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general terms and conditions of use
Enclosed you find our terms and conditions of use (as of 01.09.2011). The general conditions of use, the order and the forms can be downloaded for the download area.
§ 1 Subject of the contract
§ 2 Services by eticur)
§ 3 Obligations of the mother, the legal guardian or the child
§ 4 Certificate / handing out the stem cell concentrate from umbilical cord blood
§ 5 Remuneration
§ 6 Commencement of contract and maturity
§ 7 Termination of contract
§ 8 Liability
§ 9 Data protection
§ 10 Final clauses
Introduction
Umbilical cord blood is infantile blood which is collected from the umbilical cord, the placenta and the attached remains after the umbilical cord is cut. There are a large number of stem- and precursor cells in the umbilical cord blood. After these cells are processed, they can be frozen for a very long time. Due to a number of new research results, it can be expected that these cell- and tissue replacements can be used for the treatment of certain diseases.
eticur) in cooperation with the birth hospital and the transfusion medical and haemostaseologic department of the University Hospital Erlangen offers to collect, to process, to deep-freeze and to store the cells of the child´s umbilical cord. Hereby, the current regulations of pharmaceutical law are strictly followed.
The umbilical cord blood and the collected stem cells belong to the child. A use for research issues is excludes. The enclosed contract does not change the ownership structures, so that the sole power of disposal remains only with the child. Until the child reaches full age, it is represented by its legal guardian.
§ 1 Subject of the contract
1. The subject of the contract is the collection of umbilical cord blood from the child as well as the preparation and storage of a stem cell concentrate from umbilical cord blood. Moreover, the scope of the contract includes the proper delivery of stem cell concentrate to the treating institution.
2. It is essential for the collection of cord blood that the birth takes place in a birth centre which is already certified by the company eticur) or which will be added to the certified clinics until the time of birth.
3. The therapeutical use of stem cell concentrate from umbilical cord blood is not part of the contract.
4. When selecting the option "eticur) KOMBI" an additional subject of the contract is the entry of the umbilical cord blood data into the donation register of the transfusion medical and haemostaseologic department of the University Hospital Erlangen as far as suitability is confirmed. Irrespective to that, the ownership of the umbilical cord blood remains with the child. When the examination of the umbilical cord blood confirms that the criteria for an entry into the stem cell register are not met, the transfusion medical and haemostaseologic department of the University Hospital Erlangen informs the legal guardians of the child. Then, an individual storage of umbilical cord blood can be carried out as agreed with eticur), as far as the contract regulations (see § 2 of the contract) are fulfilled.
§ 2 Services by eticur)
1. eticur) guarantees all services which are related to the collection and storage of the stem cell concentrate from umbilical cord blood: a) Punctual delivery of a collection set before birthb) Remuneration of gynaecologist preparing all findings, according to the scale of fees for doctors. Training measures for professional collection of umbilical cord blood.c) Fulfilling the preconditions for a birth centre so it can become a certified eticur) cooperation partner. .d) Instructions for the doctor/midwife in charge, to follow the guidelines stated in the collection box for collecting umbilical cord blood, to mark it correctly and store it according to the directions. Moreover the order for the person in charge to fill out the collection protocol, to withdraw the necessary amount of blood from the mother at birth and to immediately contact the number stated on the box in order pick up the collection set. The doctor or midwife in charge at the birth centre will not collect any blood from the umbilical cord as far as this is necessary for the wellbeing of mother and child or if there are contraindications. In very seldom cases the birth centre has to stop the collection of umbilical cord blood from organisational reasons, e.g. when there is another emergency birth. e) Remuneration of the person who is collecting the umbilical cord blood according to the corresponding scale of fees.f) Transport of the umbilical cord blood from the births centre to the processing centre (stem cell bank) according to the stipulated regulations.g) Examination of the umbilical cord blood and checking the possibility to produce a stem cell concentrate from umbilical cord blood. Even when the collection of umbilical cord blood was performed well, it can happen that the umbilical cord blood is infected with bacteria or fungal organisms. Due to these reasons, it may not be possible to produce and store stem cell concentrate. Also when the collection was performed according to all regulations, it is not always possible to collect enough umbilical cord blood (after the child is born, the blood of the placenta is clotting very quickly). According to the regulations of the German Medical Association for the transplantation of stem cells from umbilical cord blood from May 1999, the lower limiting value is 60ml or ≥ 5 x 10^8 concerning cells with a nucleus. Even when the collection of umbilical cord blood has been performed well, a later examination of maternal blood can show that there was an infection at the time of birth. In this case, the maternal blood will be checked again later. Such an infection can make it impossible to produce or store stem cell concentrate. The scope of the examination is limited to the tests which are necessary for allogenic storage at the time of the collection. Al later examination of the material for pathogens which may be discovered later is not included in the contract. h) Preparation, cryo-preservation and storage of stem cell concentrate from umbilical cord blood in two different portions.i) Quality control of the stem cell concentrate from umbilical cord blood and if necessary later examination of maternal blood j) A certificate about the production, quality and storage of stem cell concentrate from umbilical cord blood is issuedk) Processing and archival storage of the relevant data. l) The stem cell material is solely handed out to the applying institution/hospital on request of the child or his legal guardian.
