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Program of support

General Conditions .pdf

of the Program of support in case of autologous reconstruction of hematopoiesis by application of own hematopoietic stem cells from umbilical cord blood - autologous transplantation

Article I

Introductory provisions

I.1 These General conditions (referred as „GC“) regulate and define the Program of support in case of autologous reconstruction of hematopoiesis by application of own hematopoietic stem cells from umbilical cord blood - autologous transplantation (referred as „Program“), participation in this Program as well as advantages and fulfillments provided within the participation in the Program. GC is the only document which regulates and defines the Program and its realization in whole and to the full extent replaces all other arrangements.

I.2 The Program is carried on by civic association Slovenský register placentárnych krvotvorných buniek, with its registered seat at Dúbravská cesta 9, 841 04 Bratislava, Slovak republic, identification number 31 771 165, registered pursuant to the Act No. 83/1990 Coll. as amended on citizens association in the registry of civic associations held by the Ministry of Interior of the Slovak republic on 16th of April 1997 under No. VVS/1-900/90-12506 (referred as „ EUROCORD SLOVAKIA “).

I.3 As the Program´s participant is deemed any physical person whose umbilical cord blood has been collected and stored by EUROCORD SLOVAKIA or within the company CORD BLOOD CENTER CZ, s.r.o., Cihlářská 643/19, 602 00 Brno-Veveří, identification number 26908697, incorporated in the Commercial Register of Companies administrated at the Regional Court in Brno, section C, insert 44708 - hereinafter referred to as “CORD BLOOD CENTER CZ, s.r.o.” (Referred as "Party") and in relation with storage of the umbilical blood the participation in the Program was expressly agreed in the respective contract. Party becomes a participant of the Program in the moment when the respective contract enters into effectuality or other moment stipulated by the respective a contract. For participation in the Program it is not decisive whether the respecitove contract is concluded between EUROCORD SLOVAKIA and Party directly or through the agent.

I.4 Program and its fulfillments are assigned exclusively for supporting autologous usage of umbilical cord blood of the Party stored by EUROCORD SLOVAKIA or by CORD BLOOD CENTER CZ, s.r.o.

I.5 Proper and on time fulfillment of all obligations stipulated by the storage contract is the condition which ensures participation in the Program. Is not decisive whether the storage contract is carried out directly between the Party (or his/her legitimate representative) and EUROCORD SLOVAKIA or the company CORD BLOOD CENTER CZ, s.r.o. ,or also other subject takes part in its realization (e.g. company CORD BLOOD CENTER, s. r. o., with its registered seat at Košická 10, 821 09 Bratislava, Slovak republic, company identification number 35 859 334, registered in the Business Register of the District Court Bratislava I, Section: Sro, Insert No.: 28983/B). Obligations coming out of the storage contract are for the purposes of these GC considered as properly and timely fulfilled if the Party (or his/her legitimate repressentative) is not delayed with performance of any of its obligations stipulated by the storage contract to the day preceding the day on which any of the diseasses stipulated by the clause II.2.2. of these GC has been diagnosed for the first time. Disease is considered as diagnosed by date when the disease was diagnosed and the diagnose confirmed by respecitove finding of the specialized doctor. Participation in the Program is regardless of abovementioned free of charge.

I.6 In case that the Party does not have full legal capacity, his/her legitimate representative will act for him/her. Unless the GC expressly stipulate otherwise, the recipient of individual fulfillments and therefore the Party is, directly a person whose umbilical cord blood was collected during his/her birth and its part (mainly hematopoietic stem cells) are after processing stored by EUROCORD SLOVAKIA or CORD BLOOD CENTER CZ, s.r.o.

I.7 The Party is included in the Program until reaches the age of 20 years. For occurrence of claim of provision of fulfillments within the Program it is necessary to ask for these fulfillments before reaching the age pursuant to the preceding sentence (i.e. 20 years of age).

I.8 Party has a right to waive the right to participate in the Program. The Party will be removed from the Program on the basis of its explicit written request delivered to EUROCORD SLOVAKIA within 30 calendar days from the day on which such request has been delivered to EUROCORD SLOVAKIA. Request for elimination from the Program is not possible to recall for any reason and it is not possible to become the Party of the Program again.

