MENSTRUAL BLOOD STEM CELL TESTING, PROCESSING, STORAGE, RETRIEVAL, EXPANSION & INFORMED CONSENT AGREEMENT

Transcription

1 MENSTRUAL BLOOD STEM CELL TESTING, PROCESSING, STORAGE, RETRIEVAL, EXPANSION & INFORMED CONSENT AGREEMENT I, (the Client ) (bearing CRM: ), engage LifeCell International Private Limited, a company incorporated under the Companies Act, 1956, and having its registered office at #26, Vandalur Kelambakkam Main Road, Keelakotaiyur, Chennai , Tamil Nadu, India ( LifeCell ), on this day of (the Enrollment Date ), to process, test, store, retrieve and expand stem cells obtained from my Menstrual Blood ( Services ) on the following terms (this Agreement ). 1. DEFINITIONS In this Agreement, (including the recitals above), unless the context otherwise requires, the following expressions shall have the following meanings: 1.1. Sample means the menstrual blood provided by the Client Client means the woman who has enrolled with LifeCell and provided her Sample for availing the Services as per the terms of this Agreement Specimen means and includes stem cells obtained from the Sample useful for (including but not limited to) potential treatment of illness such as heart failure, critical limb ischemia, etc '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 labelling of the Sample. 2. SERVICES: OPTIONS AND FEES 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 For the purpose of safety, LifeCell has the option to relocate the stored 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 5.1. If the Client chooses Annual Storage Plan, this Agreement will continue for one year from the date of preservation of the Specimen ('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 All applicable taxes including but not limited to service tax present and/or future levy, if any are payable by the Client Client may opt for prepayment of the storage fees and upgrade their Annual Storage Plan to One Time Plan or Life Time Plan by paying the applicable fee as advised by LifeCell at relevant time. Upon such payment, the Annual Storage Plan will be converted into One Time Plan or Life Time Plan or the One Time Plan will be converted into Life Time Plan and this Agreement term will be extended till the Client's 60th birth anniversary/ one hundred years or till the survival of the Client, from the date of birth of the Client, whichever is earlier LifeCell offers its Menstrual Blood stem cell banking Services under different plans, fees and payment methods as detailed in the payment plan, which the Client must choose at the time of Enrollment. CLIENT RESPONSIBILITIES 3.1. Client is responsible to collect, prepare and properly label the Sample, in accordance with the instructions given in the Collection Kit. In particular, the Client must ensure that a minimum of 10 ml of Sample is collected, since smaller quantity of Sample may not be suitable for processing. The Client shall also ensure that the forms included in the Collection Kit are duly filled up and sent to LifeCell's processing facility Client must promptly notify LifeCell in writing of any change in the Client s name or contact details (including but not limited to mailing address, telephone numbers, etc.,) or any change in the legal heir of the Client In case of retrieval of the stored Specimen for any transplant, the Client has to submit duly filled up Retrieval Form provided by LifeCell at relevant time (to be accompanied by transplant physician's certificate confirming end use in statutorily compliant transplant procedures or approved clinical trials). 4. If the Client chooses the One Time Storage Plan, this Agreement term will continue till the Client's 60th birth anniversary from the date of preservation of the Specimen If the Client chooses Life Time Storage Plan, this Agreement term will continue and shall be held as valid throughout the survival of the Client (or) for one hundred years from the date of birth of the Client, whichever is earlier. In an unfortunate situation of non-survival of the Client, this Agreement term will continue and shall be held as valid throughout the survival of the Client's legal heir (or) for one hundred years from the date of birth of the Client, whichever is earlier At least 90 days before the expiration of this Agreement, LifeCell shall intimate the Client regarding the expiry of this Agreement, along with the terms for continued storage. Accordingly, the Client can enter into a new Agreement and continue the storage of the Specimen. 6. REPRESENTATIONS AND WARRANTIES OF THE CLIENT Client represents and warrants that STORAGE 4.1. LifeCell assures to process the Menstrual Blood Specimen by using its proprietary explant culture technology and store it in vapor phase of liquid nitrogen in 4 vials [includes 2 vials of minimally manipulated Menstrual Blood Specimen, and 2 vial of Mesenchymal Stem Cells (MSCs) isolated from the entire Sample] Client may opt for storage of Specimen at either of LifeCell's licensed facilities situated at #26, Vandalur Kelambakkam Main Road, Keelakottaiyur, Chennai , Tamil Nadu, India (or) Plot #26, Sector 4, IMT Manesar, Gurgaon , Haryana, India 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 Specimen The decision to collect the Sample, test, process, store, retrieve and expand the Specimen is a completely voluntary act of the Client. 7. RIGHTS TO SPECIMEN

