STANDARD TERMS AND CONDITIONS OF SALE – ROBOTICS SURGICAL SYSTEM

These terms and conditions shall apply to and form part of all sales proposals, quotes, order forms, purchase orders and invoices for the robotics surgical system described in the quote (System) and any related hardware, software and/or services set out in the quote (together the Products). Unless otherwise expressly agreed in writing by the Smith+Nephew entity stated in the order form and/or its affiliates (together S+N) these terms and conditions shall supersede and prevail over any other terms and conditions in respect of the sale of the Products. 

 

  1. Use of Products. You will comply and will ensure that each person who uses the Products complies with all applicable laws and regulations, and all instructions, specifications and directions given by S+N with respect to the use, storage, maintenance and operation of the Products. You will not and will ensure that each person who uses the Products does not: [(i) use the Products for any purpose other than in connection with the implantation of S+N products;] (ii) use the Products for any purpose other than that for which they are designed and approved by applicable regulatory authorities; (iii) use or operate the Products prior to completion of required training on the Products. In the event that any malfunction occurs at any time, you shall immediately cease using the affected Product(s) and inform S+N without delay. You may not alter any Product or remove any notes, indication, information or reference from any Product or accompanying material. You may not sell, license, rent or otherwise make available any of the Products to any third party.
  2. Payment. Unless otherwise stated in the purchase order, payment will be due and payable within thirty (30) days of the date of invoice. Prices are subject to applicable tax. Payment shall be made in accordance with the terms set out on your statements and invoices. 
  3. Purchase Order. You shall be responsible for ensuring the accuracy of each purchase order. S+N shall be entitled to reject any purchase order that does not comply with the required format, or you are late in payment of any previous purchase order. 

 

  1. Product Returns. Written authorization for any Product returns must be obtained from your S+N customer service representative. 

 

  1. Delivery, Installation and Acceptance.

 

5.1 Delivery means: (i) with respect to hardware, delivery of the Product; (ii) with respect to software either remote delivery at your site or via download; a software activation key will be provided if applicable. Time of Delivery shall not be of the essence. Stated Delivery times are an estimate only. We shall not be liable for any loss (including loss of profit), liability or expense caused directly or indirectly by any delay in the Delivery of the Products. We give no guarantee of the exact quantity of Products delivered, but in the event that the quantity of Products delivered does not correspond with the quantity ordered (including any relevant tolerances) stated on the purchase order, you shall only be liable to pay for the amount actually ordered (subject to allowing us to collect the surplus Products in the case of over delivery). You must notify us of any discrepancy in respect of goods received and goods ordered or invoiced within fourteen (14) days of receipt of invoice. We shall retain title to all Products and have a lien (to the extent permitted by law) on all Products delivered to you until payment for SUCH Products has been received by us in full.

 

5.2 If Delivery is delayed due to Act of God, strike, pandemic, governmental action, regulatory restrictions, which are not due to the failure or omission of S+N or its subcontractors, or due to any event or circumstance beyond the reasonable control of S+N or its subcontractors, S+N shall be entitled to postpone performance for the duration of the obstruction and will agree with you additional appropriate time to resume performance and/or to make partial shipments or provide partial services. In case of permanent obstructions to Delivery of a Product, S+N shall have the right to partially or fully terminate the underlying contract or license. S+N will promptly inform you about the obstructions and, in the event of termination of the contract or license, will reimburse you for any payments already made for unavailable parts.

 

5.3 Where no acceptance procedure is performed for a Product, acceptance shall be deemed to have occurred simultaneously with Delivery. You are responsible for site and technical setup meeting any regulatory, structural, or radiation prerequisites as they may be required by S+N and/or any applicable laws or regulations. You shall obtain any permits, approvals, licenses, certifications, local or otherwise, that may be required for installation or operation of the Products. If any such requirement is expected to impact your readiness for taking delivery or installation you shall notify S+N without delay.

 

5.4 Unless otherwise agreed in writing, installation will be performed (i) remotely or (ii) by S+N within three (3) months after Delivery. You shall make third party products available during installation for any required acceptance or compatibility testing as reasonably required by S+N and shall also make available any and all reasonable IT resources and hardware reasonably required by S+N for the installation, set-up, and maintenance of the Software. We assume no responsibility for your contracts with third parties or the products covered thereunder. After successful performance of the acceptance test, you shall accept the Product and sign S+N’s acceptance protocol to verify acceptance which shall form part of the agreement between us. During the acceptance test, you shall examine the Product and any defect or missing part shall be listed in the acceptance protocol. If you perform any kind of patient treatment before signing the applicable acceptance protocol, the Product shall be deemed accepted and full payment shall be due. No Products may be used before training has been performed. 

