General Terms and Conditions
GTC (DE-02/2025)
Preamble
(1) Vita 34, a brand of FamiCord AG, (hereinafter referred to as Vita 34) pursues the collection, processing and storage of umbilical cord blood and umbilical cord tissue.
(2) The child as the owner shall be solely entitled to the power of disposal of the umbilical cord blood preparation; the use by Vita 34 or third parties shall be excluded. Until it reaches the legal age, the persons having the care and custody (hereinafter referred to as “legal representatives”) shall represent the child.
(3) Umbilical cord blood is the foetal blood from the placenta and the attached umbilical cord that is collected immediately after the umbilical cord was cut. Umbilical cord tissue is collected by cutting the umbilical cord a second time near the placenta after the umbilical cord blood was cut and the umbilical cord blood collected. The full extent of future applications of umbilical cord blood and umbilical cord tissue cannot yet be foreseen at present.
(4) The umbilical cord blood and umbilical cord tissue is processed and stored at the company’s GMP laboratory (GMP = Good Manufacturing Practice pursuant to the EU GMP directive for medicinal products for human and veterinary use). Umbilical cord blood is subject to the German Pharmaceuticals Act (AMG). Vita 34 has the manufacturing license pursuant to § 13 AMG to collect and store umbilical cord blood and the manufacturing licenses pursuant to § 20b and 20c AMG to collect and store umbilical cord tissue. The collection of umbilical cord blood and umbilical cord tissue requires the availability of a manufacturing license for the birth centre as well. If the delivery takes place in a birth centre that does not collaborate with Vita 34, Vita 34 shall be exempt from all obligations resulting from this contract, as their fulfilment has become impossible on legal grounds.
§ 1 Contractual partner and subject matter of the contract
(1) The removal and storage contract is concluded between Vita 34 and the legal representatives of the child or, in the case of multiple births, the children (usually the parents, Section 1629 (1) BGB, (hereinafter referred to as “contractual partners”, jointly also referred to as “the parties”) in their own name in favour of the child.
(2) However, only the child or, in the case of multiple births, the children (hereinafter “child” includes both the singular and the plural) authorised to dispose of the umbilical cord blood and the umbilical cord tissue as owners; any use by FamiCord or third parties is excluded. The disposal of the umbilical cord blood and umbilical cord tissue must be within the scope of the applicable pharmaceutical regulations.
(3) The child is represented by its legal representatives until it reaches the age of majority. The child may enter into the rights and obligations of this contract in place of the contractual partner upon reaching the age of majority or prior to this with the consent of the legal representatives. The contractual partner hereby agrees to this change of contractual party.
(4) The subject matter of the contract is the collection and preparation of umbilical cord blood and, if applicable, umbilical cord tissue, the storage of the umbilical cord blood preparation and, if applicable, the umbilical cord tissue as well as the services included in the selected contract variant (“Annex 1”). For the umbilical cord blood, professional processing and preparation for transport for the purpose of delivery to the prescribing physician/other authorised user is also a contractual obligation. The therapeutic use of the umbilical cord blood preparation and/or the umbilical cord tissue preparation is not the subject of the contract.
(5) The collection of umbilical cord blood and, if applicable, umbilical cord tissue takes place in a maternity centre that is a cooperation partner of FamiCord. Otherwise, FamiCord is released from all obligations arising from this contract. FamiCord will the unauthorised umbilical cord blood and/or umbilical cord tissue. The legal representatives of the child already to the destruction. A current overview of the co-operating maternity facilities can be viewed online: Klinikfinder
(6) As part of the included family option (Appendix 1), the cord blood is also tested for its suitability as a stem cell transplant for family members (“allogeneic donation”). The legal representatives consent to an HLA test being carried out on the child’s umbilical cord blood, if allogeneic. If the assessment of the umbilical cord blood at FamiCord shows that the criteria for an allogeneic donation (e.. due to anamnestic criteria, quantity or cell content) are not fully met, the blood is stored as a personal provision for the child in accordance with the selected contract variant.
