Client Enrollment Form & Agreement GCC COUNTRIES Name: .......................................................................................... CRM No.: ...................................................................................... Country: ................................City:................................................
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 Arabia FZ LLC (‘LifeCell’) to process, and store stem cells obtained from the umbilical cord tissue and/or stem cells from umbilical cord blood and/or placental blood collected at birth of the Child, and to test the blood of the birth mother 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: 1.9
‘Engraftment' means three consecutive days in which the transplant recipient's absolute neutrophil count is equal to or greater than 500/microliter with the first measurement occurring within 100 days of transplant.
1.10
‘Mesenchymal Stem Cell’ means multipotent stem cells that can differentiate into a variety of cell types and are characterized by expression of markers CD90 and CD105.
1.11
‘Specimen’ means and includes stem cells obtained from umbilical cord blood and /or placental blood and /or umbilical cord tissue individually or collectively.
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
‘Birth Mother’ means the one who has borne the child in the womb.
1.4
‘Genetic Mother’ if different from the Birth Mother means the mother from whom the egg has been obtained
1.5
‘Collection Kit’ means the kit consisting of all necessary materials provided by LifeCell to the Client after enrollment, for the purpose of collection of Maternal Blood and the Specimen.
1.6
‘LifeCell Laboratory’ means LifeCell's laboratory facilities owned and operated by its parent company LifeCell International Pvt Ltd situated at No 26, Vandalur Kelambakkam Main Road, Keelakottiyur, Chennai, India 600048, or such other laboratory that LifeCell may designate from time to time.
1.7
‘Maternal Blood’ means peripheral blood taken from Genetic Mother of the Child, observing standard phlebotomy procedures, before or after the birth of the Child.
1.8
‘Minimally manipulated stem cells’ means stem cells that have not been subjected to ex-vivo procedure such as expansion of cell populations, genetic alterations, etc.
President - LifeCell, Arabia
2. Services of LifeCell; Testing, Processing, Preserving and Storage. 2.1.
LifeCell offers its services under various options which the Client must choose in the Enrollment Form (Exhibit 2).
2.2.
LifeCell shall obtain all statutory permissions and licenses that might be required for providing the services contemplated under this Agreement.
2.3.
LifeCell also conducts the following tests: (a) a microbiological screen on the Specimen and (b) hematology analysis including blood grouping and cell counting on the Specimen, and (c) Infectious disease screening of the Maternal Blood f or Syphilis, Malar ia, Hepatitis B, Hepatitis C, HIV and cytomegalovirus.
2.4
Upon successful enrollment, LifeCell will provide the Client with the following: 2.4.1. A Collection Kit 2.4.2. A copy of the Agreement 2.4.3. A unique Client Relationship Management (CRM) identification number that enables the
Mother’s Initials
Father’s Initials
Birth Mother, if not Client
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3. Client Responsibilities. 3.1.
On the Enrollment Date, Client must complete the Enrollment Form (Exhibit 1), the Maternal Health History (Exhibit 2), and must read, understand, and execute the Informed Consent to Infectious Disease (Exhibit 4), Authorisation to collect Cord blood, cord tissue, and Maternal Blood, and release from Liability (Exhibit 5)
3.2.
Client must select qualified personnel to collect, prepare and label the Maternal Blood and the Specimen for delivery to LifeCell in accordance with the instructions given in the Collection Kit. In particular the Client must ensure that a minimum of 40 milliliters of Cord Blood, 15 centimeters of Cord Tissue and 15 milliliters of Maternal Blood is collected, since smaller specimen’s may no t be suit able f or processing. The selection of qualified personnel to collect, prepare and label the Maternal Blood and Specimen and payment for their services is Client’s sole r es p o n s i b i l i t y. T h e C l i en t o r t h e a u t h o r i z ed representative of the Client shall also ensure that the forms included in the Collection Kit are duly filled up and sent to LifeCell.
3.3.
It is the responsibility of the Client to deliver the Maternal Blood and Specimen to LifeCell's Laboratory wit hin 48 hour s of collection of Specimen. For purposes of convenience LifeCell has identified a courier company, who has the required expertise in handling the same for proper transportation. Client may choose this agency for forwarding the Maternal Blood and Specimen to LifeCell. The courier charges will be borne by LifeCell. The selected courier is not an agent of LifeCell and LifeCell is not liable for any deterioration, loss or destruction of the Maternal Blood or Specimen prior to receipt by LifeCell at LifeCell Laboratory.
insufficient/unfit for processing, US $200 (US Dollars Two Hundred Only), would be withheld, and the rest of the fees would be refunded, and in case the specimen is found to be unfit for storage for any reason, including but not limited to (i) low total nucleated cell counts or (ii) low viability, US $1,000 (US Dollars One Thousand Only), would be withheld, and the rest of the fees would be refunded. 4.3.
In the unlikely event that LifeCell elects to terminate this agreement under section 18, a pro-rated refund of the prepaid store fees will be made by LifeCell to the Client. Further, LifeCell guarantees the continuity of storage of your specimen by transferring it at its own cost to a comparable stem cell bank facility, nominated by LifeCell at no extra charge. If the Client elects to nominate an alternative facility for the transfer, the Client will have to bear the cost of the transportation.
