AT-CLI-CON-001
2013.05.27
ADIPOSE TISSUE STEM CELL BANKING
STORAGE AND RELATED SERVICES AGREEMENT
Between:- NETCELLS BIOSCIENCES (PTY) LTD and “THE CLIENT”
1
1.1
INTERPRETATION
Definitions:
1.1.1
"the/this Agreement" means this Adipose Stem Cell Storage
and Related Services Agreement, including the Informed
Consent and such other terms and conditions as may appear
on Netcells’ website namely, www.netcells.co.za in relation
hereto;
1.1.2
“Alternative Contact Person” means the individual that the
Client has elected for Netcells to make contact with, should
Netcells not be able to get hold of the Client at any given time.
This individual’s details have been included by the Client on
the signature page of this Agreement;
1.1.3
"Authorised Organisation, Institution or Person" means an
organisation, institution or person authorised in terms of the
South African National Health Act 2003, Regulation 183 on
Stem Cell 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;
1.1.19
"Netcells" means Netcells Biosciences (Proprietary) Limited
(Registration No. 2004/26428/07), and its respective
shareholders, directors, officers, employees and agents
including marketing agents and other representatives. Netcells
is a company duly registered and incorporated according to
the company laws of the Republic of South Africa;
1.1.20
"Processing/Process" means all operations involved in the
Preparation, Isolation, Characterisation, and Cryopreservation
of the Product from the Adipose Tissue;
1.1.21
"Processing Laboratory" means the Netcells laboratory where
the Adipose Tissue is processed and the Product cryopreserved
and stored;
1.1.22
“the Product” means the adipose tissue and/or the SVF derived
from the adipose tissue and/or the MSCs derived from the SVF;
1.1.23
"Storage/Storing/Store" means cryogenically storing the MSCs
under appropriate controlled conditions in registered
biomedical vaults, cryopreserved at -196 degrees Celsius;
1.1.4
“Autologous” means for use by the Client only;
1.1.24
1.1.5
"the Client” means a person whose Adipose Tissue has been
collected and who has signed the Informed Consent;
"Storage Facility" means the Cryopreservation storage tank in
which the Product is stored and the facility in which it is located;
1.1.25
1.1.6
“Adipose Tissue” means the Adipose (fat) Tissue, or an aspirate
of Adipose (fat) Tissue that contains the SVF and MSCs;
“Storage Period” means the time for which the MSCs are stored,
the amount which is to be billed and paid annually in advance,
as indicated on the Client Registration Form;
1.1.7
“Blood Tests” means the blood tests required to test for the
Transmissible Diseases as specified in clause 1.1.24;
1.1.26
"Signature date" means the date of signature of this agreement
by the last party to sign;
1.1.8
“Collection/Collect” means the lipoaspiration of Adipose Tissue
collected from the Client;
1.1.27
“SVF” means the stromal vascular fraction which is a mass of
cells that contains the MSCs and which is derived from the
adipose tissue after it has been digested;
1.1.9
“Characterisation” means the counting and verification of
viable MSCs that have been extracted from Adipose Tissue;
1.1.28
"Transmissible Diseases" means:-
1.1.10
“Competent Person” means a medical practitioner who is
competent to advise a Client in matters relating to the Product;
1.1.11
“Cryopreservation” means cooling of the Product to a
temperature of -196 degrees Celsius and maintaining it at
this temperature during storage;
1.1.12
"Days" means any day other than a Saturday, Sunday or official
public holiday in the Republic of South Africa;
1.1.13
1.1.28.1
1.1.28.2
1.1.29
H.I.V. -1 and -2 (Human Immunodeficiency Virus);
Hepatitis B and Hepatitis C viruses;
“Therapeutic/Therapy” means a product derived from the
Adipose Tissue and/or SVF and/or MSCs produced for clinical
administration.
1.2
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 may be amended from time to time.
