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Intellijoint Fee Per Use Terms and Conditions

This Fee Per Use Terms and Conditions (“FPUTC”) Agreement is to be read in conjunction with the Fee Per Use
Agreement (“FPUA”) issued by Intellijoint that references this Agreement and is signed by both Parties. Unless otherwise agreed to in writing, the following terms and conditions apply to Customer’s purchases of Intellijoint products as further defined below. Each of Intellijoint and Customer is a “Party” and together the “Parties”.

Intellijoint manufactures, and Customer wishes to use, the Intellijoint Navigation System including Intellijoint HIP or Intellijoint KNEE (the “System”) for use in total joint arthroplasty procedures (“Procedures”). The System comprises the components and parts listed under the heading Loaned Equipment on the FPUA (the “Components”) as well as the onetime-use products listed on the FPUA (“Consumables”). The System further comprises access to the cloud-based Intellijoint VIEW product for pre-operative planning (the “Services”). Each System workstation incorporates Intellijoint proprietary software and third-party software (the “Software”) which are licensed to Customer as described further below.

1. TERM, DELIVERY AND PAYMENT
1.1. Term: The term of this Agreement shall be twelve (12) months from the Effective Date (the “Initial Term”) and will automatically renew for twelve (12) month periods (each a “Subsequent Term” and together with the Initial Term the “Term”) unless terminated by one of the Parties in accordance with this Agreement.
1.2. Delivery: All Components and Consumables, including Loaned Equipment, ordered under this Agreement will be delivered EX Works (EXW, Incoterms 2020) at Intellijoint’s designated facility. Customer shall bear all freight, insurance, duties, and other costs associated with shipment from Intellijoint’s facility, and risk of loss shall transfer to Customer upon Intellijoint’s tender of the goods at such facility. Title to Consumables shall pass to Customer upon delivery EXW. Without limiting the foregoing, Intellijoint shall remain liable for any damage caused by improper boxing, crating, or packing prior to tender.
1.3. Termination: Either Party may terminate this Agreement with or without cause upon thirty (30) days’ written notice to the other Party. Upon termination, the System(s) will be removed from each Affiliated Facility by Intellijoint at Customer’s earliest convenience, and access to the Services and Software will be terminated. Consumables and Components where title has been transferred to Customer will remain with Customer. Any Consigned Consumables will be returned to Intellijoint. Customer shall be responsible for all costs associated with the return of Systems and Consigned Consumables.
1.4. Fee Per Use: Customer may use the System subject to the Fee Per Use License, outlined further below, and the payment of the Procedure Kit Fee outlined in the FPUA, for each instance in which the System is used for a Procedure at an Affiliated Facility.
1.5. Payment Terms and Invoicing: Unless otherwise specified, Intellijoint shall issue invoices to Customer for orders fulfilled or on such other basis as Intellijoint may determine, and each invoice shall state the applicable currency for payment. Customer shall remit full payment to Intellijoint within thirty (30) days from the invoice date. Late amounts may be subject to a late fee of one-point-five (1.5%) per month calculated on a simple non-compounding basis (18% per annum) or the maximum interest rate allowable by law, whichever is the highest. Customer agrees to pay any expenses incurred to process or compel the settlement of any late payments. Intellijoint, at its sole discretion, reserves the right to discontinue further shipments, without prejudice to any other lawful remedy, until past due payments are made and satisfactory assurances of Customer’s credit standing is received by Intellijoint. Should Customer elect to cancel its order, in whole or in part, Customer shall be liable to Intellijoint for reasonable cancellation charges including but not limited to all costs and expenses incurred by Intellijoint in connection with procuring and filling Customer’s purchase order up to the date of cancellation.
1.6. Invoice Disputes: If any amount of an invoice is disputed by the Customer in good faith, Customer shall pay the undisputed invoice amount when due along with a written explanation specifying the amount in dispute. Upon resolution of the amount in dispute, any disputed amount that is determined to be due and owing to Intellijoint by the Customer shall be paid by the Customer to Intellijoint immediately upon such resolution. Any invoice dispute is waived by Customer if such notice is not received by Intellijoint within thirty (30) days of the invoice date. All payments are non-refundable.
1.7. Taxes & Gross Up: All fees are exclusive of taxes, levies or duties imposed by taxing authorities (“Taxes”), and Customer shall be responsible for any applicable taxes, levies or duties (excluding taxes based on Intellijoint’s income). If Customer is a tax-exempt entity or claims exemption from any Taxes, Customer shall provide a certificate of exemption, upon execution of this Agreement, and after receipt of valid evidence of exemption, Intellijoint shall not charge any Taxes from which Customer is exempt. All payments to be made by Customer to Intellijoint under this Agreement shall be made free and clear of and without any tax withholding unless Customer is required to do so, in which case the sum payable by Customer shall be increased to the extent necessary to ensure that Intellijoint receives a sum net of any deduction or withholding equal to the sum which it would have received had no such tax withholding been made or required to be made. Customer shall promptly furnish Intellijoint with all official receipts evidencing payment of Taxes due under or in relation to this Agreement.
1.8. Price Adjustment: All prices provided under an Agreement are based off a discount rate from List Price. The List Price may be adjusted for inflation by Intellijoint for each Subsequent Term by an amount equal to or less than the annual Consumer Price Index published for the United States without any amendment to the Agreement.