Reimbursement of pro rata costs or any reasons for resolution applicable to the autologous donation pursuant to Section 6 (5) are excluded if the donation is not suitable as a family preparation under the family option.
(7) If the “public donation option” (Appendix 1) is selected, the anonymised data of the umbilical cord blood will be entered into a stem cell register, subject to suitability. The legal representatives consent to an HLA determination from the child’s umbilical cord blood. If the remaining evaluation of the umbilical cord blood at FamiCord shows that the criteria for inclusion in a stem cell register are not fully met, the blood is stored without inclusion in a stem cell register in accordance with the selected contract variant. The “public donation option” variant is then deemed not
to have been selected.
(8) If the “Preventive screening” option is selected, FamiCord will carry out a DNA analysis on the child’s umbilical cord blood for the abnormalities and incompatibilities listed in Appendix 1. FamiCord will then forward the findings to the legal representatives.
§ 2 Obligations of Vita 34
(1) Vita 34 assumes the following tasks in relation to the child in accordance with the authorisations in accordance with the pharmaceutical regulations as per preamble para. 3, which are
associated with the collection of umbilical cord blood and umbilical cord tissue and the storage of the umbilical cord blood preparation:
1. The overall responsibility for the collection of umbilical cord blood.
2. The delivery of a collection kit.
3. The assignment of the selected birth centre or attending physician or freelance midwife (hereinafter referred to as the person collecting the umbilical cord blood) collaborating with Vita 34 in Germany with the collection of the umbilical cord blood. The assignment will also include the instruction to abstain from collecting the umbilical cord blood at one’s own discretion, if this is required from a medical point of view to protect the health of mother and child.
4. The transport of the umbilical cord blood from the birth centre to the facility of Vita 34.
5. The testing of the umbilical cord blood upon receipt for its suitability for preparation.
6. a) The preparation, cryo-preservation, and storage of the umbilical cord blood preparation.
6. b) The issue of a certificate of storage.
6. c) The quality control of the umbilical cord blood preparation pursuant to the legal requirements in Germany.
7 The professional processing and preparation of the transport with the purpose of the physician / other user after repeated testing of the umbilical cord blood preparation; free transport to any centre of application in Germany.
8. The rendering of the services included in the selected type of contract (as at 01/11/2018). In case umbilical cord tissue is stored, the items 1 to 6 and 8 shall be accordingly applicable.
(2) If the tests pursuant to § 2 sec. 1 no. 5 have the result that the preparation of the umbilical cord blood is impossible or not justifiable, Vita 34 shall inform the legal representatives in writing and destroy the umbilical cord blood. In case of the additional storage of umbilical cord tissue, the preparation and storage of the umbilical cord tissue shall also be effected if the umbilical cord blood has to be destroyed for the reasons given in clause 1, if there are no other opposing reasons and in particular, if tissue was collected in a sufficient quantity and quality.
(3) Vita 34 may use reliable subcontractors to fulfil its obligations.
(4) In case Vita 34 becomes insolvent, a special insurance is provided to ensure the continued storage of the umbilical cord blood and/or umbilical cord tissue for 50 years from the initial storage.
§ 3 Obligations of the mother, the legal representatives / consent
(1) The mother or the legal representatives shall
1. Truthfully and thoroughly complete and sign the following forms submitted by Vita 34 and return them to Vita 34:
1) Medical history form until the birth
2) Copy of maternity card until the birth
3) Follow-up medical history form 14 days after the birth at the latest
4) Information and declaration of consent depending on the selected contract variant
5) Consent form regarding tissue typing pursuant to German Genetic Diagnosis Act, if contract option Donation is selected.
2. Select only a birth centre collaborating with Vita 34, indicate the desired collection of umbilical cord blood and, if applicable, umbilical cord tissue again to the physician / midwife as well as hand the collection kit and the original deed of release provided by Vita 34 over to the person collecting the umbilical cord blood and, if applicable, the umbilical cord tissue immediately before the birth pursuant to § 7, section 2, clause 2.
