CLIENT AGREEMENT
MATERNAL BLOOD AND UMBILICAL CORD STEM CELL TESTING, PROCESSING, STORAGE, RETRIEVAL, EXPANSION 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 600127, Tamil Nadu, India ('LifeCell'), this day of., 201.. (the 'Enrollment Date'), to process, test, store, retrieve and expand stem cells obtained from the Umbilical Cord collected at birth of the Child and to test the Maternal Blood collected from the Birth Mother ('Services') on the following terms (this 'Agreement'). 1. DEFINITIONS 3.3. In case of retrieval of Specimen for transplant, the Client has to submit duly filled up Retrieval Form provided by LifeCell (to be accompanied by transplant physician's certificate confirming end use in statutorily compliant transplant procedures or approved clinical trials). 4. STORAGE 4.1. LifeCell shall store in vapor phase of liquid nitrogen the red-cell reduced and plasma depleted Umbilical Cord Blood Specimen in special cryo-bags compartmentalized in volumes of 5ml and 20ml along with attached test segments (3 segments of 0.5ml each), and shall also store the Umbilical Cord Tissue Specimen in 4 vials (includes 2 vials of minimally manipulated Umbilical Cord pieces, and 2 vials of Mesenchymal Stem Cells (MSCs) isolated from the entire Umbilical Cord Tissue viz explants culture). LifeCell shall also preserve some portion of maternal blood for future testing requirements. 4.2. Client may opt for storage of Specimen at either of LifeCell's licensed facilities situated at #26, Vandalur Kelambakkam Main Road, Keelakottaiyur, Chennai 600127, Tamil Nadu, India (or) Plot #26, Sector 4, IMT Manesar, Gurgaon 122001, Haryana, India. In this Agreement, (including the recitals above), unless the context otherwise requires, the following expressions shall have the following meanings: 1.1. 'Umbilical Cord' means and includes the blood inside umbilical cord and/or placenta, and the tissue remaining after the collection of the blood. 1.2. 'Child' means the Client's baby (or babies in the event of multiple births) from whom the Umbilical Cord will be collected following his/her birth. 1.3. 'Client' means the biological parents or legal guardian of the Child or the Child after attaining the age of Eighteen. 1.4. 'Caregiver' means the Obstetrician Gynecologist and/or qualified medical professional/midwife who will be assisting in delivering the Child. 1.5. 'Maternal Blood' means peripheral blood collected from Birth Mother of the Child, which has been drawn by observing standard phlebotomy procedures taken within seven days before or after the birth of the Child. 4.3. For disaster management, back-up and added retention security, LifeCell at the request of the Client and payment of additional fees will store the Specimen simultaneously in both of its licensed facilities. 1.6. 'Specimen' means and includes stem cells obtained from Umbilical Cord useful for (including but not limited to) treatment of illness such as Thalassemia, Leukemia etc., 4.4. 1.7. 'Collection Kit' means a UN 3373 certified kit, compliant with International Air Transport Association (IATA) regulations, consisting of all essential materials required for the purpose of collection and labeling of the Maternal Blood and Umbilical Cord. For the purpose of safety, LifeCell has the option to relocate the Specimen or a part of the same at its own cost to a comparable stem cell bank facility and will provide notice to the Client within 14 days of such relocation. In case of any planned relocation, LifeCell will provide a Notice to the Client at least 14 days prior to such relocation. 5. TERM OF AGREEMENT 2. SERVICES: OPTION AND FEES 5.1. 2.1. LifeCell offers its Umbilical cord stem cell banking Services under different plans, fees and payment methods as detailed in fee schedule, which the Client must choose at the time of Enrollment. If the Client chooses Annual Storage Plan, this Agreement will continue for one year from the date of birth of the Child ('Renewal Date') and will automatically renew for successive one year period. This automatic renewal is subject to the Client paying the annual storage fee on or before the renewal date every year. 2.2. All applicable taxes including but not limited to service tax present and/ or future levy, if any are payable by the Client. 5.2. 