2 The Client is solely liable for all the obligations and responsibilities herein under and shall have all rights over the stored Specimen. Pursuant to Clause 5, in an unfortunate situation of non-survival of the Client, all the rights over the stored Specimen shall be automatically transferred to the Client's legal heir and such legal heir can continue storage of the Specimen till his/her survival. Thereupon, this entire Agreement will continue and shall be valid throughout the term of this Agreement as per the terms. 8. LIFECELL CLIENT BENEFIT PROGRAMS (FOR SINGLE SITE STORAGE) LifeCell understands the Client's need to enhance the value of their investment and also provide a comprehensive coverage for the same. 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 in rare circumstances due to unexpected medical reasons (or) due to either illness/menopause, the Client may be unable to collect the Sample. In such situations, LifeCell assures to refund all fees paid by the Client to LifeCell upon sharing of relevant declaration along with supporting evidence from a registered medical practitioner Quality Guarantee: If the Client is diagnosed for any condition/s treatable by stem cell transplantation using the stored Specimen and if in the opinion of the patient's transplant physician, should for any reason the Specimen upon retrieval does not meet the then prevailing viability criteria benchmarked against existing international best practices, then 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 (INR Two Million only) Sample Transport Assistance: At the request of the Client, LifeCell would arrange and pay for a certified service provider for X-ray free transport of the Sample to LifeCell's Laboratory 8.4. Medical Concierge: For all medical and travel information relating to stem cell transplant using the stored Specimen for the Client or 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 Client along with her immediate family members Free Stem Cell Expansion: If the Client is diagnosed for any condition/s treatable by stem cell transplantation using the stored Specimen and should cellular expansion of the stored Specimen be deemed necessary for transplant, as determined by the patient's transplant physician, LifeCell shall at no additional cost expand and provide upto 1 billion Mesenchymal Stem Cells (as and when required) derived from the Menstrual Blood based on LifeCell's then existing in house protocols ADDITIONAL CLIENT BENEFIT PROGRAMS FOR DUAL SITE STORAGE Disaster Relief: If the Client is diagnosed for any condition/s 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, harm or damage of the Sample and/or 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 (INR Two Million only). Free Worldwide Shipment: In the event of the stored Specimen and/or the matching stem cells being required for any stem cell transplant for the Client, upon the Client's request, LifeCell at its own cost shall arrange and pay for X-ray free transport of the same under cryogenic conditions to the transplant center located at any destination worldwide General Conditions for LifeCell Client Benefit Programs The Client Agreement is valid and is in force. 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 retrieval of the entire stored Specimen or on making the due payment to full extent to the Client as applicable in the Client Benefit Programs, the Client would release LifeCell from any further obligations. 9. LIFECELL ASSURANCES LifeCell hereby assures that: 9.1. 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 LifeCell upon receipt of the Sample at its laboratory would determine whether it is fit or unfit for testing, processing and /or storage In rarely occurred circumstances, if the Sample is found to be unfit, including but not limited to insufficient volume, low cell count / viability, microbial contamination of the Sample, etc. then LifeCell will notify the Client immediately and seek another collection of the Sample. This Agreement shall be deemed terminated from the date of receipt of written consent from the Client to discard the Specimen. If LifeCell does not receive written instructions within 30 days of such intimation then LifeCell shall continue storing the Specimen as is where is, however the benefits available under LifeCell Client Benefit Programs as per clause 8 shall not be applicable for this unfit Specimen The Sample and Specimen would be tested, processed, stored, retrieved and expanded in accordance to approved Standard Operating Procedures and in compliance with statutory regulations Upon successful 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 the Sample at LifeCell laboratory LifeCell understands that the stored 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 In the event of the stored Specimen being retrieved for a stem cell transplant for the Client, there are no additional costs for retrieval and upon submission of filled Retrieval Form (as provided by LifeCell at relevant time), the Specimen will be available for delivery within 7 days, or within 90 days if cellular expansion is required. At the time of retrieval, LifeCell hereby assures to extend its fullest support and co-operation to the Client to procure all the relevant regulatory permissions (if any),

