1. Definitions
This Service Level Agreement, hereinafter referred to as the “AGREEMENT”, is made between Cryos International ApS, Reg. no. 35514252, Vesterbro Torv 3, 5th floor, 8000 Aarhus C, Denmark, hereinafter referred to as “CRYOS” and the customer, hereinafter referred to as the “CUSTOMER”.
The CUSTOMER declares that it is a professional customer, e.g. an approved tissue center, fertility clinic, hospital department or authorized healthcare professionals authorized to purchase, receive and/or handle human tissues and cells.
The CUSTOMER is obliged to hold all permits, licenses and approvals necessary for the handling of human tissues and cells, and for any treatments required by the use of human tissues and cells required under the laws and regulations applicable to the CUSTOMER. On request from CRYOS the CUSTOMER must provide CRYOS with proof of valid authorization.
By entering this AGREEMENT, the CUSTOMER accepts these terms and conditions and accepts that they shall govern all relations associated to the purchase or the receipt and handling of TISSUES AND CELLS delivered by CRYOS to the CUSTOMER regardless of whether the TISSUES AND CELLS are purchased by the CUSTOMER or a third party, e.g. a PATIENT who has appointed the CUSTOMER to receive the TISSUES AND CELLS on behalf of the PATIENT as part of the PATIENT’s treatment.
CUSTOMER can use TISSUES AND CELLS for the purpose of fertility treatment, meaning treatment required to assist people in achieving a pregnancy. CUSTOMER is not allowed to use TISSUES AND CELLS for any other purposes, including but not limited to research purposes, genetic testing or any other kinds of testing or preparation not conducted by CRYOS, without prior written agreement with CRYOS.
CRYOS and the CUSTOMER are jointly referred to as the “PARTIES”. A recipient undergoing treatment with DONOR SPERM or EMBRYO hereinafter referred to as PATIENT.
Donor sperm hereinafter referred to as the “DONOR SPERM”.
Donor egg(s) hereinafter referred to as the “DONOR EGG”.
Embryo(s) created using DONOR EGG hereinafter referred to as the “EMBRYO”.
DONOR SPERM and DONOR EGG hereinafter jointly referred to as “DONOR GAMETES”.
DONOR GAMETES and EMBRYO hereinafter jointly referred to as “TISSUES AND CELLS”.
Services such as handling, collecting, receiving, processing, analyzing, preparation, storage, reservation, transportation, freezing, etc., or other services associated to the TISSUES AND CELLS are also covered by these terms and conditions.
2. DONOR GAMETES
CRYOS’ mission is to provide high quality human sperm and eggs from selected and screened donors of all ethnicities and phenotypes, and CRYOS therefore provides a wide range of DONOR GAMETES. Different parameters apply to the selection of donors and DONOR GAMETES, e.g. ID-Release, Non-ID Release, Basic Profile, Extended Profile, IUI-ready, ICI (raw semen), concentration (MOT), Adult Photo, Exclusivity, many different country specific requirements defined as Standard, Quotas, etc. Each parameter is described on CRYOS’ website.
DONOR GAMETES are donated, procured, tested, processed, preserved, stored and distributed according to the regulation in force at the time of donation and according to the applicable licenses and permits.
The criteria for donor selection are based on an analysis of the risks associated with the use of DONOR GAMETES. The relevant risk indicators are determined on the basis of medical examinations, review of the medical and behavioral history of the individuals concerned, biological testing and other relevant studies.
DONOR GAMETES on CRYOS’ website are released for clinical use according to applicable law and according to one or several Standards, as described on Cryos’ website. CRYOS disclaims, to the fullest extent possible, all other warranties, express or implied, including warranties of quality, merchantability, or fitness for a particular purpose.
CRYOS declares that when TISSUES AND CELLS are provided according to this AGREEMENT, it is not the TISSUES AND CELLS themselves that are sold but the handling including the related processing and work, such as selection and testing of the donor, preparation of documents and the handling, cryopreservation, storage, marketing, administration, etc. of the TISSUES AND CELLS.
The selection of TISSUES AND CELLS can be found on CRYOS’ website where they are added to the basket or the treatment when creating an order. To create an EMBRYO the CUSTOMER must choose whether the source of sperm is DONOR SPERM originating from CRYOS, from another authorized tissue establishment, or from the PATIENT.
The DONOR GAMETES provided by CRYOS are screened, tested and/or promoted based on defined Standards (see CRYOS’ website). CRYOS strives to comply with country specific requirements, but the CUSTOMER is responsible for verifying if the chosen TISSUES AND CELLS meet specific requirements in the treatment country. CRYOS cannot be held liable in case TISSUES AND CELLS cannot be used for treatment due to country specific requirements.