3. CLIENT RESPONSIBILITIES 3.1. Client is responsible for providing the Collection Kit to the Caregiver and arranging for collection, preparation and labeling of the Maternal Blood and Umbilical Cord for delivery to LifeCell's laboratory along with the duly filled up forms included in the Collection Kit, unless the same has been assigned to LifeCell. Client may opt for prepayment and upgrade their Annual Storage Plan to One Time Plan or Life Time Plan by paying the applicable fee as adviced by LifeCell. Upon such payment, the Annual Storage Plan will be converted into One Time Plan or Life Time Plan and the Agreement will be extended to twenty one years / one hundred years respectively or till the survival of the Child, from the date of birth of the Child. 5.3. If the Client chooses One Time Storage Plan, this Agreement will continue for twenty one years from the date of birth of the Child. 5.4. At least 90 days before the expiration of this Agreement term, LifeCell shall intimate the Client (and/or Child in case the Child has come of age) regarding the expiry of the Agreement, along with terms of continued storage. Accordingly the Child can enter into a new Agreement and continue the storage. 3.2. Client must promptly notify LifeCell in writing of any change in Client's name or contact details (including but not limited to mailing address, telephone numbers, etc.,) or current mailing address or in the legal guardianship of the Child.
5.5. If the Client chooses Life Time Storage Plan, this Agreement will continue and shall be held as valid throughout the survival of the Child (or) for 100 years from the date of birth of the Child whichever is earlier. 6. REPRESENTATIONS AND WARRANTIES OF CLIENT nearest LifeCell Service Center and not less than 8 hours for further away locations) for allowing the LifeCell arranged Caregiver to reach the venue of childbirth. 8.4. Medical Concierge: For all medical and travel information relating to stem cell transplant using the stored Specimen for the Child or his/her immediate family members, LifeCell assures to provide, at no extra cost to the Client, the relevant information regarding leading transplant physicians, approved and credible medical transplant institutions including medical travel information relating to the Child along with his/her immediate family members. 8.5. Additional Client benefit programs for dual site storage: Client represents and warrants that 6.1. She/he is the parent or legal guardian of the Child. 6.2. Client has had the opportunity to read, understand, review and consult with the Client's own legal counsel and medical professional, this Agreement, informed consents, possible risks of collection, processing, storage and possible future use of the Maternal Blood and Specimen. 6.3. The decision to collect the Umbilical Cord and Maternal Blood, test the Maternal Blood and process, store, retrieve, and expand the Specimen is a completely voluntary act of Client. 7. RIGHTS TO SPECIMEN 7.1. The Client shall have all the rights over the Specimen until the Child attains majority, further to which all rights shall be automatically transferred to the Child. In an unfortunate situation of non-survival of Child after attaining the age of majority, all the rights over the Specimen shall be automatically transferred to the parents and they can continue storage of the Specimen till survival of both the parents and this entire Agreement will continue and shall be valid throughout the term of this Agreement as per the terms. 7.2. If there is a disagreement between the parents the Mother's wish shall prevail. 7.3. The Client undertakes to inform the Child promptly of his/her right with regards to the Specimen on the Child attaining majority, including the right to renew this Agreement. 