TERMS & CONDITIONS

TOKEN TERMS AND CONDITIONS OF SALE

1. Terms and Conditions; Entire Agreement.
   1. Terms and Conditions. These token terms and conditions of sale (the “Token Terms and Conditions”) shall, by themselves and as part of the Agreement (as defined below), govern Customer’s purchase of Tokens (as defined below).
   2. Entire Agreement. These Token Terms and Conditions, together with the Loan Terms and Conditions and the Equipment Loan Agreement (collectively, the “Agreement”), (a) shall constitute the complete, exclusive and entire agreement between Customer and Vendor with respect to the loan of Equipment and purchase of Tokens, and (b) shall control over and supersede and replace all prior or contemporaneous understandings or agreements, written or oral, between Customer and Vendor with respect to such loan(s) and purchase(s), and (c) shall control over and supersede and replace, to the extent not accepted in writing by Vendor, any additional or different terms and conditions contained in any statement in any purchase order by Customer, which additional or different terms and conditions are hereby rejected and shall be void unless specifically so accepted in writing by Vendor. To the extent Customer’s order documents and any terms and conditions contained therein materially alter this Agreement, the Agreement shall be deemed a counteroffer to any offer made by Customer through Customer’s order documents. Vendor reserves the right to withhold any delivery of Equipment and/or Tokens until such counteroffer has been accepted by Customer, provided, however, that Customer’s acceptance of a delivery of Equipment and/or shall be deemed final acceptance of and agreement to the terms of such counteroffer.
   3. Definitions. Capitalized terms not otherwise defined herein shall have the meaning ascribed to them in the Equipment Loan Agreement.
2. Use of Tokens.
   1. Tokens Defined. Customer has entered into an Equipment Loan Agreement with Vendor pursuant to which Customer compensates Vendor for the loan of the Equipment on a per-procedure basis through the purchase of Equipment use tokens (the “Tokens”).
   2. Limitations on Use. The Tokens have no rights, uses, purposes, attributes, functionalities, or features, express or implied, outside the operation of Equipment and cannot be used for any purpose other than to access and use the Equipment.
   3. Limitations on Transfer. The Tokens have no cash value and are not convertible, redeemable, tradeable, exchangeable, or resalable. The Tokens can only be used by the original purchaser thereof, and any transfer of the Tokens, including to an Affiliate of Customer, requires Vendor’s prior written consent which can be withheld in its sole discretion. The Tokens do not constitute a negotiable instrument and do not give the Customer any equity or ownership rights in the Equipment or in Vendor.
3. Additional Payment Terms.
   1. Use Fee. The Use Fee is not refundable and non-redeemable, and any unused tokens will expire upon the expiration or earlier termination of the Agreement, provided, that if the Agreement is terminated by Customer for Vendor’s material breach in accordance with Section 3.1(b)(ii) of the Loan Terms and Conditions, then Vendor shall return to Customer the unused portion of the Minimum Contract Price (or subsequent package purchased by Customer), and any unpaid Use Fee shall become due and payable in accordance with the terms of this Agreement. Customer acknowledges that Tokens do not constitute a deposit, credit balance, or refundable prepayment.
   2. Right to Offset. In addition to any remedy the Vendor may have against Customer at law or in equity, Vendor may set off against, and deduct and recoup from, any amounts due to Customer under Section 3(a) hereof any amounts due or to become due from Customer to Vendor, including for the cost of repairing or replacing Equipment damaged by Customer.
   3. Late Payments. If payment is not received by the due date thereof, Vendor may assess, and Customer shall pay, a late payment charge at the rate of 1.5% per month (18% per year) or the maximum rate permitted by law, whichever is less, of the amount due from the due date to the date of payment. If Vendor retains a collection agency or attorney to collect unpaid amounts, Vendor may invoice Customer for, and Customer agrees to pay, all reasonable costs of collection, including without limitation reasonable attorneys’ fees.
   4. Taxes. If Customer indicates on the cover page hereto that it is a tax-exempt entity under Sections 501(a) and 501(c)(3) of the Internal Revenue Code of the United States, as amended, and under applicable state law, then Customer shall provide Vendor with a copy of the tax exemption certificate upon request. Vendor shall take all action required to cause Customer’s payment of the Use Fee for the Equipment to be treated as tax-exempt transactions. Vendor further agrees that the Use Fee will not, and the amounts to be invoiced hereunder (unless expressly agreed by Customer) will not, include any tax with respect to which exemption is available or indicated by Customer for it or otherwise, or any federal excise tax with respect to which Customer has furnished an applicable tax exemption determination letter.
