Enrollment Form & Client Agreement
Name: .......................................................................... CRM No.: ..................................................................... APP. No.: ...................................................................... Country :.......................................................................
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 *Client's Name Husband's Name Client's Date of Birth
Communication Address
Landmark City
State
Country
Pin Code
Telephone (Home) Country Code
Telephone Number
STD Code
Mobile 1
Mobile 2 Mobile Number
Country Code
Mobile Number
E-mail ID If Permanent Address is same as Communication Address (Tick) Permanent Address (If different from above)
Landmark City
State
Country
Pin Code
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.
* Parent or legal guardian of the Child.
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 1 of 36
APP. NO................................................
CRM NO. HOSPITAL & BIRTHING DETAILS Expected Date of Delivery
Type of Pregnancy (Tick)
Single Birth
Quads
Triplets
Twins
Consulting Doctor Obstetrician/ Gynaecologist Communication Address
Landmark City
State
Country
Pin Code
Telephone Country Code
Telephone Number
STD Code
E-mail ID
If Birthing center is same as consulting Gynaecologist (Tick) Birthing Center (if different from consulting Gynaecologist) Obstetrician/ Gynaecologist Communication Address
Landmark City
State
Country
Pin Code
Telephone Country Code
Telephone Number
Mobile Country Code
Mobile Number
E-mail ID
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 Signature Name of Signatory:
Employee Code
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 2 of 36
APP. NO................................................
CRM NO. EMPLOYMENT DETAILS Employment
Husband
Client
Employment Type (Tick)
Service
Professional
Entrepreneur
Organisation Designation Office Address
City
State
Country
Pin Code
Telephone (Office) Country Code
Telephone Number
E-mail ID
SHIPMENT DETAILS Send Collection kit to (Tick)
Permanent Address
Communication Address
Office Address
Shipping Address (if different from above)
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
If referred by an Gynaecologist or Care Giver, please provide details as below: Referring Gynaecologist Hospital City
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 Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 3 of 36
AGE P S I TH
TI N E T N IS I
NK A L B LEFT Y L L ONA
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 4 of 36
EXHIBIT - 2 APP. NO. ........................................... CRM NO.
FEE SCHEDULE Plan Name & Description
Amount in ` Protect Baby Protect Mom
BabyCord
BabyCord Duo
5,000 29,000 2,000
5,000 39,500 2,500
5,000 63,000 4,000
36,000
47,000
72,000
2,000
2,500
4,000
59,900
74,900
1,19,900
A) ANNUAL STORAGE PLAN
Enrollment Fee Processing Fee First year storage fee Total Initial Payment Annual Storage Fee(20 years) B) 21 YEAR STORAGE PLAN Enrollment, processing and storage fee for 21 years (No annual storage plan)
21 YEAR STORAGE - EMI PLANS C) 24 EMI* Enrollment, processing and storage fee for 21 years (No annual storage plan)
2 ,600
3,250
5,000
5,000
6,250
10,000
10,000
12,500
20,000
D) 12 EMI Enrollment, processing and storage fee for 21 years (No annual storage plan)
E) 6 EMI Enrollment, processing and storage fee for 21 years (No annual storage plan)
*First two EMI’s should be paid in advance
Value added service
Optional service which can be combined with any of the above services
10,000
Dual Storage-21 Year Storage
Description of Service BabyCord
Testing, processing and storage of minimally manipulated cord blood stem cells obtained from Child.
BabyCord Duo
Testing, processing and storage of minimally manipulated umbilical cord blood & cord tissue stem cells and not less than 1 Million umbilical cord tissue derived mesenchymal stem cells.
Protect Baby, Protect Mom
Testing, processing and storage of minimally manipulated umbilical cord blood & cord tissue stem cells and not less than 1 Million umbilical cord tissue derived mesenchymal stem cells obtained from Child. Testing, processing and storage of minimally expanded menstrual blood stem cells obtained from Client.
I wish to enrol for (Tick)
BABYCORD
Payment Plan
21 year Storage
Value Added Service
BABYCORD DUO
PROTECT BABY, PROTECT MOM
6 EMI
12 EMI
24 EMI
Dual Storage - 21 year Storage
PAYMENT BY CREDIT CARD Credit Card mandate (to be filled-in by the Credit Card member) Please charge my credit card as per below details
Debit Cards are not accepted
Credit Card No.:
Amount to be charged
Card Expiry Date:
Type of card:
Declaration of Card member: I hereby declare that the credit card particulars given above are correct and complete. If the transaction is delayed or not effected at all for reasons of incomplete or incorrect information, I would not hold LifeCell responsible. Name of Credit Card Member Note: Cash payment will not be accepted
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 5 of 36
AGE P S I TH
TI N E T N IS I
NK A L B LEFT Y L L ONA
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 6 of 36
EXHIBIT - 2 APP. NO. ........................................... CRM NO.
