ClearPoint Neuro, Inc.
Capital Equipment, Hardware, & Disposables Standard Terms & Conditions of Sale
1. Contract. These terms and conditions apply to the purchase by you (“Customer”) from ClearPoint Neuro, Inc., a Delaware corporation (“CLPT”), of the products described in this Agreement, which consist of CLPT’s capital equipment and hardware (the “Capital Equipment”), including the ClearPoint® Neuro System (the “ClearPoint System”) and CLPT’s disposable products (the “Disposable Products”, and with the Capital Equipment (including the ClearPoint System), referred to herein as the “Products”). By accepting delivery of any portion of the Products, Customer agrees to be bound by and accepts these terms and conditions. Inconsistent or additional terms or conditions in any order or other writing by Customer (in whatever form or whether preceding or following the order date) will not constitute terms and conditions of purchase and sale between CLPT and Customer, and CLPT expressly rejects and does not accept them.
2. Use of Products. Customer agrees and represents that it is purchasing the Products solely for Customer’s own internal use and that the Products will not be resold, exported or reshipped to any third party. Customer shall operate the Products only in accordance with the applicable Product manual and instructions for use. Customer shall not use any Product with disposable products which are not authorized by CLPT to be used with such Product (including expired, repaired, altered, modified, or reprocessed disposable products). Any breach of this Section shall be a breach of these terms and conditions and shall immediately void any license granted to Customer in connection with the Product and any claims by the Customer, including but not limited to any warranty, indemnification or service claims related to the Product. All clinical and medical treatment and diagnostic decisions are the responsibility of Customer and its professional healthcare providers.
3. Product Prices. Product prices are stated in U.S. dollars, and they do not include any applicable sales, use, excise, service or other similar taxes.
4. Payment. Any order received by CLPT is subject to credit approval. Customer authorizes CLPT to request and obtain Customer's credit report from credit reporting agencies and authorizes such credit reporting agencies to disclose it to CLPT for the purpose of completing Customer’s order. Payment of the full invoiced amount is due on delivery, and Customer will pay that amount to CLPT within thirty (30) days from the date of invoice. Customer is solely responsible for any and all applicable sales, use, excise, service and other similar taxes payable to any taxing authority in connection with Customer’s purchase and use of the Products.
5. Title; Delivery. If the Products include software, such software is licensed to Customer, not sold; no title to or other ownership interest in such software passes to Customer. Otherwise, title and risk of loss to purchased Products passes to Customer upon shipment from CLPT. In the instance of placed Capital Equipment, CLPT will retain legal title to the Capital Equipment at all times. Notwithstanding CLPT holding legal title, Customer will list CLPT as the loss payee in Customer’s insurance that insures the Capital Equipment against damage, vandalism, and theft and will provide evidence of this insurance to CLPT. Products will be shipped to the address indicated on Customer's account. Shipping and handling charges to Customer are shown on the quote or invoice. Delivery dates are approximate. Product delivery is subject to manufacturing availability. CLPT reserves the right to make delivery in installments, when feasible.
6. Shipment Variances; Acceptance. Customer will notify CLPT if Customer receives any Product that Customer did not order or if there is any Product missing from Customer’s shipment (in either case, a “variance”). CLPT will not be responsible for any variance unless Customer notifies CLPT of the variance within five (5) days after delivery of the Product to Customer. Customer will be deemed to have accepted a Product delivered by CLPT five (5) days after delivery of the Product to Customer.
7. Return of Products.
- 7.a Capital Equipment. Purchased Capital Equipment may not be returned.
