Terms and Conditions
GENERAL TERMS AND CONDITIONS
OF
TOPCON FINLAND MEDICAL,
TOPCON EUROPE MEDICAL B.V.:N SUOMEN SIVULIIKE
(hereinafter referred to as "Topcon")
Update March 2026
I. GENERAL CONDITIONS
Article 1. Applicability
1.1. These Terms, including its Annexes, as listed in Article 34, govern the sale, rental and/or licensing of the Products being provided by Topcon to Customer, as identified in the Quote or Purchase Order Confirmation. Topcon and Customer can be jointly referred to as the “Parties” and individually as a “Party”.
1.2. Customer's access to and use of the Products is subject to these Terms, any applicable Policies as shared by Topcon, as applicable to the relevant Product. General terms of purchase of the Customer are herewith explicitly rejected.
1.3. In case of conflict, the following order of precedence applies: (i) a duly executed master or specific agreement signed by both Parties; (ii) the Purchase Order Confirmation (including any schedules expressly incorporated therein); (iii) these Terms (excluding Annexes); (iv) Annexes to these Terms, excluding the DPA; and (v) applicable Policies. For data protection matters, the DPA (Annex I) provisions prevail over conflicting provisions in these Terms.
1.4. In order to offer and deliver any and all of the Products efficiently, and to be able to continuously optimize our way of working, Topcon reserves the right to unilaterally and periodically make Amendments to these Terms. Each time amended Terms are available on the Website of Topcon, visitors of the Website of Topcon shall be informed of such Amendments through a banner or pop-up on the webpage, which will be shown for a timespan of thirty (30) days. Should the Amendments to the Terms constitute a material change, Customer has the option to terminate the Agreement with a notice period of thirty (30) days, by registered letter, to: Topcon Europe Medical B.V. (legal department) Essebaan 69, 2908 LJ, Capelle aan den IJssel, The Netherlands.
Article 2. Offers and Agreement
2.1. All of Topcon's Quotes are non-binding until accepted by Customer and confirmed by Topcon in writing through a Purchase Order Confirmation, or upon Topcon’s commencement of performance in line with the Quote. Customer may not cancel or reschedule the order once it has been confirmed by Topcon unless Customer has received the prior written of Topcon. In case Topcon agrees to a cancellation or a reschedule, Customer shall remain liable for all direct costs incurred by Topcon.
2.2. Customer guarantees the accuracy and completeness of the information provided, by or on its behalf, to Topcon, on which Topcon bases its offer. Customer shall promptly notify Topcon in writing of any changes to such information during the course of the Agreement.
Article 3. Prices and Payment
3.1. Except as expressly stated otherwise, all prices are exclusive of VAT and other taxes, duties, levies, import/export charges, shipping, insurance and installation.
3.2. Topcon may adjust prices to reflect changes in cost price factors (such as costs of (raw) materials, government measures, freights, exchange rates, taxes etc.) occurring after Purchase Order Confirmation and before Delivery. Topcon will notify Customer in writing of a price increase. If Customer does not object in writing within fourteen (14) days, the increase is deemed accepted; Customer may terminate the affected order within the same period if the increase exceeds five percent (5%), to the fullest extent such late payment interest and collection costs are permitted under Applicable Law.
3.3. Payment is to be made on the agreed date and in the currency indicated by Topcon. In case no specific date for payment has been agreed upon, payment has to be made within thirty (30) days net after the invoice date. Objections to an invoice must be made prior to the payment date of the invoice.
3.4. In case Customer fails to meet their payment obligations in time, Topcon shall immediately be entitled, without any written notice being required, to charge, in addition to statutory interest, an interest of 1,5% per month plus reasonable collection costs (including legal fees) regarding outstanding amounts.
3.5. Topcon may suspend deliveries and services until all overdue amounts are paid in full. Topcon’s right to suspend deliveries shall be notwithstanding any other rights of Topcon, for example, to claim immediate fulfilment of any (payment) obligations and irrespective whether any due amounts have already been invoiced or not.
3.6. Payments by Customer shall be deemed to have been made first to settle accrued interest, and (extra) judicial costs, and thereafter they shall be charged to the oldest debt, irrespective of any indications made by Customer.
II. HARDWARE TERMS
II.A HARDWARE PURCHASE TERMS
Article 4. Delivery
4.1. Estimated Delivery dates are stated on the Purchase Order and are not of the essence.
4.2. In the event of a significant delay exceeding thirty (30) days beyond the estimated delivery date, and not caused by the Customer or Force Majeure, the Customer may provide written notice to Topcon requesting delivery within a reasonable period (not less than fourteen (14) days). If Topcon fails to deliver within such period, the Customer may terminate the affected order without penalty and receive a refund of any amounts paid for undelivered Products.
4.3. Unless agreed otherwise, all Hardware and spare parts will be delivered (the “Delivery”) as follows;
4.3.1. For Delivery to Reseller; FCA Nieuwerkerk aan den IJssel (The Netherlands) Incoterms® 2020;
4.3.2. For Delivery to end Customer; DAP [Customer location] Incoterms® 2020;
Article 5. Damages
5.1. All damages and loss apparent upon receipt of the Products must be notified immediately by the Customer to the carrier upon Delivery.
5.2. Damages that are not-apparent and any loss must be notified within five (5) business days after discovery and within the applicable warranty period.
Article 6. Trade-in Policy
If a trade-in credit is specified in the Quote, the following terms shall apply:
6.1. Timing and Eligibility. Customer shall return the Trade‑in Hardware to the Topcon‑designated facility within forty‑five (45) calendar days from the date of de‑installation. Timely return is a strict requirement for eligibility for the trade‑in credit. No extensions, exceptions, or waivers will be granted. The Customer is solely responsible for ensuring that the Trade‑in Hardware is returned on time and in the condition agreed between the Parties.
