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What Are Spare Parts for Compliant Medical Device Repairs?

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Understanding what qualifies as compliant spare parts for medical device repairs is now mission‑critical for hospitals, clinics, OEMs, and independent service organizations. In an environment shaped by FDA guidance, EU MDR rules, ISO 13485 quality systems, and IEC 62353 post‑repair testing, the way you select, qualify, and manage spare parts directly affects patient safety, regulatory risk, uptime, and total cost of ownership.

Defining Spare Parts in Medical Device Repairs

In the context of medical device repairs, spare parts are items intended to replace worn or defective components so the device can continue to function as originally designed, without changing its intended purpose or safety and performance profile. In practice, this covers anything from power supplies, circuit boards, and sensors to valves, tubing, connectors, and housing elements used to restore the device to its validated state.

EU MDR Article 23 distinguishes between parts and components that simply maintain or restore the function of a device, and items that significantly change performance or safety characteristics. If a replacement part only maintains or restores function without altering performance, it is treated as a spare part and must not degrade safety or performance. If the replacement part significantly changes performance, safety, or intended purpose, it is treated as a medical device in its own right and must meet full regulatory requirements under the MDR.

From a regulatory compliance standpoint, a spare part used in repair must, at minimum, preserve the device’s conformity to its original approvals, whether those are FDA clearances, CE marking under MDR, or other national authorizations. This means that even third‑party or “aftermarket” parts must be assessed to ensure they do not introduce new risks, invalidate labeling, or undermine performance claims.

Regulatory Framework Governing Spare Parts

The regulatory framework for compliant spare parts in medical device repairs is multi‑layered and differs slightly between jurisdictions, but several common principles emerge. Authorities focus on maintaining device safety and performance, ensuring traceability, and clarifying responsibilities among manufacturers, remanufacturers, and servicers.

In the United States, the FDA’s final guidance on servicing versus remanufacturing clarifies that activities which significantly change a finished device’s performance, safety specifications, or intended use may be considered remanufacturing rather than simple repair. When spare parts are used in ways that constitute remanufacturing, the organization performing the work may assume responsibilities similar to an original equipment manufacturer, including design controls and, in many cases, premarket submissions such as 510(k) notifications.

In the European Union, MDR 2017/745 sets explicit expectations for parts and components. Article 23 requires any person placing a replacement part on the market to ensure that it does not adversely affect the safety and performance of the device and to keep supporting evidence available for competent authorities. If a replacement part changes performance or safety in a significant way, it is treated as a device and must meet full MDR requirements, including conformity assessment, post‑market surveillance, and, where applicable, CE marking.

International standards also shape compliant spare parts usage. ISO 13485 defines quality management system requirements for organizations involved in the life cycle of medical devices, including manufacturers and providers of service and spare parts. IEC 62353 focuses on recurrent testing and testing after repair of medical electrical equipment to verify ongoing electrical safety. Together, these standards provide a framework for qualifying suppliers, controlling documentation, and testing devices after parts are replaced.

Types of Spare Parts, Accessories, and Consumables

Not every replacement item in a medical environment is a spare part, and confusing device parts with accessories or consumables can create compliance gaps. Regulators and standards bodies draw clear distinctions between these categories, each with different implications for medical device maintenance strategies.

A medical device spare part is usually an integral component of the device that is replaced to maintain or restore its original function, such as a fan, display module, controller board, bearing, or mechanical actuator. It is expected to meet the same specifications and performance tolerances as the original component, and its substitution should not alter intended use or safety classification. Many OEMs specify spare parts in their technical documentation and service manuals as part of a planned maintenance strategy.

Accessories are items that, while not integral components, are intended specifically to enable a device’s proper use, support its functions, or enhance intended performance. Examples include ultrasound probes, foot switches for surgical tables, calibration tools, docking stations, or specialized device covers used for infection control. Accessories are often subject to similar regulatory controls as the medical device itself and may require their own conformity assessment.

Consumables are products that are used up during normal operation, such as reagents, filter cartridges, printer paper, gels, or single‑use tubing. While consumables can impact device performance and measurement accuracy, they are not typically categorized as spare parts, though they must be compatible and safe when used as intended. A robust maintenance program differentiates between spare parts used during service events and consumables used in everyday clinical workflows.

OEM Spare Parts vs Third‑Party and Aftermarket Parts

Healthcare providers often face a strategic choice between original equipment manufacturer spare parts and third‑party or aftermarket alternatives for medical device repairs. Each path offers trade‑offs between cost, performance assurance, regulatory clarity, and supply chain resilience, and the optimal approach often combines multiple sourcing models.

OEM spare parts are designed, manufactured, and validated by the original device manufacturer under its quality management system. They are typically guaranteed to meet original design specifications, which means using them aligns closely with the conditions under which the device obtained regulatory clearance or CE marking. OEM parts often come with detailed installation instructions, clear traceability, integrated labeling, and compatibility with OEM software and diagnostics tools.

Third‑party and aftermarket spare parts are produced by independent manufacturers that reverse‑engineer or functionally replicate OEM components. While some low‑quality aftermarket parts may cut corners on materials or tolerances, reputable third‑party suppliers often operate under certified quality systems such as ISO 13485 and implement rigorous testing programs. Carefully selected third‑party parts can reduce costs and lead times while maintaining acceptable performance and safety.

Regulatory expectations do not prohibit the use of third‑party parts, but they place responsibility on healthcare organizations and service providers to verify that these parts do not compromise the device. This often means qualifying suppliers, reviewing their quality certifications, assessing design equivalence, and performing robust post‑repair testing, especially on critical devices. When properly managed, a hybrid strategy that leverages both OEM and high‑quality third‑party parts can deliver better uptime and cost efficiency without sacrificing compliance.

Compliance Criteria for Spare Parts in Medical Devices

To be considered compliant, spare parts used in medical device repairs must meet a series of technical, regulatory, and quality criteria. These criteria ensure that the replacement part preserves the safety and performance profile of the original device and supports ongoing regulatory conformity.

A compliant spare part must maintain the device’s intended purpose and risk profile. This means that installing the part cannot introduce new hazards, increase existing risks beyond accepted limits, or alter the device’s risk classification. Performance specifications such as accuracy, response time, energy output, and environmental tolerance must stay within the ranges validated during product development. For example, replacing an optical module in a diagnostic device must not change its measurement accuracy beyond the stated tolerance.

