1 Life-Kit Code 1 Life-Kit Code 2 Life-Kit Code 3 Unique Client Identification Code 1. ΣΤΟΙΧΕΙΑ ΜΗΤΕΡΑΣ / MOTHER S DETAILS Έντυπο Εγγραφής Πελατών /Client Registration Form Όνομα / First Ελληνικά & Αγγλικά/ Greek & English Πατρικό Επώνυμο Maiden Συζυγικό Επώνυμο Marital Surname Ημερ. Γέννησης Mother s Birth Date Ταυτ. / Διαβατήριο I.D. / Passport No. GR: EN: / /19 Παρακαλώ Επιλέξτε Please Choose Επάγγελμα Occupation Τηλέφωνα Telephone No. Άλλα Παιδιά Όνομα Other Children- Ηλικία Age Φύλο Sex Οικία/ 1. Παντ/μένη Married Διαζ/μένη Divorced Άγαμη Single Home: Εργασία/ Work: Κινητό/ Mobile: 2. ΣΤΟΙΧΕΙΑ ΠΑΤΕΡΑ / FATHER S DETAILS Όνομα Επώνυμο Surname Ταυτότητα / Διαβατήριο I.D. / Passport No. Επάγγελμα Occupation Τηλέφωνα Telephone No. Εργασία/ Work: Κινητό/ Mobile: 3. ΣΤΟΙΧΕΙΑ ΕΠΕΙΓΟΥΣΑΣ ΕΠΙΚΟΙΝΩΝΙΑΣ (ΕΚΤΟΣ ΤΩΝ ΓΟΝΕΩΝ) / EMERGENCY CONTACT (OTHER THAN PARENTS) Όνομα Επώνυμο Surname Συγγένεια Relation Τηλέφωνο σταθερό Telephone no. Κινητό Mobile no. 4. ΔΙΕΥΘΥΝΣΕΙΣ /ADDRESSES Οδός/Αριθμός Κατοικίας Home Street Address Πόλη/Επαρχία Town / District Ταχ. Τομέας Postal Code 1: 2: Τ.Θ. (Εάν Υπάρχει) P.O. Box (If Applicable) Πόλη/Επαρχια Town / District Ταχ. Τομέας Postal Code 5. A. ΥΠΗΡΕΣΙΑ ΛΗΨΗΣ ΑΙΜΑΤΟΣ ΟΜΦΑΛΙΟΥ ΛΩΡΟΥ/ CORD BLOOD BANKING SERVICE B. ΥΠΗΡΕΣΙΑ ΛΗΨΗΣ ΙΣΤΟΥ ΟΜΦΑΛΙΟΥ ΛΩΡΟΥ / CORD TISSUE SERVICE 6. ΣΤΟΙΧΕΙΑ ΙΑΤΡΟΥ / DOCTORS DETAILS Όνομα Γυναικολόγου / Μαιευτήρα Gynaecologist/Obstetrician Τόπος Τοκετού - Κλινική / Νοσοκομείο Place Of Labour - Clinic / Hospital Όνομα Παιδίατρου Paediatrician 7. ΣΤΟΙΧΕΙΑ ΤΟΚΕΤΟΥ / BIRTH DETAILS Φυσικός Τοκετός/ Natural Labour Πρόκληση Φυσικού Τοκετού/ Induced Labour Προγραμματισμένος Τοκετός Με Καισαρική Τομή Scheduled C-Section Labour Αναμενόμενη Ημ. Τοκετού/ Exp. Labour due date / /20 Ημερομηνία/date / /20 Ώρα/Time : πμ /μμ am /pm Ημερομηνία/date / /20 Ώρα/Time : πμ/ μμ am /pm 8. ΣΤΟΙΧΕΙΑ ΒΡΕΦΟΥΣ/ BABY DETAILS Αριθμός Παιδιών/ No. Of Children Φύλο/ Sex Όνομα/ Μονή Κύηση/ Single Pregnancy ΑΓΟΡΙ ΚΟΡΙΤΣΙ ΑΓΝΩΣΤΟ BOY GIRL UNKWN Δίδυμη Κύηση/ Twin Pregnancy Ταυτόσημα Δίδυμα/ Identical Twins Ναι/Yes Όχι/No ΑΓΟΡΙ ΚΟΡΙΤΣΙ AΓΝΩΣΤΟ BOY GIRL UNKWN ΑΓΟΡΙ ΚΟΡΙΤΣΙ AΓΝΩΣΤΟ BOY GIRL UNKWN ΑΓΟΡΙ ΚΟΡΙΤΣΙ ΓΝΩΣΤΟ BOY GIRL UNKWN Τρίδυμη Κύηση/ Triplet Pregnancy Ταυτόσημα Τρίδυμα/ Identical Triplets Ναι/ Yes Όχι/ No ΑΓΟΡΙ ΚΟΡΙΤΣΙ ΓΝΩΣΤΟ BOY GIRL UNKWN ΑΓΟΡΙ ΚΟΡΙΤΣΙ ΓΝΩΣΤΟ BOY GIRL UNKWN F-ADM-09/1-1
2 Στοιχεία Λήψης Αίματος Και Ιστού Ομφάλιου Λώρου, Μητρικού Αίματος & Ιατρικού Ιστορικού Details of Cord Blood, Cord Tissue Collection, Maternal Blood & Medical History Report 1. ΣΤΟΙΧΕΙΑ ΜΗΤΕΡΑΣ / MOTHER S DETAILS Όνομα Πατρικό Επώνυμο Maiden surname Συζυγικό Επώνυμο Marital surname Ημερ. Γέννησης Μητέρας Mother s Birth Date Ταυτότητα/ Διαβατήριο I.D. / Passport No. 2. ΣΤΟΙΧΕΙΑ ΥΠΕΥΘΥΝΟΥ ΛΗΨΗΣ ΑΙΜΑΤΟΣ ΚΑΙ/Η ΙΣΤΟΥ ΟΜΦΑΛΙΟΥ ΛΩΡΟΥ / PERSON RESPONSIBLE FOR CORD BLOOD AND/ OR CORD TISSUE COLLECTION Όνομα Υπεύθυνου λήψης - Ιατρός / Μαιευτήρας Doctor name responsible for collection Κλινική / Νοσοκομείο Place of collection - Clinic / Hospital 3. ΣΤΟΙΧΕΙΑ ΤΟΚΕΤΟΥ / BIRTH DETAILS Ημερομηνία Date Ώρα Time Βάρος Βρέφους Baby s Weight Φύλο Βρέφους Baby s Sex Τύπος Τοκετού Type Of Birth KG ΑΓΟΡΙ / ΚΟΡΙΤΣΙ MALE / FEMALE ΦΥΣΙΚΟΣ NATURAL ΚΑΙΣΑΡΙΚΗ C-SECTION Δόθηκε Αντιβιοτική Θεραπεία το τελευταίο 7ήμερο; Any Antibiotics Given For The Last 7 Days? Η μητέρα φέρεται να πάσχει από κάποια λοίμωξη (ίωση, εξανθήματα, φουσκωμένους λεμφαδένες κτλ) Does The Mother Appear To Suffer From Any Infection (Viral Symptoms, Rashes, And Swollen Lymph Nodes? Όχι No Όχι No Ναι Περιγραφή: Yes Description: Ναι Περιγραφή: Yes Description: 4. ΣΤΟΙΧΕΙΑ ΛΗΨΗΣ ΙΣΤΟΥ ΟΜΦΑΛΙΟΥ ΛΩΡΟΥ /CORD TISSUE COLLECTION DETAILS Ημερομηνία Λήψης Date Of Collection Συμπληρώστε Complete if Ώρα Λήψης Time Of Collection όταν διαφέρουν different from Ονοματεπώνυμο Υπεύθυνου Λήψης Responsible For Collection από τα στοιχεία τοκετού birth details Υπογραφή Signature 5. ΣΤΟΙΧΕΙΑ ΛΗΨΗΣ ΜΗΤΡΙΚΟΥ ΑΙΜΑΤΟΣ/ MATERNAL BLOOD COLLECTION DETAILS Ημερομηνία Λήψης Date Of Collection Συμπληρώστε Complete if Ώρα Λήψης Time Of Collection όταν διαφέρουν different from Ονοματεπώνυμο Υπεύθυνου Λήψης Responsible For Collection από τα στοιχεία τοκετού birth details Υπογραφή Signature ΒΕΒΑΙΩΣΗ - STATEMENT Βεβαιώνεται ότι το μητρικό δείγμα αίματος που συνοδεύει το Α.Ο.