General Terms And Conditions

1. Conclusion of Contract and Technical Ordering Process

(1) Non-Binding Nature of Offers & Contract Language
The presentation of products in the online shop does not constitute a legally binding offer by the seller, but serves as a non-binding invitation to the customer to place an order (invitatio ad offerendum). The contract shall be concluded optionally in German or English.

(2) Technical Steps of the Ordering Process in the Online Shop
The ordering process leads the customer to a binding contract conclusion via the following steps:
• Shopping Cart:
The customer selects the desired items (specifying specifications such as size and side, where applicable) and places them without obligation into the virtual shopping cart by clicking the “In den Warenkorb” (“Add to cart”) button.
• Checkout & Customer Details:
By clicking the “Checkout” button, the customer proceeds to data entry. Here, the order can be continued via an existing customer account, by registering a new account, or as a guest without registration. Alternatively, an offered express payment service (e.g. PayPal Express) can be chosen, which automatically transfers the stored address and payment details.
• Shipping and Billing Details:
The customer enters or verifies their delivery and billing address and selects the desired shipping method.
• Payment Method & Legal Texts:
The customer selects the desired payment method. Prior to completing the order, the customer is prompted to acknowledge and accept these General Terms and Conditions as well as to acknowledge the statutory instructions on the right of withdrawal.
• Review and Correction of Input Errors:
On the final order overview page, the customer can review all order details (items, quantities, addresses, payment method) once more in full. Input errors can be corrected at any time prior to submitting the order using standard keyboard and mouse functions or the back buttons of the internet browser, or the ordering process can be cancelled by closing the browser window.
• Order Submission:
By clicking the final order submission button (e.g. “Order with an obligation to pay”), the customer submits a legally binding offer to conclude a purchase contract for the goods contained in the shopping cart.

(3) Confirmation of Receipt (Order Confirmation)
Immediately after submitting the order, the customer receives an automatic email confirming receipt of their order (order confirmation). This email serves exclusively to inform the customer about the successful receipt of the order by us and expressly does not constitute an acceptance of the purchase offer.

(4) Conclusion of Contract in B2B Transactions (Entrepreneurs / Specialist Dealers)
With respect to entrepreneurs within the meaning of Section 14 BGB, a legally valid purchase contract shall neither be concluded upon placing the order nor upon receipt of the automatic confirmation of receipt (order confirmation). In the B2B sector, the purchase contract shall come into effect exclusively upon the sending of the invoice via email and/or the actual dispatch or handover of the ordered goods to the transport company.

(5) Conclusion of Contract in B2C Transactions (Consumers)
With respect to consumers within the meaning of Section 13 BGB, the contract comes into effect as follows:

• For Payment in Advance (Bank Transfer):
The automatic order confirmation email does not yet constitute an acceptance of your purchase offer, but merely confirms receipt of the order. The contract is only concluded when we accept the consumer’s payment. Sending the bank details within the order confirmation is deemed an invitation to the consumer to accept the offer by payment (in advance) within the period of 5 business days set out in Section 8 Para. 1. The conclusion of the contract occurs upon actual receipt of payment (crediting of the full invoice amount to the bank account of Masalo KG). If the amount is not received within this period of 5 business days, the consumer’s offer expires and the order is automatically canceled.

• For Instant Payment Methods (e.g., PayPal, Credit Card, Direct Debit – via PayPal):
Deviating from the above, the contract comes into effect at the moment the consumer authorizes and confirms the payment order with the respective payment service provider (e.g. PayPal). The debiting of the consumer’s corresponding account takes place immediately after confirmation of the payment order by the consumer in the ordering process. If the payment is rejected or not released by the payment service provider, no contract comes into effect.

2. Storage of the Contract Text
The contract text and order details are stored by us. The order details, together with these GTC and the cancellation policy, including the sample withdrawal form, will be sent to the customer by email. Should the order documents be lost, we will be happy to provide the customer with a copy of the stored data upon request by email, post, or telephone.

3. Retention of Title
With respect to consumers (B2C), the delivered goods remain our property until full payment of the respective purchase price. With respect to entrepreneurs (B2B), the goods remain our property until full settlement of all claims arising from an ongoing business relationship.

4. Prices, Shipping Costs, Return Costs upon Withdrawal
All prices are final prices and include the statutory value-added tax (VAT). The respective shipping costs are stated on the product pages or can be determined using the shipping cost calculator in the shopping cart on our websites. In the event of a withdrawal, you bear the direct costs of returning the goods.

