APP. NO............................................. CRM NO. EXHIBIT - 1: ENROLLMENT FORM - EXPECTANT PARENTS DETAILS To be filled in BLOCK LETTERS only using black ink ball-point pen PERSONAL DETAILS Mother s Name Husband's Name Mother s Date of Birth Communication Address Landmark City
State
Country Telephone (Home)
Pin Code
STD Code
Telephone Number
Mobile 1
Mobile 2
E-mail ID If Permanent Address is same as Communication Address (Tick) Permanent Address (If different from above)
Landmark State
City
Pin Code
Country Identity Proof
Husband
Client
Identification provided
PAN
Passport
Driving Licence
Voter ID
Other
If Other , please specify ID Proof No. If you are an existing LifeCell Client, provide 12 digit CRM No. HOSPITAL & BIRTHING DETAILS Expected Date of Delivery
Type of Pregnancy (Tick)
Single Birth
Twins
Triplets
Quads
Consulting Gynecologist Name Consulting Hospital Name
Consulting Hospital Address Landmark City
State
Country Telephone
Pin Code STD Code
MD & CEO, LifeCell International Pvt Ltd.,
Telephone Number
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 1 of 20
APP. NO............................................. CRM NO.
Delivering Hospital Details (if different from consulting Gynecologist)
Gynecologist Name Hospital Name Hospital Address
Landmark City
State
Country
Pin Code
Telephone Country Code
Telephone Number
Mobile Number
SHIPMENT DETAILS Send Collection Kit to (Tick) Shipping Address (if different from above)
Communication Address
Permanent Address
Landmark City
State
Country
Pin Code
Telephone Country Code
Telephone Number
DETAILS OF REFERENCE If referred by an existing Client, please provide details as below: Referring Client s Name Referring Client s CRM
Mobile / Phone
TICK AS APPLICABLE FOR LIFECELL SUPPORT SERVICE: Requesting LifeCell to arrange for pick up of Maternal sample and Specimen Requesting LifeCell to organise for Phlebotomist
I confirm that the information provided above is correct to the best of my knowledge and I also agree to keep LifeCell informed incase of change of above details for future communication.
Signature of Client Name:
Signature of Birth Mother if not Client
Signature of Husband Name:
Name:
Date: For LifeCell use only Name of LifeCell Executive LifeCell Authorised Signatory Name of Signatory:
MD & CEO, LifeCell International Pvt Ltd.,
Employee Code
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 2 of 20
EFAS
Umbilical Cord Tissue Processing Fee Maternal Blood Testing Fee
BabyShield (Optional) Grand Total^ ANNUAL STORAGE FEE^^
^ Taxes extra if any, as applicable. May vary according to the no.of births. ^^ Payable upon each birth anniversary of the Child.
LOAN APPLICANT DETAILS Client Name:
Loan Applicant Name:
Client Address
Loan Applicant Address
Client Signature
Loan Applicant Signature
Relationship with Client
online
<Demand Payment SMS receipt from LifeCell representative>
MD & CEO, LifeCell International Pvt Ltd.,
K
AN L B T EF
LLY L A N TIO
EN
NT I S I GE
PA S I H T
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 4 of 20
EFAS
Umbilical Cord Tissue Processing Fee Maternal Blood Testing Fee
BabyShield (Optional) Grand Total^ ANNUAL STORAGE FEE^^
^ Taxes extra if any, as applicable. May vary according to the no.of births. ^^ Payable upon each birth anniversary of the Child.
Client Name: Client Address
Client Signature
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LOAN APPLICANT DETAILS
Loan Applicant Name: Loan Applicant Address
Loan Applicant Signature
Relationship with Client
online
<Demand Payment SMS receipt from LifeCell representative>
MD & CEO, LifeCell International Pvt Ltd., Page 5 of 20
K
AN L B T EF
LLY L A N TIO
EN
NT I S I GE
PA S I H T
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 6 of 20
MATERNAL BLOOD AND UMBILICAL CORD STEM CELL TESTING, PROCESSING, STORAGE, RETRIEVAL AND INFORMED CONSENT AGREEMENT I/We, the undersigned (the Client ), on behalf of myself/ourselves and my/our unborn Child (the Child ), engage LifeCell International Private Limited, a company incorporated under the Companies Act, 1956, and having its registered office at #26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai 600127, Tamil Nadu, India ( LifeCell ), this day of ........................, 201 (the Enrollment Date ), to process, test, store and retrieve stem cells obtained from the Umbilical Cord collected at birth of the Child and to test Maternal Blood collected from the Birth Mother ( Services ) on the following terms (this Agreement ). 1.
DEFINITIONS
3.2.
Client is responsible for providing the Collection Kit to the Caregiver and arranging for collection, preparation and labeling of the Maternal Blood and Umbilical Cord for delivery to LifeCell along with the duly filled up forms included in the Collection Kit, unless the same has been assigned to LifeCell.
3.3.
Client must promptly notify LifeCell in writing of any change in Client's name or contact details (including but not limited to mailing address, telephone numbers, etc.), or current mailing address or in the legal guardianship of the Child.
3.4.
In case of retrieval of Specimen for transplant the Client has to submit duly filled up Retrieval Form provided by LifeCell (to be accompanied by transplant physician s certificate confirming end use in statutorily compliant transplant procedures.
4.
STORAGE
In this Agreement, (including the recitals above), unless the context otherwise requires, the following expressions shall have the following meanings: 1.1.
Umbilical Cord means and includes the blood inside umbilical cord and/or placenta, and the tissue remaining after the collection of the blood.
1.2.
Child means the Client s baby (or babies in the event of multiple births) from whom the Umbilical Cord will be collected following his/her birth.
1.3.
Client means the parents or legal guardian of the Child.
1.4.
Caregiver means the Obstetrician Gynecologist or qualified medical professional/midwife who will be assisting in delivering the Child.
1.5.
Client may opt for storage of Specimen at either of its licensed facilities situated at #26, Vandalur-Kelambakkam Main Road, Keelakottaiyur, Chennai 600127, Tamil Nadu, India (or) Plot #26, Sector 4, IMT Manesar, Gurgaon 122001, Haryana, India.
4.2.
For disaster management, back-up and added retention security, LifeCell at the request of the Client and payment of additional fees will store the Specimen simultaneously in both of its licensed facilities.
4.3.
LifeCell has the option to relocate the Specimen at its own cost to a comparable stem cell bank facility and will provide notice to Client within 14 days of relocation.
5.
TERM OF AGREEMENT
5.1.
This Agreement will continue for one year from the date of birth of the Child ( Renewal Date ) and will automatically renew for successive one year period until the Child attains the age of twenty one years. This automatic renewal is subject to the Client paying the annual storage fee on or before the renewal date every year.
5.2
Client may opt for prepayment of the storage fees for the remainder of the Agreement at any point during the term of the Agreement. In the event that the fees related to prepayment (as advised by LifeCell from time to time) are made, the term of the Agreement shall be revised to twenty one years from the date of birth of the Child.
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Maternal Blood means peripheral blood from Birth Mother of the Child, that has been drawn by observing standard phlebotomy procedures, taken seven days before or after the birth of the Child.
