General Terms and Conditions of Sale DMG Digital Enterprises SE

1. Scope/incorporation into contract
The following General Terms (the “General Terms”) apply to all present and future business relationships between DMG and entrepreneurs within the meaning of § 14 of the Bürgerliches Gesetzbuch (Civil Code, the “BGB”) (the “CUSTOMER”). Oral side agreements, representations, or guarantees as well as preclusions of, amendments to, and restatements of these terms shall require the express written confirmation by DMG in order for them to be valid. The foregoing also applies to the waiver of this signed writing requirement. The application of the CUSTOMER’s general terms is hereby denied, even in the event that those terms have been transmitted to DMG as part of a confirmation letter or otherwise. All terms set forth in these General Terms contain only the terms and conditions applicable between the CUSTOMER and DMG as regards the utilization of services by the CUSTOMER insofar as and to the extent that these terms and conditions have not been modified through individual stipulations between the parties. The sale, delivery, and use of the “Dentamile connect” software is subject to separate terms of use.

Part A of these General Terms and Conditions of Sale form the legal framework for the delivery and rendering of all goods and services, while Part B contains specific terms governing the purchase of hardware and software for proprietary and nonproprietary products, services, installations, and commissions.

Part A. General terms governing the sale of products offered by DMG (the “DMG Products”)

2. Contract formation
Offers made by DMG are nonbinding and subject to change. Our offers become binding only after written confirmation has been given or the DMG Products have been delivered. Technical modifications as well as changes in form, color, and weight are permitted within reason. Whenever the CUSTOMER places an order for any DMG Products, the CUSTOMER transmits a binding offer subject to an acceptance deadline of at least two weeks. Acceptance can be rendered either in writing or by delivering the DMG Products to the CUSTOMER. During the order placement process, the CUSTOMER will give its consent to the collection and storage of the data appurtenant to the order in DMG’s data processing systems; said data include, but are not limited to, the corporate data relative to the CUSTOMER.

3. Prices/payment/retention
(1) The prices of DMG apply ex works, plus value-added tax and packaging costs. Should a shipping purchase be stipulated, the transportation costs are also to be paid by the CUSTOMER. DMG is required to insure the DMG Products; any such costs shall be at the CUSTOMER’s expense. Unless otherwise stipulated, no discount will be granted and all payments must be rendered within 14 days of invoicing. The CUSTOMER shall be entitled to a setoff right only in view of claims which are not in dispute, which have been established with legal finality, or whose final decision is otherwise imminent. The CUSTOMER shall be entitled to a statutory retention right – if one exists, such as by dint of nonconformities in the DMG Products – only in view of claims arising from the same contractual relationship with DMG, which claims are not in dispute, which have been established with legal finality, or whose final decision is otherwise imminent.
(2) The prices set forth in the appended price list apply to, and are deemed fixed by stipulation for, one contractual year. Following written notice, the stipulated prices can always be readjusted annually after a contractual year has ended, provided that DMG sends said notice to the CUSTOMER by no later than two months prior to the end of the contractual year. In this case, the parties are required to renegotiate prices in good faith and with due consideration for any circumstances that may have changed. Notwithstanding the foregoing terms, DMG has the right to adjust prices for certain products at any time, if those products contain commodities whose prices are set exclusively on the world market (e.g., products with varying amounts of mercury, silver, or platinum).

4. Delivery and passage of risk
Should a delivery period not be stipulated, the delivery must be made within two months of written acceptance of the order. In all cases, confirmed orders and delivery dates shall be subject to DMG’s being supplied in an accurate, timely, and complete manner, unless that supply or a delay therein has been caused by DMG. Partial deliveries can be made to the extent such are reasonable for the CUSTOMER. DMG can make early deliveries. The delivery period shall be extended for reasonable periods of time to the extent that unforeseen hinderances prevent manufacture or delivery of the DMG Products: e.g., strike, lockouts, fire, official orders, etc. Unless otherwise stipulated in writing, shipping shall be effected by DMG “ex works,” place of delivery Hamburg, Elbgaustrasse 248, 22547 Hamburg, Germany, (EXW) INCOTERMS 2020. DMG must deliver the DMG Products by making them available to the CUSTOMER at the place of delivery in Hamburg, Elbgaustrasse 248 (place of delivery). The CUSTOMER shall bear all risks of loss of or damage to the DMG Products, commencing as of the time DMG consigns them to the means of transportation, that picks up the DMG Products, at the place of delivery.

