Terms & Conditions

PHARMACELLS LIMITED a company registered in Scotland under company number SC339685 and with our registered office at BioCity Scotland, Bo’ness Road, Newhouse, Lanarkshire, ML1 5UH. Our VAT number is 980 9216 95. Pharmacells Ltd owns the brand Oristem®.

("Pharmacells or We").

The terms and conditions set out in this Agreement, together with the Consent Form, creates a legally binding contract between us relating to the provision of the Services (the collection, testing, processing and storage of your peripheral blood sample). Please read the Consent Form and the terms and conditions in this Agreement carefully to ensure that you understand them before signing. Please retain a copy of each for your future reference.

We are regulated by the Human Tissue Authority ("HTA") to provide the Services to customers in the UK itself or in conjunction with other parties. By signing this agreement you acknowledge and agree that Pharmacells is in no way providing medical advice, care or treatment to you.

1. DEFINITIONS

1.1 In this Agreement the following words shall have the following meaning:

• (a) "Consent Form" means the consent form which must be completed and signed by you, recording your consent to the Services.
• (b) "Payment" means the upfront fee of the payment options as set out in Schedule 1.
• (c) "Sample" means the sample of peripheral blood, together with any stem cells collected from you by the Phlebotomist.
• (d) "Serious Adverse Event" means any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity.
• (e) "Serious Adverse Reaction" means an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity.
• (f) "Services" means the collection, testing, processing and storage of your Sample.
• (g) "Third Party Costs" means the cost of the collection kit, the Phlebotomist fees, the courier fees and any laboratory fees.
• (h) "Regulations" means The Human Tissue (Quality and Safety for Human Application) Regulations 2007.

2. THE AGREEMENT BETWEEN YOU AND US

2.1 Once you have contacted us, via the website or by telephone to indicate you are interested in the Services, we will send you an information pack which includes general information, two copies of this Agreement and two copies of the Consent Form. We will then phone you to arrange a consultation with a doctor over the phone regarding your general health, and to discuss the Consent Form and terms and conditions of this Agreement.

2.2 We will arrange for the Phlebotomist to contact you about a date to collect your Sample and for a collection kit to be sent to the address specified by you in your consultation once you have sent to us:

• (a) a signed copy of this Agreement;
• (b) a fully completed and signed Consent Form; and
• (c) the Payment. 2.3 Subject to the rights of termination in this Agreement, the term of this Agreement shall commence on the date Pharmacells receives the signed Agreement, Consent Form and Payment, and shall continue for 20 years on payment of the annual fees set out in Schedule 1. Thereafter, it may be continued on payment of the annual fees that will be notified to you at the time.

3. USE OF THE WEBSITE

3.1 We operate the website www.oristem.com. You can access most areas of www.oristem.com without registering your details with us and use the information contained therein for your own purposes, provided:

• (a) it is used for information purposes only, for reproduction for personal use only and not for reproduction on any other website or for commercial gain; and
• (b) no part of www.oristem.com is copied, stored in a retrieval system, or transmitted in any form or by any means to any third party without the written permission of Pharmacells Ltd unless otherwise specified.

3.2 As a customer, you will be provided with your own unique login in to view your customer records relating to your Sample. When you are provided with this login in or any other piece of information as part of our registration and/or security procedures, you must treat such information as confidential and you must not disclose it to any third party.

4. ARRANGING DATE AND TIME FOR SAMPLE COLLECTION

The Phlebotomist shall contact you directly to agree the location, date and time of collection of your Sample. Pharmacells will then contact you to confirm the appointment and notify you of your login to the customer account area of www.oristem.com. If you want to request a change to the agreed appointment or location of collection of your Sample then you should contact the Phlebotomist directly, who will then notify Pharmacells of this change. If you are unable to contact the Phlebotomist, please contact Pharmacells.

5. THE COLLECTION KIT

5.1 We will endeavour to send the collection kit to you within 7 working days of receipt of the Agreement, the Consent Form and the Payment. We do not guarantee any time for delivery of the collection kit and cannot accept responsibility for any delays in delivery which are beyond our control. If you have not received your collection kit 5 days prior to the date on which the Phlebotomist is due to collect your Sample, please notify us immediately.

5.2 When the collection kit arrives, if you notice any fault with the collection kit please notify us immediately. We will arrange for a replacement kit to be sent to you and for a courier to collect for the return of the unusable collection kit to us. If necessary, we shall organise for a new date for the Sample to be taken by the Phlebotomist.

5.3 You will be required to keep the collection kit safe and ensure that it is available to the Phlebotomist on arrival.

5.4 The collection kit is only to be used in relation to the collection of your Sample. The collection kit is uniquely bar coded to identify you and must not be used for any other person. You must not use the collection kit for any other person or purpose.

