General Conditions of Export of BIORON Diagnostics GmbH (03/2021)

1. Sphere of Application and notes

Principally these General Conditions of Export (hereinafter referred to as „GCE“) apply to all deliveries, services and offers of BIORON Diagnostics GmbH, In den Rauhweiden 20, 67354 Römerberg, Germany, (hereinafter referred to as “Seller”), provided that they have not been modified or excluded expressly and in writing.

All deviating conditions are rejected and shall not form part of any contract, even if the Seller does not declare his rejection expressly and in writing.

BIORON intends to supply exclusively to commercial enterprises, public research, examination and teaching institutes and diagnostic laboratories. Buyers who do not belong to this clientele are obliged to inform BIORON of the status and/or business operations of their company or person when first contacting BIORON or placing an order. If this information is not provided, BIORON shall be exempt from any resulting liability. BIORON is entitled to refuse orders if there are indications of misuse of its products

2 Conclusion of the Contract, Prices, Packing and Packing Costs, Dispatching, Transport Insurance

2.1 Any offers of the Seller are without obligation.
If the Seller has fixed a time for acceptance in its written and firm offer, the contract shall be deemed to be concluded, when the Buyer before expiration of such period has dispatched a written acceptance, as long as such acceptance reaches the Seller at least within 3 days after the fixed expiration date. The contractual content is defined by the specification of the Seller.

2.2 All prices are for delivery ex works of the Seller in Römerberg (EXW Incoterms 2010), German Value Added Tax excluded (refer to 2.3 and 3.1). Buyers from the European Union have to indicate their VAT-Ident.-No. at the formation of the contract. Buyers from outside the European Union are not charged with German VAT.

2.3 Unless otherwise agreed packing shall be at the discretion of the Seller. The Buyer is obliged to dispose of all packing materials.

2.4 The goods are dispatched on charge and at the risk of the Buyer.

2.5 Delivered devices and auxiliary means have to be assembled by the Buyer. If the Seller takes over the assembly and commissioning by an express agreement, his General Conditions of Assembly are applicable.

3 Delivery, Passing of Risk, Declaration

3.1 Unless otherwise agreed in writing, all deliveries will be effected exclusively ex works of the Seller in Römerberg (EXW Incoterms 2010). Any agreed deviating trade terms shall be interpreted according to the Incoterms of the International Chamber of Commerce, Paris.

3.2 Partial deliveries are permitted.

4 Time for Delivery, Delay, Cancellation of the Contract

4.1 Any dates of delivery are without obligation and only binding if agreed expressly and in writing. The period of time for delivery begins to run with dispatching of the sales confirmation, but neither prior to the production of all documents, licences, permits and further formalities which are required of the Buyer, nor before receipt of the agreed advance payments.

4.2 If the Seller is responsible for delay of delivery, the Buyer, after 3 weeks of delay – excluding other claims – is entitled to liquidated damages – if he substantiates that he has incurred damages – for each further full week of delay, payable at a rate of 0,5 % – but not exceeding 5 % in total – calculated on the value of that part of delivery which, as a consequence of the delay, cannot be used as intended. No. 8.2 applies accordingly.

4.3 If the maximum liquidated damages according to no. 4.2 are reached, the Buyer – after he has fixed an additional reasonable period combined with the announcement that acceptance of delivery will be re-fused – may notify the Seller in writing of the termination of the contract in respect of that part of the goods which are delayed, except where the Seller delivers prior to termination.

4.4 If the Buyer is in delay with an essential contractual obligation, the Seller is entitled to extend the period of time for delivery according to the period of delay. No. 5 applies analogously.

5 Acceptance of Delivery

The Buyer bears all costs of storage, insurance, protection measures etc., arising from any delayed acceptance. Without further proof the Buyer must pay per week of delay liquidated damages of at least 0,5 % of the order value, but not exceeding 5 % in total.

The Seller may demand, by notice in writing, the Buyer to accept delivery within an additional period of time if the Buyer has not accepted delivery at the fixed time of delivery. Nevertheless, this does not affect the Seller’s claim to the purchase price.
After expiration of the additional period the Seller is entitled to terminate the contract in whole or partly by notice in writing and claim damages including claims for loss of profit.

6 Payment

6.1 Unless otherwise agreed, all payments must be effected by advance payment or by confirmed documentary letter of credit (or bank guarantee, bond) at least 6 weeks prior to the date of delivery.

