About these Terms

These general terms and conditions (the “Terms”) apply to all purchases of products and services provided by Cellaviva AB (company registration number 559482-0564) via www.cellaviva.se. By placing an order with Cellaviva, you confirm that you have read and accepted these Terms, which, together with the order confirmation, constitute the binding agreement.

Where these Terms distinguish between consumers and business customers, consumer legislation, such as the Swedish Distance Contracts Act and the Swedish Consumer Sales Act, applies only to private individuals purchasing for personal use. In all other cases, the Swedish Sale of Goods Act (1990:931) and other non-mandatory law shall apply.

If any provision of these Terms conflicts with mandatory consumer law, such law shall prevail. This applies only where the purchaser is a private individual and the purchase is for personal use.

Definitions

“Consumer” means a natural person who is acting primarily for purposes outside business activities. “Business customer” means a natural or legal person acting within the scope of business activities.

Summary of the Purchase Terms and Conditions

This summary provides an overview of Cellaviva’s general terms and conditions. In the event of any conflict, the full Terms shall always prevail in their entirety.

Scope of the offering

Cellaviva AB provides products and services within stem cell collection, analysis, long-term storage, genetic testing and related health services. By placing an order via www.cellaviva.se, you confirm that you have read and accepted these Purchase Terms and Conditions.

Who may place an order?

Orders may only be placed by persons who are at least 18 years old and have legal capacity. Business customers are also welcome, provided that correct company information is provided and that the person placing the order is authorised to do so.

What is covered?

These Terms apply to all Cellaviva products and services, from collection kits and genetic tests to stem cell storage and counselling.

Prices and payment

All prices are stated in Swedish kronor (SEK), including VAT. Payment is made by invoice with a payment term of 30 days, unless otherwise agreed. Additional fees may apply, for example for uncollected shipments.

Delivery

Delivery is made within Sweden, to other EU countries and internationally. The customer is responsible for ensuring that the order is placed in good time before delivery, birth or any other medically relevant time point.

Right of withdrawal for consumers

Consumers have a 14-day right of withdrawal under the Swedish Distance Contracts Act and other applicable mandatory consumer protection legislation. Exceptions apply to sealed medical devices where the seal has been broken, and to services that have commenced after the customer’s express consent. The right of withdrawal does not apply to business customers.

Complaints

Consumers have the right to complain about defects within three years under the Swedish Consumer Sales Act or the Swedish Consumer Services Act. For business customers, the Swedish Sale of Goods Act (1990:931) and any separately agreed terms shall apply.

Personal data

Cellaviva processes personal data in accordance with the General Data Protection Regulation (GDPR) in order to fulfil agreements and legal obligations. Further information is available in our Privacy Policy.

Dispute resolution

In the event of a dispute, Cellaviva follows decisions from the Swedish National Board for Consumer Disputes (ARN). Consumers may contact the relevant consumer dispute resolution authority in their country of residence. Consumers may also bring proceedings before a competent court in accordance with applicable mandatory consumer protection legislation. For business customers, any dispute shall be settled by a Swedish general court, with Södertörn District Court as the court of first instance, unless otherwise agreed.

Table of contents

1. Contact details
2. Conditions for purchase
3. Products and services
4. Prices, payment and fees
5. Orders and formation of contract
6. Delivery and logistics
7. Right of withdrawal under the Swedish Distance Contracts Act
8. Complaints and consumer rights
9. Limitation of liability and force majeure
10. Intellectual property rights, logos and trademarks
11. Codes of conduct
12. Medical devices and in vitro diagnostics (MDR/IVDR)
13. Processing of personal data
14. Term and termination of the agreement
15. Dispute resolution and applicable law
16. Severability of individual provisions

 

1. Contact details

1.1 Company information

Cellaviva AB (EU-id SE006320) is a Swedish tissue establishment authorised by the Swedish Health and Social Care Inspectorate (IVO). The biobank is registered with IVO under number 932. Cellaviva is a wholly owned subsidiary of the publicly listed biotechnology company NextCell Pharma AB (company registration number 556965-8361), which operates within regenerative medicine and cell therapy.

The business is conducted in accordance with applicable laws and regulations, including the EU Tissues and Cells Directive, the Swedish Biobanks Act and the General Data Protection Regulation (EU 2016/679, “GDPR”). Cellaviva also complies with regulations issued by the Swedish National Board of Health and Welfare and relevant ISO standards. Cellaviva operates in accordance with Swedish healthcare and biobank regulations, regardless of the customer’s country of residence.