6.2. Ownership. Upon request by Topcon, Customer shall provide satisfactory evidence of ownership of the Trade‑in Hardware. Topcon reserves the right to reject the trade‑in if such evidence is not provided or is deemed invalid. The Trade‑in Hardware must be free of any third‑party rights, liens, or encumbrances.
6.3. Inspection and Acceptance. Topcon shall have up to fifteen (15) calendar days after receipt of the Trade‑in Hardware to inspect it and verify that it meets the agreed‑upon condition. Acceptance is at Topcon’s sole discretion and may be withheld if the Hardware is incomplete, non‑functional, damaged, or otherwise not in the agreed condition. The trade‑in credit shall be applied only upon Topcon’s written confirmation of acceptance. Title to the Trade‑in Hardware shall transfer to Topcon upon acceptance.
6.4. Shipping and Risk of Loss. Topcon will cover shipping costs only if the Customer uses Topcon‑authorized carriers and complies with Topcon’s shipping instructions. The Customer is responsible for proper packaging and secure preparation of the Trade‑in Hardware for transport. Risk of loss remains with the Customer until Topcon confirms receipt of the Trade‑in Hardware at the designated facility.
Article 7. Reservation of Title
7.1. Topcon Reserves Title and Ownership to all Hardware (including Rented Hardware) until fully paid for by the Customer. Until title passes, Customer shall not pledge, encumber or dispose of the Hardware other than in the ordinary course of business; any receivables arising from resale are hereby pledged to Topcon upon first request.
7.2. Upon default of payment by Customer, Topcon is entitled to retake possession of the Hardware as installed On-Site and Customer irrevocably permits access to premises to do so. Customer shall promptly inform Topcon of events affecting ownership of the installed Hardware or financial stability of the Customer (including bankruptcy, seizure or change of control).
II.B HARDWARE RENTAL TERM
This Section II.B applies only if Customer is renting this Hardware as specified in the Quote.
Article 8. Rented Hardware
8.1 Topcon agrees to rent to Customer the Rented Hardware for the Rental Term. Specific conditions such as Rental Fees, payment terms and Delivery dates shall be further detailed in the Quote. The Rental Term, unless otherwise specified in the Quote, shall automatically renew for additional periods equal to the original duration and for a maximum period of 4 (four) years, unless either Party gives the other written notice of non-renewal at least thirty (30) days prior to the end of the then-current rental term.
8.2 Delivery of the Rented Hardware takes place in accordance with Article 4 under Section II.A of these Terms.
Article 9. Customer’s Right to Use Rented Hardware
9.1 Customer shall have no right, title, or interest in the Rented Hardware other than the right to use it during the Rental Term.
9.2 All risk of loss or damage to the Rented Hardware is assumed by Customer, until it is returned to Topcon’s premises.
Article 10. Customer Responsibilities
10.1. Customer shall: (a) use the Rented Hardware only for its intended purpose and in accordance with Topcon's instructions and documentation; (b) keep, at its own expense, the Rented Hardware in good condition, reasonable wear and tear excepted; (c) not modify, alter, or add to the Rented Hardware without Topcon's written consent (including label, serial number or other identification marks of Topcon); (d) not sub rent, lend, or transfer the Rented Hardware; and (e) provide a suitable environment for the Rented Hardware as specified in Topcon's documentation.
10.2. Topcon may enter any premises under Customer’s control to inspect the Rented Hardware and may remove it if in Topcon’s opinion it is being abused or used beyond its capacity. Customer shall not remove the Rented Hardware from the agreed location without the consent of Topcon.
10.3. Customer acknowledges and agrees that it is renting the Rented Hardware “as is” and that Topcon has not, nor shall it be deemed to have, given or made any condition, warranty, representation or agreement of any nature whatsoever, oral or written, express or implied, statutory or otherwise.
10.4. Customer shall promptly notify Topcon of any damage to or malfunction of the Rented Hardware. If the Rented Hardware is damaged as a result of Customer's misuse, negligence, or failure to comply with the Terms, Customer shall be responsible for the cost of repairs or replacement.
10.5. Customer shall maintain adequate insurance coverage for the Rented Hardware during the Rental Term, naming Topcon as co-insured, in an amount not less than the full replacement value of the Rented Hardware. Upon request, Customer shall provide Topcon with evidence of such insurance.
Article 11. Return of Hardware
11.1. Upon expiration or termination of the Rental Term, Customer shall (a) return, unless agreed otherwise at Customer's own expense, the Rented Hardware to the site of Topcon in good condition, reasonable wear and tear expected; and (b) delete all personal data processed on and/or contained on the Rented Hardware.
11.2. If Customer fails to return the Rented Hardware within ten (10) business days after expiration or termination of the Rental Term, Topcon may - in addition to continue charging the monthly Rental Fee - (a) charge Customer a Late Return Fee as specified in the Quote, and/or (b) retake possession of the Rented Hardware wherever located, and Customer hereby authorizes Topcon to enter Customer's premises for such purpose.
11.3. If the Rented Hardware is lost, stolen, damaged beyond repair, or not returned within thirty (30) days of the due date, Customer shall pay Topcon the full replacement cost of the Rented Hardware (which shall be at least the commercial value of the Rented Hardware). In addition to any accrued late fees.
Article 12. Option to Purchase
12.1. If specified in the Quote, Customer may have the option to purchase the Rented Hardware at the end of the Rental Term for a price specified in the Quote or at fair market value (less any applicable discount), as determined by Topcon.