1.6.
Specimen means and includes stem cells obtained from Umbilical Cord useful for treatment of illness such as Thalassemia, Leukemia etc.,
1.7.
Collection Kit means the kit consisting of all essential materials required for the purpose of collection and labeling of the Maternal Blood and Umbilical Cord.
2.
SERVICES: OPTION AND FEES
2.1.
LifeCell offers its umbilical cord banking services under different plans, fees and payment methods as detailed in Exhibit 2, which the Client must choose at the time of Enrollment by completing the Exhibit 2.
2.2.
All applicable taxes including but not limited to service tax present and/or future levy , if any are payable by the Client.
3.
CLIENT RESPONSIBILITIES
3.1.
Prior to the birth of the Child, the Client must complete all the applicable Exhibits [1 to 9] and make due payment of fees. If surrogate, egg donor or sperm was used, each must fill out Exhibit 3.
MD & CEO, LifeCell International Pvt Ltd.,
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Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 7 of 20
5.3.
At least 90 days before the expiration of the twenty one year period, LifeCell shall intimate the Client (and/or Child in case the Child has come of age) regarding the expiry of the Agreement, along with terms for continued storage. Accordingly the Child can enter into a new Agreement and continue the storage.
6.
REPRESENTATIONS AND WARRANTIES OF CLIENT
8.4.
Disaster Relief: If the Child, Child s biological parents and/or Child s biological siblings is diagnosed after the enrolment date for a condition treatable by stem cell transplantation using the stored Specimen and should for any unforeseen reason that is beyond the reasonable control of LifeCell which may potentially deteriorate or cause loss of the Umbilical Cord or Specimen during transit or processing or storage, LifeCell will use its best endeavours to find a unit of suitable match (as confirmed by the patient s transplant physician) within 14 days failing which pay the Client Rs. 2,000,000 (Rupees Two Million Only).
8.5.
Quality Guarantee: If the Child, Child s biological parents and/or Child s biological siblings is diagnosed after the enrolment date for a condition treatable by stem cell transplantation using the stored Specimen and should for any reason the Specimen upon retrieval not meet LifeCell s then prevailing viability criteria benchmarked against existing international best practices, LifeCell will use its best endeavors to find a unit of suitable match (as confirmed by the patient s transplant physician) within 14 days failing which pay the Client Rs. 2,000,000 (Rupees Two Million Only).
8.6.
Sample Collection and Transport Assistance: At the request of the Client, LifeCell would arrange and pay for qualified Phlebotomist for the collection of Maternal Blood and Umbilical Cord, and/or a certified Service Provider for X-ray free transport of the Maternal Blood and Umbilical Cord to LifeCell s Laboratory, provided however that the Client provides reasonable notice (not less than two hours prior to childbirth) to LifeCell for allowing the LifeCell arranged Phlebotomist to reach the venue of childbirth.
8.7.
Worldwide Shipment Guarantee: In the event of the Specimen being required for a transplant for Child, Child s biological parents or Child s biological siblings, LifeCell upon Client s request shall arrange and pay for X-ray free transport of the Specimen under cryogenic conditions to any destination worldwide.
8.8.
Stem Cell Expansion Guarantee: If the Child, Child s biological parents and/or Child s biological siblings is diagnosed after the enrolment date for a condition treatable by stem cell transplantation using the stored Specimen and should clinical expansion of the stored Specimen be deemed necessary for transplant as determined by the patient s transplant physician. LifeCell shall at its own cost expand and provide upto 1 billion mesenchymal stem cells derived from the umbilical cord tissue based on LifeCell s in house protocols and also expand and provide the hematopoietic stem cells from the umbilical cord blood upon the technology becoming commercially available in the future.
8.9.
Medical Concierge: For all medical and travel information relating to stem cell transplant using the stored Specimen for the Child or his/her immediate family members, LifeCell assures to provide, at no extra cost to the Client, the relevant information regarding leading transplant physicians, approved and credible medical transplant institutions including medical travel information relating to the Child along with his/her immediate family members.
8.10.
General conditions for LifeCell Client Benefit Programs:
a) b)
The Client Agreement is valid and is in force. Payments would be made within 30 days by LifeCell either to Client or on behalf of Client to the transplant center, upon appropriate verification of Client s request.
Client represents and warrants that 6.1.
She / he is the parent or legal guardian to the Child.
6.2.
Client has had the opportunity to read, understand, review and consult with the Client's own legal counsel and medical professional, this Agreement, its Exhibits, possible risks of collection, processing, storage and possible future use of the Maternal Blood & Specimen.
6.3.
The decision to collect the Umbilical Cord and Maternal Blood, test the Maternal Blood and process, store and retrieve the Specimen is a completely voluntary act of Client.
7.
RIGHTS TO SPECIMEN
7.1.
The Client shall have control over the Specimen until the Child attains majority, further to which all rights shall be automatically transferred to the Child.
7.2.
If there is a disagreement between parents the Mother s wish shall prevail.
7.3.
The Client undertakes to inform the Child promptly of his/her right with regards to the Specimen on the Child attaining majority, including the right to renew this Agreement.
8.
LIFECELL CLIENT BENEFIT PROGRAMS
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LifeCell understands the Client s need to enhance the value of their investment and also provide a comprehensive coverage for their Child. Therefore LifeCell through its Client Benefit Programs provides additional guarantees, insurances, and benefits which are detailed below: 8.1.
Medical Insurance: If the Child, Child s biological Parents and/or Child s biological siblings is diagnosed after the enrolment date for a hematological condition treatable by stem cell transplantation using the stored Specimen the Client under the LifeCell Cares Program can avail up to Rs. 2,000,000 (Rupees Two Million only) to offset transplant related expenses including but not limited to procurement of an additional unit from any public cord blood registry worldwide.
8.2.
Storage Insurance: In case of demise or permanent physical disability of the Client, LifeCell would continue storage of the Specimen at LifeCell s own cost for the remaining term of the Agreement.
8.3.
Entitlement to Full Refund: LifeCell understands that the life and health of the Mother and Child are the utmost priority. In the event the Umbilical Cord is not collected due to this priority or nonsurvival of the baby at birth, LifeCell shall refund all fees paid by Client to LifeCell upon sharing of relevant declaration from the attending gynecologist.
MD & CEO, LifeCell International Pvt Ltd.,
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Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 8 of 20
C)
9.
Either upon providing a unit of suitable match or on making the due payment as applicable, the Client would release LifeCell from any further obligations.
10.
DISCLAIMER & LIMITATIONS:
10.1.
LifeCell does not perform any medical services, give any medical advice, or otherwise perform any service other than those expressly indicated in this Agreement. It disclaims all other representations, guarantees, warranties, or assurances, express or implied.
10.2.
LifeCell disclaims any responsibility to provide any other services (except those specified in this Agreement) and third party service providers like Phlebotomist, Transporter, etc., shall have the respective responsibility for their services including loss, damage, delay in delivery, etc.
10.3.
