Client Enrollment Form & Agreement April 2012 by LifeCell International

Client Enrollment Form & Agreement

Name: .......................................................................... CRM No.: ..................................................................... APP. No.: ......................................................................

Thank you Stem Cells Iâ&#x20AC;&#x2122;m here because of you!

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) Telephone Number

Country Code

Mobile 1

Mobile 2 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 9 digit CRM No.

Client's Initials

Husband's Initials

Birth Mother, if not Client

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APP. NO................................................

CRM NO. HOSPITAL & BIRTHING DETAILS Expected Date of Delivery

Type of Pregnancy (Tick)

Single Birth

Twins

Triplets

Quads

Consulting Doctor Obstetrician/ Gynaecologist Communication Address

Landmark City Country

Signature of Client

Signature of Husband

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APP. NO................................................

CRM NO.

Husband

Client

TICK AS APPLICABLE FOR LIFECELL SUPPORT SERVICES: Requesting LifeCell to arrange for pick up of Maternal sample and Specimen Requesting LifeCell to organise for Phelobotomist Client's Initials

Husband's Initials

Birth Mother, if not Client

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THIS

IS E G A P

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LifeCell International Pvt. Ltd., 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48. | 044 4744 5353 | www.Iifecellinternational.com Page 4 of 52

AN L B T EF

LLY L A N O ENTI

IS I E G A HIS P

LifeCell International Pvt. Ltd., 26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 48. | 044 4744 5353 | www.Iifecellinternational.com Page 6 of 52

CLIE

PY O C NT

AN L B T EF

LLY L A N O ENTI

IS I E G A HIS P

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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, Keelakottaiyur, Chennai 600048, India (‘LifeCell’), 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 on the following terms (this ‘Agreement’). This Agreement is entered into this _________ day of ___________________, 201______ (the ‘Enrollment Date’) and legally binds LifeCell and the Client, including the birth mother of the Child. 1. Definitions.

1.7.

cells obtained from umbilical cord blood

In this Agreement, (including the recitals above),

and /or umbilical cord tissue individually or

unless the context otherwise requires, the following

collectively.

expressions shall have the following meanings: 1.1.

‘Child’ means the Client's baby from

1.8.

‘Collection Kit’ means the kit consisting of all essential materials required for the

whom the Specimen will be collected

purpose of collection and labeling of the

following his/her birth. 1.2.

‘Specimen’ means and includes stem

Maternal Blood and Specimen, such as

‘Client’ means the parent or legal

Cord Blood Collection Bag, Cord Tissue

guardian of the Child.

Collection Containers, Bar code labels, Vacuum Test Tubes, Foam Bricks, Alcohol

1.3.

‘Birth Mother’ means the one who has

Swabs, Hologram Stickers, Maternal

borne the child in her womb. 1.4.

Blood and Specimen Collection and

‘Genetic Mother’ if different from the

Packing Instructions, Sealable Plastic

Birth Mother means the mother from

Bags and Absorbent Paper Towels, and

whom the egg has been obtained.

all packed in a certified transport container

‘Care giver’ means the Obstetrician /

Association (IATA) regulations.

compliant with International Air Transport 1.5.

Gynecologist or qualified medical professional / midwife who will be

1.9.

‘LifeCell Laboratory’ means LifeCell's licensed and accredited laboratory

assisting in delivering the Child.

facilities where the Specimen is 1.6.

‘Maternal Blood’ means peripheral

processed, tested and stored.

blood from Birth Mother of the Child, that has been drawn by observing standard

1.10.

‘Minimally Manipulated Stem Cells’

phlebotomy procedures, taken seven (7)

means stem cells that have not been

days before or after the birth of the Child.

subjected to ex-vivo procedure such as expansion of cell populations, genetic alterations, etc.

President, LifeCell International

Client's Initials

Husband's Initials

Birth Mother, if not Client

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1.11.

1.12.

‘Minimally Expanded Stem Cells’

collection of Maternal Blood and

means cells that have been obtained from

Specimen at no additional costs to the

ex-vivo isolation and not subjected to

Client. The discretion of engaging the

further passaging.

Phlebotomist shall solely vest with the Client. The Phlebotomist is not an agent of

‘Hematopoietic Stem Cells’ means

LifeCell and LifeCell shall not be

multi-potent stem cells that are

responsible in any manner for the services

characterized by the expression of the

rendered by the Phlebotomist.

marker CD34. 1.13.

‘Mesenchymal Stem Cells’ means

2.5.

arrange for pick-up of the Maternal Blood

multi-potent stem cells that can

and Specimen from the Hospital / Nursing

differentiate into a variety of cell types and

Home to LifeCell Laboratory, using a

are characterized by expression of

certified Service Provider who has the

the markers CD90 and CD105. 1.14.

LifeCell at the request of the Client would

required expertise in the correct

‘Sibling’ means a brother or sister of the

handling and transportation of such

Child having one or both parents in

Maternal Blood and Specimen at no

common.

additional costs to the Client. The Service Provider is not an agent of LifeCell and

Services of LifeCell; Testing,

LifeCell shall not be responsible in any

Processing, Preserving and

manner for the services rendered by the

Storage. 2.1.

LifeCell offers its services under various

Service Provider. 2.6.

options which the Client must choose

2.2.

