General Terms & Conditions

of Fasciotens GmbH (the "Company")

1.            Preamble

1.1         The Company operates in the field of medical technology and offers its business partners technologies and services in the researched medical products. In this context, the Company has developed medical devices for the surgical and post-operative care of people. These General Terms and Conditions ("GTC") serve to standardise the marketing and distribution of the Company's Products ("Product" or "Goods"). If a Product consists of several sub-Products, the individual sub-Products are also "Products" within the meaning of these GTC.

1.2         The Company intends to sell the medical technology to both dealers and any end Customers (e.g. hospitals) (both "Customer" or "Buyer") or to make it available in a so-called "pay-per-use model" ("PPU"), as defined in Section 6.

1.3         The Customer may only use and store the Products in accordance with the specific contracts, the Company's instructions and the instructions for use.

2.            Scope of application

2.1         The general provisions of these GTC apply to all contractual relationships entered into with the Company.

2.2         These GTC only apply if the Customer is an entrepreneur (Section 14 German Civil Code (“BGB”)), a legal entity under public law or a special fund under public law. It is not intended to conclude a contract with other Customers - in particular consumers within the meaning of Section 13 BGB.

2.3         These GTC apply exclusively. Any deviating, conflicting or supplementary General Terms and Conditions of the Customer shall not become part of the contract. This shall also apply if the Company accepts the Customer's services without reservation in the knowledge of the Customer's General Terms and Conditions.

2.4         Individual agreements made in individual cases (including collateral agreements, supplements, and amendments) shall take precedence over these GTC. Subject to proof to the contrary, the content of such agreements shall be governed by a written contract or written confirmation by the Company.

2.5         Legally relevant declarations and notifications to be made to the Company after conclusion of the contract (e.g. setting of deadlines, reminders, declaration of cancellation) must be made in writing to be effective.

2.6         References to the validity of statutory provisions are for clarification purposes only. Even without such clarification, the statutory provisions shall therefore apply unless they are directly amended or expressly excluded in these GTC.

3.            Conclusion of contract; order processing

3.1         All information provided by the Company on goods and prices prior to conclusion of the contract, as well as the offer to conclude the contract itself, are subject to change and non-binding. This shall also apply if the Company has provided the Customer with catalogues, technical documentation (e.g. drawings, plans, calculations, costings, references to DIN standards), other Product descriptions or documents - including in electronic form.

3.2         If a contract is concluded, the Customer's order for the Goods shall be deemed to be a binding contractual offer. Acceptance can be declared either in writing (e.g. by order confirmation) or by delivery of the Goods to the Customer, so that only then is a contract concluded. The Customer must point out obvious errors (e.g. spelling and calculation errors) and incompleteness of the order, including the order documents, for the purpose of correction or completion before acceptance; otherwise, the contract shall be deemed not to have been concluded.

3.3         The contract shall be concluded in German, unless another language is expressly selected and accepted by the Company.

4.            Delivery, availability of goods

4.1         The delivery period shall be agreed individually or specified by the Company upon acceptance of the order. If this is not the case, the delivery period is approx. 3 months from conclusion of the contract.

4.2         If binding delivery deadlines cannot be met for reasons for which the Company is not responsible (non-availability of the service; supply bottlenecks in Production), the Customer shall be informed of this without delay, whereby a notification of the expected new delivery date shall be made. If, contrary to expectations, this delivery date cannot be met, the Company shall be entitled to withdraw from the contract in whole or in part; any consideration already paid by the Customer shall be reimbursed immediately. Any further claims on the part of the Customer arising from the Company's failure to perform shall be excluded.

4.3         A delay in delivery shall only occur following a written reminder from the Customer. A claim for damages for delay is excluded. In the event of a culpable delay in delivery, the Customer may demand liquidated damages in the amount of 0.5% of the net price (delivery value) for each completed calendar week, but no more than a total of 5% of the delivery value of the Goods delivered late. The Company reserves the right to prove that the Customer has not suffered any damage at all or only significantly less damage than the above lump sum.