8. LIFECELL CLIENT BENEFIT PROGRAMS (FOR SIGNLE SITE STORAGE) a) Medical Treatment Assistance: If the Child, Child's biological parents and/or Child's biological siblings are diagnosed after the Enrollment Date and before the completion of twenty first birth anniversary of the Child, for a condition treatable by stem cell transplantation using the stored Specimen then LifeCell shall pay the transplant center or the Client up to ` 2,000,000 (Rupees Two Million only) as and when needed to offset transplant related expenses. If the stored Specimen is unfortunately not a suitable match for Child's biological parent or Child's biological sibling or if the Child requires an additional unit along with the stored Specimen (as confirmed by the transplant physician), then LifeCell in order to support a stem cell transplant shall pay up to ` 2,000,000 (Rupees Two Million only) for purchasing suitable matching stem cells to the patient if a matching unit is found at any public stem cell bank worldwide. b) Storage Fee Waiver: In case of demise or permanent physical disability of either of the Client during the minority of the Child, LifeCell would refund the prepaid storage fees on a pro-rata basis and shall continue storage of the Specimen at LifeCell's own cost till the Child attains the age of majority. c) Disaster Relief: If the Child, Child's biological parents and/or Child's biological siblings are diagnosed for a condition treatable by stem cell transplantation using the stored Specimen and should for any unforeseen reason that is beyond the reasonable control of LifeCell which may potentially deteriorate or cause loss of the Specimen during transit, processing and storage, LifeCell will use its best endeavours to provide suitable matching stem cells to the patient if the same is found at any public stem cell bank (as confirmed by the patient's transplant physician) within 14 days failing which pay the Client ` 2,000,000 (Rupees Two Million only). LifeCell understands the Client's need to enhance the value of their investment and also provide a comprehensive coverage for their Child. Therefore LifeCell through its Client Benefit Programs provides additional guarantees, assistance and benefits which are detailed below: 8.1. Entitlement to Full Refund: LifeCell understands that the life and health of the Mother and Child are the utmost priority. In the event the Umbilical Cord is not collected due to this priority or non-survival of the child at birth, LifeCell shall refund all fees paid by Client to LifeCell upon sharing of relevant declaration from the attending gynecologist. 8.2. Quality Guarantee: If the Child, Child's biological parents and/or Child's biological siblings are diagnosed for a condition treatable by stem cell transplantation using the stored Specimen and should for any reason the Specimen upon retrieval not meet LifeCell's then prevailing viability criteria benchmarked against existing international best practices, LifeCell will use its best endeavors to provide suitable matching stem cells to the patient if the same is found at any public stem cell bank worldwide (as confirmed by the patient's transplant physician) within 14 days failing which pay the Client ` 2,000,000 (Rupees Two Million only). 8.3. Sample Collection and Transport Assistance: At the request of the Client, LifeCell would arrange and pay for the Caregiver for the collection of Maternal Blood and Umbilical Cord, and/or a certified Service Provider for X-ray free transport of the Maternal Blood and Umbilical Cord to LifeCell's Laboratory, provided however that the Client provides reasonable time to LifeCell (not less than two hours prior to childbirth for birthing center located within 50 km radius of d) Free Worldwide Shipment: In the event of the Specimen and/or a matching stem cells being required for a transplant for Child, Child's biological parents or Child's biological siblings, LifeCell upon Client's request shall arrange and pay for X-ray free transport of the same under cryogenic conditions to the transplant center located at any destination worldwide. 8.6. Free Stem Cell Expansion: If the Child, Child's biological parents and/or Child's biological sibling is diagnosed for a condition treatable by stem cell transplantation using the stored Specimen and should clinical expansion of the stored Specimen be deemed necessary for transplant, as determined by the patient's transplant physician, LifeCell shall at no additional cost (a) expand and provide upto 1 billion Mesenchymal Stem Cells (as and when required) derived from the Umbilical Cord Tissue Specimen based on LifeCell's then existing in house protocols, and (b) also expand and provide the Hematopoietic Stem Cells from the Umbilical Cord Blood Specimen upon the technology becoming commercially available in the future.