Article II

Fundamentals

II.1 Program fundamentals is to provide the support defined by these GC to the Party of the Program in case that any of the diagnoses (diseases) stipulated in these GC will be diagnosed to the Party and the cure will be carried out under the conditions stipulated by these GC.

II.2 Condition for formation of the right to request for fulfillments provided within the Program is:

1. Occurrence of the need for autologous transplantation of hematopoietic stem cells for the Party documented by the specialized medical center confirmation of the diseases which are standardly cured by autologous transplantation.

2. The diseases which are standardly cured by autologous transplantation are pursuant to the clause II.2.1 of these GC considered:


Following Acute Leukemias

Acute Lymphoblastic Leukemia

Acute Myeloblastic Leukemia

Chronic Lymphatic Leukemia

Following Chronic Leukemias

Chronic Myeloid Leukemia (CML)

Juvenile Myelomonocytic Leukemia

Myelodyplastic Syndromes

Following Haematinic Disorders

Acquired Disorders (Aplastic Anemia)

Paroxysmal night hemoglobinuria

Following Myeloproliferative Disorders

Osteomyelofibrosis

Following Lymphoproliferative Disorders

Hodgkin’s Disease

Non-Hodgkin’s Lymphoma

Following Plasmacytic Disorders

Multiple Myeloma (Plasmacytoma)

Brain Tumor

Ewingow’s Sarcoma

Following Other Malignancies

Rhabdomyosarcoma

Neuroblastoma

Kidney Carcinoma

Germinal tumors

Rheumatoid Arthritis

System Lupus Erythematosus

Following Autoimmune Diseases

Crohn’s Disease

Immune thrombocytopenic purpura

Multiple Sclerosis

3. Pursuant to effective legal provisions (i) the transplantation indication for the Party is not considered as experimental or (ii) there has not been carried out any biomedical testing or clinical testing on the Party during the transplantation. If in case of diseases pursuant to the clause II.2.2 of these GC there is usually medically indicated autologous transplantation of hematopoietic stem cells as a suitable cure, then such cure will not be generally considered as experimental for the purpose of these GC. However, decision if the cure is experimental or is to be considered a biomedical research or clinical testing is taken in last instance by EUROCORD SLOVAKIA with its specialized employees or other specialized subject authorized by EUROCORD SLOVAKIA.

4. The condition of provision of the support is that transplantation will be executed by specialized center which has full membership in EBMD (see www.ebmt.org) or NMDP (see www.marrow.org) and is accredited for providing cell therapy by agencies JACIE (see www.jacie.org) or FACT (see www.factweb.org). Current list of medical centers will be provided to the Party on its request pursuant to the clause III.3 of these GC.

Should all the aforementioned conditions be properly fulfilled, the Party is entitled to ask for provision of the support within the Program.

II.3 There are two kinds of support provided within the Program (together in GC refer as „Support“). In first, EUROCORD SLOVAKIA within the Program shall provide (pay), pursuant to the Program conditions stipulated by these GC, the costs for the medical treatment of the Party up to the amount of 155.000,- Euro (refer as „Medical support“). Besides that, EUROCORD SLOVAKIA will provide to the Party one time financial support in the amount of 30.000,- Euro for payment of living costs related to treatment (e.g. transportation, accommodation, refer as „Personal support“). Medical support will be paid based on invoice issued by medical establishment where the Party’s transplantation took the place, directly to this medical establishment. Medical support will be paid in the invoiced price, but in the maximum of 155.000, - Euro. Maximum amount of Medical support is final and includes all taxes (for example VAT), fees, customs or other payments included to the price of medical care in the country in which medical care will be provided to Party. Personal support is provided to the Party at one time and in case that the Party does not have full legal capacity at the moment of its provision, then it will be provided to his/her legitimate representative. Medical support and Personal support shall be provided in the Euro currency or in the currency which is going to be agreed with EUROCORD SLOVAKIA.