5. Term of Agreement 5.1
This Agreement will continue for twenty one (21) years from the date of birth of the Child provided the agreement is not terminated under Section 18.
5.2
LifeCell will make reasonable attempts to notify the Client or the Child about the scheduled expiry of this Agreement at least 60 days in advance before the Child completes the age of twenty one (21) years.
5.3
If the Client or the Child consents his/her willingness to continue the storage beyond 21 years, the Child shall enter into a new Agreement with LifeCell as per the then prevailing terms.
6. Storage Terms. The Specimen will be stored as follows: 6.1.
The Specimen will initially be stored in LifeCell Laboratory in Chennai, India. LifeCell reserves the right to relocate the Specimen to another location which is equivalent to LifeCell's Laboratory.
6.2.
If the Specimen is relocated, LifeCell will notify Client within 60 days after such relocation.
Fees include the processing and testing fee and storage of the Specimen for a period of 21-years.
6.3.
The Specimen will be stored so long as all fees have been timely paid.
All fees paid by Client to LifeCell are non-refundable. However in the event of the Specimen being
6.4.
LifeCell supports the LifeCell Cares Program in accordance with clause 12 with its terms and conditions.
3.4.
During the term of the agreement, Client must promptly notify LifeCell in writing of any change in Client's name or current mailing address or in the legal guardianship of the Child.
4.
Fees for Services.
4.1 4.2.
President - LifeCell, Arabia
Mother’s Initials
Father’s Initials
Birth Mother, if not Client
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7. Informed Consent of Mother for Infectious Disease Testing. 7.1.
7.2.
By signing this Agreement and the Informed Consent for Infectious Disease & HIV testing (Exhibit 4), the Birth Mother grants her consent to perform the testing on Maternal Blood. If any test results are positive, the results will be shown to both the mother and physician indicated in the Enrolment Form. If the HIV screening test is positive, another test will be required to confirm the result. If the positive HIV screening is confirmed, the Birth Mother consents to the delivery of these results to the mother's physician indicated in the Informed Consent Form. In the event of laws requiring the disclosure of results to any authority by LifeCell or by its parent company, the Birth Mother is deemed to have given her consent. If any of the tests are positive, LifeCell may decline to continue storing the Specimen. Client shall pay the cost of any confirmatory testing, including the cost of shipping the Maternal Blood to another testing laboratory, with the prior consent of the Client. LifeCell does not assume responsibility or liability for confirmatory testing performed by another testing laboratory.
8. Representations and Warranties of Client. Client represents and warrants that 8.1.
He/she is the parent or legal guardian to the Child;
8.2.
Client has had the opportunity to consult 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;
8.3.
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;
and Maternal Blood to LifeCell. Client is aware that banking a Child's Specimen 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 Specimen is indicated, based on the nature and progression of the disease and the HLA matching for donor and recipient. 10. Obligations and Rights to Specimen. 10.1.
10.2. Any components (including but not limited to plasma and red blood cells) that remain after the Specimen is processed and that are not being stored, will be disposed off by LifeCell. 10.3. If there is a disagreement between the parents, the mother's wish and right shall prevail. On the Child attaining the age of majority, the rights and wishes of the Child shall prevail. 10.4. Upon t er mination of t his Agr eement, 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 utilize, donate for research or dispose of the Specimen. 11. Retrieval of Specimen. 11.1.
8.4.
Client has discussed this Agreement with a competent medical professional who is not an employee or agent of LifeCell.
9. Assumption of potential risk by Client. Client acknowledges that he/she has been fully informed of, accepts and agrees to the conditions, risks, limitations and costs of processing, testing and storage of the Specimen. Client assumes all risks associated with the collection, preparation and delivery of the Specimen
President - LifeCell, Arabia
If only one parent/legal guardian of the Child is the Client, such person shall be solely liable for all of the obligations and shall have all rights of the Client, including control of the Specimen. If more than one parent/legal guardian of the Child is the Client each shall be jointly and severally liable and the rights shall be held by such parents/legal guardians jointly, including control of the Specimen. The exercise of any rights and control over the Specimen will require written notice to LifeCell signed by each Client.
There is no fee payable by the Client to LifeCell for retrieval of Specimen, however, any additional expenses on account of testing of blood or third par ty expenses, including but not limit ed t o isolation, expansion, and or differentiation of stem cells at the time of issue are to be borne by the Client. The stored Specimen will be available for access or delivery by or before the end of 15th business day af ter LifeCell’s receipt of a written request from Client. The request must be made on a request form provided by LifeCell, and must be signed by the client.
Mother’s Initials
Father’s Initials
Birth Mother, if not Client
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11.2.
11.3.
The stored Specimen can only be released for use in treatments duly approved by competent governing medical authority of the domicile country and as approved by drug controller General of India a n d / o r Indian Council of Medical Research approved treatment or clinical trials. Drug Controller General of India and/or Indian Council of Medical Research approved treatments or clinical trials. If the retrieval is requested for a transplant then the request form must be accompanied by transplant physician’s certification confirming the end - use.
procedures, including mini-transplants. The transplant recipient must not have used an investigational drug within 100 days before transplantation. 12.6. The Specimen thawing procedure must be a validat ed procedure used by the transplant facility and the Specimen must be administered immediately upon thawing. 12.7.
