Legal Notice and Terms of Use

Subject

These General Conditions regulate the access and use by the patient ("User") of the diabetes support service offered by an accredited health professional ("Healthcare Provider") through the InsulCoach technological platform, owned by Insulcloud, S.L. ("Insulcloud").

The service consists of education and support sessions on diabetes conducted by nursing professionals, through video calls and other communication channels available on the Platform, with the aim of resolving doubts, reinforcing adherence to the treatment prescribed by the User's doctor, and improving their understanding of the disease (the "Support Service").

Contracting Procedure

The contracting procedure for InsulCoach is simple. To start it, you must access it from Insulcoach . You may also be able to start the purchase process from the various links offered on Insulcloud and, specifically, on its blog. You can also access it from our social networks Facebook, Twitter, Instagram, and/or LinkedIn or from one of the links found in the videos on our YouTube channel. You can also access the purchase section if we provide the link via email, WhatsApp, or any other means of communication.

IF YOU ATTEMPT TO START THE PURCHASE PROCEDURE IN ANY OTHER WAY THAN THOSE DESCRIBED HERE, INSULCLOUD DOES NOT GUARANTEE THAT YOU ARE ENTERING OUR WEBSITE TO START THE PROCESS, NOR DO WE GUARANTEE THAT YOU ARE REQUESTING OR PURCHASING ANY OF OUR PRODUCTS OR CONTRACTING ANY OF OUR SERVICES AND, THEREFORE, WE ARE NOT RESPONSIBLE FOR ANY DAMAGES OR LOSSES THIS MAY CAUSE YOU.

You must read and understand our Privacy Policy, Legal Notice, and these General Purchase Conditions and, then, if YOU agree and fully understand what is expressed in those documents and agree with the summary of your purchase, you must click on the checkbox whose legend states: "I have read and accept the Legal Notice and these General Purchase Conditions". Then you must click on SUBSCRIBE.

Next, our website will redirect you to a subpage where it will be necessary to enter a series of personal data. The personal data requested: name, surname, telephone number and valid email address, NIF/CIF, country, address, postal code, city, province, and bank details to proceed with the charge. See our Privacy policy for more information on the processing Insulcloud carries out regarding your personal data.

The purchase procedure can only be carried out in the Spanish language. If it could be carried out in another language, it will be indicated before starting the procedure.

Once the purchase process is finished, a CLIENT/USER account will be created for you to manage your purchase. To do this, the USER must freely and voluntarily provide the requested personal data. See our Privacy Policy.

Insulcloud reserves the right to cancel any contracting if there are suspicions that the purchase made is not legally valid or for other reasons.

Nature of the Service

The Support Service:

• Is not a medical emergency service.
• Does not include pharmacological prescription, issuance of medical prescriptions, or modification of the treatment guidelines indicated by the User's doctor.
• Does not replace the User's clinical relationship with their reference doctor and nurse in the public or private health system.

In the event of any symptoms that the User perceives as urgent or serious (severe hypoglycemia, loss of consciousness, chest pain, respiratory difficulty, or others), the User should call 112 or go to the corresponding emergency service, without waiting to be attended through InsulCoach.

Insulcloud does not provide healthcare. Insulcloud limits itself to providing the InsulCoach Platform, which the User and the Healthcare Provider use as a communication channel.

The User acknowledges and accepts that any question related to the health content of the Support Service should be addressed to the Healthcare Provider.

Access and Authentication Requirements

To use the Support Service, the User must:

• Be over 18 years of age, with sufficient capacity to be contractually bound or have the consent of their legal representative.
• Register on the Platform providing truthful and updated data.
• Be a resident in Spain

If you do not meet any of these requirements, please get in contact us.

The User agrees to safeguard their access credentials and not share them with third parties.

Operation of sessions and subscription

The Support Service is organized in the form of a periodic subscription that includes, as a general rule, 1 monthly video-consultation and access to the communication channels defined on the Platform.

