AGREEMENT

Company Copy

This Agreement is entered into on this………………………...day of …........................... by and between

Cryoviva Biotech Private Limited (formerly Cryobanks International India Pvt. Ltd.), a company incorporated under the
Companies Act, 1956, having its registered office at F- 2/7,Okhla Industrial Area, Phase – I, New Delhi – 110020
(hereinafter referred to as “Cryoviva”, which term unless repugnant to the context shall include its successors in interest
and permitted assigns) of the First Part;
And
Mrs./Mr. …...............………………............................Wife of / Son of Mr. ………........................….................……, Resident of
……………………........................................…. City…………………............... State …………………….................. (Hereinafter
referred to as the “Client”, unless repugnant to the context shall include its successors in interest and permitted assigns)
of the Second Part.

THIS AGREEMENT IS FOR THE FOLLOWING SERVICES TO BE PROVIDED BY
CRYOVIVA TO THE CLIENT
A. Testing, processing & Storage of Umbilical Cord Blood Stem Cells, and/or
B.Testing, processing & Storage of Umbilical Cord Tissue / MSC's from
Wharton's Jelly.
1. DEFINITIONS: In this Agreement the following expressions are
used in the context mentioned below:
1.1 CHILD - means the Client's new born baby (neonate) (or babies in
the event of multiple births) from whom the Umbilical Cord
Blood and/or Umbilical Cord Tissue will be collected following
his/her birth.
1.2 CLIENT means the biological mother or legal guardian of the Child
or the Child after attaining the age of eighteen years.
1.3 COLLECTION KIT- means a UN3373 certified kit, compliant with
International Air Transport Association (IATA) regulations. The kit
consists of all essential materials required for the collection and
labelling of Cord Blood, Maternal Blood and Umbilical Cord.
1.4 IMMEDIATE FAMILY - refer to biological father, biological mother
and biological sibling/s.
1.5 INITIAL STORAGE TERM – means twenty one years from the date
of birth of the Child.
1.6 MATERNAL BLOOD- means the peripheral blood collected from
the biological mother of the Child, which has been drawn by
observing standard phlebotomy procedures taken within seven
(07) days before or after birth of the Child.
1.7 PHYSICIAN- means the qualified registered medical practitioner
(Doctor/ Obstetrician & Gynaecologist), engaged by the Client,
responsible for conducting the delivery of the Child.
1.8 PRIVATE BANKING – means the a program wherein Client banks
their Child's Product for exclusive usage by the Child, Child's
biological sibling/s and/ or Child's biological parent/s.
1.9 PRODUCT-means the stem cells obtained from the Umbilica
Cord Blood and/or Umbilical Cord Tissue which may be used in
approved transplant treatment of the Child (autologous) or
Immediate Family.
1.10 REGISTRY – means and includes a listing of HLA (Human
Leukocyte Antigen) typing results of Umbilical Cord Blood
Product that meet specific qualifying criteria (benchmarked
against international guidelines) that may preclude it from being
eligible for utilization in a transplant, including but not limited to
cell counts, microbial contamination, pre-existing condition/s like
hemoglobinopathies, infectious diseases, etc.
1.11 SOCIAL BANKING - means a program wherein Client banks the
Child's Umbilical Cord Blood Product for nonexclusive usage,
wherein the Client also agrees to donate their Child's Umbilical
Cord Blood Product for usage by other listed Cryoviva Social
Banking Clients after the second birth anniversary of the Child.
However, the Child's Umbilical Cord Tissue Product is only
available under Private Banking scope.
1.12 SPECIMEN/S- means the Umbilical Cord Blood and/or Umbilical
Cord Tissue.
1.13 SAMPLE/S- means the portions or aliquots of Specimen/s and
maternal blood stored at Cryoviva facility, archived for possible
future testing, as per the requirement of international standards.

Dr. C.V. Nerikar Page No. : 1 of 14 Client’s Signature

(Chief Executive)
 AGREEMENT
1.14 STORAGE FACILITY- means the cryo preservation facilities of
Cryoviva, located at 129, Pace City – 1, Sector – 37, Gurugram –
122001 (Haryana), or such other facilities designated as the
Storage Facility' by Cryoviva from time to time.
1.15 TREATING DOCTOR - The qualified registered medical practitioner
responsible for performing the approved transplant treatment of
the patient using the Product.
1.16 UMBILICAL CORD BLOOD- the portion of the whole blood of a 2.4
foetus or neonate that remains in the placenta or umbilical cord
following delivery of the neonate and clamping of the umbilical
cord. Umbilical Cord Blood is typically rich in Hematopoietic
Progenitor Cells.
1.17 UMBILICAL CORD TISSUE – the inner layer (Wharton's Jelly) of a
foetus or neonate derived from the Umbilical Cord.
1.18 UMBILICAL CORD – the cord which connects the developing foetus
with the biological mother through placenta, the umbilical arteries
and vein run within this cord.
2.5
2. PROCESSING AND STORAGE OF SPECIMEN/S:
2.1 The Specimen is processed under strict laboratory conditions,
abiding to international standards, to ensure highest possible yield
of stem cells. Cryoviva shall use either the semi-automated
technology for those opting for the Saver plans or fully automated
SEPAX technology for those opting for the Blessing & Cryo Supra 2.6
Classic/Superior/Ultimate plans for processing the Umbilical Cord
Blood as per the plan selected by the Client in Exhibit 1. The stem
cells would be stored in Vapour phase of liquid nitrogen. Umbilical
Cord Tissue at present is processed using Explant technology.