When CUSTOMER orders EMBRYO, the CUSTOMER understands and accepts that there is no guarantee that the gametes will result in the ordered number of viable embryos.
If EMBRYO is ordered, the CUSTOMER must inform CRYOS of the identity of the PATIENT. It is a prerequisite that there is an identified PATIENT to receive the treatment with EMBRYO and it is the responsibility of the CUSTOMER to obtain a consent from the PATIENT. CRYOS can request the CUSTOMER to provide CRYOS with proof of consent.
If EMBRYO “Upon Request” is ordered, the CUSTOMER understand and accept that the donor is registered, but the egg donation process will only commence when the CUSTOMER has chosen the donor and ordered an egg donation treatment with a longer course of treatment related to assisted reproduction, including a longer delivery time. Despite comprehensive testing and screening of Upon Request donors, CRYOS cannot guarantee the quantity or quality of oocytes retrieved from an Upon Request donor. CRYOS makes no warranties, express or implied, regarding the suitability of the oocytes for assisted reproduction treatment. CRYOS shall not be liable for any direct, indirect, incidental, or consequential damages arising from the quantity, quality, or suitability of the oocytes retrieved.
3. Reservation of DONOR SPERM
In relation to the ordering of TISSUES AND CELLS, the chosen DONOR SPERM can be reserved for a period ordered by the CUSTOMER. CRYOS will charge a reservation fee depending on the period of a minimum of 3 months. The CUSTOMER can at any time order delivery of or terminate partly or in full reserved DONOR SPERM.
An order confirmation for the reservation will be sent to the CUSTOMER. The Reservation Period terminates automatically upon lapse or shipment from CRYOS of the last DONOR SPERM.
The Reservation Period can always be extended. Prior to expiry CRYOS will send a reminder to the CUSTOMER with information that the reservation is due to expire. Renewal is done online with the use of a username and password. By renewal, the CUSTOMER accepts that the conditions for storage will be according to the AGREEMENT in place at the time of the renewal. A confirmation for renewal will be sent to the CUSTOMER.
If payment is not received in due time CRYOS has the right to terminate the reservation.
When the CUSTOMER wants reserved DONOR SPERM delivered, this is ordered online with the use of the CUSTOMER’s username and password.
When the CUSTOMER wants to terminate the reservation, the termination is ordered online with the use of the CUSTOMER’s username and password.
If all the reserved DONOR SPERM has been used or delivered, the reservation is automatically terminated.
When the Reservation Period terminates CRYOS is entitled to buy back the remaining DONOR SPERM at the purchase price less the following percentages:
- Buyback within 14 days to 36 months after the date of the reservation: 75% of the purchase price.
- Buyback within 36 to 48 months after the date of the reservation: 50% of the purchase price.
- Buyback within 48 to 60 months after the date of the reservation: 25% of the purchase price.
- Buyback 60 months and following after the date of the reservation: 0% of the purchase price.
After the buyback CRYOS is entitled to release the remaining DONOR SPERM on CRYOS’ stock for others to purchase. This clause is not applicable for Exclusive donors.
In case of mass termination, CRYOS can postpone the termination until the end of the selected reservation period.
Exchange of reserved DONOR SPERM can only take place by terminating as per above and by making a new purchase and reservation.
CRYOS keeps an agreement in force with another licensed tissue establishment to take over storage of the reserved DONOR SPERM, if CRYOS, whatever the reason is, will not be able to continue storing the reserved DONOR SPERM.
4. Storage of EMBRYO
In relation to the ordering of EMBRYO, EMBRYO can be stored at CRYOS’ facility for a period up to 12 months after creation. It is a prerequisite for storage that the CUSTOMER provides CRYOS with the name, identification number and contact information of the PATIENT including the PATIENT’s partner if any. After 12 months of storage, the PATIENT can extend the storage period in the name of the PATIENT by contacting CRYOS.
Stored EMBRYO can be dispatched from CRYOS upon request from the CUSTOMER. The request must include a consent from the PATIENT which must be provided to CRYOS by CUSTOMER.
The storage period terminates automatically upon lapse or dispatch from CRYOS of the last EMBRYO.
When the storage period has expired, CRYOS is entitled to destroy any remaining EMBRYO. Prior to destruction CRYOS will inform the CUSTOMER.
Stored EMBRYO must be destroyed in the event of the PATIENT’s death, if the PATIENT may no longer receive treatment with assisted reproduction, and – If the PATIENT has a partner – in the event of the couple’s separation, divorce, or termination of cohabitation as well as in the event of the PATIENT’s partner’s death unless the partner has provided written consent, allowing the PATIENT to use the stored EMBRYO for treatment following the partner’s death. It is the responsibility of the CUSTOMER to check whether the above situations have occurred, and CUSTOMER must keep CRYOS informed.