The details of the sessions included, their duration, and the applicable price are described in the commercial offer in force at any time and in the contracting process.

Cancellation and rescheduling of sessions

The User may cancel or reschedule a session already reserved under the terms and deadlines indicated on the Platform.

To cancel the service contract or reschedule sessions, the User must do so through the contact section of the website insulcloud.com

The User can request additional teleconsultations if they wish by paying the stipulated price.

In case of non-attendance without prior cancellation within the established period, the session will be considered consumed.

Price, payments, and renewals

The User undertakes to pay the subscription price in the amount and frequency indicated in the contracting process, including applicable taxes.

Payment will be made through the payment methods available on the Platform. Technical management of the collection may be carried out by Insulcloud acting as a technological provider of the Healthcare Provider.

Duration, renewals, and cancellation

The subscription will have an initial duration of 90 days and will be automatically renewed for successive periods of equal duration, unless the User communicates their desire not to renew with the notice indicated on the Platform.

The User may request the cancellation of the service through the Platform itself. The cancellation will take effect at the end of the current subscription period, unless consumer regulations require otherwise.

Withdrawal

When consumer regulations apply, the User will have a period of fourteen (14) calendar days from contracting to withdraw from the Support Service, unless the service has been fully provided before that period ends and the User has expressly consented to such early execution.

In case the User exercises their right of withdrawal once the provision has started, the Healthcare Provider may demand proportional payment for the part of the service already provided at the time of withdrawal.

Claims

The User may direct their complaints and claims regarding healthcare matters directly to the Healthcare Provider through the channels indicated on the Platform.

For claims related to the InsulCoach Platform (technical or operational aspects), the User may contact Insulcloud through the contact form available on the Platform.

Object

These General Purchase Conditions regulate the remote acquisition, through the Insulcloud website, of the Insulclock v2.0 Lite medical devices in their versions compatible with KwikPen® and FlexTouch® disposable insulin pens.

Distance selling to consumers in Spain is subject, among others, to the consumer regulations of Royal Legislative Decree 1/2007 and, in the case of medical devices, to Regulation (EU) 2017/745 and Royal Decree 192/2023.

These Conditions regulate the online purchase and delivery in Spain of the following products:

• Insulclock v2.0 Lite – KwikPen® version
• Insulclock v2.0 Lite – FlexTouch® version

The offer, sale, and delivery are limited to the Spanish territory, without prejudice to the fact that Insulcloud may expand or restrict it at any time.

Nature of the product

The marketed products are medical devices and must be used exclusively in accordance with their intended purpose, their labeling, and their instructions for use.

The User must fully read the instructions for use before the first use of the product.

Product compatibility and User verification obligation

Before completing the purchase, the User must verify that the selected model corresponds exactly to the disposable insulin pen they use. In particular:

• the KwikPen® version must only be purchased for compatible pens of said type;
• the FlexTouch® version must only be purchased for compatible pens of said type.

The User declares to be aware that an incorrect choice of model may prevent or hinder the proper use of the product.

Therefore, the User assumes the responsibility of verifying, before purchasing, the compatibility of the product with their insulin pen, reviewing the information available on the website, the labeling, the instructions for use, and any other documentation provided by Insulcloud.

Insulcloud shall not be liable for purchase errors derived from an incorrect selection of the model by the User, except in cases of error attributable to Insulcloud, lack of conformity of the delivered product, or when a mandatory rule dictates otherwise.

Purchase process

The purchase process will be carried out by electronic means through the website enabled by Insulcloud.

Before confirming the order, the User will be able to review:

• the selected product;
• the total price, with a breakdown of taxes;
• shipping costs, if any;
• the delivery address;
• the payment method;
• and these General Purchase Conditions.

Perfection of the contract and order confirmation

The mere selection of products and the submission of the order by the User do not in themselves imply the automatic acceptance of the order by Insulcloud.