Cellaviva AB
Company registration number: 559482-0564
Hälsovägen 7, lift D, floor 8
141 57 Huddinge
Telephone: +46 8 735 20 10, weekdays 9.00-16.00
Email: info@cellaviva.se
Website: www.cellaviva.se

1.2 Customer support

Cellaviva offers free customer support by email and telephone, including after delivery, to the extent required to assist the customer with use of the product or questions regarding the product’s function.

1.3 Communication costs

Cellaviva only uses communication channels that do not involve any additional charges beyond the standard rate, such as email and telephone. No additional cost is charged for the customer’s contact with Cellaviva.

2. Conditions for purchase

2.1 Age requirement and legal capacity

To purchase from Cellaviva, the customer must be an adult natural person, meaning that the customer must be at least 18 years old and have full legal capacity.

2.2 Business customers

Business customers are also welcome, provided that the order is placed in accordance with these Terms and that correct company information, such as company registration number and invoicing details, is provided at the time of order.

2.3 Customer’s responsibility for provided information

The customer is responsible for ensuring that all information provided at the time of order is correct and complete. Cellaviva is not responsible for any delivery problems or unavailability of a product or service caused by incorrect information provided by the customer.

2.4 Rejection of orders

Cellaviva reserves the right to reject orders that conflict with these Terms, or where there is suspicion of improper use, unlawful purposes or breach of medical or ethical practice.

2.5 Additional requirements for certain purchases

Certain products or services may require supplementary medical information or specific written consent. The customer will be informed of this before a binding agreement is entered into.

3. Products and services

These Terms apply to all products and services offered by Cellaviva AB. Below is an overview of the main categories:

3.1 Cellavivabox

A CE-marked medical device collection kit used to collect umbilical cord blood and/or tissue from the placenta and other birth tissue in connection with childbirth. The box contains, among other things, sterile equipment, transport material and instructions. It is a prerequisite for using Cellaviva’s services for stem cell collection, analysis and storage.

3.2 Stem cell collection

A service that includes logistics in connection with childbirth, including transport of collected material from the place of birth to Cellaviva’s laboratory for further handling.

3.3 Processing and analysis

Includes laboratory-based handling of the collected material, including processing, quality assessment of cells and documentation prior to possible storage or medical use.

3.4 Storage

Long-term storage of stem cells or other biological tissue in cryopreserved or other secure form. Storage takes place under controlled conditions at Cellaviva, in accordance with the Swedish Biobanks Act, the EU Tissues and Cells Directive and other applicable legislation.

3.5 Genetic tests

Analyses of genetic material that may indicate hereditary traits, health risks or be used as decision support in medical assessments. The tests are intended for consumer use and must only be used in accordance with the accompanying instructions.

3.6 Individual support

Additional services offered before, during and after pregnancy or in other life situations. These may include counselling, information or special package solutions.

3.7 Health services

Complementary products and services aimed at promoting wellbeing, such as dietary supplements, digital tools or personalised recommendations. These are not necessarily covered by healthcare legislation.

3.8 Information and responsibility

Cellaviva strives to provide clear and accurate information about all products and services. However, minor discrepancies may occur between the information on the website and the actual design or performance of the product or service. Product descriptions, images and instructions are primarily for guidance and shall not be regarded as guarantees regarding function, appearance or results.

3.9 Changes to the offering

Cellaviva reserves the right to adjust its offering due to technical development, regulatory requirements or other relevant circumstances.

3.10 Contract term

For subscriptions or services of an ongoing nature, the commitment period stated in the relevant service agreement shall apply. For one-off purchases, there is no commitment period beyond what is required to complete the purchase.

3.11 Warranties

Cellaviva provides no additional warranties beyond those set out in written agreements or mandatory law. Please note that products classified as medical devices or IVD products may only be used in accordance with the accompanying instructions, see further section 12.

4. Prices, payment and fees

4.1 Prices

All prices are stated in Swedish kronor (SEK), including applicable value added tax (VAT), unless otherwise stated. Current prices for each product or service are stated on www.cellaviva.se.

4.2 Payment methods

Available payment options and any restrictions are stated at the beginning of the order process on Cellaviva’s website.