To the extent permitted by applicable law CRYOS disclaims liability for accidental loss of or damages to stored EMBRYO as well as loss of or damages to stored EMBRYO caused by CRYOS’ simple negligence.
5. Blastocyst Guarantee
If the CUSTOMER orders EMBRYO at CRYOS, using both DONOR EGG and DONOR SPERM originating from CRYOS’ donors, CRYOS guarantees fertilization and the development of at least one viable blastocyst (day 5 embryo) before freezing. If the unlikely event that no viable blastocysts are developed, the CUSTOMER must inform CRYOS within 14 days after the COSTUMER has been informed, if they want to utilize the guarantee. In this case CRYOS will perform a new treatment (one fertilization) using DONOR GAMETES from the same donor (if available) or a similar donor free of charge.
6. Early ID Release, ID Release and Non-ID Release
The donors are either Early ID Release, ID Release or Non-ID Release. An Early ID Release or ID Release donor cannot convert to a Non-ID Release donor or opposite.
If the donor is an Early ID Release or ID Release donor, CRYOS will disclose a number of predefined identifying information about the donor to clinics and authorities in countries where this is mandatory before or in relation to distribution, import or treatment. Furthermore, if the donor is an Early ID Release donor, CRYOS will disclose the identity of the donor to the parents of the child, at the entitled person’s request once the child is born and until the child turns 18 years old. The parents of the child must demonstrate, or render probable with a significant level of certainty, that the donor conceived child is the result of treatment with DONOR GAMETES from a specific Early ID Release donor from CRYOS. After the child has turned 18 years old, it’s solely the child who may request the information from CRYOS.
CRYOS will solely disclose the identity of an Early ID Release donor or ID Release donor to a donor conceived person at the donor conceived person’s request, once the donor conceived person has reached the age of 18 years. The donor conceived person must document, or render probable with a significant level of certainty, that he/she is the result of treatment with DONOR GAMETES from a specific Early ID Release or ID Release donor from CRYOS. The code of the donor in question must be informed to CRYOS. An Early ID Release or ID Release donor has accepted to be contacted by the parents of the child (solely applicable for Early ID Release donors) or/and by the donor conceived person. However, if an Early ID Release or ID Release donor rejects an attempted contact from the parents of the child or from a donor conceived person, or if an Early ID Release or ID Release donor does not want to establish a relation after having had an initial contact, CRYOS cannot be held liable nor responsible for that.
The CUSTOMER understands and accepts that the identity of a Non-ID Release donor will never be disclosed by CRYOS. Regardless of whether a donor is Non-ID Release, Early ID Release or ID Release, the CUSTOMER guarantees that no attempts will be made to search for or to trace donors, including search for the donor’s identity or any information that can lead to the disclosure of the donor’s identity, or the identity of other recipients or offspring related to the donors. If, regardless of this, the CUSTOMER initiates such a search or trace, the CUSTOMER shall indemnify CRYOS and the donor from any demand raised against CRYOS or the donor as a result of the CUSTOMER’s search, regardless of whether the search, directly or indirectly, has resulted in tracing or identifying the donor or other recipients or offspring related to the same donor. Notwithstanding the above, the parents of the donor conceived child are entitled to contact the donor after obtaining the donor’s identifying information from CRYOS, if the donor is an Early ID Release donor.
7. Summary of Records
For each donor a Summary of Records (SOR) can be retrieved from CRYOS’ website. The SOR carries relevant information about the donor code, the type of donor, personal data, test results, etc. and Standard release. Certain parts of the content in the description are changeable by nature since it describes a human being and its biological circumstances and conditions at a certain time. Accordingly, CRYOS can add changes to a donor profile and SOR over a period, if CRYOS receives new knowledge about a donor.
8. Quota reservation and pregnancy registration
In some countries, the CUSTOMER must hold a Quota Reservation ("QR") in order not to exceed national quotas regarding number of pregnancies/children/families per donor. The QR is a security for the CUSTOMER, that the CUSTOMER holds a family or pregnancy slot in the total country quota. If a QR is mandatory in the CUSTOMER's country, a QR will automatically be added to the CUSTOMER's basket when the CUSTOMER places an order. If a QR is not mandatory in the CUSTOMER's country, the CUSTOMER cannot purchase a QR. The QR follows CUSTOMER’s chosen treatment country at time of purchase and cannot be converted if CUSTOMER decides to continue treatment elsewhere.