The contract will be considered perfected when Insulcloud sends the User an express confirmation of the order on a durable medium, once verified, as appropriate:

• the availability of the product;
• the validity of the payment;
• the consistency of the data provided;
• the compatibility of the selected model when there are reasonable indications of error;
• and the concurrence of circumstances that justify an additional review of the order in accordance with clause 4.6.

Insulcloud will send the User, without undue delay, a purchase confirmation by email or other durable medium with the details of the order.

Reservation of order acceptance and right of non-dispatch or cancellation prior to shipping

Insulcloud reserves the right not to accept, not to dispatch, or to cancel an order before its shipment when there are objective, reasonable, and proportionate causes that justify it. This power will be exercised in good faith, in a non-discriminatory manner, and in compliance with consumer, competition, and general contracting conditions regulations. The predisposed clauses in contracts with consumers cannot cause a significant imbalance contrary to good faith.

Insulcloud may trigger a review, temporarily suspend the dispatch, or cancel the order before shipment, among others, in the following cases:

1. Lack of product availability or manifest stock error.
2. Payment incidents, risk of fraud, chargeback, inconsistency in the ownership of the payment method, or impossibility to validate the transaction.
3. Incomplete, false, inaccurate, or unverifiable delivery or billing data.
4. Reasonable indications of incorrect selection of the purchased model with respect to the User's insulin administration device, when this may compromise safety, usefulness, or use in accordance with the intended purpose of the product.
5. Orders with quantities, frequency, recurrence, pattern, or combination of references that are objectively unusual for a domestic or personal end-use purchase.
6. Reasonable indications of hoarding, resale, unauthorized distribution, commercial intermediation, diversion of the product outside the intended channel, or acquisition not intended for the own end use or that of the legitimate recipient.
7. Reasonable suspicion that the purchase may compromise traceability, product safety, regulatory compliance, or post-market surveillance.
8. Abusive use of the purchasing channel, including repeated attempts to circumvent unit limits per order, use of multiple identities, or any operation objectively oriented towards purposes other than the legitimate end use of the product.
9. Existence of a legal, regulatory, or competent authority requirement that prevents or advises against dispatch.

Insulcloud will send the User, without undue delay, a purchase confirmation by email or other durable medium with the details of the order.

• confirmation of the compatible pen model;
• verification of identity or ownership of the payment method;
• confirmation of the end-user status;
• or clarification of the delivery address.

If the User does not provide the requested information within the period indicated by Insulcloud, or if after the review objective causes persist that advise against the dispatch, Insulcloud may cancel the order.

In the event of cancellation prior to shipping, Insulcloud will notify the User of the non-acceptance or cancellation of the order and will proceed to fully refund the amounts actually paid using the same payment method used, unless a different one is legally appropriate.

The lack of acceptance or cancellation prior to shipping will not generate a right to compensation in favor of the User, except in cases of willful misconduct or gross negligence by Insulcloud, or when a mandatory rule establishes a different consequence.

Price, taxes, and shipping costs

The prices of the products will be those indicated on the website at the time of placing the order and will include, unless expressly stated otherwise, the legally applicable taxes.

Shipping costs, if any, will be shown separately before completing the purchase.

The consumer shall not be obliged to pay amounts that have not been clearly informed prior to contracting.

Payment methods

Payment may be made through the methods enabled at any given time on the website.

Insulcloud will adopt the reasonable security measures applicable to the payment process, without assuming liability for incidents not attributable to its sphere of control nor for crashes, interruptions, or errors of the payment service providers.

Delivery and logistics operator

The delivery of orders will be carried out in Spain through DHL or, where appropriate, by another equivalent logistics operator designated by Insulcloud.

Delivery will be made to the address provided by the User during the purchase process.

Delivery time

The estimated delivery time will be the one indicated on the website or in the order confirmation.

