ClearPoint Neuro, Inc.
Capital Equipment Service Terms & Conditions
1. Contract. These terms and conditions apply to the purchase by you (“Customer”) from ClearPoint Neuro, Inc., a Delaware corporation (“CLPT”), of services (“Services”) to the capital equipment and hardware described on the applicable quote or invoice (“Capital Equipment”). 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. Term. The term of the Services shall be as set forth on the applicable quote or invoice (the “Service Period”).
3. Service Prices. The fee for the Services and the due dates for payment are as set forth on the applicable quote or invoice. Service prices are stated in U.S. dollars.
4. Payment. CLPT will deliver to Customer an invoice for such fee, and Customer agrees to pay such invoice not later than thirty (30) days after the date of the invoice. Customer acknowledges that the fee payable to CLPT does not include any applicable sales, use, excise, value-added, services, consumption or other taxes or duties payable to any taxing authority in connection with the transaction between CLPT and Customer. Customer agrees that it is solely responsible for the timely payment of any and all such taxes or duties. In the event Customer defaults on its payment obligations set forth in this Section, and during the continuance of any such default, all obligations of CLPT under these Terms and Conditions will be suspended.
5. Services. CLPT will provide Customer with the following Services with respect to the Capital Equipment during the Service Period:
- Scheduled Inspection. On mutually agreed-upon dates, CLPT will provide one (1) planned visit to Customer’s site each year during the Service Period, which visit will include an inspection and performance evaluation of the Capital Equipment and any necessary remedial or routine maintenance of the Capital Equipment that can be performed on-site during such visit.
- Corrective Maintenance. With respect to defective or malfunctioning Capital Equipment, CLPT will, at its option, repair, adjust or replace such Capital Equipment. CLPT will respond to Customer’s request for maintenance as promptly as is reasonable after receipt of such request, during normal business hours. Replacement products, parts or components may be new or refurbished, and any replaced Capital Equipment, parts or components will become the property of CLPT.
- Software Updates and Bug Fixes. CLPT will provide Software Updates and Bug Fixes for the software program elements of the Capital Equipment (the “Software”) if such Software Updates and Bug Fixes become available. CLPT will provide any such Software Updates and Bug Fixes for the Software within a reasonable time after commercial release. “Bug Fix” means an error correction or minor change that is required in order to enable the existing Software to perform to the existing functional specification(s). “Software Updates” means a release of software containing substantially only error corrections and/or minor new features, functionality and/or performance improvements, but that would not be required for the existing software to perform to the existing functional specification(s). Such Software Update would not necessarily replace or extend the life of the existing software. A Software Update would be indicated where the version number is changed by incrementing the numeric digits to the right of the decimal point, e.g., versions 1.1, 1.2, 1.3 and 1.4 would each be Software Updates.
6. Limitations on Services. Customer will promptly notify CLPT of any problem, failure or malfunction of Capital Equipment which results in the inability of such Capital Equipment to perform in accordance with its functional specification(s). In the event of any such problem, failure or malfunction, Customer will immediately cease use of the affected Capital Equipment and will not resume use without CLPT’s authorization. Customer will fully cooperate with and assist CLPT in the provision of Services, including providing CLPT (or its designated service provider) entry to Customer’s site and full and safe access to the Capital Equipment. Customer will also provide CLPT with information, consultation and advice reasonably necessary to permit CLPT (or its designated service provider) to provide the Services. CLPT will not be obligated to provide maintenance-related Services hereunder if the need for maintenance results from or arises out of: (i) any repair, modification, disassembly, alteration, addition to (including, without limitation, the loading of additional software), subtraction from, reconfiguration or relocation of Capital Equipment by Customer or any third party without the express written consent of CLPT; (ii) failure of Customer to use or maintain the Capital Equipment in accordance with applicable documentation, any automated warnings or any other reasonable instructions supplied by CLPT; (iii) use of the Capital Equipment by any person who did not receive and complete CLPT’s training; (iv) inadequate virus protection, unusual physical or electrical stress, or any cause external to the Capital Equipment or beyond CLPT’s reasonable control; (v) misuse, improper storage, abuse, negligence or accident; or (vi) use of the Capital Equipment with accessories, devices, instruments or software that are not approved by CLPT, including use of any expired, repaired, altered, modified, or reprocessed disposable products with the Capital Equipment; in each case whether occurring prior to the Service Period or during the term of the Service Period.
7. Limited Warranty. CLPT warrants that the Services will be performed in a professional manner consistent with generally accepted industry standards. CLPT will promptly re-perform any non-conforming Services for no charge as long as Customer provides reasonably prompt written notice to CLPT. The foregoing remedy is Customer’s sole and exclusive remedy (and CLPT’s sole and exclusive liability) for a warranty claim relating to such non-conforming Services. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE FOREGOING WARRANTY AND REMEDY 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 THE SERVICES RENDERED UNDER THIS AGREEMENT, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
8. Limitation of Liability. IN NO EVENT WILL CLPT BE LIABLE TO THE CUSTOMER UNDER THESE TERMS AND CONDITIONS (OR OTHERWISE IN CONNECTION WITH THE SERVICES) FOR ANY INDIRECT, SPECIAL, PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES, OR FOR LOSS OF USE, REVENUE OR ANTICIPATED PROFITS, COSTS OF PROCUREMENT OF SUBSTITUTE PRODUCTS OR CAPITAL EQUIPMENT, 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 PRODUCTS, CAPITAL EQUIPMENT, LICENSED SOFTWARE, OR SERVICE PROVIDED HEREUNDER, IS LIMITED TO THE AMOUNTS PAID BY THE CUSTOMER TO CLPT FOR THE PRODUCTS, CAPITAL EQUIPMENT, 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.
9. 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.
10. 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.
11. Data Use. Customer agrees that CLPT may periodically connect to the Capital Equipment via secure drive to collect and use information from the Capital Equipment 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.
12. 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.
13. 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.
14. Access to Books and Records. To the extent required by Section 952 of the Omnibus Budget Reconciliation Act of 1980 (the “Budget Act”) or the regulations promulgated pursuant thereto, for a period of four (4) years after furnishing services hereunder with a value or cost of $10,000 or more over a twelve month period and upon written request, CLPT will make available to the Secretary of the United States Department of Health and Human Services, or the U.S. Comptroller General, or their designees, this Agreement and the books, documents and records of CLPT necessary to verify the nature and extent of the cost of such services. If CLPT provides any services through a subcontract with a related organization, such contract will contain a section similar in scope to this section, if and to the extent required by the Budget Act and/or the regulations promulgated pursuant thereto. Assignment.
15. 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 Capital Equipment is delivered, without regard to any conflict of law principles.