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Terms and conditions for PROFESSIONAL CUSTOMERS

1. General definitions and pre-requisites of the agreement

The following terms and conditions apply to

SellmerDiers Sædbank ApS
Store Torv 8, 4. sal
8000 Aarhus C
Legal reg. number: 38339087
Tissue Establishment name: SellmerDiers Sædbank Aarhus
Tissue Establishment number (DKMA-no): 261306
(hereafter referred to as the sperm bank)

and

The Customer
(hereafter referred to as the customer)

with regards to the customer’s purchase or use of donor sperm, access to donor-profile materials and purchase of handling, processing, and storage service at the sperm bank.

These terms and conditions apply to all agreements between the customer and sperm bank regardless of whether the agreement was entered in writing, by order on the sperm bank’s website, spoken agreement, or otherwise. By purchasing donor sperm or other services, the customer legally agrees to the terms and conditions.

The customer is defined as any who enters into an agreement by placing an order with the sperm bank, either with intent to purchase donor sperm, for access to donor profile materials, processing, storage, transport, or other handling of donor sperm.

The final recipient is defined as the woman who is undergoing fertility treatment with the donor sperm.

If the customer is not the final recipient, the customer is obligated to ensure that the final recipient is fully aware of the terms and conditions applicable to the donor sperm and has accepted these terms and conditions to fertility treatment with the donor sperm. If the customer fails to adhere to this requirement of conveying and ensuring that the final recipient has accepted the terms and conditions, the customer forfeits any right to hold the sperm bank liable to claims for additional costs or compensation, including any claims from the sperm donor which may arise from, or in any way be related to, this agreement.

The customer declares that the donor sperm purchased from the sperm bank will not be sold, redistributed, given away or otherwise handed over to other parties. Similarly, Pregnancy Slots and/or Rights of use (see section 7.4) purchased from the sperm bank must not be sold, redistributed, given away or otherwise handed over to other parties. All distributions of the donor sperm must be made through the sperm bank.

The customer is liable for any and all claims or liabilities that should arise through breach of contract by selling, redistributing, or otherwise entrusting the donor sperm, Pregnancy Slot and/or Right of use to others.

2. Terms of prices, order, payment, withdrawal, etc.

2.1 Prices

The current prices for the sperm bank’s products and services can be found on the sperm bank’s website. Written quotations from the sperm bank are valid for 30 days from the date of the offer.

2.2 Ordering and user account

Ordering of the sperm bank’s products and services is done via the sperm bank’s website, where the customer must create a user with a username and password in order to place an order.

The username and password to the customer’s account are private and may only be used by the user. The user is required to keep the username and password confidential. The customer accepts liability for all orders made using the user account and indemnifies the sperm bank for any claim or loss arising from orders made with the user account by others that have been improperly disclosed the username and password.

The customer is required to provide accurate information when setting up the user account, and to keep the user information, especially all contact details, up to date continually.

Once the customer has made an online order through the user account and has confirmed to have read and accepted the terms and conditions, the sperm bank will send an order confirmation and the terms and conditions to the customer’s email.

2.3 Payment

The following payment terms apply: Prepayment using the payment service on the website.

Payment with credit card: The payment will be withdrawn, when the delivery is shipped.

Payment with bank transfer: The customer must send a proof of the bank transfer before the delivery is shipped.

2.4 Cancellation policy

The customer can cancel orders of donor sperm until the time when the donor sperm is dispatched from the sperm bank against a 75% refund of the purchase price. After dispatch of donor sperm from the sperm bank, cancellation of the order is not possible. See also section 4.2 with regards to the buyback policy for donor sperm stored in the sperm bank storage.

When ordering storage services, the customer has a cancellation deadline of 14 days from the date of booking for a 75% refund of the price.

3. Terms of delivery, deficiencies and dry shippers

3.1 Ownership

Delivered donor sperm remains the property of the sperm bank until the sperm bank has received full payment from the customer for the total price of the donor sperm, including payment for transport and delivery.

The dry shippers and associated boxes are the property of the sperm bank and must be returned to the sperm bank. Further conditions regarding dry shippers are designated under section 3.7.

3.2 Delivery

Unless otherwise agreed, the sperm bank will dispatch (i.e. transfer to a shipping company) ordered donor sperm on the date chosen by the customer when placing the order.

The sperm bank may store ordered donor sperm for up to 30 days from the order date at no additional cost. After 30 days from the order date, the donor sperm passes to storage services (see further details in section 4) and will be payable according to the current storage prices. Current storage prices can be viewed in the price list on the sperm bank’s website. Payment for storage is not refundable.

The sperm bank is responsible for the donor sperm quality until it reaches the delivery address designated by the customer. See further details in section 3.5.

The donor sperm will be delivered between 8 AM and 5 PM on the agreed date of delivery.

The customer or a representative designated by the customer must be present at the delivery address to receive and sign for the delivery. If the customer or customer representative is not present at the delivery address to receive the delivery, the sperm bank does not guarantee that the donor sperm does not thaw because of delivery delay, and the sperm bank will not replace the sperm units free of charge if this should happen.

The customer or a representative designated by the customer must investigate whether the delivered donor sperm meets the promised quality, and whether the dry shipper is unopened and intact. The customer or customer representative must provide a documented check that the shipment, including transport conditions, packaging, labelling, documentation and associated samples comply with Directive 2004/23/EF of European Parliament and of the Council of March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (tissue directive).