4.3 Subscriptions and periodic invoicing

Services relating to recurring analyses, long-term storage or other ongoing services are invoiced periodically in accordance with the prices and payment intervals stated at the time of order and, where applicable, in a separate service or subscription agreement.

4.4 Additional fees

For uncollected packages, a fee of SEK 750 is charged for shipping, handling and return storage. The fee includes the cost of return transport, warehousing and administrative handling. An uncollected shipment shall not be considered an exercise of the right of withdrawal or a cancellation.

4.5 Personalised pricing

Cellaviva does not apply automated decision-making or personalised pricing.

4.6 Payment terms

Payment is made by invoice with a payment term of at least 30 days, unless otherwise stated. In the event of late payment, the following will be charged:

• Reminder fee of SEK 60
• Default interest in accordance with the Swedish Interest Act (1975:635)

Cellaviva reserves the right to carry out a customary credit assessment.

4.7 Reservations and corrections

Cellaviva reserves the right to make reservations for:

• Technical errors
• Typographical errors
• Price adjustments
• Stock discrepancies
• Circumstances beyond our control, such as exchange rate fluctuations or force majeure

The Terms and prices may be adjusted without prior notice, but changes do not affect agreements already entered into. In the event of an obviously incorrect price or term, Cellaviva reserves the right to correct the information or cancel the order, provided that the customer reasonably should have understood that an error existed.

5. Orders and formation of contract

5.1 Language of the agreement and applicable law

The agreement is entered into in Swedish or English, depending on the customer’s preference, and is governed by Swedish law. If the Terms have been presented in both Swedish and English, the Swedish version shall prevail in the event of any discrepancy between the language versions.

5.2 How orders are placed

Orders for Cellaviva’s products and services may be placed via:

• Website: www.cellaviva.se

5.3 Order confirmation and binding agreement

When the customer has placed an order, Cellaviva provides clear information in accordance with Chapter 2, Section 2 of the Swedish Distance Contracts Act before a binding agreement is entered into. The information is provided in a durable medium.

The information includes contact details, the main characteristics of the product or service, total price including taxes and fees, terms of payment, delivery, right of withdrawal and any exceptions to the right of withdrawal. A binding agreement shall be deemed to have arisen only when this information has been provided and Cellaviva has confirmed the order by email.

5.4 Rejection or adjustment of orders

Cellaviva reserves the right to reject or adjust an order in the event of:

• Products being sold out
• Incorrect price information
• Technical problems
• Other circumstances beyond Cellaviva’s control that make delivery impossible

If this occurs, Cellaviva will notify the customer without undue delay.

5.5 Special requirements for certain services

For certain services, such as stem cell collection, analysis, storage or genetic analyses, a separate agreement and/or consent form and, where applicable, medical information may be required in addition to these Purchase Terms and Conditions. These documents are provided by Cellaviva and signed digitally using BankID or another secure signing solution.

Orders for products, such as collection kits and genetic test kits, are binding in accordance with these Purchase Terms and Conditions and are invoiced in connection with the order.

For the parts of the service that require consent or additional documentation, the agreement relating to the relevant service shall be deemed to have been entered into only when all requested documents have been signed by the customer and confirmed by Cellaviva. The service cannot be performed before this has taken place. Absence of such consent does not affect the customer’s payment obligation for ordered products or other fees charged under these Terms.

5.6 Transfer of order

Orders for products and services under these Purchase Terms and Conditions may not be transferred to another natural or legal person without Cellaviva’s written approval.

An order may be placed by a person other than the person to whom the service relates. In such cases, the person placing the order is responsible for ensuring that correct information is provided and that the relevant person can be identified before the service is performed.

5.7 Cancellation

The customer may change or cancel their order free of charge, provided that the change or cancellation is made before the order has been packed or dispatched. To change or cancel an order, the customer must immediately contact Cellaviva’s customer support by telephone or email. After the product has been packed or dispatched, the ordinary terms for right of withdrawal and returns apply, see section 7.

6. Delivery and logistics

6.1 Delivery partners and transport selection

Cellaviva uses several logistics partners, such as DHL, Best Transport, PostNord and other courier and express providers, to ensure fast and secure delivery. The choice of carrier is made after individual assessment, based on the customer’s geographical location, stated estimated due date, the sensitivity of the product and the urgent nature of the delivery.

6.2 Collection kits and genetic tests

Collection kits are normally delivered to the stated address or collection point on weekdays. In special cases, the box may be handed over personally during evenings or weekends, or sent by express transport, by agreement and only in special cases where time-critical or medical reasons exist. Such measures constitute exceptions and are decided by Cellaviva on a case-by-case basis.