3 and for X-ray free transport of the stored Specimen under cryogenic conditions to the transplant center located in India or at any destination worldwide During the term of this Agreement, on every storage anniversary of the Specimen (date of preservation of the Specimen), LifeCell hereby assures to send an Annual Preservation Status Report on the most updated registered ID of the Client, which shall contain monthly temperature data of the cryo-chambers in which the Specimen is being stored that is recorded automatically from our highly advanced temperature monitoring software, thereby assuring the Client that the Specimen is safely stored in accordance to approved Standard Operating Procedures and in compliance with statutory regulations. 10. DISCLAIMER & LIMITATIONS LifeCell does not perform any medical Services, give any medical advice, or otherwise perform any service other than those expressly indicated in this Agreement. It disclaims all other representations, guarantees, warranties or assurances express or implied. h) Effects to Termination If this Agreement is terminated under Section ( within three years from the Enrollment Date, all fees paid by the Client shall be refunded after deducting a cancellation fee of 5000 (INR Five Thousand only). If this Agreement is terminated under Clause ( all fees paid by the Client to LifeCell are non-refundable. The Client reserves the right to shift the stored Specimen at their own cost to any other stem cell bank facility of their choice. c) If this 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 this Agreement is terminated under Section (d), the 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 discard the stored 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 of this Agreement. During this period, the Client shall have the option of reviving this Agreement by paying all unpaid fees and a late fee of 5000 (INR Five Thousand only). e) If this Agreement is terminated by LifeCell under Section 12.1.(f), LifeCell hereby assures that it will at its own cost arrange for transfer of the stored Specimen to a comparable stem cell bank facility and also pay this new stem cell bank for storing the Specimen for the remaining term of this Agreement. Thereupon, all the benefits available under the LifeCell Client Benefit Programs under Clause 8 of this Agreement shall automatically survive for the remaining term of this Agreement. If this Agreement is terminated by the Client under Section (f), the Client shall bear the entire cost for shifting the stored Specimen to another stem cell bank facility of their own choice. f) If this 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 this Agreement is terminated by the Client under Sections 12.1.(e) or 12.1.(g), the Client shall bear the entire cost for shifting the stored Specimen to another stem cell bank facility of their own choice. g) All refunds by LifeCell shall be processed within 30 days of receiving the complete documentation. 13. ARBITRATION LifeCell disclaims any responsibility to provide any other services (except those specified in this Agreement) and third party service providers like Transporter, etc shall have the respective responsibility for their services including loss, damage, and delay in delivery, etc 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 the Client to LifeCell or benefits available under the applicable LifeCell Client Benefit Programs (whichever is higher). However, for any act/s committed by LifeCell that are intentional and/or grossly negligent, this liability shall be subject to the discretion of the Court of Law. 11. FORCE MAJEURE 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 This Agreement may be terminated by Client at any time prior to the collection of the Sample, or by Client at any time after storage of the Specimen, or c) by LifeCell if it has exercised its right to refuse Specimen processing and/or storage for any reason, including the consequential act of Sample rejection as per Clause 9.4, or d) by LifeCell if any payment due to LifeCell during the term of this Agreement 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 the Client and LifeCell, or f) by either party upon 60 days prior written notice to the other party hereto, or g) in the event the entire Specimen is retrieved for a transplant. However, if the Client retrieves only a portion of the Specimen, this Agreement would survive along with all benefits for the term of this Agreement. in the event either law or a governmental agency or regulatory provisions or medical guidelines require us to terminate this Agreement. 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, 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. 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. The Client also hereby agrees to the release of