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Material compatibility is another core dimension. Spare parts must not introduce chemical, biological, or mechanical incompatibilities that could affect patient contact surfaces, sterilization cycles, or cleaning routines. This is especially important for devices with applied parts, such as patient leads, sensors, probes, and catheters, where contact materials must meet biocompatibility and surface cleanliness requirements.

Traceability and documentation are essential compliance criteria. Each spare part should be identifiable with a unique part number, batch or lot information, and, where relevant, a serial number. Installation of the part should be logged in maintenance records, including date, technician identity, and test results obtained after the repair. These records support audits, incident investigations, and trending of failure modes, and they help demonstrate adherence to MDR Article 23, FDA quality system regulations, and ISO 13485 traceability clauses.

Role of Quality Management Systems and ISO 13485

Quality management systems provide the backbone for compliant spare parts handling, from supplier selection and incoming inspection to installation, testing, and documentation. For medical device manufacturers and many service providers, ISO 13485 is the reference standard for structuring these processes.

Under ISO 13485, organizations must control purchased products and services, including spare parts used in manufacturing and servicing. This requires supplier qualification, defined acceptance criteria, incoming inspection procedures, and documented evidence that parts meet specifications. For repair operations, the same logic applies: spare parts must be procured from controlled sources, and their conformity must be verified before use.

Corrective and preventive action processes are pivotal in the context of spare parts. If a recurring failure is traced to a specific component, the organization’s quality system must trigger root‑cause analysis, potential design changes, supplier requalification, or updated maintenance instructions. This can lead to revisions in approved spare parts lists, updated torque settings for mechanical installations, or new testing protocols to catch early signs of degradation.

For independent service organizations, aligning their processes with ISO 13485 can be a strong differentiator. Even when not legally required, a certified quality system signals that the provider controls documentation, manages risk, handles complaints, and maintains training and competency frameworks for technicians. This makes it easier for hospitals and clinics to demonstrate that their choice of service partners and spare parts is consistent with regulatory expectations for safe device operation.

IEC 62353 and Testing After Repair

Technical standards governing testing after repair are a central part of compliant spare parts usage, especially for medical electrical equipment. IEC 62353 is widely recognized as the standard for recurrent testing and testing after repair to verify electrical safety of devices in routine clinical use.

IEC 62353 outlines methods for measuring leakage currents, earth continuity, and insulation resistance, among other parameters. After a spare part is installed, particularly in power systems, housings, applied parts, or signal paths, testing according to IEC 62353 helps confirm that the device still meets safety limits. This is crucial for devices classified according to IEC 60601‑1, where patient leakage current and protective earth integrity must remain within tightly defined limits.

Testing after repair is not just a technical formality; it is an integral part of the repair process’s compliance evidence. Maintenance records should link each spare part replacement to test reports demonstrating that safety parameters remain acceptable. For critical devices such as ventilators, defibrillators, infusion pumps, and patient monitors, automated electrical safety analyzers configured for IEC 62353 can streamline this process and reduce technician error.

Hospitals that integrate IEC 62353 into their maintenance policies strengthen their ability to show that post‑repair validation is systematic rather than ad hoc. This alignment supports internal risk management and external inspections by regulators, accreditation bodies, or notified bodies assessing quality systems and device safety.

Preventive Maintenance, Wear Parts, and Lifecycle Planning

Spare parts strategies are most effective when integrated with preventive maintenance and lifecycle management rather than only reacting to failures. Many medical devices include wear parts such as seals, bearings, tubing, fans, and contact switches that naturally degrade over time or with cyclical use. Replacing these components at planned intervals reduces unplanned downtime and lowers the risk of patient‑impacting failures.

Preventive maintenance schedules are often derived from the manufacturer’s risk analysis and performance testing, which define replacement intervals for critical components. By adhering to these recommendations and using approved spare parts, healthcare organizations can maintain device reliability while controlling maintenance costs. In many cases, consolidated spare parts kits are designed for specific service intervals, simplifying ordering and ensuring that all necessary components are on hand.

Lifecycle planning for medical devices includes decisions about when to continue repairing equipment and when to retire or upgrade it. As devices age, spare parts availability may become constrained, and manufacturers may declare end‑of‑support dates. When this happens, organizations must evaluate whether third‑party parts and service remain viable. Lifecycle strategies should include an assessment of parts obsolescence risks, safety implications of extended use, and the cost‑benefit balance between continued repairs and investment in new or refurbished devices.

Risk‑based maintenance policies prioritize resources toward high‑risk and high‑impact equipment while still managing lower‑risk devices efficiently. Aligning spare parts planning with these policies ensures that critical devices have prioritized access to validated components and rapid service support, preserving clinical capacity and reducing cancellations.

Cost, Risk, and Total Cost of Ownership

Every decision about spare parts sourcing and repair strategies connects directly to cost, risk, and total cost of ownership. While OEM parts and service contracts can appear more expensive upfront, they may reduce certain risks and administrative burdens. Conversely, third‑party parts and independent service organizations can provide cost savings and flexibility but require stronger internal controls to maintain compliance.

Direct costs include purchase price of the spare part, technician labor, logistics, and test equipment time for post‑repair verification. Indirect costs encompass downtime, rescheduling of procedures, backup device usage, and potential clinical risk if failures occur. Calculating total cost of ownership for a device portfolio requires combining these factors across the equipment’s lifecycle, accounting for age, utilization, failure rates, and parts consumption.

Risk management frameworks help translate technical and operational decisions into financial metrics. For example, a hospital might determine that using high‑quality third‑party parts for mid‑risk devices is acceptable if testing after repair is robust and supplier quality is verified, while critical life‑sustaining devices remain on OEM parts only. Documented decision criteria and periodic review of incident data and unplanned downtime help organizations adjust their spare parts policies as realities change.

In some cases, moving from a purely reactive repair model to a structured preventive maintenance and spare parts strategy reduces total cost of ownership by lowering emergency service calls, extending device life, and improving scheduling predictability. Clear internal policies around when to repair, when to replace, and which spare parts sources are acceptable play a key role in achieving this balance.