2.2 The minimum volume of Umbilical Cord Blood required is 40 ml 2.7
and length of the Cord Tissue is 20 cm, below which the Specimen
is considered to be a low volume or low length Specimen/s
respectively and in these cases the processing and storage of the
Specimen/s would happen with the verbal consent of the Client.
Though these would yield lesser cells than optimum as per current
use, but due to advancements of technology in future regarding
expansion of cells in vitro, it may make it possible for its utilization
in future, in case Cryoviva provides such services commercially in
future, then the same shall be offered free of cost to the Client.
2.3 Cryoviva upon receiving the Specimen/s and Maternal Blood shall
determine the suitability of the Specimen/s and Maternal Blood as
per the established Cryoviva acceptance/rejection criteria. In case
of the Specimen/s or Maternal Blood is found to be unsuitable for
further processing, storage or testing including but not limited to
low volume/ length of Specimen, low cell count/ viability,
haemolysis of umbilical cord blood, positive results of infectious 3.
disease marker testing on Maternal Blood, microbial
contamination of Specimen/s, then Cryoviva will inform the Client
as soon as possible, in the specified last updated contact details
and seek consent for further disposal of the Specimen/s. This
Dr. C.V. Nerikar Page No. : 2 of 14
(Chief Executive)
Agreement shall be deemed terminated from date of receipt of
such consent from the Client, for such cases where the Client
does not wish to continue the Private Storage program of the
Specimen/s. However in case of positive test result in maternal
blood for HIV infection, Cryoviva shall discard the Specimen/s as
per biohazard waste disposal procedures, and confidentially
notify the Client.
In case the consent of the Client to discard the Specimen is not
received within 06 hours from intimation to Client in case of low
volume/ length of Specimen/s, and within 30 days with respect to
other unacceptable Product criteria as mentioned in above
clause except positive test result in maternal blood for HIV
infection, then in such cases Cryoviva shall continue storage of
the Specimen on as is where is basis, subject to timely
payment by Client. However the benefits to the Client under Cell
Safety Clause mentioned in Clause 14.3 of the Agreement shall
not be applicable for such cases.
In case the consent of the Client to discard the Specimen is not
received within 06 hours from intimation to Client for Umbilical
Cord Blood received in haemolysed state, the Agreement shall be
withdrawn with immediate effect for such cases and the
Specimen shall be discarded as per the applicable bio medical
waste disposal guidelines.
In case the Maternal Blood is found to be unsuitable for testing or
is not provided, Cryoviva will notify the Client immediately and
seek another collection. In case Maternal Blood is not provided
within 07 days of cord blood collection, the Product can be used
only for autologous purposes.
For the purpose of safety, the Client understands that the
Cryoviva has the option to relocate the entire Product/s or a
sample portion thereof, due to circumstances including but not
limited to natural calamity or any business requirement, to
another Storage Facility with equivalent standards and licenses.
In case of emergency relocation of Product/s or sample, to ensure
the safety of the Product/s or sample during any calamity or
constraints faced, which are uncontrollable by Cryoviva, then
Cryoviva shall intimate the Client within 14 working days of such
relocation on the last updated contact details of the Client. In
case of any planned relocation of the Product/s or sample, the
same would be intimated to the Client at least 14 days prior to
such relocation with specified reasons for the relocation and
Cryoviva would entirely own the responsibility for the quality of
the sample during such shifting.
SERVICES TO BE PROVIDED BY CRYOVIVA:
Subject to the terms and conditions of this Agreement, Cryoviva
shall immediately on receipt of the Maternal Blood and the
Specimen, conduct or cause to be conducted the following:
Client’s Signature
 AGREEMENT
3.1 Processing, Testing, Cryo-Preservation & Long term Storage of 4.1
Umbilical Cord Blood – Processing of Umbilical Cord Blood is
performed to separate and concentrate the stem cells for
freezing. Cryo-preservation and long term storage of the frozen
Umbilical Cord Blood Stem Cells is done in the vapour phase of
liquid nitrogen tanks.
3.2 Upon successful collection, processing, testing and storage,
Cryoviva will provide the Client with a Storage Certificate
confirming successful storage of the Product along with sample
storage details and test results within 45 days of receipt of the
Maternal Blood and Specimen at Cryoviva Storage Centre.
3.3 Testing– screening of the Maternal Blood of biological mother for 4.2
infectious disease markers (IDM) for HIV, Hepatitis B, Hepatitis C,
HTLV, CMV, Syphilis, Malaria infections and NAT (HIV 1 RNA,HBV
DNA, HCV RNA) testing.
3.4 Testing is performed on Umbilical cord blood stem cell product
for ABO group and Rh type, cell counts, cell viability, CD34
analysis, sterility & haemoglobinopathy screening.
3.5 Samples of Maternal Blood and the Specimen are archived for
possible future testing, as per the requirement of international
standards. 4.3
3.6 Either the Umbilical cord tissue will be processed and cryo stored
in vapour phase of liquid nitrogen tank, or the umbilical cord
tissue will be duly processed to derive the Mesenchymal stem
cells from Wharton's jelly derived (MSCWJD), and the ready to
use MSC are cryo-preserved and stored in vapour phase of liquid
nitrogen tanks as per plan opted. To derive ready to use MSC from
preserved umbilical cord tissue a period of approximately 3 to 12
weeks is needed, according to the number of MSC required.