LifeCell Cares Program is valid for Clients who have signed LifeCell's standard Agreement, and whose payments to LifeCell for its services are continuing.
Free Worldwide Shipment: In the event of a transplant, charges on account of courier/transportation etc., to the d e s i g n a t e d destination anywhere in the world will be borne by LifeCell. For the purpose of convenience LifeCell has identified a courier company who has the required exper tise in handling the same for proper tr anspor t ation. The Client may choose t his agency for transporting the stored specimen from LifeCell laboratory. The selected courier is not an agent of LifeCell and LifeCell is not liable for any deterioration, loss or destruction of the specimen during transportation to the designated destination.
13. LifeCell Payment Guarantee If the Client's Specimen upon retrieval either (a)
does not meet LifeCell's viability criteria, or
(b)
if used in an autologous hematopoietic stem cell transplant using recognized medical procedures and fails to engraft, LifeCell will pay the Client US $ 25,000 (Twenty Five Thousand US Dollars Only) provided the following conditions are satisfied:
13.1.
Compliance to all conditions of the LifeCell Cares Program. 5
12. LifeCell Cares Program LifeCell assures that your Child's Specimen will be well cared for throughout the storage term chosen by you. In the event your Child's Specimen is required for a stem cell transplant, LifeCell understands that there may arise financial hardship, in which case LifeCell under its LifeCell Cares Program will provide the Client up to US $10,000 (Ten Thousand US Dollars only) to offset Transplant expenses, provided the following conditions are satisfied: 12.1.
The Specimen must be collected using LifeCell's Collection Kit or approved alternative collection technique.
12.2. The Specimen must be processed and at all times stored by LifeCell. 12.3. The Specimen must be used in an autologous manner for homologous use (hematopoietic reconstitution). 12.4. The Specimen must be administered under the direction of a transplant physician in a medical facility qualified and approved by competent authority for stem cell transplantation. 12.5. The Specimen must not be used in experimental
President - LifeCell, Arabia
13.2. The Specimen must contain at least 1X10 CD34+ cells per kilogram body weight of ‘recipient’. 13.3. Client will provide signed statement from the transplant physician attesting that engraftment did not occur along with supporting medical records documenting proof of non-engraftment. 13.4. LifeCell will pay within 30 days of Client's appropriate verified request. 13.5. The payment of US $ 25,000 (Twenty Five Thousand US Dollars Only) would discharge and release LifeCell from all its liabilities. 14. Disclaimers. Client acknowledges that neither LifeCell nor any of its officers, directors, shareholders, executives, employees, agents or consultants have made any representations, guarantee, warranties or assurances, express or implied, to Client regarding the success of the collection, transpor tation, testing, processing, cryopreservation, storage process or use of the Specimen. The client acknowledges the following express disclaimer and releases LifeCell from any liability if the personnel selected by the Client are unable to collect the Maternal Blood
Mother’s Initials
Father’s Initials
Birth Mother, if not Client
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or Specimen or if such personnel are unable to collect a suficient volume of Specimen for Testing, processing and storage or subsequent use or if any damage to or destruction or loss of, the Specimen or Maternal Blood by the courier selected by LifeCell. 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. 15. LIMITATION OF LIABILITY: 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. SUCH LIMITATION OF LIABILITY SHALL IN NO WAY BE DIMINISHED AS A RESULT OF THE LIFECELL CARES PROGRAM. 16. FORCE MAJEURE: CLIENT AGREES THAT LIFECELL SHALL NOT BE LIABLE FOR ANY LOSS, DETERIORATION OR DESTRUCTION OF ALL OR ANY PART OF THE SPECIMEN RESULTING FROM CAUSES OR CIRCUMSTANCES BEYOND LIFECELL'S REASONABLE CONTROL, INCLUDING, BUT NOT LIMITED TO FIRE, EXPLOSIONS, NATURAL DISASTERS, TERRORIST ACTS OR ACTS OF WAR. 17. Indemnity and Hold Harmless. Client agrees to indemnify and hold LifeCell and Client's hospital and physicians and their respective agents, employees, officers, directors, shareholders and affiliates harmless from any and all claims, liabilities, demands and causes of action asserted against them by any person or entity, including any third party beneficiary of this Agreement. 18. Termination of Agreement. This Agreement may be terminated: (a)
by Client at any time prior to the collection of the Specimen, or
(b)
by LifeCell if it has exercised its right to refuse Specimen storage for any reason, or
(c)
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, or
(d)
by mutual agreement of Client and LifeCell, or
President - LifeCell, Arabia
(e)
by either party upon 60 days prior written notice to the other party hereto, or
(f)
in the event, the Specimen is retrieved for a transplant. Both LifeCell and Client specifically agree that the notice period for termination is fair and reasonable. Upon termination of this Agreement, neither LifeCell nor Client will have any continuing obligations, claims for any loss, damages, expenses or liabilities to or against the other, save in respect of any amount which remains outstanding and payable by either party hereto.