3.3 Handling of donor sperm

The customer is advised that donor sperm is a fragile product. For this reason, it must be strongly emphasized that the shelf life of the frozen donor sperm is dependent on the storage facilities. The donor sperm can be destroyed and unsuitable for use if the instructions for its use are not followed closely, including if it is not used immediately after thawing.

3.4 Packing list

Every shipment from the sperm bank contains a shipping list with the following information/attachments:

· Order review

· Description of the product, including information on the motility of the donor sperm

· Instructions and restrictions for use of the product

· Guidance on reporting pregnancy and suspected serious adverse events that may relate to the quality or safety of donor sperm

· Safety instructions regarding handling and risks associated with shipping with liquid nitrogen (LN2) or dry ice

· Donor characteristics, attestation of test results according to applicable tissue legislation

· Single European Code(s) (SEC)

· Instructions for returning the dry shipper.

3.5 Delays

If the donor sperm is not delivered in a timely manner, and only if the donor sperm due to the delay does not meet the quality requirements, the sperm bank will free of charge send a new delivery of the ordered donor sperm, or from a similar donor in the event of donor sperm from the selected donor being sold out, provided the delay is due to circumstances borne by the sperm bank, including the shipping company’s delay. A condition for this is that the donor sperm has not been used for treatment, and that the delayed donor sperm is returned to the sperm bank in the dry shipper. Section 3.6 further details claims in cases of issues or defects. The sperm bank disclaims any liability for direct or indirect loss related to the delay, and the customer accepts that no claim can be made on this basis.

3.6 Deficiencies

Upon receiving the shipment from the shipping company, the customer or a representative designated by the customer is responsible for ensuring that a documented investigation into the status of the dry shipper and associated box is carried out immediately, ensuring that they are unbroken and intact, checking for defects, issues, missing items and additionally ensuring that the donor sperm meets the quality requirements. If this is not the case, the customer is required to immediately make a claim to the sperm bank.

If the dry shipper or the donor sperm has deficiencies that could not be found during delivery, the customer is required to make a written claim to the bank within 7 days of the deficiency being found, but no later than 14 days after receiving the shipment, otherwise the customer’s right to claim is forfeit.

The sperm bank is only responsible for any donor sperm deficiency or damage to the dry shipper/box if caused by maladministration attributable to the sperm bank or shipping company.

If the customer has made a written notification to the sperm bank of discovered deficiencies of the donor sperm, for which the sperm bank is responsible, the sperm bank will replace the donor sperm with equivalent sperm unit(s) from the same donor (or from a donor in the same donor category in the event of sperm from the selected donor being sold out). If the sperm bank exchanges the donor sperm within 14 days of the sperm bank being informed of the issue/defect, the customer is unable to direct further claims to the sperm bank, including demanding a deduction in price, terminating the contract or claiming compensation.

See further details in section 7.1 and 7.2.

3.7 Dry shippers and associated boxes

The dry shippers and their boxes are the property of the sperm bank. The customer is obligated to return the dry shippers and boxes without undue delay and in the same condition as they were delivered. Dry shippers must be returned within 7 or 14 days according to the chosen durability of the tank when placing the order. Instructions for return are included in the delivery with the packing list. If the dry shipper is not returned in a timely manner, the sperm bank is entitled to charging for the value of the dry shipper, or for rent of the dry shipper until returned.

The sperm bank is entitled to demanding compensation for the value of the dry shipper/box if these are damaged or lost during the time from delivery of the shipment at the customer until the shipping company picks it up for return shipment to the sperm bank.

If multiple customers are to have donor sperm delivered to the same address (e.g. to a fertility clinic), the sperm bank is entitled to consolidate shipments to multiple customers in the same shipping container. Such customers assume joint and several liability in being responsible for the return and value of a new dry shipper/box in case of damage or loss.

The sperm bank notes that liquid nitrogen (LN2) and dry ice can cause frostbite if not handled correctly. Before opening the dry shipper, the customer is obligated to read the enclosed safety instructions on handling and risks associated with liquid nitrogen (LN2) or dry ice enclosed. The sperm bank disclaims any responsibility for any damage caused by liquid nitrogen (LN2) or dry ice.

4. Terms and conditions regarding storage

4.1 Storage

The sperm bank offers to store donor sperm purchased by the customer in the sperm bank, in a storage under the customer’s name. The sperm is stored frozen under suitable conditions. The sperm is expected to be able to be kept fully alive and stored indefinitely in the frozen state.

Current prices are shown in the price list on the website. Payment for storage is not refundable.

Circumstances due to force majeure or similar occurring during the term of the agreement, such as strike, war, natural disasters, etc., which result in damage or loss of the sperm, will not be compensated.

If donor sperm in the storage is lost due to other circumstance for which the sperm bank is responsible, the sperm bank will replace the damaged/lost sperm units with an equivalent number of sperm units from the same donor or a donor in the same donor category, if donor sperm from the ordered donor is sold out. Other circumstance, for which the sperm bank is responsible, shall only be compensated by an amount corresponding to the price paid for the handling and testing of the sperm, as well as the storage costs for the remaining part of the contract period. Other possible direct or indirect losses are not compensated.