However the already cryo- preserved and stored ready to use
cells can be delivered to the Client within 7 working days. Testing
on Mesenchymal stem cell product includes cell counts, antigen 4.4
expression analysis, cell viability, sterility testing, potency assay,
endotoxin and mycoplasma testing. The processed MSCs during
requirement for Plans other than Cryo Supra Classic / Superior /
Ultimate would be provided based on the current or better
technology available with Cryoviva. 4.5
3.7 Medical Advisory - Cryoviva provides only advisory information
regarding the use of stem cells in transplants, and may facilitate
information on existing transplant programs in India or abroad on
Client's request. 4.6
4. RESPONSIBILITIES OF THE CLIENT:
The Client undertakes that it shall:
Dr. C.V. Nerikar Page No. : 3 of 14
(Chief Executive)
Execute the Enrolment & Consent Form along with the
Agreement and all the documents and forms required and make
full and timely payments as per the plan selected. The same shall
be submitted to Cryoviva representative/s during the time of
registration, prior to delivery or within 48 hours from the delivery
time so as to process the Specimen/s failing which Cryoviva
would not own the responsibility of processing the Specimen/s
and issuing the confirmation of the same. Informed Consent for
cord blood collection shall be provided by Client or legally
authorized representative before the biological mother is in
active labor.
Provide the Collection Kit to the Physician at the time of delivery
and arrange for collection, preparation and labelling of the
Maternal Blood, Umbilical Cord Blood and/or Umbilical Cord
Tissue for transportation to Cryoviva along with the duly filled up
Forms included in the Collection Kit. Important Delivery
Information Form shall be duly signed by the attending physician.
At the request of Client, Cryoviva shall co-ordinate the collection
of the Specimen & Maternal Blood.
Complications may occur during delivery of the Child, which
could prevent or impede the collection of the Umbilical Cord
Blood / Umbilical Cord Tissue and/or maternal blood, or provide
an inadequate Specimen. The Client further acknowledges that
medical judgment, with the best interest of the mother and
Child's health in mind, could totally prevent the Specimen/s or
Maternal Blood collection at time of delivery. The Client further
acknowledges that engagement of trained personnel well in
advance and handing over the collection kit to them at the time
of reaching the place of delivery are critical to increasing the
chances of successful sample collection.
Promptly notify Cryoviva in writing of any change in Client's name
or contact details (including but not limited to mailing address,
telephone numbers, etc.,) or any change in the legal guardianship
of the Child.
Keep informed Cryoviva about hospital or birthing centre address
and contact details where delivery is to be conducted and the due
date of the delivery of the Child, and any changes thereof to the
given address of Cryoviva as mentioned in this Agreement.
Comply with all the terms and conditions under this Agreement,
Enrolment & Consent Form and other documents and forms, as
applicable.
Client’s Signature
 AGREEMENT
5. TRANSPORTATION
5.1 On Client's request, Cryoviva may arrange and appoint a certified 7.2
courier service provider for Irradiation free transportation, of the
Maternal Blood and Specimen/s collected by Physician to
Cryoviva Laboratory/Storage Centre, provided Client provides a 7.3
reasonable notice (of not less than 2 hours prior to the child birth
for location within 20 KM radius of Cryoviva operational area & 6
hours for further away locations) to Cryoviva for making
necessary arrangements. The information of collection should be 8.
intimated to Cryoviva' representative, whose numbers are
shared with Client during the enrolment and in case of any non-
availability to our 24X7 helpline.
5.2 Client understands that transport of Specimen/s and maternal
blood from the place of childbirth to the Cryoviva laboratory, or
transport of the Product from Cryoviva laboratory to the
transplant centre, has to be done within a reasonable period of 9.
time for minimizing loss of cell viability of the Product/s.
However, disruptions in flight or other transport operations may 9.1
cause the Product to be extinguished or delayed in reaching the
destination. Client understands that no guarantee can be
provided by Cryoviva or the courier company on the safe and
timely transport, and that Client has the option of choosing the
best possible mode of transport. Utilization of qualified
Collection Kits, designed to maintain a controlled environment
for a reasonable period of time, maintenance of Specimen or 9.2
Product or sample viability and traceability at all times of
transportation; utilization of experienced courier companies
which have X-Ray or irradiation waiver procedures, will help
minimize the risks to the Specimen/s or Product during
transportation.
6. INFECTIOUS DISEASE TESTING:
Confidential notification of positive Microbial culture on cord
blood & IDM testing results for HIV, Hepatitis B, Hepatitis C, HTLV,
Syphilis and Malaria performed on maternal blood, shall be sent
to the Client/ biological mother (including surrogate mother, if
any), whose maternal blood/cord blood is tested for 9.3
IDM/Microbial culture as per Cryoviva policies, processes and
procedures respectively . If the positive test results of the IDM
screening/ Microbial culture mentioned above, are confirmed,
Cryoviva hereby confirms not to disclose the information to any
third party except as required under any law. In the event of laws
requiring the disclosure of the results to any authority, the Client
is deemed to have given consent for such an eventuality. 10.
7. FEES: 10.1
7.1 In consideration for the services being rendered by Cryoviva in
terms hereof, the Client shall pay to Cryoviva as per the plan
Dr. C.V. Nerikar Page No. : 4 of 14
(Chief Executive)
chosen as illustrated in Exhibit 1 enclosed herewith.
All applicable taxes levied currently or in future will be charged
extra, at the rates prevailing at the time of chargeability of tax and
shall be payable by the Client.
All payments made by Client to Cryoviva should be backed upon
by a valid receipt/ e-receipt. Client must insist Cryoviva
representative for the same.
MULTIPLE BIRTHS:
In the event of multiple births, if the Client desires to engage
Cryoviva to process, and store the Umbilical Cord Blood and/or
Umbilical Cord Tissue for each child, the Client must check the
appropriate box on the Enrolment and Consent Form and pay the
additional fees as applicable.