3. Promptly notify Vita 34 in writing of the name/s of the child/children after the birth.
4. Promptly notify Vita 34 of blood-borne infectious diseases of the mother or the child occurring within twelve months after the birth (e.g. hepatitis B, hepatitis C, or HIV).
(2) The legal representatives shall consent to umbilical cord blood being collected after the cord of the child / children was cut. If the contract type VitaPlusCord is selected, this consent shall apply to the collection of umbilical cord tissue as well.
(3) The mother shall agree that a blood sample is taken from her to do the necessary infection-serology tests (including HIV) at the time of the birth (± 48 h).
(4) The legal representatives shall agree that the physician / midwife / clinic submits the findings / data obtained during the pregnancy / birth to Vita 34. This shall apply as well to findings obtained after transplantation of umbilical cord blood and/or umbilical cord tissue cells. The legal representatives shall release the medical personnel from their obligation to confidentiality in this respect. The legal representatives shall agree that Vita 34 submits findings obtained by Vita 34 (except the results of the preventive screening examination) as well as copies of medical documents to the attending gynaecologist and / or physician at the clinic and that Vita 34 complies with the statutory obligations to report specific medical parameters.
(5) If the contract option of a preventive screening examination is selected, the legal representatives shall agree that molecular-genetic diagnostic tests (preventive screening examination) are performed with the child’s umbilical cord blood in accordance with the given parameters. This consent can be revoked at any time with effect for the future. The legal representatives shall be entitled not to acknowledge the examination results or parts of such results and to have them destroyed. The legal representatives shall agree to the storage of the examination material for verification of the results; this sample shall be destroyed after ten years. The legal representatives shall furthermore agree that the laboratory submits the results of the analysis in confidence to Vita 34.
§ 4 Payment/Remuneration
(1) Vita 34 receives a contract fee for the preparation of the umbilical cord blood and, if applicable, the umbilical cord tissue of a child as well as an annual fee for the storage of the umbilical cord blood or cord tissue in accordance with the selected contract variant (Annex 1).
(2) As part of the family option, it is checked whether the umbilical cord blood can also be used for family members (allogeneic). The transfer of umbilical cord blood to family members is only possible if there is sufficient tissue compatibility. Due to very strict quality requirements, it is possible that the umbilical cord blood cannot be released for relatives (e.. due to anamnestic criteria, the quantity or the cell content) but can be used for other purposes and can “only” be stored as an autologous preparation for the child.
Reimbursement of pro rata costs or any grounds for resolution pursuant to Section 6 (5) that apply to autologous donation are excluded if the donation is not suitable as a family preparation.
(3) When the contract is concluded, a deposit on the contract fee is per child in accordance with the selected contract variant (Annex 1). If the family option for the umbilical cord blood is excluded due to anamnestic reasons prior to birth and the contractual partners cancel the contract, the deposit will not be refunded (Annex 1).
After storage of the umbilical cord blood and, if applicable, the umbilical cord tissue, an invoice will be issued for the remaining amount of the contract fee. The annual fee is due annually in advance on the child’s birthday. The payment modalities depend on the selected contract variant (Annex 1). The customer agrees to the sending of an electronic invoice to the e-mail
address provided by the customer. Any changes to the e-mail address for sending invoices must be communicated immediately.
In the case of multiple births, the full contract fee is charged for the first child and only of the contract fee for the second child in accordance with the selected contract variant (Appendix 1); the contract fee is waived from the third child onwards. For the first two children, a deposit on the contract fee is charged per child in accordance with the selected contract variant (Appendix 1). The contract fee for the second child is waived if a preparation can only be successfully for one child. The annual fee is payable for each stored preparation and depends on the contract variant selected (Annex 1).
