General Terms and Conditions of
indigodental GmbH ("INDIGO")
 

1. Area of application / Incorporation in the contract

The following terms and conditions shall apply to all present and future business relationships between INDIGO and traders within the meaning of Section 14 of the German Civil Code (BGB) (hereinafter referred to as "Customer"). Verbal collateral agreements, assurances or guarantee declarations as well as exclusions, amendments or supplements to these terms and conditions shall require the express written confirmation of INDIGO in order to be effective. This shall also apply to the waiver of this written form requirement. The validity of the Customer's general terms and conditions is hereby rejected by INDIGO, even in the event that these are communicated to INDIGO in a letter of confirmation or in any other way.

2. Contract formation Offers from INDIGO

are non-binding and subject to change(s). Our offers shall only become legally binding after written confirmation or delivery of the goods. Technical changes as well as changes in shape, color and weight are permitted within reasonable limits. By ordering the goods, the Customer submits a binding offer, for which an acceptance period of at least two weeks applies. Acceptance can be declared either in writing or by delivery of the goods to the Customer. At the same time as placing the order, the Customer agrees that the data associated with the order, including the company data relating to the Customer, may be recorded and stored in INDIGO's electronic data processing system. Claims against INDIGO for the services or deliveries to be provided by INDIGO may only be assigned by the Customer with the prior written consent of INDIGO.

3. Prices/payment /retention

(1) INDIGO's prices are ex works plus VAT and packaging costs. If a sales shipment has been agreed, the transportation costs shall be paid additionally by the Customer. INDIGO shall be obliged to insure the goods; any costs shall be borne by the Customer. Unless otherwise agreed, no discount shall be granted and all payments shall be made within 14 days of the invoice date. The Customer shall only have a right of set-off in respect of claims that are undisputed, legally established. The Customer shall only be entitled to any statutory right of retention, for example due to defects in the goods, in respect of such undisputed claims, claims that have been legally established or that arise from the same contractual relationship with INDIGO.
(2) If INDIGO and the Customer have agreed a framework supply agreement, the prices shall be deemed to be fixed for one contractual year, unless otherwise agreed. The agreed prices may always be adjusted annually after the end of a contractual year following written notification from INDIGO, provided that INDIGO sends this notification to the Customer at least two months before the end of the contractual year. The parties shall then be obliged to renegotiate the prices in good faith and considering the changed circumstances. Notwithstanding the above provision, INDIGO shall be entitled to adjust the prices of certain products at any time if these products contain raw materials whose prices are determined exclusively on the world market (e.g. products with different contents of mercury, silver or platinum).

4. Delivery and passage of risk

(1) If a delivery period has not been agreed, delivery shall be effected within two months of written acceptance of the order. Confirmed orders and delivery dates shall apply in all cases subject to correct, timely and complete delivery to INDIGO, unless INDIGO is responsible for the non-delivery or delay. Partial deliveries are permissible insofar as this is reasonable for the Customer. Earlier delivery by INDIGO is permissible. The delivery period shall be extended appropriately if unforeseen obstacles prevent the manufacture or delivery of the goods, such as strikes, lockouts, fire, official restrictions, etc. The delivery period shall be extended accordingly. Unless otherwise agreed in writing, shipment by INDIGO shall be "ex works" place of delivery Hamburg, Elbgaustraße 254(EXW) in accordance with the agreements under the International Commercial Terms 2020. INDIGO shall deliver the goods by making them available to the Customer at the place of delivery Hamburg, Elbgaustraße 254 (place of delivery). The Customer shall bear all risks of loss of or damage to the goods from the time the goods are loaded by INDIGO onto the collecting means of transport at the Place of Delivery.
(2) Delayed acceptance: If the products ordered by the Customer are delivered on the agreed or specified date by making the goods available in the aforementioned warehouse, the Customer must collect them in due time. If no acceptance takes place, a grace period for acceptance of the goods of a maximum of 3 calendar days shall be agreed. If the grace period expires unsuccessfully because the goods are not collected / accepted, INDIGO shall be entitled to transport the goods to an external warehouse at the Customer's expense and store them there at the Customer's expense. The Customer shall reimburse INDIGO for all costs incurred. Instead of storing the goods in the event of default / delay of acceptance by the Customer, INDIGO may also choose a penalty for delay, which is hereby deemed to be agreed: 0.25% of the order value for each commenced calendar day of delay, up to a maximum of 5% of the total value of the order. The agreement of the contractual penalty or its assertion shall not affect the other statutory claims to which INDIGO is entitled due to delay. Any contractual penalties paid shall be offset against claims for damages.