FEE SCHEDULE Plan Name & Description
Amount in ` Protect Baby Protect Mom
BabyCord
BabyCord Duo
5,000 29,000 2,000
5,000 39,500 2,500
5,000 63,000 4,000
36,000
47,000
72,000
2,000
2,500
4,000
59,900
74,900
1,19,900
A) ANNUAL STORAGE PLAN
Enrollment Fee Processing Fee First year storage fee Total Initial Payment Annual Storage Fee(20 years) B) 21 YEAR STORAGE PLAN Enrollment, processing and storage fee for 21 years (No annual storage plan)
21 YEAR STORAGE - EMI PLANS C) 24 EMI* Enrollment, processing and storage fee for 21 years (No annual storage plan)
2 ,600
3,250
5,000
5,000
6,250
10,000
10,000
12,500
20,000
D) 12 EMI Enrollment, processing and storage fee for 21 years (No annual storage plan)
E) 6 EMI Enrollment, processing and storage fee for 21 years (No annual storage plan)
*First two EMI’s should be paid in advance
Value added service
Optional service which can be combined with any of the above services
10,000
Dual Storage-21 Year Storage
Description of Service BabyCord
CLIE
PY O C NT
Testing, processing and storage of minimally manipulated cord blood stem cells obtained from Child.
BabyCord Duo
Testing, processing and storage of minimally manipulated umbilical cord blood & cord tissue stem cells and not less than 1 Million umbilical cord tissue derived mesenchymal stem cells.
Protect Baby, Protect Mom
Testing, processing and storage of minimally manipulated umbilical cord blood & cord tissue stem cells and not less than 1 Million umbilical cord tissue derived mesenchymal stem cells obtained from Child. Testing, processing and storage of minimally expanded menstrual blood stem cells obtained from Client.
I wish to enrol for (Tick)
BABYCORD
Payment Plan
21 year Storage
Value Added Service
BABYCORD DUO
PROTECT BABY, PROTECT MOM
6 EMI
12 EMI
24 EMI
Dual Storage - 21 year Storage
PAYMENT BY CREDIT CARD Credit Card mandate (to be filled-in by the Credit Card member) Please charge my credit card as per below details
Debit Cards are not accepted
Credit Card No.:
Amount to be charged
Card Expiry Date:
Type of card:
Declaration of Card member: I hereby declare that the credit card particulars given above are correct and complete. If the transaction is delayed or not effected at all for reasons of incomplete or incorrect information, I would not hold LifeCell responsible. Name of Credit Card Member Note: Cash payment will not be accepted
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 5 of 36
ENTI T N I IS E G A P THIS
NK A L B LEFT Y L L ONA
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 8 of 36
UMBILICAL CORD STEM CELL TESTING, PROCESSING, STORAGE 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 600048, India (‘LifeCell’), this day of ........................, 201… (the ‘Enrollment Date’), to process, test, and store stem cells obtained from the umbilical cord blood and/or stem cells from umbilical cord tissue collected at birth of the Child (‘Services’) on the following terms (this ‘Agreement’).
1.
DEFINITIONS In this Agreement, (including the recitals above), unless the context otherwise requires, the following expressions shall have the following meanings:
1.1.
‘Child’ means the Client’s baby from whom the Specimen will be collected following his/her birth.
1.2.
‘Client’ means the parent or legal guardian of the Child.
1.3.
‘Caregiver’ means the Obstetrician Gynecologist or qualif ied medical professional/midwife who will be assisting in delivering the Child.
1.4.
‘Maternal Blood’ means peripheral blood from Birth Mother of the Child, that has been drawn by observing standard phlebotomy procedures, taken seven [7] days before or after the birth of the Child.
1.5.
‘Specimen’ means and includes stem cells obtained from umbilical cord blood and/or umbilical cord tissue individually or collectively.
1.6.
‘Collection Kit’ means the kit consisting of all essential materials required for the purpose of collection and labeling of the Maternal Blood and Specimen.
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.
Client may also choose to subscribe for additional services as listed in Exhibit 2 and pay the additional fees.
2.3.
All applicable taxes including but not limited to service tax is payable by the Client.
President, LifeCell International
3.
CLIENT RESPONSIBILITIES
3.1.
Prior to the birth of the Child, the Client must complete all the applicable Exhibits [1 to 8] and make due payment of fees. If surrogate, egg donor or sperm was used, each must fill out Exhibit 3.
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 Specimen for delivery to LifeCell along with the duly filled up forms included in the Collection Kit.
4.
DUAL STORAGE
4.1.