8.7. General conditions for LifeCell Client Benefit Programs: a) The Client Agreement is valid and is in force. 10.2. b) Payments shall be made within 30 days by LifeCell either to Client or on behalf of Client to the transplant center, upon appropriate verification of Client's request. c) Either upon providing a unit of suitable match or on making the due payment as applicable in the Client Benefit Program, the Client would release LifeCell from any further obligations. 9. 10.3. Client agrees that LifeCell's liability for any loss, harm, damage or claim of any kind in connection with this Agreement or the Services provided by LifeCell shall be limited to the return of an amount equal to all fees paid by Client to LifeCell or benefits available under the applicable LifeCell Client Benefit Programs (whichever is higher), except for acts committed by LifeCell that are intentional and/or grossly negligent. 11. FORCE MAJEURE LIFECELL ASSURANCE LifeCell hereby assures that: 9.1. 9.2. 9.3. LifeCell has all statutory permissions and licenses that are required for providing the Services contemplated under this Agreement. LifeCell will provide the Client with the following immediately upon Enrollment: a copy of this Agreement, a Collection Kit, and a unique Client Relationship Management (CRM) number that enables the Client to quote for all communications with LifeCell. warranties or assurances, express or implied. LifeCell disclaims any responsibility to provide any other services (except those specified in this Agreement) and third party service providers like Caregiver, Transporter, etc shall have the respective responsibility for their services including loss, damage, delay in delivery, etc. Client agrees that LifeCell's liability for causes or circumstances which are beyond LifeCell's reasonable control shall be limited to that committed under the Disaster Relief program. 12. TERMINATION OF AGREEMENT 12.1. This Agreement may be terminated LifeCell upon receipt of the Maternal Blood and Umbilical Cord at its laboratory would determine whether it is fit or unfit for testing, processing and /or storage. a) by Client at any time prior to collection of Umbilical Cord, or b) by Client at any time after storage of the Specimen, or 9.4. 9.5. In any event of Umbilical Cord is found to be unfit, including but not limited to insufficient volume/length, low cell count / viability, positive screening of infectious diseases, microbial contamination of Umbilical Cord Blood or Umbilical Cord Tissue. LifeCell will notify the Client immediately and seek instructions for disposal of the unfit Specimen. If LifeCell does not receive written instructions within 30 days of such intimation then LifeCell shall continue storing the Specimen as is where is, however the benefits available under LifeCell Client Benefit Programs as per clause 8 shall not be applicable for the unfit Specimen. c) by LifeCell if it has exercised its right to refuse Specimen processing and / or storage for any reason, including the consequential act of sample rejection as per clause 9.4, or d) by LifeCell if any payment due to LifeCell is not timely paid and such failure to pay is not cured within 30 days after receipt of notice from LifeCell of such failure to pay, without prejudice to LifeCell's right to take legal steps to recover the debt, or e) by mutual agreement of Client and LifeCell, or In the event of Maternal Blood found to be unfit or insufficient or not provided, LifeCell will notify the Client immediately and seek another collection. If the Maternal Blood is not provided within 7 days of childbirth the Specimen can be used only for autologous purposes. 9.6. The Umbilical Cord would be tested, processed, stored, retrieved and expanded in accordance to approved Standard Operating Procedures and in compliance with statutory regulations. 9.7. Upon successful collection, processing, testing and storage, LifeCell will provide the Client with a Preservation Certificate confirming successful storage of the Specimen along with sample storage details and test results within 45 days of receipt of Umbilical Cord at LifeCell laboratory. 9.8. LifeCell understands that the cryopreserved Specimen is a precious property of the Client, and therefore LifeCell shall at its own discretion never subject it to any unauthorized usage or even donate it for research or therapeutic purposes. f) by either party upon 60 days prior written Notice to the other party hereto, or g) in the event the entire Specimen is retrieved for a transplant. However, if the Client retrieves only a portion of the Specimen, this Agreement would survive along with all benefits for the term of this Agreement. h) in the event either law or a governmental agency or regulatory provisions or medical guidelines require us to terminate the Agreement. 12.2. 9.9. In the event of Specimen being retrieved for a transplant for Child, Child's biological parents and/or Child's biological siblings, there are no additional costs for retrieval and upon submission of filled Retrieval Form (as provided by LifeCell), the Specimen will be available for delivery within 7 days, or within 90 days if cellular expansion is required. 