AGREEMENT/INFORMED CONSENT FOR COLLECTION, PROCESSING AND STORAGE OF UMBILICAL CORD BLOOD

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1 AGREEMENT/INFORMED CONSENT FOR COLLECTION, PROCESSING AND STORAGE OF UMBILICAL CORD BLOOD

2 Signed in..., on.../.../... the below Parties: If both mother and father have the parental responsibility and custody of the CHILD, both mother and father need to sign this agreement: a. Mother s full name... (henceforth called MOTHER ) Name of Husband... MOTHER Address... MOTHER Phone Number... MOTHER Cell Phone Number , ID....and Tax Code No.., b. Father s full name... (henceforth called FATHER ), FATHER address... FATHER Phone Number... FATHER Cell Phone Number , ID....and Tax Code No.., Acting jointly, on behalf of their child, (henceforth called CHILD (mention the child s name if known)... and both having the parental responsibility and child s custody, henceforth called PARENTS. In case that only the mother has the parental responsibility and custody of her CHILD, only the mother will sign this agreemen: Mother s full name... (henceforth called MOTHER MOTHER Address... MOTHER Phone Number... MOTHER Cell Phone Number , ID....and Tax Code No.., acting alone, on behalf of her child, (henceforth called CHILD (mention the child s name if known)... and having the parental responsibility and child s custody, henceforth called PARENT. 2

3 - And the other party, The joint stock company named IATRIKI TECHNOLOGIA HELLINIKI TRAPEZA VLASTOKYTTARON A.E. (henceforth called STEM-HEALTH HELLAS ), located in Athens, Greece, 4 Erithrou Stavrou St and Kifisias Ave.,(within HYGEIA hospital), with Tax Registration Number , of the Tax Office (FAEE Athens), No. MAE 64648/01AT/B/07/526, Tel , Fax: , website and which will be referred to as STEM-HEALTH HELLAS. Agree and mutually consent to the following: I. OBJECTIVE STEM-HEALTH HELLAS undertakes the obligation to explain completely and concisely to the signatories or to their authorized persons, the total procedure, terms, conditions, restrictions, dangers, and the cost of the collection, transportation, and processing of the Umbilical Cord Blood (henceforth called U.C.B. ) as well as the isolation, control, and storage of stem cells (henceforth called UNIT ), according to their scientific definition, which will be isolated and collected from the U.C.B. immediately after delivery. It should be noted that the sole aim of this agreement is in relation to the storage of UNIT and has no relation to the future use of said UNIT.Furthermore, it is hereby definitely and unequivocally stated that UNIT, which will be stored in the private stem cell bank of STEM-HEALTH HELLAS belongs exclusively to PARENTS/PARENT and will not be given to any third person or used for scientific research, unless PARENTS/PARENT consent in writing. It is also stated that the procedure of collecting U.C.B. will not cause any pain or medical difficulty to either MOTHER or CHILD. This document contains the agreement regarding the above and defines the rights and obligations of the two parties of this agreement. PARENTS/PARENT expressly hereby agree that their umbilical cord blood stem cells will be processed, isolated, and stored by STEM-HEALTH HELLAS and that PARENTS/PARENT have been fully informed of, accept and agree with the terms, conditions, dangers, restrictions, and cost of storage. II. COLLECTION, TRANSPORTATION, PROCESSING, STORAGE, DISPENSATION The collection, transportation, and processing of the Umbilical Cord Blood U.C.B, as well as the storage and dispensation of UNIT will be handled in the following manner: A. COLLECTION: 1. In order for this agreement to be in effect and for the U.C.B. to be collected, transported and processed as well as the UNIT to be extracted and stored, the following must be fulfilled: a) It is the responsibility of PARENTS that the U.C.B. collection pack provided by STEM-HEALTH HELLAS is handed to the midwife or the doctor before the delivery (this process is valid for all maternities in Athens and in the rest of the country with 3

