thereof.

3.9. In the unlikely event that CryoSave ceases to continue trading for whatever reason, CryoSave has contracted its obligations in terms hereof out to an authorised organisation, institution or person, who will ensure the ongoing storage of the stem cells in terms of this Agreement.

4. Retrieval, preparation and transfer for transplant or otherwhise

4.1. Should the Client wish to retrieve the stored Stem Cells, the Client shall provide CryoSave with a minimum of 30 (thirty) calendar days’ written notice of the intended retrieval date.

4.2. Any retrieval shall be done in accordance with CryoSave’s policy and/or international standards for such, as may be amended from time to time.

4.3. When a cord blood sample is required by a Client for a cord blood stem cell transplant, CryoSave will at no cost to the Client provide the following services cover the following costs, and no fees will be levied for:

4.3.1. Tissue typing test (HLA high resolution);

4.3.2. Any other pathology laboratory tests on the cord blood pre-transplantation that are directly, reasonably and necessarily required in relation to the transplant;

4.3.3. Shipping costs of the released cord blood sample, from SA to anywhere in the world to ensure the transport of the sample in a manner that is reasonable and appropriate to transport the sample.

5. General notifications

5.1. Once the Tests have been concluded and/or the Stem Cells cryopreserved and Stored, CryoSave shall notify the Client in writing whether:

5.1.1. the Stem Cells are suitable for Storage, in which case they will be Stored in terms of this Agreement; or

5.1.2. the Stem Cells are Sub-Optimal, in which case the Client has the option to elect to: continue Storage of the Stem Cells; or destroy the Stem Cells;

5.1.3. the UCB Stem Cells fail to meet the CryoSave storage limit requirements, in which case the Client will have the option to destroy the Stem Cells.

5.1.4. in the event of a transplant, the number of stem cells in the cord blood collection is a predictor of successful engraftment. I accept that CryoSave will continue to store cord blood units that have a relatively low number of stem cells on the basis that technology exists to increase the number of stem cells (‘expand’ the number of cells) prior to transplant – although the ability to use expanded cells clinically is not currently available in South Africa.

5.2. In each of 5.1.2 and 5.1.3, the Client’s express written authorisation will be obtained.

5.3. The results of the Maternal Blood Tests will be made available to the birth Mother and/or Client.

6. Warranties and limitation of liability

6.1. The Client acknowledges that CryoSave has not made nor does not make any representations or warranties to the Client, whether express or implied, of any kind or nature, including, without limitation of the foregoing, any warranties with respect to:

6.1.1. the suitability of the UCB and/or UCT or Stem Cells for the future treatment of any disease, illness, injury or other medical affliction;

6.1.2. the advantages of transplanting Stem Cells derived from UCB and/ or UCTs over other types of treatment using Stem Cells derived elsewhere.

6.1.3. medical advice or provide any services other than those described in this Agreement.

6.2. Notwithstanding anything that may be construed to the contrary herein, CryoSave’s maximum amount of any and all liability to the Client in terms of this Agreement or with respect to any and all actions or omissions of CryoSave, or such other persons, under any and all circumstances shall be the total amount paid by the Client to CryoSave.

6.3. The Client further acknowledges that CryoSave is not responsible for the actions of others, including healthcare practitioners, nurses, midwives, the birthing hospital or medical facility, hospital or medical facility staff and couriers and transporters of the UCB and/or UCT and Stem Cells.

6.4. CryoSave shall not be liable to the Client or any other third party for any direct, indirect, special, punitive, consequential or incidental damages or losses.

6.5. CryoSave shall not be held liable for any loss or damage to the UCB and/ or UCT or Stem Cells derived therefrom caused by any event beyond its control and/or which is considered to be a force majeure event.

6.6. CryoSave shall also not be liable for any damages due to destruction of the UCB and/or UCT following cancellation of this Agreement.

7. Fees and payment

7.1. The Client acknowledges that collectively the Mother, Father and the Child are jointly and severally liable under this Agreement, for any and all amounts owing to CryoSave in terms hereof.

7.2. The Client acknowledges that in accordance with the Client Registration Documentation and subject to the further provisions of this Agreement, fees are payable on successful storage of a UCB and/or UCT. For purposes hereof successful storage has occurred if CryoSave has Stored any Optimal or Sub-Optimal Stem Cells (at the election of the Client) for the use (or potential use) and benefit of the Client.

7.3. The total cost of this service is set out in the Client Registration Documentation and which is to be paid by the Client as follows:

7.3.1. The collection fee shall be payable by the Client to CryoSave upon registration and prior to the delivery of the kit and is not refundable.

7.3.2. The Processing and Storage Fee shall be due and payable once the Client has received notification of Storage of the UCB and/or UCTs.