For genetic tests, the delivery method is adapted to the size of the shipment. If the contents fit in a letter, they are usually sent by PostNord. In other cases, trackable transport services from courier companies are used.

6.3 Delivery time and customer responsibility

To avoid collection material passing its expiry date, Cellaviva may provide recommendations regarding a suitable delivery time based on the estimated due date. The recommendations do not constitute medical advice and shall not replace dialogue with healthcare providers.

It is always the customer’s responsibility to ensure that delivery takes place in good time before childbirth. The customer may request earlier dispatch by contacting Cellaviva. If no such request is made, the customer shall be deemed to have accepted the proposed delivery time.

6.4 Normal delivery time within Sweden

The delivery time is normally up to five (5) working days from order. Unless otherwise specifically stated on the product page, shipping within Sweden is included in the stated price. For uncollected packages, a fee of SEK 750 is charged for shipping, handling and return storage.

6.5 Delivery to the EU and other countries

For deliveries within the EU outside Sweden, a fee of SEK 5,000 normally applies. Import requirements, local regulations and courier limitations may affect delivery availability. If actual costs exceed this amount, the customer will be contacted to approve any additional cost. The order is not binding until the customer has approved such additional cost.

For deliveries outside the EU, individual pricing applies. A quote will be provided upon request. The price depends on geographical location, selected services and logistical and medical conditions.

6.6 Delays and purchaser’s rights

If physical delivery is delayed without being due to the customer or force majeure, the customer has the right to:

• withhold payment,
• require delivery, or
• cancel the purchase if the purpose of the purchase would otherwise be lost.

The customer may cancel the purchase only if the purpose of the purchase would otherwise be lost and Cellaviva does not complete delivery within a reasonable time after written request.

In the event of approved cancellation, Cellaviva will refund the full amount paid by the customer for the relevant product.

6.7 Risk for the goods

The risk for the goods passes to you as customer when you have received the product. If you do not collect the package in time and it is destroyed or can no longer be used, you are responsible for it.

Once you have received the product, you are also responsible for following the instructions on how it must be stored and handled. Damage caused by incorrect handling will not be compensated by Cellaviva.

7. Right of withdrawal under the Swedish Distance Contracts Act (2005:59) for consumers

As a consumer, you have the right under the Swedish Act (2005:59) on Distance Contracts and Contracts Outside Business Premises and other applicable mandatory consumer protection legislation, to withdraw from your purchase within 14 days from the day you received the product. You do not need to provide any reason for exercising this right.

Orders placed in the capacity of a trader (business customers) are not covered by the rules on right of withdrawal under the Swedish Distance Contracts Act or other consumer protection legislation. For such purchases, the Swedish Sale of Goods Act (1990:931) and other non-mandatory Swedish legislation apply, unless otherwise specifically agreed between the parties.

Please note that Cellaviva does not offer open purchase or exchange rights beyond the statutory right of withdrawal.

7.1 How to withdraw from your purchase

To exercise your right of withdrawal, you must send a clear notice to info@cellaviva.se, or by post to the address stated in section 1.1, before the withdrawal period has expired. The withdrawal notice must have been received by Cellaviva no later than the final day of the withdrawal period in order to be valid, unless otherwise follows from mandatory law.

We confirm receipt of your notice within two (2) business days and provide instructions for any return.

To ensure correct handling, please state the order number in the notice.

7.2 Limited handling of product

You have the right to open the outer packaging and review the enclosed information to the extent necessary to determine whether you wish to keep the product. If the product has been handled to a greater extent than necessary to determine its nature, characteristics and function for such assessment, Cellaviva has the right to make a deduction for any reduction in value upon refund.

7.3 Exceptions to the right of withdrawal, sealed medical devices

The right of withdrawal does not apply to sealed medical devices if the seal has been broken. This exception follows from Chapter 2, Section 11, item 5 of the Swedish Distance Contracts Act, for health and hygiene reasons. Examples of such products are the Cellavivabox and collection kits for genetic tests.

Please note that if the seal has been broken, the right of withdrawal is deemed to have lapsed, regardless of whether the product has been used.