2. PRODUCT AVAILABILITY AND SUPPORT
2.1. System Availability: The Loaned Equipment is made available to Customer for the sole purpose of performing Procedures at the Affiliated Facilities in accordance with the quantities and locations outlined in the FPUA and the loan terms described in Appendix A. Consumables may be stored or consigned at Affiliated Facilities to enable access and availability for Procedures in accordance with the quantities and locations outlined in FPUA and the consignment terms described in Appendix B. In the event that Customer requires delivery of additional Systems, Components, or Consumables, and Customer provides Intellijoint with less than 48 hours notice prior to the Procedure start time, then an additional Late Delivery Notice Fee will apply as outlined in the FPUA.
2.2. Case Support: Customer agrees that, on the earlier of (a) sufficient staff training or (b) 120 days after the Effective Date, all use of the System for Procedures will be performed independently by Customer’s staff and physicians. If for any reason a direct sales representative of Intellijoint is used during a Procedure an additional Direct Case Support Fee will apply as outlined in the FPUA.
2.3. System Support and Updates: Intellijoint shall provide after sales service as reasonably required including providing or installing Updates (as further defined below) in order to maintain the System Software in good working order and in accordance with Intellijoint documentation during the Term of this Agreement. Updates may include bug fixes, patches and other error corrections that enhance existing System functions and operation and that do not require hardware changes (collectively, “Updates”). Updates may modify or delete in their entirety certain existing features and functionality of the System. Updates do not include the provision of Components that may need replacement from time-to-time or the provision of routine maintenance as described in Intellijoint manuals, labels or inserts. Additional coverage for replacement Components and service-level commitments may be purchased separately.
2.4. Product Upgrades: During the Term, Intellijoint may develop and offer additional products that are not currently listed on the FPUA or which provide new functionality, substantial improvements to existing functionality, or require hardware changes (“Upgrades”). Intellijoint will issue a revised FPUA, to be signed by both Parties, to incorporate Upgrades into this Agreement. Upgrades will be made available to Customer at prices equal to those offered to other similarly situated customers of Intellijoint.
2.5. Consumable Products: Consumables should be purchased only through Intellijoint and its authorized distributors and resellers in order to ensure they are manufactured by or on behalf of Intellijoint and meet Intellijoint’s quality requirements. Consumable products will be labeled as “For Single Use” or “Single Use Only” or “Do Not Reuse” or similarly to indicate that the Consumable is to be used only once in delivering patient care. Any re-use, reprocessing, remanufacture, or reconstruction of Consumables is strictly prohibited. In addition to other available remedies, the resale or reuse of any Consumable is subject to the laws and remedies available for patent infringement.
2.6. Discontinued Products: Intellijoint may discontinue any product, product line or business segment and its sole discretion and any such discontinuation shall not constitute a breach of this Agreement.
2.7. Lost, Damaged or Broken Equipment: Should any System or its constituent parts become lost, damaged or broken due to the actions, misuse, or negligence of a User, Customer, or Customer’s employees, Customer shall be responsible for the replacement of the System or its constituent parts at the then-current replacement price as maintained by Intellijoint.

3. INTELLECTUAL PROPERTY AND LICENSING
3.1. Ownership: Intellijoint shall retain all ownership of the System, and any portion thereof, along with all intellectual property rights in the System unless otherwise explicitly transferred to Customer by this Agreement or an agreement signed by both Parties. In no event shall anything in this Agreement transfer any ownership right, title or interest in the Software, the Services, or any part thereof, to Customer. Customer agrees to ensure that all Users agree and adhere to the provisions of this Section 3.
3.2. Fee Per Use License: Subject to compliance with this Agreement, Intellijoint hereby provides Customer with a limited, revocable, non-transferable, non-exclusive license to permit its Affiliates, surgeons, and surgical teams (collectively “Users”) to use the System solely to perform Procedures at the Affiliated Facilities. Additional rights and limitations related to the use of the Services are governed by the Intellijoint VIEW Terms of Service located at https://www.intellijointsurgical.com/view-terms-of-service/ (“Service Terms”). Customer shall ensure that Users do not use the System for any off-label purposes or in any experimental procedure without Intellijoint’s prior written authorization. Customer may publicly display or perform the System, including the capture and publication of any user interfaces, only for academic, research, education and demonstration purposes and in accordance with any branding guidelines published by Intellijoint. Customer shall ensure that Users do not publish, share, distribute, rent, lease, lend, alter, modify, adapt, create derivative works of, translate, deface, or reverse engineer the System or any portion thereof, or attempt to do so, or permit, acquiesce, authorize or encourage any other party to do so, without the express written permission of Intellijoint. Customer shall ensure that Users do not remove any copyright, trademark, proprietary rights, disclaimer or warning notice included on or embedded in any part of the System. Only Users at Affiliated Facilities may use the System unless Intellijoint gives its prior written consent (which consent shall not be unreasonably withheld) to have the System used at another location. Finally, Customer shall ensure that Users do not reproduce or attempt to reproduce the System, or any portion thereof, without the express written permission of Intellijoint.
3.3. Feedback and Innovations: Customer and its Users shall provide Intellijoint with feedback, suggestions, ideas, inventions, or improvements relating to the System or Services (“Feedback”). All Feedback, and all intellectual property rights therein, shall be the sole and exclusive property of Intellijoint, and Customer and its Users hereby irrevocably assign all such rights to Intellijoint. Intellijoint may use, commercialize, distribute, or otherwise exploit the Feedback or any related developments without restriction or obligation. Customer and its Users waive any claims to compensation or recognition and covenant not to assert or permit any claim or action that would restrict or interfere with Intellijoint’s or its partners’ use, distribution, or commercialization of the System, the Services, or any related developments.

