General Terms and Conditions of Sale of PolyMedics Innovations GmbH

Status: March 2024

1. Scope of Application

1.1 These General Terms and Conditions of Sale (hereinafter: “GTCS”) of PolyMedics Innovations GmbH (“PolyMedics”, “we” or “us”) apply exclusively to our customers who are entrepreneurs/traders within the meaning of Section 14 (1) of the German Civil Code (BGB), i.e. who are natural or legal persons or partnerships with legal capacity acting in the exercise of their commercial or independent professional activity when concluding the transaction, or who are legal persons under public law or special funds under public law.

1.2 These GTCS shall apply exclusively in our relationship with the customer. They shall also apply to all future business transactions and to all business contacts with the customer, such as the commencement of contract negotiations or the initiation of a contract, even if these GTCS are not expressly agreed again or if they are not expressly referred to again. We hereby expressly contradict to the validity of the customer’s general terms and conditions of order or purchase.

1.3 Acceptance of our services and deliveries by the customer shall be deemed to be acceptance of the validity of these GTCS.

1.4 If, in individual cases, contractual relationships are also established with persons or companies that are not intended to become parties to the contract, the limitations of liability in these GTCS shall also apply to such persons or companies, provided that these GTCS were included in the establishment of the contractual relationship with the third parties. This is particularly the case if the third parties gained knowledge or had knowledge of these GTCS at the time of the establishment of the contractual relationship.

1.5 Previous agreements and previous versions of our General Terms and Conditions of Sale are superseded by these GTCS.

2. Offer and Conclusion of Contract

2.1 Unless otherwise agreed, our offers are subject to confirmation and non-binding.

2.2 We shall only be bound by an order if it has been confirmed by us in writing by way of an order confirmation or if we begin with the performance of the order.

3. Confidentiality

3.1 During the term of the contract, the customer undertakes to keep secret all information which becomes accessible to him in connection with the contract and which is designated as confidential or which is recognizable as a business or trade secret due to other circumstances (“confidential information”) and not to disclose any such confidential information to third parties or utilize such information in any way, unless such disclosure or utilization is expressly approved in writing beforehand or required to achieve the purpose of the contract. This confidentiality obligation shall remain in force for a further five years after complete fulfillment or termination of the order.

3.2 The customer’s obligations under Section 3.1 also apply to business secrets within the meaning of Section 2 No. 1 of the German Business Secrets Act (Geschäftsgeheimnisgesetz, “GeschGehG”).

3.3 The customer undertakes to protect business secrets within the meaning of § 2 No. 1 GeschGehG the same way as other confidential information from being obtained by third parties by means of confidentiality measures appropriate to the circumstances. The confidentiality measures shall at least correspond to the level of care customary in the trade as well as the level of protection that the customer applies to its own business secrets of the same category.

3.4 The above shall not apply to any information which

• Was already known to the customer before the start of the contract negotiations or which are communicated by third parties as non-confidential, provided that these third parties are not in breach of confidentiality obligations on their part,
• the customer has developed independently,
• is or becomes publicly known through no fault or action of the customer or
• must be disclosed due to legal obligations or orders by a court or a public authority.

In the latter case, the customer shall notify us without undue delay before any disclosure. If the customer claims one of the above exceptions to be applicable, he shall bear the burden of proof in this respect. Further statutory confidentiality obligations shall remain unaffected hereby.

3.5 The customer shall not be entitled to obtain trade secrets or other confidential information by observing, examining, dismantling or testing an item or object within the meaning of Section 3 (1) GeschGehG (“reverse engineering”), unless the item or object has been made publicly available or mandatory legal standards permit such reverse engineering.

4. Prices

4.1 The prices in our current price list are subject to change and are net prices and are always understood ex works (EXW Denkendorf or Kirchheim unter Teck, Incoterms 2020). VAT, if applicable, will be invoiced separately to the customer at the statutory rate.

4.2 If the net order value is less than €300, we reserve the right to charge a minimum quantity surcharge. The amount oft he surcharge depends on the current price list.

4.3 Standard national shipping costs incurred in connection with an order shall be indicated to the customer in the offer and/or in the order confirmation and charged to the customer. Additional costs incurred in connection with express and special shipments will also be charged to the customer.