7.4 Exceptions to the right of withdrawal, services that have commenced

According to Chapter 2, Section 11, item 1 of the Swedish Distance Contracts Act, the right of withdrawal does not apply in the following case. If you have expressly consented to Cellaviva commencing the service before the withdrawal period has expired, and at the same time expressly confirmed that you understand that the right of withdrawal is thereby lost, the right of withdrawal does not apply to the part already performed. Such consent must be documented, for example through digital signing with BankID.

7.5 Exceptions to the right of withdrawal, customised products and services

The right of withdrawal also does not apply to products or services that are customised or individually composed according to your specific wishes, in accordance with Chapter 2, Section 11 of the Swedish Distance Contracts Act. This exception follows from Chapter 2, Section 11, item 5 of the Swedish Distance Contracts Act, and applies to products manufactured according to your instructions or otherwise given a clear personal character and therefore cannot reasonably be reused or sold to another consumer.

7.6 Separate assessment of product and service

If the service requires that you have received a Cellavivabox, for example stem cell collection, analysis and storage, the following applies:

• The product (the Cellavivabox) is covered by the right of withdrawal provided that the seal is unbroken.
• The service is covered by the right of withdrawal for 14 days from the date the agreement was entered into, provided that the service has not commenced in accordance with section 7.4.

7.7 Standard withdrawal form

To simplify your withdrawal notice, you may use the standard form provided by the Swedish Consumer Agency, available for download here:

https://publikationer.konsumentverket.se/mallar-och-blanketter/angerblankett

Consumers may also use the standard withdrawal form available through the European Commission or local consumer authorities.

The form may be sent to info@cellaviva.se or by post to our address stated in section 1.1.

7.8 Refund upon withdrawal

In the event of valid exercise of the right of withdrawal, Cellaviva will refund the amount paid by the customer for the relevant product or service, with any deduction for reduction in value under section 7.2. Refund will be made within 14 days from the day Cellaviva received a valid withdrawal notice in accordance with section 7.1.

If the product is to be returned, Cellaviva has the right to withhold the refund until the product has been returned or the customer has provided proof that it has been returned. When returning a product, the customer is responsible for ensuring that the product is appropriately packaged. Cellaviva recommends that returns are made using a trackable shipment. Cellaviva reserves the right to verify that the seal is unbroken before a refund is made.

Refund will be made using the same payment method used at the time of order, unless otherwise specifically agreed. The customer will not be charged any fees for the refund.

8. Complaints and consumer rights

Unless otherwise specifically stated, the provisions of this section apply only to consumers. For business customers, the Swedish Sale of Goods Act (1990:931) and any separately agreed written terms shall apply.

8.1 Complaint regarding product under the Swedish Consumer Sales Act

A product is considered defective under the Swedish Consumer Sales Act (2022:260) if it:

• deviates from what has been agreed,
• lacks such function or characteristics as the consumer could reasonably expect,
• does not correspond to information provided by Cellaviva in marketing, labelling or instructions, or
• otherwise does not correspond to what the consumer may require under the law.

If a product is defective, you as consumer have the right to demand rectification, replacement delivery, price reduction, cancellation and, where applicable, damages, in accordance with the provisions of Chapter 5 of the Swedish Consumer Sales Act (2022:260).

A complaint must be made within three (3) years from delivery of the product and within a reasonable time after the defect was discovered or should have been discovered. A complaint made within two months from the time you noticed the defect is always deemed to have been made in due time.

Cellaviva is responsible for defects that existed at the time of delivery and that become apparent within three (3) years from that time, in accordance with the Swedish Consumer Sales Act (2022:260).

If the product is defective, you as consumer have the right in the first instance to request that the defect be remedied or that a non-defective product be delivered, provided that this can be done without unreasonable cost or inconvenience to Cellaviva. Complaints must be made within a reasonable time from when the defect was discovered or should have been discovered. If a complaint is made within two months from the time you noticed the defect, it is always deemed to have been made in due time.

In the event of an approved complaint, you will be provided with a new product or another solution by agreement. Cellaviva pays the return shipping in such cases. You have the right to keep the defective product until a new delivery has been made.

8.2 Complaint regarding service under the Swedish Consumer Services Act

When Cellaviva stores your biological material, such as stem cells or tissue, this is done in accordance with applicable law, including:

• the Swedish Biobanks Act (2002:297)
• the Swedish Consumer Services Act (1985:716)
• the EU Tissues and Cells Directive (2004/23/EC).