TERM:
The Product/s shall be stored in accordance with the following:
The Agreement shall commence from the date of execution of
this Agreement by the Client and shall be effective for Initial
Storage Term. The Product/s, subject to the terms of Clause 2 and
Clause 3 above, will be stored at the Cryoviva Storage Facility for
the Initial Storage Term, depending upon the plan chosen,
subject to the other terms of this Agreement.
Cryoviva shall intimate the Client three months prior to the
expiration of Initial Storage Term from the date of birth of the
Child for those Clients ( except for the client who opted for Life
Term Storage Optional Plan), If the Client does not submit a
request for renewal of services two months prior to the expiry of
Initial Storage Term from the date of birth of the Child, or for
retrieval of the Products, or relinquishes and waives all its rights
and claims to the Products, Cryoviva shall have the right, in its
sole discretion, for final disposition of the Products including but
not limited to utilization for transplant or research or otherwise
dispose of the Products in any manner it deems fit.
The Products will be stored in the Storage Centre subject to the
Client complying with the terms and conditions of this
Agreement and as long as all fees payable by the Client have been
paid in a timely manner, and this Agreement is in effect, failing
which Cryoviva shall have the right to deal with the Products in
accordance with the provisions as stated in Clause 15 hereunder.
REPRESENTATIONS AND WARRANTIES:
The Client hereby represents and warrants to Cryoviva that:
She is the biological mother or client is the legal guardian of the
Child;
Client’s Signature
 AGREEMENT
10.2 The decision to collect the Specimen and Maternal Blood; test the
Maternal Blood; and process, test, store, retrieve, and expand the
Specimen/Product is a completely voluntary act of the Client;
10.3 The Client has discussed with a competent medical/legal
professional, other than an employee or agent of Cryoviva, 11.4
regarding the collection & processing of the Specimen/s and the
preservation and possible future use of the Products, including all
aspects involved medically/legally for the collection of cord
blood, if any, associated with the aforesaid; and
10.4 The Client has disclosed all relevant information including all the
answers to the health questionnaire correctly to the best of
her/his knowledge to Cryoviva.
11. CRYOVIVA SOCIAL BANKING: 11.5
Client understands that for treatment of certain medical
condition/s the Child's own Umbilical Cord Blood Product may
not be the preferred choice for a transplant, and could therefore
require a matching unit from an unrelated donor. In order to
maximize the chances of finding such a match, the Client can
benefit from the Cryoviva Social Banking Program Registry
subject to conditions, which are detailed below:
11.1 Qualifying Criteria for Registry Accession:
a. the Client provides a Maternal Blood sample of sufficient quality 11.6
and quantity within 7 days before or after childbirth; a.
b. the Client consents without any reservations to release their b.
Child's Umbilical Cord Blood Product after the second birth
anniversary of the Child for an unrelated listed Cryoviva Social
Banking Client as the need arises;
c. the Client has not on their own volition switched over to Private
Banking Program.
11.2 Retrieval for Transplant: Social Banking Clients can access the
Cryoviva Social Banking Registry and retrieve the Child's own
stored Umbilical Cord Blood Product or a matching unrelated
Umbilical Cord Blood Product for use by the Child, Child's
biological sibling/s, Child's biological parent/s and/or Child's
biological grandparent/s for any FDA approved transplant
procedure. For such accession and retrieval there would be no c.
extra cost and also no restriction on the number of matching
Product that can be retrieved.
11.3 Release Notification & Goodwill Benefit: Upon release of the
Child's Umbilical Cord Blood Product for unrelated use, Cryoviva
shall notify the Client within 30 days after such release. As a
goodwill gesture in recognition of the Client's contribution in
facilitating a transplant, Cryoviva shall refund all past fees paid by
the Client to Cryoviva (except Sample Collection Charges), waive
Dr. C.V. Nerikar Page No. : 5 of 14
(Chief Executive)
all future fees, and also provide continuity of benefits available
under the Cryoviva Social Banking Program and Cryoviva Client
Benefit Programs as applicable for the entire Term of this
Agreement.
Transfer to Private Banking Program: Clients opting for the
Cryoviva Social Banking Program can at any time, prior to the
Child's Umbilical Cord Blood Product being reserved for
transplant release, elect on their own volition to irrevocably
switch to the Cryoviva Private Banking Program. Also, Umbilical
Cord Blood Product that do not meet the qualifying criteria for
Registry accession as per Clause 11.1 would be moved to the
Cryoviva Private Banking Program.
CRYOVIVA PRIVATE BANKING PROGRAM
Clients opting for this program will be able to exercise exclusive
control of their Child's Umbilical Cord Blood Product. However,
they may not be able to access the Cryoviva Social Banking
Registry should there be a subsequent need for stem cells from an
unrelated donor. In the event of the Child's Product being
required for the Child or its Immediate Family members, the
same can be retrieved at no additional costs for use in a
transplant.
Authorization to Release for an Unrelated Stem Cell Transplant:
It is applicable only for the Cryoviva Social Banking Clients.
The Client having understood the risks, benefits, and alternatives
for the Child, hereby gives consent to release the Umbilical Cord
Blood Product of the Child to another matched and unrelated
Cryoviva Social Banking Program Client as and when required.
Information related to the Child and Client shall remain
confidential and is only available for review by individuals
designated by Cryoviva or by quality and statutory authorities as
necessary to evaluate the operations. Client also agrees that he /
she has voluntarily elected to come under the Cryoviva Social
Banking Program and the option of transferring the Umbilical
Cord Blood Product to Private Banking Program was provided by
Cryoviva at time of Enrolment and until their Child's Umbilical
Cord Blood Product was reserved for a transplant.