Λ. και /η τον Ιστό λήφθηκε από την μητέρα του βρέφους. Η λήψη αίματος έγινε κατόπιν συναίνεσης της μητέρας και σύμφωνα με τις διαδικασίες που καθορίζονται από την νομοθεσία και το ίδρυμα ιστών Lifeline. Τα στοιχεία λήψης συνοδεύονται από το ιατρικό ιστορικό στο πίσω μέρος του εντύπου. This is to certify that the maternal blood that accompanies cord blood and/or cord tissue was collected from the newborns mother. Collection consent was given by the mother and was performed according to the procedures given by Lifeline which are in line with the legislation and regulations. The Medical History Report is completed and shown at the back of this form. Υπογραφή Υπεύθυνου Λήψης Ιατρού/Μαιευτήρα Medical Professional Responsible For Collection Signature Ημερομηνία Παραλαβής Δείγματος/ Received Date LIFE-KIT CODE Temperature Recorder Number LFLE- Ώρα Παραλαβής/ Received Time LABORATORY CODE F-ADM 09/3-1
3 6. ΙΑΤΡΙΚΟ ΙΣΤΟΡΙΚΟ / MEDICAL HISTORY ΜΕΡΟΣ 1. SECTION Είστε Οι Βιολογικοί Γονείς Του Παιδιού; 1. Are You The Biological Parents Of The Child? ΜΕΡΟΣ Η Εγκυμοσύνη Είναι Αποτέλεσμα Εξωσωματικής Γονιμοποίησης; Αν Απαντήστε Την 3 & 4 3. Η Γονιμοποίηση Προήρθε Από Σπέρμα Δότη; 4. Η Γονιμοποίηση Προήρθε Από Ωάριο Δότη; SECTION Is This Pregnancy The Result Of In Vitro Fertilisation? If Answer Number 3 & 4 3. Did Fertilisation Derive From Donor Sperm? 4. Did Fertilisation Derive From Donor Ovary? ΜΕΡΟΣ 3. SECTION Εσείς Ή Ο Πατέρας Του Παιδιού Έχετε Διαγνωστεί Θετικοί Σε: HIV (Aids) Ηπατίτιδα Α,Β,Γ,Δ Ή Ε; 5. Have You Or The Father Been Diagnosed Positive For HIV (Aids) Or Hepatitis A, B, C, D Or E? 6. Ανήκετε Σε Ομάδα Υψηλού Κινδύνου Στο Ιατρικό Η Παραϊατρικό Τομέα Ή Προβήκατε Σε Ενδοφλέβια Χρήση Ναρκωτικών Ή 'Έχετε Επαφή Με Άτομα Που Πάσχουν Με Τις Ασθένειες Στον Αριθμό 5 Πιο Πάνω; 6. Do You Belong In A High Risk Group, Medical Or Paramedical Field Or Intravenous Drug User Or Do You Come In Regular Contact With Persons Suffering From The Infections In Question 5 Above? 7. Τους Τελευταίους 12 Μήνες Είχατε: Ατύχημα Με Ιατρική Βελόνα, Τρυπηθεί Για Σκουλαρίκια, Προβεί Σε Βελονισμό Ή Τατουάζ; 7. In The Last 12 Months Have You Had: Needle Accident, Piercing, Acupuncture Or Tattoo? 8. Τους Τελευταίους 12 Μήνες Είχατε: Μεταγγιστεί Με Αίμα Ή Παράγωγα Αίματος, Μεταμοσχευτεί Με Ιστό Ή Όργανο, Εμβολιαστεί Ή Πάρει Αυξητική Ή Γοναδοτροπική Ορμόνη; 8. In The Last 12 Months Have You Had: Blood Or Blood Product Transfusion, Tissue Or Organ Transplantation Or Growth Or Gonadotrophin Hormonal Treatment? 9. Έχετε Ποτέ Απορριφθεί Για Αιμοδοσία Εκτός Από Λόγους Χαμηλής Πίεσης Ή Αιμοσφαιρίνης; 9. Have You Ever Been Rejected For Blood Donation Excluding Reasons Of Low Blood Pressure Or Low Haemoglobin? 10. Πάσχετε Εσείς Ή Ο Πατέρας Του Παιδιού Από Κάποια Κληρονομική Πάθηση Όπως Θαλασσαιμία Ή Πήξης Αίματος Ή Ανοσολογική Ή Αυτοάνοσο Όπως Λύκος Και Νόσο Του Crohn s; 10. Do You Or The Child's Father Suffer From Any Inherited Condition Like Thalassaemia Or Blood Clotting Condition Or Immune Or Autoimmune Disease Such As Lupus Or Crohn s Disease? 11. Έχει Διαγνωστεί Μέλος Της Οικογένειας Σας Να Πάσχει Από Σπογγώδη Εγκεφαλοπάθεια CJD, Λευχαιμία Ή Άλλη Κακοήθεια; 11. Has Any Member Of Your Family Been Diagnosed For Spongyform Encephalopathy CJD, Leukaemia Or Any Other Malignancy? 12. Τους Τελευταίους 12 Μήνες Λάβατε Φαρμακευτική Αγωγή Για Την Θεραπεία Γονόρροιας, Σύφιλης, Χλαμυδίων, Ουρεοπλάσματος ή Μυκοπλάσματος; 12. In The Last 12 Months Have You Had Treatment For Gonorrhoea, Syphilis, Chlamydia, Ureaplasma Or Mycoplasma? 13. Έχετε Διαγνωστεί Με Ελονοσία (Μαλάρια) Ή Επισκεφτήκατε Χώρες Όπου Υπάρχει Κίνδυνος Προσβολής Από Μαλάρια; 13. Have You Been Diagnosed With Malaria Or Have You Ever Visited A Malaria Infested Country? 14. Επισκεφτήκατε Για Μακρόχρονη Διαμονή (Πέραν Των 2 Εβδομάδων) Χώρες Της Καραϊβικής, Νοτίου Αμερικής, Τροπικής Αφρικής, Μέσης Ανατολής, Μελανησίας Ή Την Νότια Ιαπωνία (Χώρες Όπου Υπάρχει Κίνδυνος Προσβολής Το ΗTLV); 15. Επισκεφτήκατε Για Μακρόχρονη Διαμονή Την Βόρεια Αμερική (ΗΠΑ, Καναδάς Και Μεξικό) Ειδικά Κατά Τους Καλοκαιρινούς Μήνες Όπου Υπάρχει Κίνδυνος Προσβολής Από Τον Ιό Του Δυτικού Νείλου (West Nile Virus); 14. Have You Ever Visited For Long Periods Of Time (More Than 2 Weeks)Countries Of The Caribbean, South America, Tropical Africa, Middle East, Melanesia or The South Of Japan Where HTLV Virus Is Endemic? 15. Have You Ever Visited For Long Periods Of Time (More Than 2 Weeks) North America (USA, Canada Or Mexico) Especially During The Summer Months Where There Is A Risk Of Contracting The West Nile Virus? Διευκρινίστε Στις Θετικές () Απαντήσεις Από Το ΜΕΡΟΣ 3: Comment On Any Positive () Answers In SECTION 3: ΥΠΟΓΡΑΦΗ ΓΟΝΕΩΝ /PARENTS SIGNATURES: F-ADM 09/3-1