2. If the examination according to § 2 clause 1 g) of the agreement reveals that a preparation of umbilical cord blood is not possible or justifiable, eticur) informs the legal guardian in written form.
3. If the examination according to § 2 clause 1 g) of the agreement reveals that the stem cell concentrate from umbilical cord blood shows lacks in quality, but a storage would still be possible, then eticur) gets in touch with the legal guardian and asks if he wishes to have the material stored despite the lacks in quality.
4. In order to fulfil the obligations from this contract, eticur) is also allowed to authorise an auxiliary at own cost.
5. The stored stem cell material is stored professionally for a period of 21 years – irrespective of the long-term existence of the company, as eticur) cooperates with the transfusion medical and haemostaseologic department of the University Erlangen as far as processing, testing and storage is concerned and the according fees are already covered beforehand. The transfusion medical and haemostaseologic department (it also issues the storages certificate) has a contractual obligation to store the material for the duration of the contract which is 25 years and to issue the material to the applying institution if needed.
6. eticur) will continue to inform parents about further developments and fields of application. These current news are also placed on the web site www.eticur.de.
7. When selecting the option "eticur) KOMBI" the transfusion medical and haemostaseologic department of the University Hospital Erlangen will enter the anonymised data of the umbilical cord blood material into the donation register. If the umbilical cord blood can be identified as a suitable transplant for a patient, the transfusion medical and haemostaseologic department of the University Hospital Erlangen will get in touch with the legal guardian or adult child in written form and ask if the transplant can be donated or not. When the legal guardians or the adult child agree to donate the umbilical cord material to the transfusion medical and haemostaseologic department of the University Hospital Erlangen within two weeks, then the property of the entire material is transferred to the public stem cell bank of the transfusion medical and haemostaseologic department of the University Hospital Erlangen. The so far paid fees plus interest is then reimbursed to the legal guardian or adult child by the University Hospital Erlangen. The interest is calculated from the basic interest rate for the expired storage duration, defined from the day of birth until the date that the declaration for donating the transplant to a third person is received. .If the legal guardian / the adult child opts against a donation, the umbilical cord blood continues to be stored in the stem cell bank of the University Hospital Erlangen for the child and by order of eticur) and the entry in the donation register is deleted. The legal guardian / the adult child can delete the entry in the register for the transfusion medical and haemostaseologic department of the University Hospital Erlangen by sending a written notice to eticur ) or directly to the transfusion medical und haemostaseologic department of the University Hospital Erlangen. The data will then be deleted.
§ 3 Obligations of the mother, the legal guardian or the child
1. Die mother has to:
a) fill out the forms provided by eticur) carefully and truthfully:
- anamnesis questionnaire,
- declaration of information and consent and
- declaration of exemption towards the person collecting the umbilical cord blood
b) inform eticur) immediately in written form if the child suffers from an infectious disease which can be transmitted by blood within 12 months after birth (e.g. Hepatitis B, Hepatitis C or HIV).
2. The legal guardian agrees: a) that umbilical cord blood is collected after the umbilical cord is clamped.b) that all findings generated during pregnancy/birth are sent to eticur) by the doctor/midwife/hospital. The legal guardian therefore releases the hospital staff from medical confidentiality. The mother agrees that the findings collected by eticur) are forwarded to the doctor / the hospital.
3. The mother agrees that her blood will be collected at birth and examined for infectious diseases (including HIV, Hepatitis B and Hepatitis C). Moreover, the mother agrees to a further withdrawal of blood if necessary (positive or undefined tests) in order to carry out further infection-serological examinations.
4. The legal guardian agrees, a) to order the gynaecologist/ midwife chosen by the mother, to fill out the examination- and consultation protocol and send it back to eticur); b) to inform the doctor/midwife again that a collection of umbilical cord blood is desired c) to immediately send a copy of the birth certificate of the child (or the children after multiple births) to eticur); d) to send an immediate written notice to eticur) should the power of representation change; e) to inform eticur) after a written notice if he agrees to a storage of the material even when there is a lack of quality or if he opts to have the material destroyed. This notice has to sent to eticur) within one month. If this notification does not reach eticur) in time, eticur) is entitled to destroy the material.
5. When selecting "eticur) KOMBI", the mother will receive the anamnesis questionnaire at least two weeks before the estimated time of birth.