(4) If the contract fee and, depending on the contract variant selected, the annual fee are not paid within three months of the due date despite a request for payment / reminder, FamiCord is entitled to terminate the contract and to destroy the cord blood or cord tissue preparation after prior notice with a period of two months after such notice.
(5) Discounts and other benefits granted by FamiCord (e.. special conditions for multiple births) cannot be combined with each other, do not apply to the deposit and are not granted retroactively.
§ 5 Price adjustment of annual fee
The annual fee is subject to a price adjustment as follows:
(1) There is no price adjustment for the first 2 years after storage of the umbilical cord blood or umbilical cord tissue.
(2) In the event that the consumer price index for Germany officially by the Federal Statistical Office changes compared to the index published in December of the year in which the contract was concluded, Vita 34 reserves the right to increase or reduce the agreed annual fee in the percentage ratio after the first two years of storage (from the third year of storage). Further adjustments are permitted after the expiry of a further year of storage. The authorised party may also demand a corresponding adjustment of the agreed annual fee. In the case of advance payment of the
annual fee depending on the contract variant selected (Annex 1), the annual fee is to be paid in advance.
(3) Vita 34 is authorised to adjust the annual fee for the first time after the end of the prepayment period. Further adjustments are permitted after the expiry of a further storage year.
(4) The contractual partner must be notified in writing of the exercise of the price adjustment right no later than four weeks after the relevant adjustment date. If the entitled party exercises its ordinary right of cancellation pursuant to Section 6 (2) after receipt of the notification at the next possible date, the adjustment the fee shall not enter into force.
(5) If the price adjustment increases the annual fee by more than 5% compared to the fixed annual fee, the beneficiary has an extraordinary right of cancellation.
(6) Should the consumer price index for Germany determined by the Federal Statistical Office no longer be continued during the term of the contract and be replaced by another index, this index shall be used accordingly for the question of value protection. In this case, the contracting parties undertake to agree a new economically appropriate value assurance clause.
(7) Irrespective of the provisions in paragraphs 2, 3, 4 and 5, Vita 34 is entitled in the event of an increase in the statutory value added tax and obliged in the event of a reduction to adjust the prices for contractual services provided from the time of the respective statutory change with effect for the future accordingly. The contractual partner has no right of cancellation in the event of this price adjustment.
§ 6 Term/cancellation/termination
(1) The contract is concluded for an indefinite period. This also applies in the event of advance payment of the annual fee in accordance with the selected contract variant (Annex 1).
(2) The contract can be cancelled by the contractual partner in accordance with the selected contract variant (Appendix 1) in text form on the child’s subsequent birthday without stating reasons. This does not restrict the right to extraordinary cancellation for good cause.
(3) Ordinary cancellation by Vita 34 is excluded. The right to extraordinary termination for good cause (e.. non-payment of remuneration in accordance with § 4, breach of obligations under
§ 3) remains unaffected by this.
(4) If the contract is cancelled by the legal representatives, Vita 34 claim to payment of the full contract fee and the annual fee remains in force.
(5) The contract is automatically terminated without the need for cancellation if
1. prior to the collection of the umbilical cord blood or tissue, there are urgent medical reasons within the meaning of the prescribed guidelines against storage. FamiCord will inform the legal representatives of this in writing.
2. the person performing the umbilical cord blood or umbilical cord tissue collection refuses the order to collect the umbilical cord blood or umbilical cord tissue or refrains from collecting it at their own discretion (Section 2 1) No. 3) or umbilical cord blood or umbilical cord tissue is not collected for other reasons.
3. the collection of the umbilical cord blood or tissue place in an institution that is not a co-operation partner of Vita 34.
4. the initial examination of the umbilical cord blood and umbilical cord tissue in accordance with Section 2 1) No. 5 shows that preparation and storage is not possible or not justifiable in accordance with Section 2 (2).