19. Arbitration. All disputes arising out of or relating to this Agreement will be resolved by arbitration. Client agrees that prior to arbitration, Client and LifeCell will attempt to resolve the dispute through good faith negotiations. If Client and LifeCell are unable to resolve a dispute, Client or LifeCell may initiate arbitration by sending a notice to the other party and a written demand for arbitration to the other par ty. The arbitration will take place in Dubai, UAE.The Arbitration would be governed by the Arbitration and Conciliation Act, 1996. All decisions of the arbitrator shall be final, binding, and conclusive and arbitration constitutes the only method of resolving disputes to this Agreement. This Section shall survive any termination or expiration of the Agreement. 20. Governing Law, Jurisdiction and Venue. This Agreement is governed by, construed and interpreted in accordance with the laws of India. Subject to the compulsory arbitration provisions of Section 19, any judicial proceedings brought against either LifeCell or Client under this Agreement will be brought in a competent court in Chennai, India. LifeCell and Client consent to the exclusive jurisdiction of the aforesaid courts and waive any objection to venue therein and irrevocably agree to be bound by any judgment rendered thereby in connection with this Agreement. 21. Confidentiality; Consent to Release. LifeCell acknowledges the confidential nature of the information provided by Client and, if different from the Client, the Birth Mother of the Child and agrees to use its reasonable best efforts to maintain the confidentiality of the information except as required by law or as permitted by this Agreement. Client and, if different, the Birth Mother of the Child hereby agree to the release of information to the hospital, laboratory or physician providing the services.
Mother’s Initials
Father’s Initials
Birth Mother, if not Client
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22. Multiple Births.
26. Survival.
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.
All provisions which by their terms require performance after the termination of this Agreement will survive the termination of this Agreement.
23. Assignment. LifeCell may assign this Agreement to any individual or entity providing a similar service. If LifeCell is acquired by or merged with or into another company, LifeCell shall require that the terms of this Agreement continue in full force and effect. 24. Notice. 24.1.
Any notice shall be sufficiently given if delivered in person or sent by express mail or by registered or certified mail, postage prepaid.
24.2. Notice to LifeCell must be delivered to LifeCell Arabia FZ LLC, 2819, Level 28, Shatha Tower, PO Box 502026, Dubai Media City, Dubai, United Arab Emirates. 24.3. Notice to Client will be delivered to the address set forth after Client's signature. Such notice will be deemed to have been given when personally delivered or received.
27. Binding Effect. All of the obligations, terms, provisions and releases set forth in this Agreement, shall be binding upon and inure to the benefit of LifeCell, the Client, and if different, the biological mother of the Child, and their respective heirs, personal representatives, successors, and assigns. 28. 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. 29. Headings. The headings in this Agreement are for reference purposes only and shall not affect the meaning or interpretation of this Agreement.
25. Entire Agreement. This Agreement and the exhibits hereto constitute the entire agreement between LifeCell, Client and, if different, the bir th mother of the Child and supersedes any prior agreements or understandings, oral and written.
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, Arabia
Mother’s Initials
Father’s Initials
Birth Mother, if not Client
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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 Arabia FZ LLC (‘LifeCell’) to process, and store stem cells obtained from the umbilical cord tissue and/or stem cells from umbilical cord blood and/or placental blood collected at birth of the Child, and to test the blood of the birth mother 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: 1.9
‘Engraftment' means three consecutive days in which the transplant recipient's absolute neutrophil count is equal to or greater than 500/microliter with the first measurement occurring within 100 days of transplant.
1.10
‘Mesenchymal Stem Cell’ means multipotent stem cells that can differentiate into a variety of cell types and are characterized by expression of markers CD90 and CD105.
1.11
‘Specimen’ means and includes stem cells obtained from umbilical cord blood and /or placental blood and /or umbilical cord tissue individually or collectively.
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
‘Birth Mother’ means the one who has borne the child in the womb.
1.4
‘Genetic Mother’ if different from the Birth Mother means the mother from whom the egg has been obtained
1.5
‘Collection Kit’ means the kit consisting of all necessary materials provided by LifeCell to the Client after enrollment, for the purpose of collection of Maternal Blood and the Specimen.
1.6
‘LifeCell Laboratory’ means LifeCell's laboratory facilities owned and operated by its parent company LifeCell International Pvt Ltd situated at No 26, Vandalur Kelambakkam Main Road, Keelakottiyur, Chennai, India 600048, or such other laboratory that LifeCell may designate from time to time.
1.7
‘Maternal Blood’ means peripheral blood taken from Genetic Mother of the Child, observing standard phlebotomy procedures, before or after the birth of the Child.
1.8
‘Minimally manipulated stem cells’ means stem cells that have not been subjected to ex-vivo procedure such as expansion of cell populations, genetic alterations, etc.
2. Services of LifeCell; Testing, Processing, Preserving and Storage. 2.1.
LifeCell offers its services under various options which the Client must choose in the Enrollment Form (Exhibit 2).
2.2.
LifeCell shall obtain all statutory permissions and licenses that might be required for providing the services contemplated under this Agreement.
2.3.
LifeCell also conducts the following tests: (a) a microbiological screen on the Specimen and (b) hematology analysis including blood grouping and cell counting on the Specimen, and (c) Infectious disease screening of the Maternal Blood f or Syphilis, Malar ia, Hepatitis B, Hepatitis C, HIV and cytomegalovirus.
2.4
President - LifeCell, Arabia
Upon successful enrollment, LifeCell will provide the Client with the following: 2.4.1. A Collection Kit 2.4.2. A copy of the Agreement 2.4.3. A unique Client Relationship Management (CRM) identification number that enables the
Mother’s Initials
Father’s Initials
Birth Mother, if not Client
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3. Client Responsibilities. 3.1.