Client agrees that LifeCell s liability for any loss, harm, damage or claim of any kind in connection with this Agreement or the services provided by LifeCell shall be limited to the return of an amount equal to all fees paid by Client to LifeCell or benefits available under the applicable LifeCell Client Benefit Programs (whichever is higher), except for acts committed by LifeCell that are intentional and/or grossly negligent.
11.
FORCE MAJEURE
LIFECELL ASSURANCE: LifeCell hereby assures that
9.1.
LifeCell has all statutory permissions and licenses that are required for providing the services contemplated under this Agreement.
9.2.
LifeCell will provide the Client with the following immediately upon enrollment; a copy of this Agreement, a Collection Kit compliant with International Air Transport Association (IATA) regulations, and a unique Client Relationship Management (CRM) number that enables the Client to quote for all communications with LifeCell.
9.3.
LifeCell upon receipt of the Maternal Blood and Umbilical Cord would determine whether it is fit or unfit for testing, processing and / or storage.
9.4.
In any event of Umbilical Cord is found to be unfit, including but not limited to insufficient volume/length, low cell count / viability, positive screening of infectious diseases, microbial contamination of Umbilical Cord, etc., LifeCell will notify the Client immediately and seek instructions for disposal of the Specimen. This Agreement shall be deemed terminated from the date of receipt of such written consent from the Client. If LifeCell does not receive written instructions within 30 days of such intimation then LifeCell shall continue storing the Specimen as is where is, however the benefits available under LifeCell Client Benefit Programs as per clause 8 shall not be applicable.
9.5.
Client agrees that LifeCell s liability for causes or circumstances which are beyond LifeCell s reasonable control shall be limited to that committed under the Disaster Relief program.
9.6.
The Umbilical Cord would be tested, processed, stored and retrieved in accordance to approved Standard Operating Procedures and in compliance with statutory regulations.
9.7.
Upon successful collection, processing, testing and storage, LifeCell will provide the Client with a Preservation Certificate confirming successful storage of the Specimen along with sample storage details and test results within 30 days of receipt of Umbilical Cord at LifeCell laboratory.
9.8.
LifeCell understands that the cryopreserved Specimen is a precious property of the Client, and therefore LifeCell shall at its own discretion never subject it to any unauthorized usage or even donate it for research or therapeutic purposes.
9.9.
In the event of Specimen being retrieved for a transplant for Child s biological parents and/or Child s biological siblings, there are no additional costs for retrieval and upon submission of filled Retrieval Form by Client the Specimen will be available for delivery within 7 days, or within 90 days if cellular expansion is required.
MD & CEO, LifeCell International Pvt Ltd.,
TERMINATION OF AGREEMENT
12.1.
This Agreement may be terminated
a)
by Client at any time prior to collection of Umbilical Cord, or
b)
by Client or Child (on attaining majority) at any time after storage of the Specimen, or
c)
by LifeCell if it has exercised its right to refuse Specimen processing and / or storage for any reason, including the consequential act of sample rejection as per clause 9.4, or
d)
by LifeCell if any payment due to LifeCell is not timely paid and such failure to pay is not cured within 30 days after receipt of notice from LifeCell of such failure to pay, without prejudice to LifeCell s right to take legal steps to recover the debt, or
e)
by mutual agreement of Client and LifeCell, or
f)
by either party upon 60 days prior written notice to the other party hereto, or
g)
in the event the entire Specimen is retrieved for a transplant. However, if the Client retrieves only a portion of the Specimen, the Agreement would survive along with all benefits for the term of the Agreement.
h)
in the event either law or a governmental agency or regulatory provisions or medical guidelines require us to terminate the Agreement.
12.2.
Effects of Termination:
a)
If the Agreement is terminated under Section 12.1.(a) all fees paid by the Client after deducting a sum of Rs. 5000 (Rupees Five Thousand only) shall be refunded.
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In the event of Maternal Blood found to be unfit or not provided LifeCell will notify the Client immediately and seek another collection. If the Maternal Blood is not provided within 7 days of childbirth the Specimen can be used only for autologous purposes.
12.
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 9 of 20
b)
If the Agreement is terminated under Section 12.1.(b) all fees paid by the Client to LifeCell are non-refundable. The Client (or) Child (on attaining majority) reserves the right to shift the Specimen at their own cost to any other stem cell bank facility of their choice.
c)
If the Agreement is terminated under Section 12.1.(c) or 12.1 (h) the Storage and / or Processing Fees would be refunded as applicable.
d)
e)
f)
13.
permitted by this Agreement. All confidential information and personal identifiable information shall be kept on secure database with adequate backup measures. Client and, if different, the Birth Mother of the Child hereby agrees to the release of information to the hospital, laboratory or physician providing the services to the Client. 16.
In the event of multiple births, if the Client desires to engage LifeCell to process, and store the cord blood and/or cord tissue for each Child, the Client must check the appropriate box on the Enrollment Form and pay the additional fees.
If the Agreement is terminated under Section 12.1.(d), Client relinquishes all rights in and to the Specimen and waives all claims to the Specimen and LifeCell shall have the right at its sole discretion to dispose of the Specimen. However, LifeCell shall continue storing the Specimen with no liabilities to the Client for a period of two years from the date of termination. During this period the Client shall have the option of reviving the Agreement by paying all unpaid fees and a late fee of Rs. 5000 (Rupees Five Thousand only).
17.
All refunds by LifeCell shall be processed within 30 days of receiving the complete documentation.
18.
NOTICE
18.1.
Notice to LifeCell must be in writing and delivered to LifeCell International Private Limited, #26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai 600127, Tamil Nadu, India.
18.2.
Notice to Client or legal guardian will be in writing and delivered to the address set forth in the Enrollment form or as updated by Client to LifeCell.
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19.
GOVERNING LAW AND JURISDICTION
20.
This Agreement is governed by, construed and interpreted in accordance with the laws of India. Courts in Chennai, Tamilnadu, India shall have exclusive jurisdiction. 15.
CONFIDENTIALITY; CONSENT TO RELEASE LifeCell acknowledges the confidential nature of the information provided to it and agrees to use its best efforts to maintain the confidentiality of the information except as required by law or as
ENTIRE AGREEMENT
This Agreement and the Exhibits hereto constitute the entire agreement between LifeCell and Client and supersede any prior agreements or understandings, oral and written. This Agreement may be modified only by written agreement of Client and Authorised Signatory of LifeCell.
All disputes arising out of or relating to this Agreement will be resolved by arbitration. The arbitration will take place in Chennai, Tamilnadu, India. The Arbitration would be governed by the Arbitration and Conciliation Act, 1996. 14.
ASSIGNMENT LifeCell may assign this Agreement to any individual or entity providing a similar service. If LifeCell is acquired by or merged with or into another company, LifeCell shall require that the terms of this Agreement continue in full force and effect. LifeCell shall notify the Client within 90 days in the event of any such assignment.
If the Agreement is terminated by LifeCell under Section 12.1.(f), LifeCell shall at its own cost arrange for transfer of Specimen to a comparable stem cell bank facility and pay the new stem cell bank for storing the Specimen for the remaining period of the Agreement. All benefits available under the LifeCell Benefit Program under Clause 8 shall survive for the remaining period of the Agreement. If the Agreement is terminated by the Client as per this Clause, the Client shall bear the entire cost for shifting the preserved Specimen to another stem cell bank facility of their own choice.