5. Delivery Terms for End Consumers (B2C only)
(1) Delivery of goods is made exclusively to delivery addresses within the Federal Republic of Germany. Consumers residing outside the Federal Republic of Germany who are entitled to purchase rights under the EU Geoblocking Regulation are free to place orders provided they specify a delivery address within the Federal Republic of Germany. A cross-border delivery to end consumers by us does not take place.

(2) The delivery period begins:

a) for payment in advance by bank transfer, on the day after actual receipt of payment (crediting of the full invoice amount to the bank account of Masalo KG),

b) when using instant payment methods (such as PayPal, credit card, direct debit), on the day after confirmation of the payment instruction by the respective service provider.

The period ends upon expiration of the last day of the period. If the last day of the period falls on a Saturday, Sunday, or a state-recognized general public holiday at the delivery location, the next business day takes the place of such day.

(3) Unless a different period is specified for the respective product in the online shop, the regular delivery time within the Federal Republic of Germany is 1 to 3 business days.

6. Exclusion of Cross-Border Consumer Shipping (B2C only)
Contracts with customers whose place of residence or billing address is outside the Federal Republic of Germany are concluded exclusively in German or English. The handling of warranty or withdrawal rights is governed by the statutory provisions of German law.

7. Instructions on Withdrawal / Right of Withdrawal
Only if the customer is a consumer within the meaning of Section 13 of the German Civil Code (BGB)—that is, a natural person who enters into a legal transaction for purposes that can predominantly be attributed neither to their commercial nor their independent professional activity—does a statutory right of withdrawal exist, regarding which we instruct as follows:

Right of Withdrawal
You have the right to withdraw from this contract within fourteen days without giving any reason. The withdrawal period will expire fourteen days from the day on which you or a third party named by you, who is not the carrier, have taken possession of the goods.

To exercise your right of withdrawal, you must inform us (Masalo KG | Lüner Weg 32a | 21337 Lüneburg | Germany | Email: shop@masalo.eu) by means of a clear statement (e.g. a letter sent by post or an email) of your decision to withdraw from this contract. You may use the sample withdrawal form provided on our website (https://www.masalo.eu/shop/media/content/withdrawal_form.pdf), which is, however, not mandatory.

The withdrawal can also be made online via the website or the “VERTRAG WIDERRUFEN” (“WITHDRAW CONTRACT”) button, in which case you will receive an electronic confirmation of receipt without delay.

Consequences of Withdrawal
If you withdraw from this contract, we shall reimburse to you all payments received from you, including delivery costs (with the exception of additional costs resulting from your choice of a type of delivery other than the least expensive standard delivery offered by us), without delay and at the latest within fourteen days from the day on which notice of your withdrawal from this contract is received by us. For this reimbursement, we will use the same means of payment that you used for the initial transaction, unless expressly agreed otherwise with you; in no event will you be charged any fees as a result of such reimbursement. We may withhold reimbursement until we have received the goods back or until you have supplied evidence of having sent back the goods, whichever is earlier.

You shall send back the goods or hand them over to us without delay and in any event no later than fourteen days from the day on which you communicate your withdrawal from this contract to us. The deadline is met if you send back the goods before the period of fourteen days has expired.
You bear the direct costs of returning the goods.

You are only liable for any diminished value of the goods resulting from handling other than what is necessary to establish the nature, characteristics, and functioning of the goods.

8. Payment Terms
(1) For Consumers (B2C):
Payment is made at the option of the consumer via payment in advance (bank transfer), PayPal, direct debit, or credit card (via PayPal). If payment in advance is chosen, we will state our bank details in the order confirmation. The full invoice amount is due for transfer to our account within 5 business days after receipt of the order confirmation. If no payment is received on our account within this period of 5 business days, the consumer’s purchase offer expires and the order is automatically cancelled. When paying via PayPal, direct debit, or credit card, the consumer’s account will be debited immediately after confirmation of the order, provided the payment service provider releases the payment.

(2) For Entrepreneurs (B2B) / Specialist Dealers:
For orders placed via the online shop as well as via email, registered dealers and commercial resellers shall exclusively have the payment method “Purchase on Account” available. The use of instant payment methods is excluded for the B2B sector. The invoice amount shall be due and payable within 14 days of receipt of the goods and the invoice without deduction. The bank details are specified on the respective invoice. In addition, the provisions regarding default and account suspension pursuant to Section 16 Para. 6 of these GTC shall apply.

9. Invoice
You will receive the invoice via email upon dispatch of the goods to the email address provided during the order process.