5. Default
Circumstances of force majeure outside DMG’s control, which render performance impossible or otherwise impede performance for any given time – such as strike, war, war-like conditions, blockades, import and export restrictions, official measures, energy or commodities shortages, and the like – even if they arise during default, shall justify DMG to postpone delivery for the duration of such event. Should such events lead to its being unreasonable for DMG to perform the contract on economic or organizational grounds, then DMG is authorized to withdraw from the contract in whole or in part. The right to postpone delivery or to withdraw from the contract exists regardless of whether the circumstances listed above occur at the place of delivery or at any of DMG’s suppliers. The CUSTOMER shall not receive any right to compensatory damages in the event that DMG exercises such rights.

6. Warranty for material defects and defects in title
6a. Material defects
(1) For the stipulated facts relating to the DMG Products, only and principally DMG’s product specification shall be controlling. Any public statements, extolling, or advertising by DMG in addition thereto shall not constitute contractual statements of fact relating to any of the DMG Products. Affirmations must be stipulated in writing. Should the DMG Products not conform with the facts, as owed, and should there exist for this reason a material defect, then DMG shall, at the option of DMG, either render supplementary and subsequent performance or make a replacement delivery. Should the shipment be nonconforming only in part, then only the nonconforming part must be replaced.
(2) The CUSTOMER must inspect the delivered DMG Products for conformity within a time period of seven (7) days of receipt. After this period lapses, the DMG Products received shall be regarded as approved. Obvious material defects must be reported in writing within a time period of seven (7) days of receipt of the DMG Products. The timely sending of that report shall suffice to preserve the deadline.
(3) Upon demand by DMG, rejected DMG Products must be returned. The shipping costs shall be borne by DMG, if the rejection is timely and substantiated; otherwise, the CUSTOMER shall bear said costs.
(4) To the extent that DMG is required by law (regardless of the legal reason therefor) to render damages, including any claims for damages in the wake of any positive breach of contract, fault during contract negotiations, and illicit act due to a defect, then this requirement to render damages is limited in accordance with Section 7 below.
(5) CUSTOMER claims as may accrue on account of material defects shall have a limitation period of one (1) year, commencing as of the date on which the DMG Product was delivered. Such does not apply in the event the defect was concealed maliciously or in the event there exist derogations from any affirmations of fact or storage life assumed by DMG under § 443 BGB. Nor does said one-year limitation period apply to claims for damages due to defects, if the damage is grounded in gross negligence of the legal representatives or executive employees of DMG or if the damage involves personal injury. The foregoing shall be without prejudice to the statutes of limitation governing recourse claims contemplated by § 479 BGB and the statutes of limitation and repose contemplated by the Produkthaftungsgesetz (Product Liability Act).
(6) In the event product liability claims are made against the CUSTOMER by a third party, the CUSTOMER shall be required to notify DMG thereof without undue delay and to produce any necessary documents relating to the claims made. DMG has the right to prosecute and to mount a defense against said claim in the name of the CUSTOMER, if DMG decides to do so within two (2) weeks of receipt of said claim notification. This right exists only within the limits that, where applicable, the CUSTOMER’s product liability insurance terms and conditions are not breached. While DMG exercises said right, the CUSTOMER shall refrain from effectuating any legal claims of its own and from mounting a defense against those claims. In the event DMG intervenes in the name of the CUSTOMER, DMG shall advise the CUSTOMER thereof without undue delay.

6b. Defects in title
(1) DMG is liable for violations of third-party rights only to the extent its performance is contractually compliant and in particular to the extent it is deployed, without change or modification, in its contractually stipulated or otherwise intended environment. DMG is liable for infringements of third-party rights only within the European Union, the European Economic Area, and at the location at which the performance is used under the contract therefor.
(2) Should a third party make a claim against the CUSTOMER that a performance by DMG infringes his, her, or its rights, the CUSTOMER shall notify DMG thereof without undue delay. DMG and, where applicable, its upstream supplier have the right, but are not required, to mount a defense against the claims made at their own expense and to the extent permissible. The CUSTOMER does not have the right to acknowledge third-party claims before DMG has had reasonable opportunity to mount a defense against the third-party rights in some other way or form.
(3) Should third-party rights be violated on account of DMG’s performance, then DMG, at its own option and at its own expense, shall (i) procure for the CUSTOMER the right to use the performance or (ii) to modify the performance into compliance or (iii) to take back the performance and reimburse any compensation rendered by the CUSTOMER for that performance (less reasonable compensation for use), if DMG cannot attain, with reasonable time and expense, some other remedy. In this case, the CUSTOMER’s interests shall be taken into consideration within reason.
(4) CUSTOMER claims accruing because of defects in title shall have the limitation period commensurate with that set forth in Part A, Section 6, subsection 5. The terms set forth in the following Section 7 apply to claims for compensatory and other damages of the CUSTOMER’s.

