Terms and Conditions
General Term
These Terms apply to all deliveries of medical devices to our Distributors. Bioimplon does not accept or recognize general terms and conditions of its Distributor regardless unconditional execution of an order unless expressly agreed to Distributor’s terms in writing.
Orders/contract awards or order confirmations shall be binding on us only if made in writing. Any and all supplements and alterations shall be made in writing. Silence to offer requests and order confirmations shall not be interpreted as their acknowledgement.
Our offer to order goods are binding for 14 (fourteen) days. All orders shall be received by us without delay, however, no later than 14 (fourteen) days after receipt of offer. Delayed or altered orders/confirmations will be deemed to be new contract offers of the Distributor.
All orders will be processed by us on advance payment, only unless agreed otherwise in our order confirmation.
Prices, Invoices and Payment
Prices are indicated in EURO and do not include Value Added Tax (VAT).
Invoices will be issued at the time of our order confirmation and shall contain the specified order references and goods. VAT shall be invoiced by us at the currently valid rate unless Distributor has forwarded its valid VAT ID No. for European reverse charge system or is located outside the EU.
Payment shall be made within 14 (fourteen) working days in advance of the delivery without any deduction and free of all charges, unless indicated and accepted by us in our order confirmation or invoice.
Payment is regarded as done at the time the invoiced amount is at our sole disposal.
Distributor is not entitled to offset any amount unless the amount is legally established, uncontested or recognized by us in writing.
Distributor has to pay interest in the amount of annually 10 % points above the applicable European base rate, however in any case not less than 12 % for each delayed payment unless for advance payments. In case of delayed advance payments Bioimplon has the right to postpone the delivery in accordance to the delay or cancel the order after more than 2 (two) weeks of delay.
Recommended prices shall be respected by the Distributor. In no case a distribution price of the goods below 20% of the recommended price shall be agreed with customer, unless coordinated and agreed with Bioimplon in advance.
Delivery and Handling
All goods will be delivered EXW (EX Work INCOTERM 2010) Bioimplon, Gießen, Germany. Distributor has to arrange shipment of goods. In case Distributor asked for shipment in its order, Bioimplon will arrange shipment on behalf of and for the account of Distributor.
The date of delivery given in our order conformation is not binding. We will inform the Distributor at least 4 (four) working days before the delivery date (goods are ready for pickup) in writing (Delivery Note).
Distributor will fail to take delivery when the goods are not picked up within 4 (four) working days after the delivery date mentioned in the Delivery Note. During default of taking delivery any accidental loss or destruction of ordered goods will be the risk of Distributor.
Distributor shall effect shipment according to the handling and storage instructions of the ordered goods and to our respective shipping instructions.
Storage at Distributor and further shipment to Distributor’s customer shall be in line with the respective instructions.
Documents and Advertising Material
Any and all advertising material, samples and other documents submitted to the Distributor shall remain our property and shall be returned free of charge in case of cancelation or at the end of business relationship.
Any advertising material used by us shall not be used by Distributor unless approved and accepted by us in writing in advance. The Distributor shall not advertise the goods with statements not approved and accepted by us in writing in advance. Distributor is liable for any damage, deterioration of health or unsatisfied treatment results resulting from noncompliance with the above stipulation or the limited intended use of the goods.
Distributor is obliged to read and understand the instruction for use of the goods including the intended use, its limitations, contra indications and possible side effects, before advertising or distributing the goods to its customer or before giving advice to a customer.
Retention Of Title and Acceptance
The title to the goods delivered shall pass to Distributor at the time of its delivery in accordance to section 3, but in no case before complete payment for the delivered goods is received by us.
The goods shall be checked by Distributor immediately after delivery and any complaints regarding incomplete, defect or false goods shall be made within 3 (three) working days. Acceptance without reclamation or no reclamation until working day No. 3 after delivery shall be stated as unlimited acceptance of supplied goods, unless Distributor can prove that the defect, or failure was hidden in a way, that Distributor could not detect it by applying all necessary care.