Upon successful collection, processing and storage, LifeCell will provide the Client

from as detailed in Exhibit 2.

with a Preservation Certificate confirming

LifeCell shall obtain all statutory

successful storage of the Specimen along

permissions and licenses that might be

with sample storage details and test

required for providing the services

results including but not limited to cell

contemplated under this Agreement.

counts, sterility, viability, and infectious disease screening for Syphilis, Malaria,

2.3

LifeCell will provide the Client with the

Hepatitis B, Hepatitis C, Human

following immediately upon enrollment:

Immunodeficiency

2.3.1.

A Collection Kit.

Cytomegalovirus.

2.3.2.

A copy of this Agreement.

2.3.3.

A unique Client Relationship Management

processing and / or storage for any

(CRM) identification number that enables

reason, such as insufficient volume, low

2.7.

Virus,

and

In the event that the Specimen is determined by LifeCell to be unfit for

2.4.

the Client to quote for all communications

cell count / viability, positive screening of

with LifeCell.

infectious diseases, microbial

LifeCell at the request of the Client would arrange a qualified Phlebotomist for the

contamination of Specimen, etc., then LifeCell will notify the Client immediately, and seek instructions for disposal of the Specimen. If LifeCell does not receive

President, LifeCell International

Client's Initials

Husband's Initials

Birth Mother, if not Client

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written instructions within 60 days of such

4.1.2.

notice then LifeCell has the right to

year Storage Plan, Client makes a one-

terminate the Agreement and destroy the

time payment which includes the

Specimen without further liability.

processing and testing fee and storage of

Client Responsibilities.

3.1.

Prior to the birth of the Child the Client

the Specimen for a period of 21-years. 4.2.

genetic testing, expansion of stem cells,

(Exhibit 1), the Maternal Health History -

etc., as listed in Exhibit 2 and pay the

Genetic Mother (Exhibit 3, as applicable),

additional fees.

the Maternal Health History - Non Client Birth Mother (Exhibit 4, as applicable) and

4.3.

refundable. However in the event of the

Exhibits (Exhibit 2,5,6,7 and 8) and make

Specimen being unfit for processing, the

due payment of fees.

processing and storage fees would be refunded, and in case the Specimen is

Client is responsible for providing the

found to be unfit for storage, the storage fees would be refunded.

of child birth, and for arranging with the Care giver for collection, preparation and labeling of the Maternal Blood and the Specimen for delivery to LifeCell, in

Terms of Agreement:

5.1.

If the Client signs-up for the Annual Storage Plan, this Agreement will continue

accordance to the instructions provided

for one year from the date of birth of the

by LifeCell. The Client or the authorized

Child and will automatically renew for

representative of the Client shall also

successive one year period until the Child

ensure that the forms included in the

attains the age of 21 Years. This automatic

Collection Kit are duly filled up and sent to

renewal is subject to the Client making

LifeCell.

payment of the annual storage fee on or

Client must promptly notify LifeCell in writing of any change in Client's name or current mailing address or in the legal

before the due date every year. 5.2.

Fees for Services.

4.1.

At Enrollment Date, Client must choose

If the Client signs-up for 21-Year Storage Plan, this Agreement will continue for

guardianship of the Child.

4.1.1.

All fees paid by Client to LifeCell are non-

must read, understand, fill and sign all

Collection Kit to the Care giver at the time

3.3.

Client may also to choose to subscribe for additional services such as newborn

must complete the Enrollment Form

3.2

21-Year Storage Plan. Pursuant to the 21-

twenty one (21) years from the date of birth of the Child. 5.3.

LifeCell will make reasonable attempts to

either the Annual Storage Plan or the

notify the Client or the Child about the

21-Year Storage Plan by completing

scheduled expiry of this Agreement at

Exhibit 2.

least 60 days in advance before the Child completes the age of twenty one (21)

Annual Storage Plan. The Annual Storage

years.

Plan includes a Processing and Testing Fee and an Annual Storage Fee.

5.4.

If the Client or the Child consents his/her willingness to continue the storage beyond 21 years, the Child shall enter into

President, LifeCell International

Client's Initials

Husband's Initials

Birth Mother, if not Client

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a new Agreement with LifeCell as per the

7.2.

then prevailing terms and storage fee. 6.

to plasma and red blood cells) that remain after the Specimen is processed and that

Representations and Warranties of

are not being stored, will be disposed off

Client: Client represents and warrants that 6.1.

Any components (including but not limited

by LifeCell. 7.3.

In the event of disagreement between the

She / he is the parent or legal guardian to

parents, the Genetic Mother's wish and

the Child.

right shall prevail. On the Child attaining the age of majority, the rights and wishes

6.2.

Client has had the opportunity to consult

of the Child shall prevail.

Client's own legal counsel to review this Agreement and related forms and Client has carefully read and understood all the terms of this Agreement. 6.3.

The decision to collect the Specimen and Maternal Blood, test the Maternal Blood

Retrieval of Specimen.

8.1.

There is no fee payable by the Client to LifeCell for retrieval of Specimen.

8.2.

access or delivery by or before the end of

and process and store the Specimen is a

the 7th business day after LifeCell's

completely voluntary act of Client. 6.4.

The stored Specimen will be available for

receipt of a written request from Client. However if the Clientâ&#x20AC;&#x2122;s chosen plan also

Client has discussed with a competent medical professional, who is not an

covers isolation and expansion of stem

employee or agent of LifeCell, regarding

cells at the time of retrieval, the expanded

the collection, processing, storage and

cells would be available for access or

possible future use of the Specimen,

delivery by or before the end of 90th

including possible risks as laid out in

business day after LifeCellâ&#x20AC;&#x2122;s receipt of a

Exhibit 8.

written request from Client.