   5. Reasonableness of Use Fee. The parties hereto represent, warrant and acknowledge that the Use Fee paid and payable hereunder by Customer to Vendor has been determined by the parties through good-faith and arm’s length bargaining, and is commercially reasonable and reflects the fair market value of the use of the Equipment and Software; the Minimum Contract Price and aggregate Use Fee does not exceed that which is reasonably necessary to accomplish the commercially reasonable business purpose of this Agreement. The Minimum Contract Price or Use Fee have not been determined in a manner that takes into account, either directly or indirectly, the volume or value of any referrals from Customer to Vendor (or its affiliates), or from Vendor (or its affiliates) to Customer. No amount paid or payable hereunder is intended, nor shall be construed to be, an inducement or payment for referral of or recommending referral of, patients by Customer to Vendor (or its affiliates), or by Vendor (or its affiliates) to Customer, or for ordering, leasing or purchasing any item, product or service covered by any governmental or private health care payment program. In addition, the Use Fee charged hereunder does not include any discount, rebate, kickback or other reduction in charge.
4. Limitations on Liability.
   1. No Indirect Damages. TO THE FULLEST EXTENT ALLOWED BY LAW, IN NO EVENT SHALL VENDOR BE LIABLE, WHETHER IN CONTRACT, TORT, STRICT LIABILITY, NEGLIGENCE, WARRANTY, OR UNDER ANY STATUTE OR ON ANY OTHER BASIS FOR ANY SPECIAL, INCIDENTAL, INDIRECT, EXEMPLARY, PUNITIVE, MULTIPLE OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION DAMAGES ARISING FROM OR RELATED TO LOSS OF USE, LOSS OF DATA, DOWNTIME, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES, OR LOSS OF REVENUE, PROFITS, GOODWILL, OR BUSINESS OR OTHER FINANCIAL LOSS, WHETHER OR NOT SUCH DAMAGES ARE FORESEEABLE AND WHETHER OR NOT VENDOR IS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, SUSTAINED BY CUSTOMER OR ANY OTHER PERSON OR ENTITY ARISING OUT OF OR CAUSED BY THE PURCHASE OR USE OF THE TOKENS, OR BY VENDOR’S PERFORMANCE OR FAILURE TO PERFORM ITS OBLIGATIONS HEREUNDER, OR BY VENDOR’S BREACH OF THIS AGREEMENT.
   2. Limitation on Liability. VENDOR’S LIABILITY TO CUSTOMER FOR DIRECT DAMAGES ARISING OUT OF THIS AGREEMENT OR THE PURCHASE AND USE OF THE TOKENS PROVIDED HEREUNDER SHALL BE LIMITED TO THE USE FEE THAT VENDOR RECEIVED FROM CUSTOMER IN THE TWELVE (12) IMMEDIATELY PRECEDING SUCH CLAIMS.
      
      
      

TERMS AND CONDITIONS OF EQUIPMENT LOAN

1. Terms and Conditions; Entire Agreement.
   1. Terms and Conditions. These terms and conditions of equipment loan (the “Loan Terms and Conditions”) shall, by themselves and as part of the Agreement, as defined below, govern Customer’s loan of Equipment from Vendor.
   2. Entire Agreement. These Loan Terms and Conditions, together with the Token Terms and Conditions and the Equipment Loan Agreement (collectively, the “Agreement”), (a) shall constitute the complete, exclusive and entire agreement between Customer and Vendor with respect to the loan of Equipment and purchase of Tokens, and (b) shall control over and supersede and replace all prior or contemporaneous understandings or agreements, written or oral, between Customer and Vendor with respect to such loan(s) and purchase(s), and (c) shall control over and supersede and replace, to the extent not accepted in writing by Vendor, any additional or different terms and conditions contained in any statement in any purchase order by Customer, which additional or different terms and conditions are hereby rejected and shall be void unless specifically so accepted in writing by Vendor. To the extent Customer’s order documents and any terms and conditions contained therein materially alter this Agreement, the Agreement shall be deemed a counteroffer to any offer made by Customer through Customer’s order documents. Vendor reserves the right to withhold any delivery of Equipment and/or Tokens until such counteroffer has been accepted by Customer, provided, however, that Customer’s acceptance of a delivery of Equipment and/or Tokens shall be deemed final acceptance of and agreement to the terms of such counteroffer.