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Core Technologies Behind Medical Device Spare Parts

Modern medical devices rely on an intricate combination of electronics, software, mechanics, optics, and materials science. Understanding the core technologies behind spare parts helps technicians and clinical engineers evaluate compatibility, reliability, and regulatory implications of component choices.

Electronic spare parts include power supply modules, printed circuit boards, microcontrollers, sensors, displays, and communication interfaces. These components must meet electromagnetic compatibility, isolation, and noise requirements that align with the device’s original design. Substituting electronic parts without matching critical parameters such as voltage tolerances, temperature stability, or electromagnetic emissions can lead to intermittent failures or measurement drift that may be difficult to detect without thorough testing.

Mechanical spare parts cover items such as housings, gears, motors, bearings, handles, latches, and enclosures. For devices exposed to repeated cleaning cycles and disinfectants, materials must withstand corrosive agents and maintain mechanical integrity. In imaging systems, robotic surgery platforms, and infusion devices, mechanical tolerances affect precision and smoothness of motion, so replacement components must meet tight dimensional specifications.

Software and firmware also play a role in many repairs. In some cases, spare parts like controller boards or user interface modules come preloaded with specific firmware versions that must be compatible with the device’s ecosystem. Upgrading or downgrading firmware as part of a repair can alter performance and must be managed under change control processes. Even when physical spare parts appear equivalent, software compatibility can determine whether a repair is compliant.

Real‑World User Cases and Measurable ROI

Real‑world experiences across hospitals and clinics show that structured spare parts strategies can deliver measurable improvements in safety, uptime, and financial performance. These case‑style scenarios illustrate how different approaches to compliant repairs influence outcomes.

Consider a large acute care hospital that implemented a centralized clinical engineering model with standardized spare parts lists for high‑volume devices such as infusion pumps and patient monitors. By defining acceptable OEM and third‑party parts, pre‑stocking components based on failure trends, and applying IEC 62353 testing after each repair, the hospital reduced average downtime per device and lowered emergency service calls. Over several years, this translated into fewer disruptions to patient care and significant labor savings in maintenance teams.

Another scenario involves a network of outpatient clinics that relied heavily on manufacturer depots for repairs of diagnostic imaging and aesthetic treatment devices. Turnaround times were long, and equipment loaner costs were rising. By identifying independent service organizations operating under ISO 13485 and using validated spare parts, the clinics reduced repair costs and turnaround times while maintaining clear documentation for compliance audits. Device availability increased, enabling more patient appointments and higher revenue per installed system.

A third example is an older fleet of devices approaching end of manufacturer support. The healthcare organization faced a choice between large capital investments in replacements and extending useful life with third‑party parts. By conducting a risk assessment and focusing compliant spare parts usage on non‑critical subsystems, combined with rigorous post‑repair testing, the organization gained several additional years of safe operation. This allowed capital funds to be directed toward truly obsolete or high‑risk equipment instead of across‑the‑board replacement.

Company Background: ALLWILL’s Approach to Spare Parts and Repairs

ALLWILL is redefining B2B medical aesthetics by focusing on innovation, trust, and efficiency, with a mission centered on solving the practical challenges practitioners face when sourcing, maintaining, and upgrading devices. Through its Smart Center for inspection, repair, and refurbishment, and its vendor management and inventory platforms, ALLWILL aligns spare parts strategies, technician networks, and data‑driven insights to ensure each device in a clinic’s portfolio meets rigorous performance standards throughout its lifecycle.

Digital Tools, Data, and Inventory Optimization

Digitalization is transforming how healthcare organizations manage spare parts for compliant medical device repairs. Modern computer‑aided facility management systems, computerized maintenance management systems, and equipment asset platforms offer real‑time visibility into device status, maintenance history, and parts consumption.

By using these systems, clinical engineering teams can analyze failure trends by model, manufacturer, component, and location. This enables predictive stocking of spare parts so that high‑risk or frequently failing components are available before a device goes down. Integration with purchasing systems helps ensure that only approved parts from qualified suppliers are ordered, shortening procurement cycles and reducing the likelihood of non‑compliant substitutions in an emergency.

Barcode and RFID tagging of both devices and spare parts improves traceability and reduces manual entry errors. Technicians can quickly identify the correct part, confirm lot and serial numbers, and record installation and test results directly at the point of service. Over time, analytics derived from these data streams support continuous improvement, helping organizations refine preventive maintenance intervals, standardize device models, and negotiate better terms with suppliers based on actual usage patterns.

Competitor Comparison Matrix: OEM vs Third‑Party vs Integrated Solutions

Hospitals and clinics rarely rely on a single model for sourcing and managing spare parts, and understanding the strengths of each approach is essential. The following simplified comparison matrix illustrates how common strategies differ across key dimensions relevant to compliant medical device repairs.

Approach Key Advantages Typical Rating Primary Use Cases
OEM parts and service High assurance of compatibility and regulatory alignment, integrated documentation and technical support Very high for safety and performance, moderate for cost efficiency Critical life‑support devices, complex imaging systems, warranties and service contracts
Third‑party ISO 13485 suppliers Lower cost, flexible logistics, access to parts after OEM support ends High for cost and availability, variable for compatibility depending on supplier quality Older devices, mid‑risk equipment, budget‑constrained environments
In‑house clinical engineering with curated parts list Control over policies, rapid response, tailored risk management High for responsiveness, dependent on internal expertise for compliance Large hospitals, integrated health systems, multi‑site clinic networks
Integrated platforms combining repair, refurbishment, and spare parts management Centralized visibility, data‑driven decisions, streamlined vendor management High across uptime, cost control, and scalability Organizations seeking portfolio‑level optimization and lifecycle management

This kind of structured comparison helps decision makers balance safety, cost, and operational flexibility and supports documented rationale for spare parts strategies during audits.

Market Trends in Medical Device Repairs and Spare Parts

The market for medical device repair services and spare parts is evolving rapidly under the combined influence of regulatory scrutiny, cost pressures, and technological complexity. Healthcare organizations are moving away from purely reactive maintenance models and toward integrated strategies that combine OEM support, third‑party service, and in‑house capabilities.