Obligations and Rights to Specimen.

7.1.

If only one parent/legal guardian of the

8.3.

The request must be made on a request form provided by LifeCell. This must be signed by the Client, and provide the

Child is the Client, such person shall be

name and address of the facility where the

solely liable for all of the obligations and

Specimen is to be delivered and the date

shall have all rights of the Client, including

of delivery is requested.

control of the Specimen. If more than one parent/legal guardian of the Child is the Client each shall be jointly and severally

8.4.

If the retrieval is requested for a transplant, the request form must be accompanied

liable and the rights shall be held by such

by transplant physicianâ&#x20AC;&#x2122;s certification

parents/legal guardians jointly, including

confirming the end-use. The stored

control of the Specimen. The exercise of

Specimen can only be released for use in

any rights and control over the Specimen

compliance with the statutory regulations

will require written notice to LifeCell signed

at the place of transplant.

by each Client.

President, LifeCell International

Client's Initials

Husband's Initials

Birth Mother, if not Client

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8.5.

Free Worldwide Shipment:

9.1.2.

hematopoietic stem cell transplant, and

In the event of a transplant, the Specimen

must be administered under the direction

would be made available for

of a transplant physician in a medical

transportation in a special cryo-shipper

facility qualified and approved by a

owned by LifeCell. For purposes of

competent authority for stem cell

convenience, LifeCell on the request of

transplantation.

the Client shall make necessary arrangements with a certified Service

The Specimen must be retrieved for a

9.2.

LifeCell Disaster Relief Program:

P ro v i d e r w h o h a s t h e re q u i re d expertise in handling and transportation of

While LifeCell shall ensure that the

such Specimen to any destination

preserved Specimen will be maintained

at no additional costs to

with utmost care, there may be

the Client. The Service Provider is not an

unforeseen events that may occur, which

agent of LifeCell and LifeCell shall not be

are beyond the reasonable control of

responsible in any manner for the services

LifeCell and which may potentially

rendered by the Service Provider.

deteriorate the Specimen during transit or

worldwide

whilst being held in cold storage 9.

LifeCell Client Benefit Programs:

premises. In the extremely unlikely

LifeCell understands the Clientâ&#x20AC;&#x2122;s need to

occurrence of such event, LifeCell will use

enhance the value of their investment and

its best endeavors to find a unit of suitable

also provide a comprehensive coverage

HLA match or pay the Client `. 1,000,000

for their Child. Therefore LifeCell through

(Rupees One Million Only) subject to the

its Client Benefit Programs provides

following conditions:

additional guarantees, insurances, and

9.2.1.

benefits which are detailed below: 9.1.

The Child or its Sibling must be positively diagnosed after the Enrolment date for a hematological malignancy treatable using

LifeCell Cares Program

the stored Specimen, and must be LifeCell understands that there may arise

scheduled for a stem cell transplant.

financial hardship in the event your Child's Specimen is required for a stem cell

9.2.2

The Specimen is lost due to change in

transplant in which case LifeCell under its

temperature arising out of loss or damage

LifeCell Cares Program will provide the

to the cold storage machinery due to

Client upto ` 500,000 (Rupees Five

operation of an insured peril (i.e.) fire,

Hundred Thousands only) to offset

lighting, explosion and implosion, aircraft

treatment related and personal family

damage, riot, strike, malicious damage

expenses, provided the following

and terrorism, storm, tempest and flood

conditions are satisfied:

and inundation, impact damage, subsidence and landslide/rockslide,

9.1.1. The Child or its sibling must be positively

bursting and/or overflowing of

diagnosed after the enrollment date

water tanks, apparatus and pipes, missile

for a hematological malignancy treatable

testing, leakage from automatic sprinkler

using the stored Specimen.

President, LifeCell International

Client's Initials

Husband's Initials

Birth Mother, if not Client

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installation, bush fire, earthquake (fire and

11.

shock), and act of terrorism. 9.3

Limitation of Liability. Client agrees that LifeCell‘s liability for any

LifeCell Payment Guarantee:

loss, harm, damage or claim of any kind in connection with this agreement or

If the Client's Specimen upon retrieval for

the services provided by LifeCell shall be

a hematopoietic stem cell transplant does

limited to the return of an amount equal to

not meet LifeCell's then prevailing viability

all fees paid by client to LifeCell. Such

criteria benchmarked against existing

limitation of liability shall in no way be

international best practices then LifeCell

diminished as a result of the LifeCell Client

will use its best endeavors to find a unit of

Benefit Program or in the event that liability

suitable HLA match to the Child or pay the

arising from acts committed by LifeCell

Client ` 1,000,000 (Rupees One Million

that are intentional and grossly negligent.

Only). 12. 9.4.

Force Majeure.

General conditions for LifeCell Client Client agrees that LifeCell shall not be

Benefit Programs:

liable for any loss, deterioration or 9.4.1.

9.4.2.

9.4.3.

The Client Agreement is valid and is in force.

destruction of all or any part of the specimen resulting from causes or

Payments would be made on appropriate

circumstances which

verification of Client’s request by LifeCell.

LifeCell’s reasonable control.