   3. Definitions. Capitalized terms not otherwise defined herein shall have the meaning ascribed to them in the Equipment Loan Agreement.
2. Equipment Use and Return.
   1. Use of Equipment. Vendor will provide training to Customer’s staff before patient use. Training may be provided by Vendor or its contractors, and the parties will agree in advance on cost allocation. Only trained personnel may use or assist with use of the Equipment. Vendor grants Customer a limited right to use the Equipment solely at the Facility during the Term. Customer must use the Equipment in accordance with Vendor’s instructions and exercise reasonable care. Customer may not transfer the Equipment, use it at another location, or permit use by unaffiliated third parties. Customer may not copy, reverse-engineer, or create derivatives of the Equipment. Customer may use the Equipment only for approved, cleared, or authorized purposes in the Facility’s jurisdiction. Off-label or unapproved use is prohibited.
   2. Care of Equipment. Vendor retains all title to the Equipment, including improvements. Customer will not create or allow any liens or encumbrances on the Equipment and will promptly remove any unauthorized liens at its own expense. Vendor is responsible for all maintenance, repairs, and replacements included in the Use Fee, except for damage caused by Customer’s negligence, recklessness, or willful misconduct. Customer may not repair or modify the Equipment without Vendor’s written consent and must promptly report malfunctions.
   3. Return of Equipment. At the end of the Term, Customer shall return the Equipment to Vendor, in the same condition as when received by Customer, reasonable wear and tear excepted. Facilities shall cease use of the Equipment upon termination or expiration of this Agreement. If this Agreement is terminated or expires, and should the Customer retain possession of the Equipment, then Vendor, by itself or through its agents, shall have the right to enter the Facility without notice to Customer and to remove and take possession of the Equipment, and hold the same free from claims of Customer and its successors and assigns.
3. Termination. The Agreement shall terminate upon the occurrence of any of the following events:
   1. Termination Without Cause. Either party may terminate this Agreement upon thirty (30) days’ prior written notice to the other party hereto.
   2. Termination for Cause. Either party may terminate this Agreement for cause if the other party fails to cure any material breach of this Agreement within thirty (30) days after receiving written notice of such breach.
   3. Termination for Regulatory or Legal Reasons. If the regulatory clearance to use the Equipment or Software is withdrawn or modified, or a change to applicable laws, legislation, regulations, rules or procedures is proposed or made, and as a result (a) a party’s continued performance under the terms of this Agreement would have a material adverse financial effect on such party; (b) the parties’ purpose for entering into this Agreement would be frustrated or rendered impossible or impracticable, or (c) a party would be at risk of being subjected to civil or criminal prosecution under state and/or federal laws, or other material adverse proceeding or effect, including without limitation, jeopardizing a party’s status as a recipient of governmental or private funds for the provision of health care services or its status as a tax-exempt organization, then the affected party shall provide notice to the other party. The parties shall attempt in good faith to amend this Agreement to the minimum extent necessary to mitigate the effects thereof. If, within ninety (90) days of providing such written notice the parties hereto acting in good faith are unable to mutually agree upon and make amendments or alterations to this Agreement to meet the requirements in question, or alternatively, the parties mutually determine in good faith that compliance with such requirements is impossible or unfeasible, then this Agreement shall be terminated without penalty, charge or continuing liability.
   4. Effect of Expiration or Earlier Termination. Upon the expiration or earlier termination of this Agreement, no party shall have any further obligations hereunder except for: (a) obligations accruing prior to the date of expiration or termination; and (b) obligations, promises or covenants contained herein which are expressly made to extend beyond the Term.