Unless otherwise agreed, Insulcloud will deliver the product without undue delay and, in any case, within a maximum period of 30 calendar days from the conclusion of the contract, in accordance with consumer regulations.

Impossibility of delivery and logistical returns

If the delivery cannot be carried out due to causes attributable to the User, including incorrect or incomplete address, repeated impossibility of delivery, or failure to collect the shipment, Insulcloud may:

• arrange a new delivery attempt;
• make the order available to the User in the applicable logistical manner;
• or terminate the purchase and refund the amount paid, deducting, where appropriate, the direct logistical costs actually incurred, provided that this has been previously informed and complies with the applicable regulations.

Order reception and incidents

The User must inspect the package and the product at the time of reception or as soon as reasonably possible.

If the packaging shows damage, manipulation, breakage, or any incident that may compromise the integrity of the product, the User must:

• record the incident with the carrier, whenever possible; and
• communicate it to Insulcloud without delay, providing photographs and a description of what happened.

The User must not use the product if they suspect it has been manipulated, altered, or damaged.

Transfer of risk

In purchases made by consumers, the risk of loss or deterioration of the product will be transferred to the User when they, or a third party indicated by them other than the carrier, acquires material possession of the product. Spanish regulations link the transfer of risk, in sales to consumers, to material possession by the consumer or their designated third party.

Right of withdrawal

Unless any of the legal exceptions apply, the consumer User will have a period of 14 calendar days from the receipt of the product to withdraw from the purchase without the need for justification.

However, the right of withdrawal may not be applicable in the legally provided cases, including, where appropriate, that of sealed goods which are not suitable for return due to health protection or hygiene reasons and which have been unsealed after delivery, provided that all the legal requirements for this are effectively met.

To exercise the withdrawal, the User must communicate their decision to Insulcloud by any means that leaves a record.

Returns

Once the withdrawal has been validately communicated, the User must return the product in accordance with the instructions provided by Insulcloud.

Insulcloud may withhold the refund until it has received the goods or until the User has presented sufficient proof of their return, whichever occurs first, in accordance with applicable regulations.

In the event of a return due to withdrawal, the User will only be liable for the decrease in value of the goods resulting from a handling other than what is necessary to establish their nature, characteristics, or functioning, in the terms provided by law.

Legal guarantee and lack of conformity

The products sold by Insulcloud are covered by the legal guarantee of conformity applicable to consumer goods.

In the event of a lack of conformity, the User may exercise the rights recognized by consumer regulations. This guarantee will not cover:

• damages derived from the incorrect use of the product;
• use contrary to the instructions for use;
• incompatibility caused by an erroneous selection of the model by the User;
• improper handling;
• or normal wear and tear.

Use in accordance with the intended purpose and safety

The User agrees to use the product exclusively in accordance with its intended purpose, labeling, and instructions for use.

In the event of an incident, malfunction, compatibility error detected after delivery, or any circumstance that could affect the safety of the product, the User must cease its use and contact Insulcloud without delay.

The commercialization and monitoring of medical devices require traceability and post-market surveillance, and operators must keep documentation and cooperate in matters of product safety.

Traceability and regulatory compliance

For reasons of product safety, regulatory compliance, traceability, after-sales service, and post-market surveillance, Insulcloud may associate the order with product identification data, batch or serial number, supply date, recipient, and other data necessary to comply with the regulations applicable to medical devices. Royal Decree 192/2023 provides for registration and traceability obligations for economic operators in the sector.

Customer service and complaints

For any query, incident, withdrawal, return, or complaint, the User may contact Insulcloud through:

• website contact section: https://www.insulcloud.com//en/contact
• email: soporte@insulcloud.com
• phone: 911 672 677
• postal address: Calle Bravo Murillo 101, 2ª, 28020 Madrid

Partial invalidity

If any clause of these Conditions were declared null or inapplicable, this will not affect the validity of the rest, which will remain in force in everything that is compatible with the applicable regulations.