On the Enrollment Date, Client must complete the Enrollment Form (Exhibit 1), the Maternal Health History (Exhibit 3), and must read, understand, and execute the Authorization to Collect Cord Blood, Cord Tissue, and Maternal Blood, and Release from Liability (Exhibit 5)
3.2.
Client must select qualified personnel to collect, prepare and label the Maternal Blood and the Specimen for delivery to LifeCell in accordance with the instructions given in the Collection Kit. In particular the Client must ensure that a minimum of 40 milliliters of Cord Blood, 15 centimeters of Cord Tissue and 15 milliliters of Maternal Blood is collected, since smaller specimen’s may no t be suit able f or processing. The selection of qualified personnel to collect, prepare and label the Maternal Blood and Specimen and payment for their services is Client’s sole r es p o n s i b i l i t y. T h e C l i en t o r t h e a u t h o r i z ed representative of the Client shall also ensure that the forms included in the Collection Kit are duly filled up and sent to LifeCell.
3.3.
It is the responsibility of the Client to deliver the Maternal Blood and Specimen to LifeCell's Laboratory wit hin 48 hour s of collection of Specimen. For purposes of convenience LifeCell has identified a courier company, who has the required expertise in handling the same for proper transportation. Client may choose this agency for forwarding the Maternal Blood and Specimen to LifeCell. The courier charges will be borne by LifeCell. The selected courier is not an agent of LifeCell and LifeCell is not liable for any deterioration, loss or destruction of the Maternal Blood or Specimen prior to receipt by LifeCell at LifeCell Laboratory.
Two Hundred Only), would be withheld, and the rest of the fees would be refunded, and in case the specimen is found to be unfit for storage for any reason, including but not limited to (i) low total nucleated cell counts or (ii) low viability, US $1,000 (US Dollars One Thousand Only), would be withheld, and the rest of the fees would be refunded. 4.3.
In the unlikely event that LifeCell elects to terminate this agreement under section 18, a pro-rated refund of the prepaid store fees will be made by LifeCell to the Client. Further, LifeCell guarantees the continuity of storage of your specimen by transferring it at its own cost to a comparable stem cell bank facility, nominated by LifeCell at no extra charge. If the Client elects to nominate an alternative facility for the transfer, the Client will have to bear the cost of the transportation.
5. Term of Agreement 5.1
This Agreement will continue for twenty one (21) years from the date of birth of the Child provided the agreement is not terminated under Section 18.
5.2
LifeCell will make reasonable attempts to notify the Client or the Child about the scheduled expiry of this Agreement at least 60 days in advance before the Child completes the age of twenty one (21) years.
5.3
If the Client or the Child consents his/her willingness to continue the storage beyond 21 years, the Child shall enter into a new Agreement with LifeCell as per the then prevailing terms.
6. Storage Terms. The Specimen will be stored as follows:
3.4.
During the term of the agreement, Client must promptly notify LifeCell in writing of any change in Client's name or current mailing address or in the legal guardianship of the Child.
6.1.
The Specimen will initially be stored in LifeCell Laboratory in Chennai, India. LifeCell reserves the right to relocate the Specimen to another location which is equivalent to LifeCell's Laboratory.
4.
Fees for Services.
6.2.
If the Specimen is relocated, LifeCell will notify Client within 60 days after such relocation.
4.1
Fees include the processing and testing fee and storage of the Specimen for a period of 21-years.
6.3.
The Specimen will be stored so long as all fees have been timely paid.
4.2.
All fees paid by Client to LifeCell are non-refundable. However in the event of the Specimen being insufficient/unfit for processing, US $200 (US Dollars
6.4.
LifeCell supports the LifeCell Cares Program in accordance with clause 12 with its terms and conditions.
President - LifeCell, Arabia
Mother’s Initials
Father’s Initials
Birth Mother, if not Client
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Testing. 7.1.
7.2.
By signing this Agreement and the Informed Consent for Infectious Disease & HIV testing (Exhibit 4), the Birth Mother grants her consent to perform the testing on Maternal Blood. If any test results are positive, the results will be shown to both the mother and physician indicated in the Enrolment Form. If the HIV screening test is positive, another test will be required to confirm the result. If the positive HIV screening is confirmed, the Birth Mother consents to the delivery of these results to the mother's physician indicated in the Informed Consent Form. In the event of laws requiring the disclosure of results to any authority by LifeCell or by its parent company, the Birth Mother is deemed to have given her consent. If any of the tests are positive, LifeCell may decline to continue storing the Specimen. Client shall pay the cost of any confirmatory testing, including the cost of shipping the Maternal Blood to another testing laboratory, with the prior consent of the Client. LifeCell does not assume responsibility or liability for confirmatory testing performed by another testing laboratory.
8. Representations and Warranties of Client. Client represents and warrants that 8.1.
He/she is the parent or legal guardian to the Child;
8.2.
Client has had the opportunity to consult 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;
8.3.
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;
banking a Child's Specimen 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 Specimen is indicated, based on the nature and progression of the disease and the HLA matching for donor and recipient. 10. Obligations and Rights to Specimen. 10.1.