Should the sperm bank during the course of the agreement, for whatever reason, be unable to continue the storage service, the sperm bank is required to comply with applicable EU directives and the Danish Tissue Act (Vævslov) to ensure the storage will be taken over by another tissue establishment for continued storage service. The customer will be notified of this by email or letter sent to the last known address.

The customer may at any time cancel the storage service, and the storage is automatically considered to be cancelled when there no longer is any sperm stored in the storage. Prepaid storage fees are not refunded.

If the customer wishes to cancel the storage service, the sperm bank must be notified in writing. The customer must at the same time notify the sperm bank whether any sperm units stored in the storage are to be transferred (distributed) to another tissue establishment’s care and responsibility at the customer’s expense, or to be discarded. Any transfer (distribution) must be made by the sperm bank by a shipping company chosen by the sperm bank.

The customer is responsible for notifying the sperm bank prior to the expiry of the prepaid storage period. The sperm bank will not consider the storage permanently expired without previously having tried to notify the customer by email to the last known email address. If the customer does not respond within 1 month of the email being dispatched, the sperm bank will consider the storage permanently expired.

Unless other written agreements between the customer and sperm bank are made, the storage service shall automatically expire in the event of the customer’s death or terminating of business.

At the expiration of the storage service for whatever reason, the donor sperm in the storage are surrendered to be the sperm bank’s property unless other written agreements are made between the customer and the sperm bank.

The customer is required to keep the contact details in the user account up to date on a regular basis. The sperm bank is not responsible if the customer has failed to keep the sperm bank informed of change in address.

4.2 Buyback and exchange policy

The sperm bank offers to buy back donor sperm units that the customer has purchased from the sperm bank and stored in the sperm bank’s storage at 75% of the purchase price. This offer for buyback is valid for 24 months from the date of purchase. The buyback offer also applies to donor sperm units in storage sperm from quarantined and permanently blocked donors and from donors that have reached the nationally defined limits for number of children/families per donor, or the sperm bank’s established quota limit (see section 5.3 and 7.4). The offer is conditional upon the donor sperm units having never left the sperm bank.

Prepaid storage fees are not refundable.

The sperm bank offers to exchange donor sperm units stored in the sperm bank’s storage from quarantined and permanently blocked donors and from donors that have reached the nationally defined limits for number of children/families per do-nor, or the sperm bank’s established quota limit. In these cases, exchange to donor sperm units of the same sperm type (IUI to IUI and ICI to ICI) from another donor in the same donor category is free of charge. Should the customer wish to exchange to another donor category or type, the sperm bank will not refund any possible price difference in the customer’s favor. If there is a price difference in the sperm bank’s favor, the customer will be charged this difference.
For all other exchanges of donor sperm in the sperm bank’s storage the customer is referred to sell back the sperm units at 75% of the purchase price and then make a new purchase on the website.

The sperm bank offers to buy back Pregnancy Slots which have not resulted in a liveborn child at the full price paid for the Pregnancy Slot.

A purchased Right of use can, as a rule, not be sold back, unless the donor is permanently blocked.

The sperm bank reserves the right to change the terms and conditions of the buy-back and exchange policy without notice. Refer to the current terms and conditions on the website.

5. The customer’s obligations after fertility treatment

5.1 Report pregnancy to the sperm bank
The customer is obligated to ensure that the final recipients who have undergone fertility treatment with the donor sperm notify the customer within 14 days of a viable pregnancy being detected. After this, the customer is required to immediately report the pregnancy to the sperm bank. This is in order for the sperm bank to ensure that the nationally defined quota for pregnancies/children per donor and the sperm bank’s internal guidelines are not exceeded. See further in section 7.4

Furthermore, the customer is obligated to ensure that the final recipients notify the customer if the pregnancy is terminated (due to, for example, stillbirth, pregnancy outside the uterus, spontaneous or provoked abortion, etc.) within 14 days of a termination of pregnancy being detected. After this, the customer is required to immediately report the termination of pregnancy to the sperm bank.

A report must be sent using Pregnancy Report Form the sperm bank’s website, or by sending a mail to: salg@sellmerdiers.dk with the following information:

· Report of pregnancy/report of termination of pregnancy

· Customer’s name and order number

· Final recipient’s name and contact information (e-mail, telephone number) and country of residence

· Country of treatment

· Donor name and SEC code

· Any information regarding twin/triplets and sibling pregnancy (if the final recipient or one in the couple already has a child or more children with the same donor).

5.2 Pregnancy Slot and Right of use – a special obligation for the customer to report the result of each insemination to the sperm bank

In case of treatment with donor sperm with a Pregnancy Slot and/or Right of use, the customer has a special obligation to keep the sperm bank informed of any outcome of the treatment.

A report form must be sent using the Pregnancy Slot Report Form the sperm bank’s website, or by sending a mail to: salg@sellmerdiers.dk

The customer is obligated ensure that the following is reported to the sperm bank:

· Positive results of treatment should be reported to the sperm bank within 14 days of the pregnancy being detected

· Negative results of treatment should be reported to the sperm bank no later than 3 weeks after treatment

· If pregnancy has been terminated (due to, for example, stillbirth, pregnancy outside the uterus, spontaneous or provoked abortion, etc.), this should be reported within 14 days of a termination of pregnancy being detected

The customer gives the sperm bank the right to contact the customer or the final recipient directly to obtain information about the outcome of treatment if the information is not received from the customer.