In the event that their Child's Umbilical Cord Blood Product
becomes a match to another Cryoviva Social Banking Program
Client, and the same is retrieved and used in a transplant, the
Child's Umbilical Cord Blood Product shall not be available for the
Child and/or its Immediate Family member's use. There may be
scenarios where a Client is unable to find a suitably matching
unit/s in the Cryoviva Social Banking Registry, as finding a suitably
matching unrelated Umbilical Cord Blood Product depends on
the number of Product's stored from the same geographical and
ethnic background of the patient.
Client’s Signature
 AGREEMENT
In such scenarios, an additional search in the inventories of
Cryoviva associated public stem cell banks shall be made and a
suitably matching unit shall be provided, if available as per terms
of this Agreement. However, in case of non-availability of 14.
matching unit, Cryoviva India under its Cryo- Specimen/s
assurance programme will provide the Client up to Rs. 20,00,000 14.1
(Rupee Twenty Lacs Only) towards Transplant expenses as when a.
required for FDA approved transplant treatment. Also, the Client
understands that autologous stem cells could be harvested from
bone marrow or peripheral blood when needed for a transplant
in certain disease conditions.
12 RIGHT TO PRODUCTS:
The Client shall be entitled to all the rights hereunder: b.
12.1 The Client shall have all the rights over the stored Product until
the Child attains majority, further to which all the rights over
the stored Product shall be automatically transferred to the Child
& Cryoviva shall recognize any claims made by the Child for the
Product.
12.2 In an unlikely and unfortunate incident of non-survival of the c.
Child after attaining the age of majority, all the rights over the
stored Product shall be automatically transferred to the Child's
biological parents and/or Child's biological siblings if any, and
they can continue storage of the Product till survival of both these d.
biological parents and Child's biological siblings, if any.
13. RETRIEVAL OF PRODUCTS:
In case of retrieval of the stored Product for any approved
transplant, the Client has to submit duly filled up Retrieval e.
Request Form provided by Cryoviva in advance before availing
this facility along with the name & address of the Treating Doctor
(to be accompanied by patient's Treating Doctor's certificate 14.2
confirming end use in statutorily compliant FDA* approved
transplant procedures). The client and the treating doctor shall
duly sign the Retrieval Request Form prior to reservation of the
Product for retrieval. Cryoviva will put in its best efforts to
complete the retrieval and shipping during business hours within
7 days, or later as per requested date and time, for Umbilical Cord 14.3
Blood Stem Cells and for ready to use Umbilical Cord Tissue Cells a.
(MSCs) if they are adequate in cell counts and viability. However
about 3 to 12 weeks will be required for expansion of MSCs if the
cell count required for treatment is higher than the number of
ready to use MSCs in storage. Client or its representative shall
have the option of designating a courier service/shipper to pick
up the stored Product/s at Cryoviva storage facility. Otherwise, at
the Client's request, Cryoviva shall ship the Product/s in an
appropriate manner, such as use of monitored cryo-shipper
Dr. C.V. Nerikar Page No. : 6 of 14
(Chief Executive)
selected by it, in order to provide safe and timely transportation.
*Current national regulations on Stem Cells apply for compliance.
CRYOVIVA CLIENT BENEFITS:
CELL MATCH
Cryoviva hereby assures to perform free HLA typing at the time of
storage & retrieval on the Child's Umbilical Cord Blood Specimen
and for Immediate Family members during requirement at the
time of retrieval for approved therapy for Clients opting for
Cryoviva Social Banking. However, the Client opting for Private
Banking shall get free HLA typing during requirement at the time
of retrieval only for approved therapy.
In case, if HLA of recipient doesn't match with the preserved
Umbilical Cord Blood Product at the time of transplant (for FDA
approved therapies only), then Cryoviva would arrange unlimited
free cord blood unit for Immediate Family members as per
requirement. This is subject to the availability of additional cord
blood unit with Cryoviva Social Banking Registry.
Client would own the responsibility to intimate Cryoviva about
the requirement for a HLA testing on the preserved Product along
with the report of the disease to be treated for the intended
recipient.
Client should also confirm the details of the Treating Doctor /
Hospital wherein the therapy has to happen so that post HLA
testing and match Cryoviva can also align with the Treating
Doctor to share the other reports and arrange the transport of
the Product.
The HLA report would be furnished within 10 days from the date
of request raised by the Client.
CELL BONUS
The Client can get an additional Umbilical Cord Blood stem cell
unit in case they require it for approved transplantation, for Child
or Immediate Family. This is subject to fulfilment of Conditions as
mentioned in Clause 14.6 herein below.
CELL SAFETY
Cryoviva assures that if the Product retrieved does not meet
viability criteria stated during preservation matching the
international standards, Cryoviva will use its best endeavors to
find a unit of suitable match within 30 days failing which Cryoviva
will pay the Client as and when required Rs.20,00,000 (Rupees
Twenty Lacs Only), subject to full payment by Client in timely
manner.
Client’s Signature
 AGREEMENT
b. Cryoviva assures that Child's Specimen/s will be well cared for
throughout the storage term chosen by the Client. In the event if
the Child or its Immediate Family member diagnosed after the
enrolment date for a condition treatable by stem cell
transplantation using the stored Product (either Child's own
Product or matching Umbilical Cord Blood Product from the
Social Banking Registry, in case of Cryoviva Social Banking Clients)
for FDA approved stem cell transplant, Cryoviva India under its
Cryo- Specimen/s assurance programme will provide the Client
up to Rs. 20,00,000 (Rupee Twenty Lacs Only) towards Transplant
expenses. The same would be provided directly to the transplant
centre or Client post verification of the documents within Thirty
(30) business days, subject to clause 14.6 of this Agreement.