4.4         If the delivery is made within the Federal Republic of Germany, the delivery is regularly carried out by the Company or a third party authorised by it. Delivery shall be ex-warehouse, which is also the place of fulfilment for the delivery and any subsequent fulfilment. At the request and expense of the Customer, the Goods shall be dispatched to another destination (sale to destination). Unless otherwise agreed, the Company shall be entitled to determine the type of dispatch (in particular transport Company, dispatch route, packaging) itself.

4.5         Delivery outside the Federal Republic of Germany shall be effected either by an intermediary or by way of sale by dispatch with the involvement of a forwarding agent (including the assumption of risk) within the meaning of Section 4.5.

4.6         The risk of accidental loss and accidental deterioration of the Goods shall pass to the Customer at the latest upon handover. In the case of sale by despatch, however, the risk of accidental loss and accidental deterioration of the Goods as well as the risk of delay shall pass to the Customer upon delivery of the Goods to the forwarding agent, carrier or other person or institution designated to carry out the despatch. If the Customer is in default of acceptance, this shall be deemed equivalent to handover.

4.7         If the Customer is in default of acceptance, fails to co-operate or if the delivery is delayed for other reasons for which the Customer or persons attributable to him are responsible, the Company shall be entitled to demand compensation for the resulting damage, including any additional costs (e.g. storage costs).

5.            Prices and shipping costs

5.1         The prices are generally based on a separate agreement at the time the contract is concluded unless a price has been expressly stated (in text form). The prices do not include statutory value-added tax.

5.2         The Company shall bear the costs for standard shipping within the Federal Republic of Germany. In the case of sale by dispatch, dispatch outside the Federal Republic of Germany or dispatch for other reasons of the Customer, the Customer shall bear the transport costs ex-warehouse and the costs of any transport insurance requested by the Customer.

5.3         Unless otherwise agreed and legally permissible, the Customer shall bear the costs of any return shipment or new delivery for which the Company is not responsible.

5.4         The purchase price is due and payable within 14 days of invoicing. The Company reserves the right, within the framework of ongoing business relations, to make a delivery in whole or in part at any time only against advance payment. Such a reservation will be declared in the order confirmation. The payment for a PPU is based on the provisions of clause 6.

5.5         The Customer shall be in default upon expiry of the respective payment deadline - without the need for a reminder. During the period of default, interest shall be charged on the purchase price or the respective payment to the PPU at the applicable statutory default interest rate. The Company reserves the right to claim further damages caused by default. The claim to commercial maturity interest (Section 353 German Commercial Code (“HGB”)) against merchants remains unaffected.

5.6         The Customer shall only be entitled to set-off or retention rights to the extent that his claim has been legally established or is undisputed.

5.7         The Company shall be entitled to refuse performance and (if necessary after setting a deadline) to withdraw from the contract if it becomes apparent after conclusion of the contract (e.g. through an application for the opening of insolvency proceedings) that the claim to payment of the purchase price is jeopardised by the Customer's inability to pay. In the case of contracts for the manufacture of non-fungible Goods (customised Products), the Company may also declare its withdrawal immediately; the statutory provisions on the dispensability of setting a deadline shall remain unaffected.

6.            Pay-Per-Use

6.1         In addition to the complete purchase of the Product, the Company offers its Customers a so-called "pay-per-use model" ("PPU"). Under this model, the Customer pays a fixed amount to the Company as a usage and provision fee ("Fee") upon receipt of the order. In addition, the Customer only pays for as long as and to the extent that the Product is actually used ("Daily Fate"), whereby a maximum number of daily rates to be paid ("Cap") is agreed. The Fee, the daily rate and the Cap shall be agreed separately in the confirmation of the respective order. Clause 4 shall apply accordingly.

6.2         The Customer must store, handle and use the Product carefully and for the intended purpose in accordance with the respective instructions for use. If a Product consists of several sub-Products, the sub-Products may only be used together in accordance with the instructions for use. If damage to the Product is caused by culpable action on the part of the Customer or a person attributable to him, the Customer must inform the Company of this immediately; reimbursement of the Fee is then excluded. In such cases, the Company reserves the right to claim further compensation.

6.3         The Customer must use the Product within the time specified by the Company. If the Product is not used within the shelf life of the Product, the Customer must inform the Company accordingly.

6.4         The Customer undertakes to inform the Company in text form as soon as the Product is used. This information must be provided within 48 hours of the start of use and must include the exact start of use.

