TERMS & CONDITIONS OF THE BIOEDEN PROCESS

1. DEFINITIONS AND INTERPRETATION

1.1 The definitions and rules of interpretation in this clause apply in these terms and conditions (Conditions).

Cells: means all those cells contained in the pulp area of the tooth treated by the BioEDEN process.  Typically these  might  include mesenchymal stem cells, chondrocytes, osteoblasts and adipocytes among others;

Contract: your purchase order and our acceptance of it;

Services: the services to be provided by us to you under the Contract;

We or us: Bioeden, Inc, a Deleware corporation. you: the person or people who purchase(s) Services from us.

1.2 Condition, schedule and paragraph headings shall not affect the interpretation of these conditions.

1.3 A person includes that person's legal and personal representatives, successors and permitted assigns.

1.4 Words in the singular shall include the plural and vice versa.

1.5 A reference to a statute or statutory provision is a reference to it as it is in force for the time being, taking account of any amendment, extension, or re-enactment and includes any subordinate legislation for the time being in force made under it.

2. RESPONSIBILITIES
 
2.2   You agree to be responsible for the Cells until your child becomes 18 years old. At the age 18 ownership of the Cells legally passes automatically to your child. In any disagreement after this time your child's requests are legally binding.

2.3  This agreement must be signed by at least one of the parents or legal guardians of the child. If both parents/guardians sign you will both be fully liable for your obligations under this agreement. We are entitled to act on the instructions of either parent/guardian, but in the event of both parents/guardians signing, the wishes of one specified parent/guardian will be followed in the event of a dispute. This person shall be known as the “owner” of the Cells until the child reaches the age of 18. If neither parent nor guardian is specified then the “owner” will be the signatory against section 1 of the contract.

2.4   Transplanting of stem Cells and other autologous Cells may well offer benefits to your child in the future.  Tests indicate that the BioEDEN process can provide a successful means of preserving Cells, including mesenchymal stem Cells, for the future. However it is not possible to offer any guarantee about the effectiveness of any stored Cells for any treatments including those involving cell transplantation, or that these Cells will provide any benefits to your child. By signing the Contract you confirm that you have given this point serious consideration before deciding to proceed.

2.5   Cells, including stem Cells, are available from alternative sources such as bone marrow and from the venous and arterial blood.  By consenting to use the BioEDEN process you must have chosen to preserve deciduous tooth Cells in the knowledge of these points made in clauses 2.4 and 2.5. You also acknowledge that cryopreservation is a comparatively new procedure. You also understand that your child or any other family member may never need to use the stored Cells.

3. COSTS OF THE BIOEDEN PROCESS

3.1   The costs of the process to collect and test the Cells must be paid when the order for the collection kit is made.  If a prepayment or a gift arrangement has already been made for the child in question then any balance outstanding must be paid at the time of ordering the collection kit.

3.2   The first annual storage fee must be paid at the time of ordering the collection kit, and on the same date each year subsequently, until storage is no longer required.

3.3   transport fee will be payable in addition to the processing fee, and must be paid at the same time.

3.4   We do not collect or transport the tooth containing the Cells, and  we have no responsibility for the transportation of the tooth and  Cells. It is your responsibility to keep the shed tooth clean and safe according to the instructions, and to arrange the transportation in  such a way that the tooth will reach us within 24 hours of being shed. Our responsibility begins when the tooth and Cells arrive at  our laboratory. See clause 2.1.

3.5  You understand that the tooth is normally discarded or saved as a souvenir.  The decision to collect, process and store the Cells is a voluntary act on the part of the parent or guardian that may allow you to protect your child's right to the specimen Cells.

3.6   It is your responsibility to ensure that accurate labelling of the tooth is made, and that you have signed the appropriate documentation in the collection kit to confirm that the kit contains the specified tooth. Do not put a tooth or teeth from more than one child in the same collection kit.