"H.I.V" means Human Immunodeficiency Virus 1 and 2 - AIDScausing virus;
1.3
This Agreement shall be governed by and interpreted in
accordance with the laws of the Republic of South Africa.
1.1.14
"Hepatitis B and C" means Hepatitis B and Hepatitis C viruses
that affect the liver causing hepatitis, jaundice and liver
dysfunction;
2
1.1.15
"HPCSA" means the Health Professions Council of South Africa;
1.1.16
“Isolation” means the extraction of SVF and/or MSCs from the
Adipose Tissue;
1.1.17
"Medical Practitioner" means inter alia, a HPCSA registered
health professional;
1.1.18
“MSCs” means Mesenchymal Stem Cells which are derived from
the SVF;
PREAMBLE
2.1
The Client has requested and consented to the Collection,
Processing, Characterisation, and Storage of the Product
obtained from Adipose Tissue collected from the Client.
2.2
The Client intends to store the Product acquired from the Adipose
Tissue for Autologous use only, i.e. for the Client’s use only and
not for siblings or close family relatives or any other party.
2.3
The Client authorises Netcells to Process and Store the Product
in terms of this Agreement and the signed Informed Consent.
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AT-CLI-CON-001
2013.05.27
ADIPOSE TISSUE STEM CELL BANKING
STORAGE AND RELATED SERVICES AGREEMENT
IT IS NOW AGREED:
3
3.1
4
4.1
4.2
4.3
5
OWNERSHIP
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 the Product shall vest exclusively with
the Client.
The Client undertakes to consult with a relevant Medical
Practitioner, and to contract with such Medical Practitioner
to make the necessary arrangements to ensure that their
Adipose Tissue is harvested via a liposuction procedure that
the Client shall be solely responsible for, as well as, solely
liable to pay for.
6.1.2
6.1.3
STORAGE OF THE MSCs
8.1
Netcells shall Store the Product in good condition for the
lifetime of the Client subject to payment being made under
clause 10 of this Agreement.
8.2
The Client after consultation with a Competent Person, may
elect to remove the Product, or parts thereof, from Storage
in accordance with clause 9, as and when deemed necessary.
9
RETRIEVALS (PREPARATION, TRANSFER AND SHIPMENT)
The Client shall have requisite Blood Tests done prior to the
harvesting of the Adipose tissue to test for Transmissible
Diseases, namely HIV and Hepatitis B and C. These Blood Tests
are for the Client’s own account.
Should the Client wish to retrieve the Product from
Cryopreservation, the Client shall provide Netcells with a
minimum of 7 (seven) day’s written notice, should no additional
laboratory work be required on the Product.
9.2
The notice in clause 9.1 shall include details and contact
numbers of the Competent Person and Authorised Organization,
Institution or Person receiving the Stored Product or
therapeutic and such other information as may be required
by Netcells to transfer the Product in a manner that ensures
integrity.
9.3
The administering Medical Practitioner shall provide Netcells
with a signed authorisation for preparation of the Product
within 7 (seven) days of the intended therapy date.
9.4
Depending on the treatment required, additional laboratory
work may be required to prepare the Product. The Product
may require additional expansion and other (intellectual
property) laboratory work in order to prepare the therapeutic
required. The cost of this additional laboratory work will be
for the Client’s own account.
PROCESSING OF THE ADIPOSE TISSUE
9.5
There is a minimal fee for retrieval to cover the cost of
preparation and courier, which will be for the Client’s own
account.
Netcells shall Process the Adipose Tissue and Store the Product,
provided that it reserves the right to refuse if:-
9.6
The Client may at any time move the Product to an alternative
storage location. The cost of moving the Product will be for
the Client’s own account, and a withdrawal fee shall be
applicable and charged to the Client.
TRANSPORTATION OF THE ADIPOSE TISSUE UNIT
The courier shall transport the Adipose Tissue to the Processing
Laboratory.
6.1.1
Once the Product has been Processed and Cryopreserved, the
Client and the Medical Practitioner shall be notified thereof
in writing.