5. The reasons for termination according to No. 1 to No. 4 only apply to the of umbilical cord blood and umbilical cord tissue if the preparation of both products (umbilical cord blood or umbilical cord tissue) is not possible according to the qualitative requirements. Otherwise, the storage of the umbilical cord blood or umbilical cord tissue will be continued. In this case, the amount of the contract fee for the storage is based on the contract fee for the storage of umbilical cord blood minus the advance payment made plus the annual fee if applicable, depending on the contract variant selected (Annex 1).
6. The reasons for cancellation according to No. 1 to No. 4 do not apply to the unsuitability of the donation as a family preparation (allogeneic suitability).
(6) In the event of termination of the contract in accordance with paragraph (5) nos. 1 to 4, FamiCord shall only receive the down payment on the contract fee in accordance with the selected contract variant (Annex 1). This does not apply to the case according to paragraph (5) no. 5 (storage of umbilical cord blood and cord tissue), for which the provisions made there apply.
(7) When storing umbilical cord blood and umbilical cord tissue, it is possible to cancel the storage of the umbilical cord blood or umbilical cord tissue. The amount of the annual fee for the remaining storage then corresponds to the annual fee for the storage of umbilical cord blood. There will be no retroactive reimbursement of the contract fee or of annual fees already paid for umbilical cord blood and umbilical cord tissue.
(8) If a contract that includes the preventive screening option in accordance with Section 3 (5) No. 3 is terminated, the amount specified in Annex 1 must also be paid to FamiCord per child for the results of the preventive screening. This also applies to multiple births.
9) If the contract ends in accordance with paragraphs (2), (3), (5) nos. 1, 2, 4 and 5 and/or paragraph (7), the legal representatives consent to Vita 34 destroying the stored umbilical cord blood or umbilical cord tissue if the entitled person does not dispose of the umbilical cord blood or umbilical cord tissue within a period of eight weeks after the end of the contract within the meaning of § 48 AMG. If the contract ends in accordance with paragraph (5) no. 3, the stored umbilical cord blood or umbilical cord shall be destroyed immediately in accordance with § 1 paragraph (5). If the
contractual relationship is terminated with one legal representative and continued with the other, the consent of both legal representatives shall continue to apply.
(10) Furthermore, this contract and thus the obligation to pay the annual fees shall end if FamiCord over the stored umbilical cord blood and/or umbilical cord tissue to the treating physician/other authorised user at the latter’s request. Paragraph (7) sentence 2 applies accordingly to the storage of umbilical cord blood and umbilical cord tissue.
§ 7 Assignment of claims
(1) The legal representatives to Vita 34 assigning all monetary claims against them in whole or in part and to Vita 34 taking the necessary measures to assert and enforce the claim in accordance with the law. The customer may disclose the necessary data (name and address of the contractual partner, amount, due date and invoice number certain forms) and hand over the necessary documents in accordance with § 402 BGB. This information and documentation will be treated as strictly confidential and will not be misused.
(2) Further regulations are set out in Vita 34 privacy policy.
§ 8 Liability of FamiCord/waiver of claims against the clinic
(1) FamiCord shall only be liable for intent and gross negligence, except in the event of a breach of material contractual obligations (obligations whose fulfilment is essential for the proper performance of the contract and on whose fulfilment the contractual partner regularly relies and may rely) or in event of injury to life, limb or health.
(2) FamiCord does not assume any guarantee for current or possible future applications of umbilical cord blood or umbilical cord tissue preparation that are not the subject of this contract in accordance with § 1.
(3) The legal representatives waive any claims in their own name and on behalf of the child against the birthing or the person who performs the umbilical cord blood or umbilical cord tissue collection and the collection of maternal bloodunless the claims are on intent or gross negligence. This does not apply to damages resulting from injury to , limb or health or from the not
breach of a material contractual obligation. For the purpose of this exclusion of liability, the legal representatives of the maternity facility or the person carrying out the umbilical cord blood or umbilical cord tissue collection shall hand over the signed original declaration of indemnity. This declaration does not affect claims of the child and the mother against FamiCord due to
culpable behaviour on the part of the birthing facility or the person performing the collection.