12.2. To exercise this option, Customer must provide Topcon with written notice at least thirty (30) days prior to the end of the Rental Term and must not be in default under this Agreement.
III. SOFTWARE TERMS
This Section III applies only if Customer is licensing Software Services as specified in the Quote. These Software Terms do not apply to the licensing of any Software Platform as made available by Topcon, such as but not limited to Harmony or RDX as well as AI applications.
Article 13. License Grant and Restrictions
13.1. Subject to Customer's compliance with these Terms and payment of the applicable Subscription Fees, Topcon grants Customer a non-exclusive, non-transferable, non-sublicensable license during the Subscription Term to access and use the Software for Customer's internal business purposes.
13.2. Customer may allow its authorized employees, contractors, and agents to access and use the Software, provided that Customer shall be responsible for ensuring their compliance with these Terms.
13.3. The license granted herein is subject to these Terms and any applicable EULA.
13.4. Topcon may modify, update, or enhance the Software from time to time, provided that such modifications, updates, or enhancements do not materially decrease the overall functionality of the Software.
Article 14. Access and Security
14.1. Topcon will provide Customer with the necessary credentials to access the Software. Customer is responsible for maintaining the confidentiality of such credentials and for all activities that occur under Customer's account.
14.2. Customer shall notify Topcon immediately of any unauthorized use of Customer's account or any other breach of security to that end upon becoming aware and/or being made aware of such unauthorized usage, for as long as Customer has access to the Software. Customer shall implement appropriate access controls to ensure that only authorized users have access to the Software.
Article 15. Customer Data
15.1. Customer is solely responsible for the accuracy, quality, integrity, legality, and appropriateness of all Customer Data and shall implement and maintain appropriate technical and organizational measures to protect the security, confidentiality, and integrity of Customer Data. As between Customer and Topcon, Customer owns all Customer Data.
15.2. Customer authorizes Topcon to use Customer Data to: (a) Provide, maintain, and improve the Software; (b) Monitor performance and ensure proper operation of the Software; (c) Analyze usage patterns to enhance user experience; (d) Respond to customer service requests and provide technical support; (e) Detect, prevent, and address technical issues and security matters; (g) Comply with applicable laws and regulations.
15.3. To the extent technically feasible, and where not necessary for the provision, maintenance, or support of the Services, Topcon shall use anonymized Customer Data for the purposes described in this Section. Personal Customer Data shall remain protected in accordance with the DPA (Annex 1) for as long as it remains non-anonymized.
15.4. If Customer provides any Feedback, Topcon shall have a royalty-free, perpetual, irrevocable right to use such Feedback without restriction.
IV. COMMON PROVISION
Article 16. Trial Program
This Article 16 applies only if Customer is participating in a Trial Program as specified in the Quote.
16.1 The Initial Trial Period, being thirty (30) days, will commence on the Trial Start Date and may be extended for additional thirty (30) day periods by mutual written agreement of the Parties, which may be in the form of an email exchange between the designated representatives of each Party.
16.2 No Fees During Trial. No purchase or fees will be charged during the Trial Period. Customer shall be responsible for any costs associated with installation, configuration, or other services provided in connection with the Trial Program, as specified in the Quote.
16.3 Equipment for Trial. Topcon will provide Customer with the necessary Product to use during the Trial Period. If the Product is a Hardware product, it shall be delivered pursuant to the terms in Section II.B (Hardware Rental Terms) to the extent applicable to a trial arrangement. For the avoidance of doubt, the insurance requirements in Section 10.5 shall also apply.
16.4 Conversion to Purchase or Rental. At any time during the Trial Period, Customer may elect to purchase or rent the Hardware or to subscribe to a license for Software by executing a new Quote or as specified in the original Quote.
16.5 If the Quote specifies automatic conversion terms, upon expiration of the Trial Period, the trial will automatically convert to either a purchase or rental of the Hardware under the terms specified in the Quote and/or Subscription to the Software, unless Customer provides written notice of its intent not to convert at least five (5) business days prior to the end of the Trial Period.
16.6 If Customer does not execute a new Quote or if automatic conversion terms do not apply or are declined by Customer, Customer's right to use the Hardware and/or Software shall automatically terminate at the end of the Trial Period.
16.7 If Customer does not convert to a purchase or rental and/or license for Software subscription, or if the Trial Program is terminated in accordance with Section II.B and Annex 2 (Definition 26. Rental Term), Customer shall return any Hardware provided by Topcon in accordance with the same Section II.B, Article 11. Return of Hardware.
Article 17. Installation and Training
Topcon shall provide: (i) installation services by a certified technician for the Products as specified in the Quote; and (ii) initial training and training material for Customer’s personnel on the proper use and operation of the Products. Customer is responsible for ensuring that all personnel using the Products have received appropriate training.
Article 18. On-Site Access
18.1 In the event that Topcon provides Customer with any On-Site Services, Customer is responsible for ensuring a safe working environment at Customer’s premises, within the broadest meaning of any and all Applicable Laws.
18.2 Customer commits to take all necessary precautions to ensure the health and safety of Workers which includes providing the Site free from recognized hazards that may cause harm, in consistency and compliance with Applicable Laws.
18.3 Should the Workers be of the opinion that the Site does not comply to such health and safety conditions, the Workers shall be entitled not to proceed with the On-Site Services, without Topcon being liable in any way and Topcon shall be able to charge Customer any cost incurred (including but not limited to travel costs).
18.4 Topcon reserves the right to cancel or reschedule installation if, in its reasonable discretion, the installation site is not suitable. A Return Service Fee may apply.