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 situated at #26, Vandalur Kelambakkam Main Road, Keelakottaiyur, Chennai 600048, Tamil Nadu, and Plot #26, Sector 4, IMT Manesar, Gurgaon 122001, Haryana.
4.2
LifeCell has the option to relocate the Specimen and will provide notice to Client within 60 days of relocation.
5.
TERM OF AGREEMENT
5.1.
If the Client signs-up for the Annual Storage Plan, 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 21 Years. This automatic renewal is subject to the Client paying the annual storage fee on or before the renewal date every year.
5.2.
If the Client signs-up for 21-Year Storage Plan, this Agreement will continue for twenty one (21) years from the date of birth of the Child.
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 9 of 36
5.3.
6.
At least three (3) months before the expiration of the 21 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 Client or Child can enter into a new Agreement and continue the storage. REPRESENTATIONS AND WARRANTIES OF CLIENT 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 Specimen.
6.3.
The decision to collect the Specimen and Maternal Blood, test the Maternal Blood and process and store 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.
RETRIEVAL OF SPECIMEN
8.1.
There is no fee payable by the Client to LifeCell for retrieval of Specimen.
8.2.
Retrieval Procedure and Time Frame:
(a)
Client has to submit duly filled up Retrieval Form (to be accompanied by Transplant Physician’s Certif icate confirming end use in case of retrievals for transplant).
(b)
After receipt of Retrieval Form, Specimen will be available for delivery within 7 business days or 90 business days if the Specimen requires expansion.
(c)
The Specimen would be released only for use in statutorily compliant transplant procedures.
President, LifeCell International
9.
LIFECELL CLIENT BENEFIT PROGRAMS 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:
9.1.
LifeCell Cares Program:
(a)
If the Child or its sibling is diagnosed after the enrolment date for a hematological condition treatable by stem cell transplantation the Client under the LifeCell Cares Program can avail up to Rs. 1,000,000 (Rupees One Million only) to offset transplant related expenses.
(b)
In case of demise of the earning member of the family, LifeCell would continue storage of the Specimen at LifeCell’s own cost for the remaining term of the Agreement (for clients who have chosen the 21-Year Storage Plan, LifeCell would issue a pro-rated refund the storage fees).
(c)
LifeCell understands that the life and health of the Mother and Child are the utmost priority. In the event the Specimen is not collected due to this priority, LifeCell shall refund all fees paid by Client to LifeCell.
9.2.
LifeCell Disaster Relief Program: If the Child or its sibling is diagnosed after the enrolment date for a hematological condition treatable by stem cell transplantation and should for any unforeseen reason that is beyond the reasonable control of LifeCell which may potentially deteriorate or cause loss of the Specimen during transit or processing or storage, LifeCell will use its best endeavors to find a unit of suitable match as confirmed by the transplant physician or pay the Client Rs. 1,000,000 (Rupees One Million Only).
9.3.
LifeCell Quality Guarantee: If the Child or its sibling is diagnosed after the enrolment date for a hematological condition treatable by stem cell transplantation 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 transplant physician or pay the Client Rs. 1,000,000 (Rupees One Million Only).
9.4.
Free Worldwide Shipment: In the event of a transplant the Specimen would be made available for transportation in a special cryo-shipper owned by LifeCell, and LifeCell would bear the cost of shipment to any destination worldwide.
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 10 of 36
9.5.
Free Stem Cell Expansion: In the event of a transplant of umbilical cord tissue stem cells LifeCell shall at its own cost expand and provide upto 500 million mesenchymal stem cells.
9.6.
General conditions for LifeCell Client Benefit Programs:
(a)
The Client Agreement is valid and is in force.
(b)
Payments would be made on appropriate verification of Client’s request by LifeCell.
10.
LIFECELL ASSURANCE LifeCell hereby assures that:
10.1.
LifeCell shall obtain all statutory permissions and licenses that are required for providing the services contemplated under this Agreement.
10.2.
LifeCell will provide the Client with the following immediately upon enrollment 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.
10.7.
The Specimen would be tested, processed and stored in accordance to approved Standard Operating Procedures and in compliance with statutory regulations.
10.8.
The Specimen would be cryopreserved at its licensed facilities throughout the term of this Agreement.
10.9.
Upon successful collection, processing 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. The current list of tests is detailed in Exhibit 9.
10.10. The Specimen will be marked and referred to only by the CRM number and shall not directly refer to the Client or Child. Personal Identifiable Data of the Client or Child will not be disclosed to any third party without express written permission. 11.
DISCLAIMER & LIMITATIONS:
11.1.
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.
10.3.
At the request of the Client, LifeCell would arrange and pay for qualified Phlebotomist for the collection of Maternal Blood and Specimen, and/or a certified Service Provider for transporting the Maternal Blood and Specimen to LifeCell’s Laboratory.