5. Scope of Delivery, Performance Deadlines, and Transfer of Risk

5.1 Our written offer or order confirmation shall determine the scope of our delivery or service. Any collateral agreement and amendment shall require our written confirmation. If our offer or our order confirmation is based on information provided by the customer (data, figures, illustrations, drawings, system requirements, etc.), our offer shall only be binding if this information was correct. If it becomes apparent after conclusion of the contract that the order cannot be carried out in accordance with the customer’s specifications, we shall be entitled to withdraw from the contract if and insofar as the customer is not prepared to accept the alternative solution proposed by us and to bear any additional costs actually incurred.

5.2 Our deliveries are free of defects if they comply with the agreed requirements with regard to quality and use as well as the agreements with regard to any accessories or instructions. However, descriptions of the goods are only authoritative to the extent that they are expressly designated as binding.

5.3 Our deliveries are made ex works (EXW Denkendorf or Kirchheim unter Teck, Incoterms 2020). We shall be entitled to provide partial performance in relation to all goods to a reasonable extent. Any shipment of the goods shall be at the risk and expense of the customer, even if we exceptionally bear the shipping costs.

5.4 If the goods cannot be shipped for reasons for which the customer is responsible, we are entitled to store the goods at the customer’s risk and expense. In such cases, the date of storage shall be deemed to be the delivery date; the warehouse receipt shall replace the shipping documents.

5.5 If the customer is in default of acceptance, we shall be entitled to demand compensation for the resulting damage and any additional expenses.

5.6 We shall be entitled to use subcontractors to fulfill our contractual obligations.

5.7 As soon as we become aware of the risk of the customer’s inability to pay, we shall be entitled to limit any delivery of goods to advance payment or the provision of security in each case. Our right to withdraw from any individual contract already entered into shall remain unaffected if and insofar as the customer fails to make an advance payment or provide security within a reasonable period.

5.8 Delivery and performance periods and dates provided are based on the best possible information, but are generally non-binding. Our delivery periods shall commence on the date of our order confirmation. However, the commencement of the delivery period as well as compliance with delivery dates shall be subject to the customer’s timely and proper performance of its duties of cooperation, the provision of all documents required and the payment of any agreed advance payments.

5.9 If it is agreed that the customer pays in advance, delivery can only take place after we have received the purchase price in full.

5.10 In the event of force majeure or other extraordinary circumstances for which we are not responsible, including but not limited to epidemics or pandemics, industrial disputes, operational disruptions, civil unrest, official measures or other unavoidable events, we shall not be in default. In such case, we shall be entitled to also withdraw from the contract if we are already in default. In particular, we shall not be in default in the event of delays in delivery if these are caused by incorrect or untimely delivery by our suppliers for which we are not responsible. In case of any hindrance of a temporary nature, the delivery periods shall be extended or shall be postponed by the period of such delay as well as a reasonable run-up period.

5.11 If for the fulfilment of an order we concluded a cover transaction (i.e. we have ordered the required delivery items from our suppliers before concluding the contract with the customer), any agreed delivery and performance deadlines are subject to our correct and timely self-supply from our suppliers/subcontractors with the deliveries and services required for our performance. If, for reasons for which we are not responsible, such correct and timely self-supply does not take place, we shall not be in default. In this case, we shall be entitled to withdraw from the contract. We shall inform the customer without delay of such impediments to performance and reimburse him any services already rendered by the customer without delay.

5.12 If we are contractually obliged to perform in advance, we may refuse any such performance incumbent on us if it becomes apparent after conclusion of the contract that our claim to consideration is endangered by the customer’s inability to pay. This shall be the case in particular if the consideration due to us is endangered by the poor financial circumstances of the customer or if other obstacles such as the event of force majeure or other exceptional circumstances for which we are not responsible, including but not limited to epidemics or pandemics, industrial disputes, operational disruptions through no fault of our own, unrest, official measures or other unavoidable events, or due to export or import bans, war events, insolvency of suppliers or sickness-related absences of necessary employees threaten the performance.

5.13 Transport insurance for goods to be shipped will only be taken out upon express request of the customer. The transport insurance shall then be taken out in the name and for the account of the customer.