The “Uniform Customs and Practices for Documentary Credits” of the International Chamber of Commerce, Paris (ERA 600), are applicable. All payments shall be effected in EURO without regard to any fluctuations of the currency exchange rate and without any reduction or discount “free pay office” of the Seller.

6.2 In case of late payment, the Seller is entitled to interest from the date on which payment was due. The rate of interest shall be 9 percentage points above the prime bank rate of the European Central Bank. The Seller in so far may suspend performance of the contract.

If the Buyer has not paid the agreed amount within a reasonable additional period not to exceed 1 month after the payment was due, the Seller shall be entitled to terminate the contract by notice in writing and claim compensation for any loss including claims for loss of profit it has incurred.

6.3 (Creditworthiness, delay in payment)
If any particular circumstances create considerable doubts regarding the Buyer’s creditworthiness, all claims resulting from the whole business relationship shall become due immediately.

The Seller also then is entitled to demand delivery against advance payment. Sentence 1 applies ac-cordingly regarding Buyer’s delay in payment for another contract with the Seller.

If payment in instalments is agreed and the Buyer delays more than 10 % of the owed purchase price, the entire purchase price shall become due immediately.

6.4 Customer specific products may be delivered if the Buyer bears the costs of development according to a prior agreement. The Seller is entitled to demand advance payment of two thirds of the purchase price regarding customer specific products or variations of those, payable 3 weeks prior to start of production at the latest.

The Buyer is not entitled to return such customer specific products.

7 Liability for Conformity of the Goods

7.1 (Duty of examination and notification)
After acceptance, the Buyer must examine the goods without delay. Therefore he must observe the recognised industry standards. In any case, the Buyer is obliged to give notice to the Seller, exactly specifying the nature of the lack of conformity, as soon as he has discovered it or ought to have discovered it. After arrangement with the Seller the Buyer is responsible for the securing of all proofs.

7.2 (Handling and storage)
The proof of adequate and dry storage of the goods,  the correct installation and maintenance as well as the careful handling of the goods including its appropriate use by suitable and trained personnel devolves on the Buyer. 7.3 (Remedy of defects, substitutional delivery)
If the goods do not conform to the contract, the Seller may remedy the lack of conformity at first and at its own discretion within four weeks after the Buyer’s request and, even if the defects are substantial, by repair or substitutional delivery.

Any repairs must be affected at the place of business of the receiver agreed in the contract. If such receiver’s place differs from the Buyer’s place of business, this must be disclosed to the Seller. Otherwise the latter shall not bear any thus increased costs.

The Buyer – on reasonable demand and according to the directions of the Seller – is obliged to participate in any repair works against reimbursement of his expenses.

7.4 (Pro rata reduction, termination of the contract)
If the Seller fails to remedy the lack of conformity according to no. 7.3 by repair or replacement, the Buy-er is entitled to a reasonable pro rata reduction of the purchase price. If the lack of conformity is fundamental, the Buyer may fix a final period for fulfilment and after fruitless expiration of such final period demand termination of the contract.

7.5 The Seller is liable for indirect losses only according to the stipulations of no. 8.2.

7.6 (Deviations customary in trade, changes in construction)
Deviations, which are customary in trade, regarding quantities, measures, quality, weights etc. are permitted. Equivalent changes in construction are reserved.

Regarding customer specific items and goods furnished with particular advertising deviations in the delivery volume of up to 10 % more or less are reserved.

7.7 (Observation of Seller’s instructions)
Instructions of the Seller about the further treatment, operation or application of the goods as well as warnings, cautions and contraindications must be observed by the Buyer, otherwise damages resulting thereof have to be borne by the Buyer.

7.8 (Tracebility)
The buyer must ensure that, as of the entry into force of the IVDR, he can read and handle the UDI code indicated on the deliverd goods for traceability purposes.

8 Liability for subsidiary Duties, General Limitation of Liability

8.1 The Seller is only liable for the contractual or pre-contractual subsidiary duties according to the provisions of nos. 4, 8.2 and no. 11.

8.2 Save as stipulated in nos. 4.2, 4.3 and 7.1 through 7.4, 8, 10 and 11 the Seller shall – without regard to the legal reasons – not be liable for any lack of conformity and damages. This applies to any damages caused by the defect or rights of third parties, including losses of production, profit or other indirect losses, whatsoever, (losses and damages not incurred in the delivered goods themselves).