4 Lifeline Code: TISSUE AND CELLS STORAGE AGREEMENT This Agreement is made on. between C.B.B. Lifeline Biotech Ltd, situated at 9, Vyzantiou street, Strovolos, Nicosia, Cyprus ( Lifeline ), (for correspondence purposes the following address should be used: P.O.Box 28987, 2084-Nicosia, Cyprus) and. ( the Mother ), I.D No:. and...( the Father ), I.D No:... both from (address). (both the Mother and the Father collectively called the Clients and all parties collectively called the Parties ). WHEREAS LIFELINE is involved in the business of providing services for the testing, processing, cryo-preservation and storage of blood and/or stem cells taken from the umbilical cord ( Cord Blood or CB or Service 1 ) and of cells and/or Tissue deriving from the umbilical cord itself ( Cord Tissue Cells or CTC or Service 2 ) upon the birth of newborns ( the Services ); WHEREAS, the Clients desire to receive Service1 and/or Service 2 from Lifeline upon their child s birth ( the Child ); 1. Scope of Agreement: a. LIFELINE and the Clients desire to enter into this Agreement so as to regulate the relations between them with regards to the provision of the Service by Lifeline to the Clients. b. The Parties acknowledge and declare that the present constitutes a legally binding agreement between Lifeline and Clients. c. The Clients further acknowledge, undertake and declare that the decision to enter into the present Agreement and to receive Service 1 and/or Service 2 from Lifeline is a completely voluntary act on their part and they are hereby providing their informed consent to receive the Service, which has been taken based on the information provided to them in the present Agreement. d. The Clients declare below the Service(s) that they desire to receive from Lifeline and Lifeline accepts to offer such Service(s) subject to the terms and conditions of this Agreement. This Agreement covers the Service(s) as shown in the table below Description of Service requested or for which present agreement is drawn Circle Yes or No to Indicate whichever service is applicable and requested by the Clients Initials Testing Processing and Storage of Umbilical Cord Blood Service 1 Testing Processing and Storage of Umbilical Cord Tissue- Service 2 e. In the case where the Clients choose to receive Service 1 only, all references to Service 2, Sample 2, CTC and Cord Tissue Cells shall be deemed deleted and the provisions of this Agreement shall apply in relation to Service 1 only. In the case where the Clients choose to receive Service 2 only, all references to Service 1, Sample 1, CB, and Cord Blood shall be deemed deleted and the provisions of this Agreement shall apply in relation to Service 2 only. In the case where the Clients choose to receive both Services 1 and 2 the provisions of this Agreement shall apply to both Services. In the case where the Clients choose to receive both Services 1 and 2 and only one of the Samples is stored this Agreement shall apply to the Service for which the relevant Sample is stored. 2. Collection and Storage of Cord Blood and/or Cord Tissue Cells: a. The Clients shall bear absolute responsibility for: (a) the notification of their medical service provider as to the existence of the present Agreement, (b) the safe and timely delivery of the collection kit(s) to their medical service provider,(c) the collection of the CB and/or CTC using the collection kit, in accordance with the instructions provided by Lifeline, which clients hereby acknowledge as fully comprehensive, and (d) the safe delivery of the CB and/or CTC and/or maternal blood at the earliest possible and no later than 48 hours from its/their collection to Lifeline s laboratory at the physical address stated above in the pre-amble of the Agreement. It is acknowledged and understood by the Clients that Lifeline has no responsibility to accept delivery of the collected Cord Blood ( Sample 1 ) and/or Cord