5.3 The sperm bank’s procedures when a sperm donor has reached a quota limit

When a sperm donor has reached the quota limit according to the national regulations and/or the sperm bank’s internally established quota, the donor sperm from this sperm donor may not be used. This also applies to customer purchased donor sperm units stored in the sperm bank storage. See further about the quota limit in section 7.4. The donor sperm may eventually – and only if in accordance with applicable national rules in the country in question – be used for siblings from the same donor, if the final recipient or her partner has a donor child from the donor already.

The customer is obligated to ensure that no treatment is performed with donor sperm from a donor that has reached the quota limit by checking the list published on the sperm bank’s website under “Restricted and limited donors”.

The customer is advised that the quota information on the website is purely indicative. The sperm bank disclaims any responsibility for failures to report pregnancies, double reporting of pregnancies, or if pregnancies in any other way have been reported in error. Likewise, the sperm bank disclaims any responsibility if a stipulated quota limit in the country in question must be calculated differently, or if the sperm bank does not know the calculation method of the country in question in relation to the quota limit.

The customer may, under specified conditions (see section 4.2), sell back purchased donor sperm units when the sperm donor has reached a quota limit, provided that the donor sperm units are in the sperm bank’s storage and has not left the sperm bank’s property. Units that have left the property of the sperm bank cannot be sold back, and the customer is obligated to discard them.

5.4 Adverse events – reporting and handling of cases where there is a suspicion of inheritance and infection risk

Despite extensive screening and testing of both donor and donor sperm, there will always be a risk that an infectious or hereditary disease could be transferred from the donor sperm to the final recipient or donor child. See further on screening and testing in section 7.1.

If the final recipient experiences a serious adverse reaction during fertility treatment, or later develops an illness which could be related to the quality or safety of the donor sperm, the customer must notify the sperm bank of this in writing as soon as possible. This also applies if the donor child, which has come from fertility treatment with donor sperm from the sperm bank, is born with, or develops a disease which may be related to the donor sperm, including hereditary or infectious diseases, syndromes, maladies, etc. This is necessary in order for the sperm bank to take appropriate action regarding the final recipient, the donor, other customers/recipients, authorities etc.

The final recipient is thus required to immediately notify the customer in the event of, for example, illness, developmental defects, or serious malformations in a donor child either during pregnancy, birth, or later during the child’s upbringing, and where this could be attributed to genetic conditions in either the recipient, the donor, them both, or in circumstances that may indicate that the donor sperm may have been contaminated with infection germs. The customer must inform the final recipient about the obligation to immediately notify the customer in such cases.

The customer must send a notification of suspected adverse events/reactions via the Adverse Reaction Form on the sperm bank’s website. The final recipient can also choose to fill in the Adverse Reaction Form herself and send it directly to the sperm bank.

When a comprehensively filled out report form has been received by the sperm bank, the sperm bank will immediately send a confirmation of the notification.

The sperm bank does not consider the adverse event/reaction to be reported prior to the confirmation being sent from the sperm bank.

The customer must inform the final recipient that she must cooperate with the sperm bank and provide all necessary information in order to make a diagnosis, and to investigate whether the adverse event originates from the sperm donor. The customer must make sure that the final recipient accepts that the sperm bank, The Danish Patient Safety Authority and customer may communicate directly and exchange information about the condition of the final recipient and donor child for the purpose of this investigation. The final recipient must agree to give the sperm bank access to relevant information from the medical records of the final recipient and donor child. The final recipient must also agree that she and donor child will provide necessary blood samples to make the diagnosis.

It is the responsibility of the customer to notify its patients of any adverse events and to refer them to genetic testing or medical consultation if relevant. The customer is obligated to inform the sperm bank of any relevant changes in the final recipient’s name and contact information, for the sperm bank to be able to communicate directly with a final recipient regarding a suspected serious adverse reaction/event.

5.5 Quarantine and permanent blocking in adverse event cases

If the sperm bank receives a notification of an adverse reaction/event, the donor sperm will, if deemed appropriate, be quarantined while an investigation into whether the origin of the adverse reaction/event stems from, or is related to, the donor sperm, is carried out. During quarantine, the donor sperm must not be used – not for siblings either. If the donor is quarantined, the sperm bank is obligated to cancel or postpone confirmed orders of donor sperm from this donor.

When the investigation is completed, the donor sperm will either be permanently blocked or released from quarantine.

If a donor is permanently blocked, the donor sperm may not be used. However, for use in Denmark, the donor sperm can under certain conditions be used for siblings from the same donor, if the final recipient has a donor child with the donor already. The customer must send a written consent from the final recipient with her acceptance of the risks and potential consequences of using the specific donor.

Outside of Denmark, further restrictions may apply to use of a permanently blocked donor sperm for siblings. The sperm bank requires a written statement from the customer to ensure that fertility treatment with donor sperm from the permanently blocked donor may take place in accordance with the national jurisdictions in the field.

When a donor is put into quarantine, the sperm bank will dispatch a notification by email to all relevant accepted and/or delivered orders of donor sperm from the donor concerned. In addition, the sperm bank will dispatch a further notification by email of the suspension of the quarantine, or permanent blocking of use, when the investigation has concluded. If the sperm donor is put under permanent blocking, the notification contains further information from the sperm bank regarding the terms on possible use of the donor sperm for siblings and informed consent.