14.4 CELL EXPANSION:
Cryoviva would provide duly expanded and cultured 1000 million
MSC's (subject to ICMR guidelines) along with all the reports of
characterization (both positive and negative markers),
Differentiation and endotoxin and mycoplasma analysis
including sterility and viability tests during the time of
requirement free of cost.
14.5 ADDITIONAL BENEFITS:
a. STORAGE FEE WAIVER:
If in an unfortunate incident of non-survival of the biological
parents, Cryoviva would continue storage of the Product at
Cryoviva's own cost for the remaining term of Agreement.
b. FREE CFU TEST:
Cryoviva shall provide free CFU test at the time of retrieval for
those opting for Private Banking and free CFU test at the time of
storage as well as retrieval for those opting for Cryoviva Social
Banking for the Child whose product is preserved with Cryoviva &
its Immediate Family members. This benefit shall be applicable
for those Clients whose payments are realized with Cryoviva as
per the payment schedule and without cheque dishonouring.
c. FREE WORLDWIDE SHIPMENT:
Cryoviva shall arrange for free shipment of the Product in
monitored Cryo Shipper to any of the location worldwide as
confirmed during the time of retrieval by the Client for the Child
or Immediate Family. Cryoviva shall abide by the local, and
national laws of the country if product is shipped to a foreign
location.
d. FREE NEW BORN SCREENING TEST
Cryoviva shall provide free Neo Screen/Neo Supreme test for the
Client opting for the Cryoviva Social Banking only.
e. FREE FULL BODY PATHOLOGY TEST FOR BOTH BIOLOGICAL
PARENTS
Cryoviva shall provide full body pathology testing free of cost
Dr. C.V. Nerikar Page No. : 7 of 14
(Chief Executive)
once for both the biological parents of the Child after realization
of full payment from the Client for the Clients opting for the
Cryoviva Social Banking.
14.6 GENERAL CONDITIONS FOR CRYOVIVA CLIENT BENEFITS
Cryoviva Client Benefits shall be provided to the Client/Child or its
Immediate Family members only if the following conditions are
satisfied:
a. Cell Bonus shall be provided subject to availability of matching
cord blood stem cell product.
b. Client can avail the Cell Bonus benefit for the Child whose product
is preserved with Cryoviva & Immediate Family members only.
c. The Specimen/Product shall be processed and at all times stored
at Cryoviva Storage Centre.
d. Client shall inform to Cryoviva in writing one month prior to
availing this facility.
e. Request to Cryoviva shall be made along with name and address
of the Treating Doctor to whom the Product/s is to be delivered
along with the therapy details.
f. The Product may be administered under the direction of a
transplant physician/Treating Doctor in a medical facility
qualified and approved by competent authority for stem cell
transplantation.
g. The Product should be administered in approved stem cell
therapy as approved by FDA at the time of processing of
Specimen.
h. Both Cell Bonus & Cell Safety benefits are applicable during the
Initial Storage Term only and for only those Clients whose
payments are realized with Cryoviva as per the payment schedule
and without cheque dishonouring. In case of any genuine case of
cheque dishonouring the confirmation of the offering shall be
backed up by a duly signed written instrument provided by
Cryoviva duly Authorized Representatives.
i. Either upon providing a unit of suitable match or on retrieval of
the entire stored Product or on making the due payment to full
extent to the Client as applicable under the Cryoviva Client
Benefits, the Client would release Cryoviva from?? any ??further
obligations.
15. TERMINATION & ITS EFFECT
15.1 This Agreement may be terminated:
By Client
a any time prior to the collection of Specimen,
b post collection of sample but pre-processing, in case of low
volume/ length, Haemolysed Umbilical Cord Blood, or
c post processing at any time prior to the retrieval of the Product.
Client’s Signature
 AGREEMENT
By Cryoviva
d if it has exercised its right to refuse Specimen/s processing and /
or storage for any reason, including the consequential act of
Specimen/s or maternal blood rejection as per Clause 2, or
e if any payment is due and is not timely paid and such failure to
pay is not cured within 30 days after receipt of notice from
Cryoviva of such failure to pay, without prejudice to Cryoviva's
right to take legal steps to recover the debt, or
f in the event, the Product is lost or destroyed during transit from
Storage Centre to Transplant Centre, or processing and storage,
for any unforeseen reason that is beyond the reasonable control
of Cryoviva,.
g in the event either law or a governmental agency or regulatory
provisions or medical guidelines require us to terminate the
Agreement.
h in the event the product is retrieved for a transplant. However, if
the Client retrieves only a portion of the product, the Agreement
would survive along with all benefits for the Term of the
Agreement.
By either party
I by mutual Agreement of Client and Cryoviva.
15.2 EFFECTS OF TERMINATION & REFUND:
a In the event that, this Agreement is terminated by the Client prior
to the collection of the Cord Blood in terms of Clause 15.1(a),
Cryoviva shall refund all amounts paid by the Client other than
the Registration Charges.
b In the event, the Umbilical Cord Blood and or/ Umbilical Cord
Tissue is found to be insufficient/ unfit for processing by Cryoviva
in terms of Clause 2 and Clause 3 above and the Agreement is
terminated under Clause 15.1(b) or 15.1(d), then the Processing
Fees and the Storage Fees paid for the applicable Product which
cannot be so processed and stored, shall be refunded by
Cryoviva. The Registration Fees shall however not be refunded to
the Client. However, in the event, the Product is found to be unfit
for storage after processing and Agreement is terminated by
Cryoviva under Clause 15.1(d), then the Storage Fees in respect of
the Product which cannot be so stored will be refunded by
Cryoviva. The Registration Fees and the Processing Fees shall
however will not be refunded to the Client.
c In case of premature withdrawal or retrieval before Initial Storage
Term of the Product by the Client, and the Agreement is
terminated by Client under Section 15.1(c), a pro-rata refund of
the Storage Fees of the unexpired period will be made and the
Client would release Cryoviva from any further obligations.