5.14 We owe the transfer of title and the transfer of the object of purchase.

5.15 We are entitled to deliver other product sizes that are close to the ordered product size.

6. Terms of Payment

6.1 The purchase price shall be due for payment in euros within 14 days of the invoice date. If we provide our deliveries or services in definable partial sections, we shall be entitled to demand payment of a corresponding part of the remuneration for each partial section. Unless otherwise agreed, invoices shall be issued immediately after delivery.

6.2 In the event of an agreed payment by instalments, the entire outstanding balance shall become due immediately if the customer is in default with two instalments entirely or to a significant extent or if he is in default with an amount at least as high as one monthly instalment during a period of time that extends over more than two instalment payments.

6.3 A discount deduction is only permitted in accordance with the relevant information on the invoice. The date of receipt of payment by us or the date of crediting to one of our bank accounts shall be deemed to be the date of payment for the discount deduction. Unless expressly agreed otherwise, the customer shall not be entitled to make deductions.

6.4 If the customer has its registered office outside Germany and the contractual agreement with the Customer does not provide for delivery against advance payment, we are entitled, even without a separate agreement, to make our performance subject to the provision of a documentary credit (letter of credit) by a bank or savings bank authorized in the European Union in accordance with the currently applicable Uniform Customs and Practice for Documentary Credits (UCP 500) of the International Chamber of Commerce (ICC) in the amount of the gross performance price. If we do not request the provision of such a documentary credit and unless otherwise agreed in the contract, our claim shall become due upon receipt of the delivery. If we make our deliveries in definable partial sections, we shall in any case be entitled to make a corresponding part of the remuneration due for each partial section and, if applicable, to demand the provision of a documentary letter of credit for each partial section.

6.5 If the customer is in default of payment, he shall compensate us for any damage caused by default, in particular interest at a rate of 9 percentage points above the base interest rate. If the customer is in arrears with the payment of a due amount or partial amount for more than 14 days, if the customer breaches the obligations arising from a reservation of title or if the consideration due to us is endangered due to poor financial circumstances of the customer, the entire outstanding balance shall become due for payment immediately. We reserve the right to charge a reminder fee of EUR 4.00 for the 2nd and 3rd reminder for each invoice due after default of payment, up to a maximum of EUR 8.00 per invoice. Once the described dunning process has been completed, the claim will be passed on to a debt collection agency for collection. In this context, we also pass on the customer’s address, order and payment data to the collection agency.

6.6 Payment by bill of exchange or acceptance shall be permitted only after an express agreement on such and only on account of payment. Any additional costs incurred in the event of payment by bill of exchange or acceptance shall be borne by the customer and shall be invoiced to the customer separately.

6.7 Only those claims which are undisputed or confirmed by way of a final legal judgment may be set off against any amount we may claim under our right to remuneration. The same applies to the exercise of a right of retention. The customer shall be entitled to exercise any right of retention only insofar as it is based on the same contractual relationship. The assignment of claims against us by the customer requires our prior approval, which we will only refuse for good cause.

7. Reservation of Title

7.1 We reserve title to delivered goods until such time as payment is rendered in full in relation to all our current and future claims against the customer arising from the concluded contract and other ongoing business transactions (secured claims).

7.2 The goods subject to retention of title shall not be pledged to any third party or assigned as security until all secured claims have been paid in full. The customer must inform us without undue delay in text or written form if and insofar as any third party accesses goods belonging to us.

7.3 In the event of the customer acting in breach of contract, including but not limited to in the event of non-payment of the purchase price due, we shall be entitled to withdraw from the contract in accordance with the statutory provisions and/or to demand the return of the goods on the basis of the retention of title. Any demand for return shall not in itself constitute a declaration of withdrawal from the contract; we are entitled to merely demand the return of the goods and reserve the right to withdraw from the contract. If the customer fails to pay the purchase price due, we may only assert these rights if we have previously set the customer a reasonable deadline for payment without success or if setting such a deadline is dispensable according to the statutory provisions.

7.4 The customer shall be entitled to resell and/or process the goods subject to retention of title in the ordinary course of business. In this case, the following provisions shall apply in addition.

