General terms and conditions for Inspire Medical Systems Inc.

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Inspire Medical Systems, Inc.
5500 Wayzata Boulevard, Suite 1600                                                      
Golden Valley, MN 55416
Vereinigte Staaten von Amerika (USA)
Telefon: +1 763-205-7970
Fax: +1 763-537-4310
E-Mail: [email protected]

(hierna ook wel "Inspire Medical Systems, Inc." of "ons" of "wij" of "ons" of "onze" of soortgelijke).

A. General Conditions - June 2016

I. Scope

  1. These general terms and conditions (GTC) apply to the products and corresponding services (hereinafter referred to collectively as “services”) of Inspire Medical Systems Inc. (hereinafter referred to as “Inspire”) in business relationships with its customers, which are entrepreneurs (hereinafter “customers”).

    These GTC are composed of general and special conditions. Special conditions take priority over general conditions and apply simultaneously. If multiple services from Inspire are used in a contract, then the special conditions pertinent to the corresponding service apply.
     
  2. The GTC also apply to future offers, contracts, deliveries, and services for the same customer, even if they have not been explicitly agreed to again separately. The version valid when the contract is concluded applies.
     
  3. Deviating, contradictory, or supplementary general terms and conditions of the customer will only be considered an integral part of the contract if and to the extent that Inspire explicitly agrees to their validity (including e-mails). This requirement for approval is applicable in all cases even, for example, when Inspire continues to provide services to the customer without reservation even after having been informed of the customer’s general terms and conditions.
     
  4. Individual agreements made with the customer for particular cases always take priority over these GTC, as long as such agreements are recorded in writing and signed by authorized representatives of all parties. Employees of Inspire are not authorized to make oral agreements that deviate from these GTC.
     
  5. Legally relevant declarations and notifications of the customer after the contract is concluded, particularly deadline setting, notices of defects, declarations of withdrawal or reduction must be in written form in order to be valid.
     
  6. References to the validity of legal requirements only serve clarification purposes. Even without such a clarification, the legal requirements apply as long as they are not directly amended or explicitly excluded by these GTC.

II. Contract Conclusion

  1. The contract with the customer enters into effect when an offer provided to the customer by Inspire is signed and Inspire receives the declaration of acceptance for this offer from the customer. Acceptance must be indicated in writing.
     
  2. Inspire reserves the right to make acceptance of orders for deliveries of Inspire products to the customer contingent on documented advance consultation or on certification of the customer for qualified application of this product in medical use.

III. Price and Payment Conditions

  1. The agreed services are provided to the customer by Inspire at the prices and subject to the conditions specified in the offer. The prices contained therein are binding.
     
  2. If nothing else has been agreed for the specific case at hand, the full agreed price is due within the thirty (30) days following receipt of the bill. Payments must be made to the bank account given on the bill as long as nothing else has been agreed.
     
  3. If the above payment period runs out without receipt of payment, the customer will be in default. Interest will be accrued on the price during the default period in accordance with the national laws. Inspire reserves the right to assert further damages for delayed payment, unless the customer can prove that there has been little or no damage caused. The right of Inspire to claim commercial interest due after due date from traders remains unaffected.
     
  4. Offset with counterclaims from the customer or withholding due to such claims is only permissible if the counterclaims are uncontested or determined to be legally valid. This does not apply if claims from the same contract of the customer are involved.
     
  5. Inspire has the right to make the delivery of products or provision of other services contingent upon full advance payment or payment of a security deposit if circumstances come to light after the contract has been concluded that might reduce the customer’s creditworthiness considerably (e.g. filing for bankruptcy).

IV. Liability

  1. Inspire’s liability for all rights and claims arising out of and in connection with the contract, contractual and non-contractual, is limited as follows, except as otherwise stated above:

    In the following cases Inspire is liable without restriction according to the legal regulations:

    a) for damages resulting from injury to life, bodily injury or health based injury on the basis of an intentional or negligent breach of duty by Inspire, its legal representatives or vicarious agents;

    b) for other damages based on an intentional or grossly negligent breach of duty by Inspire, its legal representatives or vicarious agents;

    c) if a defect was fraudulently concealed or a guarantee for the quality of the product was granted;

    d) for claims for damages under the Product Liability Act.
     