10.2. Any components (including but not limited to plasma and red blood cells) that remain after the Specimen is processed and that are not being stored, will be disposed off by LifeCell. 10.3. If there is a disagreement between the parents, the mother's wish and right shall prevail. On the Child attaining the age of majority, the rights and wishes of the Child shall prevail. 10.4. Upon t er mination of t his Agr eement, 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 utilize, donate for research or dispose of the Specimen. 11. Retrieval of Specimen. 11.1.
8.4.
Client has discussed this Agreement with a competent medical professional who is not an employee or agent of LifeCell.
9. Assumption of potential risk by Client. Client acknowledges that he/she has been fully informed of, accepts and agrees to the conditions, risks, limitations and costs of processing, testing and storage of the Specimen. Client assumes all risks associated with the collection, preparation and delivery of the Specimen and Maternal Blood to LifeCell. Client is aware that banking a Child's Specimen does NOT guarantee that
President - LifeCell, Arabia
If only one parent/legal guardian of the Child is the Client, such person shall be solely liable for all of the obligations and shall have all rights of the Client, including control of the Specimen. If more than one parent/legal guardian of the Child is the Client each shall be jointly and severally liable and the rights shall be held by such parents/legal guardians jointly, including control of the Specimen. The exercise of any rights and control over the Specimen will require written notice to LifeCell signed by each Client.
There is no fee payable by the Client to LifeCell for retrieval of Specimen, however, any additional expenses on account of testing of blood or third par ty expenses, including but not limit ed t o isolation, expansion, and or differentiation of stem cells at the time of issue are to be borne by the Client. The stored Specimen will be available for access or delivery by or before the end of 15th business day af ter LifeCell’s receipt of a written request from Client. The request must be made on a request form provided by LifeCell, and must be signed by the client.
Mother’s Initials
Father’s Initials
Birth Mother, if not Client
LifeCell Arabia FZ LLC, 2819, Level 28, Shatha Tower, PO Box 502026, Dubai Media City, Dubai, United Arab Emirates | +971 4 4494067 | www.lifecellinternational.com
Page No. 9 of 20
11.2.
11.3.
The stored Specimen can only be released for use in treatments duly approved by competent governing medical authority of the domicile country and as approved by drug controller General of India a n d / o r Indian Council of Medical Research approved treatment or clinical trials. Drug Controller General of India and/or Indian Council of Medical Research approved treatments or clinical trials. If the retrieval is requested for a transplant then the request form must be accompanied by transplant physician’s certification confirming the end - use.
12.6. The Specimen thawing procedure must be a validat ed procedure used by the transplant facility and the Specimen must be administered immediately upon thawing. 12.7.
LifeCell Cares Program is valid for Clients who have signed LifeCell's standard Agreement, and whose payments to LifeCell for its services are continuing.
Free Worldwide Shipment:
13. LifeCell Payment Guarantee
In the event of a transplant, charges on account of courier/transportation etc., to the d e s i g n a t e d destination anywhere in the world will be borne by LifeCell. For the purpose of convenience LifeCell has identified a courier company who has the required exper tise in handling the same for proper tr anspor t ation. The Client may choose t his agency for transporting the stored specimen from LifeCell laboratory. The selected courier is not an agent of LifeCell and LifeCell is not liable for any deterioration, loss or destruction of the specimen during transportation to the designated destination.
If the Client's Specimen upon retrieval either
12. LifeCell Cares Program LifeCell assures that your Child's Specimen will be well cared for throughout the storage term chosen by you. In the event your Child's Specimen is required for a stem cell transplant, LifeCell understands that there may arise financial hardship, in which case LifeCell under its LifeCell Cares Program will provide the Client up to US $10,000 (Ten Thousand US Dollars only) to offset Transplant expenses, provided the following conditions are satisfied: 12.1.
procedures, including mini-transplants. The transplant recipient must not have used an investigational drug within 100 days before transplantation.
The Specimen must be collected using LifeCell's Collection Kit or approved alternative collection technique.
12.2. The Specimen must be processed and at all times stored by LifeCell. 12.3. The Specimen must be used in an autologous manner for homologous use (hematopoietic reconstitution). 12.4. The Specimen must be administered under the direction of a transplant physician in a medical facility qualified and approved by competent authority for stem cell transplantation. 12.5. The Specimen must not be used in experimental
President - LifeCell, Arabia
(a)
does not meet LifeCell's viability criteria, or
(b)
if used in an autologous hematopoietic stem cell transplant using recognized medical procedures and fails to engraft, LifeCell will pay the Client US $ 25,000 (Twenty Five Thousand US Dollars Only) provided the following conditions are satisfied:
13.1.