7.4.1 The customer hereby assigns to us by way of security any claims against third parties arising from the resale of the goods or the item, in total or to the amount of our possible co-ownership share in accordance with the above paragraph. We hereby accept the assignment. The obligations of the customer stated in the above clause 7.2 shall also apply with regard to the assigned claims.

7.4.2 The customer shall remain authorized to collect the claim in addition to us. We undertake not to collect the claim as long as the customer meets his payment obligations to us, is not in default in relation to any payment, no application for the opening of insolvency proceedings has been filed and there is no other deficiency in his ability to pay. If this is the case, however, we may require the customer to disclose to us any assigned claim and the details of the respective debtor, and to provide all information necessary for collection, hands over the relevant documents and informs the debtors (third parties) of the assignment.

7.4.3 If the realizable value of the securities exceeds our claims by more than 10%, we shall release securities of our choice at the customer’s request.

7.5 As long as ownership has not yet been transferred to the customer, the customer is obliged to treat the goods with care and based on the specified storage conditions and to insure them adequately at replacement value against fire, water damage and theft at its own expense. The customer shall bear the costs of any necessary investments, such as maintenance and inspection work.

7.6 If the effectiveness of this retention of title is dependent on its due registration, e.g. in public registers in the customer’s country, we are entitled and authorized by the customer to affect such registration at the customer’s expense. The customer is obliged to provide all cooperation required for such registration free of charge.

8. Return Conditions (outside warranty)

8.1 Our products are excluded from return except for claims due to defects in the goods or guarantees given by us. If, in exceptional cases, we have expressly agreed to take back the goods in writing, the value to be reimbursed in the event of the goods being taken back shall be based on the age, condition and resale ability of the goods.

8.2 The customer shall bear the risks and costs for the return transportation of goods for which we have exceptionally agreed to take back the goods. In such a case, the customer shall also bear the costs for assessing the quality of the returned goods.

9. Warranty and General Liability

9.1 The limitation period for claims due to defects in our deliveries shall be one year from the date of statutory commencement of the limitation period. After expiry of this year, we may in particular also refuse subsequent performance without the customer being entitled to claim a reduction in price, withdraw from the contract or claim damages as a result. This reduction of the statutory limitation period shall not apply to claims for damages other than those based on refused subsequent performance and shall generally not apply to claims for fraudulent concealment of any defect and to recourse claims under § 445a of the German Civil Code (BGB); the statutory limitation periods shall apply to such claims.

9.2 For the purpose of determining whether an item is free of defects at the time of transfer of risk, a concluded quality agreement shall prevail over the objective requirements of the item within the meaning of § 434 (3) BGB.

9.3 An accepted intended use of the goods within the meaning of § 434 (2) no. 2 BGB, shall be subject to our comprehensive information by the Customer in writing in regard to such intended use prior to conclusion of the contract, as well as our specifically declared written consent.

9.4 The item delivered by us shall be deemed to meet the objective requirements of the usual quality with regard to the durability of the item in accordance with § 434 para. 3 sentence 1 no. 2, sentence 2 BGB, if at the time of the transfer of risk the item has the capacity to maintain its required functions and performance under normal use.

9.5 Our acceptance of the goods returned to us by the customer shall not constitute an acknowledgement of the defect, unless this is expressly declared by us.

9.6 Any claim of the customer due to defects in the delivery provided by us shall be subject to the following provisions:

9.6.1 If the delivered item is defective, we may initially choose whether we provide subsequent performance by remedying the defect (rectification) or by delivering a defect-free item (replacement delivery). The right to refuse the chosen type of subsequent performance under the statutory conditions remains unaffected.

9.6.2 We are entitled to make the subsequent performance that we owe dependent on the customer paying the purchase price due. However, the customer is entitled to retain a reasonable part of the purchase price in proportion to the defect.

9.6.3 The customer shall provide us with the reasonable time and opportunity for any subsequent performance, in particular provide us with the goods claimed to be defective for inspection purposes. In the event of a defect, we are entitled to make a subsequent delivery dependent on the customer returning the defective item and any use made of it to us step by step in accordance with §§ 346 to 348 BGB. There is no obligation to take back the replaced item.

9.6.4 We shall bear the expenses necessary for the purpose of inspection and subsequent performance, in particular any transport, travel, labor and material costs, if a defect actually exists.