In case of responsibility for a breach of fundamental contractual obligations the Seller is liable, but only for typical contractual losses which could have been reasonably foreseen. The Seller in any case is liable, however, for gross negligence, for particularly rendered guarantees, fraud, culpable caused damages to life, body or health or if there is compulsory regarding physical injuries or damages to private items under German or foreign product liability laws.

9 Tools, Plans, Sales materials, Secrecy

9.1 All rights regarding Seller’s drawings, drafts and plans, especially patent-, copy- and invention rights shall remain property of the Seller. All sales materials such as catalogues, samples and sample books, price lists etc. which have been placed at the Buyer’s disposal, remain property of the Seller and shall be returned to the Seller on demand.

9.2 Any documents pertaining to an offer, such as pictures, drawings, weights, measures, capacities or data on further qualities and other information about the contractual products and services, are only binding approximately. All proprietary and copyrights regarding information of the Seller – also in electronic form – remain with the latter.

9.3 The contractual parties agree to keep secret all commercial and technical details of their mutual business – if they have been marked as secret or if the interest in confidentiality arises from the circumstances. This also applies to the items mentioned in nos. 9.1 and 9.2, which also shall not be disclosed or made available to any third party.

9.4 The contractual parties shall also ensure that their subcontractors will be under the same confidentiality obligation as set out in no. 9.3.

10 Non-Performance, Impossibility, Inability

As far as the Seller is unable to deliver in whole or partially, the Buyer may terminate the contract by notice in writing to the Seller in respect of that part which is not delivered, save where acceptance of partial performance should be an unreasonable demand. Nos. 8.2 and 11 apply accordingly.

11 Act of God

11.1 Each party shall not be liable for non-performance, if performance is prevented by circumstances beyond the party’s control or especially by one of the following circumstances:

fire, natural disasters, war, seizure, requisition, prohibition of export, embargo or other authority measures, general shortage of materials, restrictions in the use of power, industrial disputes or if a breach of contract of subcontractors is caused by any such circumstances.

11.2 Each party may, by notice in writing, terminate the contract if performance is being prevented for more than 6 months according to no. 11.1.

12 Term of Limitation

All claims of the Buyer based on a lack of conformity with the contract shall be time limited and statute barred within 12 months from passing of risk (no. 3).

The Seller´s liability is limited to any lack of conformity, which appears within this period.

This does not affect the lawful time limitation of claims, which occur according to no. 8.2.

13 Retention of Title and Ownership

13.1 All delivered goods remain property of the Seller until all his purchase price claims resulting from the underlying contractual relationship are fully paid for, as far as such retention of ownership is valid under the applicable law.

If the validity of the retention of ownership is subject to special conditions or regulations in the country of destination, the Buyer is responsible for the observation and compliance with those conditions or regulations. He shall inform the Seller thereof. Any bills of exchange or cheques are only deemed to be fulfilment with receipt of the entire payment.

13.2 The Buyer shall assist the Seller in taking any measures necessary to protect the Seller’s ownership and title to the product in the country concerned.

The Buyer shall inform the Seller if any dangers regarding the property of the Seller should occur. This applies especially to disposals of third parties or authority measures.

13.3 The Seller – after a reminder – is entitled to cancel the contract and take back any goods delivered under retention of title after fruitless expiration of a reasonable additional period noticed to the Buyer, if the Buyer does not fulfil his contractual obligations, especially if payment is delayed. The Seller is not obliged to fix an additional period if there are legal exceptions.

13.4 The Buyer shall insure the delivered goods at his costs against theft, fire, water damages and other risks for the time until full payment is effected.

13.5 If the value of all securities exceeds the value of all secured claims by more than 10 % the Seller shall, upon request, give up securities at his discretion.

14 Liability Under Medical Products in Law

The contractual partners have to fulfil all responsibilities and liabilities resulting from the Medical Devices “Directive 93/42/EEC”, Directive 98/79/EC IVDD on In-vitro-Diagnostica respectively the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (as of entry into force) as well as  the national transformation acts for their mutual scope of responsibility, such as observance of the market, mutual in-formation and tracking back of delivered products until the end-consumer.

15 Miscellaneous

15.1 All rights and duties of either party are not assignable, except assignments of purchase price claims to banks of the Seller.