11.2.
LifeCell disclaims any responsibility to provide any other ser vices and third par ty ser vice providers like Phlebotomist, Transporter, etc shall have the respective liability for their services including loss, damage, delay in delivery, etc.
10.4.
Upon receipt of the Maternal Blood and Specimen LifeCell would determine whether it is fit or unfit for testing, processing and / or storage.
11.3.
10.5.
In any event of Specimen found to be unfit, including but not limited to insufficient volume, low cell count / viability, positive screening of infectious diseases, microbial contamination of Specimen, etc., LifeCell will notify the Client immediately and seek instructions for disposal of the Specimen. 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 9 shall not be applicable.
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 arising out of LifeCell’s negligence.
12.
FORCE MAJEURE.
10.6.
Client agrees that LifeCell’s liability for causes or circumstances which are beyond LifeCell’s reasonable control shall be limited to “LifeCell Disaster Relief Program”.
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.
Client's Initials
Husband's Initials
Birth Mother, if not Client
President, LifeCell International LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 11 of 36
13.
TERMINATION OF AGREEMENT
13.1.
This Agreement may be terminated
(a)
by Client at any time prior to collection of Specimen, or
(b)
by Client or Child (on attaining majority) at any time prior to the retrieval of the Specimen, or
(c)
(d)
have the option of reviving the Agreement by paying all unpaid fees and a re-enrollment fee. (e)
If the Agreement is terminated by LifeCell under Section 13.1.(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.
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 10.5, or
(f)
If the Agreement is terminated under Sections 13.1.(e) or 13.1.(g) a pro-rated refund of the prepaid storage fees will be made by LifeCell to the Client.
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
(g)
All refunds by LifeCell shall be processed within 30 days of receiving the completed documentation.
14.
ARBITRATION
(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 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, the Specimen is lost or destroyed for reasons beyond LifeCell’s control.
(i)
in the event either law or a governmental agency or regulatory provisions or medical guidelines require us to terminate the Agreement.
13.2.
Effects of Termination:
(a)
If the Agreement is terminated under Section 13.1.(a) only the Processing and Storage Fees would be refunded.
(b)
If the Agreement is terminated under Section 13.1.(b) all fees paid by the Client to LifeCell are non-refundable.
(c)
If the Agreement is terminated under Section 13.1.(c) the Storage and / or Processing Fees would be refunded as applicable.
(d)
If the Agreement is terminated under Section 13.1.(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
President, LifeCell International
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. 15.
GOVERNING LAW AND JURISDICTION This Agreement is governed by, construed and interpreted in accordance with the laws of India. Courts in Chennai shall have exclusive jurisdiction.
16.
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 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.
17.
MULTIPLE BIRTHS 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.
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 12 of 36
18.
ASSIGNMENT
20.
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. 19.
NOTICE
19.1.
Notice to LifeCell must be in writing and delivered to LifeCell International Private Limited, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai – 600048.
19.2.
Notice to Client will be in writing and delivered to the address set forth in the Enrollment form or as updated by Client to LifeCell.
President, LifeCell International
ENTIRE AGREEMENT This Agreement and the exhibits hereto constitute the entire agreement between LifeCell and Client and supersedes any prior agreements or understandings, oral and written. This Agreement may be modified only by written agreement of Client and Authorised Signatory of LifeCell.
21.
SURVIVAL All provisions which by their terms require performance after the termination of this Agreement will survive the termination of this Agreement
22.
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.
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 13 of 36
ENTI T N I E IS G A P THIS
NK A L B LEFT Y L L ONA
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 14 of 36
UMBILICAL CORD STEM CELL TESTING, PROCESSING, STORAGE 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 600048, India (‘LifeCell’), this day of ........................, 201… (the ‘Enrollment Date’), to process, test, and store stem cells obtained from the umbilical cord blood and/or stem cells from umbilical cord tissue collected at birth of the Child (‘Services’) on the following terms (this ‘Agreement’).
1.
DEFINITIONS In this Agreement, (including the recitals above), unless the context otherwise requires, the following expressions shall have the following meanings:
1.1.
‘Child’ means the Client’s baby from whom the Specimen will be collected following his/her birth.
1.2.
‘Client’ means the parent or legal guardian of the Child.
1.3.
‘Caregiver’ means the Obstetrician Gynecologist or qualif ied medical professional/midwife who will be assisting in delivering the Child.
‘Maternal Blood’ means peripheral blood from Birth Mother of the Child, that has been drawn by observing standard phlebotomy procedures, taken seven [7] days before or after the birth of the Child.
1.5.
‘Specimen’ means and includes stem cells obtained from umbilical cord blood and/or umbilical cord tissue individually or collectively.
1.6.