7.4. The Client may select to pay the Processing and Storage Fee in accordance with a monthly payment plan as indicated in the Client Registration Documentation. In this case, a compulsory debit order needs to be signed and should this be returned by the bank, then the Client will be liable to pay a debit order rejection fee of R150 (one hundred and fifty Rand). By signing this Agreement the Client confirms that the Client has the necessary funds to service the monthly repayments and that this repayment commitment cannot be deemed to be a reckless extension of the Client’s financial obligations.

7.5. All overdue amounts shall bear interest at a rate equivalent to the aggregate of the publicly quoted prime overdraft lending rate charged by CryoSave’s bankers plus 2% (two percent).

7.6. The Client acknowledges that any failure to effect payment of any fee or cost timeously may result in the cancellation of this Agreement by CryoSave, after written notice to the Client, which cancellation shall not limit CryoSave’s rights in terms of hereof, common law or otherwise.

7.7. Should CryoSave institute legal action against the Client for recovery of any outstanding fees, the Client shall be liable to CryoSave for any and all legal costs, including attorney and own client costs, collection fees and tracing fees.

7.8. Where no storage of any Optimal or Sub-Optimal Stem Cells has occured, no fee in respect of Processing and Storage Fee will be payable by the Client.

7.9. Where Storage of any UCB and/or UCT has occurred, an annual fee is charged to cover the escalation of CryoSave’s costs over the twenty year period. Payment hereof shall be made by means of a debit order in favour of CryoSave or electronic funds transfer that shall become due on the anniversary of the Child’s birth date of each successive year for the duration of the Storage Period.

7.10. The abovementioned annual fee may, at the discretion of CryoSave escalate annually broadly consistent with the consumer price index.

7.11. The partial or total withdrawal and/or retrieval of the UCB and/or UCT by the Client (irrespective of the reason for withdrawal) shall not entitle the Client to a refund of any fees paid or make him not liable for payment of any fees still due and payable at such time.

8. Client’s undertakings

8.1. The Client undertakes to specifically ensure that all required consents and Testing of the UCB and/or UCT and/or the birth Mother for any infectious diseases, which may include but not limited to HIV, Hepatitis B and Hepatitis C, is done 1 (one) week prior or 1 (one) week after the projected birth date (due date) of the Child.

8.2. The above tests and any further as may be required in terms of legislation or international standards, requested by CryoSave under this Agreement will be done at a registered pathology laboratory specified by CryoSave and the Client hereby unconditionally consents to the Tests and gives permission to CryoSave to collect and obtain the Test results.

8.3. The Client undertakes to, at the request of CryoSave ensure:

8.3.1. that any further, or additional medical or blood tests of the mother of the Child, that CryoSave may require to be done before birth or at any time thereafter, is done (at his cost); and

8.3.2. to complete such forms, and supply such information as requested by CryoSave from time to time

8.4. The Client acknowledges that any failure to adhere to the above request may result in CryoSave being unable to confirm/continue Storage of a UCB and/or UCT.

8.5. The Client undertakes to provide CryoSave with complete and accurate information in writing concerning contact information of the Client and the Child required by CryoSave, for the duration of the Agreement. The Client also agrees to provide such other information that CryoSave may require for the Testing of the UCB and/or UCT, Maternal Blood, performance of its services, compliance with the laws, regulations, permits and certifications, as well as for the proper identification of the Client and the Child.

8.6. If any information that the Client has provided to CryoSave changes or is no longer valid, the Client acknowledges that it is his/her/their responsibility to advise CryoSave promptly of all such changes or invalidity.

8.7. CryoSave will use all reasonable endeavours to keep confidential all information relating to the Client and/or Child. Personal information will only be held in CryoSave’s hardcopy files in a locked location and on secure electronic database and back-up files.

8.8. Information will only be released to the Client and/or Child’s Healthcare Practitioner for their internal confidential records or otherwise as requested by the Client and/or Child.

8.9. By signing this Agreement, the Client consents to CryoSave holding the Client and/or Child’s personal data for the purposes of performing CryoSave’s obligations under this Agreement.

8.10. CryoSave may from time to time send out electronic information by email or SMS to the Client, to update the Client on developments regarding CryoSave and the stem cell industry in general. The Client may at any time opt out from receiving this communication.

9. Cession and assignment

CryoSave may:

9.1. transfer the location of the processing laboratory; and/or;

9.2. transfer the Storage Facility, and/or;

9.3. cede and assign its rights and obligations under this Agreement to a third party after prior written notice to the Client.

9.4. The Client may, in writing, transfer to one or more persons his rights under this Agreement at any time and, in particular, upon this 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 Client be deceased or disabled and should there be no transferee or successor to the Client’s rights, CryoSave may, in its entire discretion, recognize the authority of any person to represent the Client.