 

  1. Software.

 

6.1 License. Subject to Customer’s payment of subscription fees and compliance with the Standard Terms, S+N grants a non-exclusive, non-transferable, non-sublicensable license to Customer to use a single copy of the Software in object code form solely for installation on the System in connection with Customer’s permitted use of the Products. Customer shall not at any time, directly or indirectly, and shall ensure that any authorized users do not: (i) copy, modify, or create derivative works of the Software or Documentation, in whole or in part; (ii) rent, lease, lend, sell, license, sublicense, assign, distribute, publish, transfer, or otherwise make available the Software or Documentation; (iii) reverse engineer, disassemble, decompile, decode, adapt, or otherwise attempt to derive or gain access to any software component of the Software, in whole or in part; (iv) remove any proprietary notices from the Software; or (v) use the Software or Documentation in any manner or for any purpose that infringes, misappropriates, or otherwise violates any intellectual property right or other right of any person, or that violates any applicable law. S+N does not make any representation that the software is free from defects, and S+N has no obligation to supply software upgrades (including without limitation new versions, or new or in-line releases). Documentation means the user manuals, guidelines and any other written documentation which may accompany the Software and/or otherwise provided to you relating to the Software. Customer accepts any further license conditions for software that may be required by third party manufacturers or licensors in so far as such conditions are commonly used. S+N will make such additional license conditions available to Customer upon request. If S+N makes any open source available to Customer, Customer agrees to comply with the terms of the relevant open source license. S+N are not responsible for any loss or damage caused by any open source software or resulting from its use, its interoperability or the exercise of any rights and obligations under the relevant open source license. A software license term shall commence upon Delivery of the Software for a minimum period of 12 months. 

 

  1. Reservation of Rights. S+N reserves all rights not expressly granted to Customer in the Standard Terms. Except for the limited rights and licenses expressly granted to Customer in the Standard Terms, nothing grants to Customer or any third party, by implication, waiver or otherwise, any intellectual property rights or other right, title, or interest in or to any registered and unregistered rights granted, applied for now or in the future under or related to any patent, copyright, trademark, trade secret, database protection or other intellectual property rights laws, and all similar or equivalent rights or forms of protection, in any part of the world, included or embodied in the Software, including in each case any updates, enhancements, improvements and modifications to the Software (S+N IP).

 

  1. Suspension. S+N may temporarily suspend Customer’s and any authorized user’s access to the Software (a Service Suspension) if: (i) S+N determines that (a) there is a threat or attack on any of the S+N IP; (b) Customer’s or any authorized user’s use of the S+N IP disrupts or poses a security risk to the S+N IP or to any other customer or vendor of S+N; (c) Customer or any authorized user is using the S+N IP for fraudulent or illegal activities; (d) Customer has ceased to continue its business in the ordinary course, made an assignment for the benefit of creditors or similar disposition of its assets, or become the subject of any bankruptcy, reorganization, liquidation, dissolution, or similar proceeding; and/or (e) S+N’s provision of the Software to Customer or any authorized user is prohibited by applicable law; (ii) any vendor of S+N has suspended or terminated S+N’s access to or use of any third-party services or products required to enable Customer to access the Software; and/or (iii) S+N does not receive payment when due of the agreed subscription fees from Customer. S+N shall use commercially reasonable efforts to provide written notice of any Service Suspension to Customer and to provide updates regarding resumption of access to the Software following any Service Suspension. S+N shall use commercially reasonable efforts to resume providing access to the Software as soon as reasonably possible after the event giving rise to the Service Suspension is cured. S+N will have no liability for any damage, liabilities, losses (including any loss of data or profits), or any other consequences that Customer or any Authorized User may incur as a result of a Service Suspension. 

 

  1. Aggregated Statistics. Notwithstanding anything to the contrary in this Agreement, S+N may monitor Customer’s use of the Software and collect and compile data and information related to Customer’s use of the Software for use by S+N in an aggregate and anonymized form, including to compile statistical and performance information related to the provision and operation of the Software (Aggregated Statistics). As between S+N and Customer, all right, title, and interest in Aggregated Statistics, and all intellectual property rights therein, belong to and are retained solely by S+N. Customer acknowledges that S+N may compile Aggregated Statistics and may (i) make Aggregated Statistics publicly available in compliance with applicable law, and (ii) use Aggregated Statistics to the extent and in the manner permitted under applicable law. 