- 7.b Disposable Products. For Disposable Products, Customer must obtain CLPT’s authorization before returning any Disposable Product. Any returned Disposable Product must be in the original packaging and packed in a second container (i.e., external packaging). A Returned Product Authorization ("RPA") number obtained from CLPT must be clearly identified on the external packaging of any returned Disposable Product. Information required to obtain the RPA number includes, without limitation, the Disposable Product catalog number, the quantity of Disposable Product to be returned, the reason for the return, the CLPT invoice number and the invoice date. Customer must prepay shipping charges on any returned Disposable Product, unless the Disposable Product is returned for repair or replacement under warranty or the Disposable Product was shipped in error by CLPT. Disposable Products shipped to Customer in error by CLPT will be fully credited to Customer's account. Otherwise, Disposable Products returned to CLPT within 60 days of the invoice date in saleable condition will be credited to Customer's account, subject to a 15% reprocessing fee that will be deducted from Customer's return credit. "Saleable condition" means that a Disposable Product is received at CLPT's facility in its original condition for resale by CLPT (e.g., the packaging has not been damaged or defaced; the Disposable Product has not been opened or used, etc.) Notwithstanding any of the foregoing to the contrary, the following Disposable Products are not eligible for return to CLPT or credit to Customer's account: (1) any Disposable Product returned without the RPA number; (2) any Disposable Product returned more than 60 days after the invoice date; or (3) any Disposable Product that has been opened or used or is not otherwise in saleable condition.
8. Limited Warranty.
- 8.a. Capital Equipment. CLPT warrants to Customer that, for a period of one (1) year from the original installation date, the Capital Equipment (i) will be free from defects in material and workmanship under normal use and (ii) will conform in all material respects with the applicable written technical specifications for such Capital Equipment (as such specifications exist on the date of delivery to Customer). If Customer promptly notifies CLPT of Customer’s warranty claim during the warranty period, CLPT will, at its option, (i) with respect to a non-conforming Capital Equipment other than software, repair, adjust or replace (with new or exchange replacement parts) the non-conforming Capital Equipment, and (ii) with respect to non-conforming software, either correct the non-conformity or replace the software. The foregoing expresses Customer’s sole and exclusive remedy, and CLPT’s sole and exclusive liability, for any breach of warranty with respect to the Capital Equipment.
- 8.b. Disposable Products. CLPT warrants to Customer that, at the time of shipment, (1) the Disposable Products will be free from defects in material and workmanship under normal use, and (2) the Disposable Products will conform in all material respects with the applicable written technical specifications for such Disposable Products, when used in accordance with the applicable user manual, technical specifications, instructions for use and labeling regarding the operation and use of the Disposable Products as made available by CLPT to Customer ("Documentation"). If Customer promptly notifies CLPT of Customer's warranty claim during the period of (a) one (1) year after shipment of the Disposable Product or (b) the remaining shelf life or the period prior to the expiration date of the Disposable Product, whichever is shorter, CLPT will, at its option, repair, adjust or replace the non-conforming Disposable Product. The foregoing expresses Customer's sole and exclusive remedy, and CLPT's sole and exclusive liability, for any breach of warranty with respect to the Disposable Products.
- 8.c. Exclusions. CLPT will not have any obligation to Customer hereunder if the warranty claim results from or arises out of: (a) any repair, modification, disassembly, alteration, addition to (including, without limitation, the loading of additional software), subtraction from, reconfiguration or relocation of a Product by Customer or any third party without the express written consent of CLPT; (b) failure of Customer to use or maintain the Product in accordance with applicable documentation, any automated warnings or any other reasonable instructions supplied by CLPT; (c) use of the Product by any person who did not receive and complete CLPT’s training; (d) use of the Product with accessories, devices, instruments or software that are not approved by CLPT, (e) inadequate virus protection, unusual physical or electrical stress, or any cause external to the Product or beyond CLPT’s reasonable control; or (f) misuse, improper storage, abuse, negligence or accident.
- 8.d. Disclaimer. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE WARRANTY AND REMEDY SET FORTH ABOVE ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES AND REMEDIES, WHETHER ORAL OR WRITTEN, EXPRESS OR IMPLIED. CLPT DOES NOT MAKE, AND HEREBY EXPRESSLY DISCLAIMS, ANY OTHER WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, IN CONNECTION WITH ANY PRODUCT, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, TITLE AND NONINFRINGEMENT. SOME STATES DO NOT ALLOW THE LIMITATION OR EXCLUSION OF IMPLIED WARRANTIES, IN WHICH EVENT THE FOREGOING LIMITATION WILL APPLY ONLY TO THE EXTENT PERMITTED BY APPLICABLE LAW.