4. REPORTING AND COMPLIANCE
4.1. Compliance with Laws and Use: Customer shall use the Systems solely in accordance with their intended use, labeling, and instructions for use provided by Intellijoint, and in compliance with all applicable laws, regulations, professional standards, and regulatory approvals in the jurisdiction(s) where the Systems are used. This includes, without limitation: (a) compliance with the requirements of the U.S. Food and Drug Administration (“FDA”); (b) Health Canada; and (c) any other comparable regulatory authority with jurisdiction over the Systems (collectively, “Regulatory Authorities”).
4.2. Cooperation: Customer shall cooperate fully with Intellijoint in connection with any inspections, inquiries, or requests for information from Regulatory Authorities relating to the Systems, and shall promptly notify Intellijoint of any such contact.
4.3. Reporting Obligations: Customer shall promptly report to Intellijoint, and in no event later than twenty-four (24) hours after becoming aware, any incident or near incident involving the System that resulted in, or could have resulted in, death or serious injury. Customer shall report within five (5) business days any other complaints, notices, or comments relating to the identity, quality, durability, reliability, safety, effectiveness, or performance of the System. Without limiting the foregoing, Customer shall provide Intellijoint with all information necessary to enable Intellijoint to comply with its post-market surveillance and vigilance reporting obligations under applicable law, including without limitation: (a) United States: Medical Device Reporting requirements under 21 C.F.R. Part 803; (b) Canada: Medical Device Regulations, SOR/98-282, including mandatory problem reporting requirements under sections 59–61; or (c) any other comparable regulatory authority with jurisdiction over the Systems. For clarity, Customer’s reporting obligations under this Section 4.3 are in addition to, and not in substitution for, any mandatory reporting obligations Customer or its personnel may have directly to Regulatory Authorities under applicable law.
4.4. Intellijoint Notification: Intellijoint shall promptly notify Customer of any adverse event, field action, recall, correction, or other matter relating to the safety, performance, or regulatory compliance of the System that Intellijoint is required to report to a Regulatory Authority and that may reasonably affect Customer’s use of the System. Such notice shall be provided in writing and in sufficient detail to allow Customer to comply with its own obligations to patients, staff, and applicable Regulatory Authorities.
4.5. Investigations: Customer shall reasonably cooperate with Intellijoint in investigating any incidents, complaints, or reports, including providing timely access to relevant personnel, data, and medical records (subject to applicable privacy laws). Customer shall not file any report with a Regulatory Authority or initiate any recall or corrective action without Intellijoint’s prior written consent, unless such filing or action is legally required. Where local law requires Customer to file directly with a Regulatory Authority, Customer shall provide Intellijoint with advance written notice (where practicable) and a copy of any such filing promptly after submission.
4.6. Recall and Field Safety Corrective Action: Intellijoint shall have sole authority to determine whether a recall or field safety corrective action (“FSCA”) is required and shall be responsible for regulatory filings and authority communications. Customer shall fully cooperate with Intellijoint in implementing and completing such recall or FSCA, including identification, segregation, return, or destruction of affected Systems. Unless a recall or FSCA results from Customer’s breach of this Agreement, negligence, willful misconduct, or unauthorized use, Intellijoint shall bear the reasonable costs and expenses of such recall or FSCA; otherwise, Customer shall indemnify Intellijoint for such costs.
4.7. Failure to Comply: Failure by Customer to comply with any of the obligations set forth in this Section 4, including timely reporting of incidents, cooperation with investigations, or execution of recall or corrective actions, shall constitute a material breach of this Agreement. In addition, any such failure shall give rise to an indemnity obligation by Customer under Section 9.5, and Intellijoint shall be entitled to exercise any rights or remedies available under this Agreement or at law, including suspension of Customer’s access to the System or Services until the breach is remedied.