4. Representations, Warranties and Covenants.
   1. Authority. Each party hereby represents and warrants to the other party that (i) it is duly incorporated or organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization; (ii) it has the power, authority and legal right to enter into this Agreement and to perform the duties and obligations contemplated hereunder, and that it has taken all necessary corporate action to authorize execution of this Agreement; (iii) all necessary consents, approvals and authorizations of governmental authorities and other persons required to be obtained related to the performance of this Agreement have been obtained and all approvals will be in full force and effect during the Term; and (iv) the execution and delivery of this Agreement will not materially conflict with or violate any material requirement of any applicable law or regulation and does not materially conflict with or constitute a material default under any contractual obligation enforceable against it.
   2. Title to Equipment. Vendor represents and warrants that it has sufficient right, title and interest in the Equipment to fulfill its obligations under this Agreement.
   3. Equipment Warranties. Vendor represents and warrants that: (i) the Equipment provided under this Agreement shall be free from defects in workmanship and material at the time of delivery and conform to the manufacturer’s published specifications and; and (ii) the Equipment shall comply with all applicable federal, state and local laws rules and regulations. Vendor further represents and warrants that throughout the Term, Vendor shall, and all Equipment shall conform to, be and shall remain in compliance with, all applicable federal, state and local laws, regulations, ordinances, regulations and codes. Vendor further warrants that the Equipment, when used in accordance with the specifications, has received all applicable regulatory clearances and/or approvals and that all Equipment delivered to Customer will be in compliance with FDA regulations. Any modification of the Equipment or Software by anyone other than Vendor, or any combination or use of the Equipment or Software with instruments, equipment or software not authorized by Vendor, will void this warranty.
   4. Customer’s Remedies. Customer shall promptly notify Vendor in writing of a defect or non-conformance during the applicable warranty period. If Vendor determines that such defect or non-conformance is covered by the warranty provided hereunder, then Vendor will, in its discretion: (i) repair or replace the affected Equipment, or (ii) refund the Use Fee paid for the affected Equipment. If Vendor elects to repair or replace a Product, Vendor shall notify Customer of the anticipated time to repair or replace the Equipment, and Vendor shall use commercially reasonable efforts to repair or replace the Equipment within such time. Vendor may use new or refurbished parts or Equipment or components that are equivalent to new in performance and reliability and are at least functionally equivalent to the original component or Equipment. Vendor may elect to repair the Equipment at Customer’s premise using Vendor employees or contractors, or have the Equipment returned to Vendor for repair, provided that Customer must obtain a Return Material Authorization number from Vendor before returning any Equipment to Vendor. If Vendor concludes, after examining and testing returned Equipment, that it is not covered by the warranty, Vendor will notify Customer and return the Equipment at Customer’s expense. THIS SECTION 5(d) SETS FORTH CUSTOMER’S SOLE AND EXCLUSIVE REMEDIES, AND VENDOR’S SOLE LIABILITY, FOR DEFECTIVE OR NONCONFORMING EQUIPMENT, AND SHALL APPLY EVEN IF SUCH REMEDIES FAIL OF THEIR ESSENTIAL PURPOSE.
   5. Customer’s Warranties. Customer represents and warrants to Vendor that it is a healthcare provider licensed to perform the surgical procedures for which the Equipment and Software will be used, and that the Equipment and Software will only be used by licensed medical personnel with the requisite training, experience and skill to perform such surgical procedures, and only in facilities suitable for such surgical procedures.
   6. Warranty Disclaimer. SUBJECT TO THE LIMITATIONS IMPOSED BY APPLICABLE LAW, THE WARRANTIES DESCRIBED IN THIS SECTION 5 ARE VENDOR’S SOLE AND EXCLUSIVE WARRANTIES WITH RESPECT TO THE EQUIPMENT, AND ARE IN LIEU OF ALL OTHER WARRANTIES, STATUTORY, EXPRESS OR IMPLIED, ALL OF WHICH OTHER WARRANTIES ARE EXPRESSLY DISCLAIMED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT, OR REGARDING RESULTS OBTAINED THROUGH THE USE OF THE EQUIPMENT (INCLUDING WITHOUT LIMITATION, CLAIM OF INACCURATE, INVALID OR INCOMPLETE RESULTS), WHETHER ARISING BY STATUTE OR OTHERWISE AT LAW OR IN EQUITY, OR FROM A COURSE OF PERFORMANCE, DEALING OR USAGE OF TRADE.