If the donor has a worldwide quota “WQR15” or “WQR50”, it means that CRYOS will limit the sale of quotas to 15 respectively 50 families (siblings not included) per donor worldwide. By purchase/reservation it is mandatory to purchase a Worldwide Quota Reservation (WQR). The purchase of a WQR applies globally and is not linked to, dependent on, or affected by any country-specific quota (QR).
If the donor does not have a WQR15 or WQR50, no worldwide quota exists and CUSTOMER should be aware that the number of donor half-siblings worldwide may be substantial in some instances.
A QR or a WQR is fully refundable for the CUSTOMER within a period of 3 years from the date of purchase of the QR or WQR provided that a pregnancy/birth is not obtained, and that the CUSTOMER has no DONOR SPERM or EMBRYOS left for future treatments. Upon expiry date of the period of 3 years QR or WQR is non-refundable for the CUSTOMER.
Prior to expiry of the period of 3 years from the date of purchase of a QR or WQR, CRYOS will send e-mails to the CUSTOMER reminding the CUSTOMER to convert the QR or WQR to a pregnancy registration in case a pregnancy/birth is obtained, or to terminate the QR or WQR against a refund, if a pregnancy is not obtained or if the CUSTOMER does not want to proceed with the chosen donor.
The CUSTOMER is obligated to register a pregnancy as soon as the pregnancy has come to the knowledge of the CUSTOMER. Pregnancies are registered online with the use of a username and password.
The CUSTOMER must register if the pregnancy is a sibling (the PATIENT already has a child with the same donor). The CUSTOMER must also register if the pregnancy is terminated (abortion, extra uterine pregnancy or stillborn).
When entering this AGREEMENT, the CUSTOMER accepts that CRYOS is entitled to continue contacting the CUSTOMER until the result of the treatment has been registered.
The CUSTOMER can check on CRYOS’ website if the quota for each donor has been reached. The quota is calculated as the number of pregnancies registered minus siblings and abortions. The CUSTOMER should be aware that the quota reservation is not a guarantee. CRYOS disclaims all responsibility if pregnancies are not registered, if pregnancies are registered twice or incorrectly, if the quota in the country in question is calculated differently, or if CRYOS does not know the quota or calculation methods of the country in question.
9. Genetic matching
CRYOS provides two types of genetic matching services: “Panel Matching” and “Single Gene Matching”, collectively “Genetic Matching”.
Genetic Matching is used prior to fertility treatment to compare one or more recessive genes between the Genetic Parent (the intended parent who provides the egg or sperm for the conception of a child) and the donor to assess whether there is a variant in the same gene in both the Genetic Parent and the donor that causes an increased risk of genetically hereditary diseases in the child. In the affirmative case, the result of the matching will be a "No-Match". If no such increased risk is identified, the result of the matching will be a "Match".
Panel Matching is a broad and general matching that matches more than 300 of the Genetic Parent’s genes – the ones with the highest risk of causing a serious disease - up against the genes of the donor. When the order for Panel Matching is confirmed, CRYOS sends the Genetic Parent a test kit to extract a saliva sample. The Genetic Parent must return the saliva sample to CRYOS or directly to the external authorised laboratory performing the Panel Matching on behalf of CRYOS that will forward the sample to the external authorised laboratory. CRYOS is not responsible for the Genetic Parent’s correct use of the test kit.
Single Gene Matching is a service where CRYOS tests the donor for variants in a specific gene in which the Genetic Parent has a variant identified by a genetic screening performed on the Genetic Parent. In order for CRYOS to perform Single Gene Matching CRYOS must receive a copy of the genetic report. CRYOS will share the report with an external authorised laboratory for the purpose of performing Single Gene Matching.
The CUSTOMER accepts that CRYOS is only able to provide the result "Match" or "No-match". The CUSTOMER will receive the matching result from CRYOS. In case the result is a "No-match" CRYOS recommends that the CUSTOMER selects another donor. In case of a "No-match" result, the CUSTOMER may have a new Genetic Matching performed up against another chosen donor free of charge to the CUSTOMER until a "Match" is obtained.
The CUSTOMER accepts that Genetic Matching does not test all hereditary diseases, and CRYOS disclaims liability for the accuracy of the tests performed in connection with Genetic Matching. The CUSTOMER further accepts that Genetic Matching cannot discover gene modifications in eggs, sperm or in the fetus occurred spontaneously.
10. Adverse reactions
If the CUSTOMER receives information about any adverse reactions, including hereditary diseases, syndromes, multiple and isolated malformations, associations, etc., because of using TISSUES AND CELLS, the CUSTOMER is obliged to inform CRYOS about this immediately so CRYOS can take the necessary action in relation to other CUSTOMERs, authorities, etc. The CUSTOMER agrees to provide the necessary information by filling out the website form Report of Conditions, so CRYOS can make an evaluation.