6.5         The Customer shall return the used Product to the Company or a third party designated by the Company immediately (no later than 48 hours) after use without being requested to do so, stating the duration of use. If a Product consists of several Product parts and if a Product part may be used several times in accordance with the specific contract and the Company's instructions, the Customer shall return the used part to the Company or a third party designated by the Company immediately after the last authorised use without being requested to do so, stating the duration of use. The number of authorised uses is specified in the instructions for use.

6.6         The daily rates shall be invoiced by the Company. In the event of failure to provide information on the application in accordance with Clause 6.2 and the late return of the application in accordance with Clause 6.5 the amount up to the Cap and a penalty surcharge of 25% of the fee shall be due immediately.

6.7         Besides, the provisions of these GTC shall apply, in particular, the exclusions or reductions of liability of the Company pursuant to Clause 8 and Clause 9 shall apply accordingly to PPU.

7.            Retention of title

7.1         The retention of title agreed below serves to secure all current and future claims of the company against the customer arising from the business relationship existing between the parties.

7.2         The Company reserves title to the Goods (delivery item) until full payment of all current and future claims of the Company against the Customer arising from the business relationship. The Goods and the Goods covered by the retention of title which take their place in accordance with the following provisions are hereinafter referred to as "Goods subject to retention of title".

7.3         The Customer shall store the reserved Goods free of charge for the Company.

7.4         The Goods subject to retention of title may neither be pledged to third parties nor assigned as security before full payment of the secured claims. The Customer must inform the Company immediately in writing if an application is made to open insolvency proceedings or if third parties seize the reserved Goods belonging to the Company (e.g. seizure) in order to enable the Company to enforce its property rights. In the event of seizure, the Customer must immediately inform third parties of the Company's ownership.

7.5         The Customer is authorised to resell and/or process the Goods subject to retention of title in the ordinary course of business until the event of realisation, provided that the Company has given its prior written approval in individual cases. In this case, the following provisions shall apply in addition:

7.5.1     It is agreed that the processing shall be carried out in the name and for the account of the Company as manufacturer and that the Company shall directly acquire ownership or - if the processing is carried out from materials of several owners or the value of the processed item is higher than the value of the reserved Goods - co-ownership (fractional ownership) of the newly created item in the ratio of the value of the reserved Goods to the value of the newly created item. In the event that no such acquisition of ownership should occur for the Company, the Customer hereby transfers its future ownership or - in the above-mentioned ratio - co-ownership of the newly created item to the Company as security. If the reserved Goods are combined or inseparably mixed with other items to form a single item and if one of the other items is to be regarded as the main item, the Company shall, insofar as the main item belongs to it, transfer co-ownership of the single item to the Customer on a pro-rata basis in the ratio specified in sentence 1.

7.5.2     In the event of the resale of the reserved Goods, the Customer hereby assigns to the Company by way of security the resulting claim against the purchaser - in the case of co-ownership by the Company of the reserved Goods in proportion to the co-ownership share. The same applies to other claims that take the place of the reserved Goods or otherwise arise with regard to the reserved Goods, such as insurance claims or claims arising from unauthorised action in the event of loss or destruction. The Company accepts the assignment. The rights specified in Clause 7.4 shall also apply with regard to the assigned claims.

7.5.3     The Company revocably authorises the Customer to collect the claims assigned to the Company in its own name. The Company may only revoke this direct debit authorisation in the event of realisation.

7.6         The Company will release the Goods subject to retention of title and the items or claims taking their place if their value exceeds the amount of the secured claims by more than 10%. The selection of the items to be released thereafter shall lie with the Company.

7.7         If the Company withdraws from the contract in the event of the Customer's behaviour in breach of contract - in particular default of payment - (enforcement event), it shall be entitled to demand the return of the reserved Goods.

8.            Warranty for material defects

8.1         The statutory provisions shall apply to the Customer's rights in the event of material defects and defects of title (including incorrect and short delivery as well as defective instructions for use), unless otherwise specified below. In all cases, the special statutory provisions shall remain unaffected in the case of final delivery of the unprocessed Goods to a consumer, even if the consumer has further processed them (supplier recourse pursuant to Section 478 BGB) and such a contract is not to be concluded by the Company. Claims arising from supplier recourse are excluded if the defective Goods have been further processed by the purchaser or another entrepreneur, e.g. by installation into another Product, or have otherwise been used for further utilisation.