Article 19. Warranty
19.1 Warranty Period. Topcon warrants that the Products are free from defects in materials and workmanship and where applicable with the requirement of Applicable Laws to medical devices for a period of (i) 24 months from Delivery for Topcon Products, (ii) 12 months from Delivery for Non-Topcon Products and Accessories and (iii) 90 days from Delivery for Parts).
19.2 No Implied Warranty. Except as expressly provided in a separate agreement executed by the Parties, the Products are provided "as is" and Topcon disclaims all other warranties, express or implied, including without limitation warranties of merchantability, fitness for a particular purpose, accuracy, or non-infringement, to the extent permitted by Applicable Law. Topcon does not warrant that the Products will be uninterrupted or error-free or that the Products will meet Customer's specific requirements. This disclaimer does not limit any express warranties set forth in these Terms with respect to the Products ordered by Customer. Nothing in this clause shall limit or exclude liability for death or personal injury that cannot be excluded under mandatory provisions of Applicable Law, including applicable medical device regulations.
19.3 Exclusion of Warranty. No warranty period shall be applicable in case the Customer has (i) processed, repaired, abused, misused or modified the Products, or (ii) allowed third parties to use, process, repair, abuse or modify the Products, or (iii) delivered the Products to third parties, or (iv) has not used the Products in accordance with maintenance and application procedures provided to it by Topcon, or (v) fails to meet any of its other obligations towards Topcon. In case any of the aforementioned events has occurred, Topcon shall not be obliged to repair any Product, or to reimburse the purchase price of the relevant Product to Customer.
Article 20. Service and Support
20.1 Topcon shall provide service and support for the Products in accordance with Policies referenced in the Purchase Order or Purchase Order Confirmation. Customer's sole and exclusive remedies for any unavailability, non-performance, or other failure of the Products to perform are those set forth in these Terms.
20.2 Extended service and support plans may be available for purchase as specified in the Quote and upon signature of a separate agreement.
Article 21. Obligations of the Customer
21.1 Customer is responsible for their own equipment and software to obtain access to the internet in order to ensure the quality and the integrity of the systems and technical infrastructure of the Hardware required for the provision of services, Customer will ensure that: (i) only authorized and capable persons shall have access to the systems of Topcon; (ii) Customer is not misusing and or acting in breach of any Applicable Law and/or regulations by using Topcon’s system; (iii) Customer has sufficient rights to meet its obligations arising from the agreements entered into with Topcon, if any; (iv) Customer’s systems, also entailing the software with which Customer is connected to the system of Topcon, are free of any defects and/or viruses, that can cause damages to Topcon’s system.
21.2 Recall of Hardware. Customer shall cooperate and comply with all mandates and/or instructions by the competent national authorities and/or Topcon relating to recall of any Products. Topcon will reimburse Customer for reasonable, documented and pre-approved costs strictly necessary to execute any recall procedures, as instructed by the authorities or Topcon except where the conduct of Customer, and/or any other person(s) engaged by Customer has given rise to the recall of any Topcon Hardware.
Article 22. Obligation of Customer acting as Reseller
22.1 If Customer has obtained Topcon prior authorization, Customer shall be entitled to resell the Products in the Territory separately defined between Customer and Topcon.
22.2 Customer shall obtain and maintain all necessary licenses, permits, and approvals required to legally market and sell the Products.
22.3 Customer shall: (i) promptly report to Topcon any suspected or actual health or safety risks and any of their customer complaints related to the Products; (ii) maintain appropriate records of their customers; (iii) follow Topcon’s instructions regarding recalls or corrective actions; and (iv) retain adequate documentation of marketing materials and their customer communications, particularly regarding complaints.
22.4 Customer shall ensure its personnel are appropriately trained in relation to the Products and applicable regulations, and shall comply with all applicable anti-money laundering laws.
22.5 Customer agrees to comply with the Topcon Business Partners’ Code of Conduct - TOPCON.
Article 23. Return Policy
23.1 To be eligible for a return, Customer shall have obtained a RMA number from Topcon and the Product must be; (i) in unused/new condition and in the original packaging; (ii) returned within thirty (30) calendar days of receipt thereof by the Customer, to Topcon; (iii) including a proof of purchase (i.e. the accepted Purchase Order or Quote nr.).
23.2 The Return Policy does not apply to any (i) Rented Hardware or Trial Products; (ii) Product being dead on arrival (see Article 20) or (iii) wrong pricing, a wrong application of the discount or a wrong quotation if the order confirmation sent by Topcon was not disputed by Customer within 2 working days after being sent or (iv) Customized marketing materials.
23.3 There are certain situations where only partial Refunds might granted, at the discretion of Topcon; (i) Products with obvious signs of use/wear (outside of normal wear and tear); (ii) any Product not in its original condition, that is damaged or missing parts;
23.4 Refunds. Products shall be returned at Customer’s costs and c once Products return is received and inspected, Customer will be sent an email notification with the status of the Refund.
23.5 If the return has been approved, your Refund will be processed, and a credit will automatically be applied to your account minus a restocking fee of 20% of the net amount invoiced with a minimum of 250€ at Topcon’s discretion.
Article 24. Export Control
24.1. Customer may only export, re-export, sell, transmit, transfer, or otherwise make available, directly or indirectly, any Product, including any corresponding documentation, received from or owned by Topcon, if Customer is in compliance with any and all applicable national and international (re-)export control laws, rules and regulations
24.2. Customer will identify and obtain any and all export and re-export license requirements or other official authorization required to export and/or re-export the relevant Product as well as carry out any customs formalities for the export or re- export of the Product. Prior to any transfer of Product to a third party, Customer will ensure that (i) the transfer will not infringe any embargo imposed by the European Union, United States of America and/or United Nations; (ii) the Product to be transferred is not intended for use in connection with armaments, nuclear technology or weapons, if and to the extent such use is subject to prohibition or authorization, unless required authorization is provided; and (iii) the regulations of all applicable Sanctioned Party Lists of the European Union and the United States of America concerning the trading with entities, persons and organizations listed therein, are considered and followed.