4 the exception of MITERA and LETO where the collection pack is supplied through internal procedures within the maternities). b) PARENTS/PARENT should inform the Doctor and Maternity Hospital in which the delivery will take place, prior to the delivery, of their desire to have the UNIT of their CHILD collected and stored by STEM-HEALTH HELLAS. It is the responsibility of PARENTS/PARENT to make sure that the Maternity Hospital where the delivery is to take place has the capability of collecting U.C.B. and that the Doctor is willing to undertake at his own risk, the obligation to proceed with the U.C.B. collection according to internationally established procedures, which both the Doctor and STEM-HEALTH HELLAS have been certified with. c) PARENTS/PARENT should have signed the consent form regarding the collection of U.C.B., the collection of MOTHER's blood for the purpose of laboratory examination, this contract as well as the accompanying health questionnaire for the cryopreservation of the UNIT. 2. The blood should be collected by the Doctor or by specialized staff of the Maternity Hospital or Clinic appointed by the Doctor, using internationally established and scientifically accepted methods. It is the Doctor's responsibility to see that the U.C.B. is packed correctly for the transportation to the STEM-HEALTH HELLAS laboratory in order to be processed and stored. If for any reason the minimum amount of suitable U.C.B. of 40ml is not collected, then automatically, without further notice destruction of the U.C.B. sample will occur since according to international medical literature data, U.C.B. volumes below 40ml are not suitable for storage and further future use. The laboratory owes to send parents a certificate of destruction signed by the Director of the laboratory. Along with the U.C.B., MOTHER's blood should also be collected and sent. MOTHER's blood should have been collected either during the delivery or at the latest within 48 hours after delivery, to confirm that MOTHER doesn't suffer from any transmittable disease which could affect the UNIT's condition and quality. B. TRANSPORTATION: Immediately after the delivery, PARENTS/PARENT themselves have the responsibility to immediately communicate with STEM-HEALTH HELLAS via telephone to the number indicated on the U.C.B. collection pack, so that the authorized delivery service collect the U.C.B from the Maternity Hospital and transports it, at his own risk, to STEM-HEALTH HELLAS s laboratory. C. PROCESSING: U.C.B. should be sent to STEM-HEALTH HELLAS at the latest, within 40 hours after collection. After this deadline, U.C.B. will be received and processed by STEM- HEALTH HELLAS, only by PARENTS/PARENT written consent. 1. PARENTS/PARENT has been informed by STEM-HEALTH HELLAS on the methods of collection and processing of U.C.B. as well as the processes used for the isolation and storage of UNIT from U.C.B. These processes are quite recent in the scientific community and consequently it is not possible to provide guarantees or assurances of successful and effective therapeutic results. 2. In order to exclude the possibility of any transmittable disease from MOTHER to CHILD, MOTHER's blood will undergo the examinations mentioned in article III, in 4