If CRYOS receives information as per above, the information will be assessed and if relevant the donor will be put in quarantine and it will be assessed if the information is related to the TISSUES AND CELLS. Subsequently, the TISSUES AND CELLS are either released for sale or permanently blocked.
CRYOS will notify the CUSTOMER about donors who are quarantined. The CUSTOMER agrees not to use TISSUES AND CELLS from quarantined donors, irrespective of whether delivery has taken place.
CRYOS will notify the CUSTOMER about donors who are permanently blocked. TISSUES AND CELLS from permanently blocked donors can only be used in treatments related to assisted reproduction by PATIENTS who have already conceived a child with TISSUES AND CELLS from the permanently blocked donor provided that the PATIENT accepts a special online declaration form.
EMBRYO may be used by the PATIENT even if the PATIENT does not already have a conceived child with TISSUES AND CELLS from the permanently blocked donor. Use of EMBRYO depends on the national legislation in the country where the PATIENT is to be treated and will typically require approval of the treatment by the authorized healthcare professional performing the treatment. Pursuant to Danish legislation, use of EMBRYO requires that the PATIENT is thoroughly informed and that genetic counseling is made available to the PATIENT before the EMBRYO is used. CUSTOMER is responsible for verifying if EMBRYO can be used for treatment in the treatment country. CRYOS cannot be held liable in case EMBRYO cannot be used for treatment due to country specific requirements.
The CUSTOMER agrees that CRYOS may send notices about donors who are in quarantine or permanently blocked for confirmed, delivered and reserved orders of TISSUES AND CELLS. If the order includes a delivery address which is different from the invoice address and if there is an e-mail address connected to this delivery address, the CUSTOMER agrees that CRYOS may send such information to this e-mail address as well.
In case a donor is under investigation for genetic diseases, CRYOS is obligated to cancel or postpone shipping of confirmed orders. TISSUES AND CELLS from permanently blocked donors can only be delivered if the CUSTOMER accepts a special online declaration form. If the CUSTOMER wants to terminate a reservation of a permanently blocked donor, this can be done as per above.
11. Release and Standards
CRYOS declares that DONOR GAMETES delivered is released for clinical use according to one or several Standards, as described on CRYOS’ website. Donors and DONOR GAMETES are selected, screened and comply with certain legal requirements associated with type and age of donor, sexual transmitted infections, quarantine, consent, etc., prevailing at the time of donation. This does not mean that donors or DONOR GAMETES ordered meet all possible requirements in the country/jurisdiction of destination or treatment.
CRYOS strives to comply with country specific requirements, but the CUSTOMER is responsible for checking if the chosen TISSUES AND CELLS meet specific requirements in the treatment country. CRYOS cannot be held liable in case TISSUES AND CELLS cannot be used for treatment due to country specific requirements.
12. Other issues
Despite the examination and testing for an extensive number of conditions and diseases in both the donor as well as the DONOR SPERM, see also CRYOS’ website about screening, there is always a minimal risk that infectious or hereditary diseases are transmitted with DONOR SPERM. From the Summary of Records (“SOR”) available at each donor’s profile at CRYOS’ website it appears for which infectious or hereditary diseases the donor has been tested. It is CRYOS’ assessment that the risk of transmission of infectious and hereditary diseases is lower than in the general population.
In case CRYOS is informed about transmissible or heredity diseases or unknown or unwanted heredity conditions in the DONOR SPERM after the order has been confirmed (irrespectively of whether the order has been delivered or not), and if this is not due to faults or deficiencies for which CRYOS is responsible, CRYOS disclaims all responsibility.
CRYOS declares that when DONOR SPERM in this AGREEMENT is sold, it is not the gametes themselves that are sold but the related processing and work, such as selection and testing of the donor, manufacturing of documents and the handling, freezing, storage, marketing, administration, etc. of the gametes. When EMBRYO is provided it is the treatment including creating the embryo(s), that is sold.
Information in the donor’s extended profile as well as the photos are provided by the donor. When drafting the extended donor profile CRYOS may edit the information provided such as removal of identifying details about the donor, combining text and proofreading. It is CRYOS’ belief that the data provided is correct, but CRYOS disclaims any liability in the event the data provided should not be correct.
CRYOS declares that compensation to donors has been in accordance with local regulations at the time and place of donation. If additional information about the media is required, contact CRYOS.
CRYOS processes personal data about CUSTOMER and PATIENT as specified in the Privacy Policy and the Cookie Policy which are incorporated in this AGREEMENT by reference. When personal data about the PATIENT is shared with the CUSTOMER, the CUSTOMER acts as independent data controller as set out in the Regulation (EU) 2016/679 General Data Protection Regulation (GDPR) and must ensure to be fully compliant with all applicable data protection and privacy legislation including but not limited to GDPR.