8.2         Insofar as the quality has not been expressly agreed, it shall be assessed in accordance with the statutory provisions whether a defect exists or not. Public statements made by the Company, a co-operation partner of the Company or other third parties (e.g. advertising statements) shall in no case lead to liability on the part of the Company.

8.3         The Customer's claims for defects presuppose that he has fulfilled his statutory duties of inspection and notification of defects (Section 377, 381 HGB). If a defect becomes apparent during delivery, inspection or at any later point in time, the Customer must notify the Company of this in writing without delay. The notification shall be deemed immediate if it is made within one week, whereby the timely dispatch of the notification shall suffice to meet the deadline. Irrespective of this obligation to inspect and give notice of defects, the Customer must notify the Company in writing of obvious defects (including incorrect and short deliveries) within one week of delivery, whereby the timely dispatch of the notification shall also be sufficient to meet the deadline. If the Customer fails to carry out the proper inspection and/or fails to give immediate notice of defects (within the meaning of Section 377 (2) HGB), the Goods shall be deemed to be in conformity with the contract and the Customer can no longer derive any rights from the improper condition.

8.4         The use of defective Goods is not permitted. If a defect could not be discovered upon delivery, any further use of the defective Goods must be discontinued immediately upon discovery. If the delivered or leased item is defective, the Company may initially choose between subsequent fulfilment by remedying the defect (subsequent improvement) or by delivering a defect-free item (replacement delivery). The right to statutory refusal of subsequent fulfilment remains unaffected. The Company is entitled to make the subsequent fulfilment owed dependent on full payment of the purchase price. However, the Customer shall be entitled to retain a reasonable part of the purchase price in proportion to the defect.

8.5         The Customer must give the Company the time and opportunity required for the subsequent fulfilment owed; in particular, the rejected Goods must be made available for inspection purposes (even if they are supposedly completely destroyed). In the event of a replacement delivery, the Customer must return the defective item regardless of its condition.

8.6         The Company shall be entitled to demand reimbursement of the costs incurred (e.g. inspection and transport costs) in the event of an unjustified request to remedy a defect.

8.7         Even in the case of defects, the Customer shall only be entitled to claim damages or reimbursement of futile expenses in accordance with Section 9 and are otherwise excluded.

8.8         If multiple use of a Product is permitted under the specific individual contract and the Company's instructions, the above warranty rights shall only apply up to the time of the first use. There is no subsequent warranty. Anything else shall only apply if the Company or a third party commissioned by it has cleaned the Product itself and inspected it for any material defects.

9.            Other liability

9.1         Unless otherwise stated in these GTC, including the following provisions, the Company shall be liable in the event of a breach of contractual and non-contractual obligations in accordance with the statutory provisions.

9.2         The Company is liable for damages - regardless of the legal grounds - within the scope of fault-based liability in cases of intent and gross negligence. In the event of simple negligence, the Company is liable, subject to statutory limitations of liability (e.g. care in our own affairs; insignificant breach of duty), only

9.2.1     for damages resulting from injury to life, limb or health and

9.2.2     for damages resulting from the breach of a material contractual obligation (an obligation whose fulfilment is essential for the proper execution of the contract and on whose compliance the contractual partner regularly relies and may rely) of the Company; in this case, however, the Company’s liability is limited to compensation for foreseeable, typically occurring damages.

Any further liability for damages is excluded.

9.3         The obligations arising from the above Clause 9.2 shall also apply to breaches of duty by or in favour of persons whose fault the Company is responsible for in accordance with statutory provisions. They shall not apply if the Company has fraudulently concealed a defect or has assumed a guarantee for the quality of the Goods and for claims of the Buyer under the Product Liability Act.