10. Warranty
The provider is liable for material defects in accordance with the applicable statutory provisions, in particular Sections 434 et seq. BGB. With respect to entrepreneurs, the warranty period for items delivered by the provider is 12 months.

11. Liability
(1) Claims of the customer for damages are excluded. Excluded from this are claims for damages by the customer resulting from injury to life, body, or health, or from the breach of essential contractual obligations (cardinal obligations), as well as liability for other damages based on an intentional or grossly negligent breach of duty by the provider, its legal representatives, or vicarious agents. Essential contractual obligations are those whose fulfillment is necessary to achieve the objective of the contract.

(2) In the event of a breach of essential contractual obligations, the provider shall only be liable for the foreseeable damage typical for the contract if caused by simple negligence, unless it concerns claims for damages by the customer resulting from injury to life, body, or health.

(3) The restrictions of Paras. 1 and 2 also apply in favor of the legal representatives and vicarious agents of the provider if claims are asserted directly against them.

(4) The provisions of the German Product Liability Act (Produkthaftungsgesetz) remain unaffected.

(5) Data protection claims and statutory grounds of action are not covered by this limitation of liability.

12. Data Protection
The data protection regulations of the GDPR (DSGVO) and the BDSG apply. Information regarding the collection, processing, and storage of your personal data as well as your rights as a data subject can be found in our separate Privacy Policy on our website.
https://www.masalo.eu/en/privacy-notice-and-disclaimer

13. Validity
The offers on the internet are valid for as long as they are displayed on the internet.

14. Applicable Law
(1) Contracts between the provider and the customer shall be governed by the law of the Federal Republic of Germany, excluding the UN Convention on Contracts for the International Sale of Goods (CISG) and international private law.

(2) If the customer is a merchant, a legal entity under public law, or a special fund under public law, the place of jurisdiction for all disputes arising from contractual relationships between the customer and the provider shall be the registered office of the provider. The competent court at the registered office of Masalo KG, 21337 Lüneburg, is agreed upon as the place of jurisdiction. With respect to consumers, this choice of law applies only insofar as no mandatory statutory provisions of the state in which the consumer has their domicile or habitual residence are restricted.

(3) Should individual provisions of this contract be legally invalid, the remaining parts of the contract shall remain binding. The invalid provisions shall be replaced by the statutory regulations, where available. However, if this would represent an unreasonable hardship for one of the contracting parties, the contract shall become invalid as a whole.

15. Delivery, Transfer of Risk, and Packaging Licensing (B2B only)
(1) The provisions of this section apply exclusively to contracts with entrepreneurs within the meaning of Section 14 BGB (B2B). For consumers (B2C), the statutory provisions apply.

(2) Unless expressly agreed otherwise in writing, all cross-border deliveries to entrepreneurs shall be made freight collect ex works or warehouse (FCA pursuant to Incoterms® 2020).

(3) The risk of accidental loss and accidental deterioration of the goods shall pass to the entrepreneur as soon as the goods have been handed over to the transport company (e.g. DHL) or have left the warehouse of Masalo KG for the purpose of shipment.

(4) The entrepreneur shall be deemed the importer in the destination country. The entrepreneur is solely responsible for fulfilling, at their own expense, all public-law obligations applicable in the country of destination—in particular the registration and licensing obligations pursuant to the EU Packaging Regulation (PPWR) and the respective national packaging laws.

16. Special Distribution, Training, and Order Conditions for Dealers (B2B only)
(1) The provisions of this section apply exclusively to contracts with dealers, medical supply stores, pharmacies, and resellers who are entrepreneurs within the meaning of Section 14 BGB (B2B).

(2) Distribution Territories, Exclusive Protection Zones, and Regulatory Export Restrictions:
a) MDR Medical Devices (e.g. Masalo® Cuff MED): The medical devices delivered to the entrepreneur comply in their delivered version exclusively with the legal and linguistic requirements for placing on the market within the Federal Republic of Germany. Any cross-border distribution or export of these medical devices by the entrepreneur to other countries is only permitted if the entrepreneur ensures, on their own responsibility and at their own expense, that all requirements of Regulation (EU) 2017/745 (MDR) and national laws (including country-specific labelling, instructions for use in the local language, country-specific registrations / REPs) are fully met in the destination country. Distribution to countries where these regulatory requirements are not met is prohibited by law and contractually forbidden.

b) Sports Supports and Other Non-Medical Products: For products that are not qualified as medical devices, the free movement of goods within the EU internal market applies.

c) Exclusive Territories (Active vs. Passive): Masalo KG maintains exclusive distribution systems with sole distribution partners for certain territories (in particular for the Republic of Austria). The entrepreneur is expressly prohibited from engaging in active sales (e.g. through targeted advertising, setting up country-specific websites, or opening branches) for all products of Masalo KG (both medical and sports products) into these protected exclusive territories. Passive sales (the processing of unsolicited orders from these countries) remain unaffected, provided that, in the case of medical devices, the regulatory requirements pursuant to letter a) are met.