5. Default

(1) Force majeure: Circumstances of force majeure beyond INDIGO's control which make performance/delivery temporarily impossible or otherwise hinder it, such as strikes, war, warlike conditions, blockades, import and export restrictions, official measures, energy or raw material shortages and the like, even if they occur during a delay, shall entitle INDIGO to postpone delivery for the duration of this event. If such events result in the performance of the contract becoming economically and organizationally unreasonable for INDIGO, INDIGO shall be entitled to withdraw from the contract in whole or in part. The right to postpone delivery or to withdraw from the contract shall exist irrespective of whether the circumstances listed above occur at the place of delivery or at one of INDIGO's suppliers. The exercise of these rights by INDIGO shall not entitle the Customer to claim damages.
(2) If a sales shipment has been agreed between INDIGO and the Customer (e.g. in accordance with INCOTERMS CPT, CIP, DAP, DDP) and an agreed delivery time has been exceeded without there being an obstacle to delivery in accordance with 5. (1) above, the Customer must grant a reasonable grace period of at least two weeks in writing. If INDIGO culpably fails to comply with this grace period, the Customer shall be entitled to withdraw from the contract, but not to assert claims for damages for non-performance or delay, unless INDIGO is guilty of intent or gross negligence. If the delay in delivery is not due to an intentional breach of contract for which INDIGO is responsible, the liability for damages shall be limited to the foreseeable, typically occurring damage.

6. Warranty for material defects and defects of title

Part A: Material defects

(1) In principle, only INDIGO's product specifications shall be deemed to be the agreed quality of the goods. Public statements, promotions or advertising by INDIGO shall not constitute contractual quality specifications of the goods. Guarantees must be agreed in writing. INDIGO does not assume any warranty for the purposes expected and/or intended by the Customer and the use of the products purchased from INDIGO. Unless expressly notified by INDIGO, clinical trials and other clinical tests of the products in accordance with the provisions of the Medical Device Regulation ("MDR") are the responsibility of the Customer. This also applies to biocompatibility testing, for which the Customer is solely responsible.
(2) If the goods do not have the quality owed and there is therefore a material defect, INDIGO shall provide subsequent performance by repair or replacement delivery at INDIGO's discretion. If a consignment is only partially defective, only the defective part shall be replaced.
(3) The Customer must inspect the delivered goods for defects within a period of seven (7) days from receipt. After expiry of this period, the goods received shall be deemed to have been approved. Obvious material defects must be reported in writing within the period of seven (7) days from receipt of the goods. Timely dispatch shall suffice to meet the deadline.
(4) Rejected goods must be returned at INDIGO's request. The shipping costs shall be borne by INDIGO if the complaint is timely and justified, otherwise they shall be borne by the Customer.
(5) Insofar as INDIGO is obliged to pay damages in accordance with statutory provisions (irrespective of the legal grounds), including any claims for damages for positive breach of contract, culpa in contrahendo and tort due to a defect, this obligation to pay damages shall be limited in accordance with clause 7 (Liability).
(6) The Customer's claims for material defects shall become time-barred after one (1) year, beginning with the delivery of the item. This shall not apply in the event of fraudulent concealment of the defect or in the event of deviation from any quality or durability guarantees assumed by INDIGO pursuant to § 443 BGB. Furthermore, this one-year limitation period shall not apply to claims for damages due to defects if the damage is due to gross negligence on the part of INDIGO's legal representatives or executives or if it concerns personal injury. The statutory provisions on the limitation period for any recourse claims pursuant to § 479 BGB and on the limitation and preclusion periods under the Product Liability Act shall remain unaffected.
(7) In the event of a claim being made against the Customer by a third party on the basis of product liability claims, the Customer shall be obliged to inform INDIGO of this immediately and to provide the necessary documents relating to the claim. INDIGO shall have the right to pursue and defend this claim on behalf of the Customer if INDIGO decides to do so within two (2) weeks of receipt of the notification of the claim. This right exists only within the limits that the terms of any product liability insurance of the Customer are not violated. While INDIGO is pursuing this right, the Customer shall not make any legal claims of its own in defense of this claim. In the event that INDIGO intervenes on behalf of the Customer, INDIGO shall inform the Customer immediately.