Tissue Cells ( Sample 2 ) outside of normal business hours. b. Upon delivery to Lifeline of all Client recruitment information including the medical history questionnaire provided by the Clients, Lifeline shall thereafter decide whether or not to approve the procurement (collection).the decision of Lifeline on whether to approve or refuse the procurement (collection) shall be deemed as granted unless otherwise communicated in writing to the Clients by Lifeline within 10 days from the date of signing this Agreement. In case of refusal of the procurement by Lifeline, Lifeline shall return the collection kit enrolment fee to the Clients. c. Upon proper delivery of Sample 1 and/or Sample 2 to Lifeline, in accordance with the provisions of clause 2.a. above, Lifeline shall perform evaluation and or clinical tests to determine whether the Sample(s) is/are suitable for storage. Subject to the provisions of Clause 2e, Lifeline shall store the CB cells and/or the Cord Tissue Cells in an appropriate medium. d. Thereafter, Lifeline shall store the Sample(s) for the duration of this Agreement or until earlier termination of this Agreement as set forth hereunder. e. It is provided that, in the case where any of the Sample(s) at the time of collection, processing, testing or storage does not fulfil the scientific and or physical criteria applied by Lifeline, Lifeline reserves the right at all times to refuse to store the Sample(s) and/or any of them. Such scientific criteria leading to the rejection for storage of a Sample include but are not limited to the situation where a Sample is not collected properly or when a Sample tests positive for certain microbial infection(s) or contamination. In the event where the Clients choose to receive both Services and only one of the Samples is suitable for storage, only such Sample shall be stored by Lifeline.
5 f. The Clients hereby acknowledge and accept that: (a) the unit where the Sample(s) and/or any of them shall be processed and stored may be operated and controlled by a party other than Lifeline to whom Lifeline may subcontract all or part of the obligations under this Agreement at any given point during the term of this Agreement. Further the Sample(s) and/or any of them may be transferred to another unit and/or the unit may be transferred to another location and that (b) Lifeline reserves the right at any time, to assign all its rights and obligations to any individual, association, foundation, partnership, or other corporation, which either provides a similar service(s) or intends subsequent to such assignment to provide similar service(s) and is licensed or accredited under the law to provide such similar service. Lifeline shall notify the Clients in writing at their above address in case (a) or (b) above happens. This Agreement is not assignable by the Clients without the prior written consent of Lifeline and without the joint consent of both Clients. 3. Ownership of Cord Blood and Cord Tissue Cells and access and transfer of the Sample(s): a. Lifeline shall recognize the Child as the beneficial owner of the stored Sample(s) and the Clients as the joint custodians (Trustees on behalf of the Child) of the stored Sample(s) until the Child reaches majority of age. Upon the Child reaching majority, Lifeline shall cease to recognize any claims made by the Clients in relation to the CB and the CTC. b. Upon submission to Lifeline by the Clients or by the Medical Centre of the Clients choice of a relevant written request duly signed by both Clients or by one of them if the other is deceased, accompanied (if required by Lifeline) by an appropriate medical report, the stored Sample(s) and/or any of them will be made available for collection by the Medical Centre of the Clients choice for use by the Child provided that prior to release all legal regulations in effect regarding various standards for the sample s and the recipient s safety as such are derived from the legislation and accreditation standards are satisfied. All fees due to Lifeline must be paid in full prior to the Cord Blood and or Cord Tissue Cells being made available. c. In the situation where the Clients will request the issuing of the stored Sample(s) and/or any of them prior to the Child reaching majority for use by a person other than the Child, Lifeline may release the stored Sample(s) and/or any of them to the Clients Medical Centre of their choice, upon the provision by the Clients of any documentation which Lifeline may request based on legal advice for the safeguard of the provisions of the legislation in effect at the time. d. In the situation where both Clients pass away before the Child reaches majority, Lifeline shall consider that the appointed guardian of the Child shall replace the Clients as to their obligations as well as to their rights emerging from the present Agreement. 