‘Collection Kit’ means the kit consisting of all essential materials required for the purpose of collection and labeling of the Maternal Blood and Specimen.
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.
Client may also choose to subscribe for additional services as listed in Exhibit 2 and pay the additional fees.
2.3.
All applicable taxes including but not limited to service tax is payable by the Client.
President, LifeCell International
CLIENT RESPONSIBILITIES
3.1.
Prior to the birth of the Child, the Client must complete all the applicable Exhibits [1 to 8] and make due payment of fees. If surrogate, egg donor or sperm was used, each must fill out Exhibit 3.
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 Specimen for delivery to LifeCell along with the duly filled up forms included in the Collection Kit.
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1.4.
CLIE
3.
4.
DUAL STORAGE
4.1.
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 situated at #26, Vandalur Kelambakkam Main Road, Keelakottaiyur, Chennai 600048, Tamil Nadu, and Plot #26, Sector 4, IMT Manesar, Gurgaon 122001, Haryana.
4.2
LifeCell has the option to relocate the Specimen and will provide notice to Client within 60 days of relocation.
5.
TERM OF AGREEMENT
5.1.
If the Client signs-up for the Annual Storage Plan, 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 21 Years. This automatic renewal is subject to the Client paying the annual storage fee on or before the renewal date every year.
5.2.
If the Client signs-up for 21-Year Storage Plan, this Agreement will continue for twenty one (21) years from the date of birth of the Child.
Client's Initials
Husband's Initials
Birth Mother, if not Client
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5.3.
6.
At least three (3) months before the expiration of the 21 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 Client or Child can enter into a new Agreement and continue the storage. REPRESENTATIONS AND WARRANTIES OF CLIENT 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 Specimen.
6.3.
The decision to collect the Specimen and Maternal Blood, test the Maternal Blood and process and store 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.
CLIE
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.
RETRIEVAL OF SPECIMEN
8.1.
There is no fee payable by the Client to LifeCell for retrieval of Specimen.
8.2.
Retrieval Procedure and Time Frame:
(a)
Client has to submit duly filled up Retrieval Form (to be accompanied by Transplant Physician’s Certif icate confirming end use in case of retrievals for transplant).
(b)
After receipt of Retrieval Form, Specimen will be available for delivery within 7 business days or 90 business days if the Specimen requires expansion. The Specimen would be released only for use in statutorily compliant transplant procedures.
President, LifeCell International
LIFECELL CLIENT BENEFIT PROGRAMS 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:
9.1.
LifeCell Cares Program:
(a)
If the Child or its sibling is diagnosed after the enrolment date for a hematological condition treatable by stem cell transplantation the Client under the LifeCell Cares Program can avail up to Rs. 1,000,000 (Rupees One Million only) to offset transplant related expenses.
(b)
In case of demise of the earning member of the family, LifeCell would continue storage of the Specimen at LifeCell’s own cost for the remaining term of the Agreement (for clients who have chosen the 21-Year Storage Plan, LifeCell would issue a pro-rated refund the storage fees).
(c)
LifeCell understands that the life and health of the Mother and Child are the utmost priority. In the event the Specimen is not collected due to this priority, LifeCell shall refund all fees paid by Client to LifeCell.
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7.2.
(c)
9.
9.2.
LifeCell Disaster Relief Program: If the Child or its sibling is diagnosed after the enrolment date for a hematological condition treatable by stem cell transplantation and should for any unforeseen reason that is beyond the reasonable control of LifeCell which may potentially deteriorate or cause loss of the Specimen during transit or processing or storage, LifeCell will use its best endeavors to find a unit of suitable match as confirmed by the transplant physician or pay the Client Rs. 1,000,000 (Rupees One Million Only).
9.3.
LifeCell Quality Guarantee: If the Child or its sibling is diagnosed after the enrolment date for a hematological condition treatable by stem cell transplantation 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 transplant physician or pay the Client Rs. 1,000,000 (Rupees One Million Only).
9.4.
Free Worldwide Shipment: In the event of a transplant the Specimen would be made available for transportation in a special cryo-shipper owned by LifeCell, and LifeCell would bear the cost of shipment to any destination worldwide.
Client's Initials
Husband's Initials
Birth Mother, if not Client
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9.5.
Free Stem Cell Expansion: In the event of a transplant of umbilical cord tissue stem cells LifeCell shall at its own cost expand and provide upto 500 million mesenchymal stem cells.
9.6.
General conditions for LifeCell Client Benefit Programs:
(a)
The Client Agreement is valid and is in force.
(b)
Payments would be made on appropriate verification of Client’s request by LifeCell.
10.
LIFECELL ASSURANCE LifeCell hereby assures that:
10.1.
LifeCell shall obtain all statutory permissions and licenses that are required for providing the services contemplated under this Agreement.