 

  1. Customer obligations. Customer is responsible and liable for all uses of the Software resulting from access provided by or on behalf of Customer, directly or indirectly, whether such access or use is permitted by or in violation of this Agreement. Without limiting the generality of the foregoing, Customer is responsible for all acts and omissions of authorized users, and any act or omission by an authorized user that would constitute a breach if taken by Customer will be deemed a breach by Customer. Customer shall make all authorized users aware of these provisions and shall cause authorized users to comply with such provisions.

 

  1. Updates and Modifications. S+N reserves the right to make updates, modifications and/or improvements to the Software without any obligation to provide such updates, modifications and/or improvements in Software previously provided to Customer.  S+N reserves the right to require Customer to accept Software revisions or upgrades deemed necessary by S+N, at its sole discretion, and Customer agrees to cooperate with the implementation of any such updates, modifications or improvements. Customer specifically acknowledges that this provision does not include enhancements to the Software that must be paid for by Customer through a separate support services agreement.

 

  1. S+N IP. Customer acknowledges that, as between Customer and S+N, S+N owns all right, title, and interest, including all intellectual property rights, in and to the S+N IP.

 

  1. Customer Data. S+N acknowledges that, as between S+N and Customer, Customer owns all right, title and interest, including all intellectual property rights, in and to the information, data, and other content, in any form or medium, that is submitted, posted, or otherwise transmitted by or on behalf of Customer or an authorized user through the Software (Customer Data).  In respect of the RI.Insights Platform, Customer Data will include without limitation all data sets comprising case data and system logs stored on the System at Customer’s facility (System Data) and the clinical outcome results of patients treated using the System (Outcomes Data). Customer shall obtain all necessary consents associated with Customer and S+N’s use of the Customer Data. Customer hereby grants to S+N (a) a non-exclusive, royalty-free, worldwide license to reproduce, distribute, and otherwise use and display the Customer Data and perform all acts with respect to the Customer Data as may be necessary for S+N to provide the Software to Customer, (b) a non-exclusive, perpetual, irrevocable, royalty-free, worldwide license to reproduce, distribute, modify, prepare derivative works of and otherwise use and display for any purpose Customer Data incorporated within the Aggregated Statistics[ and (c) in respect of the RI.Insights Platform an exclusive, perpetual, irrevocable, royalty-free, worldwide license to use, edit, compile and disseminate the System Data and Outcomes Data (together the RII Data) as S+N sees fit (including without limitation for such educational, promotional, regulatory, research, development and commercial purposes as S+N may determine),] which license shall survive termination or expiry of these terms and conditions. All concepts, discoveries, analysis, designs, ideas, inventions, methods, tests and results which are developed by S+N or at S+N’s instructions arising from or relating to the RII Data (including but not limited to the design of medical devices) and all intellectual property rights relating to the same shall be the property of S+N. RII Data may include data that is considered protected health information under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) or, if permitted by Customer, de-identified protected health information. If Customer Data includes data that is considered protected health information under HIPAA and use of the Software thereby triggers obligations under HIPAA, the parties shall execute a business associate agreement in a form mutually agreed between the Parties. 

 

  1. Feedback. If Customer or any of its employees or contractors sends or transmits any communications or materials to S+N by mail, email, telephone, or otherwise, suggesting or recommending changes to the S+N IP, including without limitation, new features or functionality relating thereto, or any comments, questions, suggestions, or the like (Feedback), S+N is free to use such Feedback irrespective of any other obligation or limitation between the Parties governing such Feedback. Customer hereby assigns to S+N on Customer’s behalf, and on behalf of its employees, contractors and/or agents, all right, title, and interest in, and S+N is free to use, without any attribution or compensation to any party, any ideas, know-how, concepts, techniques, or other intellectual property rights contained in the Feedback, for any purpose whatsoever, although S+N is not required to use any Feedback.

 

6.10  Third Party Web Hosting Platform.  The Software shall be made available to Customer via a third-party web hosting platform owned by Brainlab AG (BL). Customer acknowledges that as an additional term of its use of the Software it must accept BL’s terms and conditions for web hosting services.

 