9.6.5 The customer shall bear the costs of rectification or subsequent performance incurred as a result of the purchased item having been taken to a location other than the customer’s business premises after delivery.

9.6.6 In the event that any claim for rectification of a defect by the customer proves to be unjustified, we shall be entitled to claim reimbursement of the costs incurred from the customer.

9.6.7 If the customer is a merchant within the meaning of the German Commercial Code (HGB), the following shall also apply:

• The customer’s claims for defects, in particular the claims for subsequent performance, withdrawal from the contract, reduction in price and damages, require that the customer has complied with his statutory obligations to inspect the goods and give notice of defects (§§ 377, 381 HGB). If a defect becomes apparent during the inspection or later, we must be notified of this in writing without delay. The notification shall be deemed to be made without delay if it is made within 10 days of discovery of the defect, 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 shall notify us in writing of obvious defects (including incorrect and short deliveries) within fourteen days of delivery, whereby the timely dispatch of the notification is also sufficient to meet the deadline. If the customer fails to duly inspect the goods and/or notify us of defects, our liability for the defects not notified shall be excluded. This shall not apply if we have fraudulently concealed the defect.
• A merchant is any entrepreneur who is entered in the commercial register or who operates a commercial business and requires a commercially organized business operation.

9.7 The customer may claim damages only as follows:

9.7.1 For damages based on

• an intentional or grossly negligent breach of duty on our part, or
• an intentional or grossly negligent breach of duty by one of our legal representatives, executives or or agents (“Erfüllungsgehilfe” within the meaning of § 278 BGB)

of obligations that are not essential contractual obligations (cardinal obligations) and are not main or ancillary obligations in connection with defects in our deliveries.

9.7.2 for damages based on the intentional or negligent breach of essential contractual obligations (cardinal obligations) on our part, on the part of one of our legal representatives, executives or agents (“Erfüllungsgehilfe” within the meaning of § 278 BGB). Essential contractual obligations (cardinal obligations) within the meaning of the above subsections 9.7.1 and 9.7.2 are obligations whose fulfillment is essential for the proper execution of the contract and on whose compliance the customer regularly relies.

9.8 Furthermore, we shall be liable for damages due to the negligent or intentional breach of obligations in connection with defects in our delivery (subsequent performance or ancillary obligations) and for damages that fall within the scope of protection of a guarantee (assurance) expressly given by us or a guarantee of quality or durability.

9.9 In the event of a breach of an essential contractual obligation due to slight negligence, liability shall be limited in amount to the damage typically to be expected and foreseeable for us at the time of conclusion of the contract when exercising due care.

9.10 Claims for damages by the customer in the event of a simple negligent breach of a material contractual obligation shall become time-barred one year after the statutory limitation period begins. This does not apply to damages resulting from injury to life, limb or health.

9.11 Claims for damages against us arising from mandatory statutory liability, for example under the Product Liability Act, as well as from injury to life, limb or health shall remain unaffected by the above provisions of this paragraph and shall exist to the extent permitted by law within the statutory time limits.

9.12 If third parties are commissioned or involved in the initiation or execution of the contractual relationship between the parties, the above-mentioned warranty and liability limitations shall also apply to the third parties.

9.13 The customer’s rights pursuant to Sections 445a, 445b and 478 BGB in the event that claims are asserted against the customer or its other customers in a supply chain shall remain unaffected in accordance with the following provisions:

9.13.1 The customer shall bear the burden of proof to establish that the expenses for subsequent performance were necessary and that he could not have refused subsequent performance to his buyer in accordance with Section 439 (4) BGB or could not have provided subsequent performance in a more cost-effective manner.

9.13.2 Any claim under § 445a para. 1 BGB shall expire under § 445b para. 1 BGB within two years from our delivery to the customer. These periods shall also apply if a longer period would apply according to § 438 BGB.

9.13.3 The limitation period for the customer’s claims against us based on a defect in a newly manufactured item as defined in §§ 437 and 445a para. 1 BGB shall expire at the earliest two months after the date on which the customer has satisfied the claims of his buyer, provided that the claims had not yet expired in the relationship between the customer and his buyer. This suspension of expiry shall end at the latest five years after the date on which we have delivered the item to the customer.