 

Part B: Defects in title

(1) INDIGO shall only be liable for infringements of third-party rights if the performed service is used in accordance with the contract and, in particular, in the contractually agreed and otherwise in the intended environment of use without any changes. INDIGO shall only be liable for infringements of third-party rights within the European Union and the European Economic Area and at the place where the service is used in accordance with the contract.
(2) If a third party asserts a claim against the Customer that a service provided by INDIGO infringes its rights, the Customer shall notify INDIGO immediately. INDIGO and, if applicable, its upstream suppliers shall be entitled, but not obliged, to defend against the asserted claims at their expense to the extent permissible. The Customer shall not be entitled to recognize third-party claims before it has given INDIGO a reasonable opportunity to defend the rights of third parties by other means.
(3) If third-party rights are infringed by a service provided by INDIGO, INDIGO shall, at its own discretion and expense, (i) procure the right for the Customer to use the service or (ii) design the service without infringing the rights or (iii) take back the service, reimbursing the remuneration paid by the Customer (less reasonable compensation for use), if INDIGO cannot achieve any other remedy with reasonable effort. The interests of the Customer shall be considered appropriately.
(4) The Customer's claims for defects of title shall become time-barred in accordance with Clause 6, Part A, paragraph (6).

7. Liability

(1) INDIGO shall be liable for damages based on intent or gross negligence and for personal injury in accordance with the statutory provisions. In the event of a slightly negligent breach of material contractual obligations which are indispensable for achieving the purpose of the contract and on the strict observance of which the Customer must therefore be able to rely, and in the event of an intentional or grossly negligent breach of those obligations by simple vicarious agents of INDIGO, INDIGO shall be liable in accordance with the statutory provisions limited to such damages as were foreseeable for INDIGO in terms of type and scope when the contract was concluded. Otherwise, all claims by the Customer for compensation for direct or indirect damage - irrespective of the legal grounds, including any claims for compensation for breach of pre-contractual obligations and tort - are excluded.
(2) The statutory liabilities due to the absence of a quality guaranteed by INDIGO or under the Product Liability Act shall remain unaffected.
(3) Limitation period: Claims for damages and reimbursement of expenses by the Customer shall be subject to a limitation period of one year in accordance with Section 6, Part A, paragraph (6). This limitation period shall not apply to (i) claims for damages in cases of injury to life, limb and health, (ii) product liability claims, (iii) grossly negligent breaches of duty. Version 04_2024 ME

8. Reservation of Title

(1) INDIGO shall retain title to the purchased item until receipt of all payments from the respective delivery. The Customer shall be entitled to process and sell the goods in the ordinary course of business as long as it is not in default of payment of the purchase price. If the goods are processed in accordance with §§ 946, 947 BGB, INDIGO's ownership of the newly created item shall continue, on a pro rata basis to the exclusion of § 950 BGB. The Customer hereby assigns the claims resulting from the resale or further processing to INDIGO in full by way of security. INDIGO accepts this assignment. If the Customer sells the goods subject to retention of title together with other goods not supplied by INDIGO, the assignment shall only apply to the invoice amount resulting from the resale of the goods subject to retention of title by INDIGO. INDIGO revocably authorizes the Customer to collect the claims arising from the resale of the INDIGO goods. The revocation may only be exercised by INDIGO if the Customer does not properly meet its payment obligations to INDIGO, but in the event of default in payment only after the unsuccessful expiry of a reasonable grace period. After revocation, INDIGO shall be authorized to collect the claims arising from the resale of the goods subject to retention of title. In the event of revocation, the Customer shall be obliged to inform its Customers of the assignment of the claim and to provide INDIGO with all information and documents required for collection.
(2) The Customer is obliged to store the reserved goods for INDIGO carefully and to insure them properly against loss and damage at its own expense. He hereby assigns his claims arising from the insurance contracts to INDIGO already today. INDIGO accepts this assignment. If the Customer acts in breach of contract, INDIGO shall be entitled to seize the goods. The request for surrender, repossession and seizure of the reserved goods shall not constitute a withdrawal from the contract.
(3) INDIGO undertakes to release the security to which INDIGO is entitled at the Customer's request to the extent that the value of INDIGO's security exceeds the claim to be secured by more than 15%. INDIGO shall be entitled to select the security to be released.

