Professional Documents
Culture Documents
1. DEFINITIONS cell counts, microbial contamination, pre-existing
In this Agreement (including the recitals above), condition/s like hemoglobinopathies, infectious
unless the context otherwise requires, the following diseases, etc.
expressions shall have the following meanings:
1.11. ‘Colony Forming Unit (CFU) Assay’ is a qualitative and
1.1. 'Caregiver' means the Obstetrician/Gynecologist and/or quantitative method, by which the proof of
qualified medical professional/midwife who will be 'multipotency and proliferation capacity,’ the most vital
assisting in delivering the Child. property of a stem cell, is assessed. This shows the
capacity of a single stem cell, not only to differentiate
1.2. 'Child' means the Client's baby (or babies in the event into specialized cellular lineages (cell potency) but also
of multiple births) from whom the Umbilical Cord Blood ensure proliferation to an acceptable number of each
will be collected following his/her birth. of the specialized cell types.
1.3. 'Client' means the biological parents or legal guardian 1.12. ‘Viability’ denotes the percentage of alive (viable) stem
of the Child or the Child after attaining the age of cells present in the Umbilical Cord Blood which is
majority. capable of engraftment.
1.4. 'Collection Kit' means a UN 3373 certified kit, compliant 1.13. ‘Mesenchymal Stromal Cells / Stem Cells (MSC’s)’ are
with International Air Transport Association (IATA) stem cells that are plastic-adherent when maintained
regulations, consisting of all essential materials in standard culture conditions, they express cell
required for the purpose of collection and labelling of surface molecules/markers like CD105, CD73 and
the Maternal Blood and Umbilical Cord Blood. CD90, and lack expression of CD45, CD34, CD14, CD19
and HLA-DR and also differentiate to osteoblasts,
1.5. 'Maternal Blood' means the peripheral blood collected adipocytes and chondroblasts in vitro.
from Birth Mother of the Child, which has been drawn
by observing standard phlebotomy procedures taken 1.14. ‘Human Leukocyte Antigen (HLA)’ are proteins or
within seven days before or after the birth of the Child. markers found on most cells in the body, and is used
by the immune system to differentiate between own
1.6. 'Umbilical Cord Blood' means the blood inside the cells and others. HLA typing is used to match patients
umbilical cord and/or placenta. and donors for bone marrow or peripheral blood or
umbilical cord blood stem cell transplants.
1.7. 'Specimen' means and includes banked or
cryopreserved stem cells obtained from the Umbilical 1.15. ‘Inherited Diseases Testing’ is a next generation
Cord Blood, unless specifically mentioned otherwise. sequencing (NGS) based test that searches for
variations in the coding regions of genes known to
1.8. 'Private Banking' means a program wherein Client cause rare inherited diseases of pediatric-onset.
banks their Child's Specimen for exclusive usage by
the Child and/or Child's biological sibling/s and/or 1.16. 'Pediatric Cancer Profiling’ is a next generation
Child's biological parent/s and/or Child's biological sequencing (NGS) based test for comprehensive
grandparent/s, as applicable. genomic profiling of all forms of childhood cancer,
including but not limited to leukemia, brain tumors, and
1.9. 'Community Banking' means a program wherein Client a diverse group of solid tumors.
banks the Child's Umbilical Cord Blood Specimen for
non-exclusive usage, wherein the Client also agrees to 2. SERVICES: OPTION AND FEES
donate their Child's Umbilical Cord Blood Specimen for
usage by other LifeCell Community Banking Program 2.1. LifeCell offers its Umbilical Cord Blood Stem Cell
Clients after the second birth anniversary of the Child. Banking Services under different plans, fees and
As per clause 7.2, the Client can also retrieve the payment methods as detailed in the Plan and
Specimen/s of other LifeCell Community Banking Payments section, which the Client must choose at the
Program Clients. time of Enrollment.
1.10. 'Registry' means and includes listing of HLA (Human 2.2. All applicable taxes including but not limited to Goods
Leukocyte Antigen) typing results of Umbilical Cord and Services Tax, present and/or future levy, if any, are
Blood Specimens that meet specific qualifying criteria payable by the Client.
(benchmarked against international guidelines) that
may preclude it from being eligible for utilization in 3. CLIENT RESPONSIBILITIES
stem cell transplantation, including but not limited to
LifeCell International Private Limited, # 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600127, Tamil Nadu, India.
| 1800 266 5533 | www.lifecell.in |
3.1. Client is responsible for providing the LifeCell 5.2. Client may opt for prepayment of the storage fees and
Collection Kit to the Caregiver and arranging for upgrade their Annual Storage Plan to OneTime Plan or
collection, preparation and labelling of the Maternal LifeTime Plan, or upgrade their OneTime Plan to
Blood and the Umbilical Cord Blood for delivery to LifeTime Plan by paying the applicable fees as advised
LifeCell's laboratory along with the duly filled up forms by LifeCell at relevant time. Upon such payment, the
included in the Collection Kit, unless otherwise Annual Storage Plan will be converted to OneTime Plan
specified by the Client to LifeCell for assistance as per or LifeTime Plan, or the OneTime Plan will be
Clause 8.9. converted to LifeTime Plan and this Agreement term
will be extended to twenty one years or seventy five
3.2. Client must promptly notify LifeCell in writing regarding years respectively from the date of birth of the Child
any change in Client's name or contact details until the survival of the Child and the Child's biological
(including but not limited to mailing address, telephone parents and Child’s biological siblings (if any),
numbers, email id, etc.) or any change in the legal whichever is later.
guardianship of the Child.