10. Obligations of the Customer, Notification of Incidents, and customers

10.1 The customer shall ensure compliance with all relevant provisions for handling of the goods and the safety conditions from the time of delivery of the goods. In particular, the customer shall ensure compliance with the relevant statutory provisions of the German Medicinal Products Act (Medizinproduktegesetz) and the ordinances issued in this respect and shall take particular care to comply with the provisions on storage, labeling and expiry periods.

10.2 The goods may only be passed on in the original packaging with the original imprint and original package leaflet. It is prohibited to pass on the goods for purposes other than those stated in the original package leaflet or to advertise for such other purposes.

10.3 If the customer becomes aware that a patient or a user of the goods has suffered a deterioration in health in connection with the goods – outside of known adverse reactions – we must be informed of this immediately. Upon request, the customer shall inform us and/or the competent authorities to whom he has delivered the specific goods and other goods from the same batch that we have delivered to him.

11. Final Provisions, Export Control Provisions, Choice of Law, Place of Jurisdiction, Contractual Language, Severability Clause, Indication of VAT ID

11.1 The deliveries and services (fulfillment of the contract) are subject to the provision that there are no obstacles to fulfillment due to national or international regulations, in particular export control regulations as well as embargoes or other sanctions. The customer undertakes to provide all information and documents required for the export/transfer/import. Delays due to export inspections or approval procedures shall suspend deadlines and delivery times in this respect. If the necessary approvals are not granted, the contract shall be deemed invalid with regard to the parts concerned.

11.2 The contractual relationship is subject to the law of the Federal Republic of Germany to the exclusion of the UN Convention of Contracts for the International Sale of Goods (CISG).

The place of performance and exclusive place of jurisdiction for all disputes arising between the parties out of or in connection with contracts to which these GTCS apply or any disputes concerning the validity of these GTCS shall be the head office of PolyMedics Innovations GmbH at 73230 Kirchheim u. Teck, provided that the customer is a merchant, a legal entity under public law or a special fund under public law or the customer has no general place of jurisdiction in the Federal Republic of Germany or has relocated its place of jurisdiction abroad. Notwithstanding the above, we shall be entitled to commence legal proceedings in relation to the assertion of any claim against the customer at his general place of jurisdiction.

A merchant is any entrepreneur who is entered in the commercial register or who operates a commercial business and requires a commercially organized business operation. The customer has his general place of jurisdiction abroad if he has his place of business abroad.

11.3 If the customer does not have a general place of jurisdiction inside the EU, Switzerland or the EEA or relocates its place of jurisdiction from inside the EU, Switzerland or EEA to outside the EU, Switzerland or EEA, the following shall apply instead of the agreement of place of jurisdiction of clause 11.3:

All disputes arising out of or in connection with contracts to which these GTCS apply or any disputes concerning the validity of these GTCS shall be finally settled in accordance with the Arbitration Rules of the German Institution of Arbitration (DIS), excluding recourse to the ordinary courts of law. The arbitration tribunal shall consist of three arbitrators. The place of arbitration shall be Stuttgart, Germany. The language of the proceedings shall be German.

11.4 Contractual language shall be English. If the parties make use of another language the English version of any contractual document and the English version of these GTC shall prevail.

11.5 The mother language of the responsible persons in our company is not English, neither is English the mother language of most of our Customers. And these GTC are drafted according to German law. Therefore, the meaning of any chosen English term shall be interpreted by translating such terms into German and the German text of such translation or the translated German term and the meaning of the term or section in the German version is authoritative according to the German legal understanding.

11.6 If any provision in these GTCS or a provision within the framework of other agreements is or becomes invalid, this shall not affect the validity of all other provisions or agreements.

11.7 The customer shall provide us with the valid VAT identification number issued to him by a member state of the European Union immediately upon conclusion of the contract. The customer is also obliged to inform us of any changes to the VAT identification number at any time. Should we incur any damage due to a missing, incorrect or incomplete notification of the VAT identification number by the customer, in particular due to a resulting loss of the tax exemption for intra-Community deliveries in accordance with §§ 4 No. 1 lit b), 6a of the German sales tax law (UstG), the customer shall be obliged to compensate us. The foregoing obligation shall not apply if there is no culpable breach of a duty by the customer.