Storage is carried out under controlled and secure conditions in accordance with authorisation from the Swedish Health and Social Care Inspectorate (IVO). The service is considered defective if Cellaviva deviates from:

• what follows from Section 4 of the Swedish Consumer Services Act (professional performance),
• applicable safety regulations, or
• expressly agreed terms, cf. Section 9 of the Swedish Consumer Services Act.

Complaints must be made within a reasonable time after the defect was discovered or should have been discovered. However, complaints may not be made later than three years after the assignment was completed, unless otherwise follows from a warranty or similar undertaking. What constitutes a reasonable time depends on the circumstances, but two months is generally considered acceptable.

If the service relates to an item that has been in Cellaviva’s possession, the complaint period is calculated from the time the item was returned to the customer.

8.3 Consumer’s right to withhold payment

If the product is defective or the service is deficient, you have the right to withhold as much of the payment as is required to secure your claims.

8.4 Dispute resolution

In the event of a dispute, Cellaviva follows decisions from the Swedish National Board for Consumer Disputes (ARN). Consumers may contact the consumer dispute resolution authority in their country of residence. You may also submit a complaint via the EU online dispute resolution platform:

https://ec.europa.eu/odr

Postal address to ARN:

Allmänna reklamationsnämnden
Box 174
101 23 Stockholm
Sweden

9. Limitation of liability and force majeure

9.1 Force majeure

Cellaviva is not liable for delays, failure to perform or damage caused by circumstances beyond our control and which we could not reasonably have foreseen or influenced. Examples of such force majeure events include:

• Pandemic, epidemic or other serious spread of infection
• Strike, lockout or other labour conflict
• Natural disasters, fire or flood
• Technical disruptions, power outages or transport problems
• Government actions or changes in legislation

Such events do not result in liability for damages or any other sanction for Cellaviva. Force majeure events shall therefore be interpreted in accordance with general principles of contract law and do not include circumstances that could reasonably have been avoided through reasonable planning.

To invoke force majeure, Cellaviva must notify the customer without undue delay of the obstacle, its impact and expected duration.

9.2 Limitations of liability regarding services

Cellaviva is not liable for damage or losses occurring after the material has been released to you, or arising as a result of instructions for handling, transport or use not having been followed.

9.3 Limitations of liability regarding products

Cellaviva’s products, such as collection kits and genetic tests, are intended to be used in accordance with accompanying instructions and any medical advice. The product must not be used after the expiry date, if the seal has been broken, or in a manner that deviates from its intended purpose.

Cellaviva is not liable for damage or loss arising as a result of:

• use contrary to the product’s instructions,
• use after the seal has been broken,
• use after the expiry date, or
• handling contrary to medical advice.

Cellaviva is also not liable for defects caused by incorrect storage or negligent handling after the product has been delivered.

Cellaviva is not liable for the manufacturer’s incorrect labelling, deficiencies in product information or product safety, beyond what is required under mandatory legislation.

9.4 Limitation of liability for business customers

For business customers, Cellaviva is not liable for indirect damage, such as loss of profit, production loss or other consequential loss, unless otherwise expressly agreed in writing. This limitation applies only to the extent permitted under the Swedish Sale of Goods Act (1990:931). Cellaviva is, however, always liable for damage caused by gross negligence or intent.

9.5 General limitation of liability

Cellaviva strives to provide clear and accurate information about all products and services. However, minor discrepancies may occur between the information on the website and the actual design or performance of the product or service. Product descriptions, images and instructions are for guidance and do not constitute guarantees regarding function, appearance or results.

Cellaviva provides no additional warranties beyond those set out in written agreements or mandatory law.

Cellaviva reserves the right to adjust its offering due to technical development, regulatory requirements or other relevant circumstances.

Cellaviva is not liable for damage or loss arising as a result of:

• incorrect use,
• omitted information from the customer,
• use contrary to instructions or medical advice,
• incorrect information at the time of order or delivery.

This also includes lost opportunity to collect material where the cause is incorrect information from the customer or failure to request earlier delivery.

10. Intellectual property rights, logos and trademarks

All content published on Cellaviva’s website, including but not limited to text, images, graphics, logos, audio files, video clips, software and trademarks, is protected by intellectual property rights under applicable legislation on copyright, trademark protection and design protection.

This material belongs to Cellaviva AB or its licensors and may not be used, copied, reproduced, published, distributed, transferred, modified or stored in any form without the express written permission of the rights holder.