  2. In all other cases, Inspire is also liable for slight negligence, including its legal representatives and vicarious agents, only insofar as the damage is caused through a breach of essential contractual obligations (obligations, whose fulfillment is necessary for the proper execution of the contract in the first place and on whose compliance the client regularly trusts), whereas this liability is limited to the typical damages that were foreseeable for Inspire upon conclusion of the contract.
     
  3. Otherwise, Inspire's liability is excluded.

V. Data Protection

The data protection conditions of Inspire apply.

VI. Final Conditions

  1. Place of performance and the exclusive place of jurisdiction is Netherland; additionally, Inspire is  entitled to sue the customer at its place of business.
     
  2. The contract is governed by dutch law, excluding dutch international private law and the UN  Sales Convention (CISG).
     
  3. Should individual clauses become or be ineffective or unenforceable partially or in whole, this will not affect the effectiveness of the remaining clauses. The ineffective or unenforceable clause is replaced by a clause that comes closest to the economic purpose of this clause.
     
  4. The customer pledges to treat as confidential all materials, devices, documents, and information that are legally protected, contain business or trade secrets of Inspire, or are marked as confidential and are made available or revealed to the customer while carrying out duties under the contract even after the contract has been terminated.

    This obligation does not apply to such information for which the customer proves that they
     
    • were already publicly known at the time of disclosure; or
    • have become publicly known after disclosure, except by breach of this agreement or by a breach of contract by a third party, or
    • were in the lawful possession of the customer at the time of disclosure and were not obtained, directly or indirectly, by the customer or a third party under a non-disclosure agreement concluded with the customer;
    • was developed by the customer independently of the confidential information received under this agreement.
       

B. Special Conditions for Device Sales – June 2018

I. Contractual Products

Inspire has developed the products defined in Attachment 1, including product description and other specifications. This list is subject to Inspire product adjustments in the interest of general sales policies. The status of the list is relevent at the point in time when the (individual) contract is concluded.

II. Single Delivery Contract

Products are acquired through single delivery contracts.

III. Delivery/Transfer of Risk

  1. The manufacturer’s factory or warehouse is the fulfillment location for the delivery obligations of Inspire.
     
  2. The product will be delivered to a specific location upon request of the customer. Inspire reserves the right to determine the delivery method, the transport modalities, and the delivery service used. In the case of a sale of an item to be delivered, the risk transfers to the customer at the latest when the product is given to the carrier, shipper, or other third party charged with delivering the item. If shipping or the delivery of a product is delayed as the result of circumstances caused by the customer, the risk transfers to the customer on the day on which the product being delivered is ready for shipping and Inspire has informed the customer of this. In this case, Inspire has the right to store the product at the cost and at the risk of the customer if it is not retrieved within four business days (see no. 3.9).
     
  3. When a product is purchased for delivery, Inspire will cover the shipping costs and any customs duties incurred for delivery to the defined delivery address. When 24 hour rush delivery through an express service or courier is ordered by the customer, the customer is responsible for paying the portion of shipping costs for additional express charges that exceed the costs for standard delivery.
     
  4.  The delivery time is agreed individually or specified by Inspire when the offer is submitted. If this is not the case, the delivery time is assumed to be 1-5 workdays from the conclusion of the contract.
     
  5. The delivery time agreement is binding, but does not constitute an absolute fixed number for future transactions.
     
  6. If the delivery time is not adhered to as the result of an event for which Inspire is not at fault (including strike or lockout), the delivery time will be delayed by the duration of the disruption plus a suitable starting period. The customer will be immediately informed of this and provided with the new planned delivery time. If the delivery cannot be made by the new delivery time, Inspire has the right to withdraw from the contract in part or in full; any compensation already paid out by the customer will be immediately refunded.
     
  7. The occurrence of a delay caused by Inspire is governed by the applicable legal regulations. Claims to delay damages will only arise if (and if the customer proves) the delay was purposefully caused by or resulted from the gross negligence or purposeful wrongful action of Inspire, its employees, its fulfillment or performance assistants, or its upstream suppliers. In all cases, however, a written warning must be received from the customer. If Inspire goes into default, the customer’s claim to compensation for damages is limited to a generalized reimbursement for their delayed payment damages. The flat payment for damages amounts to 0.5 % of the net price (order value) for each calendar week completed, but is not to exceed a total of 5 % of the order value. Inspire reserves the right to provide proof that the customer did not suffer any damages or only suffered negligible damages that were lower than the aforementioned flat payment.
     