10.2.
LifeCell will provide the Client with the following immediately upon enrollment 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.
10.3.
10.7.
The Specimen would be tested, processed and stored in accordance to approved Standard Operating Procedures and in compliance with statutory regulations.
10.8.
The Specimen would be cryopreserved at its licensed facilities throughout the term of this Agreement.
10.9.
Upon successful collection, processing 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. The current list of tests is detailed in Exhibit 9.
10.10. The Specimen will be marked and referred to only by the CRM number and shall not directly refer to the Client or Child. Personal Identifiable Data of the Client or Child will not be disclosed to any third party without express written permission. 11.
DISCLAIMER & LIMITATIONS:
11.1.
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.
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At the request of the Client, LifeCell would arrange and pay for qualified Phlebotomist for the collection of Maternal Blood and Specimen, and/or a certified Service Provider for transporting the Maternal Blood and Specimen to LifeCell’s Laboratory.
11.2.
LifeCell disclaims any responsibility to provide any other ser vices and third par ty ser vice providers like Phlebotomist, Transporter, etc shall have the respective liability for their services including loss, damage, delay in delivery, etc.
10.4.
Upon receipt of the Maternal Blood and Specimen LifeCell would determine whether it is fit or unfit for testing, processing and / or storage.
11.3.
10.5.
In any event of Specimen found to be unfit, including but not limited to insufficient volume, low cell count / viability, positive screening of infectious diseases, microbial contamination of Specimen, etc., LifeCell will notify the Client immediately and seek instructions for disposal of the Specimen. 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 9 shall not be applicable.
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 arising out of LifeCell’s negligence.
12.
FORCE MAJEURE.
CLIE
10.6.
Client agrees that LifeCell’s liability for causes or circumstances which are beyond LifeCell’s reasonable control shall be limited to “LifeCell Disaster Relief Program”.
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.
Client's Initials
Husband's Initials
Birth Mother, if not Client
President, LifeCell International LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 17 of 36
13.
TERMINATION OF AGREEMENT
have the option of reviving the Agreement by paying all unpaid fees and a re-enrollment fee.
13.1.
This Agreement may be terminated
(a)
by Client at any time prior to collection of Specimen, or
(b)
by Client or Child (on attaining majority) at any time prior to the retrieval of the Specimen, or
(c)
(d)
(e)
If the Agreement is terminated by LifeCell under Section 13.1.(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.
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 10.5, or
(f)
If the Agreement is terminated under Sections 13.1.(e) or 13.1.(g) a pro-rated refund of the prepaid storage fees will be made by LifeCell to the Client.
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
(g)
All refunds by LifeCell shall be processed within 30 days of receiving the completed documentation.
14.
ARBITRATION
(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 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.
CLIE
15.
GOVERNING LAW AND JURISDICTION This Agreement is governed by, construed and interpreted in accordance with the laws of India. Courts in Chennai shall have exclusive jurisdiction.
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(h)
in the event, the Specimen is lost or destroyed for reasons beyond LifeCell’s control.
(i)
in the event either law or a governmental agency or regulatory provisions or medical guidelines require us to terminate the Agreement.
13.2.
Effects of Termination:
(a)
If the Agreement is terminated under Section 13.1.(a) only the Processing and Storage Fees would be refunded.
(b)
If the Agreement is terminated under Section 13.1.(b) all fees paid by the Client to LifeCell are non-refundable.
(c)
If the Agreement is terminated under Section 13.1.(c) the Storage and / or Processing Fees would be refunded as applicable.
(d)
If the Agreement is terminated under Section 13.1.(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
President, LifeCell International
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.
16.
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 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.
17.
MULTIPLE BIRTHS 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.
Client's Initials
Husband's Initials
Birth Mother, if not Client
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18.
ASSIGNMENT
20.
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. 19.
NOTICE
19.1.
Notice to LifeCell must be in writing and delivered to LifeCell International Private Limited, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai – 600048.
19.2.
Notice to Client will be in writing and delivered to the address set forth in the Enrollment form or as updated by Client to LifeCell.
President, LifeCell International
This Agreement and the exhibits hereto constitute the entire agreement between LifeCell and Client and supersedes any prior agreements or understandings, oral and written. This Agreement may be modified only by written agreement of Client and Authorised Signatory of LifeCell. 21.
CLIE
ENTIRE AGREEMENT
SURVIVAL All provisions which by their terms require performance after the termination of this Agreement will survive the termination of this Agreement
22.
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.
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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 - 48 | 044 4744 5353 | www.lifecellinternational.com Page 19 of 36
NTEN I S I GE A P S THI
TI
NK A L B LEFT Y L L ONA
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 20 of 36
EXHIBIT - 3 CRM NO.:
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
1.
