SBT

1. Our deliverable and performance are exclusively based on the following terms, unless anything different has explicitly been agreed in writing.
2. Conflicting purchasing terms of the customer will only become an integral part of the contract if expressly agreed in writing from our part.
   

1. Our quotations are subject to change. Any orders or agreements, whether in written form or verbal, only become effective and binding once confirmed by us in writing. The same applies for any verbal side-agreements and assurances. In the event of immediate delivery, however, our invoice would replace an order confirmation. 
2. Our deliverable and performance are based on the price-lists ruling at any one time or individual quotations. If price changes have occurred after order placement, we are entitled to charge the buyer the new prices at the moment goods are delivered or services are rendered.
3. Should the customer’s financial circumstances and/or solvency worsen essentially, following contract conclusion, or should such circumstances have existed at the time of contract conclusion, yet have come to knowledge subsequently, we are entitled to withdraw from the contract or to demand advance payment.
4. Our prices are to be understood net, ex works or warehouse, plus the currently ruling value-added tax, where applicable.
5. We reserve absolute rights of property and proprietary exploitation concerning cost estimates, drawings and any other documents, which have been placed at the customer’s disposal. They may not be passed on to third parties without previous agreement from us in writing.
6. Documents provided in conjunction with a bid procedure, such as illustrations, drawings, etc., containing indications of weights and measurements, as well as descriptions of quality and characteristics, are only approximate and not to be regarded as guaranteed. Only those characteristics, which have been confirmed in writing, are warranted. Any reference to standards constitutes only a rough product assessment without any warranty for characteristics as defined by those standards, unless such warranty has been declared in writing.
7. Information given on the scope of use and application concerning our products, technical advices and any other indications, are provided to the best of our knowledge, yet without commitment, referring also to any possible property rights of third parties, and do not exempt the customer from testing the goods properly as to their suitability for the intended purposes.
   

1. Goods are delivered ex works or warehouse. Shipping costs are to be covered by the customer. Dispatch route and means of transport are left to our discretion, unless specially agreed otherwise. Cost of packaging is only charged in cases of particular packaging requirements causing additional expenditure.
2. Unless otherwise agreed, goods are shipped without insurance coverage from our part. Transfer of perils occurs at the moment goods are delivered to a forwarding agent or freight carrier, yet no later than at the time when the goods leave either warehouse or supplier works. 
3. Once readiness for dispatch has been announced, goods must be called off without undue delay. Should this not be done, we are entitled, at our own discretion, to either ship or store the goods at the buyer’s risk and expense, and to issue a respective invoice right away. Transfer of perils occurs once the goods are ready for shipment and are placed at the customer’s disposal. 
4. Disposable packages cannot be returned. In cases of commission processing, no packaging material can be returned, whatsoever.
   

1. Periods for delivery and fixed dates have only approximate validity, unless agreed in writing to be binding. Periods for delivery begin one week after receipt of order, yet in case of an explicit order confirmation, the period for deliver begins at the moment the customer has received the order confirmation.
2. We reserve the right to withdraw totally or partly from the contract, in the event of incorrect or delayed delivery from the part of our sub-supplier. The customer is not allowed to refuse acceptance of partial deliveries.
3. In cases of force majeure, acts of labour disputes, official intervention, plus business disturbances through no fault of our own, we are entitled to postpone the delivery by an equal amount of time as the delay caused by such effects, or to withdraw totally or partly from the contract. We will inform the customer immediately as to the reason for the hindrance.
4. Should we be behind schedule, the customer is entitled to define an adequate period of grace and, should delivery not be effected within the period of grace, to withdraw from the contract. Indemnity claims are excluded, unless deliberate intention or culpable negligence on our part or on the part of any auxiliary person can be proven.
   

1. Any deficiencies, including the lack of warranted characteristics, must be claimed for immediately in writing, yet no later than within a preclusion period of seven days from receipt of goods. This applies in particular, although not exclusively, to the terms of sterility and expiry. After the preclusion period of seven days, claims for deficiencies, which became evident by thorough examination, can no longer be brought forward.
2. In the event of any claim for deficiencies, we are entitled to visually control and inspect the objected goods.
3. We accept deficient goods to be returned against compensation delivery. Alternatively, we would pay compensation for the reduced value.
4. Should a compensation delivery fail, or prove impossible within an adequate term, the customer has the option to withdraw from the contract. 
5. In cases of custom-made products and procurement of special products, any return consignments are excluded.
6. All further claims, whatsoever, in particular compensation for damages, irrespective of legal basis, are excluded, unless we are liable due to imperative statutory provisions in cases of deliberate intention or culpable negligence.
   

1. Insofar as the clauses mentioned above do not contain any specific provisions, a customer claim for damages is excluded, irrespective of legal basis (e.g. non-compliance, impossibility of performance, positive contract violation, violation of contract and duties during contractual negotiations, unlawful act, settlement between joint debtors, etc.), unless we are liable due to imperative statutory provisions in cases of deliberate intention or culpable negligence.
2. In the event culpable negligence by any one of our auxiliary persons can be proven, our liability to pay damages is limited to the damage which was foreseeable for us as a possible consequence of a contract violation, based on the circumstances existing or cognoscible at the time of contract conclusion.
3. Sales and distribution outside of the scope of the EU Medical Device Regulation (MDR) (EU) 2017/745 requires explicit written approval by biocon Medizintechnik GmbH. Sales and distribution within the scope of FDA requirements are prohibited.
4. In case of international sales and distribution, the customer engages to inform biocon about local, country-specific requirements. Otherwise, such information cannot be factored into the products and exhibits no fault on the part of biocon Medizintechnik GmbH.
5. All claims against us, irrespective of legal basis, lapse one year after transfer of perils to the customer, at the latest.
   