4. Payment Terms and Term of Agreement a. The Clients acknowledge and accept the Fees as specified in this agreement and agree to abide by the following payment terms. In the case of multiple gestation, the total amount of Fees shall be payable for the 1 st child and thereafter they shall be reduced by 50% for each additional child. b. The Enrolment and Delivery Cord Blood and Cord Tissue Cells Collection Kit Fee amounts to including 15% V.A.T: and is payable in advance upon the execution of this Agreement and is non-refundable. c. The term of this Agreement shall commence on the date of delivery of the Sample(s) to Lifeline by the Clients and shall remain valid for either one of the durations as described below which are put in effect according to the payment option elected by the Clients: (i) Plan A (1) In the case where only Service 1 is chosen or only Sample 1 is suitable for storage: One off payment of including VAT: (2) In the case where only Service 2 is chosen or only Sample 2 is suitable for storage: One off payment of including VAT: (3) In the case where both Service 1 and Service 2 are chosen and both Samples 1 and 2 are suitable for storage: One off payment of including VAT: (4) In the case that the clients request both Service 1 and Service 2 and one of the Samples, either 1 or 2 is suitable for storage: One off payment as mentioned in 4 c (i) (1) or c (i) (2) above will be applied. With the election of Plan A, this Agreement shall be valid (in relation to the Service or Services chosen or for the service(s) suitable for storage) for an initial period of twenty (20) years, which may be renewed with written notice by the Clients or the Child assuming responsibility towards Lifeline and the payment to Lifeline of the then applicable for renewal storage fee at least within six months from its expiration. It is provided that the whole amount is payable in advance, within thirty (30) days from the labour date provided that the Sample(s) is/are found suitable for storage. In the situation where the Sample(s) is/are requested for medical use prior to the expiration of the 20 year period, Lifeline undertakes to refund the proportion (and depending on whether one or both Samples are requested for medical use) of the storage fee paid for the years for which the Sample(s) were not stored. For the purposes of this paragraph yearly storage fees shall be as indicated in Lifelines audited accounts for the year preceding the year in which storage has ceased. (ii) Plan B -In the case where only Service 1 is chosen Clinical tests fees of plus an annual Storage fee of (inc. 15% VAT) will be charged. -In the case where only Service 2 is chosen Clinical tests fees of plus an annual Storage fee of (inc. 15% VAT) will be charged. -In the case where both Services 1 and 2 are chosen Clinical tests fees of plus an annual Storage fee of (inc.15% VAT) will be charged. With the election of plan B, which is only available to permanent residents of Cyprus, the Agreement shall be valid (in relation to the Service or Services chosen or the service suitable for storage) for a period up to the 31 st December of the calendar year of its execution and it shall thereafter be automatically renewed for one-year periods, unless either Party gives at least sixty (60) days written notice prior to the expiration date determining its intent not to renew this Agreement. The Fee is payable within thirty (30) days from the labour date provided that the Sample(s) is/are found suitable for storage. 2