ARBITRATION
MULTIPLE BIRTHS
SURVIVAL All provisions which by their terms require performance after the termination of this Agreement will survive the termination of this Agreement.
21.
SEVERABILITY If any part of this Agreement is found to be invalid or unenforceable, such provision is deemed modified to the extent necessary to make the Agreement enforceable, and this Agreement shall otherwise remain in full force and effect.
I ACCEPT ALL TERMS AND CONDITIONS OF THIS AGREEMENT Name and Signature of Father/Legal Guardian
Name and Signature of Mother/Legal Guardian
Name of Birth Mother if not Client Signature of Birth Mother if not Client Date:
MD & CEO, LifeCell International Pvt Ltd.,
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 10 of 20
MATERNAL BLOOD AND UMBILICAL CORD STEM CELL TESTING, PROCESSING, STORAGE, RETRIEVAL AND INFORMED CONSENT AGREEMENT I/We, the undersigned (the Client ), on behalf of myself/ourselves and my/our unborn Child (the Child ), engage LifeCell International Private Limited, a company incorporated under the Companies Act, 1956, and having its registered office at #26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai 600127, Tamil Nadu, India ( LifeCell ), this day of ........................, 201 (the Enrollment Date ), to process, test, store and retrieve stem cells obtained from the Umbilical Cord collected at birth of the Child and to test Maternal Blood collected from the Birth Mother ( Services ) on the following terms (this Agreement ). 1.
DEFINITIONS
3.2.
Client is responsible for providing the Collection Kit to the Caregiver and arranging for collection, preparation and labeling of the Maternal Blood and Umbilical Cord for delivery to LifeCell along with the duly filled up forms included in the Collection Kit, unless the same has been assigned to LifeCell.
3.3.
Client must promptly notify LifeCell in writing of any change in Client's name or contact details (including but not limited to mailing address, telephone numbers, etc.), or current mailing address or in the legal guardianship of the Child.
3.4.
In case of retrieval of Specimen for transplant the Client has to submit duly filled up Retrieval Form provided by LifeCell (to be accompanied by transplant physician s certificate confirming end use in statutorily compliant transplant procedures.
4.
STORAGE
In this Agreement, (including the recitals above), unless the context otherwise requires, the following expressions shall have the following meanings: 1.1.
Umbilical Cord means and includes the blood inside umbilical cord and/or placenta, and the tissue remaining after the collection of the blood.
1.2.
Child means the Client s baby (or babies in the event of multiple births) from whom the Umbilical Cord will be collected following his/her birth.
1.3.
Client means the parents or legal guardian of the Child.
1.4.
Caregiver means the Obstetrician Gynecologist or qualified medical professional/midwife who will be assisting in delivering the Child.
1.5.
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Client may opt for storage of Specimen at either of its licensed facilities situated at #26, Vandalur-Kelambakkam Main Road, Keelakottaiyur, Chennai 600127, Tamil Nadu, India (or) Plot #26, Sector 4, IMT Manesar, Gurgaon 122001, Haryana, India.
4.2.
For disaster management, back-up and added retention security, LifeCell at the request of the Client and payment of additional fees will store the Specimen simultaneously in both of its licensed facilities.
4.3.
LifeCell has the option to relocate the Specimen at its own cost to a comparable stem cell bank facility and will provide notice to Client within 14 days of relocation.
5.
TERM OF AGREEMENT
5.1.
This Agreement will continue for one year from the date of birth of the Child ( Renewal Date ) and will automatically renew for successive one year period until the Child attains the age of twenty one years. This automatic renewal is subject to the Client paying the annual storage fee on or before the renewal date every year.
5.2
Client may opt for prepayment of the storage fees for the remainder of the Agreement at any point during the term of the Agreement. In the event that the fees related to prepayment (as advised by LifeCell from time to time) are made, the term of the Agreement shall be revised to twenty one years from the date of birth of the Child.
CLIE
Maternal Blood means peripheral blood from Birth Mother of the Child, that has been drawn by observing standard phlebotomy procedures, taken seven days before or after the birth of the Child.
1.6.
Specimen means and includes stem cells obtained from Umbilical Cord useful for treatment of illness such as Thalassemia, Leukemia etc.,
1.7.
Collection Kit means the kit consisting of all essential materials required for the purpose of collection and labeling of the Maternal Blood and Umbilical Cord.
2.
SERVICES: OPTION AND FEES
2.1.
LifeCell offers its umbilical cord banking services under different plans, fees and payment methods as detailed in Exhibit 2, which the Client must choose at the time of Enrollment by completing the Exhibit 2.
2.2.
All applicable taxes including but not limited to service tax present and/or future levy , if any are payable by the Client.
3.
CLIENT RESPONSIBILITIES
3.1.
Prior to the birth of the Child, the Client must complete all the applicable Exhibits [1 to 9] and make due payment of fees. If surrogate, egg donor or sperm was used, each must fill out Exhibit 3.
MD & CEO, LifeCell International Pvt Ltd.,
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 11 of 20
5.3.
At least 90 days before the expiration of the twenty one year period, LifeCell shall intimate the Client (and/or Child in case the Child has come of age) regarding the expiry of the Agreement, along with terms for continued storage. Accordingly the Child can enter into a new Agreement and continue the storage.
6.
REPRESENTATIONS AND WARRANTIES OF CLIENT
8.4.
Disaster Relief: If the Child, Child s biological parents and/or Child s biological siblings is diagnosed after the enrolment date for a condition treatable by stem cell transplantation using the stored Specimen and should for any unforeseen reason that is beyond the reasonable control of LifeCell which may potentially deteriorate or cause loss of the Umbilical Cord or Specimen during transit or processing or storage, LifeCell will use its best endeavours to find a unit of suitable match (as confirmed by the patient s transplant physician) within 14 days failing which pay the Client Rs. 2,000,000 (Rupees Two Million Only).
8.5.
Quality Guarantee: If the Child, Child s biological parents and/or Child s biological siblings is diagnosed after the enrolment date for a condition treatable by stem cell transplantation using the stored Specimen and should for any reason the Specimen upon retrieval not meet LifeCell s then prevailing viability criteria benchmarked against existing international best practices, LifeCell will use its best endeavors to find a unit of suitable match (as confirmed by the patient s transplant physician) within 14 days failing which pay the Client Rs. 2,000,000 (Rupees Two Million Only).
8.6.
Sample Collection and Transport Assistance: At the request of the Client, LifeCell would arrange and pay for qualified Phlebotomist for the collection of Maternal Blood and Umbilical Cord, and/or a certified Service Provider for X-ray free transport of the Maternal Blood and Umbilical Cord to LifeCell s Laboratory, provided however that the Client provides reasonable notice (not less than two hours prior to childbirth) to LifeCell for allowing the LifeCell arranged Phlebotomist to reach the venue of childbirth.
8.7.