5. PRIVACY AND REGULATORY
5.1. Privacy: The collection, use, retention, disclosure or other processing (collectively “Processing”) of any personally information (“PI”) and personal health information (“PHI”) for use with the System is governed by the Intellijoint Privacy Notice, accessible at https://www.intellijointsurgical.com/privacy-notice/. If either Party wishes to Process PI or PHI in a manner not contemplated by the Privacy Notice, the Party intending to Process the PI or PHI (the “Requesting Party”) must provide prior written notice to the other Party (the “Approving Party”) regarding its intention(s) and the Requesting Party must further obtain the prior written agreement of the Approving Party prior to Processing the PI or PHI in any manner that would impose legal obligations with respect to the Processing of the PI or PHI of the Approving Party.
5.2. Allocation of Roles: For purposes of applicable privacy laws: (a) Customer shall be deemed the “data controller” (or equivalent term under local law) with respect to any personal information or personal health information that it collects and provides to Intellijoint in connection with the System, and shall be responsible for ensuring a valid legal basis for processing, providing required notices, and obtaining any necessary consents from data subjects; and (b) Intellijoint shall be deemed the “data processor” (or equivalent) and shall process such information solely on behalf of Customer and in accordance with this Agreement, applicable privacy laws, and Customer’s documented instructions.
5.3. Security Measures: Intellijoint shall implement and maintain appropriate technical and organizational measures, consistent with industry standards and applicable privacy laws, designed to protect personal information and personal health information against unauthorized or unlawful processing and against accidental loss, destruction, damage, theft, alteration, or disclosure. Such measures shall include, at a minimum, encryption in transit, access controls, and audit logging.
5.4. Breach Notification and Cooperation: Each Party shall promptly, and in no event later than seventy-two (72) hours after becoming aware, notify the other Party of any actual or suspected unauthorized access to or disclosure of personal information or personal health information in its possession or control (“Data Breach”). Each Party shall cooperate fully with the other in investigating, mitigating, and complying with any legal or regulatory obligations arising from a Data Breach, including notification to affected individuals or Regulatory Authorities where required.
5.5. Canadian Privacy Compliance: To the extent applicable to this Agreement, Intellijoint shall comply with: (a) the Personal Health Information Protection Act, 2004 (Ontario) (“PHIPA”); (b) the Personal Information Protection and Electronic Documents Act, S.C. 2000, c. 5 (“PIPEDA”), where applicable; and (c) any provincial privacy legislation deemed substantially similar to PIPEDA. Intellijoint agrees not to use or further disclose any Personal Information or Personal Health Information (as defined under PHIPA, PIPEDA, or applicable provincial laws) other than as permitted by applicable law and the terms of this Agreement. Intellijoint shall make its internal practices, books, and records relating to such information available to the extent required by PHIPA, PIPEDA, or other applicable law.
5.6. US Privacy Compliance (HIPAA): To the extent applicable to this Agreement, Intellijoint shall comply with the Health Insurance Portability and Accountability Act of 1996, as codified at 42 U.S.C. §1320d (“HIPAA”), and its implementing regulations, including the Privacy Rule, Security Rule, and Breach Notification Rule. Intellijoint agrees not to use or further disclose any Protected Health Information (“PHI,” as defined under HIPAA) other than as permitted by applicable law and the terms of this Agreement. Intellijoint shall make its internal practices, books, and records relating to PHI available to the extent required by HIPAA. If and to the extent a Business Associate Agreement (“BAA”) is required, the Parties shall enter into a separate written BAA, which shall govern in the event of conflict with this Agreement.
5.7. Access to Books and Records (US Only): The following clause is included herein to address Section 1861(v)(1)(I) of the Social Security Act and corresponding regulations to the extent it applies to this Agreement (as well as any prior agreements for the same or similar services). If said section of the Social Security Act is not applicable to this Agreement then this section shall be deemed not to be part of this Agreement and shall be null and void. Until the expiration of four (4) years after the furnishing of services pursuant to this Agreement, Intellijoint shall make available upon written request of the Secretary of Health and Human Services or the United States Comptroller General or any of their duly authorized representatives, this Agreement, books, documents, and records which are necessary to verify the nature and extent of costs incurred by Intellijoint under this Agreement; and if Intellijoint carries out any of the duties of this Agreement through a subcontract, with a value or cost of $10,000 or more over a twelve (12) month period (including contracts for both goods and services in which the service component is worth $10,000 or more over a twelve (12) month period), with a related organization, such subcontract must contain a clause to the effect that until the expiration of four years after the furnishing of services pursuant to such subcontract, the related organization shall make available upon written request of the Secretary of Health and Human Services or the United States Comptroller General or any of their duly authorized representatives, the subcontract, books, documents, and records of such organization that are necessary to verify the nature and extent of such costs.
5.8. Exclusion and Debarment (U.S. Only): Intellijoint represents and warrants that it has not been debarred, suspended, excluded, or otherwise determined to be ineligible to participate in any U.S. federal healthcare program, including without limitation Medicare and Medicaid (“Debarred”). Intellijoint shall immediately notify Customer if, during the Term, it becomes Debarred or receives notice of actual or threatened action that could result in Debarment. Customer shall have the right to terminate this Agreement immediately upon written notice if Intellijoint becomes Debarred.

6. INSURANCE
6.1. Insurance: Intellijoint shall maintain, at its expense, insurance policies with financially sound and reputable insurers sufficient to cover its potential liabilities under this Agreement and as required by applicable law, including: (a) Commercial general liability insurance in the amount of Five Million Dollars ($5,000,000) per occurrence; (b) Worker’s compensation and employer’s liability insurance per statutorily required minimums in the amount of Two Million Dollars ($2,000,000) for each incident, Two Million Dollars ($2,000,000) disease-policy limit and Two Million Dollars ($2,000,000) disease for each employee; (c) Medical device liability insurance in the amount of Ten Million Dollars ($10,000,000) for products and completed operations; and (d) Cyber liability of Five Million Dollars ($5,000,000) in coverage for network security and privacy risks including coverage for related regulatory defense and penalties and coverage for data breach expenses.
6.2. Subrogation: All insurance policies shall waive subrogation rights against Customer except to the extent attributable to Customer’s gross negligence or willful misconduct.
6.3. Evidence: Intellijoint shall, upon written request, provide Customer with certificates of insurance evidencing the foregoing coverages.
6.4. Professional Liability: Nothing in this Section 6 shall be construed to relieve Customer, its physicians, or staff of their responsibility to maintain professional liability and malpractice insurance as required by applicable law.