Article III

Mechanism of support

III.1 When the Party asks for the support, he/she has to call call-center on the phone no. + 420 800 900 138. Call-center will register request of the Party and send by agreed way the form for request for providing the support within the Program. Party is obliged to fill out the form entirely and properly, sign it and deliver to EUROCORD SLOVAKIA. The moment of delivery of the properly filled and signed form of request (refer as „Request“) to EUROCORD SLOVAKIA is considered as the moment when the Party asked for the Support within the Program. After delivery of the Request, the Party will be informed who is his/her contact person (refer as „Contact person“) and if EUROCORD SLOVAKIA does not in particular case expressly settle otherwise the Party is obliged to communicate only with the Contact person.

III.2 After EUROCORD SLOVAKIA will receive the Request, EUROCORD SLOVAKIA asks the Part for the y transcription (copy) of medical documentation or other documentation of the Party and also the Party will be asked to provide EUROCORD SLOVAKIA with all necessary authorizations and approvals. The delivery of all documents and provision of all authorizations required by EUROCORD SLOVAKIA is one of the conditions for providing the Support to the Party. Submission of all required documents and approvals asked by EUROCORD SLOVAKIA is paid and carried out exclusively at the expense of the Party. The costs of translation of the required documents asked by EUROCORD SLOVAKIA for the purpose assessments are paid by EUROCORD SLOVAKIA.

III.3 After all required documents and approvals will be received to EUROCORD SLOVAKIA according to the clause III.2 of these GC, EUROCORD SLOVAKIA will assess whether all conditions for the provision of the Support are properly fulfilled. In case that all conditions within the Program are properly fulfilled, EUROCORD SLOVAKIA will send on the basis of request to the Party current list of medical establishments according to II.2 GC.

III.4 The Party, based on its own decision, will select medical establishment according to clause II.2 of these GC and will agree with the medical establishment conditions of cure procedure. When selecting the medical establishment the Party acts individually. EUROCORD SLOVAKIA will provide the Party, based on its request, only with assistance in form of sending him/her the list of medical establishments refer to the clause III.3 of these GC. EUROCORD SLOVAKIA does not otherwise assist with the process of selection of medical establishment and communication between the Party and medical establishment. Agreement on individual conditions is therefore only on the Party, its doctors and particular medical establishment r. EUROCORD SLOVAKIA is involved in whole process only as an entity performing storage of collected and processed cord blood, and only in this context provides synergy. EUROCORD SLOVAKIA can also provide the confirmation under which undertakes to cover the costs of provision of medical care pursuant to these GC to the maximum amount of Medical support directly to the medical establishment.

III.5 The provision of the support is concurrently depended ) on the fulfillment of all following conditions: relevant specialized doctor diagnoses the Party one of the diagnoses pursuant to these GC, medical establishment selected by the Party as defined in clause III.4 of these GC in written form with final validity and on the basis of assessment of all relevant facts issues a confirmation of indication of autologous transplantation together with the proposal of used therapy and decides about the performance of the treatment of the Party using his/her stored and processed stem cells in EUROCORD SLOVAKIA or in CORD BLOOD CENTER CZ, s.r.o (this decision must be shown to EUROCORD SLOVAKIA or CORD BLOOD CENTER CZ, s.r.o.) and simultaneously there is an agreement reached between the medical estabilishment and EUROCORD SLOVAKIA how the costs of medical care will be paid.

III.6 Procedure in terms of GC, resp. its parts is carried out, until the complete and current compliance with all conditions stipulated in the clause III.5 of these GC is reached. After fulfillment of all conditions, the Party will be notified in written form that its support has been admitted. Subsequently, on the basis of this notice the Party will be provided with Medical support as well as Personal support. Medical support will be provided under terms stipulated by these GC so that it will be provided directly to particular medical establishment according to an agreement between EUROCORD SLOVAKIA and that medical establishment. Personal support will be provided directly to the party, resp. to his/her legal representative, and will be given to Party´s bank accont. Personal support will be granted immediately after confirmation of eligibility in support.ty's

III.7 EUROCORD SLOVAKIA has the right under the Agreement about the method of providing Medical support ask from the medical establishment to undertake the obligation to provide EUROCORD SLOVAKIA with the final invoice, and after the medical establishment will receive one or more payment on account from EUROCORD SLOVAKIA, medical establishment has commitment to send EUROCORD SLOVAKIA definitive and detailed account. EUROCORD SLOVAKIA can require acceptance of commitment of an undertaking to return unused portion of the advance payment for health care provided to the Party. EUROCORD SLOVAKIA is also entitled to require the submission of the documents referred to in the original written version signed by the legal representative of the medical center. Any documents, especially accounting and tax, EUROCORD SLOVAKIA is entitled to require, in form and content meeting the requirements of Slovak law.