Worldwide Shipment Guarantee: In the event of the Specimen being required for a transplant for Child, Child s biological parents or Child s biological siblings, LifeCell upon Client s request shall arrange and pay for X-ray free transport of the Specimen under cryogenic conditions to any destination worldwide.
Client represents and warrants that 6.1.
She / he is the parent or legal guardian to the Child.
6.2.
Client has had the opportunity to read, understand, review and consult with the Client's own legal counsel and medical professional, this Agreement, its Exhibits, possible risks of collection, processing, storage and possible future use of the Maternal Blood & Specimen.
6.3.
The decision to collect the Umbilical Cord and Maternal Blood, test the Maternal Blood and process, store and retrieve the Specimen is a completely voluntary act of Client.
7.
RIGHTS TO SPECIMEN
7.1.
The Client shall have control over the Specimen until the Child attains majority, further to which all rights shall be automatically transferred to the Child.
7.2.
If there is a disagreement between parents the Mother s wish shall prevail.
7.3.
The Client undertakes to inform the Child promptly of his/her right with regards to the Specimen on the Child attaining majority, including the right to renew this Agreement.
8.
LIFECELL CLIENT BENEFIT PROGRAMS
CLIE
8.8.
Stem Cell Expansion Guarantee: If the Child, Child s biological parents and/or Child s biological siblings is diagnosed after the enrolment date for a condition treatable by stem cell transplantation using the stored Specimen and should clinical expansion of the stored Specimen be deemed necessary for transplant as determined by the patient s transplant physician. LifeCell shall at its own cost expand and provide upto 1 billion mesenchymal stem cells derived from the umbilical cord tissue based on LifeCell s in house protocols and also expand and provide the hematopoietic stem cells from the umbilical cord blood upon the technology becoming commercially available in the future.
8.9.
Medical Concierge: For all medical and travel information relating to stem cell transplant using the stored Specimen for the Child or his/her immediate family members, LifeCell assures to provide, at no extra cost to the Client, the relevant information regarding leading transplant physicians, approved and credible medical transplant institutions including medical travel information relating to the Child along with his/her immediate family members.
8.10.
General conditions for LifeCell Client Benefit Programs:
a) b)
The Client Agreement is valid and is in force. Payments would be made within 30 days by LifeCell either to Client or on behalf of Client to the transplant center, upon appropriate verification of Client s request.
LifeCell understands the Client s need to enhance the value of their investment and also provide a comprehensive coverage for their Child. Therefore LifeCell through its Client Benefit Programs provides additional guarantees, insurances, and benefits which are detailed below: 8.1.
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Medical Insurance: If the Child, Child s biological Parents and/or Child s biological siblings is diagnosed after the enrolment date for a hematological condition treatable by stem cell transplantation using the stored Specimen the Client under the LifeCell Cares Program can avail up to Rs. 2,000,000 (Rupees Two Million only) to offset transplant related expenses including but not limited to procurement of an additional unit from any public cord blood registry worldwide.
8.2.
Storage Insurance: In case of demise or permanent physical disability of the Client, LifeCell would continue storage of the Specimen at LifeCell s own cost for the remaining term of the Agreement.
8.3.
Entitlement to Full Refund: LifeCell understands that the life and health of the Mother and Child are the utmost priority. In the event the Umbilical Cord is not collected due to this priority or nonsurvival of the baby at birth, LifeCell shall refund all fees paid by Client to LifeCell upon sharing of relevant declaration from the attending gynecologist.
MD & CEO, LifeCell International Pvt Ltd.,
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 12 of 20
C)
9.
Either upon providing a unit of suitable match or on making the due payment as applicable, the Client would release LifeCell from any further obligations.
10.
DISCLAIMER & LIMITATIONS:
10.1.
LifeCell does not perform any medical services, give any medical advice, or otherwise perform any service other than those expressly indicated in this Agreement. It disclaims all other representations, guarantees, warranties, or assurances, express or implied.
10.2.
LifeCell disclaims any responsibility to provide any other services (except those specified in this Agreement) and third party service providers like Phlebotomist, Transporter, etc., shall have the respective responsibility for their services including loss, damage, delay in delivery, etc.
10.3.
Client agrees that LifeCell s liability for any loss, harm, damage or claim of any kind in connection with this Agreement or the services provided by LifeCell shall be limited to the return of an amount equal to all fees paid by Client to LifeCell or benefits available under the applicable LifeCell Client Benefit Programs (whichever is higher), except for acts committed by LifeCell that are intentional and/or grossly negligent.
11.
FORCE MAJEURE
LIFECELL ASSURANCE: LifeCell hereby assures that
9.1.
LifeCell has all statutory permissions and licenses that are required for providing the services contemplated under this Agreement.
9.2.
LifeCell will provide the Client with the following immediately upon enrollment; a copy of this Agreement, a Collection Kit compliant with International Air Transport Association (IATA) regulations, and a unique Client Relationship Management (CRM) number that enables the Client to quote for all communications with LifeCell.
9.3.
LifeCell upon receipt of the Maternal Blood and Umbilical Cord would determine whether it is fit or unfit for testing, processing and / or storage.
9.4.
In any event of Umbilical Cord is found to be unfit, including but not limited to insufficient volume/length, low cell count / viability, positive screening of infectious diseases, microbial contamination of Umbilical Cord, etc., LifeCell will notify the Client immediately and seek instructions for disposal of the Specimen. This Agreement shall be deemed terminated from the date of receipt of such written consent from the Client. If LifeCell does not receive written instructions within 30 days of such intimation then LifeCell shall continue storing the Specimen as is where is, however the benefits available under LifeCell Client Benefit Programs as per clause 8 shall not be applicable.
9.5.
Client agrees that LifeCell s liability for causes or circumstances which are beyond LifeCell s reasonable control shall be limited to that committed under the Disaster Relief program. 12.
TERMINATION OF AGREEMENT
12.1.
This Agreement may be terminated
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In the event of Maternal Blood found to be unfit or not provided LifeCell will notify the Client immediately and seek another collection. If the Maternal Blood is not provided within 7 days of childbirth the Specimen can be used only for autologous purposes.
9.6.
The Umbilical Cord would be tested, processed, stored and retrieved in accordance to approved Standard Operating Procedures and in compliance with statutory regulations.
9.7.
Upon successful collection, processing, testing and storage, LifeCell will provide the Client with a Preservation Certificate confirming successful storage of the Specimen along with sample storage details and test results within 30 days of receipt of Umbilical Cord at LifeCell laboratory.
9.8.
LifeCell understands that the cryopreserved Specimen is a precious property of the Client, and therefore LifeCell shall at its own discretion never subject it to any unauthorized usage or even donate it for research or therapeutic purposes.
9.9.
In the event of Specimen being retrieved for a transplant for Child s biological parents and/or Child s biological siblings, there are no additional costs for retrieval and upon submission of filled Retrieval Form by Client the Specimen will be available for delivery within 7 days, or within 90 days if cellular expansion is required.