6 The storage fee for the first period of the Agreement is calculated on a prorated basis, based on the number of months remaining for storage until the expiration of the specific calendar year. The subsequent annual storage fees shall be payable in advance at the beginning of each calendar year. With the election of Plan B a Direct Debit Form must be signed by the Clients for the remittance of the annual Storage Fees. The Clients acknowledge and accept that the annual storage fee based on Plan B shall remain subject to VAT increases and increases of the fee itself at the reasonable discretion of Lifeline, which shall not rise beyond inflation, from the last day of the determination of the fee. Lifeline undertakes that it shall give prior written notice of 30 days to the Clients in such a situation. (d) The medical service provider of the Clients who shall perform the collection of the CB and/or CTC may be paid a Collection Fee by Lifeline on behalf of the Clients, which covers for the provided services and is included in the service Fee as specified above. Lifeline s involvement in assisting the payment process does not render Lifeline an agent of the medical provider. (e) For as long as the Sample(s) is/are being stored, the Clients shall remain responsible for the timely payment of all fees, until: (i) the Child obtains majority of age/maturity and (ii) he/she assumes the responsibility in writing towards Lifeline. (f) The Clients shall at all times during the term of this Agreement be responsible to notify Lifeline of any changes in billing information, including changes of address and phone number and address and any other contact details. 5. Termination of Agreement a. This Agreement shall terminate: (i) automatically in the situation where Lifeline does not receive and/or does not store the CB and the CTC, (ii) immediately upon a written notice by Lifeline to the Clients to the above mentioned address and without prejudice to its rights for damages in the situation where the Clients fail to comply with the payment terms. b. Upon termination and/ or expiration of this Agreement, the Clients acknowledge and accept that: (i) automatically all their rights and those of the Child, in relation to the stored Sample(s) and all and any claims whatsoever they or the Child may have towards Lifeline with regard to this Agreement, the services hereunder and the Sample(s) shall be given up and shall be waived, and agree that neither Lifeline nor any of its officers, directors, shareholders, executives, employees, agents, distributors, or consultants shall have any further liability whatsoever towards the Clients and towards the Child, (ii) Lifeline shall not be liable to return any fees already paid by the Clients and or the Child, (iii) Lifeline shall dispose the Sample(s) in accordance with approved procedures. c. In case where the clients decide to terminate this agreement even though the CB and/or CTC was found suitable for storage by Lifeline they are obligated to pay the Clinical tests fee which is Lifeline s Liability a. Lifeline s obligations and liabilities are expressly limited to the services expressly described in this Agreement as services given to the clients by Lifeline and no other services are provided under this agreement. Lifeline expressly disclaims any responsibility to provide any other services. Furthermore, Lifeline performs no medical services, gives no medical advice nor otherwise performs any other function or activity other than those expressly provided herein. b. The Clients acknowledge and accept that neither Lifeline nor any of its officers, directors, shareholders, executives, employees, agents, distributors, or consultants have made any representations or have given any guarantees or warranties, express or implied, to the Clients of any kind or nature, nor have there been any representations, warranties or guarantees including, without limiting the generality of the foregoing, (i) the suitability of CB and/or CTC for future treatment of any disease, (ii) the successful treatment of diseases through CB and/or CTC transplantation, (iii) advantages of CB and/or CTC transplantation over other types of treatment using stem cells and/or of cells and Tissue deriving from the umbilical cord itself and (iv) the suitability for a particular purpose or use of any product or service hereunder and (v) that the suitability for storage as the case may be, guarantees adequate quantity of cells and or the viability or