5 laboratories approved by STEM-HEALTH HELLAS. The total cost of these examinations is included in the overall storage costs. 3. STEM-HEALTH HELLAS undertakes the obligation to isolate the UNIT after having received U.C.B., to go through the identification of TNCC and CD34 + cells and proceed with the storing of UNIT in liquid nitrogen or another suitable, scientifically recognized medium. 4. PARENTS/PARENT is required to inform STEM-HEALTH HELLAS in writing and within 24 hours in case they do not wish to proceed with further processing and storing of the stem cells. D. STORAGE: Thereafter, UNIT will be stored in liquid nitrogen. The procedure of processing U.C.B. and storing UNIT will take place under stringent laboratory conditions, at the latest within 48 hours after the birth of CHILD, in order to ensure the maximum viability of stem cells. PARENTS/PARENT is informed that the uses of stem cells for therapeutic purposes represent recent scientific developments and it is not possible to provide guarantees or assurances of successful and effective therapeutic results. E. AVAILABILITY OF STEM CELLS: 1. The stem cells (UNIT) can be available only for the benefit of the CHILD. The CHILD, while still a minor and until he obtains legal rights according to the law, will be represented jointly by his PARENTS/PARENT. The only case that it is permitted to PARENTS/PARENT to make the UNIT available to a third party is when a close relative, such as a sibling, a parent or a relative of 1 st degree, has been afflicted by a life threatening disease which can only be cured with stem cells transplantation (UNIT). 2. In the event that during the duration of the contract the PARENTS/PARENT requests that the stem cells (UNIT) be made available for transplant in accordance with the provisions of the contract, they should advise so STEM- HEALTH HELLAS in writing. Their request should mention the address of the hospital where the UNIT should be sent, as well as the name of the doctor who will be in charge of the procedure. 3. STEM-HEALTH HELLAS is required by law and the FACT-Netcord standards to store blood of the MOTHER and U.C.B. for tests in the future prior to the release of the UNIT*. PARENTS/PARENT is informed that the compatibility test of the Human Leukocyte Antigen (HLA) of the isolated stem cells from U.C.B. must be performed prior to them being used for a directed allogeneic transplantation (when the donor and the recipient are different people). STEM-HEALTH HELLAS then prepares the UNIT for transportation and in accordance with the approved procedures and within the time frame that has been requested by the PARENTS/PARENT. 4. STEM-HEALTH HELLAS undertakes the obligation for FREE preparation and transportation of stem cells to any transplant center in the world, accompanied by its own staff to ensure quick and safe delivery, in case of lifethreatening disease for the child or first degree relatives. 5

6 5. STEM-HEALTH HELLAS is a private stem cells storage bank and can store UNITS that do not fully comply with the standards of FACT-NetCord. Stored UNITS that do not comply with the standards of FACT-NetCord include UNITS that fall into the following cases: - Collection bag with a label that has not been placed on the bag. - Collection bag with records that are not correct or are missing. - Omissions/Errors in the form Necessary Birth Information, for example in the field of phenotypical abnormalities. - Insufficient quantity of mother s blood for conducting tests. - Stored UNITS with errors (grammatical or not) in the name and in the label attached to the bag. - A positive indication for a transmitted disease in the mother s blood. - UNITS whose viability during freezing and storing is below 50%. The utilization of these UNITS rests on the doctor who is to perform the cure. *Units that are kept for future tests include: - Two samples U.C.B. of minimum volume 100μl (ml, 10-6 lt) included in the storage bag. - At least two vials/samples U.C.B. that contain 1-2x10 7. mononuclear cell each. - Two vials with serum or plasma U.C.B. not processed with Heparin of minimum volume 2 cubic centimeters (ml) each. - UC.B (~0.5 cubic centimeters, ml) for the preparation of at least 50 mg (10-6 g ) genomic DNA for future genetic tests. - Two vials of serum or plasma from the expectant mother not processed with Heparin of minimum volume 2 cubic centimeters (ml) each, maintained at -70 C the lowest. - Blood from the biological MOTHER (~0.5 cubic centimeters, ml) for the preparation of at least 50μg (10-6 g ) genomic DNA for future genetic tests. III. MEDICAL EXAMINATION OF MOTHER'S BLOOD For the secure and successful processing and storage of UNIT by STEM- HEALTH HELLAS, it is medically necessary that the doctor collects a sample of MOTHER s blood during the delivery or within 48 hours after delivery, into special vacutainers, which are included in the collection pack. PARENTS/PARENT is responsible for informing the Doctor about the collection of the blood, and the Doctor is then responsible for collecting the blood. MOTHER s blood and a part of U.C.B. will be subject to a range of laboratory tests, including tests to determine blood type and Rhesus. In order to exclude the possibility of MOTHER having a transmittable disease which might be transmitted to the CHILD, MOTHER s blood must go through a range of tests in approved laboratories of the HYGEIA GROUP, to indicate the possible existence of transmittable diseases. The list of tests below is indicative: - HIV I & II (Antibodies for the virus causing AIDS) - Antigen P24 for AIDS - Anti HCV/antibody (Hepatitis C virus). - HbsAg (Australian Antigen Hepatitis B virus ) - HbcAg (Antibody core for Hepatitis B). - In case of a positive result of the HbcAg, a HBV NAT (virus of Hepatitis B via a nucleic acid test) is performed. 6