MD & CEO, LifeCell International Pvt Ltd.,
a)
by Client at any time prior to collection of Umbilical Cord, or
b)
by Client or Child (on attaining majority) at any time after storage of the Specimen, or
c)
by LifeCell if it has exercised its right to refuse Specimen processing and / or storage for any reason, including the consequential act of sample rejection as per clause 9.4, or
d)
by LifeCell if any payment due to LifeCell is not timely paid and such failure to pay is not cured within 30 days after receipt of notice from LifeCell of such failure to pay, without prejudice to LifeCell s right to take legal steps to recover the debt, or
e)
by mutual agreement of Client and LifeCell, or
f)
by either party upon 60 days prior written notice to the other party hereto, or
g)
in the event the entire Specimen is retrieved for a transplant. However, if the Client retrieves only a portion of the Specimen, the Agreement would survive along with all benefits for the term of the Agreement.
h)
in the event either law or a governmental agency or regulatory provisions or medical guidelines require us to terminate the Agreement.
12.2.
Effects of Termination:
a)
If the Agreement is terminated under Section 12.1.(a) all fees paid by the Client after deducting a sum of Rs. 5000 (Rupees Five Thousand only) shall be refunded.
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 13 of 20
b)
If the Agreement is terminated under Section 12.1.(b) all fees paid by the Client to LifeCell are non-refundable. The Client (or) Child (on attaining majority) reserves the right to shift the Specimen at their own cost to any other stem cell bank facility of their choice.
c)
If the Agreement is terminated under Section 12.1.(c) or 12.1 (h) the Storage and / or Processing Fees would be refunded as applicable.
d)
e)
f)
13.
If the Agreement is terminated under Section 12.1.(d), Client relinquishes all rights in and to the Specimen and waives all claims to the Specimen and LifeCell shall have the right at its sole discretion to dispose of the Specimen. However, LifeCell shall continue storing the Specimen with no liabilities to the Client for a period of two years from the date of termination. During this period the Client shall have the option of reviving the Agreement by paying all unpaid fees and a late fee of Rs. 5000 (Rupees Five Thousand only). If the Agreement is terminated by LifeCell under Section 12.1.(f), LifeCell shall at its own cost arrange for transfer of Specimen to a comparable stem cell bank facility and pay the new stem cell bank for storing the Specimen for the remaining period of the Agreement. All benefits available under the LifeCell Benefit Program under Clause 8 shall survive for the remaining period of the Agreement. If the Agreement is terminated by the Client as per this Clause, the Client shall bear the entire cost for shifting the preserved Specimen to another stem cell bank facility of their own choice.
permitted by this Agreement. All confidential information and personal identifiable information shall be kept on secure database with adequate backup measures. Client and, if different, the Birth Mother of the Child hereby agrees to the release of information to the hospital, laboratory or physician providing the services to the Client. 16.
In the event of multiple births, if the Client desires to engage LifeCell to process, and store the cord blood and/or cord tissue for each Child, the Client must check the appropriate box on the Enrollment Form and pay the additional fees. 17.
18.
NOTICE
18.1.
Notice to LifeCell must be in writing and delivered to LifeCell International Private Limited, #26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai 600127, Tamil Nadu, India.
18.2.
Notice to Client or legal guardian will be in writing and delivered to the address set forth in the Enrollment form or as updated by Client to LifeCell.
All refunds by LifeCell shall be processed within 30 days of receiving the complete documentation.
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ARBITRATION
19.
GOVERNING LAW AND JURISDICTION
CONFIDENTIALITY; CONSENT TO RELEASE LifeCell acknowledges the confidential nature of the information provided to it and agrees to use its best efforts to maintain the confidentiality of the information except as required by law or as
ENTIRE AGREEMENT
This Agreement and the Exhibits hereto constitute the entire agreement between LifeCell and Client and supersede any prior agreements or understandings, oral and written. This Agreement may be modified only by written agreement of Client and Authorised Signatory of LifeCell.
20.
This Agreement is governed by, construed and interpreted in accordance with the laws of India. Courts in Chennai, Tamilnadu, India shall have exclusive jurisdiction. 15.
ASSIGNMENT LifeCell may assign this Agreement to any individual or entity providing a similar service. If LifeCell is acquired by or merged with or into another company, LifeCell shall require that the terms of this Agreement continue in full force and effect. LifeCell shall notify the Client within 90 days in the event of any such assignment.
All disputes arising out of or relating to this Agreement will be resolved by arbitration. The arbitration will take place in Chennai, Tamilnadu, India. The Arbitration would be governed by the Arbitration and Conciliation Act, 1996. 14.
MULTIPLE BIRTHS
SURVIVAL All provisions which by their terms require performance after the termination of this Agreement will survive the termination of this Agreement.
21.
SEVERABILITY If any part of this Agreement is found to be invalid or unenforceable, such provision is deemed modified to the extent necessary to make the Agreement enforceable, and this Agreement shall otherwise remain in full force and effect.
I ACCEPT ALL TERMS AND CONDITIONS OF THIS AGREEMENT Name and Signature of Father/Legal Guardian
Name and Signature of Mother/Legal Guardian
Name of Birth Mother if not Client Signature of Birth Mother if not Client Date:
MD & CEO, LifeCell International Pvt Ltd.,
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 14 of 20
CRM NO.:
EXHIBIT - 3: MATERNAL HEALTH HISTORY (GENETIC MOTHER) The following questions are required for determination of donor-eligibility, and have not been developed by LifeCell. We understand that there may be sensitivities to some of the questions, and apologize for the inconvenience. LifeCell has made an effort to modify these questions from those published and required by the AABB (Formerly the American Association of Blood Banks) to minimize your discomfort. YES NO 1.
Do you currently have or have a history or a family history of any medical condition that could affect the collection or use of the stem cells such as,
a)
Cancer, Diabetes, Hepatitis, Blood Disease, Bleeding problem, Heart Disease, Drug or Alcohol abuse
b)
HIV/AIDS or a positive test for the HIV/AIDS virus, Malaria, Chaga's disease.
c)
Tested positive for HTLV, had adult T-Cell Leukemia or had unexplained paraparesis (partial paralysis affecting the lower limbs?)
d)
Stroke, Seizure or multiple sclerosis, Lung disease, Kidney disease, Liver disease, Babesiosis, Genetic disorder.
2.
Do you currently have or are you being treated for any type of infection?
3.
Do you have, or have a family history of, Dementia, degenerative or neurological disease, or Creutzfeld Jakob disease?
4.
In the past 6 months have you received a bite from an animal suspected of Rabies?
5.
Have you been treated for HPV or Genital herpes, Syphilis, Gonorrhea or other sexually transmitted disease in the last 12 months?
6.
In the past 12 months have you had any immunizations, tattoos, body piercing, an accidental needle-stick, or come into contact
with someone's blood, open wound, or small pox vaccination site and/or bandage? 7.
In the past 12 months have you been in Juvenile detention, lock-up, jail or prison for more than 72 hours?
8.
In the past 12 months have you lived with a person who has Hepatitis?
9.
Have you in the past 5 years taken intravenous drugs not prescribed by a physician?
10.
Have you in the past 5 years used clotting factor concentrates?
11.
Have you in the past 5 years received compensation for sex?
12.