7. WARRANTY
7.1. Software and Services Warranty: Intellijoint warrants that, for the Term of this Agreement, the Software and Services will function in all material respects in accordance with Intellijoint’s specifications and documentation.
7.2. System Warranty: Intellijoint warrants that, for the Term of this Agreement, the Components will be free from defects in workmanship and materials when used for Procedures in accordance with this Agreement and Intellijoint’s instructions.
7.3. Consumables Warranty: Consumables are warranted to be free from defects in workmanship and materials until the earlier of (a) their use in a Procedure, or (b) the expiration date printed on the labeling. Consumables are single-use only and no warranty applies after use.
7.4. Regulatory Warranty: Intellijoint warrants that, as of the Effective Date and during the Term, the System is lawfully marketed, licensed, and cleared (as applicable) for their intended use in the jurisdiction(s) where provided to Customer.
7.5. Exclusive Remedies: Customer’s sole and exclusive remedy for any breach of the warranties in Sections 7.1, 7.2 and 7.3 shall be, at Intellijoint’s option, the repair or replacement of the non-conforming Software, Consumables, or Components.
7.6. Warranty Conditions: The warranties set out in Sections 7.1, 7.2 and 7.3 are contingent upon: (a) the System used in accordance with approved labeling and directions for use; (b) the System not altered by Customer; (c) the System being used in conjunction with Consumables provided under this Agreement; (d) the Consumables being manufactured by Intellijoint or on its behalf; (e) the Consumables not being reused, reprocessed, remanufactured, reconstructed, or otherwise altered after their initial single use; and (f) proper maintenance of the System in accordance with Company recommended maintenance procedures. Any warranty claim under this Section 7 must be submitted in writing within ninety (90) days from the date the Customer knew or reasonably should have known of the defect.
7.7. Intellectual Property Warranty: Intellijoint warrants that, to the best of its knowledge, the System, when used in accordance with this Agreement, does not infringe any third-party patents, copyrights, or trade secrets in the territory where Affiliated Facilities operate and where Systems are used by the Customer in accordance with this Agreement. This warranty does not apply to claims arising from (a) use of the System in combination with products, services, or data not provided by Intellijoint; (b) modifications made by any party other than Intellijoint; (c) Customer’s failure to use updated or modified versions of the System provided to avoid an alleged or actual infringement; (d) Customer’s use of the System outside the territory or in jurisdictions where regulatory clearance or approvals have not been obtained; or (e) compliance by Intellijoint with designs, specifications, or instructions provided by Customer.
7.8. No Implied Warranties: EXCEPT AS EXPRESSLY SET OUT HEREIN, NEITHER PARTY MAKES ANY WARRANTIES, CONDITIONS, ENDORSEMENTS, REPRESENTATIONS OR GUARANTEES, WHETHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY CONDITIONS, ENDORSEMENTS, GUARANTEES, REPRESENTATIONS OR WARRANTIES OF DURABILITY, MERCHANTABILITY, MERCHANTABLE QUALITY, SATISFACTORY QUALITY, ACCURACY, TITLE, NON-INFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE OR USE, OR ARISING FROM A STATUTE OR CUSTOM OR A COURSE OF DEALING OR USAGE OF TRADE. WITHOUT LIMITING THE FOREGOING, INTELLIJOINT DOES NOT REPRESENT OR WARRANT THAT THE SYSTEM SHALL FUNCTION WITHOUT FAILURE, ERROR OR INTERRUPTION. THE LIMITATIONS ON LIABILITY, EXCEPTIONS TO LIMITATION AND DISCLAIMER OF IMPLIED WARRANTIES SHALL SURVIVE TERMINATION OR EXPIRATION OF THIS AGREEMENT.

8. CONFIDENTIALITY
8.1. Confidentiality: As used herein, the “Confidential Information” of a Party will mean any and all technical and non-technical information disclosed by such Party (the “Discloser”) to the other Party (the “Recipient”), which may include without limitation: (a) information the Discloser has marked or identified as confidential or proprietary; (b) intellectual property including but not limited to trade secrets, patents, patent applications, and related documentation; and (c) Discloser’s business plans, business methodologies, financial condition, financial projections, or development plans. Recipient agrees that at all times and notwithstanding any termination or expiration of this Agreement it will hold in strict confidence and not disclose to any third-party any Confidential Information of the Discloser, except as approved in writing by the Discloser, and will use the Confidential Information of the Discloser only as reasonably necessary to fulfill the purposes of this Agreement. The Recipient will also protect such Confidential Information with at least the same degree of care that the Recipient uses to protect its own Confidential Information, but in no case, less than reasonable care.
8.2. Access to Confidential Information: The Recipient will limit access to the Confidential Information of the Discloser to only those of the Recipient’s affiliates, employees, partners, contractors, investors or authorized representatives having a need to know (herein “Representatives”). Prior to a Representative receiving Confidential Information they will be advised of the obligations contained in this Agreement. Recipient undertakes to ensure that all Representatives to whom it discloses the Confidential Information will comply with the confidentiality obligations set out in this Section 8 as if they were parties to this Agreement. Recipient further undertakes to ensure its Representatives enter into written confidentiality and non-disclosure agreements substantially similar to this Agreement. Representatives must either agree in writing to be bound by this Agreement, or have previously entered into a binding confidentiality agreement with the Recipient that affords substantially similar protection of the Confidential Information as this Agreement.
8.3. Exceptions to Confidentiality: Recipient will not have any obligations under this Agreement with respect to a specific portion of the Confidential Information of the Discloser if the Recipient can demonstrate that such portion of Confidential Information: (a) was in the public domain at the time it was disclosed to the Recipient; (b) entered the public domain subsequent to the time it was disclosed to the Recipient, through no fault of the Recipient; (c) was already lawfully in the Recipient’s possession at the time it was disclosed to the Recipient; (d) was communicated to the Recipient free of any obligation of confidence subsequent to the time it was disclosed to the Recipient; or (e) was independently developed by employees or agents of the Recipient without reference to the Confidential Information. Notwithstanding the above, the Recipient may disclose certain Confidential Information of the Discloser, without violating the obligations of this Agreement, to the extent such disclosure is required by a valid order of a court or other governmental body having jurisdiction, provided that the Recipient uses all reasonable efforts to provide sufficient notice of this requirement to the Discloser to enable the Discloser to seek an order limiting or preventing the disclosure of the Confidential Information.
8.4. Survival: The obligations in respect of Confidential Information shall survive for three (3) years following the expiration of this Agreement, or in the case of trade secrets, for so long as the information remains a trade secret. For clarity, the terms of this Agreement are confidential and shall not be disclosed by either Party except to those employees, agents or officers or professional advisors with a need to know the information. Upon termination or expiration of this Agreement, the Recipient shall return or destroy all Confidential Information of the Discloser in the Recipient’s possession or control. Notwithstanding any other term in this Agreement, neither Party is obligated to erase confidential information archived by their automatic security or disaster recovery systems. Any such retained copy shall remain subject to the confidentiality and non-use obligations of this Agreement.
8.5. Equitable Relief: Each Party acknowledges that any breach or threatened breach of this Section 8 would give rise to irreparable harm for which monetary damages would be inadequate, and in such event the non-breaching Party shall be entitled to seek equitable relief, in addition to any other remedy available under this Agreement or at law or in equity, without the posting of a bond.