6. SAMPLE COLLECTION

6.1 The collection of the Sample using the Pharmacells collection kit will be carried out by a Phlebotomist who is an appropriately qualified and authorised person to collect peripheral blood. The Phlebotomist operates under an agreement with Pharmacells for blood collection in accordance with the Regulations.

6.2 The Phlebotomist will not collect your Sample until they have completed a risk assessment form which is necessary to confirm the safe handling and collection of your Sample. It is your responsibility to ensure that the address that you provide and the space for collection within it are appropriate as described in the information pack. In the event that the Phlebotomist considers that it is unsafe or there is a risk to collect the Sample, they shall not collect the Sample and shall inform Pharmacells accordingly. Pharmacells shall then contact you to discuss why the Phlebotomist assessed that they could not take the Sample. If it is possible to take your Sample either at a different address or to change any circumstances that would make the collection pass the risk assessment, Pharmacells shall arrange for the Phlebotomist to make another appointment and you shall be charged for a second visit. If the Phlebotomist risk assessment fails a second time, this Agreement will be cancelled with Pharmacells entitled to keep the Payment.

6.3 The Phlebotomist will leave a copy of Pharmacells' information pack regarding the Services with you after collecting your Sample.

6.4 Once your Sample has been collected by the Phlebotomist, we shall arrange for an authorised courier to take it from the Phlebotomist to the HTA regulated laboratory for processing. The couriers also operate under an agreement covering blood collection with Pharmacells in accordance with the Regulations.

7. PROCESSING OF YOUR SAMPLE

7.1 Pharmacells has an agreement with HTA authorised laboratories to process your Sample ready for long term, temperature controlled, cryostorage.

7.2 There is a risk that your Sample pay be contaminated either prior to or during collection processing. Contamination or testing positive in biological tests can affect the viability and the future suitability of your Sample for storage or therapeutic use. As part of the Services and as required by the Regulations, an extract from the Sample shall undergo such testing. We will notify you of the results in the event of any Serious Adverse Events, Serious Adverse Reactions or in the case of a positive serology test. In the case of Serious Adverse Event and Serious Adverse Reactions Pharmacells are obliged to also notify the HTA under the terms of their HTA licence.

7.3 In the event that the Sample collected is found to have been contaminated, there is a Serious Adverse Events, Serious Adverse Reactions or a positive serology test and you acknowledge that it may not be suitable for storage or any future use, you authorise us to destroy the Sample. In these circumstances, this Agreement will be cancelled.

7.4 If in our opinion either:

• (a) the volume of the Sample collected is too small; or
• (b) the viability of the Sample collected is too low to be suitable for storage we will contact you to discuss your wishes regarding the processing and storage of the Sample. If you decide to proceed with the storage we cannot give any guarantee that there will be sufficient volume for therapeutic use or otherwise if the Sample is required in the future and you acknowledge this if you ask us to proceed. If you do not wish to proceed, this Agreement will be cancelled.

8. STORAGE OF SAMPLE

8.1 Pharmacells has an agreement with HTA authorised facilities for the long term cryostorage of the Sample.

8.2 Once the Sample has arrived at the facility for long term storage Pharmacells will provide you with a certificate detailing the exact location of your Sample within the freezer. Your Sample will never be moved or accessed without your prior written consent.

8.3 Your Sample shall be stored for 20 years (as long as you pay the annual fee set out in Schedule 1 if you have chosen option 2 or 3). If you do not wish to continue to store your Sample, you can notify us and terminate this Agreement. We are obliged under the Regulations and our HTA licence to continue to store the Sample for a 10 year period after this Agreement ends. After such 10 year period, the Sample will be destroyed. You agree to consent to the destruction of the Sample following the end of the 10 year period without further reference to you.

9. FEES AND PAYMENT

9.1 The fees for the Services are payable by you to Pharmacells in accordance with the terms of this clause. The fees are intended to cover the costs of administration, collection kit, testing, processing and secure storage of your Sample.

9.2 The fees for the Services are set out in Schedule 1. You may choose the option that you wish by ticking the relevant box in Schedule 1. The annual fee for the option chosen shall be payable within [30 days] of the anniversary of this Agreement each year. If we have not received the annual fee within 15 days of the anniversary of the Agreement, we shall notify you at the address you provided in this Agreement. If the annual fee remains unpaid for 30 days following the anniversary of this Agreement, you agree that this Agreement is terminated.

9.3 Any further fees which may be charged to you will be notified to you at the time, if applicable. This may include courier service charges which will be charged to you in the event that you request the Sample be transferred to another storage provider in accordance with Clause xx.

9.4 If any payment due to Pharmacells by you remains unpaid for a period of more than 14 days after the date on which it fell due, Pharmacells shall be entitled to be paid an additional fee of £50 to cover the administration costs incurred in dealing with late payment. For the avoidance of doubt the figure of £50 is a genuine attempt by Pharmacells to estimate the costs it would incur in those circumstances.