10. DISCLAIMER & LIMITATIONS: 10.1. LifeCell does not perform any medical Services, give any medical advice, or otherwise perform any service other than those expressly indicated in this Agreement. It disclaims all other representations, guarantees, Effects of Termination: a) If the Agreement is terminated under Section 12.1.(a) all fees paid by the Client shall be refunded after deducting a cancellation fee of ` 5000 (Rupees Five Thousand only). b) If the Agreement is terminated under Section 12.1.(b) all fees paid by the Client to LifeCell are non-refundable. The Client reserves the right to shift the Specimen at their own cost to any other stem cell bank facility of their choice. c) If the Agreement is terminated under Section 12.1.(c) or 12.1 (h) the Storage, and / or processing fees would be refunded as applicable. d) If the Agreement is terminated under Section 12.1.(d), Client relinquishes all rights in and to the Specimen and waives all claims to the Specimen and LifeCell shall have the right at its sole discretion to dispose of the Specimen. However, LifeCell shall continue storing
the Specimen with no liabilities to the Client for a period of two years from the date of termination. During this period the Client shall have the option of reviving the Agreement by paying all unpaid fees and a late fee of ` 5000 (Rupees Five Thousand only). e) If the Agreement is terminated by LifeCell under Section 12.1.(f), LifeCell shall at its own cost arrange for transfer of Specimen to a comparable stem cell bank facility and pay the new stem cell bank for storing the Specimen for the remaining period of the Agreement. All benefits available under the LifeCell Benefit Program under Clause 8 shall survive for the remaining period of the Agreement. If the Agreement is terminated by the Client as per this Clause, the Client shall bear the entire cost for shifting the preserved Specimen to another stem cell bank facility of their own choice. f) If the Agreement is terminated under Sections 12.1.(e) or 12.1.(g) a pro-rated refund of the prepaid storage fees will be made by LifeCell to the Client. If the agreement is terminated by the Client as per this clause, the Client shall bear the entire cost for shifting of the preserved Specimen to another stem cell bank facility of their own choice. g) 13. All refunds by LifeCell shall be processed within 30 days of receiving the complete documentation from the Client. 17. ASSIGNMENT LifeCell may assign this Agreement to any individual or entity providing similar service. If LifeCell is acquired by or merged with or into another Company, LifeCell shall require that the terms of this Agreement continue in full force and effect. LifeCell shall notify the Client within 90 days in the event of any such assignment. 18. NOTICE 18.1. Notice to LifeCell must be in writing and delivered to LifeCell International Private Limited, No.26, Vandalur-Kelambakkam Main Road, Keelakottaiyur, Chennai 600127, Tamil Nadu, India. 18.2. Notice to Client or legal guardian will be in writing and delivered to the address set forth in the Enrollment form or as updated by Client to LifeCell. 19. ENTIRE AGREEMENT This Agreement and the informed consent hereto constitute the entire agreement between LifeCell and Client and supersedes any prior agreements or understandings, oral and written. This agreement may be modified only by written agreement of Client and Authorised Signatory of LifeCell. 20. SURVIVAL All provisions which by their terms require performance after the termination of this Agreement will survive even after the termination of this Agreement. CONFIDENTIALITY; CONSENT TO RELEASE LifeCell acknowledges the confidential nature of the information provided to it and agrees to use its best efforts to maintain the confidentiality of the information except as required by law or as permitted by this Agreement. All confidential information and personal identifiable information shall be kept on secure database with adequate backup measures. Client and, if different, the Birth Mother of the Child MULTIPLE BIRTHS In the event of multiple births, if the Client desires to engage LifeCell for its Services, for each Child, the Client must check the appropriate box on the Enrollment Form and pay the additional fees. GOVERNING LAW AND JURISDICTION This Agreement is governed by, construed and interpreted in accordance with the laws of India. Courts in Chennai, Tamil Nadu, India, shall have exclusive jurisdiction. 15. 16. ARBITRATION All disputes arising out of or relating to this Agreement will be resolved by arbitration. The arbitration will take place in Chennai, Tamil Nadu, India. The arbitration would be governed by the Arbitration and Conciliation Act, 1996. 14. hereby agrees to the release of information to the hospital, laboratory or physician providing the Services to the Client. 21. SEVERABILITY If any part of this Agreement is found to be invalid or unenforceable, such provision is deemed modified to the extent necessary to make the Agreement enforceable, and this Agreement shall otherwise remain in full force and effect.