Customers who have sperm units from a sperm donor under quarantine in storage in the sperm bank, will be advised of this in the event where the customer requests shipment of sperm units from the donor during a period in which the donor is under quarantine. Customers with sperm units in storage from a sperm donor subject to permanent blocking shall be notified of this when the investigation is completed.

The customer is obligated to ensure that the final recipient receives relevant notifications from the sperm bank of quarantine, release from quarantine, and permanent blocking.

The sperm bank will dispatch the notice regarding quarantine, release from quarantine, and permanent blocking to the email address of the customer.

Notifications regarding a permanent blocked sperm donor will also be sent directly to the final recipients’ email addresses (as far as the sperm bank is informed of their email addresses).

The customer agrees that the sperm bank may send notifications to all email addresses that the customer has disclosed to the sperm bank when placing the order, including contact details of the customer from customer’s user account in the sperm bank and to email addresses disclosed to the sperm bank at the time of information of an adverse event/reaction. The customer agrees to keep the sperm bank informed of any changes in relevant contact information.

The sperm bank also publishes a list of all sperm donors currently under quarantine or subject to permanent blocking on the sperm bank website, under ”Restricted and Limited Donors”. Prior to every fertility treatment or self-treatment with the donor sperm, the customer is required to ensure that treatment in breach of these terms is not carried out with donor sperm placed under quarantine, or permanent blocking, by examining the list on the sperm bank’s website.

The sperm bank offers to exchange units of donor sperm stored in the sperm bank storage, if the donor is put under either quarantine or permanent blocking in accordance with the conditions specified in section 4.2.

The sperm bank offers to exchange units of donor sperm that have been delivered to the customer or left the property of the bank, if the donor is put under either quarantine or permanent blocking, to donor sperm units of the same sperm type (IUI to IUI and ICI to ICI) from another donor in the same donor category. It is a prerequisite for exchange that the donor sperm units have been stored properly in accordance with applicable procedures, either in a continuously cold dry shipper (it is noted in the packing list provided how long the dry shipper can remain cold), or stored at an authorized tissue establishment with authorized storage procedures for sperm.

6. Donor categories

It is possible to choose donors in the following 3 donor categories from the sperm bank: ”No ID-release” donor (without a profile), ”ID-release, donor’s decision in 18 years” (with a profile) or ”ID-release” donor (with a profile). The following terms apply to the respective donor categories.

The customer is responsible for verifying that the customer under applicable national laws is permitted to obtain and use donor sperm of the ordered category.

6.1 No ID-release (without a profile)

The final recipient will be able to get the following basic information about the donor: Race, ethnicity, eye colour, hair colour, height, weight, blood type and occupation/education. It is not possible to get a donor profile in this category, but a brief description of our employees’ impression of the donor and a look-alike image of a known person with similar looks are available. For some of the “No ID-release donors” a childhood photo will be available (only donors that have specifically consented to the release of a childhood photo).

By choosing a donor without ID-release, final recipient must accept that the donor shall remain anonymous and that it for this reason will not be possible to obtain information about the donor’s identity at any time. There must be no attempt at any time to locate or seek the donor, donor’s children or other family. If the final recipient should initiate or assist in tracing the donor, donor’s children or other family despite the mandatory terms in the contract, the customer is required to indemnify the sperm bank and the donor for any claim raised against the sperm bank or donor due to this, whether the trace is successful or not.

6.2 ID-release, donor’s decision in 18 years (with a profile)

The customer/final recipient will receive a donor profile consisting of 8-15 pages of personal information about the donor in addition to the basic information. The information includes the donor’s background, education, family relations, interests, hobbies, personality, detailed information about appearance, facial features and body build, staff assessment, photos of the donor during childhood and a handwritten greeting, etc.

By choosing a donor in the donor category ”ID-release, donor’s decision in 18 years”, the donor does not have to decide whether his identity is going to be released until a donor child upon reaching 18 years of age contacts the sperm bank wishing to contact the donor. The donor has agreed that the sperm bank (or a professional third party which has been given the assignment by the sperm bank) may contact the donor to inquire whether his identity may be disclosed to a donor child that has reached 18 years of age and contacted the sperm bank to request contact with the donor.

Documentation proving that the child is a result of donor sperm from the donor concerned is required. The sperm bank may demand a DNA-test to clarify this. It is also required that the pregnancy regarding the donor child in question was reported to the sperm bank as described in section 5.1.

Only if the donor unconditionally indicates to the sperm bank that they agree, will the sperm bank assist in establishing/communicating contact between the donor child and donor. An example of this could be the sperm bank releasing the donor’s identity in the form of name, date of birth, and last known address to the donor child, after which the donor child initiates contact. If the donor wishes, the contact can also remain anonymous.

If the donor does not wish the child to know his identity or have any anonymous contact with the child, the donor will remain unknown to the child. The donor identity is not disclosed if the donor has passed away, and therefore has no option to decide whether to disclose his identity if a donor child upon reaching the age of 18 inquires at the sperm bank wishing for contact.

If the donor does not wish the donor child to know his identity, or if the donor has passed away, the donor’s anonymity must be respected, and the same terms and conditions as noted under the section “No ID-release” (without profile) apply.

The child’s parents cannot at any time obtain identifying information about the donor from the sperm bank.

To cover the costs of contacting the donor and possibly establish contact between the donor child and donor, including possible facilitation of anonymous contact and determining whether the donor child is a result of treatment with donor sperm from the donor (possible DNA-test), an administrative fee must be paid when the donor child inquires after reaching 18 years of age.