7 - HTLV I & II (Antibodies for human Τ- cell Leukemia virus Type I and II) - VDRL (RPR) (Syphilis) - CMV (IgG & IgM) (Antibodies for Cytomegalovirus) STEM-HEALTH HELLAS may request a second blood collection if the first collection of the MOTHER s blood is not sufficient for the laboratory tests. In case of a positive result in any of the above tests performed on MOTHER s blood, and/or of the bacterial tests performed on the CHILD s cord blood, STEM-HEALTH HELLAS will notify the PARENTS/PARENT whether the unit is suitable or not for storage (satisfactory quality of the UNIT). PARENTS/PARENT will confirm in writing to STEM-HEALTH HELLAS their consent either for discard or for storage of the unit. In case MOTHER s blood is found positive in the tests for transmittable diseases (with the exception of CMV antibodies for Cytomegalovirus) and PARENTS/PARENT wishes to store the UNIT, the UNIT will be stored in a separate tank with liquid Nitrogen (quarantine). If 6 months after birth it is confirmed that the CHILD does not suffer from the disease, then the UNIT will be transferred to the normal nitrogen storage tank. IV. LIMITATIONS OF RESPONSIBILITY 1. The cryopreservation storage room where UNIT will be stored is under the control and operation of STEM HEALTH HELLAS. STEM-HEALTH HELLAS's responsibilities are only with regard to U.C.B.'s processing, as well as the UNIT's isolation and storage according to the circumstances and terms hereby mentioned. 2. STEM-HEALTH HELLAS retains the right to transport the UNIT to another cryopreservation laboratory or change the location of the cryopreservation storage room. 3. STEM-HEALTH HELLAS retains the right to deny, for any reason, the U.C.B.'s collection and the UNIT's isolation and storage (for example if for the collection the STEM-HEALTH HELLAS s collection kit is not used). 4. STEM-HEALTH HELLAS does not provide any other kind of services except for those described herein. 5. STEM-HEALTH HELLAS is not responsible for the loss of U.C.B. or UNITS caused by a force majeure (for example: natural disasters, war, acts of terrorism), which might cause partial or total destruction of U.C.B. or UNITS. Furthermore, in case of loss, degradation or destruction of U.C.B. or UNIT for any reason, other than intentionally or from deceit or gross negligence by STEM-HEALTH HELLAS, it's sole responsibility is to return to PARENTS/PARENT an amount equal to the cost of collection, processing and/or storage equal to that which STEM-HEALTH HELLAS has received. 6. STEM-HEALTH HELLAS in cooperation with the stem cell bank Cryobanks International Services-Athens of IASO Group, proceeded in establishing the Association of Accredited Stem Cell Banks, whose aim is to guarantee retention of stem cells in case where one of the banks ceased to function. 7. STEM-HEALTH HELLAS is not responsible in case of contamination of U.C.B. during collection. 7