5.3. At least 90 days before the expiration of this
3.3. In the case of retrieval of Specimen/s and/or expanded Agreement term, LifeCell shall notify the Client (or the
MSC’s for any approved stem cells transplant/s and/or Child on attaining the age of majority) regarding the
approved clinical trial/s, as applicable, the Client has to expiry of this Agreement, along with the terms of
submit duly filled up Retrieval Form provided by continued storage. Accordingly, the Client (or the Child
LifeCell at relevant time (to be accompanied by on attaining the age of majority) can enter into a new
patient's transplant physician's certificate confirming Agreement and continue the storage of the Specimen.
end use in statutorily compliant approved transplant
procedures or approved clinical trial/s). 6. REPRESENTATIONS AND WARRANTIES OF CLIENT
Client represents and warrants that:
4. STORAGE
6.1. She/he is the parent or legal guardian of the Child.
4.1. LifeCell assures to process the Umbilical Cord Blood
Specimen by using its personalized PrepaCyte-CB® 6.2. Client has had the opportunity to read, understand,
processing technology involving red blood cell review and consult with the Client's own legal counsel
reduction and plasma depletion and store it in vapor and medical professional, this entire Agreement,
phase of liquid nitrogen in special cryo-bags informed consents, possible risks of collection,
compartmentalized in volumes of 5 mL and 20 mL processing, storage and possible future use of the
along with attached test segments (6 segments of 0.2 Maternal Blood and Specimen/s.
mL each). LifeCell shall also store some portion of the
6.3. The decision to collect the Umbilical Cord Blood and
Maternal Blood in special cryo-vials, in case needed,
Maternal Blood, test the Maternal Blood, and test,
for future testing requirements.
process, store, expand and retrieve the Specimen/s is a
completely voluntary act of the Client.
4.2. Client may opt for primary storage of Specimen at
either of LifeCell's licensed facilities situated at No. 26,
7. LIFECELL COMMUNITY BANKING PROGRAM
Vandalur Kelambakkam Main Road, Keelakottaiyur,
Chennai - 600127, Tamil Nadu, India or Plot No. 26,
Client understands that for treatment of majority of the
Sector 4, IMT Manesar, Gurugram - 122001, Haryana,
medical condition/s, the Child's own Umbilical Cord
India.
Blood Specimen may not be the preferred choice for
stem cell transplant (in the opinion of the patient's
4.3. For disaster management, back-up and added retention
transplant physician) and could therefore require
security, LifeCell will store the Specimen
Specimen/s from matching unrelated donor/s. In order
simultaneously in both of its licensed facilities, as per
to maximize the chances of finding such suitable
Client's preferred locations, hereby known as the Dual
matching Specimen/s, the Client can benefit from the
Storage Service.
LifeCell Community Banking Program subject to
conditions, which are detailed below:
4.4. For the purpose of safety, LifeCell has the option to
relocate the entire stored Specimen or a part of the
7.1. Qualifying Criteria for Community Banking Program
same at its own cost to a comparable stem cell bank
Client to Access LifeCell Registry:
facility and will provide Notice to the Client within 14
days of such relocation. In case of any planned a. the Client provides Maternal Blood sample of
relocation, LifeCell will provide Notice to the Client at sufficient quality and quantity within seven days before
least 14 days prior to such relocation. or after childbirth;
b. The Client submits the duly filled Maternal Health
5. TERM OF AGREEMENT History Questionnaire;
c. The Client submits the duly filled Infant Health
5.1. If the Client chooses the Annual Storage Plan, this
History Questionnaire and signed by a registered
Agreement term will continue and shall be held as valid
medical practitioner;
for one year from the date of birth of the Child
('Renewal Date') and will automatically renew for d. the Client consents without any reservations to
successive one year period until the survival of the release their Child's Umbilical Cord Blood Specimen
Child and Child's biological parents and Child’s after the second birth anniversary of the Child to other
biological siblings (if any), whichever is later. This listed LifeCell Community Banking Client as the need
automatic renewal is subject to the Client paying the arises;
LifeCell International Private Limited, # 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600127, Tamil Nadu, India.
| 1800 266 5533 | www.lifecell.in |
e. the Client has not on their own volition elected to should there be a subsequent need for stem cells from
irrevocably switch over to LifeCell Private Banking unrelated donor/s. In the event of the Child's own
Program. Specimen being required for the Child and/or Child's
biological sibling/s and/or Child's biological parent/s
f. Even if the LifeCell Community Banking Program and/or Child's biological grandparent/s, the same can
Client’s Umbilical Cord Blood Specimen does not meet be retrieved by the Client at no additional costs for any
specific qualifying criteria (benchmarked against stem cell transplant/s or any clinical trial/s approved
international guidelines) for listing in LifeCell Registry, by national or international regulatory health bodies as
the Client shall continue to enjoy all the benefits under applicable.