One key trend is the growing importance of transparency and data in the repair ecosystem. Regulators and payers are increasingly interested in how service decisions impact patient safety, while providers seek granular cost and uptime data to inform capital planning. This has led to tighter documentation of spare parts usage, more rigorous tracking of repair outcomes, and closer evaluation of external service partners, including their quality certifications and testing standards.

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Another trend is the rise of specialized service providers and platforms that coordinate spare parts sourcing, technician dispatch, warranty management, and refurbishment across multiple brands. For many providers, especially in medical aesthetics and outpatient specialties, these ecosystem players reduce the complexity of dealing with numerous OEMs and local vendors. At the same time, OEMs are expanding their service offerings, emphasizing remote diagnostics, predictive maintenance, and bundled programs that include parts, service, and software updates.

Building a Compliant Spare Parts Policy

Developing a coherent policy for spare parts and compliant repairs is essential for any organization responsible for medical devices. A well‑defined policy outlines which types of parts are acceptable, how they are evaluated, and how decisions are documented, helping align clinical engineering, procurement, risk management, and clinical leadership.

An effective policy defines categories of devices by risk level and clinical impact, then sets clear rules for each category. For example, life‑sustaining and high‑risk devices may require OEM parts only, or third‑party parts may be allowed only when accompanied by stronger post‑repair testing and documented evidence of equivalence. Mid‑risk and low‑risk devices may have more flexibility, enabling cost savings and broader supplier options.

The policy should also specify qualification criteria for suppliers, such as ISO 13485 certification, documented testing protocols, field performance history, and responsiveness to complaints. Internal processes for change control, deviation management, and periodic policy review ensure that the spare parts strategy evolves with regulatory updates, fleet composition, and technological advances. Education and training for technicians and procurement staff help ensure consistent application of the policy day to day.

Training, Competency, and Human Factors

Even the best spare parts strategy depends on the skills and judgment of the people who implement it. Technician training, competency management, and human factors considerations are fundamental to compliant medical device repairs and safe spare parts use.

Technicians must be trained not only in mechanical and electronic repair techniques but also in the specific regulatory and safety context of medical devices. This includes understanding the difference between repair and remanufacturing, recognizing when a replacement part might change performance characteristics, and knowing when to escalate decisions to engineering or quality teams. Familiarity with IEC 62353, OEM service manuals, and applicable local regulations forms part of this training.

Competency management involves tracking certifications, training records, and on‑the‑job assessments. Organizations may adopt tiered authorization models where certain technicians are authorized to work only on defined device types or perform only specific procedures. Training also extends to documentation practices, such as correctly recording spare parts used, test results, and observations about device behavior after repair. Human factors, such as workload, shift patterns, and tool usability, must also be considered to minimize error rates.

Future Trends in Spare Parts and Compliant Repairs

As technology, regulation, and healthcare delivery models continue to evolve, the landscape for spare parts and compliant medical device repairs will keep changing. Forward‑looking organizations already see several trends shaping the future of this domain.

One emerging trend is the integration of predictive maintenance based on device telemetry and advanced analytics. By monitoring parameters such as error codes, motor currents, temperatures, and usage cycles in real time, systems can predict when components are likely to fail and schedule spare parts replacements before downtime occurs. This approach requires secure connectivity and robust data pipelines but can dramatically improve uptime and reduce unexpected failures.

Another trend is greater standardization of interfaces and components across device families, allowing more modular repairs and potentially broader compatibility of spare parts. As regulatory scrutiny on repair data increases, manufacturers and service organizations may collaborate more closely to share field performance information and jointly refine maintenance strategies. This could lead to new models of shared risk and shared savings around device uptime and service quality.

Finally, environmental and sustainability considerations are gaining importance. Extending device life through responsible repairs and refurbishment, while ensuring compliance and safety, is increasingly viewed as part of a healthcare organization’s environmental stewardship. Spare parts strategies that balance safety, cost, and environmental impact will likely become a standard expectation for device management teams.

FAQ

What Are Spare Parts for Compliant Medical Device Repairs

  • Spare parts for compliant medical device repairs ensure devices function safely and meet regulatory standards. They include replacement components, manuals, and certified consumables designed for reliability, sterility, and compatibility with specific models. Using approved parts minimizes downtime and preserves warranty and performance.

How do compliant spare parts impact device reliability

  • Using certified spare parts reduces failure risk, maintains calibration accuracy, and extends device life. It also supports consistent performance across service cycles, helping clinics avoid unexpected downtime and costly rework.

What constitutes a compliant spare part

  • A compliant spare part is one that is approved or validated by the original manufacturer or regulatory authority for a specific device model, ensuring compatibility, safety, and performance.

Who should supply compliant spare parts for medical devices

  • Authorized distributors, OEM parts suppliers, and certified third-party service providers with access to validated components and documentation should supply compliant spare parts to maintain regulatory alignment.

What is the role of a service provider in parts compliance

  • A service provider ensures parts are genuine or properly validated, performs correct installation, and documents traceability, warranty status, and service history to support regulatory audits.

What are common spare parts used in medical device repairs

  • Common items include batteries, filters, seals, hoses, connectors, calibration tools, display panels, and firmware/software update kits, all sourced from reputable channels.

What happens if noncompliant parts are used

  • Noncompliant parts can void warranties, compromise safety, breach regulatory requirements, and lead to failed inspections or recertification costs.

Why is traceability important in spare parts management

  • Traceability confirms the origin, batch, and usage of each part, supporting audits, accountability, and quality control across repair and maintenance workflows with ALLWILL Smart Center ensuring compliant documentation through its MET system at ALLWILL.

Conversion‑Focused Next Steps for Healthcare Organizations

Healthcare leaders responsible for medical equipment should start by assessing how their current spare parts and repair practices align with regulatory expectations and best practices. Reviewing existing policies, service contracts, and maintenance data can reveal gaps in supplier qualification, parts traceability, or post‑repair testing that need attention.

From there, organizations can define a risk‑based spare parts policy, segment device fleets by criticality, and identify where OEM parts, third‑party suppliers, or integrated platforms are most appropriate. Investing in training for clinical engineering teams and updating documentation processes strengthens both compliance and operational resilience. By approaching spare parts management as a strategic function rather than a tactical procurement issue, hospitals and clinics can improve safety, reduce downtime, and optimize the total cost of ownership for their medical devices.