Have you ever received whole blood, blood factor products, blood derivatives, growth hormones, Insulin (Bovin/Beef), Hepatitis B Immuno Globulin, Unlicensed Vaccine bone or skin graft, or a tissue, organ (either human or animal), dura mater or bone marrow transplant?
13.
Have you in the past 12 months had intimate contact with a male who has ever had sexual contact with another male, anyone who has HIV/AIDS or anyone who has hemophilia or has used clotting factor concentrates, or a positive test for HIV/AIDS virus, anyone who has hepatitis or anyone described in question 9,10,11?
14.
From 1980 through 1996 have you
a.
Spent 3 months or more cumulatively in the United Kingdom? If so, what city and country?
b.
Resided at a US military base in Europe for 6 months or more cumulatively? If so, what city and country?
15.
From 1980 to present have you spent 5 years or more in Europe cumulatively? If so, what city and country?
16.
Have you ever been diagnosed or suspected of having an acute respiratory disease such as (but not limited to) West Nile Virus, SARS, or Tuberculosis?
17.
In the past 3 years have you been outside the Country of your current residence? If so, what city & country?
18.
Have you experienced any of the following conditions that can be signs or symptoms of HIV/AIDS?
a.
Unexplained weight loss or night sweats?
b.
Blue or purple spots in your mouth or skin?
c.
Swollen lymph nodes for more than one month?
d.
White spots or unusual sores in your mouth?
e.
Cough that wont go away or shortness of breath?
f.
Diarrhea that won't go away?
g.
Fever of more than 100.5 F for more than 10 days?
19.
Have you had significant exposure to any substance that may be transferred in toxic doses, such as lead, mercury and gold?
For LifeCell Medical Team use only Reviewed by:..................................................
MD & CEO, LifeCell International Pvt Ltd.,
Date:...............................................................
Client's Initials
Signature:........................................................
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 15 of 20
CRM NO.:
EXHIBIT - 4: MATERNAL HEALTH HISTORY (NON-CLIENT BIRTH MOTHER) The following questions are required for determination of donor-eligibility, and have not been developed by LifeCell. We understand that there may be sensitivities to some of the questions, and apologize for the inconvenience. LifeCell has made an effort to modify these questions from those published and required by the AABB (Formerly the American Association of Blood Banks) to minimize your discomfort. YES NO 1.
Do you currently have or have a history or a family history of any medical condition that could affect the collection or use of the stem cells such as,
a)
Cancer, Diabetes, Hepatitis, Blood Disease, Bleeding problem, Heart Disease, Drug or Alcohol abuse
b)
HIV/AIDS or a positive test for the HIV/AIDS virus, Malaria, Chaga's disease.
c)
Tested positive for HTLV, had adult T-Cell Leukemia or had unexplained paraparesis (partial paralysis affecting the lower limbs?)
d)
Stroke, Seizure or multiple sclerosis, Lung disease, Kidney disease, Liver disease, Babesiosis, Genetic disorder.
2.
Do you currently have or are you being treated for any type of infection?
3.
Do you have, or have a family history of, Dementia, degenerative or neurological disease, or Creutzfeld Jakob disease?
4.
In the past 6 months have you received a bite from an animal suspected of Rabies?
5.
Have you been treated for HPV or Genital herpes, Syphilis, Gonorrhea or other sexually transmitted disease in the last 12 months?
6.
In the past 12 months have you had any immunizations, tattoos, body piercing, an accidental needle-stick, or come into contact
with someone's blood, open wound, or small pox vaccination site and/or bandage? 7.
In the past 12 months have you been in Juvenile detention, lock-up, jail or prison for more than 72 hours?
8.
In the past 12 months have you lived with a person who has Hepatitis?
9.
Have you in the past 5 years taken intravenous drugs not prescribed by a physician?
10.
Have you in the past 5 years used clotting factor concentrates?
11.
Have you in the past 5 years received compensation for sex?
12.
Have you ever received whole blood, blood factor products, blood derivatives, growth hormones, Insulin (Bovin/Beef), Hepatitis B Immuno Globulin, Unlicensed Vaccine bone or skin graft, or a tissue, organ (either human or animal), dura mater or bone marrow transplant?
13.
Have you in the past 12 months had intimate contact with a male who has ever had sexual contact with another male, anyone who has HIV/AIDS or anyone who has hemophilia or has used clotting factor concentrates, or a positive test for HIV/AIDS virus, anyone who has hepatitis or anyone described in question 9,10,11?
14.
From 1980 through 1996 have you
a.
Spent 3 months or more cumulatively in the United Kingdom? If so, what city and country?
b.
Resided at a US military base in Europe for 6 months or more cumulatively? If so, what city and country?
15.
From 1980 to present have you spent 5 years or more in Europe cumulatively? If so, what city and country?
16.
Have you ever been diagnosed or suspected of having an acute respiratory disease such as (but not limited to) West Nile Virus, SARS, or Tuberculosis?
17.
In the past 3 years have you been outside the Country of your current residence? If so, what city & country?
18.
Have you experienced any of the following conditions that can be signs or symptoms of HIV/AIDS?
a.
Unexplained weight loss or night sweats?
b.
Blue or purple spots in your mouth or skin?
c.
Swollen lymph nodes for more than one month?
d.
White spots or unusual sores in your mouth?
e.
Cough that wont go away or shortness of breath?
f.
Diarrhea that won't go away?
g.
Fever of more than 100.5 F for more than 10 days?
19.
Have you had significant exposure to any substance that may be transferred in toxic doses, such as lead, mercury and gold?
For LifeCell Medical Team use only Reviewed by:..................................................
MD & CEO, LifeCell International Pvt Ltd.,
Date:...............................................................
Client's Initials
Signature:........................................................
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 16 of 20
EXHIBIT - 5: CONSENT OF NON-CLIENT BIRTH MOTHER FOR COLLECTION: The undersigned Birth Mother of the Child has reviewed the above the Agreement, and hereby acknowledges and agrees that she is not the legal guardian of the Child, is not a party to the Agreement, and is not a third-party beneficiary of the Agreement. Birth Mother hereby waives, releases and abandons any and all rights or entitlement to the Umbilical Cord, Specimen and Maternal Blood. Birth Mother consents and agrees to the testing of the Maternal Blood Specimen as referenced in the agreement and in Exhibit 7 of 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 or provision of the Agreement, or to exercise any right of the Client under the 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 the Umbilical Cord, including the Maternal Blood.
EXHIBIT - 6: INFORMED CONSENT TO INFECTIOUS DISEASE & HIV TESTING LifeCell requires infectious disease testing to be done on the maternal blood that includes HIV testing, in conjunction with the processing of Cord Blood. The costs of these screening tests are included in the initial fee. The maternal blood sample must be drawn at the time of delivery independent of previous infectious disease/HIV testing which may have been done during pregnancy. I understand, if the volume of the maternal blood sample is insufficient or missing, a fresh sample of maternal blood will be drawn within 7 days of delivery. If the sample is not drawn the Specimen will automatically be quarantined, which may affect its status for transplant use. Also I understand that a portion of the blood would be stored for potential future testing. Screening for Infectious Diseases: I am aware that my blood will be screened for transfusion transmitted infections. The screening procedure involves testing of my blood for Syphillis, Hepatitis B, Hepatitis C, HIV, HTLV I & II, Cytomegalovirus, and Malaria. If any of these tests is positive, a confirmatory test is performed by a qualified external agency and only if the confirmatory test is positive, then further course is decided with counselling. The results will not be disclosed to any other party without consent, except to the extent disclosure is required by law.