Personal data, including all data necessary to ensure traceability pursuant to applicable legislation to which CRYOS or the CUSTOMER is subject, must be stored for a minimum of 30 years from clinical use.
13. Prices
Prices are according to CRYOS' current prices as they appear on CRYOS' website: http://cryosinternational.com. CRYOS reserves the right to change prices without notice. Prices are exclusive VAT. In case the CUSTOMER is not registered in the EU with a VAT number, local national VAT will be added. Services not delivered, e.g. services conducted in Denmark, for instance storage, will be added 25% VAT.
In case an order has been confirmed with a discount or according to special prices those prices apply.
14. Payment
30 days net after date of invoice.
CRYOS reserves the right to refuse credit and ask for prepayment.
In the event of late payment, CRYOS shall be entitled to charge default interest in accordance with applicable mandatory law. In addition, CRYOS may charge reasonable reminder fees and recover compensation and costs for recovery of overdue amounts, including administrative and collection costs.
15. Online account
The CUSTOMER must register an online account with CRYOS before online orders can be registered. It is the CUSTOMER’s responsibility to keep the registered data on the account updated. The CUSTOMER will keep and protect the username and password in such a way that no other except the CUSTOMER has access. If the username and password is informed by the CUSTOMER to other persons or organisations, any actions on the CUSTOMER’s account are at the CUSTOMER’s responsibility and the CUSTOMER holds CRYOS harmless for any liability or additional costs arising out of or in any way relating to this AGREEMENT as per the terms of Waiver of Claims and indemnification in this AGREEMENT.
If there is suspicion that the account may have been compromised, CRYOS reserves the right to require the CUSTOMER to reset its password.
16. Information & correspondence
All information and correspondence to the CUSTOMER will be sent by e-mail. The CUSTOMER accepts that all information is in English. CRYOS disclaims all responsibility if information, whatever the reason is, does not reach the CUSTOMER. If the CUSTOMER does not have an e-mail address, the CUSTOMER can request that such information is sent by ordinary mail. CRYOS is entitled to charge a fee for ordinary mail service.
17. Order confirmation
When the CUSTOMER submits an order, CRYOS will send confirmation to the CUSTOMER. When the order is confirmed, this AGREEMENT becomes legally binding. In case of fault and deficiencies in the confirmation, the CUSTOMER is obliged to inform CRYOS about this without undue delay. In case of amendments to the order, a new confirmation will be sent. In such cases, the latter confirmation will repeal any earlier confirmations sent. It is recommended that the CUSTOMER prints all received information on paper or another lasting media.
18. Property rights
Delivered TISSUES AND CELLS remain the property of CRYOS until CRYOS has received full payment from the CUSTOMER of the total price of the TISSUES AND CELLS as well as delivery, transport and packaging.
19. Delivery terms
Shipment of TISSUES AND CELLS is ordered by the CUSTOMER at the business day before shipment. If the CUSTOMER requests shipment before 12.00 AM (CET) on a business day, CRYOS can ship the TISSUES AND CELLS on the same day against payment of an additional fee.
TISSUES AND CELLS are shipped DAP (Delivered At Place) according to Incoterms 2020. This means door-to-door excluding any local customs formalities like customs clearance, import permits, duty and tax. Shipping and insurance are included. The legal risk of the TISSUES AND CELLS transfers to the CUSTOMER when the TISSUES AND CELLS are delivered at the address of the CUSTOMER. CRYOS is particularly not liable for any faults or deficiencies that occur after delivery due to the CUSTOMER's handling or processing of the TISSUES AND CELLS.
The transport time from the day of shipping until delivery has taken place may vary depending on the destination and other conditions. Normally 1-3 weekdays (calculated from the day after shipping) are expected in EU countries and 2-5 weekdays (calculated from the day after shipping) in the rest of the world. For some destinations outside EU, customs procedures may delay delivery significantly.
All shipments are handled by either CRYOS or a recognized courier company, which offers high-quality transport and logistics solutions.
If the TISSUES AND CELLS are picked up at CRYOS, delivery is EXW (Ex Works) according to Incoterms 2020. This means that CRYOS makes the TISSUES AND CELLS available at its premises and from that moment on, the CUSTOMER takes on all costs, responsibilities and risks associated with transporting the TISSUES AND CELLS to its destination. Delivery has taken place when the TISSUES AND CELLS are handed over to the courier appointed by or on behalf of the CUSTOMER. The CUSTOMER declares having an agreement with the courier.