Compliance to all conditions of the LifeCell Cares Program. 5
13.2. The Specimen must contain at least 1X10 CD34+ cells per kilogram body weight of ‘recipient’. 13.3. Client will provide signed statement from the transplant physician attesting that engraftment did not occur along with supporting medical records documenting proof of non-engraftment. 13.4. LifeCell will pay within 30 days of Client's appropriate verified request. 13.5. The payment of US $ 25,000 (Twenty Five Thousand US Dollars Only) would discharge and release LifeCell from all its liabilities. 14. Disclaimers. Client acknowledges that neither LifeCell nor any of its officers, directors, shareholders, executives, employees, agents or consultants have made any representations, guarantee, warranties or assurances, express or implied, to Client regarding the success of the collection, transpor tation, testing, processing, cryopreservation, storage process or use of the Specimen. The client acknowledges the following express disclaimer and releases LifeCell from any liability if the personnel selected by the Client are unable to collect the Maternal Blood or Specimen or if such personnel are unable to collect
Mother’s Initials
Father’s Initials
Birth Mother, if not Client
LifeCell Arabia FZ LLC, 2819, Level 28, Shatha Tower, PO Box 502026, Dubai Media City, Dubai, United Arab Emirates | +971 4 4494067 | www.lifecellinternational.com
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or Specimen or if such personnel are unable to collect a suficient volume of Specimen for Testing, processing and storage or subsequent use or if any damage to or destruction or loss of, the Specimen or Maternal Blood by the courier selected by LifeCell. 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. 15. LIMITATION OF LIABILITY: 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. SUCH LIMITATION OF LIABILITY SHALL IN NO WAY BE DIMINISHED AS A RESULT OF THE LIFECELL CARES PROGRAM. 16. FORCE MAJEURE: CLIENT AGREES THAT LIFECELL SHALL NOT BE LIABLE FOR ANY LOSS, DETERIORATION OR DESTRUCTION OF ALL OR ANY PART OF THE SPECIMEN RESULTING FROM CAUSES OR CIRCUMSTANCES BEYOND LIFECELL'S REASONABLE CONTROL, INCLUDING, BUT NOT LIMITED TO FIRE, EXPLOSIONS, NATURAL DISASTERS, TERRORIST ACTS OR ACTS OF WAR. 17. Indemnity and Hold Harmless. Client agrees to indemnify and hold LifeCell and Client's hospital and physicians and their respective agents, employees, officers, directors, shareholders and affiliates harmless from any and all claims, liabilities, demands and causes of action asserted against them by any person or entity, including any third party beneficiary of this Agreement. 18. Termination of Agreement. This Agreement may be terminated: (a)
by Client at any time prior to the collection of the Specimen, or
(b)
by LifeCell if it has exercised its right to refuse Specimen storage for any reason, or
(c)
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, or
(d)
by mutual agreement of Client and LifeCell, or
President - LifeCell, Arabia
(e)
by either party upon 60 days prior written notice to the other party hereto, or
(f)
in the event, the Specimen is retrieved for a transplant. Both LifeCell and Client specifically agree that the notice period for termination is fair and reasonable. Upon termination of this Agreement, neither LifeCell nor Client will have any continuing obligations, claims for any loss, damages, expenses or liabilities to or against the other, save in respect of any amount which remains outstanding and payable by either party hereto.
19. Arbitration. All disputes arising out of or relating to this Agreement will be resolved by arbitration. Client agrees that prior to arbitration, Client and LifeCell will attempt to resolve the dispute through good faith negotiations. If Client and LifeCell are unable to resolve a dispute, Client or LifeCell may initiate arbitration by sending a notice to the other party and a written demand for arbitration to the other par ty. The arbitration will take place in Dubai, UAE.The Arbitration would be governed by the Arbitration and Conciliation Act, 1996. All decisions of the arbitrator shall be final, binding, and conclusive and arbitration constitutes the only method of resolving disputes to this Agreement. This Section shall survive any termination or expiration of the Agreement. 20. Governing Law, Jurisdiction and Venue. This Agreement is governed by, construed and interpreted in accordance with the laws of India. Subject to the compulsory arbitration provisions of Section 19, any judicial proceedings brought against either LifeCell or Client under this Agreement will be brought in a competent court in Chennai, India. LifeCell and Client consent to the exclusive jurisdiction of the aforesaid courts and waive any objection to venue therein and irrevocably agree to be bound by any judgment rendered thereby in connection with this Agreement. 21. Confidentiality; Consent to Release. LifeCell acknowledges the confidential nature of the information provided by Client and, if different from the Client, the Birth Mother of the Child and agrees to use its reasonable best efforts to maintain the confidentiality of the information except as required by law or as permitted by this Agreement. Client and, if different, the Birth Mother of the Child hereby agree to the release of information to the hospital, laboratory or physician providing the services.
Mother’s Initials
Father’s Initials
Birth Mother, if not Client
LifeCell Arabia FZ LLC, 2819, Level 28, Shatha Tower, PO Box 502026, Dubai Media City, Dubai, United Arab Emirates | +971 4 4494067 | www.lifecellinternational.com
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22. Multiple Births.
26. Survival.
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.
All provisions which by their terms require performance after the termination of this Agreement will survive the termination of this Agreement.
23. Assignment. LifeCell may assign this Agreement to any individual or entity providing a similar service. If LifeCell is acquired by or merged with or into another company, LifeCell shall require that the terms of this Agreement continue in full force and effect. 24. Notice. 24.1.
Any notice shall be sufficiently given if delivered in person or sent by express mail or by registered or certified mail, postage prepaid.
24.2. Notice to LifeCell must be delivered to LifeCell Arabia FZ LLC, 2819, Level 28, Shatha Tower, PO Box 502026, Dubai Media City, Dubai, United Arab Emirates. 24.3. Notice to Client will be delivered to the address set forth after Client's signature. Such notice will be deemed to have been given when personally delivered or received.