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        8.  MRP’S WARRANTIES, IF ANY.

(a) Equipment Sold “As Is.” UNLESS OTHERWISE STATED ON THE QUOTE OR IN A WRITING SIGNED BY AN MRP OFFICER, BUYER AGREES THAT THE EQUIPMENT SOLD IN THIS AGREEMENT IS BEING SOLD ON AN “AS IS,” “AS AVAILABLE” BASIS, SUBJECT TO SECTIONS 8(c) AND 9, AND HAVE NO WARRANTIES OR REPRESENTATIONS OF ANY KIND, WHETHER IMPLIED OR ARISING BY LAW, STATUTE OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR USE, NON-INFRINGEMENT, WORKMANLIKE MANNER, QUALITY, ACCURACY, TITLE, AND/OR IMPLIED FROM A COURSE OF DEALING OR PERFORMANCE USAGE IN TRADE.

(b) Special Order Product. If this Agreement includes the sale of a product that MRP does not currently have or typically keep in stock, in MRP’s sole determination, but is acquired from a third party specifically for Buyer (a “Special Order Product”), then Buyer agrees that (i) Buyer, at its sole discretion, has made the selection of such Special Order Product, (ii) such Special Order Product is being acquired by MRP solely at the request of Buyer, (iii) no representation, warranty or guarantee has been made by MRP with respect to such Special Order Product, (iv) the obligation of Buyer to pay MRP for the Special Order Product is absolute and unconditional, and (v) Buyer waives and releases MRP from all claims, damages and losses arising out of such Special Order Product. Special Order Products carry no right to inspection before or after delivery, and MRP is not responsible for examining or evaluating such Special Order Products. MRP makes no warranty about Special Order Products and offerings of the third party (including description of the Special Order Product). MRP does not assume any responsibility or liability for the actions, product and content of all these and any other third parties. If there are any problems with any Special Order Product, Buyer must contact the manufacturer of such Special Order Product for assistance.

(c) Limited Warranties, If Any.

(i) If the Quote expressly states that the Equipment has a warranty for a certain time (a “Warranty Period”), then MRP warrants that the Equipment shall be in good working order under normal use for the Warranty Period, which Warranty Period shall commence from the date of delivery to Buyer (the “Delivery Date”), unless otherwise approved by an MRP Officer in writing, except for the following: (A) New (not used or pre-owned) Equipment that is to be serviced by MRP: if the Quote is silent, warranted to be in good working order under normal use for one hundred eighty (180) days from the Delivery Date; (B) Used Equipment sold refurbished by MRP: if the Quote is silent, warranted to be in good working order under normal use for thirty (30) days from the Delivery Date; (C) Consumable/disposable Equipment: if the Quote is silent, warranted to have been shipped from MRP in functional condition, and no additional warranty shall apply; no service shall be provided either. These items should be inspected for obvious damage, subject to Section 6 and 8(e), and MRP’s obligation under this warranty and this Section 8(c)(i)(C) is limited to replacement of the Equipment; and (D) New (not used or pre-owned) Equipment that is to be serviced by the manufacturer: if the Quote is silent, MRP makes no warranty for any such Equipment. Buyer’s sole warranty for any such Equipment, if any, shall be the original manufacturer’s warranty, which MRP agrees to pass on to Buyer, as applicable. (ii) For the limited warranties of Section 8(c)(i), including exceptions (A) and (B), but not (C) or this (D), Buyer is entitled to telephone, e-mail and video technical assistance and, subject to Sections 8(d) and 8(e), repair or replacement of such Equipment, in MRP’s sole discretion, should the Equipment become inoperative through normal use during the Warranty Period. Loaner equipment is not provided, but if so arranged by MRP, Buyer shall pay MRP the cash list price of any unreturned loaner equipment provided by MRP within seven (7) days of a written demand from MRP. (iii) Repair or replacement under any limited warranty of Equipment may be with parts or products that are new, used or refurbished, carrying the same limited warranty for the remaining term of the original item. Repairs or replacements shall not interrupt, extend or prolong the term of the warranty. (iv) For Services purchased under this Agreement, MRP warrants that the Services shall be performed using competent personnel in a professional manner in accordance with generally recognized industry standards for similar services. Subject to Sections 6 and 8(e) herein, if any Service was not performed in accordance with the aforementioned warranty, then MRP shall, in its sole discretion, either (A) repair or re-perform the applicable Service, or (B) credit or refund the price of such Service at the pro rata contract rate.

(d) Exclusions. MRP reserves the right, without liability, to void all warranties and remedies, including any obligation to service, repair, replace or otherwise remedy defects, errors or failures of the Equipment due to the occurrence of any of these events, and MRP shall be in no way responsible for: (i) handling, maintenance or use in a manner that is inconsistent with and/or contrary to the original manufacturer’s or MRP’s recommended procedures and/or instructions, including, without limitation, use of or with an unauthorized third-party good or part; (ii) any failure or damage resulting from negligence, alteration, modification or relocation of the Equipment by Buyer, its employees, agents or representatives; (iii) attempted or actual unauthorized dismantling, disassembling, service, repair, addition or change of the Equipment, including, without limitation, changing the serial number or shot count; (iv) abnormal wear and tear, including, without limitation, use under abnormal conditions (e.g., unclean, dusty, or exposure to extreme electromagnetic radiation, temperature or humidity); or (v) damage or failure of the Equipment due to a Force Majeure Event or a problem in the premises of the Equipment. In any of the above situations, or for any Equipment that has no warranty, MRP has sole discretion to service the Equipment, at Buyer’s expense, at MRP’s then-in-effect rates for service, labor, travel, shipping and materials.

(e) Notice and Inspection. The limited warranties contained in this Section 8 are made on condition that immediate written notice of any noncompliance with the Equipment’s and/or the Service’s warranty be given to MRP, and provided that MRP’s inspection reveals that Buyer’s claim is valid under the terms of such warranty.