8 8. A UNIT which has been stored is the possession of and falls under the exclusive control of the signatory parties or their authorized delegated persons. When the person from whom U.C.B. has been collected becomes an adult, he/she automatically attains full control. V. PERSONAL DATA PROTECTION STEM-HEALTH HELLAS retains the right to ask PARENTS/PARENT to provide specific personal information with relation to themselves or CHILD in order to provide its services according to this agreement. PARENTS are responsible for the accuracy of this information. STEM-HEALTH HELLAS will use PARENTS/PARENT and CHILD personal data and information only in order to provide its services according to this agreement. PARENTS/PARENT's and CHILD's personal data and information are absolutely confidential and it is forbidden for STEM-HEALTH HELLAS to provide them to any third person without PARENTS/PARENT' consent, with the exception of Public Authorities, and involving cases in which the provision of this information to third persons is demanded by Greek Law, for instance the law n. 2472/1997 regarding Protection of Personal Data Process. For this reason, STEM-HEALTH HELLAS insures that the transportation of U.C.B. and MOTHER's blood be done exclusively by use of a unique barcode (BARCODE). VI. DURATION OF AGREEMENT-TERMINATION-CANCELLATION 1. This agreement is valid from the date on which it is signed by both parties and expires at the completion of the storage time, which is twenty (20) years from the date of CHILD's birth. STEM-HEALTH HELLAS will inform the PARENTS/PARENT and CHILD in an appropriate fashion at least two (2) years before the expiry of this agreement, and PARENTS/PARENT as well as CHILD will have the right to ask in writing for an extension of the UNIT's storage by STEM-HEALTH HELLAS, for as long as they wish, provided that they pay the storage fees in advance for that period, at the fees that exist at that time. In case that PARENTS/PARENT or CHILD do not give written notification regarding their desire to discontinue the storage of UNIT and terminate this agreement, after the contractual period of twenty (20) years, this agreement will automatically be renewed for another five (5) years at the current cost at that time. STEM- HEALTH HELLAS will then inform PARENTS/PARENT and CHILD about their obligation to pay the additional cost. In case that PARENTS/PARENT or CHILD do not notify STEM-HEALTH HELLAS of their desire to continue the UNIT' S storage for another five (5) years and do not settle their accounts, within three (3) months of the notification by STEM-HEALTH HELLAS, then STEM-HEALTH HELLAS retains the right to unilaterally terminate this agreement and to destroy that particular UNIT, without any further notification to PARENTS/PARENT or CHILD.STEM-HEALTH HELLAS informs PARENTS/PARENT that based on today s facts the expiration date of the contract constitutes also a probable termination date of the product (UNIT). 2. STEM-HEALTH HELLAS has the right to move the UNIT in other cryopreservation premises or change the location of the cryopreservation area, 8

9 only in writing to the contractual PARENTS/PARENT, providing the reasons of the anticipated move. 3. This agreement will also be terminated in case that PARENTS or CHILD ask for the dispensing of the UNIT before the contract period is terminated. In this case, as well as in case that the PARENTS/PARENT wants to cancel this agreement before the end of the contract period, the fees that will have already been paid will not be refunded. VII. MISCELLANEOUS TERMS 1. Any modifications, corrections, or additions to this agreement will only be made in writing by authorized representatives of the parties. Any kind of services, notifications, or written communications concerning this agreement will be sent to the parties' addresses as indicated herein. 2. In case that any term of this agreement be considered void, illegal, or in any manner unenforceable, the power or enforceability of the other terms will not be affected and this agreement will continue to be valid. 3. STEM-HEALTH HELLAS has the right to communicate in the future with parents. 4. STEM-HEALTH HELLAS has the right to conduct periodic quality controls with the stored UNITS in order to safeguard their safe storage during the contractual period. 5. PARENTS/PARENT is obliged to inform STEM-HEALTH HELLAS if the CHILD from whom the U.C.B. was collected develops a disease (particularly if the disease is congenital). 6. PARENTS/PARENT is obliged to inform STEM-HEALTH HELLAS in case there is a change in their personal records. 7. PARENTS/PARENT is obliged to send to STEM-HEALTH HELLAS a copy of the official birth certificate if the CHILD from whom the U.C.B. was collected was born out of wedlock. This written text constitutes a full agreement between parties regarding the hereby mentioned subject and replaces any previous written or oral agreement, declaration or condition regarding this subject. VIII. APPLICABLE LAW AND RESOLUTION OF DISPUTES 1. This agreement, as well as any dispute that might arise in relation to it, will be governed by Greek Law and be interpreted according to it. 2. Disputes that could arise from this agreement or be related to this agreement fall under the jurisdiction of Athens' Courts. 9

10 IN WITNESS THEREFORE, this text has been signed in duplicate by the indicated parties. Each party has received one (1) copy. On behalf of PARENTS/PARENT On behalf of STEM-HEALTH HELLAS A.... B.... Nikolaos Nicolaidis Managing Director 10