7. Liability
(1) DMG is liable for damage based on wrongful intent or gross negligence and for personal injuries, as prescribed by law. In the case of negligently caused property damage or financial losses, DMG is liable only in the event material contractual duties were breached which are indispensable given the purpose of the contract and on whose strict observance the CUSTOMER must, for that very reason, be able to rely, and in the case that those duties have been breached in a wrongful or grossly negligent manner by simple auxiliary agents of DMG, DMG is liable as prescribed by law – in all cases, however, the damage shall be capped at the damage that, at the time of contract formation, was foreseeable and typical of the kind of contract. Apart from the foregoing, all compensatory claims of the CUSTOMER regarding direct or indirect damage – regardless of the legal reason therefor, including compensatory claims regarding any breach of precontractual duties and as may arise from any illicit action – are precluded. Unless otherwise governed herein, liability claims shall have a limitation period of one (1) year, commencing as of the date on which the corporeal thing was delivered, save for any liability for injury to life, limb, and health.
(2) Statutory liability because of the absence of a fact relating to the DMG Products that was affirmed by DMG or by dint of the Produkthaftungsgesetz (Product Liability Act) remain applicable.
(3) DMG will maintain full documentation of the batches of the order delivered to the CUSTOMER. The CUSTOMER warrants to DMG that the DMG Products disposed of by the CUSTOMER shall be traceable and recallable. The CUSTOMER must inform DMG without undue delay of any damage event concerning any product delivered by DMG and shall guarantee without undue delay that a recall of the entire product shall be effectuated in order to avert damage, provided DMG demands that the CUSTOMER do so.

8. Retention of title
(1) DMG shall retain the title in the corporeal thing purchased until such time as all payments from each respective delivery has been received. The CUSTOMER has the right to process and to dispose of the DMG Products in the normal course of business for as long as it does not enter into default on the payment of the purchase price. Should the DMG Products be processed under § 946 and § 947 BGB, then DMG’s title in the corporeal thing so created shall continue, prorated, in existence, with § 950 BGB being precluded. As collateral, the CUSTOMER hereby assigns, in full, any claims resulting from the resale and/or the subsequent processing of said thing to DMG. DMG hereby accepts said assignment. Should the CUSTOMER dispose of the retention DMG Products, together with other DMG Products not delivered by DMG, then the assignment shall be deemed to apply only to the amount invoiced for the resale of the DMG retention DMG Products. DMG empowers the CUSTOMER, revocably, to collect any claims arising from the resale of DMG Products. DMG can revoke such powers only if the CUSTOMER does not duly satisfy its payment obligations to DMG, but in the event of payment default, only after a reasonable grace period has lapsed without remedying the default. After revocation, DMG shall be empowered to collect the claims arising from the resale of the retention DMG Products. In the event of revocation, the CUSTOMER shall be required to advise its customers of the claims assignment and to provide to DMG all information and documents as may be required to recover said claims.
(2) The CUSTOMER is required to hold in safekeeping, with the due level of care, the DMG retention DMG Products and to insure them at its own costs against loss, theft, or damage. The CUSTOMER hereby assigns to DMG its claims arising from its insurance policies. DMG hereby accepts said assignment. In the event of contract-breaching conduct by the CUSTOMER, DMG shall have the right to access the DMG Products. The demand to surrender, to take back, and to pledge any corporeal thing subject to a retention right shall not cause a withdrawal from the contract.
(3) DMG is required to release any collateral, to which it is entitled, upon demand by the CUSTOMER, provided the value of DMG’s collateral exceeds more than 15% of the claim secured thereby. DMG shall be able to choose which collateral it shall release.