   7. Equipment Maintenance. Maintenance is included in the Use Fee, and the Equipment shall be subject to regular maintenance by Vendor in order to ensure its proper operation, safety, and compliance with the applicable regulatory requirements. The Vendor will perform preventive maintenance (periodic inspections, checks, adjustments), corrective maintenance (troubleshooting and repairs in the event of a breakdown), and technical or software updates necessary for the compliant use of the equipment. Vendor maintenance does not include, and the Use Fee does not cover, repairs resulting from improper use, negligence, or unauthorized modification of the Equipment by the Customer. A price list for spare parts and after sale service will be shared with the Customer.
   8. Obligations of the Customer. Customer undertakes to: comply with the Vendor’s operating and maintenance instructions, keep an up-to-date maintenance log for the equipment, allow access to the equipment to the Vendor or its service provider for inspection purposes, and immediately inform the Vendor of any serious breakdown, incident, or malfunction likely to affect the safety of patients or users.
   9. Equipment Downtime. In the event of prolonged immobilization of the equipment for maintenance purposes, the parties agree to consult with each other in order to define the appropriate arrangements (provision of replacement equipment, adjustment to the Minimum Contract Price, or any other solution).
5. Regulatory; Compliance.
   1. Non-Exclusion. Vendor represents and warrants that neither it, nor any of its employees, agents or other contracted staff (collectively referred to in this Section as “employees”) has been or is about to be excluded from participation in any Federal health care program. If at any time during the Term of the Agreement, Vendor: (i) is charged with a criminal offense related to Federal health care program or is proposed for exclusion from participation in Federal health care program or procurement or non-procurement programs; or (ii) has notice that any of its employees has been charged with a criminal offense related to Federal health care program or is proposed for exclusion, Vendor agrees to notify Customer immediately. In the event of any such notification, Customer shall have the right to terminate the Agreement immediately upon notice to Vendor.
   2. Anti-Kickback Statute. The parties in good faith believe that the Agreement fully complies with the provisions of 42 U.S.C. 1320a-7b (the Medicare/Medicaid “Anti-Kickback Statute”). Neither Customer nor Vendor are, by virtue of this Agreement or otherwise, willfully offering, paying, soliciting, or receiving remuneration in return for referring an individual to or from each other for the furnishing of any item or service reimbursed under the Medicare or other federal or state health care programs. The Use Fee payable hereunder 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 a state health care program. The parties intend for this Agreement to comply with the Anti-Kickback Statute and the equipment rental safe harbor thereunder (42 C.F.R. §1001.952(c)); this Agreement shall be interpreted and construed therewith.
   3. Adverse Events; Recalls. Vendor shall monitor adverse event and other failure reports or complaints and promptly advise Customer of information indicating a significant trend of adverse events, consumer or practitioner complaints, or failures or injuries related to the use of the Equipment. If Vendor or any governmental or regulatory authority determines that a recall of the Equipment is necessary, Vendor has the sole and absolute right to implement such recall campaign and to provide for the return of recalled Equipment from Customer, as determined by Vendor in its reasonable discretion, and at Vendor’s sole cost and expense. If a recall campaign is implemented, at Vendor’s option and sole cost, Vendor shall either replace any defective Equipment or provide replacement Equipment to Customer. Supplier will be liable for all of Customer’s costs associated with any recall campaign if such recall campaign is based upon a reasonable determination that the Goods fail to conform to the warranties set forth in this Agreement.
   4. Referral Relations. In relation to and for purposes of compliance with the “Stark” law, 42 U.S.C. § 1395nn, Vendor represents and warrants that: (i) it is not a physician owned distributor, (ii) it is not owned by one or more providers or physicians (as defined by the Stark law, and (iii) there are no physicians or providers with investment interests in the Vendor, in the case of (ii) and (iii) where any such ownership or investment interest would cause this arrangement to create a financial relationship between a “DHS entity” and a physician.