the LifeCell Community Banking Program and the
LifeCell Client Benefit Programs. 8. LIFECELL CLIENT BENEFIT PROGRAMS
In order to provide a comprehensive coverage for the
7.2. Retrieval for Stem Cells Transplant: LifeCell Child and/or Child's biological sibling/s and/or Child's
Community Banking Clients can access the LifeCell biological parent/s and/or Child's biological
Registry after the Enrollment Date (even during the grandparent/s as applicable, LifeCell through its Client
initial first two years from date of birth of the Child) Benefit Programs provides additional guarantees,
and during the entire tenure of this Agreement, and assistance and benefits which are detailed below:
retrieve the Child's own stored Specimen and/or
matching unrelated Umbilical Cord Blood Specimen/s 8.1. Entitlement to Full Refund: LifeCell understands that
including for medical condition/s diagnosed prior to the life and health of the Mother and Child are the
the Enrollment Date, for use by the Child and/or Child's utmost priority. Hence, in rare circumstances, if the
biological sibling/s and/or Child's biological parent/s Umbilical Cord Blood is not collected for any reason
and/or Child's biological grandparent/s for any stem including this priority or in an unfortunate situation of
cell transplant/s or clinical trial/s approved by national non-survival of the Child at birth, LifeCell shall refund
or international regulatory health bodies as applicable. all fees paid by the Client to LifeCell upon sharing of
Client is required to fulfill the Qualifying Criteria as per relevant declaration from the attending gynecologist.
Clause 7.1 to become part of the LifeCell Community
Banking Program. LifeCell assures that for accessions 8.2. Medical Treatment Assistance for Hematopoietic Stem
and retrievals of matching unrelated Umbilical Cord Cells Transplantation: If after the Enrollment Date and
Specimens from the LifeCell Registry there would be before the completion of the Child's twenty first birth
no extra cost and also no restriction on the number of anniversary, the Child and/or Child's biological
matching Specimens that can be retrieved by the sibling/s and/or Child's biological parent/s are
LifeCell Community Banking Program Client. diagnosed of medical condition/s treatable using the
Child’s own Specimen and/or matching unrelated
7.3. Release Notification & Goodwill Benefit: Upon release
Umbilical Cord Blood Specimen/s from the LifeCell
of the Child's Umbilical Cord Blood Specimen for stem
Registry (applicable only to LifeCell Community
cell transplant by other listed LifeCell Community
Banking Clients) through an approved hematopoietic
Banking Program Client, LifeCell shall notify the donor
stem cell transplantation, then LifeCell shall pay the
Client within 30 days after such release. As a goodwill
Client as per actual expenses or ₹2,000,000 (INR Two
gesture in recognition of the Client's contribution in
Million only) whichever is lesser in order to offset the
facilitating this transplant, LifeCell shall refund all past
costs of such transplantation. In the unfortunate
fees paid by the Client to LifeCell (except Sample
scenario that the Child’s own Specimen and/or
Collection Charges), waive all future fees, and also
Umbilical Cord Blood Specimen/s listed on the LifeCell
provide continuity of benefits available under the
Community Banking Registry (applicable only to
LifeCell Community Banking Program and LifeCell
LifeCell Community Banking Clients) is either no longer
Client Benefit Programs as applicable until seventy five
available and/or not a suitable match to the patient for
years from the date of birth of the Child.
stem cell transplant (in the opinion of the patient's
transplant physician), then LifeCell will source
7.4. Transfer to Private Banking Program: Clients opting for
alternative matching Umbilical Cord Blood Specimen/s
the LifeCell Community Banking Program can at any
from any public stem cell bank worldwide within 14
time, prior to the Child's Umbilical Cord Blood
days for value not exceeding ₹2,000,000 (INR Two
Specimen being reserved for transplant release, elect
Million only). In case if the matching Umbilical Cord
on their own volition to irrevocably switch to the
Blood Specimen/s is not found in any public stem cell
LifeCell Private Banking Program. Also, Umbilical Cord
banks worldwide, then in order to support
Blood Specimens that do not meet the qualifying
transplantation from any other approved stem cell
criteria for LifeCell Registry accession as per Clause
sources (like bone marrow or peripheral blood),
7.1 would be moved to the LifeCell Private Banking
LifeCell shall pay as per actual expenses or ₹2,000,000
Program. However, in the event the Child is diagnosed
(INR Two Million only) whichever is lesser, to the Client,
of medical condition/s that may require the use of
in order to offset the costs of such stem cells
Child's own Umbilical Cord Blood Specimen, the Client
transplantation.
may exclusively reserve the Child's own Specimen
without exiting the LifeCell Community Banking
8.3. Free Umbilical Cord Blood Stem Cells Expansion: If
Program by providing documentary evidence from the
after the Enrollment Date and before the completion of
treating transplant physician to LifeCell.