11 STEM-HEALTH HELLAS S.A. HEALTH QUESTIONNAIRE MOTHER SNAME&SURNAME Genetic Birth Mother MOTHER'S DATE OF BIRTH: FATHER S NAME: MOTHER S NAME: FATHER S NAME & SURNAME: Genetic Legal OBSTETRICIAN S NAME &SURNAME/MATERNITY HOSPITAL: If yes, please specify in the space provided on page 13. No. PERSONAL HISTORY QUESTIONS 1 Have you ever been rejected as a blood donor? 2 Have you ever been positively diagnosed with an hepatitis virus? 3 Have you ever had jaundice or hepatopathy? 4 Have you ever been positively diagnosed with HIV/AIDS? 5 Have you ever been positively diagnosed with HTLV-I or ΙΙ? 6 During the last 12 months, have you received Hepatitis B Immunoglobulin (HBIG)? 7 Have you ever been positively diagnosed with malaria? 8 During the last 12 months, have you had a tattoo, used needles or had an acupuncture? 9 During the last 12 months, have you been positively diagnosed with a sexually transmitted disease, including syphilis or gonorrhea? 10 During the last 12 months, have you been diagnosed with a severe disease or been subjected to surgery? 11 Cancer/Leukemia Any type of cancer or leukemia before the age of 20? 12 Have you ever received a transplantation and blood or blood product transfusion? 13 Have you ever received factor condensate for an hemorrhagic disorder? 14 During the last 12 months, have you lived or had close or sexual contact with any person with active or chronic viral hepatitis or jaundice? 15 During the last 12 months, have you had close or sexual contact with any person suffering from HIV/AIDS or positively diagnosed with HIV/AIDS? 16 Did you ever have close or sexual contact with a person who was born or had lived in Africa since 1977? 17 Did you ever live or travel to a foreign country (except Europe and N. America)? If yes, please specify at the space provided, including when, where and for how long) 18 Have you lived in the United Kingdom for a period of 6 months until 1990? YES NO MOTHER S SIGNATURE DATE 11

12 No. FAMILY GENETIC HISTORY QUESTIONS 1 Red Blood Cell diseases Sickle-cell anemia? Thalassemia? Elliptocytosis? Relative with disease / explanation YES NO 2 White Blood Cell diseases Chronic granulomatous disease? Wiskott-Aldrich? 3 Platelet diseases Glanzmann s disease? Congenital Thrombocytopenia? 4 Metabolic diseases/storage diseases Leukodystrophies? Ataxia Teleangiectasia? Hunter s disease? Purpura? 5 Neurological disorders Creutzfeld-Jakob s disease? Huntington's chorea? Alzheimer s disease? 6 Immunodeficiency Severe combined immunodeficiency (SCID)? Hypoglobulinaemia? Nezelhof syndrome? 7 Immune System disorders Lupus? Rheumatoid arthritis? 8 Musculoskeletal disorder/connective tissue disorder Osteopetrosis (NOT osteoporosis)? Mucopolysaccharidosis? 9 Other Hemolytic anemia? Hemophilia? Disease requiring chronic blood transfusions? Glycogen storage disease? Other congenital diseases? MOTHER S SIGNATURE DATE 12

13 No. GYNECOLOGICAL HISTORY YES NO QUESTIONS 1 Is this your first pregnancy? If not, please specify at the space provided how many other pregnancies you have had and how many alive children have been born from those other pregnancies? 2 Did you have any significant medical issues during pregnancy? 3 Have you ever taken the drugs Roacutane (for acme), Etretnate or Neotigason (for psoriasis)? 4 Was your pregnancy a result of in-vitro fertilization? 5 If yes, a donor egg or sperm has been used for this pregnancy? 6 Have you ever had an abortion or intra-uterine fetal death? 7 Have you ever had an abnormal result in antenatal screening or an abnormal pregnancy? MOTHER S SIGNATURE DATE 13

14 14

By my signature on this agreement,

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