RISK RELATING TO STEM CELL BANKING
RISKS RELATING TO STEM CELL BANKING Stem cell banking has several inherent risks which may relate to collection, processing, testing, storage, and usage of the stem cells. The relevant risks in each of these areas are described below only to enable better decision making by Clients and shall in no way reduce LifeCell s liability due to gross negligence or diminish the benefits available under the LifeCell Client Benefit Programs. It has to be noted that these risks are by no means comprehensive and are only indicative. COLLECTION RISKS Collection of sample is usually done after clamping of the umbilical cord and separation of the mother and child and hence poses no risks to either one. However inherent risks of microbial contamination of sample present in the birth canal may render the sample unfit for storage. Certain circumstances or complications during delivery may entirely prevent the collection of sample or collection of adequate quantity of sample required for storage purposes. Client understands that engagement of trained personnel well in advance and handing over the collection kit to them at the time of reaching the place of delivery are critical to increasing the chances of successful sample collection. Further the birth mothers by law are required to screen and test for infectious diseases using peripheral venous blood. The collection of maternal blood may cause discomfort, possible bruising and swelling around the puncture site; rarely an infection; and uncommonly, faintness from the procedure. Client assumes all risks involved in collection of maternal blood, and also understands that if any of the results of infectious diseases testing is positive then LifeCell may decline to continue storing the sample. TESTING RISKS The samples are tested for reporting of the identity and quality of sample, based on the results of which a decision is taken on transplantation upon eventual need. LifeCell through extensive use of automated, bi-directionally interfaced, bar-coded sample handling, and in-house testing, that helps reduce the chances of errors; active participation in proficiency testing programs; and maintenance of accreditation from reputed institutions provides Clients the assurance they seek on the reported results. However errors may happen in the pre-analytic, analytic, and post-analytic phases of testing due to systems, processes, and procedures involved in the transmission and reporting of test results. Client understands if in doubt that they have the opportunity of seeking external testing at their own costs to reconfirm the results reported by LifeCell, for which LifeCell would offer its fullest cooperation. STORAGE RISKS Long-term storage of samples could be associated with risks of either loss of viability, transmission of infectious diseases; partial or total loss due to reasons beyond reasonable control of LifeCell. However no assurance can be provided on the maintenance of viability for indefinite storage, and that the sample may also be lost due to equipment failure and / or accident which may render the sample unfit for transplantation. By placing the samples with bar-codes in overwrap bags and metal canisters where applicable; maintenance of samples in vapor phase nitrogen; and placement high-risk/ quarantine samples in a separate vessel help avoid the chances of cross-contamination. Also maintenance of adequate nitrogen levels in the vessels through piped supply from bulk tanks for automated top-ups; provision of continuous monitoring and automated alarm systems onto storage vessels, and supply with triple layer supply of electricity (power grid, uninterrupted power supply, and diesel generator) minimize chances of temperature deviations which may result in loss of viability. Adequate facility design considerations, running of regular stability testing programs, maintenance of Sample at multiple locations and procurement of insurance covers in accordance to the risks, and procedures for safety and emergency handling also help in providing added confidence. TRANSPORTATION RISKS Transport from the place of childbirth to the LifeCell laboratory, or transport from LifeCell laboratory to the transplant center has to be done within a reasonable period of time for minimizing loss of viability. However due to disruptions in flight or other transport operations, non-maintenance of temperature due to poor refrigeration of foam bricks or performance of the dry shippers, improper packaging due to non-following of instructions provided, accidents, or theft, may cause the sample to be lost or delayed in reaching the destination. Utilization of certified collection and distribution kits designed to maintain a controlled environment for a reasonable period of time, maintenance of sample traceability at all times of transport, utilizing experienced courier companies which have x-ray waiver procedures, will help minimize these risks during transportation. Client understands that no guarantee can be provided by LifeCell or the courier company on the safe and timely transport, and that Client has the option of choosing the best possible mode of transport.