9. INDEMNIFICATION AND LIMITATIONS OF LIABILITY

CUSTOMER ACKNOWLEDGES AND AGREES THAT THE SYSTEM IS AN ADJUNCT TO, AND NOT A REPLACEMENT FOR, A SURGEON’S KNOWLEDGE, EXPERTISE, AND JUDGMENT AND AS SUCH, RESPONSIBILITY FOR THE USE OF THE SYSTEM IN SURGERY REMAINS WITH THE SURGEON.

9.1. Indemnification: Intellijoint shall, at its expense, indemnify, defend and hold harmless Customer and its Affiliates and their respective directors, officers, employees, surgeons, and representatives (collectively “Customer Indemnitees”) from and against any third-party claim, action or regulatory proceeding brought against a Customer Indemnitee to the extent the claim or action is based upon a claim that: (a) Consumables manufactured by or on behalf of Intellijoint are faulty or that used in accordance with the instructions of Intellijoint they have caused damage to a patient that is not the result of the surgeon’s judgment and expertise; or (b) that the System failed to operate strictly in accordance with the documentation provided by Intellijoint and without modification or misuse during a Procedure and caused damage to a patient that is not the result of the surgeon’s judgment and expertise (each a “Customer Claim”), as well as: (c) any facts or circumstances that would constitute a breach by Intellijoint of any of its representations, warranties or obligations under this Agreement; (d) that Intellijoint’s technology used to provide the System infringes or misappropriates any copyright, trade secret, registered patent or registered trademark right of a third party in the territory where Affiliated Facilities operate, provided that Intellijoint may, at its option, discharge this indemnification obligation by pursuing one of the remedies set out in Section 9.4; (e) any claim or action arising from Intellijoint’s failure to comply with applicable regulatory requirements in connection with the manufacture, labeling, marketing, sale, distribution, or other regulatory clearance or approval of the System or Consumables in the territory where Affiliated Facilities operate; (f) any unauthorized disclosure or use of PHI caused by Intellijoint’s failure to comply with its privacy obligations under this Agreement; or (g) gross negligence, willful misconduct, or violation of law by Intellijoint, its employees or its subcontractors. Intellijoint shall indemnify each Customer Indemnitee for all losses, damages, costs, and expenses, including reasonable legal fees, arising from any matter described in this Section 9.1.
9.2. Exceptions to Indemnification: In no event will Intellijoint have any obligations or liability under this Section 9 arising in whole or in part from any content, information or data provided by Customer or other third parties or in cases where such finding of liability would not have existed but for the provision of the same. Intellijoint shall not be required to indemnify Customer in the event of: (a) modification of the System by Customer that is in conflict with Customer’s obligations or as a result of any prohibited activity as set forth herein; (b) use of the System in a manner inconsistent with the documentation; (c) use of the System in combination with any other application, product, or service not provided by Intellijoint if such claim would not have occurred without such combination; or (d) use of the System in a manner not otherwise contemplated by this Agreement or in contravention of applicable law. Customer shall take all reasonable steps to mitigate any loss or damage giving rise to claims under this Section 9.
9.3. Notice of Claim: Customer must: (a) promptly notify Intellijoint of any claim under this Section 9; (b) give Intellijoint the right to conduct the defence and settlement of the claim; and (iii) act in accordance with the reasonable instructions of Intellijoint and give Intellijoint such assistance as Intellijoint reasonably requests provided that Intellijoint reimburses Customer for any out-of-pocket expenses it incurs as a result.
9.4. Infringement Remedy: If the System infringes or may be alleged to infringe a third party’s copyright, registered patent or registered trademark in the territory or country where Affiliated Facilities operate, then Intellijoint may: (a) obtain the right for Customer, at Intellijoint’s expense, to continue using the System; (b) provide a non-infringing functionally equivalent replacement; or (c) modify the System so that they no longer infringe. If Intellijoint does not believe that the options described in this Section 9.4 are reasonable, then Intellijoint may suspend or terminate Customers’ use of the affected System, or any portion thereof, for convenience effective immediately. The remedies under this Section 9.4 shall be the Customer’s only remedy for intellectual property infringement.
9.5. Customer Indemnification: Customer shall defend Intellijoint and its Affiliates and their respective directors, officers, employees and representatives (including Intellijoint Reps) from and against any claim, action or regulatory proceeding based upon or arising from: (a) any facts or circumstances that would constitute a breach by Customer of any of its representations, warranties or obligations under this Agreement; (b) any violation by Customer of applicable laws; (c) any bodily injury, death or property damage resulting or arising from a Procedure, including the use of the System or Consumables, other than a Customer Claim; or, (d) any modification, alteration, or misuse of the System or Consumables by Customer or its Users, including without limitation: (i) use of the System or Consumables other than as permitted by this Agreement or the applicable documentation; (ii) use in connection with any third-party products, software, hardware, data, or services not provided or approved in writing by Intellijoint; or (iii) use for off-label or experimental purposes without the prior written consent of Intellijoint; and (e) any failure by Customer to comply with the reporting obligations or regulatory cooperation provisions under this Agreement. Intellijoint must: (1) immediately notify Customer of any claim; (2) give Customer the right to conduct the defence and settlement of the claim; and (3) act in accordance with the reasonable instructions of Customer and give Customer such assistance as Customer reasonably requests provided that Customer reimburses Intellijoint for any out-of-pocket expenses it incurs as a result.
9.6. Limitation of Liability for Indemnification: Except as expressly provided below, each Party’s total aggregate liability arising out of or in connection with this Agreement, whether in contract, tort (including negligence), strict liability, or otherwise, shall not exceed the greater of (a) the fees paid by Customer to Intellijoint under this Agreement in the twelve (12) months immediately preceding the event giving rise to the claim; (b) the limits of insurance coverage actually carried and applicable to the claim; or (c) USD $500,000. Notwithstanding the foregoing, nothing in this Agreement shall limit or exclude liability for: (i) death or personal injury caused by a Party’s negligence; (ii) a Party’s gross negligence, willful misconduct, or fraud; (iii) breach of confidentiality obligations; (iv) willful infringement of intellectual property rights; or (v) Customer’s payment obligations.
9.7. Exclusion of Consequential Damages: IN NO EVENT SHALL INTELLIJOINT BE LIABLE TO CUSTOMER OR ANY THIRD PARTY UNDER THIS AGREEMENT FOR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION ANY LOSS OF PROFITS, REVENUES, GOODWILL, OR BUSINESS INTERRUPTION, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, OR ANY OTHER LEGAL THEORY, EVEN IF INTELLIJOINT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE FOREGOING EXCLUSION SHALL APPLY TO THE MAXIMUM EXTENT PERMITTED BY LAW.