the Child's twenty first birth anniversary, the Child
and/or Child's biological sibling/s and/or Child's
7.5. LIFECELL PRIVATE BANKING PROGRAM
biological parent/s are diagnosed of medical
Clients opting for this program will be able to exercise condition/s treatable using the Child’s own Specimen
exclusive control of their Child's Umbilical Cord Blood and/or matching unrelated Umbilical Cord Blood
Specimen. However, they may not be able to access Specimen/s from the LifeCell Registry (applicable only
the LifeCell Community Banking Program Registry to LifeCell Community Banking Clients) through an
LifeCell International Private Limited, # 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600127, Tamil Nadu, India.
| 1800 266 5533 | www.lifecell.in |
approved transplantation/s or approved clinical trial/s
and should cellular expansion of the Umbilical Cord 8.8. Disaster Relief: Should for any unforeseen reason, that
Blood Specimen/s be deemed necessary for such is beyond the reasonable control of LifeCell, which may
transplant, as confirmed by the patient's transplant potentially deteriorate or cause loss, harm and
physician, LifeCell at no additional cost to the Client damage, entirely or partly, of the Umbilical Cord Blood
shall provide the expansion of hematopoietic stem and/or Specimen/s, during transit, processing and/or
cells derived from Umbilical Cord Blood Specimen/s storage, and upon Specimen/s and/or expanded MSC’s
based on LifeCell's in-house protocols becoming being required for stem cells transplant is unfit and/or
commercially available in future and subjected to insufficient, then LifeCell shall pay ₹2,000,000 (INR
applicable approvals by local and national regulatory Two Million only) to the Client if it is unable to source
authorities. expanded MSC’s or matching Umbilical Cord Blood
Specimen/s from any public stem cell bank worldwide
8.4. Free Guaranteed Mesenchymal Stromal/Stem Cells and/or from the LifeCell Registry (applicable only to
(MSC’s) Expansion: If after the Enrollment Date and LifeCell Community Banking Clients) within 14 days for
before the completion of the Child's twenty first birth a value not exceeding ₹2,000,000 (INR Two Million
anniversary, the Child and/or Child's biological only).
sibling/s and/or Child's biological parent/s are
diagnosed of medical condition/s treatable using 8.9. Sample Collection and Transport Assistance: At the
MSC’s in approved transplantation/s or approved request of the Client and upon payment of applicable
clinical trial/s, as confirmed by the patient's transplant fees, LifeCell would arrange for a certified and trained
physician, LifeCell at no additional cost to the Client paramedic for the collection of the Maternal Blood and
shall provide upto 1 billion ready-to-use allogeneic Umbilical Cord Blood, and/or a certified service
MSC’s within 7 days, either by Drugs Controller General provider for transport of the Maternal Blood and
of India (DCGI) and/or The Central Drugs Standard Umbilical Cord Blood to LifeCell's Laboratory, provided
Control Organisation (CDSCO) and/or Indian Council of however that the Client provides reasonable time to
Medical Research (ICMR) approved, allogeneic LifeCell for allowing the paramedic to reach the
expanded mesenchymal stromal cells / stem cells, birthing center i.e. not less than two hours prior to
ready-to-use cryopreserved product, derived from childbirth for a birthing center located within 50 km
donated adult human bone marrow or allogeneic MSC’s radius of nearest LifeCell Service Center, and not less
derived from Wharton’s Jelly of voluntarily donated than 8 hours for further away locations.
human Umbilical Cord Tissue manufactured based on
LifeCell's in-house protocols subjected to applicable 8.10. Storage Fee Waiver: In case of unfortunate demise or
approvals by local and national regulatory authorities. permanent physical disability of either of the Client
during the minority of the Child, LifeCell would refund
8.5. Free Worldwide Shipment: Upon submission of duly the prepaid storage fees on a pro-rata basis and shall
filled Retrieval Form by the Client (as provided by continue storage of the Specimen at LifeCell's own
LifeCell at relevant time) for retrieval of Specimen/s cost till the Child attains the age of majority.
and/or expanded MSC’s for any approved stem cells
transplant/s or approved clinical trial/s, LifeCell at no 8.11. General Conditions for LifeCell Client Benefit
additional cost to the Client shall make the same Programs:
available for delivery within 7 days. LifeCell shall also
a. This Client Agreement is valid and is in force.
LifeCell International Private Limited, # 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600127, Tamil Nadu, India.
| 1800 266 5533 | www.lifecell.in |
advanced temperature monitoring software, thereby
9. LIFECELL ASSURANCES
assuring the Client that the Child’s Specimen is safely
During the entire tenure of this Agreement, LifeCell stored in accordance to approved Standard Operating
hereby assures the Client that: Procedures and in compliance with statutory
regulations.
9.1. LifeCell has all statutory permissions and licenses that
are required for providing the Services contemplated 9.11. During the entire term of this Agreement, at the time of
under this Agreement. retrieval for every stem cell transplantation, LifeCell
shall perform at no additional cost to the Client,
9.2. LifeCell shall provide the Client with the following genetic tests like Inherited Diseases Testing and
immediately upon Enrollment: copy of this Agreement Pediatric Cancer Profiling on the Child's own stored
and formal e-receipt, a Collection Kit, a unique Client Specimen and/or matching unrelated Umbilical Cord
Relationship Management (CRM) number that enables Blood Specimen/s from LifeCell’s Registry and/or
the Client to quote for all communications with LifeCell matching Umbilical Cord Blood Specimen/s from any
and unique login ID and password to access the Client public stem cell bank worldwide (as confirmed by the
portal on LifeCell’s website. patient's transplant physician).