        9.  DISCLAIMERS; NO OTHER WARRANTY. EXCEPT TO THE EXTENT AS PROVIDED IN SECTION 8(c)(i)(D), BUYER ACKNOWLEDGES THAT MRP IS NOT BOUND BY ANY WARRANTY THAT MAY BE SET FORTH IN A MANUFACTURER’S WRITTEN MATERIALS THAT WOULD HAVE APPLIED HAD BUYER PURCHASED THE EQUIPMENT DIRECTLY FROM THE MANUFACTURER IN ITS UNUSED STATE. BUYER ACKNOWLEDGES THAT BUYER HAS NOT RELIED UPON ANY WARRANTY OTHER THAN AS SET FORTH IN THIS AGREEMENT. IN ADDITION, BUYER ALSO HEREBY ACKNOWLEDGES AND AGREES THAT ANY ORAL OR WRITTEN STATEMENTS CONCERNING USE AND REGULATION OF MEDICAL DEVICES SOLD BY MRP ARE AND SHALL BE CONSTRUED AS FOR INFORMATIONAL PURPOSES ONLY AND WITHOUT WARRANTY OR ASSURANCE BY MRP AS TO THEIR ACCURACY OR VALIDITY. MRP ALSO HEREBY DISCLAIMS ANY AND ALL WARRANTIES REGARDING OTHER MEDICAL CARE OR HELP, INCLUDING THE SELECTION OF AESTHETIC AND MEDICAL PROCEDURES AND PRODUCTS FOR, OR CARE OF, PATIENTS. THE LIMITED WARRANTIES OF THIS AGREEMENT, IF APPLICABLE TO ANY EQUIPMENT OR SERVICE FURNISHED UNDER THIS AGREEMENT, CONSTITUTE THE ONLY WARRANTIES MADE WITH RESPECT TO THE EQUIPMENT AND/OR SERVICE AND ANY DEFECT, DEFICIENCY OR NONCONFORMITY. TO THE EXTENT PERMITTED BY LAW, SUCH WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED BY LAW, COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE OF TRADE OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO, ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY, TITLE, NONINFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

        10.  LIMITATION OF LIABILITY. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, UNDER NO CIRCUMSTANCES SHALL MRP BE LIABLE FOR ANY INDIRECT, PUNITIVE, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY OR SPECIAL DAMAGES, ARISING FROM, RELATED TO OR CAUSED, DIRECTLY OR INDIRECTLY, WHETHER FORESEEABLE OR NOT, BY THE EQUIPMENT AND/OR THE SERVICES, THE USE OR INABILITY TO USE THE EQUIPMENT, THE RESULTS GENERATED FROM THE EQUIPMENT AND/OR THE SERVICES, THIS AGREEMENT, ANY OTHER ACT OR OMISSION OF MRP, OR BASED UPON ANY OTHER LEGAL THEORY. IN NO EVENT SHALL MRP BE LIABLE FOR ANY LOSSES OF REVENUE, USE, BUSINESS OPPORTUNITY, PROFIT, SAVINGS OR ANY OTHER DAMAGES DUE TO ANY CAUSE WHATSOEVER, EVEN IF MRP OR ITS AGENTS HAS BEEN ADVISED OF THE POSSIBILITY THEREOF. THE FOREGOING IS A SEPARATE, ESSENTIAL TERM OF THIS AGREEMENT, AND SHALL BE EFFECTIVE UPON THE FAILURE OF ANY REMEDY, EXCLUSIVE OR NOT. IN NO EVENT WILL MRP’S TOTAL LIABILITY UNDER THIS AGREEMENT EXCEED THE PURCHASE PRICE ACTUALLY PAID TO MRP BY BUYER FOR THE EQUIPMENT AND/OR THE SERVICES GIVING RISE TO THE CLAIM FOR WHICH DAMAGES ARE BEING SOUGHT. NO SUIT OR ACTION MAY BE BROUGHT BY BUYER, ITS SHAREHOLDERS, DIRECTORS, MANAGERS, EMPLOYEES OR AGENTS FOR ANY BREACH OF THIS AGREEMENT MORE THAN ONE (1) YEAR AFTER THE ACCRUAL OF SUCH CAUSE OF ACTION. IT IS AGREED THAT MRP’S LIABILITY IS SO LIMITED. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, BUYER ASSUMES ALL RISK AND LIABILITY FOR THE RESULTS OBTAINED BY THE USE OF ANY EQUIPMENT IN THE PRACTICE OF ANY PROCESS, WHETHER IN TERMS OF OPERATING COSTS, GENERAL EFFECTIVENESS, SUCCESS OR FAILURE, AND REGARDLESS OF ANY ORAL OR WRITTEN STATEMENTS MADE BY MRP, BY WAY OF TECHNICAL ADVICE OR OTHERWISE, RELATED TO THE USE OF THE EQUIPMENT.

        11.  BUYER’S REPRESENTATIONS AND WARRANTIES. Buyer represents and warrants to MRP that: (a) Buyer is duly organized, validly existing, and in good standing in the jurisdiction of Buyer’s formation; (b) Buyer is duly qualified to do business and is in good standing in every jurisdiction in which such qualification is required; (c) Buyer has the full right, power, and authority to enter into this Agreement and to perform Buyer’s obligations under this Agreement; (d) the execution of this Agreement by the person whose signature is set forth at the end hereof has been duly authorized by all necessary corporate action of Buyer; (e) when executed and delivered by each of MRP and Buyer, this Agreement will constitute the legal, valid and binding obligation of Buyer, enforceable against Buyer in accordance with its terms; (f) Buyer is in compliance with all applicable laws relating to this Agreement, the Equipment and the operation of Buyer’s business; (g) Buyer is not insolvent and is paying all of its debts as they become due; and (h) all financial information that Buyer has provided to MRP is true and accurate and fairly represents Buyer’s financial condition.

        12. PROPRIETARY RIGHTS.

(a) Ownership. No sale shall be construed as granting to Buyer any license or other right in, or to, any of MRP’s (i) patents; (ii) trademarks; (iii) internet domain names, whether or not trademarks, registered by any authorized private registrar or governmental authority, web addresses, web pages, websites and URLs; (iv) works of authorship, expressions, designs and design registrations, whether or not copyrightable, including copyrights and copyrightable works, software and firmware, technical data, data files, and databases and other specifications and documentation; (v) trade secrets; (vi) environmental or other testing applicable to the Equipment and/or the Services; and (vii) industrial and other intellectual property rights, and all rights, interests, and protections that are associated with, equivalent or similar to, or required for the exercise of, any of the foregoing, however arising, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights or forms of protection pursuant to the laws of any jurisdiction throughout in any part of the world (collectively, the “Intellectual Property Rights”).