III.8 In special cases EUROCORD SLOVAKIA can provide, based on special Party’s request, Personal support before the acceptance document is sent out pursuant to clause III.6 of these GC. This step can be proceed especially in the cases when it is necessary to pay the transportation costs to particular medical establishment in order to find out whether the medical establishment will provide the treatment for the Party. To provide part of Personal support prescribed in this section the party does not have legal right (it is the right of EUROCORD) and is not possible to demand it and this offer will be exclusively given based on the EUROCORD SLOVAKIA sole decision.

III.9 In case that the cure will be not provided by using the stem cells stored by EUROCORD SLOVAKIA, because of any reasons on the side of the Party, EUROCORD SLOVAKIA is entitled to ask for the whole financial support given by itself. Aforesaid applies without taking into consideration whether the support (or its part) was paid directly to the medical establishment as payment or down payment for medical care given to the Party or it was directly paid to Party.

III.10 Notwithstanding the clause III.9 of these GC, the Party is not obliged to return the support granted, if the treatment using the stored stem cells of the Party cannot be done for medical reasons.

III.11 Amount of support stipulated by these GC is final. However, if not spent at once, it is possible to redraw within up to a maximum amount stipulated by these GC, for example, in the case of repetition of a treatment using the stem cells of Party stored in EUROCORD SLOVAKIA or in CORD BLOOD CENTER CZ, s.r.o. (e.g. if not in the primary treatment used all stored blood stem cells by EUROCORD SLOVAKIA or by CORD BLOOD CENTER CZ, s.r.o. of Party).

III.12 If the Party becomes eligible, but the cost of health care, which, under the Program should be paid from Medical support would be charged by public health insurance, only Personal support will be provided for the Party. In the case that funds from public health insurance were not be able to fully pay costs of health care, Party will be granted under the terms of the Program and Medical support up to its maximum amount.

Article IV

Final regulation

IV.1 The Party by being member of the Program explicitly acknowledges that it is fully aware with these GC and agrees with them and undertakes to respect them. Party acknowledges that in the case of the issues associated with the Program the final decision is always made by EUROCORD SLOVAKIA.

IV.2 Providing support in case of the infringement of any conditions determined by these GC (e. g. allergenic use, experimental treatment, other than the diagnosis, treatment in other than one of the prescribed medical centers) is possible only under EUROCORD SLOVAKIA decision. However, it is not claimable in any case.

IV.3 EUROCORD SLOVAKIA is entitled to, only by its own (sole) decision, change these GC or cancel the Program. Change of these GC will be published on the official website of EUROCORD SLOVAKIA www.eurocord.sk (refer as "Website"). The Website will always publish the current version of GC. GC will also be sent on request to anyone to look in. Change of GC is effective from the time specified in the new or changed GC. The new version of GC will be published on the Website generally 15 calendar days ahead of the moment of its effectiveness. During this period, the previous version of GC will be also published on the Website.

IV.4 EUROCORD SLOVAKIA has the right to exclude from participation in the Program person whose conduct is capable in any way harm the good reputation of the Program, the Program itself or possibly a good reputation and good name of EUROCORD SLOVAKIA or CORD BLOOD CENTER CZ, s.r.o., EUROCORD SLOVAKIA 's or CORD BLOOD CENTER CZ’s activities or any subject in cooperation with EUROCORD or CORD BLOOD CENTER CZ, s.r.o.. EUROCORD SLOVAKIA is entitled to exclude a person from the Program, which in any the acts or omissions causes or may cause EUROCORD SLOVAKIA/ CORD BLOOD CENTER CZ, s.r.o. or EUROCORD SLOVAKIA/CORD BLOOD CENTER CZ, s.r.o. collaborators any injury or damage. Decision to exclude the Party from the Program is final.

IV.5 This version of GC is valid and effective from 01.12. 2010

Bratislava, 01. 12. 2010