Warranty
Without prejudice to other statutory provisions, the following shall apply:
Bioimplon warrants the quality of the goods in such a way that at the time of delivery no failure, no defect or no mis-design of the good can be stated. The evaluation of such fault has to respect the intended use, its limitations in the instruction for use and all contra indications and possible side effects which are listed in the instruction for use or well known in the respective medical professional society. The success of the medical treatment cannot be guaranteed by the use of the goods but shall be within the state of medical art.
Warrantee is excluded, if the defect or failure is caused or alleged to be caused by incorrect handling or storage by the Distributor or by Distributor’s misleading information, customer advice or advertising.
In case of reasoned warranty, we shall at our option, replace or refund any affected goods.
Warranty claims have to be raised in writing within 12 (twelve) months after delivery (warranty period).
No other liability for false or defect goods will be accepted unless for cases of death, personal injury or damage to health in which our liability is limited to gross negligence or intent.
Nothing in this clause will limit or affect our statutory product liability to any customer. If a customer will raise such claim against the Distributor, Distributor shall inform us immediately. No acknowledgement, compensation or concession shall be given by the Distributor without our written consent.
Market Surveillance and Vigilance
The Distributor shall install and keep valid a market surveillance system regarding the delivered goods. This system shall include the full traceability with our LOT or charge number of all delivered goods down to the end user.
The Distributor shall inform us without delay of any event, adverse reaction, unexpected side effect or any other problem with the goods which the Distributor will become aware of.
Bioimplon will take care of all reportable events to the competent authority. In case the Distributor is obliged by statutory national law to report events to its authority, a copy of such report shall be sent to us, immediately.
As legal manufacturer of the goods Bioimplon is obliged and entitled to evaluate and decide about any corrective action or field safety action or note. The Distributor shall not issue a field safety note or perform any recall unless advised to do so by us. If the Distributor makes a recall or places a field safety note without our consent, all cost and damages will be incurred by the Distributor. We are entitled to claim for any compensation of suffered damage or loss due to such unauthorized action.
To follow our statutory obligations for market surveillance, the Distributor shall cooperate and give all required information in respect to corrective actions, product liability claims or other situations in which a root cause analysis is required by us and the Distributor has such requested data or information.
In case the Distributor will be contacted by any competent authority in regard to the distribution of delivered goods, the Distributor shall inform and copy us of all correspondence. Bioimplon will support the Distributor in all such requests and shall have the right to comment or contact the authority, directly.
The Distributor has to store all information and data, which are or could be relevant and might be forwarded to Bioimplon in respect to this section 7 for at least 15 years. The Distributor has to offer Bioimplon these data and information for takeover, in case of stop of business, insolvency or before planning the data destruction.
Studies with the Goods
The goods are medical devices under European law. The Distributor shall perform a clinical investigation or any other study with the goods only after respecting all legal approvals and requirements. Bioimplon shall be informed about such studies in advance.
In case the Distributor performs a study or an observational investigation without additional invasive treatment all data and results shall be shared with Bioimplon. The Distributor is entitled to ask for reasonable financial compensation.
Supply Channel and Obligatory Customer Information
The Distributor shall ensure that the goods will be sold to professional users only who are well familied with such medical devices and the respective medicinal procedure. Any doubts shall be clarified.
Bioimplon offers training or information support for end user. The Distributor shall evaluate whether its customer might need such training or additional information before using the goods.
Any claim due to insufficient knowledge, practice or information of the user shall be incurred by the Distributor and the Distributor shall held Bioimplon free and harmless of all such claims.
No Agent Relation
The Distributor is an independent entity. Nothing in the business relation shall be constructed as employment or commercial agent relationship.
The Distributor shall not be entitled to act on behalf of or to act for the account of Bioimplon.
Governing Law, Place Of Fulfillment and Jurisdiction
The law of the Federal Republic of Germany shall apply to all sales to the Distributor excluding the 1980 UN Convention on Contracts for the International Sale of Goods and German laws of international conflict.
The place of fulfillment for our performances shall be at Gießen.
The place of jurisdiction shall be Gießen. We shall also be free to sue the Distributor at his general place of jurisdiction.
Severability
In the event of individual stipulations of these General Terms and Conditions of Sale being or becoming invalid in whole or in part, this shall not affect the validity of the other stipulations. The invalid stipulations shall be replaced by such regulations which would come as close as possible to the economic purpose.