9.3. LifeCell upon receipt of the Maternal Blood and 10. DISCLAIMER & LIMITATIONS:
Umbilical Cord Blood at its laboratory would determine
whether it is fit or unfit for testing, processing and/or 10.1. LifeCell does not perform any medical Services, give
storage. any medical advice, or otherwise perform any Services
other than those expressly indicated in this Agreement.
9.4. In rarely occurred circumstances, if the Child's It disclaims all other representations, guarantees,
Umbilical Cord Blood is of insufficient volume and/or is warranties or assurances express or implied.
unfit for processing and/or storage, LifeCell shall notify
the Client and discard the Specimen after receiving a 10.2. LifeCell disclaims any responsibility to provide any
written consent from the Client. However, if LifeCell other Services (except those specified in this
does not receive a written consent within 30 days of Agreement) and third party service providers like
such notification, LifeCell shall continue storing the Caregiver, Transporter, etc. shall have the respective
Specimen. In such an event, the Client shall continue to responsibility for their services including any loss,
enjoy the benefits under the LifeCell Community harm, damage, delay in delivery, etc.
Banking Program and the LifeCell Client Benefit
Programs as long as the entire applicable fees are paid 10.3. Client agrees that LifeCell's liability for any loss, harm,
to LifeCell by the Client. damage or claim of any kind in connection with this
Agreement or Services provided by LifeCell and/or
9.5. As per the statutory regulations, if the Maternal Blood third party service providers shall be limited to the
is not provided within 7 days before or after childbirth, return of an amount equal to all fees paid by the Client
the Child's Specimen can be used only for autologous to LifeCell or benefits available under the applicable
purposes. LifeCell Client Benefit Programs as per Clause 8
(whichever is higher). However, for any act/s
9.6. The Specimens would be tested, processed, stored, committed by LifeCell that are intentional and/or
expanded and retrieved in accordance to approved grossly negligent, this liability shall be subject to the
Standard Operating Procedures and in compliance with discretion of the Court of Law.
statutory regulations.
11. FORCE MAJEURE
9.7. Upon successful collection, processing, testing and
Client agrees that LifeCell's liability for causes and/or
storage, LifeCell will provide the Client with a circumstances which are beyond LifeCell's reasonable
Preservation Certificate confirming storage of the control shall be limited to that committed under
Specimen along with sample storage details and test ‘Disaster Relief’ Program.
results within 45 days of receipt of the Maternal Blood
and Umbilical Cord Blood at LifeCell's laboratory.
12. TERMINATION OF AGREEMENT
9.8. LifeCell shall at its own discretion never subject the
12.1. This Agreement may be terminated
Specimens to any unauthorized usage and/or donate it
for research and/or therapeutic purposes unless this a. by Client at any time prior to the Umbilical Cord
Agreement is terminated as per clause 12.1 (d). Blood collection, or
b. by Client at any time after storage of the
9.9. Upon submission of the duly filled Specimen Search Specimen, or
Request Form by the Client (as provided by LifeCell at
c. by Client on their own will if they do not wish to
relevant time), a search shall be commissioned in the
continue storage of the Child's Specimen, including the
LifeCell Registry for the LifeCell Community Banking
consequential act of sample rejection as per clause
Clients and results shall be provided within 4 days.
9.4, or
9.10. During the entire term of this Agreement, on every birth d. by LifeCell if any payment due to LifeCell during
anniversary of the Child, LifeCell hereby assures to the entire term of this Agreement is not timely paid by
send an Annual Preservation Status Report on the most the Client and such failure to pay is not cured within 30
updated registered Email ID of the Client, which shall days from the due date of such payment, without
contain monthly temperature data of the prejudice to LifeCell's right to take legal steps to
cryo-chambers in which the Child’s Specimen is being recover the debt, or
stored that is recorded automatically from our highly
e. by mutual agreement of Client and LifeCell, or
LifeCell International Private Limited, # 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600127, Tamil Nadu, India.
| 1800 266 5533 | www.lifecell.in |
In case of surrogate births, the Child’s biological
f. by either party upon 60 days prior written Notice
to the other party hereto, or mother’s health history shall be duly filled and
submitted by the Client to LifeCell. The Child’s
g. in the event the entire Specimen is retrieved for stem non-birth mother shall register as Client at time of
cell transplantation (applicable only to LifeCell Private Enrolment to execute all rights of the Child’s biological
Banking Program Clients). However, if the Client mother as stated in this Agreement.
retrieves only a portion of the Specimen, this
Agreement would survive along with all benefits for the
14. ARBITRATION
entire term of this Agreement.
h. in the event either law or a governmental agency or All disputes arising out of or relating to this Agreement
regulatory provisions or medical guidelines requires will be resolved by arbitration. The arbitration will take
LifeCell to terminate this Agreement. place in Chennai, Tamil Nadu, India and the language
shall be English. The arbitration will be governed by the
12.2. Effects of Termination: Arbitration and Conciliation Act, 1996, as amended
from time to time.