4 information to the hospital, laboratory or physician providing the Services to the Client. 16. This Agreement including the sections on the risks relating to stem cell banking, list of the tests performed and the informed consents hereto constitute this entire Agreement between LifeCell and the Client and supersede any prior Agreements or understandings, oral and/or written. This Agreement may be modified only by written Agreement of the Client and Authorised Signatory of LifeCell and such modifications thereupon shall also constitute as a part of this entire Agreement. ASSIGNMENT LifeCell may assign this Agreement to any individual or entity providing a similar service. If LifeCell is acquired by or merged with or into another company, LifeCell shall require that the terms of this Agreement continue in full force and effect. LifeCell shall notify the Client with 90 days in the event of any such assignment. 17. NOTICE Notice to LifeCell must be in writing and delivered to LifeCell International Private Limited, No.26, Vandalur-Kelambakkam Main Road, Keelakottaiyur, Chennai , Tamil Nadu, India 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. 18. ENTIRE AGREEMENT 19. SURVIVAL All provisions which by their terms require performance after the termination of this Agreement will survive the termination of this Agreement. 20. 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.

5 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. For better transparency, 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 The Sample is collected by the Client using a menstrual cup (provided in the Collection Kit) which has to be worn inside the vagina. Though this cup is very convenient to use and safe; however, inherent risks of microbial contamination of the Sample may render the Sample unfit for storage. Certain circumstances like unexpected medical reasons or illness or menopause may entirely prevent the collection of the Sample or collection of adequate quantity of the Sample required for storage purposes. TESTING RISKS The Sample and Specimen are tested for reporting their identity and quality, 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 that if in doubt, 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 the Specimen could be associated with risks of either loss of their viability, partial or total loss of the Specimen due to reasons beyond the reasonable control of LifeCell. However, no assurance can be provided on the maintenance of viability for indefinite storage, and that the Specimen may also be lost due to equipment failure and / or accident which may render the Sample unfit for transplantation. By placing the Specimen with bar-codes in overwrap bags and metal canisters where applicable; maintenance of Specimen in vapor phase of liquid nitrogen; and placement high-risk/ quarantine Specimen in a separate dewar help avoid the chances of cross-contamination. Also, maintenance of adequate nitrogen levels in the dewars through piped supply from bulk tanks for automated top-ups; provision of continuous monitoring and automated alarm systems onto dewars, and supply with triple layer supply of electricity (power grid, uninterrupted power supply, and diesel generator) minimize the chances of temperature deviations which may result in loss of viability. Adequate facility design considerations, running of regular stability testing programs, maintenance of Specimen 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 to the Client. TRANSPORTATION RISKS Transport of the Sample from the Client's place of collection to the LifeCell laboratory, or transport of the stored Specimen 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 and/or Specimen 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 and Specimen 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 third party courier company on the safe and timely transport, and that Client has the option of choosing the best possible mode of transport. APPLICATION RISKS Menstrual blood, like bone marrow, is 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 clinical trials into commercial applications. Client also understands that stem cells obtained from the menstrual blood may need further processing before use for a transplant. Client is aware that banking the menstrual blood stem cells does not guarantee that a stem cell transplant would be the first or best course of treatment for any particular medical condition or that the Client s own stem cell is useful for every medical condition treatable by stem cell transplantation. The patient's transplant physician ultimately decides whether the use of the Client s Specimen is indicated, based on the nature and progression of the medical condition, and in case of an allogenic stem cell transplantation, depending on the HLA matching between donor and recipient.

6 LIST OF TESTS PERFORMED LifeCell commits to perform the below mentioned tests at no additional costs to the Client. Menstrual Blood Stem Cells Sterility Viable Mononuclear Cell count At retrieval for transplant Viable Mononuclear Cell count Sterility Mycoplasma Cell Morphology Cell Proliferation Assay Flow Marker Positives: CD 90, 73, 105 Flow Marker Negatives: CD 34,45,14,19, HLA-DR Endotoxin HLA typing for Donor & Recipient Cell Morphology LC/DOM/CA/FEMME/03-2