(3) Platform prohibition (Amazon):
The entrepreneur is prohibited from offering, advertising, or selling products of Masalo KG on the online marketplace “Amazon” (including all national Amazon country platforms such as amazon.de, amazon.com, etc.). Distribution via Amazon is permitted only if Masalo KG has first entered into an express written agreement with the entrepreneur. Without such an agreement, Amazon distribution remains reserved to Masalo KG. Masalo KG reserves the right to have unauthorized offers on Amazon removed by the platform operator.

(4) Training and Advisory Obligation (Quality Assurance & Online Sales):
As the products are medical devices with a specific counter-traction operating principle, the entrepreneur is obliged to comprehensively train their sales staff using the training materials provided by Masalo KG prior to the initial sale. The entrepreneur shall ensure that end customers are advised exclusively by trained specialist staff who can flawlessly demonstrate and guide the correct application and use of the Masalo® Cuff MED. Dispensing the product without the legally required advice and fulfillment of the requirements of Section 83 MPDG is prohibited. If the entrepreneur offers the products in their own online shop, they are obliged to provide an equivalent, professional digital support service. This service must guarantee individual advice and assistance with application or sizing problems (e.g. via email, video call, or by reviewing customer submissions such as photographs of the applied product) provided by trained employees of the dealer. The acknowledgment of this training and advisory obligation is a prerequisite for setting up a dealer account.

(5) Ordering Obligations & Exclusion of Selection Orders:
Orders by entrepreneurs must be placed exclusively by stating the customer number via email or via the official online shop. Fax orders are excluded. Entrepreneurs are only permitted to use the payment method “Purchase on Account” in the online shop; the use of instant payment methods (such as PayPal, credit card, etc.) is excluded for the B2B sector. Pursuant to Section 1 Para. 4, the contract shall only be concluded upon invoicing or dispatch of the goods. Invoice and delivery

addresses must be specified correctly upon ordering; subsequent invoice amendments are excluded. Within the scope of B2B transactions, selection orders are strictly prohibited. A right of return or exchange for properly delivered goods is expressly excluded.

(6) Payment Terms, Default & Account Suspension:
Invoices are due and payable within 14 days of receipt without deduction. If the entrepreneur defaults on payment, Masalo KG reserves the right to withhold pending deliveries and temporarily suspend the dealer account for further orders. If Masalo KG repeatedly has to send payment reminders or dunning notices due to non-compliance with the payment terms, it is entitled to permanently suspend the dealer account, completely cease supplies, and rescind all existing contracts.

(7) Inclusion and Retention in the Specialist Dealer Directory:
Inclusion and remaining in the official Masalo® specialist dealer directory (Premium Dealer) is a voluntary, free-of-charge service provided by Masalo KG. A prerequisite for this is that the dealer stocks at least one item of the Masalo® Cuff MED per size and arm side at all times in order to be able to supply acute patients immediately, and does not trigger purely single orders. If this stock level falls below the minimum requirement or in the event of breaches of contractual distribution and training obligations, the dealer will be removed from the directory.

(8) Sanctions for Breach of Support and Quality Advisory Obligations:
Compliance with the training, advisory, and support obligations regulated in Para. 4 and Para. 5 (in particular the individual, professional digital support for online sales) is of paramount importance for protecting the brand reputation and the therapeutic efficacy of the medical device. If the entrepreneur culpably breaches these obligations—in particular through pure, support-free clearance sales via automated systems without providing the required individual support—Masalo KG shall be entitled to demand a reasonable contractual penalty for each case of non-compliance, to be determined by Masalo KG and, in the event of a dispute, reviewed by the competent court. Furthermore, in such an event, Masalo KG shall be entitled to permanently suspend the dealer account with immediate effect, cease supplies, and rescind all existing contracts.

17. Contact Details:

Masalo KG
Luener Weg 32a
21337 Lüneburg
Germany

Tel.: +49 (0) 4131 / 727 15 97
Web: www.masalo.eu
Email: shop@masalo.eu
USt.-ID: DE351597312