10. OTHER TERMS
10.1. Independent Contractor: In the performance of this Agreement, it is mutually understood and agreed that Intellijoint is at all times acting and performing as an independent contractor with, and not an employee or joint venturer of, Customer.
10.2. Survival: The provisions that by their nature are intended to survive the termination or expiration of this Agreement shall continue to be in effect after the termination or expiration of the Agreement.
10.3. Severability: Should any provision of this Agreement be deemed illegal or unenforceable, the remainder shall nonetheless be given full force and effect.
10.4. Assignment: Neither Party may assign this Agreement or any of its rights or obligations hereunder without the prior written consent of the other Party, except that either Party may assign this Agreement without the other Party’s consent (a) to any of its Affiliates, (b) in connection with a merger, acquisition, corporate reorganization, or sale of all or substantially all of its business or assets, or (c) to any successor entity by operation of law. For purposes of this Agreement, an “Affiliate” means any entity that directly or indirectly controls, is controlled by, or is under common control with Intellijoint. Any permitted assignee shall assume all assigned obligations, and this Agreement shall be binding upon and inure to the benefit of the Parties and their respective permitted successors and assigns. Any assignment in violation of this Section 10.4 shall be null and void.
10.5. Waiver: No failure by any party to insist upon the strict performance of any covenant, agreement, term, or condition of this Agreement or to exercise a right or remedy shall constitute a waiver. No waiver of any breach shall affect or alter this Agreement, but each and every covenant, condition, agreement and term of this Agreement shall continue in full force and effect with respect to any other existing or subsequent breach.
10.6. Governing Law: If the Customer is located in Canada, this Agreement shall be governed by and construed in accordance with the laws of the province of Ontario, and any applicable federal laws of Canada, without giving effect to its choice of law principles. If the Customer is located in the United States, this Agreement shall be governed by and construed in accordance with the laws of the state of New York, and any applicable laws of the United States of America, without giving effect to its choice of law principles.
10.7. Amendment: This Agreement may only be amended by a written instrument executed by each of the Parties.
10.8. Notices: All notices, requests, demands and other communications under this Agreement shall be in writing and shall be deemed to have been duly given if (a) delivered by hand, (b) mailed by certified or registered mail with postage prepaid, on the third business day after the date on which it is so mailed, or (c) sent by facsimile or email, upon oral confirmation of receipt.
10.9. Counterparts: This Agreement may be executed in counterparts each of which when executed by any of the parties shall be deemed to be an original, and such counterparts shall together constitute one and the same Agreement.

APPENDIX A
Equipment Loan Terms

Overview: Customer wishes to store the Loaned Equipment at the Affiliated Facilities as listed in the FPUA solely in order that the Loaned Equipment be readily available for use in Procedures.