It is also not permitted to use Cellaviva’s name, logo or trademarks for marketing purposes without written approval.

Unauthorised use may result in claims for damages, injunctions subject to penalty or criminal liability in accordance with applicable legislation, such as the Swedish Copyright Act (1960:729) and the Swedish Trademarks Act (2010:1877).

11. Codes of conduct

Cellaviva AB is currently not subject to any industry-wide code of conduct. If such a code is introduced, information about its content, legal effect and how it can be accessed will be published on www.cellaviva.se.

12. Medical devices and in vitro diagnostics (MDR/IVDR)

12.1 Application of MDR and IVDR

Certain products provided by Cellaviva are covered by Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). This applies, for example, to CE-marked collection kits and test containers classified as medical devices or in vitro diagnostic devices.

The products are CE-marked and meet the general safety and performance requirements under applicable EU legislation.

12.2 Use

For example, the Cellavivabox and test containers may be classified as medical devices or in vitro diagnostic devices. These products may only be used in accordance with the accompanying instructions.

12.3 Limited right of withdrawal

For health and hygiene reasons, the right of withdrawal does not apply to sealed medical devices where the seal has been broken, in accordance with Chapter 2, Section 11, item 5 of the Swedish Distance Contracts Act.

12.4 Third-party products

For products supplied by third parties, Cellaviva is responsible for ensuring that distribution takes place in accordance with consumer legislation.

13. Processing of personal data

Cellaviva AB is the data controller and processes personal data in accordance with the General Data Protection Regulation (GDPR).

Personal data is processed for the purpose of:

• fulfilling agreements,
• complying with legal obligations,
• ensuring medical documentation and traceability, and
• where express consent has been given, use in ethically approved research in accordance with the Swedish Biobanks Act (2002:297).

Personal data may be shared with logistics partners, laboratories and other subcontractors, to the extent required to fulfil the above purposes. These recipients act as Cellaviva’s processors or independent controllers, depending on the nature of the processing.

13.1 Customer rights

Under the GDPR, Articles 15-22, the customer has the right to:

• request access to their personal data (register extract),
• request rectification or erasure of incorrect data,
• object to processing or request restriction,
• exercise the right to data portability,
• lodge a complaint with the Swedish Authority for Privacy Protection (imy.se), or the relevant supervisory authority in the customer’s country of residence.

13.2 Legal basis for processing

Cellaviva processes personal data based on:

• Article 6(1)(b) GDPR, performance of a contract,
• Article 6(1)(c) GDPR, legal obligation,
• Article 6(1)(a) GDPR, consent,
• Article 9(2)(h) GDPR, processing of special categories of personal data for healthcare purposes, including diagnostics and biobanking under Swedish legislation.

The processing is carried out with high confidentiality and in accordance with applicable biobank and data protection legislation.

The full Privacy Policy is available at www.cellaviva.se.

14. Term and termination of the agreement

Agreements for one-off purchases apply until delivery has been made and payment has been completed.

Agreements for stem cell storage and other ongoing services apply until further notice, or for the commitment period specifically stated in the relevant service agreement.

Termination of ongoing agreements must be made in writing. Notice period, form of termination and any fees are regulated in the relevant subscription or storage agreement.

Cellaviva confirms receipt of termination in writing within five (5) working days from receipt of the termination notice.

Upon termination of an ongoing agreement, the agreement ends at the end of the current payment period, unless otherwise agreed. No refund is made for an already commenced period, unless otherwise specifically agreed.

15. Dispute resolution and applicable law

These Terms and all agreements entered into with Cellaviva shall be interpreted and applied in accordance with Swedish law.

Any dispute shall first be attempted to be resolved by mutual agreement between the parties.

If no agreement is reached, the consumer has the right to contact:

• the Swedish National Board for Consumer Disputes (ARN), Box 174, 101 23 Stockholm, Sweden, arn.se
• the EU online dispute resolution platform, https://ec.europa.eu/odr
• or bring proceedings before a Swedish general court. The consumer always has the right to bring proceedings before the court of their place of residence.

For business customers, any dispute shall be settled by a Swedish general court with Södertörn District Court as the court of first instance, unless otherwise agreed.

16. Severability of individual provisions

If any provision of these Terms is found to be invalid, unlawful or unenforceable, this shall not affect the validity of the remaining provisions. In such case, the Terms shall be interpreted and applied as if the invalid provision had never existed, to the extent compatible with law and the parties’ original intention.