APPLICATION RISKS Umbilical cord blood, like bone marrow and peripheral blood, is rich in hematopoietic progenitor cells, and has been used in the treatment of a variety of inherited or acquired disorders, including hematologic malignancies, metabolic disorders, and immunodeficiencies. Umbilical cord tissue, like the bone marrow, is also rich in mesenchymal progenitor cells, and is potentially useful for several regenerative medicine applications which are currently under-investigation in several clinical trials around the world. However there is no guarantee of successful transformation of these trials into commercial applications. The quantity of cells required for transplant varies depending upon eventual use and/ or patient body weight. While techniques for expansion of umbilical cord blood stem cells have been promising there is no guarantee that these will be eventually successful. Client also understands that cells obtained from the umbilical cord tissue may need further processing before use. Client is aware that banking a Child s sample does not guarantee that a stem cell transplant would be the first or best course of treatment for any particular disease or that a Child s own stem cell is useful for every disease treatable by stem cell transplantation. A medical care provider ultimately decides whether the use of the Child s sample is indicated, based on the nature and progression of the disease, and HLA matching between donor and recipient.
LIST OF TESTS PERFORMED
LIST OF TESTS PERFORMED LifeCell commits to performing the below mentioned tests at no additional costs to the Child, Child s biological parents and/or Child s biological siblings. Cord Blood: Blood grouping & RH typing Total Nucleated Cell count Total Mononuclear Cell count Total CD 34 Cell count CD 34 Stem Cell Viability Sterility At retrieval for transplant HLA Typing for Donor & Recipient CFU Assay Maternal Blood: Anti - HBC Anti - HCV CMV - IgG Syphilis Malaria Nucleic Acid test (HCV and HIV) Haematocrit Haemoglobinopathies CMV - IgM HBSAg HIV I/II Blood grouping & RH typing HTLV I/II No additional cost for confirmatory tests Cord Tissue: Viable Cell count Sterility At retrieval for transplant Viable Cell count Sterility Mycoplasma Cell Morphology Flow Marker Positives: CD 90, 73, 105 Flow Marker Negatives: CD 34, 45, 14, 19, HLA-DR Endotoxin HLA testing Cell Proliferation Assay
Consents
CONSENT OF NON-CLIENT BIRTH MOTHER FOR COLLECTION: The undersigned Birth Mother of the Child has reviewed the above the Agreement, and hereby acknowledges and agrees that she is not the legal guardian of the Child, is not a party to the Agreement, and is not a third-party beneficiary of the Agreement. Birth Mother hereby waives, releases and abandons any and all rights or entitlement to the Umbilical Cord, Specimen and Maternal Blood. Birth Mother consents and agrees to the testing of the Maternal Blood Specimen as referenced in the Agreement and in Exhibit 7 of this Agreement and consents and agrees to the release of the test results to the Client. Birth Mother agrees she has no right to enforce any term, condition or provision of the Agreement, or to exercise any right of the Client under the Agreement. Birth Mother acknowledges that she has been fully informed of the procedures associated with cellular donation and the alternatives to cellular donation and accepts and agrees to the benefits, limitations, risks, and discomfort of cellular donation and has had the opportunity to access donor advocacy service. Birth Mother has been given the opportunity to ask questions and had those questions answered satisfactorily. Birth Mother assumes all risks associated with the collection of the Umbilical Cord, including the Maternal Blood. INFORMED CONSENT TO INFECTIOUS DISEASE & HIV TESTING LifeCell requires infectious disease testing to be done on the maternal blood that includes HIV testing, in conjunction with the processing of Cord Blood. The costs of these screening tests are included in the initial fee. The maternal blood sample must be drawn at the time of delivery independent of previous infectious disease/hiv testing which may have been done during pregnancy. I understand, if the volume of the maternal blood sample is insufficient or missing, a fresh sample of maternal blood will be drawn within 7 days of delivery. If the