  8. The rights of the customer as defined in no. I.4. (Liability) and the legal rights of Inspire, particularly for an exclusion of liability (e.g. due to impossibility or unreasonableness of the service and/or second attempt to fulfill the order) remain unaffected.
     
  9. If the customer delays acceptance, fails to cooperate, or causes the delay of delivery for some other reasons for which the customer is responsible, Inspire has the right to require compensation for any damages arising from this, including additional expenditures (e.g. storage costs). Inspire charges a flat fee amounting to 25 euros per calendar day for this starting at the planned time of delivery or – if there is no time of delivery – starting with notification that the product is ready to ship. Proof of higher damages and other legal claims of Inspire, particularly compensation of additional expenses, appropriate compensation, and termination remain unaffected by this; but the flat rate must be credited against other claims for money. The customer is permitted to provide proof that Inspire did not suffer any damages or only suffered negligible damages that were lower than the aforementioned flat payment.
     
  10. Inspire has the right to make partial deliveries, as long as this is reasonable for the customer.

IV. Retention of Ownership

  1. All products remain the property (products) of Inspire until the transfer of risk is transferred to the customer as defined in 3.2 above, regardless of the payment balances due to Inspire within the context of the business relationship (secured accounts payable).
     
  2. If the customer fails to act in compliance with the contract Inspire has the right to take the product back after Inspire has set a suitable grace period to remidy the breach. The customer is responsible for covering any transport costs incurred for the return.
     
  3. If Inspire takes back the products, this constitutes a withdrawal from the contract. Seizing the product also constitutes a withdrawal from the contract by Inspire. This does not affect Inspire's obligation to set a reasonable deadline for payment before withdrawal. Inspire can use any products it takes back. The charge for reclamation will be set at the amount the customer owes Inspire, once Inspire has charged a suitable amount for the costs of reclamation.
     
  4. The customer can use the products as long as they are not in default.
     
  5. Seizing and transfer by way of security of the products are not permissible. If a third party is given access to the products belonging to Inspire, the customer must immediately inform Inspire in writing and inform the third party of Inspire’s right of ownership.
     
  6. If the value of the securities exceed the value of the open accounts receivable against the customer by more than 10 %, Inspire must release the 10 % securities that make up the difference between the security amount and the amount due upon request of the customer.

V. Warranty

  1. Legal regulations govern the rights of the customer in cases of material defects and defects of title (including incorrect and short deliveries as well as improper installation), as long as nothing else is agreed in these GTCs (Part I and II.).
     
  2. The agreed quality of the products forms the basis for defect liability. All product descriptions considered to be a subject of the individual contract constitute an agreement on the quality of the product, with it making no difference who has provided the product descriptions.
     
  3. If the quality has not been agreed upon, legal regulations must be used to judge if a defect is present or not. Inspire does not, however, take any responsibility for the public statements made by third parties (e.g. advertising statements) unless they are agents or vicarious agents of Inspire. In this case, the liability limitations according to Section I. 4 (Liability) apply.
     
  4. The delivered products must be carefully inspected immediately following delivery at the customer’s location or the third party defined by the customer. A product will be considered approved if Inspire does not receive a written letter of compliant regarding an obvious defect or other defect that was discernible during an immediate careful inspection within seven workdays of delivery of the delivery item or otherwise within seven workdays of discovery of the defect or the point int time at which the defect is recognized by the customer during normal use of the delivery item or after closer inspection. If requested by Inspire, the defective object must be returned. Returns must always be coordinated with Inspire in advance. In the case that the letter of complaint is justified, Inspire will reimburse the costs for the most inexpensive shipping method; this does not apply if the costs increase, because the delivered item is located at a different location than the location where it would normally be used.
     