As the sperm bank is only obliged to keep information about the donor for 30 years, the sperm bank does not guarantee that the sperm bank can assist in establishing contact between the donor child and the donor later than 30 years after the pregnancy with the donor child in question has been reported to the sperm bank.

6.3 ID-release (with a profile)

The customer/final recipient will receive a donor profile consisting of 8-15 pages of personal information about the donor in addition to the basic information. The information includes the donor’s background, education, family relations, interests, hobbies, personality, detailed information about appearance, facial features and body build, staff assessment, photos of the donor during childhood, and a handwritten greeting, etc.

By choosing an ID-release-donor, the sperm bank (or a professional third party which has been given the assignment by the sperm bank) will, when the donor child reaches the age of 18, and only upon the donor child’s request, assist in establishing/communicating contact between the donor child and the donor. An example of this could be releasing the donor’s identity in the form of name, date of birth, and last known address to the donor child, after which the donor child initiates contact.

Documentation proving that the child is a result of treatment with donor sperm from the donor concerned is required. The sperm bank may demand a DNA-test to clarify this. It is also required that the pregnancy regarding the donor child in question was reported to the sperm bank as described in section 5.1.

Although the donor has committed to a personal meeting with the donor child for approximately 1 hour in duration, the sperm bank cannot guarantee or be held responsible for whether the donor will consent to any meetings or other means of contact with the donor child after the child has reached the age of 18. In addition, the sperm bank cannot be held responsible if it is not possible to locate the donor despite releasing the name, date of birth and last known address.

In the event of the donor’s passing, and the sperm bank being aware of this, the donor’s identity will not be released to the donor child. If the donor has passed away, the anonymity of the donor must be respected, and the same terms and conditions as noted under the section “No ID-release” (without a profile) apply.

The child’s parents cannot at any time obtain identifying information about the donor from the sperm bank.

To cover the costs of contacting the donor, and possibly establish contact between the donor child and donor and determining whether the donor child is a result of donor sperm from the donor (possible DNA-test), an administrative fee must be paid when the donor child inquires after reaching 18 years of age.

As the sperm bank is only obliged to keep information about the donor for 30 years, the sperm bank does not guarantee that the sperm bank can assist in establishing contact between the donor child and the donor later than 30 years after the pregnancy with the donor child in question has been reported to the sperm bank.

7. Donors and donor sperm

7.1 Approval and screening of donors

The sperm bank selects and screens the donors in accordance with applicable quality and safety standards, as stipulated in applicable EU directives regarding human tissue and cells, and as implemented in the Danish Tissue Act (Vævslov). The purpose is to exclude donor applicants with disease germs, infectious diseases, genetic diseases, etc., which could pose a risk of illness to the customer or donor child.

Donor applicants are subject to a comprehensive approval process following applicable regulations, Danish Patient Safety Authority/Health Authority recommendations, and the Sperm Bank’s internal standards. The selection criteria include donor age, assessment of risk behavior, donor interviews, questionnaire responses, review of the medical history of the donor and donor’s family, a physical examination performed by a medical practitioner and – if required – assessment by the sperm bank’s specialist doctor in genetic. The screening process includes sperm, blood, and urinalysis for the testing of sperm quality and for a wide range of infectious and genetic diseases which are listed on the sperm bank’s website. In addition, donors are evaluated, physical examined and tested for infectious diseases on an ongoing basis throughout the donor period.

Donor sperm may be released either by a Nucleic Acid Test (NAT) or following a minimum of six months (180 days) of quarantine and a negative re-test for infectious diseases.

The customer must not carry out its own testing or genetic marker analysis of donor sperm from the sperm bank without the sperm bank’s prior written consent.

The customer/final recipient accepts, that in spite of the sperm bank’s compliance with all regulations concerning investigations, screenings and tests for a large number of infectious and hereditary diseases and conditions in the donor and donor sperm, there will always be a risk of an infectious or hereditary disease being transferred from the donor sperm to the final recipient or donor child. This is a basic condition with biological material, which sperm is.

Despite careful investigations into genetic diseases, a certain risk of diseases stemming from the sperm donor’s genetic conditions. All people have, to a greater or lesser extent, disease genes that alone or in combination with another’s genes can cause a genetic disease in a child.

The sperm bank makes no guarantees and disclaims every responsibility in regard to transmitting of infectious or hereditary diseases. If it should emerge and be documented that an infectious or hereditary disease has been transmitted through the donor sperm to the final recipient or the child, the sperm bank will only refund the customer what corresponds to the direct cost of purchase of the donor sperm.

7.2 Preparation and quality of the donor sperm

The sperm bank prepares and handles the donor sperm in accordance with the recommendations of the Danish Patient Safety Authority/Health Authority on standards for hygiene, safety and labelling aimed at minimizing risk for any contamination, labelling errors or exchanging of donor sperm.

Despite the above measures, there will always be a minimal risk of contamination, labelling errors, or exchanging of the donor sperm. The sperm bank makes no warranties and disclaims any liability in this regard. If it should emerge and be documented that the donor sperm has been contaminated, mislabeled, or exchanged through an error by the sperm bank, the sperm bank will only refund the customer/final recipient what corresponds to the direct cost of purchase of the donor sperm.