24.3 Customer represents and covenants that it shall not export, re-export, sell, transmit, transfer, or otherwise make available, directly or indirectly, any Product received from or owned by Topcon, including any corresponding documentation, to a particular person or entity, if Customer has reason to believe that such person or entity will transfer or sell the Product in violation of this Article 24.
24.4. If required to conduct export control checks, Customer shall provide Topcon with all information pertaining to the recipient of the Product, the destination and the intended use thereof, as well as any applicable export control restrictions.
24.5. Topcon shall not be liable for, and Customer shall indemnify and hold Topcon harmless for and against, any damages, losses, liabilities, costs and expenses (including advisor’s fees) incurred or to be incurred as a result of any non-compliance by Customer with this Article 24 and/or any applicable export control regulations.
24.6. Any violation of Customer of this Article 24 and/or any applicable export control regulations constitutes a material breach of the Agreement, and Topcon reserves the right to seek appropriate remedies. As part of the contractual remedies that Topcon will have at their disposal, Topcon will be entitled to; (i) termination of the Agreement and (ii) a penalty amounting to fifty percent (50%) of the total value of the Agreement or the total price of all Products exported under the Agreement, whichever is higher, with a minimum penalty of 50.000 EUR.
Article 25. Limitation of Liability
This Article 25 applies to any liability on the part of Topcon, regardless of the legal basis of such liability.
25.1 Topcon shall never be liable for damages, losses and costs incurred or to be incurred as a result of untimely deliveries or deliveries made in part. For any other damages, losses and costs than those mentioned in Article 25.2 and notwithstanding the provisions of Article 5 of these Terms, and to the extent allowed under Applicable Laws, Topcon shall only be liable for damages which are accountable to willful misconduct or gross negligence on the part of Topcon, its employees and sub-contractors
25.2 In the event that Topcon is liable, Topcon shall only be liable for damages resulting from the willful misconduct or gross negligence of Topcon, provided, however, that Topcon shall in no event be liable for any indirect damages, loss of anticipated profits, loss of contracts, incurred losses, loss of savings and incurred expenses or other consequential damage
25.3 Topcon furthermore shall not be liable for damages where the amount of the damages exceeds the amount paid out to Topcon (and for which reasonable cover is provided) under their business liability insurance. If and to the extent that the incurred damage is not covered by a business liability insurance, but Topcon is liable on the basis of this Article 25, such liability is in any case limited to financial damage, which is the direct result of the acts or omissions of Topcon and such liability shall in any event be limited to the purchase price of the Products which have caused the damages in question.
25.4 The provisions of this Article 25 do not affect product liability based on mandatory provisions of Applicable law.
Article 26. Indemnification
Customer is liable for and shall indemnify and hold harmless Topcon (and its respective, employees, officers, directors, agents, and counsel) from and against any and all claims, demands, suits, damages, losses, liabilities, costs and/or expenses (including attorney’s fees and court or arbitration costs) (a) of third parties which arise out of or are related to the willful misconduct or gross negligence on the part of Customer, its group companies and/or its and their respective employees, agents and/or commissionaires; (b) resulting from a breach by Customer, its group companies and/or its and their respective employees, agents and/or commissionaires, of any of its and their (contractual) obligations towards Topcon, except in the event such claims, demands, suits, damages, losses, liabilities, costs and/or expenses are due to willful misconduct or gross negligence on the part of Topcon.
Article 27. No Waiver
The failure of Topcon to enforce any provisions of these Terms or respond to a breach by Customer or other parties shall not in any way constitute a waiver of Topcon’s right to enforce subsequently any provisions of these Terms or to act with respect to similar breaches.
Article 28. Security
28.1. In case Topcon has good reason to believe that Customer will not strictly fulfill its (contractual) obligations towards Topcon, Customer is obliged, at Topcon's first request, to provide satisfactory security in the form requested by Topcon
28.2. As long as Customer does not fulfill any of its obligations as set forth in these Terms , Topcon has the right to suspend the fulfillment of its obligations towards Customer without any form of compensation being due to Customer.
28.3. In case Customer fails to comply with Topcon's request as mentioned of these Terms within fourteen (14) days after having received a written notification, all obligations of Customer shall become due and payable.
Article 29. Non – Performance
29.1 If Customer fails to comply with any of their obligations under these Terms, Topcon reserves the right to terminate or suspend any agreement, reclaim Hardware, and seek compensation without owing any liabilities to Customer
29.2 Upon termination by Topcon under these Terms or any agreement, all claims against Customer become immediately due, and Topcon may suspend any further performance of their obligations under the Terms or the Agreement as a whole
29.3 If circumstances beyond Topcon's control prevent performance, Topcon may rescind agreements with Customer.
29.4 Circumstances beyond Topcon's control include actions (excluding willful misconduct and gross negligence) of persons engaged by Topcon, unsuitability of Product used by Topcon, third-party claims against Customer (other than those that are eligible for indemnification as described in Article 24.2), governmental restrictions, strikes, illness, transport issues, supplier delays, production disruptions, natural/nuclear disasters, war, or any similar events beyond Topcon's reasonable control.
Article 30. Intellectual Property Rights
30.1 The Customer hereby acknowledges that the IP Rights are and shall remain the property of Topcon, any of its group companies or the relevant third parties from which Topcon or its group companies has received a license to use the IP Rights. Topcon reserves the right to modify the IP Rights at any time.