9. Limited Software License. Any and all software program elements for the ClearPoint System (“Software”) are provided under license and are not sold to Customer. Subject to these Terms and Conditions, CLPT grants to Customer a non-exclusive, non-transferable, non-sublicensable, limited license to use and perform the Software, solely as incorporated as part of CLPT’s ClearPoint System in machine-executable object code form and solely in connection with the operation of the ClearPoint System as described in the applicable system documentation and in accordance with these Terms and Conditions. The foregoing license is valid only for the single, dedicated computer workstation on which the Software is installed. CLPT retains and reserves all other rights to the Software. Customer will not sell, rent, lease, license, time share, transfer, provide any third party access to, copy, reproduce, modify, reverse engineer, decompile, disassemble, attempt to derive the source code for, create a derivative work of, translate, create other versions of, or otherwise manipulate, any Software. Customer acknowledges and agrees that the structure and organization of the Software are valuable trade secrets of CLPT, and Customer agrees to protect and preserve the Software as CLPT’s confidential proprietary information. The inclusion of a copyright notice on any portion of any Software or any documentation for the Software will not cause or be construed to cause it to be a published work. Customer shall not modify or remove any copyright, government restricted rights, or other proprietary rights notices or legends in or on the Software or documentation. The Software operates on a dedicated, stand-alone computer workstation; Customer may not install any other software on such dedicated workstation. In the event Customer violates any of the terms set forth in these terms and conditions, CLPT (or any of its Software Licensors) will be entitled to immediately terminate the license granted herein and require that Customer cease use of the Software, in addition to seeking any other legal or equitable remedies available to CLPT. The provisions of this license that by their nature are intended to survive expiration of termination of this license shall so survive. SOFTWARE INCLUDED WITH THE CLEARPOINT SYSTEM IS AN ADVISORY DEVICE AND IS NOT DESIGNED TO SUBSTITUTE FOR THE PRIMARY DEFENSES AGAINST DEATH OR INJURY DURING SURGICAL, MEDICAL OR OTHER POTENTIALLY HAZARDOUS APPLICATIONS, WHICH WILL CONTINUE TO BE THE SKILL, KNOWLEDGE AND EXPERIENCE OF THE USER OF THE SOFTWARE. CLPT DOES NOT MARKET OR DISTRIBUTE THE SOFTWARE AS A SUBSTITUTE FOR SUCH DEFENSES OR WITH UNAPPROVED DICOM CONNECTIONS.
Any license provided herein to use the ClearPoint Maestro Brain Model shall be subject to the following additional terms: (i) the license to the ClearPoint Maestro Brain Model is limited to use of the Software for analysis of patient clinical data solely for those patients who were treated at the Customer’s facility (i.e., the facility where the ClearPoint System is located) by the Customer’s Neurological Surgery division, and (ii) the license to the ClearPoint Maestro Brain Model shall not permit use of the software in connection with any clinical studies or other investigational uses.
Certain components of the Software are licensed by CLPT from third parties (collectively, the “Software Licensors”). The following additional terms and conditions apply with respect to such components (collectively, the “Software Components”):
Title and ownership of the Software Components and any accompanying documentation and all intellectual property rights therein shall remain with the Software Licensors and their licensors.
Customer may use the Software Components only as an integrated component of the Software and strictly for Customer’s own internal business purposes, and may not sell, rent, lease, license, time share, use the Software Components on a service bureau basis, or otherwise transfer or provide access to the Software Components to any third parties. Customer may not copy, reproduce, modify, adapt, alter, translate, reverse engineer, decompile, disassemble, or otherwise render the Software Components into human readable form in order to gain access to the Software Components source code in any way or to produce any work derived from the Software Components or translate or create other versions of the Software Components. Software Licensors will have no liability to Customer or any other person or organization that is granted rights to the Software (i.e., any end-user of the Software) for any express or implied warranties or any indirect, incidental, special, or consequential damages. THE SOFTWARE COMPONENTS ARE NOT DESIGNED TO SUBSTITUTE FOR THE PRIMARY DEFENSES AGAINST DEATH OR INJURY DURING SURGICAL, MEDICAL OR OTHER POTENTIALLY HAZARDOUS APPLICATIONS, WHICH WILL CONTINUE TO BE THE SKILL, KNOWLEDGE AND EXPERIENCE OF THE USER OF SUCH SOFTWARE. CLPT DOES NOT MARKET OR DISTRIBUTE THE SOFTWARE COMPONENTS AS A SUBSTITUTE FOR SUCH DEFENSES OR WITH UNAPPROVED DICOM CONNECTIONS.