3.7   It is important  that  you  complete  the Liability Waiver, sign it and return it with the Tooth. The Bioeden Process cannot start without the signed consent form.

3.8   We understand that there is a risk of contamination or infection in a shed tooth. This is likely to happen in less than 10% of teeth. Consequently we immediately on receipt check the Cells for health and viability. In the unlikely event that the Cells are not considered healthy enough to store properly we will inform you immediately, and ask you to supply another replacement tooth when possible. There will be NO further charge for handling the replacement tooth.

3.9 It is your responsibility to carefully follow all the instructions with regard to the saving, keeping and transporting of the tooth. Please arrange for the collection kit to be sent to you in good time once you realise that the tooth in question is loose, and will soon be shed - don't leave ordering the collection kit until the last minute. This way you will have the kit in good time, and also have a good opportunity to familiarise yourself with the procedures.

4.  PROCESSING AND WITHDRAWAL

4.1   You are responsible for communicating with the courier to pick up the collection kit at the earliest opportunity and the courier is responsible for the transport of the kit.  We are responsible for the tooth and Cells as soon as it arrives at our laboratory.

4.2   As soon as the collection kit is opened the Cells will be carefully removed from the tooth. They will be examined to check their health and condition. They will then be processed to confirm that they are viable Cells, and will be tested and observed for a set period to confirm their welfare. After this they will be immediately stored.  You will be able to check confidentially by telephone which stage in the process your Cells are at.   If we are unhappy with any significant part of the condition of your Cells we will inform you immediately, and ask you to supply a replacement tooth. There will be no further charges to collect or process a replacement tooth.

4.3   All the Cells in the tooth will be stored - not just the stem Cells. The other Cells MAY be suitable to use in medical treatments in the future, so it is best to save them all.  Our responsibility is to store the Cells in the most professional way possible, and when requested, make them available to medical professionals who may, or may not, be able to make use of them. No guarantee is given that any of the Cells can or will be used in the future or that any future use of the Cells will be effective.

4.4   All the work involved in opening the collection package, extracting, checking, processing and storing the Cells will be performed by our authorised employees who are trained, qualified and supervised to the standards specified under the auspices of the FDA.   Processing and storage will take place in our own facility in Austin, TX. 

4.5   The Cells will be owned and controlled exclusively or jointly, as requested, by the parent(s) or guardian(s) of the child.  However once the child reaches the age of 18 the child shall automatically take over all control and ownership immediately.

4.6    You agree to keep us informed at all times of a current address and telephone number for contact with yourself.

4.7   In the event that you request the return of the preserved specimen from storage the request must be made in writing and signed by the owner of the Cells. The Cells will be made available under these circumstances to the care of a named medical doctor or named hospital manager only. The named health professional will be responsible for arranging a suitable courier to attend our premises to collect the Cells, and it is their responsibility to provide a suitable vessel to transport cryogenically stored Cells. It is important to note that the Cells are cryogenically frozen and maintained at a temperature of minus 185 degrees Centigrade. Any contact with any part of the human body could result in serious or fatal injury. We will NOT be responsible for assessing the suitability of the presented container.  We shall require evidence in writing of the appropriate qualifications of both the health professional and the carrier before releasing the Cells.  As soon as the Cells are placed in the provided container we have no further responsibility for the Cells. The responsibility for the Cells passes back at that point to the owner, or depending on the arrangements they have made the carrier/ health professional concerned.

4.8   The owner must pay an annual fee at the appropriate date each year (see 3.2) for storage.  If the fee is unpaid we will contact the owner and remind them that payment is due.  If payment has still not been made, or if no contact has been possible, after 28 days following the due date of payment we reserve the right to remove the Cells from storage. In this event we will again try to contact the owner both before and after removal.  If the owner has made no arrangement to collect the Cells after removal from storage they will subsequently be dealt with as we see fit, and the owner informed at the last recorded address that we have for them.