27. Binding Effect. All of the obligations, terms, provisions and releases set forth in this Agreement, shall be binding upon and inure to the benefit of LifeCell, the Client, and if different, the biological mother of the Child, and their respective heirs, personal representatives, successors, and assigns. 28. 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. 29. Headings. The headings in this Agreement are for reference purposes only and shall not affect the meaning or interpretation of this Agreement.
25. Entire Agreement. This Agreement and the exhibits hereto constitute the entire agreement between LifeCell, Client and, if different, the bir th mother of the Child and supersedes any prior agreements or understandings, oral and written.
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, Arabia
Mother’s Initials
Father’s Initials
Birth Mother, if not Client
LifeCell Arabia FZ LLC, 2819, Level 28, Shatha Tower, PO Box 502026, Dubai Media City, Dubai, United Arab Emirates | +971 4 4494067 | www.lifecellinternational.com
Page No. 12 of 20
EXHIBIT - 1
ENROLLMENT FORM - EXPECTANT PARENTS' DETAILS To be filled-in BLOCK LETTERS only using black ink ball-point pen
PERSONAL DETAILS Mother's Name Father's Name Mother's Date of Birth D
D
M
M
Y
Y
Y
Y
Communication Address
Landmark City
State
Country
Postal Code
Telephone (Home) Country Code
City / Area Code
Mobile 1
Telephone Number
Mobile 2 Country Code
Mobile Number
Mobile Number
E-mail ID If Permanent Address is same as Communication Address (Tick) Permanent Address (If different from above)
Landmark City
State
Country
Postal Code
Identity Proof
Father
Mother
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 digits CRM No.
LifeCell Arabia FZ LLC, 2819, Level 28, Shatha Tower, PO Box 502026, Dubai Media City, Dubai, United Arab Emirates | +971 4 4494067 | www.lifecellinternational.com
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EMPLOYMENT DETAILS Employment
Father
Mother
Employment Type (Tick)
Service
Professional
Entrepreneur
Organisation Designation Office Address
City
State
Country
Postal Code
Telephone (Office) Country Code
City / Area Code
Telephone Number
E-mail ID
SHIPMENT DETAILS Sent Collection Kit to (Tick)
Communication Address
Permanent Address
Office Address
Shipping Address (if different from above)
Landmark City
State
Country
Postal Code
Telephone Country Code
City / Area 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 a Gynaecologist / Healthcare Professional, please provide details as below: Referring Gynaecologist or Healthcare Professional Hospital City
Mobile / Phone
LifeCell Arabia FZ LLC, 2819, Level 28, Shatha Tower, PO Box 502026, Dubai Media City, Dubai, United Arab Emirates | +971 4 4494067 | www.lifecellinternational.com
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HOSPITAL & BIRTHING DETAILS Expected Date of Delivery D
Type of Pregnancy (Tick)
D
M
M
Y
Single Birth
Y
Y
Twins
Y
Triplets
Quads
Consulting Doctor Obstetrician/ Gynaecologist
Communication Address
Landmark City
State
Country
Postal Code
Telephone Country Code
City / Area Code
Telephone Number
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
Postal Code
Telephone Country Code
City / Area 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 in case of change of above details for future communication.
Signature of Mother
Signature of Father
Name:
Name:
Signature of Birth Mother if not Client Name:
Date : D
D
M
M
Y
Y
Y
Y
For LifeCell use only
Name of LifeCell Executive LifeCell Authorised Signature Name of Signatory:
Employee Code
LifeCell Arabia FZ LLC, 2819, Level 28, Shatha Tower, PO Box 502026, Dubai Media City, Dubai, United Arab Emirates | +971 4 4494067 | www.lifecellinternational.com
Page No. 15 of 20
FT ALLY LE N O I T N IS INTE E G A P THIS
BLANK
LifeCell Arabia FZ LLC, 2819, Level 28, Shatha Tower, PO Box 502026, Dubai Media City, Dubai, United Arab Emirates | +971 4 4494067 | www.lifecellinternational.com
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LifeCell Arabia FZ LLC, 2819, Level 28, Shatha Tower, PO Box 502026, Dubai Media City, Dubai, United Arab Emirates | +971 4 4494067 | www.lifecellinternational.com
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LifeCell Arabia FZ LLC, 2819, Level 28, Shatha Tower, PO Box 502026, Dubai Media City, Dubai, United Arab Emirates | +971 4 4494067 | www.lifecellinternational.com
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LifeCell Arabia FZ LLC, 2819, Level 28, Shatha Tower, PO Box 502026, Dubai Media City, Dubai, United Arab Emirates | +971 4 4494067 | www.lifecellinternational.com
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FT ALLY LE N O I T N IS INTE E G A P THIS
BLANK
LifeCell Arabia FZ LLC, 2819, Level 28, Shatha Tower, PO Box 502026, Dubai Media City, Dubai, United Arab Emirates | +971 4 4494067 | www.lifecellinternational.com
Page No. 20 of 20
LifeCell Arabia FZ LLC, 2819, Level 28, Shatha Tower, PO Box 502026, Dubai Media City, Dubai, United Arab Emirates | +971 4 4494067 | www.lifecellinternational.com
LifeCell Arabia FZ LLC, 2819, Level 28, Shatha Tower, PO Box 502026, Dubai Media City, Dubai, United Arab Emirates