30.2 Customer acknowledges and agrees that, in case any license to use any IP Rights granted to Topcon by a third party shall terminate or cease to exist for whatever reason, such termination may result in the (immediate) termination of the IP Rights License granted by Topcon to Customer. Topcon shall not be liable for any damages, losses, liabilities, costs and expenses (including advisor’s fees) incurred or to be incurred by Customer as a result of any termination of the IP Rights License.
30.3 Customer shall not, and shall not permit any authorized users to: (a) use the Software Services other than as permitted by this Agreement and any applicable EULA; (b) copy, modify, or create derivative works of the Software; (c) reverse engineer, decompile, disassemble, or otherwise attempt to discover the source code of the Software; (d) rent, lease, lend, sell, sublicense, assign, distribute, publish, transfer, or otherwise make available the Software to any third party; (e) remove any proprietary notices from the Software; or (f) use the Software in any manner that could damage, disable, overburden, or impair the Software or interfere with any other party's use of the Software.
Article 31. Confidentiality
31.1 The Receiving Party will not use the Confidential Information of the Disclosing Party for any purpose other than as necessary to fulfill its obligations or to exercise its rights under the agreement, and by Topcon to improve the Hardware and/or the Software Service (the “Purpose”). The Receiving Party will not disclose Confidential Information of the Disclosing Party to any third party; provided that the Receiving Party may disclose Confidential Information to its partners, officers, directors, employees, contractors, affiliates, agents, advisors, or representatives who need access to such Confidential Information for the Purpose and who are subject to written confidentiality obligations at least as stringent as the obligations set forth in this article 29. Each party accepts responsibility for the actions of its partners, officers, directors, employees, contractors, affiliates, agents, advisors and representatives, and will protect the other party’s Confidential Information in the same manner as it protects its own valuable confidential information, but with no less than reasonable care. The Receiving Party will promptly notify the Disclosing Party upon becoming aware of a breach or threatened breach hereunder and will cooperate with any reasonable request of the Disclosing Party in enforcing its rights.
31.2 Confidential Information does not include information which: (i) is known by the Receiving Party prior to receipt from the Disclosing Party, without any obligation of confidentiality; (ii) becomes known to the Receiving Party directly or indirectly from a source other than one having an obligation of confidentiality to the Disclosing Party; (iii) lawfully becomes publicly known or otherwise publicly available, except through a breach of the agreement; or (iv) is independently developed by the Receiving Party without use of or access to the Disclosing Party’s Confidential Information. The Receiving Party may disclose Confidential Information pursuant to the requirements of applicable law, legal process or government regulation, but only after it notifies the Disclosing party (if legally permissible) to enable the Disclosing party to seek a protective order or otherwise to contest such required disclosure, at Disclosing Party’s expense.
Article 32. Data Protection and Security
Under specific circumstances Topcon may and shall process Personal Data only as a data processor acting on behalf of Customer in order to perform its obligations under these Terms and in line with Applicable Privacy Laws, Annex I, including its sub-annexes, is applicable to such processing activities. Should Topcon process additional personal data or for other purposes than detailed in Annex I, Parties will enter into a separate data processing agreement.
Article 33. Returns of Products.
In the event of returns the Product by Customer to Topcon (i.e.in line with rental terms (Article 11), Trade-in Policy (Article 6) or Trial Program (Article 16.7), Customer will ensure that the Product is purged from all Personal Data stored on the Product, prior to its return to Topcon. Topcon’s discovery of residual data shall not be considered as processing of personal data under the GDPR. Topcon will promptly notify the Customer and agree on how to settle the immediate deletion of the Personal Data. Such deletion shall occur automatically. Customer shall implement necessary measures to prevent unauthorized access to personal data by Topcon.
Article 34. Applicable law; Competent Court
Norwegian law shall be applicable to all legal relationships between Customer and Topcon. The provisions of the Vienna Convention on the International Sale of Goods (1980) shall not apply. All disputes arising under or in connection with (the performance of) any agreement between you and Topcon as well as any disputes regarding these Terms shall be brought exclusively before the District Court of Helsinki.
Article 35. List of Annexes to these Terms
Annex I. Data Processing Agreement
Annex II. Definitions
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ANNEX I. DATA PROCESSING ANNEX
Article 1. BACKGROUND AND PURPOSE
- Following the purchase or rental of the Hardware and/or the license of Software by Customer under the Terms, Data Processor may, from time to time, access, use, delete, modify, maintain, collect and/or transfer personal data on behalf of the Data Controller in order to perform the services (such as repair or maintenance of Hardware or license to Software) agreed upon in the Terms (“Main Services”). In such cases, in accordance with Section 30 of the Terms , this Annex I (“Data Processing Annex” or “DPA”) is applicable.
- The processing by Topcon may comprises exclusively the following type of PD (name, surname, e-mail address, civil registration number, Medical data related to eye disease and the user’s name, company, address, email address, credit card information, login credentials (user name, password), IP address and related information) and the following categories of data subjects (Users of Topcon’s Products and Patients of the Customer).
Article 2. SCOPE
- The Data Processor is authorized to process personal data on behalf of the Data Controller pursuant to the terms set forth in this DPA. The PD will not be changed, modified or collected by Topcon. Processing, maintaining, access, deletion, transfer, and use may occur in only connection with the sale of a Product and the provision of Services.
- If this DPA is contrary to – or incompatible with – the provisions in the Terms or the provisions in specific agreement(s) agreed between the Parties, the provisions in this DPA will prevail. To the extent that provisions in specific agreement(s) are intended to replace the provisions of this DPA, such provisions will only prevail if these do not cause Data Processor or Data Controller to be in breach of Applicable Privacy Laws.