The sperm bank assesses the sperm cells in accordance with the sperm bank’s standards for sperm quality/progressive motility. The quality of the IUI units is at either minimum MOT 20 million/ml. or minimum MOT 10 million/ml. IUI units contains 0,5 ml. As regards the quality of the ICI units, the sperm bank guarantees minimum MOT 20 million and minimum 1 ml. seminal fluid.
Counting of sperm cells may vary due to human or technical factors (such as thawing temperature, laboratory tools used and the individual count performed by the laboratory worker). If the customer wants to complain about the quality/motility, this requires that the unit has not been used for fertility treatment and that the procedure for handling the donor sperm described in the package list has been followed. A counting chart from the sperm bank must be obtained, completed and returned.

7.3 Information about the donor in the donor profile

The information provided by the donor profile is derived from the sperm bank’s employee observations and measurements (appearance) and impression of the donor, as well as from the donor’s own information. Photos of the donor as a child are also provided by the donor. The sperm bank is convinced that this information is correct, but cannot guarantee this and disclaims any responsibility for erroneous information about the donor in the donor profile.

7.4 Quotas – number of donor children per donor

The customer is informed of the rules in Danish legislation limiting the number of viable pregnancies of Danish recipients treated in Denmark with donor sperm from the same donor. This means that sperm from the same donor can only be used to create a maximum of 12 donor children in Denmark. However, more than 12 children can be created with the intent of additional siblings from the same donor, if the final recipient or her partner has a child from the donor already. Furthermore, frozen embryos fertilized with sperm from a donor who has later reached 12 pregnancies can still be used.

A sperm donor will be quarantined if reaching 6 viable pregnancies of Danish recipients treated in Denmark within the first year of distribution of sperm from the donor for treatment in Denmark. The quarantine will apply to donor sperm for treatment of Danish recipients in Denmark. The customer can choose to either wait until the donor sperm is released from quarantine or exchange the donor sperm if stored in the sperm bank’s storage (see section 4.2).

Countries of outside of Denmark may also have rules that limit the number of viable pregnancies from the same donor. The sperm bank complies with any nationally established pregnancy limits that the sperm bank is aware of.

The customer is informed that due to the limitations of quotas in some countries, donor sperm from a specific donor will only be sold in combination with pregnancy a slot. A Pregnancy Slot implies – depending on specific national legislation – that the recipient has the right to conceive – either as many children (a family) with a donor as the recipient may want, or one child only.

The customer is informed that the sperm bank has adopted internal guidelines limiting the amount of viable pregnancies worldwide with sperm from the same donor in the categories “ID-release” and “ID-release, donor’s decision in 18 years”. This means that sperm from the same donor in these two categories of donors can be used to create 25 children. However, more than 25 children can be created for twin pregnancies, and if the donor sperm is used with the intent of additional siblings from the same donor, if the final recipient or her partner has a child from the donor already. Furthermore, frozen embryos fertilized with sperm from a donor who has later reached 25 pregnancies can still be used. The sperm bank reclaims all responsibility for exceedance of the pregnancy limit in other cases, for instance if pregnancies are reported after the limit of 25 children has been reached, or if a customer/clinic has not complied with her/its obligations to ensure compliance with pregnancy limits.

For donors in the category “ID release” and “ID release, donor’s decision in 18 years”, the customer can purchase the right to one of the maximum 25 viable pregnancies worldwide (Right of use of a specific donor). The Right of use may be relevant to purchase if the customer wants to ensure that the donor does not reach the pregnancy limit of 25 children until the customer has succeeded in obtaining pregnancy. The price of the Right of use is shown in the current price list on the sperm bank’s website. The sperm bank reserves the right to impose restrictions on the number of Rights of use per donor. A purchased Right of use can, as a rule, not be sold back, unless the donor is permanently blocked.

The customer must stay informed of the quota limit on the sperm bank’s website under “Restricted and Limited Donors”. Here a full list is published detailing all sperm donors that have reached their maximum quota in accordance with national rules and/or the sperm bank’s internally established quota.

Procedures when a donor has reached a quota limit are further described in section 5.3.

7.5 Compensation of donors, etc.

Donors have agreed that the primary purpose of the donation is to help the childless fulfil their desire to have a child.

The donors have accepted in writing that the donor sperm may be distributed to the customers of the sperm bank for the purpose of fertility treatment of women to whom the identity of the donor is unknown and of whom the donor does not know the identity.

The donor receives a compensation of 300 Danish Kroner per donation (subject to adjustments over time) to cover expenses for attendance, loss of earnings, transportation etc.

The sperm bank declares that the price of donor sperm is determined based upon the work, processing, knowledge associated with preparing the sperm for use in sperm donation including, for example, selection, screening, ongoing testing of donors, receipt and handling of donor sperm donations, laboratory handling, freezing and storage of the sperm, preparation of documents, donor profiles, marketing and administration, etc. Thus, there is no sale of germ cells as such, but rather sale of the above-mentioned work.

7.6 Donor’s legal status

The donor has waived all rights to paternity of a donor child. This has been a basic prerequisite for the donor’s donation of donor sperm, that he cannot be considered or judged to be a legal father of the donor children resulting from his sperm donation.

In fertility treatment with the donor sperm, the final recipient acknowledges and accepts that the donor cannot be considered a legal father to donor children resulting from his sperm donation. The final recipient fully waives all right of requirement regarding parenting/paternity and any rights that may arise from this when entering into fertility treatment with the donor sperm. In fertility treatment with the donor sperm, the final recipient acknowledges and accepts that the donor cannot be held bound or liable for any relationship arising from his sperm donation.