9.5 Payment for Services must be by cheque made payable to Pharmacells Ltd or by bank transfer/BACS or CHAPS payment using your full name and postcode as the reference and paid to Pharmacells Ltd at Natwest Bank, sort code 60-30-21, account number 28683722.

10. CANCELLATION RIGHTS

10.1 You may cancel this Agreement by notifying us in writing as follows:

• (a) for any reason within 7 days of receiving the collection kit provided that you have not opened the sealed collection kit or used it for any purpose and you return the collection kit to us at your own cost and in the same condition as you received it; or
• (b) in the circumstance set out in Clauses 7.3 or 7.4;
• (c) at any time by giving 30 days written notice to us; or
• (d) in the event that: (i) a resolution is passed or a winding up order is made for the winding up of Pharmacells; or (ii) a receiver is appointed over any of the assets or undertakings of Pharmacells; or (iii) a receiver is appointed over any of the assets or undertakings of Pharmacells; or (iv) Pharmacells enters into a voluntary arrangement with any of its creditors. 10.2 In the event that you cancel your order under Clauses 10.1(a) or 10.1(b) we shall refund 50% of the Payment.

10.3 In the event that you decide to cancel your order under Clause 10.1(c) we shall be entitled to keep the Payment, but you are released from any obligation to pay any subsequent annual fees.

10.4 In the event that you cancel your order under Clauses 10.1(c) or 10.1 (d), we shall at your written request, and upon payment of all sums due to Pharmacells under this Agreement, and at your cost use our reasonable endeavours to procure that the Sample is transferred to an alternative storage provider of your choice, provided that transfer to such storage provider is in compliance with applicable legislation including the Regulations and our HTA licence.

10.5 We may (without limiting any other remedy available) at any time cancel your order by giving notice to you if you do not comply with your obligations under these Terms and Conditions and (if possible) fail to resolve the issue within 30 days after being required to do so.

10.6 Upon the cancellation of this Agreement for any reason (except where indicated that there is no requirement for further reference to you) we will, at your request, transfer the Sample to another storage provider at your risk and cost. Such transfer to another storage provide will only be effected where we are legally permitted to do so and once any sums due to Pharmacells from you have been paid. If you do not request the Sample to be transferred to another storage provider within 30 days of cancellation or you fail to make due all payments within 30 days of the cancellation of your order, you acknowledge and agree that we may dispose of the Sample in accordance with Clause 8.3 10.7 In the event of storage failure the Sample will be moved to a HTA licensed storage premises in accordance with the Human Tissue (Quality and Safety for Human Application) Regulations 2007.

11. RELEASE OF SAMPLE

11.1 We will not release the Sample where to do so would contravene any law. We will only release the Sample to a qualified medical practitioner or another appropriately qualified person in accordance with legislation prevailing at the time and on your written request, or if release is required by any court order. We will only release the Sample to an alternative storage provider requested by you provided that all fees payable to us have been paid. You agree that the costs of delivery are at your sole expense and we may invoice you for any such costs incurred which you agree to pay by return upon receipt. If you wish the Sample to be delivered to an address outside of the UK mainland, we will release the Sample to you at our address, and you will be responsible for the costs and the risk in relation to the delivery of the Sample to your chosen address.

11.2 We shall use all reasonable endeavours to deliver the Sample on any requested date but you must give us as much notice as possible and you acknowledge and agree that we will not be responsible for any delays in delivery beyond our reasonable control.

11.3 To release the Sample, you will be required to sign a confirmation letter which Pharmacells shall post out to you at the address held by them, or any alternative address as notified by you, together with a self addressed envelope for return by you. Your Sample will not be released until Pharmacells has received the signed confirmation letter. You will be solely responsible for the Sample as soon as it is delivered and you accept that we will no longer be responsible.

12. WARRANTY

12.1 We warrant to you that the Services will be provided using reasonable care and skill and provided that you comply with your obligations, in accordance with these Terms and Conditions.

12.2 By entering into this Agreement for the Services you warrant that you are legally capable of entering into binding contracts, you are at least 18 years old and live in the UK.

12.3 You acknowledge and accept that we cannot give any guarantees with respect to any: (a) suitability of the Sample for the future treatment of diseases; (b) successful treatment of diseases through Sample transplantation; (c) advantages of Sample transplantation over other types of treatment using stem cells; or (d) successful transplantation of the Sample; and you enter into this Agreement on this understanding.

13. OUR LIABILITY

13.1 Our liability to you in respect of any fault relating to the collection kit is limited to the cost of replacing the collection kit.

13.2 Our liability to you in respect of any loss or damage due to our negligence, or the negligence of any of our employees or the parties who work with us in the provision of the Services, shall be limited to direct losses you suffer which we could have reasonably been foreseen at the date of this Agreement up to the maximum amount of [£1 millon].