Upon payment (or providing a unit of

13.

suitable HLA match) Client would thereby

are

beyond

Indemnity to Hold Harmless. Client agrees to indemnify and hold

discharge and release LifeCell from all its

LifeCell, its respective agents, employees,

liabilities.

officers, directors, shareholders and affiliates harmless from any and all claims,

10. Disclaimers.

liabilities, demands and causes of action Neither LifeCell nor any of its officers,

asserted against them by any third party.

directors, shareholders, employees, agents or consultants have made any representations, guarantee, warranties or assurances, express or implied, to the Client of any kind other than those disclosed herein LifeCell does not perform any medical services, give any medical advice, or otherwise perform any functions other than those expressly indicated;

LifeCell

expressly

disclaims any responsibility to provide any other services.

14.

Termination of Agreement.

14.1

This Agreement may be terminated

14.1.1. by Client at any time prior to the collection of the Specimen, or 14.1.2. by LifeCell if it has exercised its right to refuse Specimen storage for any reason, including the consequential act of sample rejection as per clause 2.7 ,or 14.1.3. by LifeCell if any payment due to LifeCell is not timely paid and such failure to pay is

President, LifeCell International

Client's Initials

Husband's Initials

Birth Mother, if not Client

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not cured within 30 days after receipt of

prepaid store fees will be made by

notice from LifeCell of such failure to pay,

LifeCell to the Client.

15.

14.1.4. by mutual agreement of Client and

Arbitration: All disputes arising out of or relating to this

LifeCell, or

Agreement will be resolved by arbitration.

14.1.5. by either party upon 60 days prior written

The arbitration will take place in Chennai,

notice to the other party hereto, or

Tamilnadu, India. The Arbitration would be governed by the Arbitration and

14.1.6. in the event, the Specimen are retrieved

Conciliation Act, 1996. All decisions of the

for a transplant. However, if the Client

arbitrator shall be final, binding, and

retrieves only a portion of the Specimen

conclusive and arbitration constitutes the

the Agreement would survive and

only method of resolving disputes to this

continue until the entire Specimen has

Agreement.

been retrieved. 14.2

Effects of Termination:

16.

This Agreement is governed by, construed

14.2.1. If the Agreement is terminated under

and interpreted in accordance with the

Section 14.1.3, Client relinquishes

laws of India. Courts in Chennai shall have

all rights in and to the Specimen and

exclusive jurisdiction.

waives all claims to the Specimen and LifeCell shall have the right at its sole

Governing Law and Jurisdiction.

17.

discretion to dispose of the Specimen.

Confidentiality; Consent to Release. LifeCell acknowledges the confidential

However, LifeCell shall continue storing

nature of the information provided by

the Specimen with no liabilities to the

Client and, if different from the Client, the

Client for a period of two years from the

Birth Mother of the Child and agrees to

date of termination. During this period the

use its reasonable best efforts to maintain

Client shall have the option of reviving the

the confidentiality of the information

Agreement by paying all unpaid fees and a

except as required by law or as permitted

re-enrollment fee.

by this Agreement. Client and, if different,

14.2.2. If the Agreement is terminated by LifeCell

the Birth Mother of the Child hereby agree

under Section 14.1.5, LifeCell shall at its

to the release of information to the

own cost arrange for transfer of Specimen

hospital, laboratory or physician providing

to a comparable stem cell bank facility and

the services to the Client.

pay the new stem cell bank for storing the Specimen for the remaining period of the Agreement. 14.2.3. If the Agreement is terminated under

18.

Multiple Births. In the event of multiple births, if the Client desires to engage LifeCell to process, and

Section 14.1.6 a pro-rated refund of the

President, LifeCell International

Client's Initials

Husband's Initials

Birth Mother, if not Client

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store the cord blood and/or cord tissue for

mother of the Child and supersedes any

each Child, the Client must check the

prior agreements or understandings, oral

appropriate box on the Enrollment Form

and written.

and pay the additional fees. 19.

22.

Assignment.

All provisions which by their terms require

LifeCell may assign this Agreement to any

performance after the termination of this

individual or entity providing a similar

Agreement will survive the termination of

service. If LifeCell is acquired by or

this Agreement.

merged with or into another company, LifeCell shall require that the terms of this

20.

23.

All of the obligations, terms, provisions

effect.

and releases set forth in this Agreement, shall be binding upon and inure to the benefit of LifeCell, the Client, and their

Any notice shall be sufficiently given if

respective

delivered in person or sent by express mail

representatives, successors, and

or by registered or certified mail, postage

assigns.

prepaid. 20.2.

24.

Notice to LifeCell must be delivered to

personal

Severability.

invalid or unenforceable, such provision is

Vandalur Kelambakkam Main Road,

deemed modified to the extent necessary

Keelakotaiyur, Chennai â&#x20AC;&#x201C; 600048.

to make the Agreement enforceable, and

Notice to Client will be delivered to the

this Agreement shall otherwise remain in

address set forth in the Enrollment form or

full force and effect.

as updated by Client to LifeCell. 21.

heirs,

If any part of this Agreement is found to be

LifeCell International Private Limited, 26

20.3.

Binding Effect.

Agreement continue in full force and

Notice.

20.1.

Survival.

Entire Agreement.

25.

Headings. The headings in this Agreement are for

This Agreement and the exhibits hereto

reference purposes only and shall not

constitute the entire agreement between

affect the meaning or interpretation of this

LifeCell, Client and, if different, the birth

Agreement.