  1.   DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS LIMITED WARRANTIES SET FORTH IN THE STANDARD TERMS, THE SYSTEM AND THE PRODUCTS (INCLUDING WITHOUT LIMITATION ALL SOFTWARE AND DOCUMENTATION) PROVIDED BY S+N ARE PROVIDED “AS IS.” S+N HEREBY DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY OR OTHER (INCLUDING ALL WARRANTIES ARISING FROM COURSE OF DEALING, USAGE OR TRADE PRACTICE), AND SPECIFICALLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT. WITHOUT LIMITING THE FOREGOING, S+N MAKES NO WARRANTY OF ANY KIND THAT THE SOFTWARE OR DOCUMENTATION, OR ANY PRODUCTS OR RESULTS OF THE USE OF ANY OF THEM, WILL MEET CUSTOMER’S OR OTHER PERSONS’ REQUIREMENTS, OPERATE WITHOUT INTERRUPTION, ACHIEVE ANY INTENDED RESULT, BE COMPATIBLE OR WORK WITH ANY OTHER GOODS, SERVICES, TECHNOLOGIES OR MATERIALS (INCLUDING ANY SOFTWARE, HARDWARE, SYSTEM OR NETWORK), OR BE SECURE, ACCURATE, COMPLETE, FREE OF HARMFUL CODE OR ERROR FREE. ANY OPEN-SOURCE COMPONENTS AND OTHER THIRD-PARTY MATERIALS ARE PROVIDED “AS IS” AND ANY REPRESENTATION OR WARRANTY OF OR CONCERNING ANY OF THEM IS STRICTLY BETWEEN CUSTOMER AND THE THIRD-PARTY OWNER OR DISTRIBUTOR OF SUCH OPEN-SOURCE COMPONENTS AND THIRD-PARTY MATERIAL.

 

  1. Warranty and Liability. 

 

7.1 System Warranty. The System is warranted to conform in all material respects to the legal manufacturer’s standard specification in effect at the time of Delivery to Customer for a period of 12 months beginning on the earlier of: (i) 6 months after Delivery; (ii) 3 months after installation; (iii) on acceptance of the System; or (iv) on first use of the System (the Warranty Period). No warranty is given regarding fitness for a particular purpose or commercial practice. Warranty for general wear and tear is also excluded. To the extent that the System does not comply with this warranty during the Warranty Period, Customer’s sole and exclusive remedy is the repair or replacement of the System in S+N’s discretion, without charge and within a reasonable period of time. This warranty does not cover and is voided by any of the following: (i) Products packaged or labeled by someone other than S+N or its authorized agents; (ii) Products not used in compliance with the specifications, instructions or claims for use of the Products or the Standard Terms; (iii) damage due to misuse, reprocessing, alteration, unauthorized repair or negligent handling or damage due to lack of care by the owner, user, or handler of the Products including but not limited to continued use following malfunction, storage, handling or cleaning; and (iv) any other damage inflicted to Products by or on behalf of Customer or any third party. This warranty applies only to the original purchaser of the System from S+N and is not transferable. 

 

7.2 Liability.  Nothing in the Standard Terms excludes or limits: (i) either Party’s liability for death or personal injury caused by negligence, fraud or fraudulent misrepresentation or any other liability which cannot be limited or excluded by law; or (ii) Customer’s obligation to pay the agreed fees. Neither party shall be liable whether in tort (including for negligence), breach of statutory duty, contract, misrepresentation, or otherwise for: (i) loss of profits, revenue or business, loss of goodwill, loss of or corruption to data, or loss of anticipated savings; or (ii) any special, indirect or consequential loss, in each case however arising in connection with the System and the Products even if that loss or damage was reasonably foreseeable or a party was aware of the possibility of that loss or damage arising. The total aggregate liability of either party in connection with the System and the Products (and any other matter under the Standard Terms) is limited to the sum equal to the fees paid by Customer to S+N during the twelve (12) months preceding the event giving rise to the relevant cause of action.

 

  1. Servicing, Maintenance and Support. 

 

8.1 Requests for repairs and servicing must be notified to your S+N customer service representative in writing. Servicing of Products outside of the Warranty Period shall require the existence of: (i) a service and maintenance agreement; or (ii) in case of software, a license support agreement (remote services) and an application support agreement (onsite services) (together the Support Agreements). If the relevant Support Agreement(s) do not exist at the time that a service is required, preventative or remedial maintenance and support can be undertaken for a fee based on S+N’s standard rates and the time taken to provide support.

 

8.2 In the event that one or more of the Products that are covered under a Support Agreement reach the original manufacturer designated “end of service” or otherwise are no longer offered commercially by the original manufacturer, S+N may terminate the Support Agreement(s) immediately upon written notice and refund a pro-rated amount of any advance service fees paid pro rated for the unused portion of the relevant agreement. S+N shall have no obligation to perform services or deliver parts for Products declared “end of service” beyond the end of service date. 

 

  1. Termination. 

 

9.1 Termination Rights. Either party shall have the right to terminate with immediate effect: (i) Software licenses or any other ongoing contractual relationships if there is a material breach by the other party not remedied within thirty (30) days of receipt of written notice; and/or (ii) all contracts if the other party becomes subject to voluntary or involuntary bankruptcy, receivership, or formal insolvency proceedings in any jurisdiction. 