13.3 Nothing in this Agreement seeks to exclude our liability for the following: (a) any death or personal injury caused as a direct result of our negligence or the negligence of our employees; (b) fraud or fraudulent misrepresentation; or (c) any other matter for which it would be illegal for us to exclude or attempt to exclude our liability.

13.4 We shall in no way be liable to you for any loss or damage suffered by you as a result of your failure to comply with the terms of this Agreement.

13.5 Subject to Clauses 13.1, 13.2 and 13.3 we exclude all other liability for damage or loss suffered in connection with the provision of the Services under this Agreement whether direct or indirect to the maximum extent permitted by law.

13.6 You acknowledge and understand that we shall not be liable to you, or be considered to be in breach of this Agreement, because of any delay in performing, or any failure to perform, any of our obligations if the delay or failure was due to your acts or omissions or to any other cause beyond our reasonable control, including what would be considered a force majeure event.

13.7 Should there be loss of the Sample whilst in the care of Pharmacells, which was beyond our control, we will reimburse you £250.

13.8 You acknowledge that the Sample will be divided into two separate vials to minimise loss or damage to the Sample. These vials may be kept together for some time prior to delivery to long term cryostorage. Therefore, in the event of any loss or damage to the Sample for whatever reason, it may not be possible to have a "back-up" sample.

14. CONFIDENTIALITY AND DATA PROTECTION

14.1 Pharmacells will use all reasonable endeavours to keep confidential all information relating to you, including your personal data. All Samples will be labelled with unique reference numbers and bar coded. We will only disclose your information related to the Sample to those parties who assist us in the performance of the Services only to the extent required in order to provide the Services. Other than as set out in this Clause 14 none of the information held on our database or the databases of our agreed partners will be disclosed or released to third parties other than as required by law or by regulators such as the HTA.

14.2 Pharmacells and the parties it engages to provide the processing and storage services on its behalf are registered under the Data Protection Act 1998 and will process all personal data in accordance with its obligations under that Act. Personal information will only be held on a secure database and/or database backup. The Phlebotomist shall only have access to your personal data as required in order to collect your Sample. By accepting this Agreement, you consent to our, and our service provision partners, holding and processing your personal data where required (including sensitive personal data) for the purposes of performing our obligations under this Agreement and you also acknowledge and agree that we may disclose any such personal data as otherwise required by law or the regulators including the HTA . We will not disclose personal data to any other party without your consent.

15. WRITTEN COMMUNICATIONS

15.1 By law, some of the information or communications we send to you must be in writing. You agree that communication with us may largely be by electronic means. We may contact you by e-mail or provide you with information by posting notices on our website. You agree to this electronic means of communication and you acknowledge that all contracts, notices, information and other communications that we provide to you electronically comply with any legal requirement that such communications be in writing. This condition does not affect your statutory rights.

15.2 All notices given by you to us must be given to Pharmacells Limited by letter to our registered address set out in this Agreement or via e-mail. We may give notice to you by either e-mail or postal address we hold for you or in any of the ways specified in Clause 15 above. Notices will be deemed received and properly served immediately when posted on our website, 24 hours after an e-mail is sent, or three days after the date of posting of any letter. In proving the service of any notice, it will be sufficient to prove, in the case of a letter, that such letter was properly addressed, stamped and placed in the post and, in the case of an e-mail, that such e-mail was sent to the specified e-mail address of the addressee.

15.3 It is your responsibility to inform us of any changes to your contact details. If you change your address or any other details, you must promptly notify us of this change in writing or via the email address set out above.

16. MISCELLANEOUS

16.1 These Terms and Conditions are binding on you and us and on our respective successors and assignees.

16.2 This Agreement is solely for your benefit, and cannot be transferred to any other party. No express terms of this Agreement or any term implied under it is enforceable pursuant to the Contracts (Rights of Third Parties) Act 1999 by any person who is not a party to it.

16.3 No waiver by us of any of the terms of this Agreement will be effective unless it is expressly stated to be a waiver and is communicated to you in writing in accordance with clause 15 above.

16.4 If any of the terms of this Agreement are determined by any Court or other competent authority to be invalid, unlawful or unenforceable to any extent, the other provisions of this Agreement shall remain valid and enforceable.

16.5 This Agreement, together with the Consent Form, constitutes the whole agreement between us and supersedes any previous discussions, correspondence, negotiations, previous arrangement, understanding or agreement between us relating to the provision of the Services. Nothing in this Clause limits or excludes any liability for fraud.

16.6 We have the right to revise and amend the terms and conditions under this Agreement from time to time if such change is required to be made by law or regulatory authority.

16.7 This Agreement shall be construed under English law and the English Courts shall have the non-exclusive jurisdiction to hear any disputes arising out of this Agreement.