EXHIBIT - 7: AUTHORIZATON TO COLLECT UMBILICAL CORD: RELEASE FROM LIABILITY The undersigned is participating in Umbilical Cord program. The program requires the collection of Umbilical Cord at the time of birth of the Child. The collection procedure is outlined in Umbilical Cord Collection Instructions. Consent is hereby granted by the undersigned to the medical professionals attending to the birth to perform the collections. The undersigned acknowledges that complications may occur during collection of Umbilical Cord which could prevent or impede the collection of the Umbilical Cord or procedure an inadequate Specimen. The undersigned further acknowledge that medical judgment, with the best interest of the mother and Child in mind, could totally prevent the collection. The undersigned hereby releases and forever discharges LifeCell, the obstetrician or certified nurse midwife, the hospital or birthing center, and their respective officers, directors, shareholders, employees, agents, representatives, affiliates, successors and assigns (collectively, the Released Parties ) of and from any and all liability for any and all loss, harm, damage or claim of any kind arising from or relating to the collection of, or failure to collect, the Umbilical Cord. The undersigned acknowledges that, by this release, the undersigned is giving up any right she may otherwise have, now or in the future, to sue or otherwise seek monetary damages or other relief against any of the Released Parties for any reason relating to the collection of, or failure to collect, the Umbilical Cord. I have read the above information and hereby give the consent to perform the above required tests. Name of the Client
Name of the Husband
.......................................................................
...............................................................
Obstetrician / Gynaecologist Name
Date
Client s Signature ..............................................
Husband s Signature .............................................
.......................................................................................................................................
.........................................
MD & CEO, LifeCell International Pvt Ltd.,
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 17 of 20
EXHIBIT - 8: RISKS RELATING TO STEM CELL BANKING Stem cell banking has several inherent risks which may relate to collection, processing, testing, storage, and usage of the stem cells. The relevant risks in each of these areas are described below only to enable better decision making by Clients and shall in no way reduce LifeCell s liability due to gross negligence or diminish the benefits available 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 sample 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 sample present in the birth canal may render the sample unfit for storage. Certain circumstances or complications during delivery may entirely prevent the collection of sample or collection of adequate quantity of sample 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 place of delivery are critical to increasing the chances of successful sample collection. Further the birth mothers by law are required to screen and test for infectious diseases using peripheral venous blood. The collection of 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 is positive then LifeCell may decline to continue storing the sample. TESTING RISKS The samples are tested for reporting of the identity and quality of sample, based on the results of which a decision is taken on transplantation upon eventual need. LifeCell through extensive use of automated, bi-directionally interfaced, bar-coded 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-analytic phases of testing due to systems, processes, and procedures involved in the transmission and reporting of test results. Client understands if in doubt that 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 storage of samples could be associated with risks of either loss of viability, transmission of infectious diseases; partial or total loss due to reasons beyond reasonable control of LifeCell. However no assurance can be provided on the maintenance of viability for indefinite storage, and that the sample may also be lost due to equipment failure and / or accident which may render the sample unfit for transplantation. By placing the samples with bar-codes in overwrap bags and metal canisters where applicable; maintenance of samples in vapor phase nitrogen; and placement high-risk/ quarantine samples in a separate vessel help avoid the chances of cross-contamination. Also maintenance of adequate nitrogen levels in the vessels through piped supply from bulk tanks for automated top-ups; provision of continuous monitoring and automated alarm systems onto storage vessels, and supply with triple layer supply of electricity (power grid, uninterrupted power supply, and diesel generator) minimize chances of temperature deviations which may result in loss of viability. Adequate facility design considerations, running of regular stability testing programs, maintenance of insurance covers in accordance to the risks, and procedures for safety and emergency handling also help in providing added confidence. TRANSPORTATION RISKS Transport from the place of childbirth to the LifeCell laboratory, or transport from LifeCell laboratory to the transplant center has to be done within a reasonable period of time for minimizing loss of viability. However due to disruptions in flight or other transport operations, non-maintenance of temperature due to poor refrigeration of foam bricks or performance of the dry shippers, improper packaging due to non-following of instructions provided, accidents, or theft, may cause the sample to be lost or delayed in reaching the destination. Utilization of certified collection and distribution kits designed to maintain a controlled environment for a reasonable period of time, maintenance of sample traceability at all times of transport, utilizing experienced courier companies which have x-ray waiver procedures, will help minimize these risks during transportation. Client understands that no guarantee can be provided by LifeCell or the courier company on the safe and timely transport, and that Client has the option of choosing the best possible mode of transport.
MD & CEO, LifeCell International Pvt Ltd.,
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 18 of 20
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. Umbilical cord tissue, like the bone marrow, is also rich in mesenchymal progenitor cells, and is potentially useful for several regenerative medicine applications which are currently under-investigation in several clinical trials around the world. However there is no guarantee of successful transformation of these trials into commercial applications. The quantity of cells required for transplant varies depending upon eventual use and/ or patient body weight. While techniques for expansion of umbilical cord blood stem cells have been promising there is no guarantee that these will be eventually successful. Client also understands that cells obtained from the umbilical cord tissue may need further processing before use. Client is aware that banking a Child s sample does not guarantee that a stem cell transplant would be the first or best course of treatment for any particular disease or that a Child s own stem cell is useful for every disease treatable by stem cell transplantation. A medical care provider ultimately decides whether the use of the Child s sample is indicated, based on the nature and progression of the disease, and HLA matching between donor and recipient.
EXHIBIT - 9: LIST OF TESTS PERFORMED LifeCell commits to performing the below mentioned tests at no additional costs to the Client.
Cord Blood:
Blood grouping & RH typing Total Nucleated Cell count Total Mononuclear Cell count
Total CD 34 Cell count CD 34 Stem Cell Viability Sterility
At retrieval for transplant
HLA Typing for Donor & Recipient
CFU Assay
Maternal Blood:
Anti - HBC Anti - HCV CMV - IgG Syphilis Malaria Nucleic Acid test (HCV and HIV)
Haemoglobinopathies
CMV - IgM HBSAg HIV I/II Blood grouping & RH typing HTLV I/II No additional cost for confirmatory Tests
Cord Tissue:
Viable Cell count
Sterility
At retrieval for transplant
Viable Cell count Sterility Mycoplasma Cell Morphology
Flow Marker CD 90, 31, 105 (Positive) Flow Marker 34, 45 (Negative) Endotoxin HLA testing
MD & CEO, LifeCell International Pvt Ltd.,
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 19 of 20
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NA O I T EN
BLA T F E L
INT
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LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 | 044 4744 5353 | www.lifecell.in Page 20 of 20
BC/EFCA/ASP/Apr 14/V-013