a. If this Agreement is terminated under Section
12.1.(a), all fees paid by the Client to LifeCell shall be 15. GOVERNING LAW AND JURISDICTION
refunded after deducting a cancellation fee of ₹7,500
(INR Seven Thousand Five Hundred only). This Agreement is governed by, construed and
b. If this Agreement is terminated under Section interpreted in accordance with the laws of India. Courts
12.1.(b), all fees paid by the Client to LifeCell are in Chennai, Tamil Nadu, India, shall have exclusive
non-refundable. The Client reserves the right to shift jurisdiction.
the Child’s Specimen at their own cost to any other
stem cell bank facility of their choice. 16. CONFIDENTIALITY; CONSENT TO RELEASE
c. If this Agreement is terminated under Section
LifeCell acknowledges the confidential nature of the
12.1.(c) or 12.1.(h), the Storage and/or Processing fees
information provided to it and agrees to use its best
would be refunded, as applicable.
efforts to maintain the confidentiality of the
information except as required by law or as permitted
d. If this Agreement is terminated under Section
12.1.(d), the Client relinquishes all rights in and to the by this Agreement. All confidential information and
Child's Specimen and waives all claims to the Child’s personal identifiable information shall be kept on a
Specimen and LifeCell shall have the right to discard secure database with adequate backup measures.
and/or donate the Child's Specimen at its sole Client and, if different, the Birth Mother of the Child
discretion. However, LifeCell shall continue storing this hereby agrees to the release of information to the
Specimen with no liabilities to the Client for a period of hospital, laboratory or physician providing the Services
two years from the date of termination of this to the Client.
Agreement. Client can revive this Agreement within
this grace period of two years by paying the applicable 17. MULTIPLE BIRTHS
storage fee along with a late fee of ₹5,000 (INR Five
Thousand only) if the payment is paid after 30 days as In the event of multiple births, if the Client desires to
mentioned in Clause 12.1.d. engage LifeCell for its Services, for each Child, at the
time of Enrollment the Client must check the
e. If this Agreement is terminated by LifeCell under appropriate box in the birthing section and pay the
Section 12.1.(f), LifeCell hereby assures that it will at relevant additional fees to LifeCell.
its own cost arrange for transfer of the Child's
Specimen to a comparable stem cell bank facility and 18. ASSIGNMENT
also pay this new stem cell bank for storing the Child’s
Specimen for the remaining term of this Agreement. 18.1. LifeCell may assign this Agreement to any individual
Thereupon, all the benefits available under the LifeCell or entity providing similar service. If LifeCell is
Client Benefit Programs under clause 8 of this acquired by or merged with or into another Company,
Agreement shall automatically survive for the LifeCell shall require that the terms of this Agreement
remaining term of this Agreement. If this Agreement is continue in full force and effect. LifeCell shall notify the
terminated by the Client under Section 12.1. (f), the Client within 90 days in the event of any such
Client shall bear the entire cost for shifting the Child’s assignment.
Specimen to another stem cell bank facility of their
own choice. 18.2. The Client shall have all the rights over this Agreement
f. If this Agreement is terminated under Sections until the Child attains the age of majority, further to
12.1.(e) or 12.1.(g) a prorated refund of the prepaid which all the rights over this Agreement shall be
Storage fees will be made by LifeCell to the Client. If automatically transferred to the Child. The Client
this Agreement is terminated by the Client under undertakes to inform the Child promptly of his/her
Sections 12.1.(e) or 12.1.(g), the Client shall bear the rights with regards to the Child's Specimen on the Child
entire cost for shifting of the Child's Specimen to attaining the age of majority, including the right to
another stem cell bank facility of their own choice. renew this Agreement. In an unfortunate situation of
non-survival of the Child after attaining the age of
g. All payments and refunds by LifeCell shall be
processed within 30 days of receiving the complete majority, all the rights over this Agreement shall be
documentation from the Client. automatically transferred to the Child's biological
parents and Child's biological siblings, if any. If there is
any disagreement between the Child's parents, the
13. SURROGACY
Child's Mother's wish shall prevail.
LifeCell International Private Limited, # 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600127, Tamil Nadu, India.
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19. NOTICE written Agreement of the Client and the Authorised
Signatory of LifeCell who has signed in this
19.1. Notice to LifeCell must be in writing and delivered Agreement and such modifications thereupon shall
to LifeCell International Private Limited, No. 26, supersede any prior Agreements or understandings,
Vandalur-Kelambakkam Main Road, oral and/or written and shall constitute as a part of
Keelakottaiyur, Chennai - 600127, Tamil Nadu, this entire Agreement
India.
21. SURVIVAL
19.2. Notice to Client or legal guardian will be in writing
and delivered to the address set forth in the All provisions which by their terms require
Enrollment section or as last updated by Client to performance after the termination of this Agreement
LifeCell. will survive even after the termination of this
Agreement.
20. ENTIRE AGREEMENT
22. SEVERABILITY
This Agreement including the Exhibits, sections on
the Risks Relating to Stem Cell Banking, List of If any part of this Agreement is found to be invalid or
the Tests Performed, Maternal Health History, unenforceable, such provision will be deemed
Infant Health History and the Informed Consents modified to the extent necessary to make the
hereto constitute this entire Agreement between Agreement enforceable, and this Agreement shall
LifeCell and the Client and supersede any prior otherwise remain in full force and effect.