Do you currently have or have a history or 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 (Bovine/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 questions 9, 10 or 11?
President, LifeCell International
Client's Initials
Husband's Initials
NO
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 21 of 36
13.
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?
14.
From 1980 to present have you spent 5 years or more in Europe cumulatively? If so, what city and country?
15.
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?
16.
In the past 3 years have you been outside the Country of your current residence? If so, what city & country?
17.
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?
18.
Have you had significant exposure to any substance that may be transferred in toxic doses, such as lead, mercury and gold?
Genetic Mother’s Name:.....................................................
For LifeCell Medical Team use only. Reviewed by:..................................................
Genetic Mother’s Signature:...............................................
Date:..................................................................................
President, LifeCell International
Date:............................................................... Signature:........................................................
Client's Initials
Husband's Initials
Birth Mother, if not Client
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EXHIBIT - 4 CRM NO.:
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
1.
Do you currently have or have a history or 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 (Bovine/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 questions 9, 10 or 11?
President, LifeCell International
Client's Initials
Husband's Initials
NO
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 23 of 36
13.
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?
14.
From 1980 to present have you spent 5 years or more in Europe cumulatively? If so, what city and country?
15.
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?
16.
In the past 3 years have you been outside the Country of your current residence? If so, what city & country?
17.
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?
18.
Have you had significant exposure to any substance that may be transferred in toxic doses, such as lead, mercury and gold?
Birth Mother’s Name:.....................................................
For LifeCell Medical Team use only. Reviewed by:..................................................
Birth Mother’s Signature:...............................................
Date:..................................................................................
President, LifeCell International
Date:............................................................... Signature:........................................................
Client's Initials
Husband's Initials
Birth Mother, if not Client
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EXHIBIT - 5 Consent of Non-Client Birth Mother for Collection: The undersigned Birth Mother of the Child has reviewed the above processing, Storage and Informed Consent Agreement (the Agreement”), and hereby acknowledge 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, Maternal Blood Specimen, and or Menstrual Blood Specimen. 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 Birth Mother has been fully informed of the procedures associated with cellular donation and the alternatives to cellular donation and accepts and agrees to the benefits, limitatations, 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 Specimen, including the Maternal Blood Specimen. Birth Mother’s Signature
Date: ……………………...............
Birth Mother’s Name: …………………..................................................................................................................
Gynaecologist’s Name:.........................................................................................................................................
Gynaecologist’s Address……………………………...............................................................................................
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 samples. 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. 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, Cytomegalovirus, HTLV and Malaria. If any of these tests is positive, a confirmatory test is performed by an approved 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. I have read the above information and hereby give the consent to perform the above required tests. Birth Mother’s Signature
Date: ……………………...............
Birth Mother’s Name: …………………..................................................................................................................
Gynaecologist’s Name:.........................................................................................................................................
Gynaecologist’s Address.......................................................................................................................................
President, LifeCell International
Client's Initials
Husband's Initials
Birth Mother, if not Client
LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com Page 25 of 36
EXHIBIT -7 Authorization to collect Cord Blood; Release from Liability The undersigned is participating in BabyShield program. The program requires the collection of umbilical cord blood at the time of birth of the Child. The collection procedure is outlined in BabyShield umbilical cord blood 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 blood which could prevent or impede the collection of the cord blood 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 cord blood. 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 cord blood. Name of the Client ……....................................................................... Name of the Husband ……............................................................... Client’s Signature .......................................... Husband’s Signature ............................................. Obstetrician / Gynaecologist Name ……………....................................................................................................................................... Date …………………….........................................
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 to enable better decision making by Clients. 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 be screened and tested for infectious diseases using peripheral venous blood. This maternal blood collection 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,
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Birth Mother, if not Client
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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. 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. 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.
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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: 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
CFU Assay
Maternal Blood:
Anti - HBC Anti - HCV CMV - IgG Syphilis Malaria Nucleic Acid test (HCV and HIV)
Cord Tissue:
Cell Proliferation Assay Cell Morphology
Viable Cell count Gram Staining
At retrieval for transplant
Viability Flow Marker CD 105 Sterility Mycoplasma
Flow Marker CD 90 Flow Marker CD 31 Endotoxin HLA testing
Menstrual Blood:
Total Nucleated Cell count Cell Morphology
Viable Cell count Gram Staining
At retrieval for transplant
Viability Flow Marker CD 105 Sterility Mycoplasma
Flow Marker CD 90 Flow Marker CD 31 Endotoxin HLA testing
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CMV - IgM HBSAg HIV I/II Blood grouping & RH typing HTLV I/II
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APP. NO. ........................................... CRM NO.