The Customer shall comply with all export and re-export restrictions and regulations imposed by the government of the United States. If the Customer is an agency or instrumentality of the United States Government, the Software Components are “commercial computer software” and “commercial computer software documentation”, pursuant to FAR 12.212 or DFAR 227.7202, and their successors, as applicable, use, reproduction and disclosure of the Software Components is governed by the terms of this license.
Each of the Software Licensors is a third party beneficiary to the terms of this Limited Software License that apply to them and are entitled to the rights and benefits hereunder and may enforce the provisions hereof as if they were a party hereto.
10. Customer Indemnification. To the fullest extent permitted by applicable law, Customer hereby assumes all liability for, and agrees to indemnify, defend and hold harmless CLPT from, any third party claims relating to or arising from the negligence or willful misconduct of Customer (or that of its medical staff, employees, agents, representatives or affiliates) in using or possessing any Product. Notwithstanding the foregoing, Customer’s indemnification obligations will not apply to the extent relating to or arising from CLPT’s negligence or willful misconduct.
11. Limitation of Liability. IN NO EVENT WILL CLPT BE LIABLE TO THE CUSTOMER UNDER THESE TERMS AND CONDITIONS (OR OTHERWISE IN CONNECTION WITH THE PRODUCTS) FOR ANY INDIRECT, SPECIAL, PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES, OR FOR LOSS OF USE, REVENUE OR ANTICIPATED PROFITS, COSTS OF PROCUREMENT OF SUBSTITUTE PRODUCTS, LOSS OF STORED OR TRANSMITTED DATA, WHETHER IN AN ACTION IN CONTRACT, TORT, BREACH OF WARRANTY, PRODUCT LIABILITY, STATUTE, EQUITY OR OTHERWISE, EVEN IF CLPT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE TOTAL AGGREGATE LIABILITY, IF ANY, OF CLPT FOR ALL DAMAGES AND BASED ON ALL CLAIMS ARISING FROM OR IN CONNECTION WITH THESE TERMS AND CONDITIONS, OR ARISING FROM A PRODUCT, CLEARPOINT SYSTEM, LICENSED SOFTWARE, OR SERVICE PROVIDED HEREUNDER, IS LIMITED TO THE AMOUNTS PAID BY THE CUSTOMER TO CLPT FOR THE PRODUCT, CLEARPOINT SYSTEM, LICENSED SOFTWARE, OR SERVICE WHICH GAVE RISE TO THE LIABILITY. THE LIMITATION OF LIABILITY AND EXCLUSION OF DAMAGES WILL APPLY EVEN IF THE LIMITED REMEDIES FAIL OF THEIR ESSENTIAL PURPOSE.