suitability for use of the CB and/or CTC at any point in the future. c. Should any complications occur during labour, the discretion to collect CB and/or CTC is entirely on the medical service provider of the Clients. The medical service provider in no way acts as an agent of Lifeline and therefore, collection of CB and/or CTC cannot be guaranteed by Lifeline and therefore the Clients release from liability and waive all claims against Lifeline and its shareholders, directors, officers, employees, representatives, agents and consultants with regards to the collection of the CB and/or CTC. d. Lifeline does not provide any guarantee against any possible loss due to natural disasters or any other cause which is reasonably beyond Lifeline s control, or any Act of God, which may cause destruction or deterioration to the CB and/or the CTC, for any reason other than Lifeline s gross negligence. Lifeline s liability for loss occurring otherwise than due to Lifelines negligence, shall be limited to the return of any amount equal to the most recently yearly Storage Fee as indicated in Lifelines audited accounts for the year preceding the year in which loss has occurred. Lifelines maximum liability for negligence shall be limited to the maximum amount provided by Lifelines professional indemnity insurance in force at the applicable time. e. The Clients agree to indemnify, defend and hold harmless Lifeline, the processing laboratory and any of Lifeline s distributors, shareholders, directors, officers, employees, consultants and other representatives from and against any and all liability, loss, expense, lawyers fees, or claims from injury or damages, from and or third parties, arising out of the services provided under this Agreement. The Clients further acknowledge and accept that Lifeline is not responsible for the actions of others including but not limited to the Client s medical service provider, the hospital or its staff, and transporters of the CB and/or the CTC. 7. Informed Consent a. The Clients hereby acknowledge, declare and accept that they have full knowledge of the terms set out in this Agreement and that they are bound by the said terms and that that they have been fully informed and fully understand the nature of the Service(s) provided by Lifeline and its potential dangers and risks. 3
7 b. The Clients acknowledge, understand and accept: (i) that alternative sources of stem cells exist, and that cells harvested from these alternative sources have been used successfully to treat diseases and or medical conditions; and (ii) that the procurement (collection), processing and storage of CB and of CTC are procedures that do not guarantee the suitability of the cellular therapy product(s) or the stored cells and or tissue for their support of any medical condition anytime in the future and that the clinical applications of such cellular therapy products continue to evolve, change or differentiate and that new applications will possibly continue to be discovered; and (iii) that the CB cells and CTC cells will be stored in appropriate equipment however, the duration of sustainable and proliferate value of the stored cells necessary (a) to rejuvenate the hematopoietic system, (b) to support other therapies, is not yet scientifically proven; and (iv) the potential dangers of future use of the CB and of the CTC, which include among others, the possibility that treatment with the use of CB cells and/or CTC cells may not be effective, that there is a risk of intoxification, organ damage, failure to engraft and possibility of death; and (v) the use of CB cells and of CTC cells may not be suitable for treatment of all diseases or conditions and that the decision to use or not to use the CB cells and/or CTC cells lies primarily on the medical service provider and the application (transplant) Medical Centre with the consent of the Clients, and the Child; and (vi) that the number of CB cells contained in the stored unit may not be sufficient for use by any person and may not be sufficient for use for a specific and or any treatment as this will be determined in the future according to the type of the disease, the patients weight, age, applications of laboratory multiplication techniques of cells and or any other factors or criteria which may