- The Data Processor may process PD pursuant to only the documented instructions provided by the Data Controller (”Instructions”). This DPA constitutes the Instructions at the time of signing which are: the Data Processor shall Process the Personal Data in order for the Data Processor and its Sub-Processors to provide the Main Services in accordance with the Agreement.
- The Instructions may be amended at any time or further clarified by the Data Controller, in accordance with Section 9.
Article 3. THE DATA PROCESSOR’S OBLIGATIONS
- Technical and organizational safety measures
- The Data Processor is responsible for implementing the technical and organizational measures (the “TOM”) necessary to ensure an appropriate level of safety to the data being processed. The TOM shall be carried out taking into account the current technical level, implementation costs, and the nature, extent, composition, and purpose of the processing concerned, as well as the risks of varying probability and severity of the rights of natural persons.
- A full list of the TOM referred to in Article 4.1.a shall be made available to the Data Controller upon their first request.
- Data Processor guarantees Data Controller that Data Processor will implement the appropriate TOM in such a way that Data Processor’s processing of personal data meets the requirements of the Applicable Privacy Laws.
- Employees and Subcontractors
- Data Processor shall ensure that employees and subcontractors who process PD for the Data Processor (i) have committed to confidentiality or are subject to appropriate statutory confidentiality; (ii) only process personal data in accordance with the Instructions and (iii) only have access to PD is limited to those for whom it is necessary to process personal data in order to meet Data Processor’s obligations towards Data Controller.
- Documentation of compliance with obligations
- Data Processor shall, upon written request, document that the Data Processor (i) meets his/her obligations under this DPA and in accordance with the Instructions and (ii) complies with the provisions of Applicable Privacy Laws currently in force regarding the personal data processed on behalf of Data Controller.
- Data Processor’s documentation thereof must be made available within a reasonable time period.
- Data Processor shall, upon written request, contribute to and provide access to audit. An audit must be carried out by an independent third party selected by Data Controller and approved by Data Processor. Data Processor cannot reject a proposed third party without reasonable justification. The independent third party must sign a non-disclosure Agreement with the Data Processor. A request for an audit must be made with at least seven (7) days of notice.
- Records of procesing activities. Since the data processing concerns, inter alia, the health information of Data Controller’s customers/patients, Data Processor must continuously keep a legally required record of the processing activities.
- Data Controller must be notified of a Security Breach without undue delay.
- Assistance. To the extent necessary and reasonable, Data Processor shall assist with Controller’s obligations under Applicable Privacy Laws and Data Processor reserves the right to charge (reasonable costs) for such assistance.
Article 4. DATA CONTROLLER'S OBLIGATION
- Data Controller shall ensure that all Data processed have been collected in accordance with the provisions of the Applicable Privacy Laws. Therefore Data Controller warrants Data Processor that it has obtained all authorization and permits to transfer the data to Data Processor for the completion of the Main Services.
- Data Controller shall remain the sole responsible for the transfer of the data to Data Processor in order to enable the provision of the Main Services by Data Processor. In no event shall Data Processor be responsible of the loss, breach, accidental destruction of the Personal Data before it has been given access to the Data for the completion of the Services.
Article 5. SUB-DATA PROCESSORS
- The Data Processor may use a third party for the processing of personal data for the Data Controller which Data Controller acknowledges (“Sub-Data Processor”) the list of which is available upon request. For the avoidance of doubt, the list of Sub-Data Processors is updated at the own discretion of the Data Processor, the only duty of Data Processor, regarding this Article 5.1., towards Data Controller is therefore to inform them correctly on appointed Sub-Data Processors.
- The Data Controller hereby agrees that the Data Processor may allow the Data Processor’s affiliates (where Affiliate of any particular person means any other person controlling, controlled by, or under common control with such person) including parent company, Topcon Corporation (Japan), to process personal data for the Data Controller as Sub-Data Processors.
- The Data Processor and the Sub-Data Processor shall enter into a written agreement that imposes on the Sub-Data Processor the same data protection obligations as the Data Processor (including pursuant to this DPA). The Data Processor is directly respomsible for the Sub-Data Processor's processing of the personal data in the same manner as if the Data Processor himself/herself had carried out the processing.
Article 6. TRANSFER TO THIRD-PARTY COUNTRIES AND INTERNATIONAL ORGANIZATIONS
- The Data Processor may only (in addition to transferring to Topcon Corporation-Japan) transfer personal data to third-party countries (i.e., countries outside the EU/EEA) or international organizations to the extent that this is stated in the Instructions provided by the Data Controller or is otherwise approved in writing by the Data Controller.
- In any event, the transfer of personal data may only occur to the extent permitted by the personal data legislation currently in force.
Article 7. DATA PROCESSING OUTSIDE OF THE INSTRUCTIONS
- The Data Processor may process personal data outside of the Instructions in cases where it is required by applicable law.
- When processing personal data outside the Instructions, Data Processor must notify Data Controller of the reason for this. The notification must be made prior to the processing and must include a reference to the regulatory requirements governing the processing
- Notification shall not be made if notification would be contrary to applicable law.
Article 8. MODIFICATION OF THE INSTRUCTIONS
Prior to any modification of the Instructions, the Parties shall, to the greatest extent possible, discuss and agree upon, if possible, the implementation of the changes, including the implementation time and costs.
Article 9. LIABILITY AND LIMITATIONS OF LIABILITY
The Parties are liable in accordance with the Section 23 of the Terms.
Article 10. TERMINATION
- The Data Processor’s authorization to process personal data on behalf of the Data Controller lapses upon termination the provision of the Main Services no matter the reason.