TISSUES AND CELLS are transported in either a dry ice container at approximately - 78.5 °C or a nitrogen vapor tank at approximately -196 °C. The TISSUES AND CELLS are placed in a canister within the nitrogen tank, which is then secured in a transport box to ensure the safe transport of the biological materials.
Upon allocation of reserved DONOR SPERM or stored EMBRYO to the CUSTOMER, the reserved DONOR SPERM or stored EMBRYO shall be held by CRYOS as custodian on behalf of the CUSTOMER. The CUSTOMER accepts that the reserved DONOR SPERM or stored EMBRYO remain physically stored at CRYOS' premises solely for storage purposes and at the CUSTOMER's request. Risk shall pass to the CUSTOMER at the time of such allocation, except to the extent that any loss is caused by CRYOS' negligence, wilful misconduct or breach of its storage obligations.
20. Delay
If the TISSUES AND CELLS are not delivered on time and if the delay is due to circumstances for which the CUSTOMER bears the risk, CRYOS disclaims all responsibility in this connection, and the CUSTOMER loses the right to claim damages for delay. If the delivery of TISSUES AND CELLS is delayed due to circumstances for which CRYOS is responsible, CRYOS agrees to cancel the order in case of DONOR SPERM orders. Other orders cannot be cancelled. If the CUSTOMER wishes to cancel the order for that reason, the CUSTOMER has an obligation, if possible, to return the DONOR SPERM immediately so that it is received frozen by CRYOS no later than 7 days for small nitrogen tanks and no later than 12 days for large nitrogen tanks after the DONOR SPERM was shipped from CRYOS. If the delayed delivery is a CO2 shipment, the CUSTOMER has an obligation to contact CRYOS immediately in order to make further agreement on the return of the CO2 shipment to CRYOS, if possible.
All shipments of TISSUES AND CELLS are sealed before they leave CRYOS. If the CUSTOMER has broken the inner seal, the CUSTOMER cannot make use of the right of cancellation. The CUSTOMER has been informed that TISSUES AND CELLS must be returned unthawed and undamaged, and, for safety reasons, the TISSUES AND CELLS cannot be returned if the inner seal has been broken.
21. Nitrogen tanks/shipping boxes
The CUSTOMER must return any nitrogen tank and its shipping box without undue delay. The nitrogen tank and its shipping box must be returned within 7 days (small tank) or 12 days (large tank) after shipping date from CRYOS. If the tank and its shipping box have not been returned within the specified time, CRYOS is entitled to demand a weekly rent (at present EUR 100 per commenced week) from the CUSTOMER.
Nitrogen tanks/shipping boxes shall remain the property of CRYOS.
CRYOS is entitled to claim the full value from the CUSTOMER for a new tank and its shipping box if it is damaged or lost between delivery and pick up for return.
CRYOS is entitled to consolidate shipments in case more orders from different patients is to be shipped to the CUSTOMER.
The CUSTOMER knows frozen TISSUES AND CELLS are fragile products and thus it is strongly emphasized that the durability of the frozen TISSUES AND CELLS is dependent on the storage facility and that it may be damaged if not used immediately after thawing.
22. Faults and deficiencies
The CUSTOMER undertakes to handle the TISSUES AND CELLS strictly in accordance with CRYOS’ instructions on handling, packaging and safety, which are included in the shipping box or otherwise provided together with the order. CRYOS has validated these instructions according to applicable EU requirements in Annex II in the European Commission Directive 2006/86/EC.
Upon delivery the CUSTOMER must examine the TISSUES AND CELLS for non-conformity. Claims must be notified to CRYOS within a reasonable period after the fault or deficiency has been discovered by the CUSTOMER and no later than 7 days after delivery has taken place. Otherwise, the CUSTOMER loses the right to claim the fault or deficiency. Visible damage must be reported to the carrier and/or CRYOS immediately.
CRYOS is only responsible for damage to the TISSUES AND CELLS if the damage is due to faults, deficiencies or neglect caused by CRYOS. CUSTOMER must involve CRYOS in investigating a non-conformity prior to placing the responsibility.
The CUSTOMER is aware that DONOR SPERM is a biological material and accepts that the actual amount of progressive motile sperm cells can vary +/- 20 percent without being a fault or deficiency.
If the CUSTOMER has informed CRYOS, in writing and on time, of any existing faults or deficiencies for which CRYOS is responsible, CRYOS will replace the TISSUES AND CELLS. If CRYOS replaces it within reasonable time, the CUSTOMER cannot demand a reduction of the purchase price or cancel the AGREEMENT.