Agreements or understandings, oral and/or
written. This Agreement may be modified only by
LifeCell International Private Limited, # 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600127, Tamil Nadu, India.
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EXHIBIT 1: CONSENT OF NON-CLIENT BIRTH MOTHER FOR COLLECTION
The Birth Mother of the Child has reviewed this Agreement, and hereby acknowledges and agrees that she is not the legal guardian
of the Child, is not a party to this Agreement, and is not a third-party beneficiary of this Agreement. Birth Mother hereby waives,
releases and abandons any and all rights or entitlement to the Maternal Blood, Umbilical Cord Blood and Specimen. Birth Mother
consents and agrees to the testing of the Maternal Blood as referenced in this Agreement and consents and agrees to the release
of the test results to the Client. Birth Mother agrees she has no right to enforce any term, condition/s or provision of this
Agreement, or to exercise any right of the Client under this Agreement. Birth Mother acknowledges that she has been fully
informed of the procedures associated with cellular donation and the alternatives to cellular donation and accepts and agrees to
the benefits, limitations, risks, and discomfort of cellular donation and has had the opportunity to access donor advocacy service.
Birth Mother has been given the opportunity to ask questions and had those questions answered satisfactorily. Birth Mother
assumes all risks associated with the collection of Umbilical Cord Blood, including the Maternal Blood.
LifeCell International Private Limited, # 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600127, Tamil Nadu, India.
| 1800 266 5533 | www.lifecell.in |
physician to take an informed decision on the use of such Specimen. The results of this test shall not be disclosed to any other
party without Client’s consent, except to the patient’s transplant physician and the extent disclosure is required by law. LifeCell
anonymizes and retains the information on a secure computer that can only be accessed by specified personnel. The Client having
understood the aforementioned points regarding the intention of performing these tests hereby voluntarily consents and gives
permission to perform the Inherited Diseases Testing and Pediatric Cancer Profiling Testing.
LifeCell International Private Limited, # 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600127, Tamil Nadu, India.
| 1800 266 5533 | www.lifecell.in |
RISKS RELATED TO STEM CELL BANKING
Umbilical Cord Blood Stem Cell Banking has several inherent risks which may relate to collection, processing, testing, storage and
usage of the stem cells. For better transparency to the Client, the relevant risks in each of these areas are described below only to
enable better decision making. However, LifeCell commits that this shall in no way reduce its liability for any loss, harm, damage
or claim of any kind in connection with this Agreement or the Services provided by LifeCell or in no way diminish the benefits
available as per Clause 8 under the LifeCell Client Benefit Programs. It has to be noted that these risks are by no means
comprehensive and are only indicative.
COLLECTION RISKS
Collection of Umbilical Cord Blood is usually done after clamping of the Umbilical Cord and separation of the Mother and Child and
hence poses no risks to either one. However, inherent risks of microbial contamination of the Umbilical Cord Blood present in the
birth canal may render the Umbilical Cord Blood unfit for storage. In rarely occurred circumstances or certain complications during
delivery may entirely prevent the collection of Umbilical Cord Blood or collection of adequate quantity of the Umbilical Cord Blood
required for storage purposes. Client understands that engagement of trained personnel well in advance and handing over the
Collection Kit to them at the time of reaching the venue of childbirth are critical to increasing the chances of successful collection
of the Maternal Blood and Umbilical Cord Blood. Further, the Child's birth mother by law is required to be screened and tested for
infectious diseases using peripheral venous blood. The collection of the Maternal Blood may cause discomfort, possible bruising
and swelling around the puncture site; rarely an infection; and uncommonly, faintness from the procedure. Client assumes all risks
involved in collection of Maternal Blood, and also understands that if any of the results of infectious diseases testing on the
Maternal Blood is positive, then LifeCell may decline to continue storing the Child's Umbilical Cord Blood and/or Specimen.
TESTING RISKS
The Umbilical Cord Blood and Specimens are tested for reporting their identity and quality based on the results of which a decision
is taken on transplantation upon eventual need. LifeCell through extensive use of automated, bidirectionally interfaced, barcoded
sample handling, and in-house testing, that helps reduce the chances of errors; active participation in proficiency testing programs;
and maintenance of accreditation from reputed institutions provides Clients the assurance they seek on the reported results.
However, errors may happen in the pre-analytic, analytic, and post-analytical phases of testing due to systems, processes, and
procedures involved in the transmission and reporting of test results. Client understands that if in doubt, they have the opportunity
of seeking external testing at their own costs to reconfirm the results reported by LifeCell, for which LifeCell would offer its fullest
cooperation.
STORAGE RISKS
Long-term cryo-preservation of the Specimens may be associated with risks of either loss of their viability, partial or total loss of
the stored Specimens due to reasons beyond the reasonable control of LifeCell. However, no assurance can be provided on the
maintenance of viability for indefinite storage, and that the Specimens may also be lost due to equipment failure and/or accident
which may render the sample unfit for transplantation.