  5. If the delivered product is defective, the customer can first require that the defect be resolved as they choose (repair or delivery of a flawless item/delivery of a replacement) in the form of a supplementary delivery. In the case that the customer does not declare which of the two rights they would like to make use of, Inspire can set a suitable deadline for them. If the customer does not make a choice by the specified deadline, the right to choose will be transferred to Inspire when the deadline runs out. In this case, Inspire has the right to make fulfillment of supplementary deliveries contingent upon the customer paying the purchase price due, delivery versus payment. The customer is, however, entitled to hold back an appropriate amount of the purchase price in relation to the defect and suitable to cover the costs necessary for resolving the defect. If a replacement is delivered, the customer must give back the defective item in accordance with legal regulations. When this is not possible, for example because the products are not implanted yet, the customer must give Inspire the necessary time and opportunity to perform the supplementary delivery, and particularly must provide access to or hand over the product that is the subject of the complaint for inspection purposes.
     
  6. Inspire will cover the costs for visiting and supplementary delivery, including transport, travel, work, and material costs (but not advising and implanting costs), if the defect occurs before delivery or one year thereafter and as long as the costs have not increased due to the fact that the product is being used at a location other than the delivery location. Should it transpire that the demand for supplementary delivery is not justified, especially if there was no defect, then Inspire reserves the right to require the customer to reimburse its costs. This applies unless the customer was unable to recognize that there was not a defect.
     
  7. The warranty does not cover wear or defects caused by:
    • use or operation in an application or environment other than that intended by Inspire
    • maintenance work carried out by employees who are not employed by Inspire or without written consent of Inspire,
    • using products that are not compatible with Inspire products
    • making changes to the products (particularly when it comes to replaced parts or consumables) that are not in keeping with the original specifications
    • other actions running contrary to the specifications of Inspire (particularly operation, use, or maintenance instructions).
    This does not apply if the customer can prove that the defect was not caused by one of the aforementioned excluded defect causes.
     
  8. The warranty also loses its validity if the customer changes the product without approval from Inspire or allows third parties to change the product without approval from Inspire, thus making it impossible or unreasonably difficult to resolve the defect (self repair). In any case, the customer must cover the added costs of defect resolution caused by the change.
     
  9. Claims of the customer to compensation for damages or payment for wasted expenses are only valid in accordance with the stipulations of no. I.4 (liability) and are otherwise excluded.
     
  10. The general period of limitation for claims arising from material and title defects regarding the product is one year from delivery. The period of limitation of the Product Liability Act remains unaffected. Otherwise, the legal periods of limitation apply exclusively to the damage compensation claims of the contract partner in accordance with I.4 (liability).
     
  11. This clause does not constitute a limitation of the rights of Inspire in relation to the customer, in cases where claims are made against Inspire for product defects or other warranties or other defects that were not caused by Inspire and for which Inspire can assert rights of recourse or other claims against the customer.

VI. Product Liability

  1. Inspire will recognize its responsibilities for claims arising from product liability when it can be shown that the claims made in this regard can be attributed to products delivered by Inspire. The customer will immediately inform Inspire of any product defects or risks in using the product that the customer identifies.
     
  2. The customer is obligated to use the products as intended. In regards to its business relationship with Inspire, the customer will therefore do everything possible when using the products to shield Inspire from any obligations from third parties, particularly when these arise due to violations of applicable laws (particularly, but not limited to, the dutch Medicinal Devices Act and the  Medicinal Product Operations Ordinance) or of the instructions for use from Inspire. Of course this does not apply when the obligations are the responsibility of Inspire or its vicarious agents. The customer has the right to proof this at any time. If claims from product liability result, however, from the fact that the customer has changed the products, their equipment, and/or their packaging beyond what is deemed proper use or if warning notices are changed or removed, and/or if incorrect instructions are given for use or the products are used incorrectly, then Inspire is not responsible for the product liability claims of third parties within the inner relationship.
     
  3. If Inspire is forced to issue a recall to third parties, Inspire is obligated to cover any costs arising from this. Regardless, the customer will assist Inspire and the measures mandated by Inspire as long as it is reasonable to expect the customer to do so.
     
  4. Inspire pledges to keep the customer free of claims from third parties that arise from product liability claims.
     
  5. Inspire will maintain sufficient product liability obligation insurance at its own cost.

VII. Regulatory Specifications

Inspire will comply with the regulatory specifications applicable to it as a medicinal product manufacturer, particularly those requirements arising from the Medical Product Act and Inspire will also maintain the necessary approvals for distributing contract products in the contract region. Specifically, Inspire operates a quality management system certified in accordance with ISO 13485.