sample is not drawn the Specimen will automatically be quarantined, which may affect its status for transplant use. Also I understand that a portion of the blood would be stored for potential future testing. Screening for Infectious Diseases: I am aware that my blood will be screened for transfusion transmitted infections. The screening procedure involves testing of my blood for Syphillis, Hepatitis B, Hepatitis C, HIV, HTLV I & II, Cytomegalovirus, and Malaria. If any of these tests is positive, a confirmatory test is performed by a qualified external agency and only if the confirmatory test is positive, then further course is decided with counselling. The results will not be disclosed to any other party without consent, except to the extent disclosure is required by law. AUTHORIZATON TO COLLECT UMBILICAL CORD: RELEASE FROM LIABILITY The undersigned is participating in Umbilical Cord program. The program requires the collection of Umbilical Cord at the time of birth of the Child. Consent is hereby granted by the undersigned to the medical professionals attending to the birth to perform the collections. The undersigned acknowledges that complications may occur during collection of Umbilical Cord which could prevent or impede the collection of the Umbilical Cord or procedure an inadequate Specimen. The undersigned further acknowledge that medical judgment, with the best interest of the mother and Child in mind, could totally prevent the collection. The undersigned hereby releases and forever discharges LifeCell, the obstetrician or certified nurse midwife, the hospital or birthing center, and their respective officers, directors, shareholders, employees, agents, representatives, affiliates, successors and assigns (collectively, the Released Parties ) of and from any and all liability for any and all loss, harm, damage or claim of any kind arising from or relating to the collection of, or failure to collect, the Umbilical Cord. The undersigned acknowledges that, by this release, the undersigned is giving up any right she may otherwise have, now or in the future, to sue or otherwise seek monetary damages or other relief against any of the Released Parties for any reason relating to the collection of, or failure to collect, the Umbilical Cord. I have read the above information and hereby give the consent to perform the above required tests. Name of the Client... Client s Signature... Name of the Husband... Husband s Signature... Obstetrician / Gynaecologist Name... Date...
CONSENT FOR CONDUCTING THE BABYSHIELD SERVICES BabyShield is a screening test to screen for metabolic disorders. These disorders are mainly genetic in nature due to which there is metabolic derangement in the body leading to increased/decreased levels of certain metabolites or their byproducts. These disorders have wide spectrum of manifestations- from completely asymptomatic to life threatening conditions. Many such disorders if detected & treated early, helps child to live a normal life & hence early detection is important. Samples taken for analysis could be either or all of the following: 1. Urine sample on filter paper 2. Cord blood or heel-prick sample on filter paper (Cord Blood Collected by Doctor/ nurse at the time of delivery; Heel-prick collected 48 hours after delivery) All these modes of collection are very safe, simple & are not associated with any major complications. A mild inflammation may occur at heel prick site in few patients, but it is self limiting. Being specialized investigations, there are continuous developments in methods of estimation, estimating new metabolites etc. For such reasons the lab may use leftover samples for new developments which in a way contributes for the scientific developments in this field. With this background we need your consent. CONSENT I Mr. / Mrs. child for BabyShield new born screening profile. hereby authorize the hospital to collect & send blood/ cord blood/ urine sample of my I also permit the lab to use leftover samples for new developments & research. I have been explained all the information mentioned in the background above & I have understood the same. Signature: Name: Place: Date:
www.lifecell.in 1800 419 5555 LifeCell International Pvt Ltd CIN: U85196TN2004PTC053577 #26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai - 600 127 Tamil Nadu, India.