However, these risks may be minimized by placing the stored Specimens with barcodes in overwrap bags and metal canisters
where applicable; maintenance of Specimens in vapor phase of liquid nitrogen; and placement of high-risk/ quarantine Specimens
in a separate dewar to avoid the chances of cross-contamination. Also, maintenance of adequate nitrogen levels in the dewars
through piped supply from bulk tanks for automated top-ups; provision of continuous monitoring and automated alarm systems
onto dewars, and supply with triple layer supply of electricity, power grid, uninterrupted power supply, and diesel generator;
minimize the chances of temperature deviations which may result in loss of viability. Adequate facility design considerations,
running of regular stability testing programs, maintenance of Specimens at multiple locations and procurement of insurance
covers in accordance to the risks and procedures for safety and emergency handling also help in providing added confidence to
the Client.
TRANSPORTATION RISKS
Transport of the Umbilical Cord Blood and Maternal Blood from the place of childbirth to the LifeCell’s laboratory, or transport of
the stored Specimen/s from LifeCell laboratory to the patient's transplant center has to be done within a reasonable period of time
for minimizing loss of viability. Utilization of certified Collection and distribution kits designed to maintain a controlled
environment for a reasonable period of time will help minimize these risks during such transportation. Disruptions in flight or other
transport operations, accidents, or theft, may cause the Umbilical Cord Blood and/or Specimen/s to be lost or delayed in reaching
the destination. The maintenance of Umbilical Cord Blood and/or the Specimen/s traceability at all times of transport and utilizing
experienced courier companies will help minimize these risks during transportation. Lastly, the Client understands that no surety
can be provided by the third party courier company or by LifeCell on the safe and timely transport and hence, the Client has the
option of choosing at their own cost the best possible mode of transport of the Umbilical Cord Blood and/or the Specimen/s.
APPLICATION RISKS
Umbilical Cord Blood like bone marrow and peripheral blood, is rich in hematopoietic progenitor cells, and has been used in the
treatment of a variety of inherited or acquired disorders, including hematologic malignancies, metabolic disorders, and
immunodeficiencies, etc. Also, several registered human clinical trials around the world are currently exploring the potential of
Umbilical Cord Blood Specimen to treat medical condition/s like Cerebral Palsy, Type 1 Diabetes, Autism Spectrum Disorder,
Traumatic Brain Injury, Stroke, Hearing Loss, etc. However, there is no guarantee of successful transformation of these human
LifeCell International Private Limited, # 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600127, Tamil Nadu, India.
| 1800 266 5533 | www.lifecell.in |
clinical trials into commercial applications. The quantity of stem cells required for transplant varies depending upon the eventual
use and/or patient's body weight. While techniques for expansion of Umbilical Cord Blood Specimens have been promising, there is
no guarantee that these will be eventually successful. Client is aware that banking the Child’s Specimen does not guarantee that a
stem cell transplant would be the first or best course of treatment for any particular medical condition/s or that the Child’s own
stem cell is useful for every medical condition/s treatable by stem cell transplantation. The patient’s transplant physician
ultimately decides whether the use of the Child’s Specimen is indicated, based on the nature and progression of the medical
condition/s and in case of an allogeneic stem cell transplantation, depending on the HLA matching between donor and recipient.
LIST OF TESTS PERFORMED
LifeCell commits to perform all the below mentioned tests at no additional cost to the Client for the Child, Child's biological
sibling/s, Child's biological parent/s and Child's biological grandparent/s from the Enrollment Date till the entire tenure of this
Agreement.
Cord Blood
At time of storage: Within 2 years from the date of birth of the Child:
(Only for Specimens listed in LifeCell Community Banking Program Registry)
Cord Blood Group & Rh Typing
Cord Blood Volume Hemoglobinopathies
Total Nucleated Cell Count Human Leukocyte Antigen (HLA) Typing by Next-Generation Sequencing
Total Mononuclear Cell Count Colony Forming Unit (CFU) Assay
Total CD 34 Cell Count
CD 34 Stem Cell Viability At retrieval for transplant:
Hematocrit
Sterility Total Nucleated Cell Count
Total Mononuclear Cell Count
Total CD 34 Cell Count
CD 34 Stem Cell Viability
Hematocrit
Sterility
Colony Forming Unit (CFU) Assay
HLA Typing by Next-Generation Sequencing (NGS) for Donor
HLA Typing by Next-Generation Sequencing (NGS) for Recipient
Inherited Diseases Testing by Next-Generation Sequencing (NGS)
Pediatric Cancer Profiling Testing by Next-Generation Sequencing (NGS)
Maternal Blood: Blood Grouping & Rh Typing CMV - IgM Anti - HCV
Anti - HBC HIV I/II HBSAg
CMV - IgG Syphilis HTLV I/II
Nucleic Acid test (HBV, HCV & HIV) Malaria
No additional cost to the Client for
confirmatory tests
Mesenchymal Stromal
Cells / Stem Cells (MSC’s)
LC/DOM/CB-CA/11-19/010
LifeCell International Private Limited, # 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600127, Tamil Nadu, India.
| 1800 266 5533 | www.lifecell.in |