5.  TERMINATION

5.1  We must reserve the right to refuse to process or store any particular sample without explanation but this will only be in exceptional circumstances and we will use our reasonable endeavours to consult with you if we feel this necessary.

5.2   You may cancel this agreement at any time before the tooth has arrived for processing.  In that event you will only be liable for an administrative fee of up to $100.00 incurred up to that point.

5.3  Cancellation must be made in writing, and received at our office before any processing of the tooth and Cells has begun.

6.  LIMITATION OF LIABILITY - THE CUSTOMER'S ATTENTION IS PARTICULARLY DRAWN TO THE PROVISIONS OF THIS  CONDITION

6.1 This condition 6 sets out our entire financial liability (including any liability for the acts or omissions of our employees, agents and sub- contractors) to you in respect of:

6.1.1 any breach of the Contract;

6.1.2 any use made by you of our Services; and 

6.1.3 any representation, statement or negligent act or omission arising under or in connection with the Contract.

6.2 All warranties, conditions and other terms implied by statute or common law are, to the fullest extent permitted by law, excluded from the Contract.

6.3 Nothing in these Conditions limits or excludes our liability:

6.3.1 for death or personal injury resulting from negligence; or

6.3.2 for any damage or liability incurred by you as a result of fraud or fraudulent misrepresentation by us.

6.4 Subject to condition 6.2 and condition 6.3, we shall not be liable for:

6.4.1. loss of use; or

6.4.2 loss of corruption of data or information; or

6.4.3 any special, indirect, consequential or pure economic loss, costs, damages, charges or expenses.

6.5 OUR TOTAL LIABILITY IN CONTRACT, TORT (INCLUDING NEGLIGENCE OR BREACH OF STATUTORY DUTY),  MISREPRESENTATION, RESTITUTION OR OTHERWISE ARISING IN CONNECTION WITH THE PERFORMANCE OR  CONTEMPLATED PERFORMANCE OF THE CONTRACT SHALL BE LIMITED TO THE PRICE PAID FOR THE SERVICES.

6.6   You are responsible for the safe keeping of the tooth prior to transportation, organising the transportation at a suitable time, packaging  the tooth and preparing it for transportation.

6.7   The carrier is responsible for the carriage of the tooth in accordance with their standard terms and conditions.

6.8   We are responsible for the tooth and Cells once it has been delivered to our laboratory.

6.9 There is no liability to you if we are unable to isolate or store a reasonable cell specimen when the Cells are examined.

6.10 In the event of the loss of a cell specimen while in our care during processing, which was caused by an act or omission by us, our employees or agents,  we will reimburse all storage costs incurred up to that point - even if we are not responsible for the loss of the specimen. In the event that all Cell samples placed in storage in our facility are lost which was by  an act or omission by ourselves, our employees or agents, we will reimburse all storage costs incurred up to that point- even if we are not responsible for the loss of the specimen.

6.11 We shall have no liability to you under the Contract if we are prevented from or delayed in performing our obligations under the Contract or from carrying on our business by acts, events, omissions or accidents beyond our reasonable control, including strikes, lock-outs or other industrial disputes (whether involving our workforce or any other party's), failure of a utility service or transport network, act of God, war, riot, civil commotion, malicious damage, compliance with any law or governmental order, rule, regulation or direction, accident, breakdown of plant or machinery, fire, flood, storm or default of suppliers or sub-contractors.

7. DATA PROTECTION

You acknowledge and agree that details of your name, address and payment record may be submitted to a credit reference agency, and personal data will be processed by and on our behalf in connection with the Services.