9. Packaging + instructions for use

(1) The parties may agree that INDIGO shall be responsible for purchasing and stocking the packaging materials for the contractual product. The Customer shall always remain responsible for the content and design of the Artwork, advertising and instructions for use of the contractual product. INDIGO may, at its own discretion, decide on the quantities of materials to be purchased for the production of the packaging in order to keep the overall costs low and better control the price of the Contractual Product. It is agreed that the Customer shall bear all costs of the unused packaging material if (i) a change in the specification and/or a change in the design of the Contractual Product has been made by the Customer or by a new legal requirement or (ii) the Customer no longer wishes to stock the Contractual Product or (iii) the Contract has been terminated by the Customer or the Contract expires without any further business relationship with INDIGO.
(2) INDIGO shall provide specifications, instructions for use and further information on the product in German and English. Further translations into other languages are not offered and shall - if requested by the Customer - be produced by the Customer at its own responsibility and expense. If liability claims are asserted against INDIGO in connection with errors and/or defects in the Customer's (language) translation, the Customer shall indemnify INDIGO against any claims and assume the resulting damages.

10. Traceability / incident reports / product returns / compliance with medical device regulation (MDR)

(1) INDIGO shall maintain full documentation on the batches of the order delivered to the Customer. The Customer warrants to INDIGO the traceability and recallability of the products sold by it. The Customer shall always maintain appropriate records to ensure the traceability of each product purchased from INDIGO. The Customer must keep the necessary documents (e.g. invoices) for at least 15 years (Art. 25 MDR). Upon first request, the Customer shall provide INDIGO with a copy of all documents that prove the traceability of the products to the end Customer in the event of (i) an incident, (ii) Customer complaints, (iii) other necessary cases in connection with medical device law or (iv) justified suspicions of infringements of industrial property rights (e.g. trademark law) in connection with the product.
(2) Without prejudice to the Customer's notification obligations imposed by law, the Customer must in any event notify INDIGO in writing of any incident of which it becomes aware, as defined below: Malfunction, failure or alteration of the characteristics or performance or inappropriateness/incorrectness of the labeling or instructions for use of a product, which has led, could have led or could lead directly or indirectly to the death or deterioration of the health of a patient, a user or any other person. Such incidents must be reported to INDIGO immediately after the Customer becomes aware of them, but no later than 3 (three) working days thereafter. The Customer shall immediately ensure that the entire product is recalled to prevent damage if INDIGO requests the Customer to do so.
(3) If the Customer violates statutory provisions or regulatory provisions in the distribution, operation or use of the products, it shall be obliged to indemnify INDIGO against all damages, losses, claims and costs resulting from the aforementioned breach of duty if and insofar as it has committed this breach of duty intentionally or negligently.
(4) The Customer shall have further duties to provide information: INDIGO shall be entitled, after consultation with the Customer, to carry out quality audits/inspections at the Customer's premises, which serve to ensure the Customer's obligations stated herein and further regulated in the contract.

11. Venue and law

The law of the Federal Republic of Germany shall apply to the exclusion of the provisions of the UN Convention on Contracts for the International Sale of Goods and the conflict of laws. The place of jurisdiction is Hamburg. Should individual provisions of this contract be or become invalid, this shall not affect the validity of the remaining provisions.