The sperm bank will set as a condition for “ID-release” of donor’s identity to the donor child after the donor child has reached the age of 18, that the donor child accepts in writing that the donor cannot be considered a legal father. This also applies to donor children from donors in the donor category “ID-release, donor’s decision in 18 years”.

If circumstances should change in the future making it unable to secure the sperm donor against being held as the legal father or other legal obligations, as assumed in connection with his donation, for example due to amended legislation or legal requirements, the sperm bank reserves the right to refuse disclosure of donor identity of donors in the donor category “ID-release” and “ID-release, donor’s decision in 18 years” to donor children wishing contact.

8. Parental declaration

Before carrying out any fertility treatment with the donor sperm, the final recipient must guarantee to assume parental responsibility in relation to the donor child/children resulting from treatment with donor sperm from the sperm bank, and to care for and treat the donor child/children as their own child/children.

9. Traceability

The customer undertakes to assist in ensuring full traceability from donor to recipient and vice versa with respect to donor sperm supplied by the sperm bank.

To ensure traceability, the sperm bank will keep donor records for at least 30 years after clinical use, in accordance with the Danish Tissue Act (Vævslov).

To ensure traceability, the customer must keep records with relevant documentation of the recipient’s fertility treatment with donor sperm from the sperm bank for at least 30 years.

In the event of termination of activities, the customer and the sperm bank are obliged to transfer records and other relevant documentation and stored donor sperm to another authorized tissue establishment.

10. Disclaimer

The sperm bank cannot guarantee that treatment with donor sperm will lead to pregnancy, or that any pregnancy will lead to a viable and healthy child. The sperm bank cannot be held responsible for a donor child’s appearance, intelligence, mental health and personality traits.

The customer/final recipient accepts that the sperm bank cannot be held liable for any possible complications associated with neither pregnancy, birth, nor maternity period. The sperm bank disclaims any responsibility for unwanted pregnancy, multiple pregnancy, spontaneous abortion, pregnancy outside the uterus, stillbirth, genetic, hereditary or infectious disease, etc.

The sperm bank/sperm bank employees cannot be held liable for outcome or consequence of fertility treatment, or for the child’s characteristics, physical or mental status, beyond what may be due to Danish law’s general rules regarding healthcare professional’s responsibility for errors and oversights.

The sperm bank disclaims any liability for damages or costs that may be of direct or indirect consequence of fertility treatment with the donor sperm. For example, the sperm bank does not cover medical expenses, travel expenses, accommodation, loss of income, and other consequential costs irrespective of whether there are errors or defects for which the sperm bank is responsible.

11. Processing of personal data

The customer must at any time contribute to ensuring that the level of data protection complies with the EU General Data Protection Regulation (GDPR).

According to this Agreement, the sperm bank may process and transfer personal data concerning donors to the customer, including donors’ medical history, test results and other sensitive data. The legal basis for the transfer to the clinic is the donor’s consent and/or Article 6(1)(b) and (c) and Article 9(2)(b), (f), (h) and (i) of the General Data Protection Regulation. In processing personal data concerning donors, the customer will be considered data controller as regards this data, and the customer is bound as such by the aforementioned rules (GDPR).

According to this Agreement, the customer may process and transfer personal data concerning final recipients to the sperm bank, including information about pregnancy and birth. The legal basis for the transfer to the sperm bank will generally be the final recipient’s consent and/or Article 6(1)(b) and (c) and Article 9(2)(b), (f), (h) and (i) of the General Data Protection Regulation. In processing personal data concerning final recipients, the sperm bank will be considered data controller as regards this data, and the sperm bank is bound as such by the aforementioned rules (GDPR).

The sperm bank’s privacy policy can be viewed on the sperm bank’s website and must be reviewed and accepted before placing an order on the sperm bank’s website.

12. Privacy, confidentiality and disclosure of donor information

The sperm bank declares that it would keep all information about the customer/final recipient and, if applicable, the resulting donor child strictly confidential. Information will only be disclosed to the extent that the sperm bank is required contractually or by law.

The customer/final recipient accepts and acknowledges that the sperm bank is required to ensure full anonymity of donors in a number of situations. Reference is made to, among others, terms and conditions described in section 6.

The customer/final recipient agrees not to – in breach of the terms of this contract – attempt to find the identity of the donor or to locate the donor or donor’s family, as this would be a violation of the donor’s privacy and harm the sperm bank’s business.

If the customer/final recipient nevertheless, and in breach of this contract, discloses information about the donor or attempts to trace the donor, it could result in legal action and lawsuits from the sperm bank and/or donor claiming compensation. The customer/final recipient undertakes to indemnify the sperm bank for any loss or claim directed at the sperm bank arising from the customer’s/final recipient’s unauthorized disclosure of donor information and attempts to trace the donor.

13. Applicable laws and jurisdiction

The customer accepts that any dispute arising from this contract or use of the donor sperm must be settled in accordance with Danish laws and legislation in Aarhus Courthouse. This applies to both disputes between the customer and the sperm bank, and disputes involving further parties, e.g. the final recipient, donor child and donor. The customer further accepts that the legal language is Danish, and that Danish law and Danish legal system must be used, regardless of international rules on applicable laws may lead to another result.

 

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