8.  GUARANTEE

8.1 We guarantee:

8.1.1 the suitability and quality of the collection kit. We also guarantee the accuracy of the instructions to save and pack the tooth;

8.1.2   that the BioEDEN process will be provided using all reasonable skill and attention, and that ongoing checks will be constantly made on the quality of the process and the quality of the storage in line with the demands of the FDA regulations;

8.1.3   that all processes and equipment are constantly monitored. Our laboratory and storage staff will receive continuing professional training in the appropriate processes and techniques;

8.1.4   that once we have received your Cells and personal data they will be in our direct care.  We will not transfer the principal sample of Cells to the care or premises of any third party. We maintain very high standards of security at our facility for the   protection of specimens and data. (We reserve the right to store the secondary sample at whichever facility we feel is most suitable. This facility may or may not be owned by us);

8.1.5   that full professional confidentiality will apply at all times to all records and information which we hold.

8.2 We cannot guarantee:

8.2.1 that the stored Cells will be suitable for any future treatment of injury or disease;

8.2.2 that successful treatment of any injury or disease will be performed with stem Cells or any of the other types of stored tooth Cells;

8.2.3 that stored tooth Cells may be any more suitable for treatments in future than any other kind of autologous Cells.

9. WARRANTY

9.1 You warrant:

9.1.1 that you are the person (or people) legally entitled to own and be responsible for the tooth and Cells defined in this contract;

9.2.2 that you have read all parts of the Contract including these terms and conditions, and given them due consideration before signing it - thereby accepting them.

10. VARIATION

No variation of the Contract or these Conditions or of any of the documents referred to in them shall be valid unless it is in writing and signed by or on behalf of each of the parties.

11. WAIVER

11.1 A waiver of any right under the Contract is only effective if it is in writing and it applies only to the party to whom the waiver is addressed and the circumstances for which it is given.

11.2 Unless specifically provided otherwise, rights arising under the Contract are cumulative and do not exclude rights provided by law.

12. SEVERANCE

12.1 If any provision (or part of a provision) of the Contract is found by any court or administrative body of competent jurisdiction to be invalid, unenforceable or illegal, the other provisions will remain in force.

12.2 If any invalid, unenforceable or illegal provision would be valid, enforceable or legal if some part of it were deleted, that provision will  apply with whatever modification is necessary to make it valid, enforceable and legal.

13. STATUS OF PRE-CONTRACTUAL STATEMENTS

Each of the parties acknowledges and agrees that, in entering into the Contract it does not rely on any undertaking, promise, assurance, statement, representation, warranty or understanding (whether in writing or not) of any person (whether party to these terms and conditions or not) relating to the subject matter of the Contract, other than as expressly set out in the Contract.

14. ASSIGNMENT

14.1 The Customer shall not, without our prior written consent, assign, transfer, charge, sub-contract or deal in any other manner with all or any of its rights or obligations under the Contract.

14.2 We may at any time assign, transfer, charge, sub-contract or deal in any other manner with all or any of our rights or obligations under the Contract.

15. RIGHTS OF THIRD PARTIES

The Contract is made for the benefit of the parties to it and (where applicable) their successors and permitted assigns and is not intended to benefit, or be enforceable by, anyone else.

16. NOTICES

Notice given under the Contract shall be in writing, sent for the attention of the person, and to the address or fax number, given in the Contract (or such other address, fax number or person as the relevant party may notify to the other party) and shall be delivered personally, sent by fax or sent by pre-paid, first-class post or recorded delivery. A notice is deemed to have been received, if delivered personally, at the time of delivery, in the case of fax, at the time of transmission, in the case of pre-paid first class post or recorded delivery, 48 hours from the date of posting and, if deemed receipt under this condition 16 is not within business hours (meaning 9.00 am to 5.30 pm Monday to Friday on a day that is a business day), at 9.00 am on the first business day following delivery. To prove service, it is sufficient to prove that the notice was transmitted by fax, to the fax number of the party or, in the case of post, that the envelope containing the notice was properly addressed and posted.

17. GOVERNING LAW AND JURISDICTION

17.1 The Contract and any dispute or claim arising out of or in connection with it or its subject matter, shall be governed by, and construed in accordance with, the laws of the State of Texas.

17.2 The parties irrevocably agree to binding arbitration to settle any dispute or claim that arises out of or in connection with the Contract or its subject matter.