Dr. C.V. Nerikar Page No. : 8 of 14
(Chief Executive)
d If the Agreement is terminated under Section 15.1(e), Client
relinquishes all rights in and to the Product and waives all claims
to the Product then Cryoviva shall have the right at its sole
discretion to dispose of the Product. However, Cryoviva shall
continue storing the Product with no liabilities to the Client for a
period of one year from the date of termination. During this
period the Client shall have the option of reviving the Agreement
by paying all unpaid fees along with applicable interest and a re-
registration fee of Rs. 2,000/-. But, in this case the benefits to the
Client under Cell Safety shall not be applicable.
e If the Agreement is terminated under Sections 15.1.(f), then in
that case if the Child, Child's biological parents and/or Child's
biological siblings are diagnosed for any condition/s treatable by
approved stem cell transplantation using the stored Product then
Cryoviva will use its best endeavours to provide suitable matching
stem cells to the patient if the same is found at any public stem
cell bank (as confirmed by the patient's Treating Doctor) or from
the Cryoviva Social Banking Registry (applicable only to the
Cryoviva Social Banking Clients) within 30 days failing which pay
the Client as and when needed up to Rs. 2,000,000 (Rs. Twenty
Lakhs only). For avoidance of doubt, this benefit shall survive the
termination of the Agreement and shall be binding on the Parties
till the fulfilment of the obligation by the Cryoviva as per this sub-
clause.
f If the Agreement is terminated under Sections 15.1(g) a pro-rated
refund of the prepaid storage fees will be made by Cryoviva to the
Client.
g If the Agreement is terminated by Cryoviva under Clause 15.1(i),
Cryoviva shall at its own cost arrange for transfer of Product to a
comparable stem cell bank facility and pay the new stem cell bank
for storing the Product for the remaining period of the
Agreement. Further, if the Agreement is terminated by the Client
as per clause 15.1 (i) or 15.1 (c), the Client shall bear the entire
cost for shifting the preserved Specimen to another stem cell
bank facility of their own choice. But, if the Client fails to shift the
Specimen within 60 days' time from the date of termination of
Agreement, then the Cryoviva shall have full right to either use or
discard the Product as per its discretion.
h Cryoviva understands that during pregnancy and delivery of the
Child the health of mother and Child is of top most priority. In the
event the umbilical cord blood and umbilical cord tissue and /or
maternal blood is not collected due to this priority, then Cryoviva
would pay back the entire fees given by the Client upon receipt of
a relevant declaration from the attending gynaecologist
/Physician.
Client’s Signature
 AGREEMENT
I In the event of refund of fees by the Cryoviva to the Client for
whatsoever reason including those mentioned in clause 15 & 17,
all the duties/obligations/liabilities of the Cryoviva towards the
Client ends and this Agreement shall stand terminated.
j Refunds, if any, by Cryoviva shall be processed within 45 days of
receiving the completed documentation from Client.
16. DISCLAIMER:
16.1 Neither Cryoviva nor any of its directors, representatives,
officers, employees, consultants and agents have made any 18.
representations, guarantees or warranties, express or implied, to
the Client of any kind other than those expressly disclosed herein.
However, any amendments issued would be valid only if signed
by duly authorized representatives of Cryoviva.
16.2 Cryoviva expressly disclaims any responsibility to provide
services other than as specifically stated under this Agreement. In
case of any special services to be provided, the same is to be
confirmed via written instruction issued as amendment to the 19.
Agreement signed by duly authorized representatives of 19.1
Cryoviva.
17. LIMITATION OF LIABILITY:
17.1 The Client acknowledges that Cryoviva shall have no liability
whatsoever to the Client, in the event of a default on part of 19.2
any/all third party services, wherein applicable, regarding
collection or transportation of Specimen in delivering the
Specimen/s and Maternal Blood to Cryoviva laboratory/Storage
Centre and in transportation of Product/s to the transplant centre
or Treating Doctor/Physician. The respective third party vendors 20.
like Physician/Phlebotomist, Transporters/ Courier Agencies shall
have the respective responsibility for their services including loss,
damage, delay in delivery, etc. However, Cryoviva values the
Client's interest in choosing for banking the valuable stem cells of 20.1
the Child with it. Hence on evidence of such an event Cryoviva
would agree to provide a free matching Umbilical Cord Blood unit
from its Social Banking Registry or associate public banking 20.2
inventory subject to availability should the Child or Immediate
Family need such sample.
17.2 It is hereby agreed between the Parties that Cryoviva liability to 21.
the Client in respect of the aforesaid shall be limited to the refund 21.1
in accordance with Clause 15.2 of this Agreement or the benefits
available under Clause 11 or Clause 14 of this Agreement
(whichever is applicable). In any other cases which are not
mentioned in Clause 15.2 herein, Cryoviva liability for any loss, 21.2
harm, damage or claim of any kind in connection with this
Agreement or the services provided by Cryoviva shall be limited
Dr. C.V. Nerikar Page No. : 9 of 14
(Chief Executive)
to the return of an amount equal to all fees paid by the Client to
Cryoviva. The Client /Child for whom the Product is stored shall at
all times be deemed to be bound by the terms and conditions of
this Agreement. The Client hereby indemnifies and agrees to hold
harmless Cryoviva, its directors, representatives, officers,
employees, consultants, agents, shareholders, and affiliates from
any and all claims, liabilities, demands and causes of action
asserted against Cryoviva by such Child.