6. Confidentiality.
   1. Confidentiality Obligations. During the course of performance of the Agreement, it is expected that each party will learn of certain confidential and proprietary information and/or trade secrets of the other party (the “Confidential Information”). The Confidential Information includes, but is not limited to, (i) all non-public information concerning a party’s business affairs, proprietary information and trade secrets, internal reports, patient lists, marketing plans, purchasing information, pricing information, strategic plans, sales tracings, financial and other business information and clinical information, (ii) all non-public information the other party knows or reasonably should know is to be or should be treated as confidential, and (iii) all materials that are marked as confidential or proprietary. All Confidential Information is and remains, the property of the disclosing party. The receiving party will not, directly or indirectly, (a) use any Confidential Information for any purpose that is not directly and solely related to the performance of its obligations under the Agreement, (b) publish or disclose any Confidential Information to any third party, or (c) use the Confidential Information in any manner for any other purposes. The receiving party shall maintain the Confidential Information in a secure manner that is at least as protective as that which the receiving party uses with respect to its own confidential and proprietary information, but in no event less than reasonable protection. The receiving party will take such action as necessary, including agreements with or instructions to its employees and agents, to enable it to perform its obligations with respect to Confidential Information.
   2. Exceptions. Confidential Information shall not include information that (i) is in or comes into the public domain without violation of this Agreement, (ii) is known by the receiving party prior to disclosure to it by the other party, (iii) is received by the receiving party from a third party lawfully and under no obligation of confidentiality subsequent to this Agreement, (iv) is released by the owner to others without restriction, or (v) is independently developed by the receiving party, provided that the person or persons developing this information have not had exposure to the same information as received from the disclosing party as demonstrated by competent evidence.
   3. Compelled Disclosures. In the event either party believes it is required by law (whether pursuant to oral questions, interrogatories, requests for information or documents, subpoena, civil investigative demand or similar process) to disclose any Confidential Information, it shall provide the disclosing party with prompt notice thereof so that the disclosing party may seek and appropriate protective order and/or waive compliance with this Agreement; provided, however, that if, in the absence of a protective order or the receipt of a waiver hereunder, such party is in the reasonable opinion of its counsel and compelled to disclose Confidential Information not otherwise disclosable hereunder to any legislative, judicial or regulatory body, agency or authority or else be exposed to liability for contempt, fine, or penalty, or to other censure, such Confidential Information may be disclosed, but only to the extent necessary to avoid such contempt, fine or penalty.
   4. Remedies. Both parties acknowledge that a breach or attempted breach of this Section 7 may cause irreparable damage and that damages at law will be an insufficient remedy. Accordingly, both parties agree that the aggrieved party shall be entitled as a matter of right to injunctive relief without necessity of bond or proof of damages, in order to restrain the breach or threatened breach of Confidential Information.
   5. Protected Health Information. Customer warrants that its possession and use of the Equipment does not require the disclosure or use of, or access to, any Protected Health Information by Vendor, and Customer shall not disclose to Vendor any Protected Health Information hereunder.
7. Indemnification; Insurance.
   1. By Vendor. Vendor shall indemnify, defend and hold harmless Customer and its trustees, directors, officers, employees, agents, and representatives (each, a “Customer Indemnitee”) from and against any third party claims, demands, investigations, suits, or causes of action (each, a “Claim”) asserted against a Customer Indemnitee with respect to actual or alleged losses, liabilities, injuries, deaths, damages, fines, penalties, costs, and expenses (including reasonable attorneys’ fees and expenses), relating to or arising out of: (i) breach by Vendor of the representations, warranties or other terms of this Agreement; (ii) Vendor’s or its employees, agents or representatives non-compliance with or violation of any federal, state or local law, rule, regulation or ordinance; (iii) injuries to persons or property caused by defective or non-conforming Equipment, and (iv) grossly negligent or willful acts or omissions of Vendor or its employees, agents, or representatives, provided, however, that Vendor is under no obligation to indemnify Customer to the extent the Claim is subject to Customer’s indemnification obligation in Section 7(b) below.
   2. By Customer. Customer shall indemnify, defend and hold harmless Vendor, its affiliates and their respective directors, officers, employees, agents, and representatives (each, a “Vendor Indemnitee” and collectively with the Customer Indemnitee, an “Indemnitee”) from and against any Claim asserted against a Vendor Indemnitee with respect to actual or alleged losses, liabilities, injuries, deaths, damages, fines, penalties, costs, and expenses (including reasonable attorneys’ fees and expenses), relating to or arising out of: (i) breach by Customer of the representations, warranties or other terms of this Agreement, including without limitation use of the Equipment for procedures for which it does not have regulatory clearance or approval; (ii) Customer’s or its employees, agents, or representatives non-compliance with or violation of any federal, state or local law, rule, regulation or ordinance; (iii) injuries to persons or property caused by a Customer Indemnitee, and (iv) grossly negligent or willful acts or omissions of Customer or its employees, agents, or representatives, provided, however, that Customer is under no obligation to indemnify Vendor to the extent the Claim is subject to Vendor’s indemnification obligation in Section 7(a) above.