(b) Prohibited Acts. Buyer shall not (i) take any action that might interfere with any of MRP’s rights in or to Intellectual Property Rights, including MRP’s ownership or exercise thereof; (ii) challenge any right, title, or interest of MRP in or to the Intellectual Property Rights; (iii) make any claim or take any action adverse to MRP’s ownership of the Intellectual Property Rights; (iv) register or apply for registrations, anywhere in the world, for MRP’s trademarks or any other trademark that is similar to MRP’s trademarks or that incorporates MRP’s trademarks in whole or in confusingly similar part; (v) use any mark, anywhere that is confusingly

similar to MRP’s trademarks in whole or in confusingly similar part; (vi) engage in any action that tends to disparage, dilute the value of or reflect negatively on the Equipment and/or the Services or any of MRP’s trademarks; (vii) misappropriate any of MRP’s trademarks for use as a domain name without prior written consent from MRP; or (viii) alter, obscure or remove any of MRP’s trademarks, or trademark or copyright notices or any other proprietary rights notices placed on the

Equipment, marketing materials or other materials that MRP may provide.

        13.  CONFIDENTIAL INFORMATION. Without the prior written consent of MRP,Buyer, directly or indirectly, shall not disclose (and will direct its directors, shareholders, employees and agents not to disclose) any Confidential Information. The term “Confidential Information” means any information of or relating to MRP or the Equipment and/or the Services not generally known to the public (other than as a result of disclosure in violation of this Agreement) in spoken, printed, electronic or any other form or medium, including, but not limited to, business processes, practices, methods, policies, plans, publications, documents, research, operations, services, strategies, techniques, agreements, contracts, transactions, potential transactions, know-how, trade secrets, databases, manuals, records, supplier information, financial information, accounting information, legal information, marketing information, pricing information, payroll information, personnel information, and supplier lists.

        14.  NON-SOLICITATION. Buyer agrees not to solicit or hire any personnel of MRP involved with the delivery of the Services during the provision of such Services and for twelve (12) months after the completion of such Services; provided, however, that Buyer may hire individuals employed by MRP who, without other solicitation, respond to advertisements or solicitations aimed at the general public.

        15.  EQUITABLE REMEDIES. Buyer acknowledges and agrees that (a) a breach or threatened breach by Buyer of any of its obligations under Sections 13 or 14 would give rise to irreparable harm to MRP for which monetary damages would not be an adequate remedy and (b) in the event of a breach or a threatened breach by Buyer of any such obligations, MRP shall, in addition to any and all other rights and remedies that may be available to MRP at law, at equity, or otherwise in respect of such breach, be entitled to equitable relief, including a temporary restraining order, an injunction, specific performance, and any other relief that may be available from a court of competent jurisdiction, without any requirement to post a bond or other security, and without any requirement to prove actual damages or that monetary damages will not afford an adequate remedy. Buyer agrees that Buyer will not oppose or otherwise challenge the appropriateness of equitable relief or the entry by a court of competent jurisdiction of an order granting equitable relief, in either case, consistent with the terms of this Section 15.

        16.  INDEMNIFICATION. Buyer agrees to indemnify, defend and hold harmless MRP and its directors, shareholders, employees and agents (collectively, “MRP Indemnitees”) against any liability, damage, loss or expense incurred by or imposed in connection with any claims, suits, actions, demands or judgments arising out of (a) any breach or non-fulfillment of any representation, warranty or covenant set forth in this Agreement by Buyer or its directors, managers, employees or agents (collectively, “Buyer’s Agents”); (b) any negligent act or omission or willful misconduct of Buyer or Buyer’s Agents in connection with this Agreement; (c) any bodily injury, death of any person or damage to real or tangible personal property caused by Buyer or Buyer’s Agents, including the use of unauthorized parts in or service of the Equipment; (d) any failure by Buyer or Buyer’s Agents to comply with any applicable laws; (e) any fraud or other intentional acts by Buyer or Buyer’s Agents; and (f) the use or operation of the Equipment, including, without limitation, any medical and/or surgical procedures performed by Buyer, and any of Buyer’s Agents, using the Equipment unless said damages are determined by a court of competence jurisdiction to be solely by the gross negligence of MRP or solely as result of a breach by MRP of the limited warranties contained herein.

        17.  DEFAULTS; REMEDIES. Notwithstanding anything herein to the contrary, should Buyer fail to pay for the order or any other amount, in whole or in part, when due or perform its other obligations under this Agreement or as otherwise mutually agreed in writing between Buyer and MRP (each, a “Default”), then MRP may take any and all actions available under law or equity to collect said amounts with a ten (10) day prior written notice, including, but not limited to, enforcing its security interest, accelerating the payment of and declaring immediately due and payable any unpaid balance of the order, referral to outside collection agencies and/or commencement of legal action. MRP’s rights shall be cumulative, and it shall not be required to have attempted to realize upon to the Equipment before taking any other collection actions. MRP may require that Buyer assemble and return any or all of the Equipment to MRP and, in the event Buyer fails to return such Equipment peaceably, enter upon the premises where such Equipment is located, with or without legal process, and repossess such Equipment. Upon a Default, Buyer agrees to pay upon MRP’s demand: (i) all costs and expenses incurred by MRP or its assignee in connection with the enforcement of any remedies, including all expenses incurred in connection with the return, sale, release or other disposition of the Equipment, including attorneys’ fees and other costs incurred by MRP or its assignee in enforcing or defending its rights and remedies under this Agreement and any other written agreement between Buyer and MRP.

        18.  COMPLIANCE WITH LAWS. Buyer shall (a) carry out the transactions contemplated by this sale and deal with the Equipment in conformity with all applicable laws, rules and regulations of all government authorities, including, without limitation, export laws, (b) obtain all permits and licenses required in connection with the purchase, shipment, installation or use of the Equipment, and (c) be solely responsible to fully understand and comply with laws, rules and regulations. Any information provided is as a convenience only.