I ACCEPT ALL TERMS AND CONDITIONS OF THIS AGREEMENT

Name and Signature of Mother/Legal Guardian

Name and Signature of Father/Legal Guardian

Name of Birth Mother if not the Client

Signature of Birth Mother if not the Client

Date:

President, LifeCell International

Client's Initials

Husband's Initials

Birth Mother, if not Client

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1.7.

cells obtained from umbilical cord blood

In this Agreement, (including the recitals above),

and /or umbilical cord tissue individually or

unless the context otherwise requires, the following

collectively.

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.

T N E I L C

‘Specimen’ means and includes stem

1.8.

COPY

‘Collection Kit’ means the kit consisting of all essential materials required for the purpose of collection and labeling of the Maternal Blood and Specimen, such as

‘Client’ means the parent or legal

Cord Blood Collection Bag, Cord Tissue

guardian of the Child.

Collection Containers, Bar code labels, Vacuum Test Tubes, Foam Bricks, Alcohol

1.3.

‘Birth Mother’ means the one who has

Swabs, Hologram Stickers, Maternal

borne the child in her womb. 1.4.

Blood and Specimen Collection and

‘Genetic Mother’ if different from the

Packing Instructions, Sealable Plastic

Birth Mother means the mother from

Bags and Absorbent Paper Towels, and

whom the egg has been obtained.

all packed in a certified transport container

‘Care giver’ means the Obstetrician /

Association (IATA) regulations.

compliant with International Air Transport 1.5.

Gynecologist or qualified medical professional / midwife who will be

1.9.

‘LifeCell Laboratory’ means LifeCell's licensed and accredited laboratory

assisting in delivering the Child.

facilities where the Specimen is 1.6.

‘Maternal Blood’ means peripheral

processed, tested, and stored.

blood from Birth Mother of the Child, that has been drawn by observing standard

1.10.

‘Minimally Manipulated Stem Cells’

phlebotomy procedures, taken seven (7)

means stem cells that have not been

days before or after the birth of the Child.

subjected to ex-vivo procedure such as expansion of cell populations, genetic alterations, etc.

President, LifeCell International

Client's Initials

Husband's Initials

Birth Mother, if not Client

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1.11.

1.12.

‘Minimally Expanded Stem Cells’

collection of Maternal Blood and

means cells that have been obtained from

Specimen at no additional costs to the

ex-vivo isolation and not subjected to

Client. The discretion of engaging the

further passaging.

Phlebotomist shall solely vest with the Client. The Phlebotomist is not an agent of

‘Hematopoietic Stem Cells’ means

LifeCell and LifeCell shall not be

multi-potent stem cells that are

responsible in any manner for the services

characterized by the expression of the

rendered by the Phlebotomist.

marker CD34. 1.13.

‘Mesenchymal Stem Cells’ means

2.5.

arrange for pick-up of the Maternal Blood

multi-potent stem cells that can

and Specimen from the Hospital / Nursing

differentiate into a variety of cell types and

Home to LifeCell Laboratory, using a

are characterized by expression of

certified Service Provider who has the

the markers CD90 and CD105. 1.14.

LifeCell at the request of the Client would

required expertise in the correct

‘Sibling’ means a brother or sister of the

handling and transportation of such

Child having one or both parents in

Maternal Blood and Specimen at no

common.

additional costs to the Client. The Service Provider is not an agent of LifeCell and

Services of LifeCell; Testing,

LifeCell shall not be responsible in any

Processing, Preserving and

manner for the services rendered by the

PY Service Provider. O C LifeCell offers its services under variousNT 2.6. Upon successful collection, processing LIE Cchoose options which the Client must and storage, LifeCell will provide the Client

Storage. 2.1.

2.2.

from as detailed in Exhibit 2.

with a Preservation Certificate confirming

LifeCell shall obtain all statutory

successful storage of the Specimen along

permissions and licenses that might be

with sample storage details and test

required for providing the services

results including but not limited to cell

contemplated under this Agreement.

counts, sterility, viability, and infectious disease screening for Syphilis, Malaria,

2.3

LifeCell will provide the Client with the

Hepatitis B, Hepatitis C, Human

following immediately upon enrollment:

Immunodeficiency

2.3.1.

A Collection Kit.

Cytomegalovirus.

2.3.2.

A copy of this Agreement.

2.3.3.

A unique Client Relationship Management

processing and / or storage for any

(CRM) identification number that enables

reason, such as insufficient volume, low

2.7.

Virus,

and

In the event that the Specimen is determined by LifeCell to be unfit for

2.4.

the Client to quote for all communications

cell count / viability, positive screening of

with LifeCell.

infectious diseases, microbial

LifeCell at the request of the Client would arrange a qualified Phlebotomist for the

contamination of Specimen, etc., then LifeCell will notify the Client immediately, and seek instructions for disposal of the Specimen. If LifeCell does not receive

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Client's Initials

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Birth Mother, if not Client

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written instructions within 60 days of such

4.1.2.

notice then LifeCell has the right to

year Storage Plan, Client makes a one-

terminate the Agreement and destroy the

time payment which includes the

Specimen without further liability.

processing and testing fee and storage of

Client Responsibilities.

3.1.