23. Other responsibilities
The CUSTOMER is obliged to transfer the content of this AGREEMENT to the PATIENT who is subsequently treated with the TISSUES AND CELLS or to anyone who subsequently purchases the DONOR SPERM from the CUSTOMER. If the transfer of this AGREEMENT has not taken place in such cases, the CUSTOMER holds CRYOS harmless for any liability or additional costs arising out of or in any way relating to this AGREEMENT as per the terms of Waiver of Claims and indemnification in this AGREEMENT.
CRYOS does not guarantee that treatment with the TISSUES AND CELLS will result in a pregnancy or that the pregnancy will result in the birth of a healthy and viable child or children.
Despite detailed security precautions there is always a minimal risk that TISSUES AND CELLS are mixed, mislabeled or contaminated. In such cases, and if it can be documented that it is the fault of CRYOS, CRYOS will refund the purchase costs of TISSUES AND CELLS.
Donors and DONOR GAMETES are tested for infectious diseases and recessive gene variants performed by external authorized laboratories. There may be a small residual risk of the donor having an infectious disease or being a carrier of a recessive genetic variant despite the testing, and CRYOS cannot guarantee for the accuracy of such tests. The CUSTOMER expressly acknowledges that irrespective of CRYOS’ examination and testing for an extensive number of conditions and diseases in both the donor and the DONOR GAMETES a risk remains of transmitting an infectious or hereditary disease, disorder, or birth defect by treatment with the DONOR GAMETES. DONOR GAMETES might also contain traces of antibiotic(s) and protein(s) from the culture and/or processing media, used for processing. Despite detailed security precautions there is always a minimal risk that DONOR GAMETES are mixed, mislabeled, or contaminated. CRYOS disclaims all responsibility for any damage, which may be the result of transmitted diseases or unwanted or unknown hereditary conditions contained in the TISSUES AND CELLS. To the extent permitted under applicable law CRYOS disclaims any liability for risks such as those described in this subsection. To the extent permitted by applicable law CRYOS disclaims liability for accidental loss of or damages to reserved DONOR GAMETES caused by CRYOS’ simple negligence.
CRYOS disclaims all responsibility for damage caused by frozen TISSUES AND CELLS, CO2, or LN2 such as leakage, spillage, loss, or damage caused by storage of LN2 under pressure.
CRYOS disclaims all responsibility for any other circumstances including, but not limited to, fertility treatment, unwanted pregnancy, multiple pregnancies, spontaneous abortion, extra uterine pregnancy, stillborn, expenses for medicine, transport and travel expenses, accommodation, loss of profit, sales or income, loss of time and clientele, or ensuing costs or other direct or indirect losses or expenses which may be the result of delays, fault or deficiencies whether CRYOS is responsible for this or not. This also includes circumstances caused by force majeure or other circumstances which are beyond
CRYOS’ influence such as strikes, lockouts, transport difficulties, detention, goods retained at customs, confiscation, epidemics and pandemics, war, martial conflicts or civil unrest, vandalism, terrorism, radioactivity or natural disasters.
CRYOS’ total aggregate liability arising out of or in connection with this AGREEMENT shall be limited to an amount equal to the total fees actually paid by the CUSTOMER to CRYOS in connection with the purchase giving rise to the claim.
CRYOS disclaims all liability for damage to real estate and personal and movable property of the CUSTOMER, unless such damage is caused by CRYOS’ gross negligence or willful misconduct.
24. Waiver of Claim and indemnification
The CUSTOMER expressly releases, indemnifies, defends and holds harmless CRYOS, its agents, employees, officers, directors, shareholders, representatives, independent contractors, customers, successors and affiliates to the fullest extent permitted by law from and against any claims, loss, damage, expenses, liabilities, demands, offsets, causes of action and attorney’s fees arising out of or in any way relating to this AGREEMENT, including, but not limited to the collection, freezing, sale, purchase, storage, shipping, release, loss, damage or destruction of the TISSUES AND CELLS.
25. Disputes
Any dispute between the PARTIES, which may originate from this AGREEMENT, must be sought resolved by means of negotiation in which the PARTIES are obligated to try to find an amicable solution.
If the PARTIES cannot reach an agreement through negotiation no later than 6 weeks after commencement of the negotiations, each of the PARTIES is entitled to hand over the case for the decision of the ordinary courts.
It has been agreed between the PARTIES that the case will be decided according to Danish law although international choice of law rules may give rise to another choice of law. It has also been agreed between the PARTIES that the language will be Danish, and the District Court of Aarhus will decide this matter.
26. Governing Version of the Agreement
If, after entering into this AGREEMENT, the CUSTOMER accepts a new version of the SLA, whether through the online ordering process or by any other means, the new version shall replace and supersede all previously accepted or signed versions with effect from the time of acceptance. The most recently accepted version shall thereafter govern the relationship between the PARTIES.
Updated October 1st 2026