- Under this Data Processing Agreement, the Data Processor and Sub-Data Processors shall return all personal data processed by the Data Processor to the Data Controller upon termination of the Data Processing Agreement to the extent that the Data Controller is not already in possession of the personal data. Subsequently, the Data Processor is required to delete all personal data from the Data Controller. The Data Controller may request the documentation necessary thereof.
ANNEX II. DEFINITIONS
- “Agreement” means the entire agreement between the Parties regarding the purchase or rental of the Products, including these Terms and any applicable Policies.
- “Amendments” means update, alteration or change made by Topcon to these Terms.
- “Applicable Law” means all applicable laws and regulations (including, without limitation, export control laws and Applicable Privacy Laws) of the country (or state) in which the relevant Topcon entity has its principal place of business, without regard to conflict of law principles.
- “Applicable Privacy Laws” means Regulation (EU) 2016/679 (the “GDPR”), effective May 25, 2018, together with any implementing laws of EU Member States, and, where applicable, the UK Data Protection Act 2018, the UK GDPR, and any other applicable data protection legislation, as amended from time to time.
- “Confidential Information” means any and all non- public information disclosed by one party (the “Disclosing Party”) to the other party (the “Receiving Party”) in any form or medium, whether oral, written, graphical or electronic, pursuant to the agreement, that is designated confidential or proprietary, or that a reasonable person should understand is confidential or proprietary. Confidential Information includes, but is not limited to: the terms of the agreement, information related to either party’s technology, whether or not patentable or copyrightable, Hardware, Software, Software services, know-how, trade secrets, specifications, business plans, pricing information, promotional and marketing activities, finances and other business affairs, Topcon Hardware and anything else created or developed by Topcon in connection with the agreement and the Hardware. Customer will not remove or destroy any proprietary markings or restrictive legends placed upon or contained in the Hardware, Software Service and/or related materials.
- “Customer” means the legal entity identified in the relevant Quote or Purchase Order Confirmation.
- “Customer Data” means all data provided by or on behalf of Customer to Topcon.
- “Data Controller” means Customer, as defined under Applicable Privacy Laws..
- “Data Processor” means Topcon, as defined under Applicable Privacy Laws.
- “DPA” means the Data Processing Agreement.
- “EULA” means the End User License Agreement.
- “Feedback” means any suggestions, ideas, enhancement requests, or other feedback provided by the Customer regarding the Software or Services.
- “Force Majeure” has the meaning given in Article 6:75 of the Dutch Civil Code (DCC).
- “Hardware” means the medical equipment and related accessories sold or rented by Topcon to the Customer, as specified in the Purchase Order Confirmation.
- “Initial Trial Period” means thirty (30) calendar days from the Trial Start Date.
- “IP Rights” means, but is not limited to, any and all intellectual property rights including but not limited to patents, trademarks, software, tradename and copyrights.
- “Late Return Fee” means a monthly fee, chargeable at Topcon’s sole discretion, for late return of rented Hardware, capped at 2% of the commercial value of such Hardware.
- “On-Site” and “On-Site Services” means at the Customer’s location and Services performed specifically at the Customer’s location, including installation, commissioning, training, and site assessments.
- “Parts” means consumables and components such as batteries, chargers, cables, valves, hoses, and other mechanical parts used in connection with the Products.
- “Personal Data” has the meaning given in Articles 4 and 9 of the GDPR.
- “Policies” means Topcon’s applicable documentation, including the Software EULA, Service Level Agreement, and any service policies applicable to the Products under these Terms.
- “Products” means the Hardware, Software, and related Services.
- “Purchase Order Confirmation” means the written confirmation issued by Topcon accepting a Customer’s purchase order.
- “Quote” means the quotation issued by Topcon describing the Products and/or Services to be provided.
- “Rental Fees” means the fees payable for rental of Hardware, as specified in the Quote and/or Purchase Order Confirmation.
- “Rented Hardware” means the Hardware rented by the Customer, as specified in the Quote and/or Purchase Order Confirmation.
- “Rental Term” means the duration of the rental, which, unless otherwise specified in the Quote, shall automatically renew for additional periods equal to the original duration as specified in the Quote, unless either Party gives the other written notice of non-renewal at least thirty (30) days prior to the end of the then-current Rental Term.
- “Return Service Fee” means the fee charged for handling returned Hardware, as specified in the Quote and/or Purchase Order Confirmation.
- “Security Breach” means any personal data breach involving accidental or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to Personal Data processed by Topcon on behalf of the Customer. Topcon shall notify the Customer of any such breach in accordance with Applicable Privacy Laws.
- “Site” means the premises of either the Customer or Topcon, as applicable in the relevant context.
- “SLA” means the Service Level Agreement.
- “Software” or “Software Services” means the data-driven software solutions developed and provided by Topcon, whether as standalone products or in conjunction with Hardware, including any platforms made available on a subscription basis. Further details are set out in the applicable EULA.
- “Subscription Fees” means the fees payable by the Customer for access to the Software, as specified in the Quote and/or Purchase Order Confirmation.
- “Subscription Term” means the duration of the Customer’s subscription to the Software, as specified in the Quote and/or Purchase Order Confirmation.
- “Terms” means these General Terms and Conditions of Sale of Topcon.
- “Topcon Products” means Products branded with the Topcon name or logo. “Non-Topcon Products” means Products not branded with the Topcon name or logo. “Accessories” means products that are separate from, but used in connection with, Topcon Products or Non-Topcon Products.
- “Trial Program” and “Trial Period” mean a program allowing the Customer to evaluate Hardware for a limited time.
- “Trial Start Date” means the date on which the Trial Period begins, typically the installation date at the Customer’s Site.
- “Website” means Topcon’s official website.
- “Workers” means Topcon’s employees, agents, and subcontractors acting on its behalf.