        19.  FURTHER ASSURANCES. Upon MRP’s reasonable request, Buyer shall, at its sole cost and expense, execute and deliver all such further documents and instruments, and take all such further acts, necessary to give full effect to this Agreement.

        20.  ASSIGNMENT; SUCCESSORS AND ASSIGNS. Buyer cannot delegate any duties nor assign any rights or claims under this Agreement without MRP’s prior written consent, and any such attempt or assignment shall be void. In the event that Buyer finances its acquisition of any Equipment with a third party, Buyer may direct MRP to transfer title of such Equipment to such third-party financing company, with all remaining terms and conditions of this Agreement remaining in full force and effect. This Agreement is binding on and inures to the benefit of the parties to this Agreement and their respective permitted successors and permitted assigns.

        21.  NO THIRD-PARTY BENEFICIARIES. Subject to Section 16, this Agreement benefits solely the parties to this Agreement and their respective permitted successors and assigns, and nothing in this Agreement, express or implied, confers on any other person any legal or equitable right, benefit, or remedy of any nature whatsoever under or by reason of this Agreement.

        22.  GOVERNING LAW; VENUE. The application of the UN Convention on Contracts for the International Sale of Goods is expressly excluded. The parties agree that any and all claims, demands, disagreements, controversies or disputes arising out of or relating to this Agreement and any agreement or document delivered in connection herewith (collectively, “Claims”) shall be governed by and construed in accordance with the laws of the State of Utah and adjudicated exclusively in the state and federal courts located in or nearest to Summit County, Utah, which courts shall have the sole and exclusive jurisdiction and venue for adjudication of all Claims. The parties hereby agree upon, consent and stipulate to the jurisdiction and venue of the aforementioned courts for the adjudication of all Claims, to the exclusion of all other courts, forums and venues whatsoever.

        23.  NON-DISPARAGEMENT. Buyer shall not disparage MRP or MRP’s trademarks, websites, products or services, or display any such items in a derogatory or negative manner on any website or in any public forum or press release.

        24.  NOTICES. Any notice, demand, or communication required, permitted or desired to be given hereunder shall be deemed effectively given when personally delivered, when sent by electronic means, when received by overnight courier, or when mailed by prepaid, certified or registered mail, return receipt requested, addressed to the other party at its address set forth on the Quote or to such other address that the receiving party may designate from time to time in accordance with this Section 25.

        25.  PUBLIC ANNOUNCEMENTS. Unless otherwise stated herein, neither party shall issue a press release or otherwise advertise, make a public statement or disclose to any third-party information pertaining to the relationship arising under this Agreement, the existence or terms of this Agreement, the underlying transactions between MRP and Buyer or agent for Buyer or refer to the other party in relation to this Agreement without the other party’s prior written approval.

        26.  ENTIRE AGREEMENT; ADDITIONAL OR INCONSISTENT TERMS. Subject to Section 32, this Agreement constitutes the sole and entire agreement between the parties hereto relating to the subject matter hereof, and any unincorporated representation, affirmation of fact, course of prior dealings, promise or condition in connection therewith, or usage of the trade, shall not be binding on either party. Terms and conditions set forth which differ from, conflict with or are not included in this Agreement shall not be part of any agreement between MRP and Buyer unless both parties specifically accept such terms and conditions in writing.

        27.  WAIVER. No waiver under this Agreement is effective unless it is in writing and signed by the party waiving its right. Any waiver authorized on one occasion is effective only in that instance and only for the purpose stated and does not operate as a waiver on any future occasion. None of the following constitutes a waiver or estoppel of any right, remedy, power, privilege or condition arising from this Agreement: any failure or delay in exercising any right, remedy, power or privilege or in enforcing any condition under this Agreement; or any act, omission or course of dealing between the parties.

        28.  SURVIVAL. Subject to the limitations and other provisions of this Agreement, the representations and warranties of Buyer contained herein shall survive the expiration or earlier termination of this Agreement for a period of twelve (12) months after such expiration o termination and (b) this Section 29 and Sections 10, 12, 13, 14, 15, 16, 17, 21, 22, 23, 24, 26, and 32 of this Agreement, as well as any other provision that, in order to give proper effect to its intent, should survive such expiration or termination, shall survive the expiration or earlier termination of this Agreement. All other provisions of this Agreement shall not survive the expiration or earlier termination of this Agreement.

        29.  RELATIONSHIP OF PARTIES. Nothing in this Agreement creates any agency, joint venture, partnership or other form of joint enterprise, employment or fiduciary relationship between the parties. Neither party has any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other party or to bind the other party to any contract, agreement or undertaking with any third party.

        30.  HEADINGS. The headings in this Agreement are for reference only and do not affect the interpretation of this Agreement.

        31.  ORDER OF PRECEDENCE. In the event of conflict between the Quote, a written agreement by MRP, and these Terms, the order of priority shall be: (1) the written

agreement by MRP, if only if executed by an MRP Officer, (2) the Quote and (3) these Terms, and only to the extent of the direct conflict. Notwithstanding the foregoing, MRP shall not be bound by, and specifically objects to, any terms, conditions or other provisions, both written and oral, which are different from, in addition to or inconsistent with the provisions of this Agreement which are set forth in any purchase order, receipt, acceptance, confirmation, correspondence or otherwise of, or by, Buyer. Fulfillment of Buyer’s order shall not constitute acceptance of any of Buyer’s terms and conditions and does not serve to modify or amend the terms and conditions contained herein.

        32.  SEVERABILITY. If any part of this Agreement is held to be void, illegal or unenforceable, then it shall be deemed to be severed from this Agreement and the remaining provisions shall continue in full force and effect; provided, however, that if any fundamental term or provision of this Agreement is held to be void, illegal or unenforceable, the remainder of this Agreement shall be unenforceable. Upon a determination that any term or provision is void, illegal or unenforceable, the parties shall negotiate in good faith to modify this Agreement to effect the original intent of the parties as closely as possible in order that the transactions contemplated hereby be consummated as originally contemplated to the greatest extent possible.