15.2 Modifications, amendments or further subsidiary agreements to this GCE are required in written form.

15.3 Any contract concluded under this GCE shall remain valid although single conditions should be or become invalid.

15.4 The Buyer only is entitled to offset claims or to suspend contractual performance regarding claims which have not been denied by the Seller or which have been awarded by the courts.

15.5 (Trademarks, trade names, marketing, industrial property of the Seller)
Only with the prior written consent and only in the interest of the Seller the Buyer is allowed to make use of or to have registered any trademarks, trade names or other signs of the Seller.

15.6 (Industrial property of third parties)
The Buyer is responsible that industrial property rights of third parties are not infringed due to its direc-tions regarding forms, measures, colours, weights etc. The Buyer shall indemnify the Seller, including all costs and expenses occurring before and outside the courts and assist the Seller on its demand in any litigation against claims of third parties based on infringement of the aforesaid industrial property rights.

16 Compliance with Law

The Seller is responsible for the compliance with the relevant German regulations, which are decisive unless otherwise agreed and as far as products made in Germany are exported. The observation and implementation of the relevant foreign trade law (e.g. import or foreign exchange licences etc.) and further laws outside Germany is the Buyer´s obligation.

17 Place of Performance, Dispute Resolution, Court of Jurisdiction, Applicable Law

17.1 Place of performance shall be – if not otherwise agreed – the works of the Seller in 67354 Römerberg, Germany.

17.2 All disputes arising out of or in connection with contracts under these GCE shall be finally settled at the place of the Seller’s head-office, without recourse to the courts, in accordance with the Rules of Arbitra-tion of the International Chamber of Commerce, Paris, by one or more arbitrators designated in conformity with the said Rules. The losing Party, as determined by the arbitrators, shall pay all reasonable expenses incurred to the prevailing Party in connection with any such dispute. Place of arbitration shall be D-67065 Ludwigshafen, Germany.

17.3 Instead the arbitration court provided for in No. 17.2 the competent state courts for D-67065 Ludwigshafen, Germany, shall make final and binding decisions, regarding disputes with Buyers from the European Union or from Iceland, Norway or Switzerland.

17.4 The Seller in any case and at its discretion is entitled to invoke the state courts at the place of business of the Buyer. Then and insofar the competence of the arbitration court in no. 17.2 becomes obsolete.

17.5 All contracts concluded under this GCE shall be subject to the United Nations Convention on Contracts for the International Sale of Goods (CISG) from 11.04.1980.Subsidiary substantive and procedural law shall be that in force at the Seller´s place of business.

18 Data Protection Law, General Data Protection Regulation (GPDR)

As far as any personal data are processed by the Seller within the scope of the contractual relationship or in preparation of the contract, the Seller shall process these solely within the scope of the statutory provisions, in particular under in compliance with the provisions of the European General Data Protection Regulation (GDPR) and the EU Data Protection Adjustment and Im-plementation Act (Datenschutzanpassungs- und Umsetzungsgesetz EU; BDSG new).

The Seller shall process the personal data of the Buyer which the Seller obtains from the Buyer or from any third parties within the scope of contract preparation and execution. These usually are contact details (name, address, phone number, email address), bank and payment transaction details (bank, account details, payment reference, credit card information if applicable), in-formation from publicly available sources, information from databases and credit agencies (e.g. internet, commercial register, rating agency) as well as other data that the Buyer provides to the Seller freely.

The Seller will transmit the Buyer’s personal data to public authorities/public bodies as far as required by predominant legal provisions.

If applicable, the Seller will transmit the Buyer’s personal data to companies of the Seller’s group of undertakings and to external service providers. The latter may be located outside of the European Economic Area and may not have the same level of the protection of personal data. In such a case, the Seller shall ensure that transmission takes place solely in compliance with the statu-tory provisions.

The Buyer has the right to obtain information about his personal data stored by the Seller, to have inaccurately stored personal data rectified or to change his consent to processing activities at any time, also without stating any rea-sons, effective for the future, to revoke it, to have processing of his personal data restricted for the future, to object to it or to demand deletion.

The Buyer has the right to lodge a complaint with a data protection authority. The supervisory authority competent for the Seller is the state officer for data protection and freedom of information in Rheinland-Pfalz, Hintere Bleiche 34, D-55116 Mainz.


(Version 05/03/2021)

BIORON Diagnostics GmbH