1. The customer undertakes to report all complaints, objections, incidents, suspected incidents and non-conformities (including suspected cases) to biocon without delay in accordance with the EU Medical Device Regulation (MDR) (EU) 2017/745 and the German  Medical Devices User Reporting and Information Ordinance (MPAMIV) so that biocon can fulfil the relevant applicable legal and regulatory requirements.

§ 8
Obligations of distributors according to MDR

1. If the customer acts as a distributor in accordance with Art. 2 MDR, he shall be obliged to demonstrably fulfil the general obligations of the distributor in accordance with Art. 14 MDR.
   
2. If a distributor carries out activities as of the manufacturer according to Art. 16 MDR, it he must inform biocon about these activities and have a quality management system in place.
3. The obligations shall continue to apply for the period after termination of the business relationship.

1. When purchasing CE marked medical devices, the customer is obliged to document and, if necessary, disclose a complete batch traceability for all products sold and distributed free of charge for his area of responsibility up to the end user (if necessary also via other trade organizations), so that in the event of a recall action his end users can be addressed and the corresponding medical device can be removed from the market.
2. Should the customer not comply with this obligation, he will have to bear all costs associated with a product recall.

1. Unless anything different has been agreed explicitly, the following payment terms apply for every invoice within 10 days, net.
   The payment term is counted from the date of invoice, which is issued on the day of dispatch or placement of goods at the customer’s disposal, ready for shipment. 
2. Neither offsetting against contested counter claims, nor withhol-ding any due payments of invoices are admissible.
   

 § 11
Default Interest, Late Payments

1. If the payment term of 10 days maximum from date of invoice as granted in § 10, clause 1, is being exceeded, default interest becomes due immediately. The interest rate to be applied is calculated from the ruling interest rate of the European Central Bank, plus seven percentage points (Directive 2000/35/EC dated June 29, 2000).       
   The right for assertion of a higher default damage remains unaffected.
2. We are not bound to effect any further shipments contractually agreed, as long as due invoices, default interest charges and possible additional expenses have not been paid in full.
3. Should the customer be in default with a due payment, or should circumstances become known which cast the customer’s credit-worthiness into doubt, we may declare all open accounts to be due immediately, including those which had been deferred, or for which securities have been given or bills of exchange have been issued. In this case we are also entitled to effect pending deliveries only upon prepayment, to demand securities, or to withdraw from the contract after an adequate period of grace, without prejudice to any further legal rights.  
   Expenses for collection and legal proceedings, including all related measures necessary (e.g. obtaining information, appointing a debt collecting agency) will be charged to the customer. 
   

1. We reserve the proprietary rights on the goods delivered until all due debt claims resulting from the business relationship have been fully settled, including default interest, plus possible costs and expenses. In the event of current account, the reserved proprietary rights hold good for security of our balance claim. 
2. The customer may sell the goods that are subject to the retention of title only in the usual course of business. The customer assigns to us all receivables, including possible securities, resulting from the selling-on, up to the value of our claims for past-due payments. In the event that the retained goods are sold together with other goods not belonging to us, assignment of claims from the selling-on applies to the value of retained goods. If the customer sells retained goods, which have been processed with other goods not belonging to us, the assignment applies to the value amount of our co-ownership share. 
3. The customer is entitled to collect receivables from the selling-on until our revocation, which is admissible at any time. Upon our request, the customer is bound to inform his buyers about the retention of title existing in our favour and to provide us with disclosure and documents needed for the collection of outstanding debts. We ourselves are likewise entitled to disclose the assignment vis-à-vis the customer’s buyers, at the expense of the customer. The assertion of the retention of title will only become effective as withdrawal from the contract if explicitly declared by us in writing.
4. Bailment of retained goods or transfer of ownership to third parties, are excluded. In the event of bailment, the customer must expressly disclose the existing retention of title and must inform us immediately.
5. By means of contract conclusion, the customer grants us irrevocable admission to his business premises and warehouse, en-abling us to assess the existing inventory of unpaid goods under our proprietary rights. 
6. If the value of securities due to us exceeds the total of receivables with the customer by more than 20 %, we are obliged to release securities, at our discretion, in an adequate proportion, upon request by the customer. 
   

1. Place of performance for all obligations resulting from this contract is our company’s place of business.
2. Place of jurisdiction for all disputes related to this contract, including actions on bills or cheques, is Obernburg (Germany), if the customer is a registered trader, a corporate body under public law, special property under public law, or has no general place of jurisdiction in domestic Germany. We are also free, at our option, to bring an action against the customer at the court of his general place of jurisdiction,
3. The contractual relations are exclusively subject to German law. The pertinent laws on the international purchase of moveable objects and on the conclusion of such purchase contracts do not apply.
   

1. We process customer data we receive, regarding or in accordance with the business relation, no matter if originated from the customer himself or from a third person, in compliance with the EU General Data Protection Regulation and to the German Federal Data Protection Act. 
   

 § 15
Final Clause

1. Should any of the provisions of these business terms be, or become, ineffective, or should any uncovered aspect emerge from a contract concluded on the basis of these business terms, the effectiveness of the other provisions will not be affected. In this respect, a provision shall rather prevail, which comes closest to what the contracting parties had intended, or would have intended by spirit and purpose of the contract, if they had considered this aspect in the first place.
   

Date of issue: October 2021