§ 4 Certificate / delivery of the stem cells concentrate from umbilical cord blood
1. After the necessary examinations, the transfusion medical and haemostaseologic department of the University Hospital Erlangen will collect and store the stem cell concentrate from umbilical cord blood and issue a certificate (according to the information in § 3 of the agreement) concerning the production, quality and storage of the stem cell concentrate from umbilical cord blood.
2. Solely the child or the legal guardian is always entitled to dispose of the stem cell concentrate from umbilical cord blood according to the legal regulations and to withdraw it from eticur). If the stem cells are required, a written notification has to be sent. This notification is also a termination of the contract according to § 6 of the agreement.
3. A partial reimbursement is not possible when the umbilical cord blood is withdrawn before the contract is terminated. When selecting “eticur) KOMBI" , a reimbursement regulation according to the conditions stipulated in § 2 clause 7 apply when the material is handed over to the public stem cell bank of the transfusion medical and haemostaseologic department of the University Hospital Erlangen.
§ 5 Remuneration
1. For the duration of the contract (25 years), eticur) receives following remuneration which also covers all services included in this contract: a) The fee for one child is EUR 2,500 including VAT. As soon as the contract is concluded, a prepayment of EUR 300 is due. After a successful storage and issue of the certificates according to § 4 clause 1 the remaining fee of EUR 2,200 is due. b) After the birth of twins, the fee for the second child reduces by EUR 1,000 to EUR 1,500 including VAT. When the contract is concluded, the amount of EUR 300 is to be paid and after the certificate has been issued, the additional amount of EUR 1,200 is due. c) When further children are born, parents will receive a loyalty rebate worth EUR 150. d) Any discounts granted by eticur) and other rebates can not be combined and can also not be granted retrospectively.
2. We offer financing options by the financing service provider "medipay". This offer can be adjusted to your requirements. (see annex: medipay pre-contract)."medipay" decides upon the financing possibilities. When "medipay" does not grant a financing option, the legal guardian can withdraw from the contract by informing eticur) in written form. In such a case, the contract fee does not have to be paid, but we charge an amount of EUR 195 if the collection box and the trolley have already been delivered and are not returned un-opened. If the legal guardian does not withdraw from the contract after "medipay" refused a financing option, then the fee has to be paid in full. If according to reasons stipulated in § 7 clause 2, a premature termination of the contract should take place, the financing agreement becomes invalid. If applicable, eticur) will charge expenses worth EUR 195 for the conditions stipulated there. As far as discounted prices are concerned (further children or twins), no interest-subsidise payment via “medipay” is possible.
3. eticur) offers the possibility to pay in instalments. In this case, a prepayment of EUR 300 has to be paid. The remaining amount of EUR 2.200 is then settled by 10 monthly instalments worth EUR 250. This agreement includes a handling fee of EUR 100 and is collected from your bank account. The fees for return debit notes will be charged to the customer and cost 20 EUR. If a return debit note should occur two times in a row, then the remaining fee has to be paid immediately.
4. eticur) will issue an invoice with the individual fee which has to be paid. If the invoice is not settled within 6 weeks after it was issued, eticur) will destroy the stem cell concentrate from umbilical cord blood after a prior notification within a period of four weeks.
5. A termination of the contract according to § 7 clause 1 of the agreement, does not affect the due payments to eticur). Also there is no claim for a partial or entire repayment of the fee.
6. As far as the fee-related legal consequences for a premature termination of the contract are concerned, we refer to § 7 clause 2 of the agreement.
§ 6 Commencement of contract and maturity
1. This contract has a maturity of 25 years and starts with the birth of the child. The maturity of the contract prolongs by another 10 years when the young adult informs eticur) two months before the termination of the initial contract in written form. He then has to pay a prolongation fee of EUR 330 plus the then valid VAT. This ten-year contract can be repeated as long as the donor wishes. If the customer price index which is published by the Federal Statistics Office for Germany should rise by at least 10 percent in the year that the contract is concluded = 100 compared to the month of the commencement of the contract, eticur) is entitle to adjust the fee for the prolonged contract in the same relation.
2. Already now, eticur) agrees to agree to a prolongation of the contract according to figure 1 of the general conditions after the maturity of the initial contract is achieved.
3. If the contract is not prolonged within two months after the contract expired, eticur) will inform the young adult by letter that it will destroy the cell concentrate from umbilical cord blood after the contract expires. This applies when the owner has not used the stem cell material.
4. It is the obligation of the legal guardian of the child to provide eticur) with the current address of the child as soon as it reached full age (see § 10 clause 4).
§ 7 Termination of contract
1. The contract can be terminated by the child at any time without giving any reasons. In such a case the claim for remuneration by eticur) remains untouched according to § 5 clause 4 of the agreement. The contract can only be terminated in written form. A proper notice of termination by eticur) is not possible. The right for an extraordinary notice of cancellation due to an important reason remains untouched.