1. Conditions of Loan: Customer shall receive and safely keep the Loaned Equipment as provided in this Agreement. Without limiting the foregoing Customer shall:
1.1. Store the Loaned Equipment only at the facilities set out in FPUA without the express prior written authorization of Intellijoint;
1.2. Use the Loaned Equipment, and ensure its Affiliates and the surgeons and their surgical teams use the Loaned Equipment, including any Software, only in accordance with and as permitted by this Agreement;
1.3. Take all reasonable steps to ensure that the Loaned Equipment are made available in a timely manner, fully functioning and with sufficient Consumables at the surgeon’s scheduled Procedures, and to the extent this is not possible, provide sufficient notice of its inability to satisfy this requirement to the applicable Intellijoint Rep, to enable them to do so
1.4. Take reasonable care to protect the Loaned Equipment from loss or damage which shall not be less than the care, protection and shelter from adverse environmental conditions that Customer takes of its own medical equipment
1.5. At all times while the Loaned Equipment are covered by this Agreement, maintain adequate insurance against the loss of, or damage to the Loaned Equipment, or if the facility at which a Loaned Equipment is stored belongs to an Affiliate, ensure that that Affiliate does so, and upon request by Intellijoint, deliver evidence of such insurance to Intellijoint;
1.6. Maintain and not remove, and ensure that its Affiliates and the surgeons and surgical teams maintain and do not remove, all copyright, trademark, proprietary rights, disclaimer or warning notices included on or embedded in any part of the System;
1.7. Provide access to the Loaned Equipment at any time upon request by Intellijoint, and without limiting the foregoing, Customer shall provide the Loaned Equipment to Intellijoint in accordance with any regularly scheduled maintenance for the Loaned Equipment for which Intellijoint provides reasonable notice to Customer;
1.8. Not transfer, sell, assign, lease, sublicense, pledge or otherwise dispose of, encumber or suffer a lien or encumbrance upon, or against, or purport or attempt to do any of the aforementioned acts, in respect of the Loaned Equipment, without Intellijoint’s express prior written permission to do so;
2. Return of Loaned Equipment: Subject to reasonable wear and tear, return the Loaned Equipment to Intellijoint in the same condition as when delivered by Intellijoint
3. Minimum Usage: Unless otherwise agreed in writing, Intellijoint shall have the right to terminate Customer’s right to receive Loaned Equipment under this Agreement, or retrieve Consigned Consumables from the Customer if the total usage by Customer does not demonstrate a sufficient volume to justify consignment.

APPENDIX B
Consigned Consumable Terms

Overview: Customer wishes to store Consumables provided by Intellijoint Surgical at one or more facilities (“Consigned
Consumables”) in order that the Consigned Consumables be readily available for use in Procedures

1. Consignment: The quantities of Consigned Consumables that the Customer wishes to hold at each customer facility are provided in Agreement. Should any of the Consigned Consumables be lost or damaged, Customer shall be responsible for the cost of replacement at then-current prices as may be updated from time to time.
2. Replenishment: Intellijoint will replenish the Consigned Consumables on a regular basis in order to maintain the quantities set out in Agreement, however, quantities actually available at a facility at any given time may be higher or lower than those stated in Agreement. If more permanent changes are required, an updated list will be provided to Customer for review and signature, which will not be unreasonably withheld, and will serve as an amended Agreement when executed.
3. Audit: Customer will maintain adequate records to allow Intellijoint to determine the use of the Consigned Consumables and Loaned Equipment held at Customer’s facility. Intellijoint reserves the right to, during regular business hours, physically audit the stocking levels and condition of Consigned Consumables and Loaned Equipment held at Customer’s facility. In the event that Intellijoint’s audit of such Consigned Consumables and Loaned Equipment concludes that either a shortfall or surplus exists, Intellijoint and Customer agree to use commercially reasonable efforts to timely account for any such discrepancy.
4. Ownership: Nothing in this Agreement transfers any ownership right, title or interest in the Consigned Consumables to Customer, its Affiliates, or surgeons until the Consigned Consumables are purchased by Customer for use in a Procedure. Intellijoint may at any time request the return of the Consigned Consumables and Customer shall immediately make the Consigned Consumables available for Intellijoint or its representatives to pick up.
5. Consumption: Upon usage of any Consigned Consumables by Customer (“Consumption”), Customer will issue to Intellijoint a purchase order for the Consigned Consumables consumed (the “Purchase Order”) no later than twenty-four (24) hours following Consumption. Such Purchase Order must identify the catalog number, batch (lot) number, description, quantity, and size of the Consigned Consumables consumed. Upon receipt of the Purchase Order, Intellijoint shall submit an invoice to Customer for replacement Consumables. Such Purchase Order will also serve as notice for Intellijoint to replenish the Consigned Consumables inventory. Customer agrees to make payment to Intellijoint consistent with the terms contained in the Agreement.
6. Expired Products and Returns: Unless otherwise agreed in writing, all returns of products supplied hereunder shall be coordinated with the local Intellijoint sales representative. Customer shall be responsible for removing expired Long Term Loan Products from its inventory and documenting such removal. Within three business days of such removal, Customer shall contact Intellijoint to request replacement Long Term Loan Products. Intellijoint, at its option, may either ship such replacement products or reduce the inventory of Long-Term Loan Products maintained by Customer. Intellijoint will not charge Customer for Consumables sent to replace expired inventory unless specific replacement costs apply and are provided in writing. Intellijoint shall under no circumstances be held responsible for Customer’s use of any expired Consigned Consumables, and Customer shall hold harmless and indemnify Intellijoint for any and all damages arising from any such use of expired Consigned Consumables, as such use is expressly contrary to this Agreement.