 

9.2 Effect of Termination. Upon termination, Customer will stop using the Products and delete the Software and Customer will remain responsible for all fees that Customer has incurred through to the effective date of termination. Any provisions of the Standard Terms that by their nature are intended to survive expiry of termination, will survive expiration or termination, including without limitation provisions relating to intellectual property, confidentiality and limitations and exclusions of liability.

 

  1. Confidentiality 

 

Either Party (Receiving Party) may become aware of confidential information of the other Party (Disclosing Party), including, but not limited to, commercial, financial, technical, operational and other information relating to the business of the Disclosing Party,  its affiliates and its third parties. The Receiving Party (a) will maintain in confidence all such confidential information; and (b) will not disclose such information to any third party, and particularly not to other vendors, distributors, group purchasing organizations, consultants or purchasers; and (c) will only use such information for the sole purpose of performing its obligations under these terms and conditions, save to the extent that any disclosure is made (i) with the other party’s written consent, or (ii) to the extent such disclosure is required by law, regulation, stock exchange or pursuant to the request of any regulatory or governmental entity or court of competent jurisdiction.  In connection with Customer’s use of the Products: (a) Customer may state publicly that it is a S+N customer; and (b) S+N may state publicly that Customer is a S+N customer and include Customer’s name and/or logo in a list of S+N customers in Chronicle’s online or offline promotional materials.

 

  1. Data Privacy and Security.

11.1 Customer shall create data backups before S+N performs services as well as on a regular basis. In order to provide support services in a more effective and time efficient manner as well as for the improvement of the Products and customer support procedures, S+N shall be entitled to collect technical and statistical data stored on your systems at your site or via a permanently established machine-to-machine (M2M) secure online connection (including for example hospital name and system status data such as disk/disk space or RAM status). Data collected will be stored and processed exclusively for the above mentioned purposes. Such data does not allow S+N to re-identify any natural person. 

 

11.2 S+N shall be entitled to use certain data it receives in the course of providing product support in a form that will not allow the respective personnel to re-identify any natural person from it (e.g. a patient, physician or hospital staff). Such use occurs for the purposes of (i) fulfilling legal obligations (e.g. product monitoring and reporting obligations), or (ii) exercising legitimate interests and lawful purposes, in particular those to improve the quality, reliability and functionality of Products by using selected support data (e.g. de-identified CT or MRI images) to test new product releases. 

 

11.3 Each party undertakes to observe its respective obligations under applicable data protection laws and regulations. Customer acknowledges and agrees that S+N may remotely access the Products at the Customer’s site within the scope of this Agreement and may collect and process data by using cloud services in order to perform remote services. Certain Products require a single personal registration of each authorized health care professional or administrator using the Product, including the user’s location. S+N is entitled to disable or otherwise restrict the access to Products, including but not limited to deletion of data, if S+N has reason to believe that the Customer is in violation of its obligations of confidentiality or applicable laws and/or regulations.

 

  1. Compliance. 

S+N’s provision of Products will not be construed to constitute a promotion or approval by S+N of uses that are other than, or contrary to, those indications (commonly called “off-label” uses). S+N will not be responsible for damages or losses of any kind arising out of “off-label” uses.  All transactions with S+N in connection with the Products are made in good faith on the basis of arms’ length negotiation. Customer will comply with all applicable laws in connection with these terms and conditions and the use of the Products and all applicable related regulations and the Smith+Nephew Code of Conduct which can be found at:https://www.smith-nephew.com/compliance/code-of-conduct-and-business-principles/ and such policies and procedures as S+N may notify to you from time to time.

 

  1. Subcontractors. S+N and its affiliates shall be entitled to appoint subcontractors to perform any services. Customer shall allow S+N, and its affiliates and subcontractors access to the Products, including online access if remote service is performed. 

 

  1. Governing Law and Dispute Resolution. These terms will be construed in accordance with the laws of Tennessee, without regard to or application of conflict of law principles. In the event of any dispute or difference arising out of or in connection with or in relation to these terms, including any question regarding the existence, validity, termination, application or interpretation of these terms or any of its provisions or any claim, disagreement or dispute arising out of or relating to these terms and conditions, each party shall use all reasonable commercial endeavours to settle the dispute amicably by agreement between the parties within 90 days of such dispute arising. In the event that the parties are unable to resolve the dispute within such 90 day period, such dispute shall be submitted to the courts of Shelby County. The application of the UN Convention on Contracts for the International Sale of Goods is expressly excluded. The prevailing party will be entitled to recover its costs and expenses associated with the legal proceedings, including without limitation reasonable fees and costs for attorneys, accountants, collection, expert witnesses and other professionals.