12. Compliance with Law and Reporting. Each party shall comply with all laws, rules, and regulations applicable to the party in connection with the performance of its obligations in connection with this transaction, including, but not limited to, those relating to affirmative action, fair employment practices, FDA, Medicare fraud and abuse, and the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"). Each party represents and warrants to the other party that it is not excluded from participation in any Federal Health Care Program or debarred, suspended, or otherwise excluded from participating in any other federal procurement program or activity. In the event of a party’s breach of this section, the other party may terminate the transaction immediately without further penalty or liability. Pursuant to applicable legal requirements, device manufacturers are required to report data annually on any items of value, including, but not limited to, fees, meals, educational items, gifts, expense reimbursements and other payments or items of value (“payments”), provided to health care professionals and health care organizations. Customer agrees that CLPT may report and publicly disclose such payment information, including, but not limited to, Customer’s name, the amount of CLPT’s payment, if any, and a description of the payment. The parties acknowledge that the Product prices may reflect discounts, rebates, or other reductions in price (collectively, “discounts”), and it is their intention that such discounts shall be administered consistent with the discount safe harbor to the federal anti-kickback statute (42 USC 1320a-7b(B)(3)(A)) and the related regulatory discount safe harbor (42 CFR 1001.952(h)). CLPT will reflect when a discount applies on invoices or alternative documents, and Customer may request additional documentation of purchases and discounts hereunder as necessary to facilitate appropriate reporting. To the extent and as required by applicable law, regulations, or other contractual obligations, it is Customer’s responsibility to appropriately report or reflect such discounts, including any bundled discounts, on cost reports or claims submitted to third party payors, including but not limited to federal or state health care programs. The sole purpose of the transaction underlying these terms and conditions is to enter into a commercially reasonable and fair market value arrangement. The parties in good faith believe that the transaction fully complies with the provisions of 42 U.S.C. 1320a-7b (the “Anti-Kickback Statute”). Neither party is, by virtue of this transaction or otherwise, knowingly or willfully offering, paying, soliciting, or receiving remuneration in return for referring an individual to or from the other party for the furnishing of any item or service reimbursed under any government health care programs. The Product prices do not take into account the volume or value of any referrals or business otherwise generated between the parties for which payment may be made in whole or in part under Medicare or any other government health care programs.
13. Force Majeure. Each party shall be excused from performing its obligations if such delay or default is caused by events beyond its reasonable control, including, but not limited to, acts of God, acts of any civil or military authority, fire, floods, war, embargoes, labor disputes, riots, accidents, terrorism, national emergency, strikes, the failure of its subcontractors or suppliers, pandemics, epidemics, viral outbreaks, or by any other cause not within the control of the party whose performance is interfered with which, by the exercise of reasonable diligence, such party is unable to prevent, whether of the class or causes enumerated above or not. The obligation to make payment for Products shall never be excused by a force majeure event. For the sake of clarity, any supply chain or operational disruption due to COVID-19 shall be considered a force majeure event.
14. Data Use. Customer agrees that CLPT may periodically connect to the ClearPoint System via secure drive to collect and use information from the ClearPoint System for CLPT’s own business purpose (including, but not limited to, for data analytics activities, for research, product and service development and improvement (including the development of new offerings), substantiation of marketing claims and for benchmarking purposes). The information collected does not contain any protected health information (within the meaning of the HIPAA Privacy Rule) or any information that can identify an individual.
15. Notices. Any notice hereunder must be sent by mail or nationally recognized overnight courier (i) if to Customer, at the address indicated by Customer in relation to its account for Product orders; or (ii) if to CLPT, at 120 S. Sierra Ave., Suite 100, Solana Beach, CA 92075, Attention: Chief Financial Officer.
16. Severability. Whenever possible, each provision of these Terms and Conditions will be interpreted in a manner to be effective, valid and enforceable. If, however, any provision of these Terms and Conditions is held to be illegal, invalid or unenforceable under any present or future law, then such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating or affecting in any manner whatsoever the remainder of such provision or the remaining provisions of these Terms and Conditions. Furthermore, Customer and CLPT will negotiate in good faith a provision as similar in terms to such illegal, invalid, or unenforceable provision as may be possible and still have such similar provision be construed and enforced as legal, valid, and enforceable.
17. Miscellaneous. These Terms and Conditions may not be amended, modified or altered except by a writing signed by both parties. Notwithstanding the foregoing, Customer understands and acknowledges that CLPT may amend, revise or update its Standard Terms and Conditions of Sale from time to time. Customer’s obligations hereunder may not be assigned without the prior written consent of CLPT. No delay on the part of either party in exercising any right, power or privilege hereunder will operate as a waiver thereof. These Terms and Conditions will be governed by and construed in accordance with the laws of the state where the Products are delivered, without regard to any conflict of law principles.