9.4         The Company shall not be liable for damage caused by third-party negligence (e.g. incorrect use of the Product). Under no circumstances shall the Company be liable for ensuring that the respective user of the medical technology (or the Product) carries out a correct, proper and professional application on the patient. This includes in particular, although not exclusively, the (incorrect) use of the Product on a Product class not expressly designated by the Company (e.g. use of a Product which, according to the Company's instructions, must not/cannot come into contact with wounds or internal body surfaces, although this occurs in the context of the complaint/application and a wound infection with subsequent conditions then develops, for example). The Customer shall indemnify the Company against any claims for compensation by third parties, insofar as these are not based on a breach of contract on the part of the Company arising from this contractual relationship and a direct liability of the Company towards the third party is possible on the merits.

9.5         The Company shall not be liable for orders placed by Customers using unlawfully obtained payment or other order data (e.g. "phishing" of credit card data, identity fraud, etc.).

10.         Statute of limitations

10.1       Notwithstanding Section 438 (1) No. 3 BGB, the general limitation period for claims arising from material defects and defects of title shall be one year from delivery (or, where permissible, from the transfer of risk), unless a special statutory case exists.

10.2       The above limitation period shall also apply to contractual and non-contractual claims for damages by the Customer that are based on a defect in the Goods, unless the application of the regular statutory limitation period (Sections 195, 199 BGB) would lead to a shorter limitation period in individual cases. In all other respects, the statutory limitation periods shall apply.

11.         Confidentiality

11.1       The Company and the Customer are obliged to maintain confidentiality regarding Confidential Information, even after the end of this contract. "Confidential information" is all information and documents of the respective other party that is labelled as confidential or is to be regarded as confidential due to the circumstances, in particular information about operational processes, business relationships and know-how, as well as all work results.

11.2       Excluded from this obligation is such Confidential Information,

11.2.1  which was demonstrably already known to the recipient when the contract was concluded or which subsequently becomes known to the recipient from a third party without violating a confidentiality agreement, statutory provisions or official orders;

11.2.2  which is publicly known at the time of conclusion of the contract or is made public thereafter, unless this is due to a breach of this contract; or

11.2.3  which must be disclosed due to legal obligations or by order of a court or authority. As far as permissible and possible, the recipient obliged to disclose will inform the other party in advance and give it the opportunity to take action against the disclosure.

11.3       The Customer and the Company shall comply with the relevant data protection regulations. Personal data will only be collected, processed or used to the extent that this is necessary for the fulfilment of the contract and is permitted under the relevant statutory provisions. Any further collection, processing and utilisation of your personal data shall only take place if this is permitted by law or if you have given your consent.

11.4       Further information can be found in the Company's Privacy policy.

12.         Further development

12.1       The Company is an innovative company that aims to further develop and continuously improve its Products in the field of medical technology. The Company therefore intends to collect and analyse the practical experience of its Customers with the Product in order to constantly review and improve the Product and thus achieve even better performance for the Customer and even better patient care.

12.2       In this respect, the Company is endeavouring to create a register or an evaluation of the completed applications of its Products in order to further develop its Products. In order to achieve this, it is necessary for Customers to forward patient information to the Company. The Customers will therefore forward the information to the Company at regular intervals, provided that the Customer has lawfully collected the information in compliance with the General Data Protection Regulation (GDPR) and the German Federal Data Protection Act (BDSG) and the information is actually forwarded to the Company in anonymised form and cannot be individualised.

12.3       It should be noted that in no case should or can the information lead to the individualisation of patients, rather only information such as age, gender and the course of use of the Product is sufficient

13.         Miscellaneous

13.1       These GTC or an agreement within the scope of the other contractual relationship shall neither establish a corporate relationship nor agency relationship nor any other relationship under corporate law between the contracting parties.

13.2       Amendments and additions to these GTC and the resulting agreement must be made in writing. This also applies to the amendment or cancellation of this clause.

13.3       The contract shall be governed by German law to the exclusion of the United Nations Convention on Contracts for the International Sale of Goods of 11 April 1980 (UN Sales Convention) and to the exclusion of private international law.

13.4       The place of jurisdiction for all disputes in connection with the Company's services is - insofar as permissible – Cologne (Germany).

13.5       Should any of the above provisions be or become invalid or unenforceable, this shall not affect the validity of the remaining provisions. In place of the invalid or unenforceable provision, the valid provision that comes closest to the economic purpose of the provision to be replaced shall be deemed agreed. The same applies to the supplementary interpretation of the contract in the event of a loophole.

Cologne, May 2024