9.1
5.2
6.1
8
NOTIFICATION
Netcells shall not be responsible or liable for any compromise
to the integrity of the Adipose Tissue during such Collection.
Once the Adipose Tissue has been Collected, the Medicial
Practitioner will call Netcells to arrange for the courier.
6
7.1
HARVESTING OF THE ADIPOSE TISSUE
5.1
5.3
7
Netcells shall not be responsible or liable for any compromise
to the integrity of the Adipose Tissue during such
transportation, which is beyond its control.
This Agreement and the requisite Informed Consent have not
been completed, have been incorrectly and/or inadequately
filled out and/or have not been signed; and/or
The requisite blood tests as required in Clause 4.3 have not
been complied with, or as a consequence of the testing, the
presence of Transmissible Diseases is detected; and/or
The services fee as set out in Clause 10.1 hereof has not
been paid.
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ADIPOSE TISSUE STEM CELL BANKING
STORAGE AND RELATED SERVICES AGREEMENT
10
10.1
10.1.1
10.1.2
10.2
10.3
11
11.1
11.1.1
11.1.2
11.1.3
12
12.4
The Client further acknowledges that Netcells is not responsible
for the actions of others, including physicians, hospitals or
medical facilities, their staff and couriers and transporters
of the Product.
The total cost of this service is set out in the Client Registration
Form which is to be paid by the Client as follows:-
12.5
the total amount is payable upon Registration;
the Storage Fee is payable annually in advance and will first
be billed on the first anniversary of initial storage.
The storage fee will be subject to inflationary revision on an
annual basis.
Netcells shall not be held liable for any loss or damage to the
Product derived therefrom caused by any event beyond its
control and which is considered to be a force majeure event.
13
TERMS AND CONDITIONS OF PAYMENT
The Client acknowledges that the failure to effect payment
of any fee or cost timeously may result in the cancellation of
this Agreement by Netcells, after written notice to the Client.
The cost of the required Blood Tests is for the Client’s
own account.
WARRANTIES
The Client acknowledges that Netcells has not made nor does
it make any representations or warranties to the Client,
whether express or implied, of any kind or nature whatsoever,
including, without limitation of the aforegoing, any warranties
with respect to:the suitability of the Client’s Adipose Tissue and/or SVF and/or
MSCs derived there from for the future treatment of any
aesthetic condition, disease, illness, injury or other medical
affliction;
the successful treatment of any disease, illness, injury or
other medical affliction through stem cell transplantation;
the advantages MSCs based therapies have versus other
therapies.
LIMITATION OF LIABILITY
12.1
Notwithstanding anything that may be construed to the
contrary in this clause 12, Netcells’ 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 Netcells,
or such other persons, under any and all circumstances shall
be the total amount paid by the Client to Netcells hereunder.
12.2
For the avoidance of doubt, Netcells will refund the
aforementioned amount to the Client should anything adverse
happen to the Client’s Product during Processing and Storage
thereof. The Client indemnifies, defends and holds harmless
Netcells, from and against any and all claims concerning the
Client’s rights in and to the Product.
12.3
Netcells shall not be liable to the Client or any other third
party for any direct, indirect special, punitive, consequential
or incidental damages or losses.
ASSIGNMENT
Netcells may:-
13.1
transfer the location of the Processing Laboratory, and/or;
13.2
transfer the Storage Facility, and/or;
13.3
cede and assign any and all of its rights and obligations under
this Agreement to an Authorised Organisation, Institution or
Person after prior written notice thereof to the Client provided
that the Client shall be given full details as to such Authorised
Organisation, Institution or Person in advance.
14
14.1
14.1.1
14.1.2
TERMINATION
Netcells reserves the right to refuse the Adipose Tissue and
the Product derived there from for Storage, and to terminate
this Agreement in the following circumstances:Failure by the Client to provide the results of the Blood Tests
required, the information that Netcells requires for the
performance of its services and/or failure by the Client to
comply with any laws, regulations and/or accreditations
required of it;
In the event that the full payment of the processing fees
and/or any surcharges due as per the Client Registration Form,
not having been received by Netcells.