not be known today; and (vii) that the CTC cells contained in the stored unit are not intended to be used as a cellular therapy product directly but have to undergo laboratory manipulation for the expansion of this cell population and the manufacturing of an appropriate cellular therapy product prior to application; and (viii) that the Sample(s) stored by Lifeline under this Agreement may never be found necessary for use and that there is no way to determine whether the Child or a family member will ever develop a disease or condition which may require a stem cell treatment. c. As Lifeline is in no way providing medical advice, care or treatment to the Clients, the Clients are strongly advised to obtain independent medical advice with regards to receiving the Service(s) from Lifeline, including without limitation, potential benefits, risks and dangers of collecting and storing the Sample(s). 8. Clinical Tests and Personal Data a. The Clients understand and accept that for the purpose of testing whether the CB and/or CTC is suitable for storage, it may be necessary to obtain a blood sample from the Mother either seven days before and/or after the delivery of the child in order to carry out a variety of clinical tests including but not limited to tests for Hepatitis B and C, HIV, infectious agents, including those causing AIDS, hepatitis and syphilis. The Clients further understand and accept that the CB and/or CTC of the Child may also be tested by Lifeline for any and or all of the above mentioned diseases and infections and any other infections and diseases that Lifeline may deem proper. b. Lifeline acknowledges the right of the Clients to request the results of any clinical tests carried out by Lifeline and undertakes to provide such results to the Clients upon their request. c. The Clients hereby provide their express consent to Lifeline to: (i) obtain the Mother s blood sample (ii) carry out any and all of the above tests and or any other tests deemed necessary by Lifeline to the Mother s and or the Child s blood and or the CB and/or the CTC; (iii) release internally and or to its subcontractors the results of any tests, of which Lifeline was informed of, with regards to the Mother and or the Child and to release the Child s and family s medical records (including the Father s) to Lifeline and its subcontractors. d. Lifeline undertakes towards the Clients that their personal data and those of their Child are safe with Lifeline and that they shall not be used and or processed for any reason other than as provided under the terms of this Agreement without the prior consent of the Clients, and that they shall be kept in a Data Bank created and managed by Lifeline in accordance with the provisions of the Processing of Personal Data (Protection of Individuals) Law of Miscellaneous Each provision of this Agreement shall be enforceable independently of all other provisions and its validity, legality or enforceability shall not be affected if any other provision becomes invalid, illegal or unenforceable in any respect under any law. If at any time any provision of this Agreement is or becomes invalid, illegal or unenforceable in any respect under any law but would be or become valid, legal or enforceable if some part of the provision were deleted or amended, the provision in question shall remain in force with such deletion or with such amendment as may be necessary to make the provision valid, legal and enforceable. Except where expressly provided to the contrary in this Agreement, all provisions shall inure to the benefit of and shall be binding on the parties to this Agreement, their successors, including their personal representatives and or administrators. This Agreement constitutes the entire understanding of the parties with respect to the subject matter hereof and supersedes any and all prior understandings and agreements, whether written or oral, with respect to such subject matter. 10. Governing Law This Agreement shall be governed by and construed and enforced in accordance with the laws of Cyprus. We, the Clients certify that we have read the preceding, we understand its contents, and that any questions we have pertaining to this Agreement have been answered... Mother s Signature Father s Signature Lifeline s Signature 4