2. The contract terminates prematurely without cancellation when a) a collection of umbilical cord blood did not take place. As far as it is not the fault of eticur), no expenses have to be paid as far as the collection box including the trolley are sent back to eticur) unopened. When the collection box including the trolley can not be sent back unopened, a fee of EUR 195 VAT is due. b) blood was collected and sent to the processing centre, but not enough blood could be stored (see. § 2 clause 1 g). In such a case a fee of EUR 195 including VAT is due. If the storage is justified even if the minimum amount of material is not reached, this happens upon the wish of the legal guardian and then the entire storage fee is due. c) the initial examination of the umbilical cord blood or the blood of the mother according to § 2 clause 1 g) of the agreement shows that the preparation or storage is not possible or not justifiable (see § 2 clause 2 of the agreement), e.g. when the blood is contaminated, when the mother suffers from an infection at the time of birth of the cells with a nucleus are not suitable for the cryo-preservation. In such a case, a handling fee of EUR 195 including VAT is due. If storing the material is justified although the material shows slight lacks in quality (slight contamination) and the legal guardian still opts for storage, then the entire fee is due. d) a quality control of the stem cell concentrate from umbilical cord blood according to § 2 clause 1 of the agreement shows lacks in quality which make a further storage impossible or do not justify a further storage. In such a case a handling fee of EUR 195 including VAT is due.
3. When the contract is terminated according clause 1 or 2 by eticur), the umbilical cord blood or the stem cell concentrate from umbilical cord blood is destroyed if despite a written notice, the child did not opt for the delivery of the material within two weeks.
§ 8 Liability
1. The liability of eticur) for the subject stated in § 1 clause 1 of the contract is based on legal regulations. This also applies for any third party which is ordered by eticur) in order to execute the contract. Mainly the transfusion medical and haemostaseologic department of the University Hospital Erlangen.
2. The liability von eticur) and its cooperation partners for the subject stated in § 1 clause 1 of the contract, is limited to deliberate acts and grosse negligence. This does not apply for any damages because of bodily injury, sickness or disease or the infringement of significant obligations (cardinal obligations), where there is a liability for each negligence.
3. If the stem cell concentrate is destroyed or spoiled by accident or in an unauthorised way, the liability is limited to additional charges for the own donation (e.g. peripheral stem cells) or a transplantation from a foreign donation. Moreover, eticur) is not liable for any probably missed chances for treatment.
4. For current or probable future use of stem cell concentrate from umbilical cord blood, according to § 1 clause 3 of the agreement which are not part of this contract, eticur) does not take over any liability.
§ 9 Data protection
1. In order to carry out the contract, eticur) is authorised to store the personal data of the child and the legal guardian and forward this information to the cooperation partner as far as this is necessary to fulfil the contract. eticur) handles those data confidentially and also commits its contract partners to confidentiality.
2. eticur) is allowed to forward all necessary data which are needed to use the stem cell concentrate for therapeutical measures to a third party.
§ 10 Final clauses
1. The place of performance for all obligations from this contract is Munich.
2. There are no other agreements than the ones stated in this contract. Any changes or amendments in this contract have to be made in written form. This also applies for the written form requirement.
3. If single conditions of this contract should become invalid, the other clauses of this contract remain untouched. The parties commit themselves to implement the rule that comes closest to the ineffective close. This also applies for contractual gaps.
4. If there is a change concerning the address or name, the parties will immediately inform each other in written form. Moreover, the legal guardian has to inform eticur) immediately should any changes occur as far as the power of representation is concerned. This also includes the information about a new address when the child reaches full age. If changes are not disclosed, eticur) is entitled to obtain the information from the registry offices.
5. Only German Law applies. There is no conflict of laws.
Revocation of order An order can be cancelled within four weeks without giving reasons. An order cancellation has to be carried out in written form (e.g. letter, fax, e-mail). The time limit begins as soon as the customer receives order confirmation by eticur). In order to meet the cancellation period, it is enough to send out the revocation in time.
The revocation has to be sent in written form to following address: eticur) GmbH, Am Klopferspitz 19, 82152 Martinsried/Planegg
You can also send it to us by post, fax +49 (0)89-125981-19 or e-mail info@eticur.de.
Cancellation consequences
When the cancellation is effective, both parties have to return any received services. If you are not be able to return the collection box including the trolley or only able to return it an already opened state, you will have to pay a compensation for the value worth EUR 195. The trolley and the collection box have to be sent back to us on our cost and our liability. Any payment obligations have to be settled within 30 days. The deadline begins with you sending back the notice of withdrawal, for us with its receipt. End of the revocation clause.
© 2004-2012 eticur) GmbH, Am Klopferspitz 19, 82152 Martinsried, Tel. +49 (89) 125981-0