9. Traceability / incident reports / product returns concerning medical devices
(1) In the case of DMG Products that are to be regarded as medical devices, DMG shall maintain full documentation on the batches of the order delivered to the CUSTOMER. CUSTOMER warrants to DMG the traceability and recallability of the DMG Products sold by CUSTOMER. CUSTOMER shall at all times maintain appropriate records to ensure the traceability of each product purchased from DMG. The CUSTOMER shall keep the documents necessary for this purpose (e.g. invoices) for at least 10 years. Upon first request, CUSTOMER shall provide DMG with copies of all documents proving the traceability of DMG Products to the end customer in case of (i) an Incident, (ii) customer complaints, (iii) other necessary cases related to medical device law or (iv) reasonable suspicion of infringement of intellectual property rights (e.g. trademark law) related to the DMG Product.
(2) Without prejudice to the CUSTOMER ‘s notification obligations imposed by law, the CUSTOMER shall in any case notify DMG in writing of any incident defined as follows of which it becomes aware: malfunction, failure or change in characteristics or performance, or improper labeling or operating instructions of a DMG Product, which directly or indirectly caused, could have caused, or could cause death or deterioration of the health condition of a patient, user or other person. Notifications of such incidents to DMG shall be made immediately after CUSTOMER becomes aware of them, but no later than 3 (three) business days thereafter. The CUSTOMER shall immediately ensure the recall of the entire DMG Product to prevent damage if DMG requests the CUSTOMER to do so.
(3) Insofar as the CUSTOMER violates statutory provisions or regulatory provisions in the distribution, operation or use of the Products, the CUSTOMER shall be obliged to indemnify DMG against all damages, losses, claims and costs resulting from the aforementioned breach of duty if and insofar as the CUSTOMER has committed such breach of duty intentionally or negligently.

10. Venue and law
The law of the Federal Republic of Germany shall apply, to the exclusion of UN purchasing law and of any conflict of laws. The venue shall be Hamburg, Germany. Should individual provisions of this contract be or become null and void, then such shall be without prejudice to the validity of the remaining terms hereof.

Part B: Special terms governing the sale of hardware and nonproprietary software products

The terms set forth in this section of Part B amend and/or restate the terms contemplated under Part A exclusively as regards the sale and delivery of hardware and nonproprietary software. To the extent that the terms set forth in this section do not so amend/restate, the terms of the section contemplated under Part A remain applicable even for the sale of hardware and nonproprietary software.