14.2
In the event of Netcells not having received payment of the
Storage Fee within 6 (six) months after being billed to the
Client (ie the Client’s account is in arrears of more than 6 (six)
months) and should Netcells have contacted the Client 3
(three) times in writing to the last contact details provided
by the Client, including notification to the Alternative Contact
Details, then Netcells shall have the right to destroy the
Product.
14.3
Notwithstanding the a foregoing, the Client may terminate
this Agreement once the Adipose Tissue has been processed
and stored, on 7 (seven) Days prior written notice to Netcells.
In this instance, no refund shall be payable by Netcells to
the Client.
14.4
Upon death, and the provision of a Death Certificate to Netcells
by the Client’s legal successor and/or representative, the
stored Product shall be destroyed, as they are for Autologous
use only.
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ADIPOSE TISSUE STEM CELL BANKING
STORAGE AND RELATED SERVICES AGREEMENT
15
15.1
15.2
15.3
15.4
15.5
15.6
15.7
MAINTAINANCE AND PROTECTION OF CLIENT INFORMATION
The Client undertakes to provide Netcells with complete and
accurate information in writing concerning contact information
of the Client required by Netcells. The Client also agrees to
provide such other information that Netcells may require for
the testing of blood, performance of its services, compliance
with the laws, regulations, permits and certifications, as well
as for the proper identification of the Client.
16
The parties choose as their domicilium citandi et executandi
their respective addresses set out on the Netcells website
(in respect of Netcells) and the Client Registration Form (in
respect of the Client).
17
If any information that the Client has provided to Netcells
changes or is no longer valid, the Client acknowledges that
it is his/her/their responsibility to advise Netcells promptly
of all such changes or invalidity.
Netcells will use all reasonable endeavours to keep confidential
all information relating to the Client. Personal information
will only be held in Netcells’ hardcopy files in a locked location
and on a secure electronic database and back-up files.
By signing this Agreement, the Client consents to Netcells
holding the Client’s personal data for the purposes of
performing Netcells’ obligations under this Agreement.
Netcells may from time-to-time send out electronic information
by e-mail or sms to the Client, to update the Client on
developments regarding Netcells and the stem cell industry
in general. The Client may at any time opt out from receiving
these communications.
DISPUTES
Any dispute, other than where interdictory relief is sought,
arising out of or pursuant to this Agreement shall be referred
to Arbitration and addressed in accordance with the rules and
processes of the Arbitration Foundation of Southern Africa.
18
Where third parties have been contracted to manage off-site
storage of Netcells’ Client information, the same confidential
procedures will be ensured.
Information will only be released to the Client’s Medical
Practitioner for their internal confidential records or otherwise
as requested by the Client. Information may also be released
for the purposes of performing Netcells’ obligations under
this Agreement. None of the information held on Netcells’
database will otherwise be disclosed or released to any third
parties other than those required by law and otherwise as
those specifically authorised by the Client to receive same.
DOMICILIUM AND NOTICES
ENTIRE AGREEMENT
This Agreement constitutes the entire Agreement between
the parties.
19
VARIATION AND CANCELLATION
No agreement varying, adding to, deleting from or cancelling
this Agreement shall be of any force or effect unless reduced
to writing and signed by or on behalf of the parties.
20
INDULGENCES
No indulgence granted by a party shall constitute a waiver
of any of that party's rights under this Agreement.
SIGNED
ALTERNATIVE CONTACT PERSON
NAME:
MANAGING DIRECTOR
NETCELLS BIOSCIENCES (PTY) LTD
IDENTITY NUMBER:
CELLPHONE NUMBER:
THE CLIENT
EMAIL ADDRESS:
DATE:
POSTAL ADDRESS:
CLIENT NO.:
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