FORCE MAJEURE:
If Cryoviva is prevented from performing its obligation hereunder
from causes which are beyond its reasonable control, such as, but
not limited to, acts of God or elements, bandhs, embargoes or
Government orders or restrictions then Cryoviva would be
relieved of its liability as per the sub-clause 15.2(e) of this
Agreement.
CONFIDENTIALITY:
Cryoviva shall put in its best efforts to maintain strict
confidentiality of the information provided by the Client in
accordance with the relevant laws of India except as may be
required to be disclosed under Government regulations or laws
or as may be permitted under this Agreement.
The Client hereby agrees to the release of information by
Cryoviva with regard to such person or the Child, to the hospital,
laboratory or to the Physician/ Treating Doctor providing services
to the Client, or if different the biological mother of the Child.
NOTICES:
All notices shall be in writing signed by the person giving it and
may be served by hand delivery, prepaid recorded delivery or
registered/speed post addressed as follows:
If to the Client: Address given in the Enrolment & Consent Form
duly signed by the Client or any change of address thereafter
notified to Cryoviva by the Client.
If to Cryoviva: At: 129, Pace City - 1, Sector - 37, Gurugram -
122001. Tel - +91 124-3341301-305, or any change of address
thereafter notified to Client by Cryoviva.
GOVERNING LAW, DISPUTE RESOLUTION AND JURISDICTION
In the event any dispute arises between the parties, the disputes
shall be settled by arbitration in accordance with the Arbitration
and Conciliation Act, 1996 as amended thereto. The seat & Venue
of arbitration shall be Delhi & the language shall be English.
This Agreement is governed by, construed and interpreted in
accordance with the laws of India and the Courts of Delhi shall
have exclusive jurisdiction.
Client’s Signature
 AGREEMENT
22 GENERAL 22.7
22.1 This Agreement shall be binding upon and be enforceable by the
legal representatives and assigns of the parties. If any of the
provisions herein become invalid, illegal or unenforceable, the
validity, legality or enforceability of the remaining provisions shall
not in any way be affected or impaired.
22.2 The Client acknowledges that he/ she has been fully informed of,
accepts and agrees to the conditions, risks, limitations and
consequences attached with the storage of Product/Specimen.
22.3 Cryoviva reserves the right to assign or transfer its rights and
obligations hereunder to any of its related entities or to any third
party having equivalent preservation standards to ensure safety
of the sample for the committed tenure.
22.4 Each party shall bear all its costs and expenses incurred in the
negotiation, preparation, execution and implementation of this
Agreement.
22.5 Nothing herein shall be deemed to constitute a partnership
between the parties or constitute any party the agent of the 22.8
other.
22.6 The Agreement, Enrolment & Consent Form, Instructions for
Collection of Umbilical Cord Blood, Cord Tissue & Maternal
Blood, Risks related to Stem Cell Banking and the exhibits hereto
shall form part of this Agreement and construed as one
document and constitute the entire Agreement between
Cryoviva and Client and supersede any prior Agreements or
understandings oral and written. This Agreement may be
modified only by duly executed written Agreement between
Client and authorized signatory of Cryoviva.
IN WITNESS WHEREOF THE PARTIES HAVE SET THEIR RESPECTIVE HANDS THE DAY AND YEAR FIRST ABOVE WRITTEN.
Accepted by Cryoviva Biotech Pvt. Ltd.
Dr. C.V. Nerikar
(Chief Executive)
Witnesses:
1. Name.............................................................................................. Signature ……………………………............
2. Name.............................................................................................. Signature …………………….........………...
Page No. : 10 of 14
This Agreement may be executed in electronic form by electronic
means of executing or authenticating transactions (“Electronic
Form”) as per the relevant Indian laws. For avoidance of doubt, it
is clarified that communications in Electronic Form include any
writing or action undertaken on any technology platform, mobile
application or Website provided by Cryoviva. The use of a key
pad, mouse or other device to select an item, button, icon or
similar act/action, or to otherwise provide instructions on a
mobile application or a website or in accessing or making any
transaction regarding this Agreement constitutes a signature,
acceptance and agreement as if actually signed in writing. Each
Party agrees and confirms that any writing or action made or
undertaken by such Party in Electronic Form shall be valid,
binding and legally enforceable against the Party and such Party
shall not raise any objection or claim or disclaim any liability
under or in relation to the validity or enforceability of a writing or
action solely on account of it being in Electronic Form.
BY DULY SIGNING THIS AGREEMENT, THE CLIENT HEREBY
ACKNOWLEDGES THAT SHE / HE HAS RECEIVED INFORMATION
CONCERNING THE RISKS, BENEFITS, DISCOMFORTS, AND
ALTERNATIVES TO SPECIMEN/S AND MATERNAL BLOOD
PROCUREMENT; THAT SHE OR HE HAS HAD AN OPPORTUNITY TO
HAVE ACCESS TO PRE PROCUREMENT INFORMATION AND
ADVOCACY SERVICES; THAT SHE OR HE HAS BEEN GIVEN THE
OPPORTUNITY TO ASK QUESTIONS AND HAD THOSE QUESTIONS
ANSWERED SATISFACTORILY.
Accepted by Client/s:
________________________
Name & Signature