LifeCell International Private Limited Regd. Office: 26, Vandalur-Kelambakkam Road, Keelakotaiyur, Chennai - 600 048 TEMPORARY RECEIPT Receipt No: ..................................................
Date:
Received with thanks from Mr./Ms. .......................................................................................................................................................................................... towards enrollment vide APP...No. ...........................................................................................a sum of .Rs.............................................................................................................................................................................................................................................................Only) towards Enrollment/Processing/Storage fees by way of Cash/Credit Card/*Cheque/ *DD /EFT No. Date...................................... Drawn on......................................................................................... Branch................................................ City.................................. Plan No. : ................................................................................................ Plan Name:.......................................................................................... EDD:.......................................................................................................... *Cheque/DD Subject to realization
Note : A computer generated “Receipt” will be sent along with the Preservation certificate For LifeCell use only
For LifeCell International Private Limited
Computer Receipt No :
N E I L C
Y P O TC
Authorised Signatory
For LifeCell use only Payment received by
:
...........................................................................
Designation
:
...........................................................................
Center
:
...........................................................................
Center’s Tel. No.
:
...........................................................................
TOLL FREE
:
1800 - 419 - 5555 (Name of the center incharge)
Signature of the center incharge
President, LifeCell International
Client's Initials
Husband's Initials
Birth Mother, if not Client
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ENTI T N I E IS G A P THIS
NK A L B LEFT Y L L ONA
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APP. NO. ........................................... CRM NO.
LifeCell International Private Limited Regd. Office: 26, Vandalur-Kelambakkam Road, Keelakotaiyur, Chennai - 600 048 TEMPORARY RECEIPT Receipt No: ..................................................
Date:
Received with thanks from Mr./Ms. .......................................................................................................................................................................................... towards enrollment vide APP...No. ...........................................................................................a sum of .Rs.............................................................................................................................................................................................................................................................Only) towards Enrollment/Processing/Storage fees by way of Cash/Credit Card/*Cheque/ *DD /EFT No. Date...................................... Drawn on......................................................................................... Branch................................................ City.................................. Plan No. : ................................................................................................ Plan Name:.......................................................................................... EDD:.......................................................................................................... *Cheque/DD Subject to realization
Note : A computer generated “Receipt” will be sent along with the Preservation certificate For LifeCell use only
For LifeCell International Private Limited
Computer Receipt No :
C
Y P O RC E T EN
Authorised Signatory
For LifeCell use only Payment received by
:
...........................................................................
Designation
:
...........................................................................
Center
:
...........................................................................
Center’s Tel. No.
:
...........................................................................
TOLL FREE
:
1800 - 419 - 5555 (Name of the center incharge)
Signature of the center incharge
President, LifeCell International
Client's Initials
Husband's Initials
Birth Mother, if not Client
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THI
BLA T F E LY L L A N TIO N E T IS IN E G A SP
NK
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APP. NO. ........................................... CRM NO.
LifeCell International Private Limited Regd. Office: 26, Vandalur-Kelambakkam Road, Keelakotaiyur, Chennai - 600 048 TEMPORARY RECEIPT Receipt No: ..................................................
Date:
Received with thanks from Mr./Ms. .......................................................................................................................................................................................... towards enrollment vide APP...No. ...........................................................................................a sum of .Rs.............................................................................................................................................................................................................................................................Only) towards Enrollment/Processing/Storage fees by way of Cash/Credit Card/*Cheque/ *DD /EFT No. Date...................................... Drawn on......................................................................................... Branch................................................ City.................................. Plan No. : ................................................................................................ Plan Name:.......................................................................................... EDD:.......................................................................................................... *Cheque/DD Subject to realization
Note : A computer generated “Receipt” will be sent along with the Preservation certificate For LifeCell use only
For LifeCell International Private Limited
Computer Receipt No :
E C E F LI
PY O C LL
Authorised Signatory
For LifeCell use only Payment received by
:
...........................................................................
Designation
:
...........................................................................
Center
:
...........................................................................
Center’s Tel. No.
:
...........................................................................
TOLL FREE
:
1800 - 419 - 5555 (Name of the center incharge)
Signature of the center incharge
President, LifeCell International
Client's Initials
Husband's Initials
Birth Mother, if not Client
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AGE P S I TH
TI N E T IS IN
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AGE P S I TH
TI N E T IS IN
BLA T F E YL L L A ON
NK
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AGE P S I TH
TI N E T IS IN
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LifeCell International Pvt Ltd, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48 | 044 4744 5353 | www.lifecellinternational.com
TOLL FREE: 1800 - 419 - 5555 | SMS ‘BABYCORD’ TO 53456 | www.lifecellinternational.com LifeCell International Private Limited, 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 048 Phone: +91 44 4744 5353 | email: contactus@lifecellinternational.com