Prior to the birth of the Child the Client

the Specimen for a period of 21-years. 4.2.

genetic testing, expansion of stem cells,

(Exhibit 1), the Maternal Health History -

etc., as listed in Exhibit 2 and pay the

Genetic Mother (Exhibit 3, as applicable),

additional fees.

the Maternal Health History - Non Client Birth Mother (Exhibit 4, as applicable) and

4.3.

refundable. However in the event of the

Exhibits (Exhibit 2, 5,6,7 and 8) and make

Specimen being unfit for processing, the

due payment of fees.

processing and storage fees would be refunded, and in case the Specimen is

Client is responsible for providing the

found to be unfit for storage, the storage fees would be refunded.

of child birth, and for arranging with the Care giver for collection, preparation and labeling of the Maternal Blood and the

PY O C T accordance to the instructions provided N E I L by LifeCell. The Client or the Cauthorized Specimen for delivery to LifeCell, in

5.1.

representative of the Client shall also

before the due date every year. 5.2.

4.1.

At Enrollment Date, Client must choose

If the Client signs-up for 21-Year Storage Plan, this Agreement will continue for

guardianship of the Child. Fees for Services.

Child and will automatically renew for

payment of the annual storage fee on or

Client must promptly notify LifeCell in

Storage Plan, this Agreement will continue for one year from the date of birth of the

renewal is subject to the Client making

LifeCell.

current mailing address or in the legal

If the Client signs-up for the Annual

attains the age of 21 Years. This automatic

Collection Kit are duly filled up and sent to

writing of any change in Client's name or

Terms of Agreement:

successive one year period until the Child

ensure that the forms included in the

4.1.1.

All fees paid by Client to LifeCell are non-

must read, understand, fill and sign all

Collection Kit to the Care giver at the time

3.3.

Client may also to choose to subscribe for additional services such as newborn

must complete the Enrollment Form

3.2

21-Year Storage Plan. Pursuant to the 21-

twenty one (21) years from the date of birth of the Child. 5.3.

LifeCell will make reasonable attempts to

either the Annual Storage Plan or the

notify the Client or the Child about the

21-Year Storage Plan by completing

scheduled expiry of this Agreement at

Exhibit 2.

least 60 days in advance before the Child completes the age of twenty one (21)

Annual Storage Plan. The Annual Storage

years.

Plan includes a Processing and Testing Fee and an Annual Storage Fee.

5.4.

If the Client or the Child consents his/her willingness to continue the storage beyond 21 years, the Child shall enter into

President, LifeCell International

Client's Initials

Husband's Initials

Birth Mother, if not Client

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a new Agreement with LifeCell as per the

7.2.

then prevailing terms and storage fee. 6.

to plasma and red blood cells) that remain after the Specimen is processed and that

Representations and Warranties of

are not being stored, will be disposed off

Client: Client represents and warrants that 6.1.

Any components (including but not limited

by LifeCell. 7.3.

In the event of disagreement between the

She / he is the parent or legal guardian to

parents, the Genetic Mother's wish and

the Child.

right shall prevail. On the Child attaining the age of majority, the rights and wishes

6.2.

Client has had the opportunity to consult

of the Child shall prevail.

Client's own legal counsel to review this Agreement and related forms and Client has carefully read and understood all the terms of this Agreement. 6.3.

The decision to collect the Specimen and Maternal Blood, test the Maternal Blood

Retrieval of Specimen.

8.1.

There is no fee payable by the Client to LifeCell for retrieval of Specimen.

8.2.

access or delivery by or before the end of

and process and store the Specimen is a

the 7th business day after LifeCell's

completely voluntary act of Client. 6.4.

The stored Specimen will be available for

receipt of a written request from Client. However if the Clientâ&#x20AC;&#x2122;s chosen plan also

Client has discussed with a competent

covers Y isolation and expansion of stem P O C cells at the time of retrieval, the expanded employee or agent of LifeCell, regarding T N E cells would be available for access or the collection, processing, storage CLIand delivery by or before the end of 90th medical professional, who is not an

possible future use of the Specimen, including possible risks as laid out in

business day after LifeCellâ&#x20AC;&#x2122;s receipt of a

Exhibit 8.

written request from Client.

Obligations and Rights to Specimen.

7.1.

If only one parent/legal guardian of the

8.3.

The request must be made on a request form provided by LifeCell. This must be signed by the Client, and provide the

Child is the Client, such person shall be

name and address of the facility where the

solely liable for all of the obligations and

Specimen is to be delivered and the date

shall have all rights of the Client, including

of delivery is requested.

control of the Specimen. If more than one parent/legal guardian of the Child is the Client each shall be jointly and severally

8.4.

If the retrieval is requested for a transplant, the request form must be accompanied

liable and the rights shall be held by such

by transplant physicianâ&#x20AC;&#x2122;s certification

parents/legal guardians jointly, including

confirming the end-use. The stored

control of the Specimen. The exercise of

Specimen can only be released for use in

any rights and control over the Specimen

compliance with the statutory regulations

will require written notice to LifeCell signed

at the place of transplant.

by each Client.

President, LifeCell International

Client's Initials

Husband's Initials

Birth Mother, if not Client

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8.5.

Free Worldwide Shipment:

9.1.2.

hematopoietic stem cell transplant, and

In the event of a transplant, the Specimen

must be administered under the direction

would be made available for

of a transplant physician in a medical

transportation in a special cryoshipper

facility qualified and approved by a

owned by LifeCell. For purposes of

competent authority for stem cell

convenience, LifeCell on the request of

transplantation.

the Client shall make necessary arrangements with a certified Service

The Specimen must be retrieved for a

9.2.