   3. Procedure. The party seeking indemnification will provide the indemnifying party (the “Indemnitor”) with timely notice of any Claim for which indemnification will be sought hereunder; provided, however, that failure to provide timely notice shall relieve the Indemnitor of its duty to indemnify only to the extent such delay prejudices the Indemnitor. The Indemnitee will permit the Indemnitor to assume full responsibility for the investigation of, preparation for, and defense of any Claim for which indemnification is sought, and the Indemnitee will reasonably cooperate with the Indemnitor in defending the Claim. The Indemnitor may not compromise or settle any such Claim without the Indemnitee’s prior written consent. The Indemnitee shall have the right in its sole discretion and at its sole expense to select and obtain representation by separate legal counsel.
   4. Insurance. During the Term and for not less than five years thereafter, each party shall, as applicable, self-insure and/or maintain liability insurance on commercially reasonable terms, including insurance against damages because of bodily injury, including death, property damage. Each party shall maintain workers’ compensation insurance as required by law. For clarity, insurance effected or procured by a party shall not reduce or limits such party’s obligation to indemnify and defend the Indemnitees as contemplated in this Section 7.
8. Software License.
   1. License Grant. Subject to this Agreement and payment of the Use Fee, Vendor hereby grants Customer a nonexclusive, nontransferable, non-sublicensable license to use the object-code software and related documentation provided with the Equipment (the “Software”) solely in connection with Customer’s use of the Equipment.
   2. Restrictions. Customer may not modify, combine, reverse-engineer, decompile, sublicense, transfer, or use the Software outside the scope of this Agreement.
   3. Intellectual Property Rights. All intellectual property rights in the Equipment and Software remain exclusively with Vendor. Any improvements or modifications to the Equipment or Software arising from Customer’s evaluation, use or feedback belong solely to Vendor. Customer acquires no ownership or intellectual property rights under this Agreement and will not take any action that jeopardizes Vendor’s rights.
9. Limitations on Liability.
   1. No Indirect Damages. TO THE FULLEST EXTENT ALLOWED BY LAW, IN NO EVENT SHALL VENDOR BE LIABLE, WHETHER IN CONTRACT, TORT, STRICT LIABILITY, NEGLIGENCE, WARRANTY, OR UNDER ANY STATUTE OR ON ANY OTHER BASIS FOR ANY SPECIAL, INCIDENTAL, INDIRECT, EXEMPLARY, PUNITIVE, MULTIPLE OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION DAMAGES ARISING FROM OR RELATED TO LOSS OF USE, LOSS OF DATA, DOWNTIME, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES, OR LOSS OF REVENUE, PROFITS, GOODWILL, OR BUSINESS OR OTHER FINANCIAL LOSS, WHETHER OR NOT SUCH DAMAGES ARE FORESEEABLE AND WHETHER OR NOT VENDOR IS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, SUSTAINED BY CUSTOMER OR ANY OTHER PERSON OR ENTITY ARISING OUT OF OR CAUSED BY THE EQUIPMENT OR SOFTWARE, OR BY VENDOR’S PERFORMANCE OR FAILURE TO PERFORM ITS OBLIGATIONS HEREUNDER, OR BY VENDOR’S BREACH OF THIS AGREEMENT, OR RELATED TO THE POSSESSION OR USE OF THE EQUIPMENT OR SOFTWARE.
   2. Limitation on Liability. VENDOR’S LIABILITY TO CUSTOMER FOR DIRECT DAMAGES ARISING OUT OF THIS AGREEMENT OR THE USE OF THE EQUIPMENT AND SOFTWARE PROVIDED HEREUNDER SHALL BE LIMITED TO THE AMOUNTS THAT VENDOR RECEIVED FROM CUSTOMER FOR THE APPLICABLE EQUIPMENT IN THE TWELVE (12) IMMEDIATELY PRECEDING SUCH CLAIM.