(4) In the event of negligent destruction or other rendering unusable of the umbilical cord blood or umbilical cord tissue or the stem cell preparation from umbilical cord blood or umbilical cord tissue, Vita 34’s liability is limited to reimbursement of the additional costs for a possible own donation (e.. cell separation, bone marrow) or for a third-party donation of stem cells (e.g. cell separation, bone marrow). There are no further liability claims, in particular FamiCord is not liable for any lost therapy opportunities.
§ 9 Data protection
(1) Vita 34 is authorised to store the personal data of the child and the legal necessary for the execution of the contract and to pass it on to its contractual partners to the extent necessary for the fulfilment of the contract. Vita 34 treats this data confidentially and also obliges its contractual partners to maintain confidentiality.
(2) Vita 34 is authorised to pass on the data necessary for the use of the umbilical cord blood for therapeutic purposes to the doctor/other authorised user on request.
(3) If the public donation option is chosen, Vita 34 will only pass on the preparation data, but no personal data (except date of birth), to the stem cell register or, in the case of donation, to the doctor using the preparation.
(4) Further regulations are set out in Vita 34’s privacy policy.
§10 Final provisions
(1) The parties shall inform each other immediately in writing of any change of address or name. The legal representatives shall also notify Vita 34 immediately of any change in the representation relationship. The legal representatives shall inform the child about the content of the contract, in particular about the child’s ownership rights, at the latest when the child
reaches the age of majority.
(2) The transfer of this contract or of obligations or rights arising from this contract to a third party by Vita 34 requires the consent of the authorised party.
(3) Amendments and additions to this agreement must be made in writing to be effective. This also applies to the amendment or cancellation of this written form clause.
(4) Should provisions of this agreement be or become invalid or unenforceable, this shall not affect the validity of the remaining contractual provisions. In such a case, the contracting parties undertake to replace the ineffective or provision with a new provision that comes as close as possible to the legal and economic success envisaged when the contract was concluded. The above provisions shall apply accordingly in the event that the contract proves to be incomplete.
(5) German law applies.
Information on the right of withdrawal
Right of withdrawal
You may withdraw from this contract without stating any reasons within fourteen days. The period of withdrawal is fourteen days and starts with the date on which the contract is concluded.
To exercise the right of withdrawal, you need to submit an explicit declaration (sent e.g. by mail, fax, or e-mail) of your decision to withdraw from this contract to
Vita 34
FamiCord AG
Perlickstrasse 5
D-04103 Leipzig
T: +49 (0) 341 487 92 0
F: +49 (0) 341 487 92 20
To comply with the period of withdrawal, it is sufficient to send the declaration on the withdrawal prior to the expiry of this period.
Consequences of withdrawal
If you withdraw from the contract, we shall reimburse any payment made by you, including the cost of delivery (except for the additional cost arising from your choice of another than the low priced standard type of delivery), promptly and at the latest within fourteen days after we received the declaration of withdrawal. We will use the same means of payment that you used for the initial transaction, unless otherwise expressly agreed. We will in no event charge extra costs for such reimbursement.
You have to return the goods (the collection kit) promptly and in any case at the latest within fourteen days after you informed Vita 34 about your withdrawal to Vita 34, FamiCord AG, Perlickstrasse 5, D-04103 Leipzig. This period shall be regarded as complied with, if you send the goods prior to the expiry of this period.
You will bear the charges for the return.
You need to pay for a possible depreciation of the goods only, if this depreciation is the result of you handling the goods in way that is not required to check the quality, properties, and functionality of the goods.
If you requested that the services start during the period of withdrawal, you have to pay an adequate amount corresponding to the portion of the services already rendered at the date on which you informed us about your decision to withdraw from the contract compared to the total scope of services provided for in the contract.
End of information on right of withdrawal