LifeCell Disaster Relief Program:

P ro v i d e r w h o h a s t h e re q u i re d expertise in handling and transportation of

While LifeCell shall ensure that the

such Specimen to any destination

preserved Specimen will be maintained

at no additional costs to

with utmost care, there may be

the Client. The Service Provider is not an

unforeseen events that may occur, which

agent of LifeCell and LifeCell shall not be

are beyond the reasonable control of

responsible in any manner for the services

LifeCell and which may potentially

rendered by the Service Provider.

deteriorate the Specimen during transit or

worldwide

whilst being held in cold storage 9.

LifeCell Client Benefit Programs:

premises. In the extremely unlikely

LifeCell understands the Clientâ&#x20AC;&#x2122;s need to

occurrence of such event, LifeCell will use

enhance the value of their investment and

PY O C T for their Child. Therefore LifeCell through N E I L C provides its Client Benefit Programs

its best endeavors to find a unit of suitable

also provide a comprehensive coverage

HLA match or pay the Client `. 1,000,000 following conditions:

additional guarantees, insurances, and

The Child or its Sibling must be positively

9.2.1.

benefits which are detailed below: 9.1.

(Rupees One Million Only) subject to the

diagnosed after the Enrolment date for a hematological malignancy treatable using

LifeCell Cares Program

the stored Specimen, and must be LifeCell understands that there may arise

scheduled for a stem cell transplant.

financial hardship in the event your Child's Specimen is required for a stem cell

9.2.2

The Specimen is lost due to change in

transplant in which case LifeCell under its

temperature arising out of loss or damage

LifeCell Cares Program will provide the

to the cold storage machinery due to

Client upto ` 500,000 (Rupees Five

operation of an insured peril (i.e.) fire,

Hundred Thousands only) to offset

lighting, explosion and implosion, aircraft

treatment related and personal family

damage, riot, strike, malicious damage

expenses, provided the following

and terrorism, storm, tempest and flood

conditions are satisfied:

and inundation, impact damage, subsidence and landslide/rockslide,

9.1.1. The Child or its sibling must be positively

bursting and/or overflowing of

diagnosed after the enrollment date

water tanks, apparatus and pipes, missile

for a hematological malignancy treatable

testing, leakage from automatic sprinkler

using the stored Specimen.

President, LifeCell International

Client's Initials

Husband's Initials

Birth Mother, if not Client

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installation, bush fire, earthquake (fire and

11.

shock), and act of terrorism. 9.3

Limitation of Liability. Client agrees that LifeCell‘s liability for any

LifeCell Payment Guarantee:

loss, harm, damage or claim of any kind in connection with this agreement or

If the Client's Specimen upon retrieval for

the services provided by LifeCell shall be

a hematopoietic stem cell transplant does

limited to the return of an amount equal to

not meet LifeCell's then prevailing viability

all fees paid by client to LifeCell. Such

criteria benchmarked against existing

limitation of liability shall in no way be

international best practices then LifeCell

diminished as a result of the LifeCell Client

will use its best endeavors to find a unit of

Benefit Program or in the event that liability

suitable HLA match to the Child or pay the

arising from acts committed by LifeCell

Client ` 1,000,000 (Rupees One Million

that are intentional and grossly negligent.

Only). 12. 9.4.

Force Majeure.

General conditions for LifeCell Client Client agrees that LifeCell shall not be

Benefit Programs:

liable for any loss, deterioration or 9.4.1.

9.4.2.

The Client Agreement is valid and is in force.

specimen resulting from causes or circumstances which

Payments would be made on appropriate verification of Client’s request by LifeCell.

9.4.3.

destruction of all or any part of the

T N E I L suitable HLA match) Client would Cthereby Upon payment (or providing a unit of

are

beyond

CO13.PY Indemnity to Hold Harmless. LifeCell’s reasonable control.

Client agrees to indemnify and hold

discharge and release LifeCell from all its

LifeCell, its respective agents, employees,

liabilities.

officers, directors, shareholders and affiliates harmless from any and all claims,

10. Disclaimers.

liabilities, demands and causes of action Neither LifeCell nor any of its officers,

asserted against them by any third party.

LifeCell

expressly

disclaims any responsibility to provide any other services.

14.

Termination of Agreement.

14.1

This Agreement may be terminated

President, LifeCell International

Client's Initials

Husband's Initials

Birth Mother, if not Client

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not cured within 30 days after receipt of

prepaid store fees will be made by

notice from LifeCell of such failure to pay,

LifeCell to the Client.

15.

14.1.4. by mutual agreement of Client and

Arbitration: All disputes arising out of or relating to this

LifeCell, or

Agreement will be resolved by arbitration.

14.1.5. by either party upon 60 days prior written

The arbitration will take place in Chennai,

notice to the other party hereto, or

Tamilnadu, India. The Arbitration would be governed by the Arbitration and

14.1.6. in the event, the Specimen are retrieved

Conciliation Act, 1996. All decisions of the

for a transplant. However, if the Client

arbitrator shall be final, binding, and

retrieves only a portion of the Specimen

conclusive and arbitration constitutes the

the Agreement would survive and

only method of resolving disputes to this

continue until the entire Specimen has

Agreement.

been retrieved. 14.2

Effects of Termination:

16.