10. Termination, cancellation and breach

10.1. CryoSave reserves the right to terminate this Agreement in the following circumstances:

10.1.1. failure of the Client to provide the UCB and/or UCT, and/or the Maternal Bloods and/or the information that CryoSave requires for the performance of its services or compliance with this Agreement, the law, regulations or accreditation;

10.1.2. receipt of the results of the Tests, and according to CryoSave’s internal quality and accreditation requirements or the relevant government regulations or statute, indicating that the UCB and/or UCT is not viable for storage;

10.1.3. should the UCB and/or UCT yield insufficient Stem Cells, then no Storage shall take place, and accordingly, the Client shall incur no liability in regard to the Processing and Storage Fee;

10.1.4. in the event that the payment due has not been received within 30 (thirty) calendar days after the date of written notification to the Client to effect payment;

10.1.5. in the event of the Client not responding within 6 (six) months after the expiration date of the Storage Period, despite CryoSave having notified the Client at least twice, within 6 (six) months prior to the date of expiration and once within the 6 (six) months after expiration.

10.2. The Client may terminate this Agreement at any time upon written notice to CryoSave, provided all associated costs and fees are settled in full.

10.3. On termination, the Client can elect that stored Stem Cells are:

10.3.1. transferred to an alternative Storage Facility (once all outstanding fees have been paid, including the withdrawal fee); or

10.3.2. destroyed; or

10.3.3. donated for quality control or research purposes; or

10.3.4. donated to a public bank/registry.

10.3.5. If no election has been made, then the Stem Cells will be destroyed.

10.4. Notwithstanding the foregoing, this Agreement, along with all further liabilities with regard to annual Storage fees, will be terminated on withdrawal by the Client of all the Stored UCB and UCT.

11. Domicile and notices

11.1. The Client shall appoint an address for receiving communication during the Storage Period and shall be responsible for immediately advising CryoSave in writing of any changes.

11.2. CryoSave chooses as its address for the receipt of all notices: P.O. Box 39660, Garsfontein East, 0060, Pretoria, Republic of South Africa; alternatively, E-mail: admin@CryoSave.co.za; alternatively, fax number +27 86 219-9157.

11.3. Either party shall be entitled to vary the addresses set out above on written notice to the other.

11.4. Notices may be sent by e-mail, fax or air post. E-mail and fax shall be deemed to have been received on the day following transmission and if sent by air post, on the tenth day after posting, provided that any change of address sent to CryoSave shall only be deemed to have been received after written acknowledgement is sent to the Client.

12. Miscellaneous

12.1. Any dispute, other than where an interdict is sought, arising out of or pursuant to this Agreement shall be addressed in accordance with the rules and processes of the Arbitration Foundation of Southern Africa.

12.2. This Agreement, the appendices and other information emailed to the Client, constitutes the entire Agreement between the parties.

12.3. No agreement varying, adding to, deleting from or cancelling this Agreement shall be effective unless reduced to writing and signed by or on behalf of the parties.

12.4. No indulgence granted by a party shall constitute a waiver of any of that party’s rights under this Agreement.

12.5. This Agreement may be signed by the parties in counterparts.

13. Protection of private information

CryoSave is obligated to protect personal information of clients, legally and ethically, at all times. I thus understand that no personal information will be disseminated to any third party without my express, written and informed consent in accordance with the provisions of the Protection of Personal Information Act, No. 4 of 2013 and the National Health Act No. 62 of 2003.

I acknowledge that once my personal information is passed on to a third party by CryoSave with my consent, whether on the basis of a referral to another service provider or for the purposes of institution of legal action, the information thereafter falls outside the control of CryoSave.

I also acknowledge that the capture and storage of my personal information by CryoSave is necessary to ensure an updated and complete medical record related to my medical history in order for accurate evaluation and determinations to be made with the appropriate conclusion at any time, either by CryoSave or another service provider or legal practitioner, where and if applicable.

My contact details are only for the purposes of the records of CryoSave and if applicable, the institution of future legal process in the event of my default or failure to ensure due and timely payment – unless otherwise stated with my consent.

My record remains the property of CryoSave and which is legally required to be retained by CryoSave for periods as stipulated by existing legislation. Clients are entitled to obtain details contained within such records, if so requested.

14. Electronic Communication

The Client acknowledges that this agreement does not infringe any provision of the Electronic Communications and Transactions Act, No. 25 of 2002.

This agreement shall constitute a valid and binding agreement in accordance with Section 22 of the Electronic Communications and Transactions Act, No. 25 of 2002. No written confirmation or reciprocal signature by the Client and/or CryoSave is required to give effect to the rights and obligations established by the agreement.