11. Hardware (3-D printers and accessories)
(1) The place of delivery, place of destination, and further constituents of performance shall be determined in the respective offer extended to the CUSTOMER; here, the place of delivery/destination is the CUSTOMER’s registered office, as set forth in the order.
(2) Unless otherwise stipulated, it is incumbent upon the CUSTOMER to install and to configure the hardware and/or software after receipt. The CUSTOMER shall test, thoroughly, the hardware and/or software prior to deployment for conformity and usability in the existing hardware. Should the test reveal that there are no material nonconformities, the CUSTOMER must accept the hardware. Nonconformities must be reported to DMG without undue delay within five (5) work days of their discovery; otherwise the hardware shall be regarded as having been accepted. Should the CUSTOMER refuse acceptance by citing material nonconformities, then DMG shall have the right to effectuate subsequent performance or replacement delivery and, subsequent to that performance or delivery, to give notice again that such is ready for acceptance. Should acceptance not be effectuated by the CUSTOMER within a time period of fourteen calendar days or should, within that time period, no written statement by the CUSTOMER be provided describing exactly how which parts of which performance remains unfulfilled, then acceptance shall be deemed to have been effectuated.
(3) DMG can stipulate with the CUSTOMER that DMG render certain performances during the installation/hardware commissioning process at the CUSTOMER’s premises. Insofar as DMG assumes hardware installation services, the following applies: within the sphere of its establishment, the CUSTOMER must ensure that any prerequisites necessitated by the rendering of the services are fulfilled, including, but not limited to, providing at no charge requisite infrastructure such as work stations, work supplies/material, telecommunications connection, and so forth. The CUSTOMER must honor scheduled appointments. The CUSTOMER shall review and shall be responsible for guaranteeing that, at the place of commissioning, the prerequisites necessary for safe operations are fulfilled. It is presumed that, as regards any relevant rooms, the CUSTOMER is in compliance with applicable rules and regulations concerning its establishment. Further duties to assist shall be listed in any offer necessitating them. Prior to commencing any installation work, DMG shall designate an authorized person as a contact person. DMG can also cause services to be carried out, in whole or in part, by subcontractors of its choosing. The choice of subcontractor shall be at DMG’s own discretion. DMG’s installation work includes work required to take into due commission hardware and the corresponding software. As part of the transfer of natural possession to the CUSTOMER, there shall be training, based on an instruction manual, on how to use the hardware and software. DMG can, at its own free discretion, determine the nature, scope, and duration of these services; DMG is also free to suspend, at any time, any work regarding the commissioning of hardware and software, if DMG believes such to be pertinent and will not be required to render damages, substitute/subsequent performance for such suspension.
(4) Any DMG services to take hardware into commission, as provided at no charge by the CUSTOMER, is voluntary aid provided to the CUSTOMER and do not constitute any required part and/or some ancillary performance of the purchase and delivery of hardware. The failure of such services, be they cancelled or otherwise refused, shall not give the CUSTOMER cause to withdraw (from the hardware purchase contract), to offset claims, to assert any right of retention, or to assert any rights arising from applicable warranty law.
(5) DMG does not produce the software responsible for the direct operation of the hardware (3D printer) (hereafter, the “Third-Party Software”); DMG provides this Third-Party Software to the CUSTOMER in/with the hardware and approves of operating this hardware in compliance with the specifications made by the Third-Party Software’s producer. The Third-Party Software’s producer grants the CUSTOMER a simple license to operate the hardware in accordance with the operation specification. The respective software producer’s terms of use and licensing apply to the acquisition and maintenance of the Third-Party Software. Any installation, maintenance, servicing, or other services are not part of the performance by DMG; those services must be stipulated and, where applicable, compensated separately between the CUSTOMER and such producer. DMG merely ensures that the Third-Party Software and its updates is installed on the hardware separately and provides such for use with the printer as described by DMG insofar as the CUSTOMER has a valid usage and licensing agreement with the producer of the Third-Party Software. The CUSTOMER is required to comply with the instructions of the software producer.
(6) DMG disclaims any liability for any damage that results from any installation of the Third-Party Software that is either nonconforming or not authorized by DMG, and DMG assumes no warranties of any kind for defects, nonconformities and/or the omission present in the Third-Party Software. There shall be precluded any claims to any reduction in price/subsequent performance against DMG in connection with nonconformities in or caused by the Third-Party Software.
(7) The CUSTOMER is required to operate the hardware and the software in keeping with the instruction and operation manuals. The specification in the user documentation is exhaustive as regards the facts relating to the hardware or Third-Party Software. The hardware and corresponding Third-Party Software are not medical products, but are used for the manufacture of medical products (custom-made products) and are operated in a healthcare-provider environment. For this reason, the CUSTOMER is required to operate and to monitor the hardware and the Third-Party Software in compliance with the requirements set forth in provisions of law governing medical products and to use that hardware and software in accordance with their intended purpose, as specified by DMG; in particular, the CUSTOMER shall guarantee – in the event of resale – that the hardware is traceable and recoverable.
(8) The foregoing warranty contemplated by Part A, Section 6, and the liability contemplated by Part A, Section 7, relate only to the hardware and not to the Third-Party Software and shall be rendered by DMG to the extent described only if, when operating the hardware, the CUSTOMER complies with the instructions specified by DMG. Further disclaimers of liability and/or disclaimers and/or refusals of warranty actions by DMG are given, if (i) the CUSTOMER uses software from third parties to operate the hardware which have not been supplied or approved by DMG and/or (ii) changes to the hardware, repairs to the hardware, or other encroachments into the control units, the motor, or regarding any mechanical and/or electrical functions – which have not been authorized by DMG – have been effectuated regarding the hardware; and/or (iii) nonconformities exist in the hardware that were caused at the CUSTOMER’s through ancillary or consequential damage such as water or overheating damage, electrical discharges, misuse, neglect, or improper storage or usage; and/or there exists a system environment for which DMG is not responsible; and/or (iv) the CUSTOMER uses the hardware other than as intended by DMG and/or the CUSTOMER operates the hardware in breach of applicable medical product law, unless the CUSTOMER evinces that the abovementioned facts and circumstances are not causative for the occurrence of the nonconformity.
(9) During any warranty work (see Part A, Section 6, above), DMG can loan out to the CUSTOMER a replacement for the nonconforming hardware. Besides in the case of performances expressly inclusive of data backups, DMG disclaims all liability for the loss of data, provided the damage would not have occurred within the CUSTOMER’s sphere of responsibility, had the data been backed up properly. A proper data backup shall be presumed whenever the CUSTOMER backs up its data at least daily in a machine-readable form and, by extension, guarantees that those data can be recovered with reasonable efforts. Extending beyond the foregoing, DMG’s liability for the loss of data shall be limited to expenditures typical of recovery efforts in cases involving wrongful intent and gross negligence, which expenditures would have arisen had the data been backed up properly.
(10) The execution of maintenance agreements concerning third-party software in the hardware shall be effected by the CUSTOMER in its sole responsibility.