Governing Law and Jurisdiction. This Agreement is governed by, construed

14.2.1. If the Agreement is terminated under

and interpreted in accordance with the

Section 14.1.3, Client relinquishes

laws of India. Courts in Chennai shall have

all rights in and to the Specimen and

P17.Y O C T N discretion to dispose of the Specimen. E I L C storing However, LifeCell shall continue waives all claims to the Specimen and

LifeCell shall have the right at its sole

the Specimen with no liabilities to the

exclusive jurisdiction. Confidentiality; Consent to Release. LifeCell acknowledges the confidential nature of the information provided by Client and, if different from the Client, the

Client for a period of two years from the

Birth Mother of the Child and agrees to

date of termination. During this period the

use its reasonable best efforts to maintain

Client shall have the option of reviving the

the confidentiality of the information

Agreement by paying all unpaid fees and a

except as required by law or as permitted

re-enrollment fee.

by this Agreement. Client and, if different,

14.2.2. If the Agreement is terminated by LifeCell

the Birth Mother of the Child hereby agree

under Section 14.1.5, LifeCell shall at its

to the release of information to the

own cost arrange for transfer of Specimen

hospital, laboratory or physician providing

to a comparable stem cell bank facility and

the services to the Client.

pay the new stem cell bank for storing the Specimen for the remaining period of the Agreement. 14.2.3. If the Agreement is terminated under

18.

Multiple Births. In the event of multiple births, if the Client desires to engage LifeCell to process, and

Section 14.1.6 a pro-rated refund of the

President, LifeCell International

Client's Initials

Husband's Initials

Birth Mother, if not Client

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store the cord blood and/or cord tissue for

mother of the Child and supersedes any

each Child, the Client must check the

prior agreements or understandings, oral

appropriate box on the Enrollment Form

and written.

and pay the additional fees. 19.

22.

Assignment.

All provisions which by their terms require

LifeCell may assign this Agreement to any

performance after the termination of this

individual or entity providing a similar

Agreement will survive the termination of

service. If LifeCell is acquired by or

this Agreement.

merged with or into another company, LifeCell shall require that the terms of this

20.

23.

Binding Effect.

Agreement continue in full force and

All of the obligations, terms, provisions

effect.

and releases set forth in this Agreement, shall be binding upon and inure to the

Notice.

20.1.

Survival.

benefit of LifeCell, the Client, and their

Any notice shall be sufficiently given if

respective

delivered in person or sent by express mail

representatives, successors, and

or by registered or certified mail, postage

assigns.

prepaid.

24.

heirs,

personal

Severability.

If any part of this Agreement is found to be PY invalid O C or unenforceable, such provision is T N Vandalur Kelambakkam Main Road, E I L deemed modified to the extent necessary C Keelakotaiyur, Chennai â&#x20AC;&#x201C; 600048.

20.2.

Notice to LifeCell must be delivered to

LifeCell International Private Limited, 26

to make the Agreement enforceable, and

20.3.

Notice to Client will be delivered to the

this Agreement shall otherwise remain in

address set forth in the Enrollment form or

full force and effect.

as updated by Client to LifeCell. 21.

Entire Agreement.

25.

Headings. The headings in this Agreement are for

This Agreement and the exhibits hereto

reference purposes only and shall not

constitute the entire agreement between

affect the meaning or interpretation of this

LifeCell, Client and, if different, the birth

Agreement.

I ACCEPT ALL TERMS AND CONDITIONS OF THIS AGREEMENT

Name and Signature of Mother/Legal Guardian

Name and Signature of Father/Legal Guardian

Name of Birth Mother if not the Client

Signature of Birth Mother if not the Client

Date:

President, LifeCell International

Client's Initials

Husband's Initials

Birth Mother, if not Client

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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 of any medical condition that could affect the collection or use of the stem cells such as,

Cancer, diabetes, hepatitis, blood disease, bleeding problem, heart disease, drug or alcohol abuse.

HIV/AIDS or a positive test for the HIV/AIDS virus, HTLV, malaria, Chaga's disease.

Stroke, seizure or multiple sclerosis, lung disease, kidney disease, liver disease, babesiosis, genetic disorder.

Do you currently have or are you being treated for any type of infection?

Do you have, or have a family history of, dementia, degenerative or neurological disease, or creutzfeld Jakob disease?

In the past 6 months have you received a bite from an animal suspected of rabies?

Have you been treated for a sexually transmitted disease in the last 12 months?

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?

In the past 12 months have you been in juvenile detention, lock-up, jail or prison for more than 72 hours?

In the past 12 months have you lived with a person who has hepatitis?

Have you in the past 5 years taken intravenous drugs not prescribed by a physician?

10.

Have you in the past 5 years received compensation for sex?

11.

Have you ever received whole blood, blood factor products, blood derivatives, growth hormones, bone or skin graft, or a tissue, organ (either human or animal), dura mater or bone marrow transplant?

12.

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 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

Birth Mother, if not Client

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13.

From 1980 through 1996 have you:

Spent 3 months or more cumulatively in the United Kingdom? If so, what city and country?

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? If so, what city & country?

17.

Have you experienced any of the following conditions that can be signs or symptoms of HIV/AIDS?

Unexplained weight loss or night sweats?

Blue or purple spots in your mouth or skin?

Swollen lymph nodes for more than one month?

White spots or unusual sores in your mouth?

Cough that wont go away or shortness of breath?

Diarrhea that won't go away?

Fever of more than 38.6 degree celcius 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 Motherâ&#x20AC;&#x2122;s Name:.....................................................

For LifeCell Medical Team use only. Reviewed by:..................................................

Genetic Motherâ&#x20AC;&#x2122;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 (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. 1.