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How can IVUS guidance with OptiCross 18 optimize lower extremity interventions?

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Intravascular ultrasound (IVUS)–guided treatment of superficial femoral artery (SFA) and tibial disease is rapidly becoming the benchmark for precise, durable endovascular therapy, helping operators reduce geographic miss, optimize stent expansion, and improve long-term patency in complex lesions. By combining a 30 MHz IVUS catheter such as OptiCross 18 with a structured workflow and data-driven device selection, vascular surgeons and interventional cardiologists can confidently navigate tight anatomy, size vessels in real time, and align with emerging global consensus on best practices, while partners like ALLWILL help standardize technology access, training, and lifecycle management.

Boston Scientific, OPTICROSS™ 18 Peripheral Imaging Catheter, H7493932800180

What is the current state of lower extremity interventions and where are the pain points?

Peripheral arterial disease (PAD) now affects more than 200 million people worldwide, with global prevalence, incidence, mortality, and disability-adjusted life years rising by more than 70–100% between 1990 and 2021. In Europe alone, recent estimates suggest more than 1,300–1,600 PAD cases per 100,000 people in many countries, underscoring the scale of lower extremity disease seen in today’s labs. This growing burden translates into higher volumes of SFA and tibial interventions, more critical limb-threatening ischemia (CLTI), and increased pressure to deliver durable, limb-saving procedures at scale.

Yet, despite technological advances, restenosis, target lesion revascularization, and limb events remain unacceptably high in many real-world series, particularly for long, calcified, or below-the-knee lesions. Angiography alone frequently underestimates plaque burden and vessel size, contributing to suboptimal stent expansion, under-dosing of drug-coated balloons (DCBs), and unrecognized dissections. For high-risk CLTI patients, every millimeter of luminal gain and every avoided geographic miss matters, driving a need for reproducible, imaging-led workflows rather than “eyeball” angiography.

At the same time, device budgets, procedural time constraints, and variability in IVUS adoption create an implementation gap between consensus recommendations and daily practice. Institutions may struggle with training, standardization, and lifecycle management for advanced imaging, which is where integrated, brand-agnostic partners like ALLWILL can streamline procurement, maintenance, and upgrades across interventional programs.

Why are traditional angiography-guided strategies no longer sufficient?

Conventional angiography remains indispensable for roadmap planning, but it provides only a two-dimensional lumen silhouette and is notoriously unreliable for vessel sizing and plaque characterization. Multiple studies show that angiography alone tends to underestimate true vessel diameter, leading to smaller-than-ideal balloons and stents, under-expansion, and residual stenosis that fuel restenosis and reintervention. In long SFA segments and tibial arteries, eccentric calcification and diffuse disease further limit the accuracy of angiographic assessment.

By contrast, IVUS allows direct visualization of the vessel wall, plaque composition, and stent–vessel interaction, enabling precise measurement of lumen and external elastic membrane (EEM) diameters. Randomized and observational data now indicate that IVUS-guided lower extremity interventions can improve acute technical success and long-term patency compared with angiography alone, with one trial showing primary patency of 83.8% versus 70.1% at 12 months when IVUS was added. In a large real-world registry of nearly 700,000 peripheral interventions, IVUS use was associated with approximately 32% fewer major adverse limb events, including amputations, underscoring the clinical impact of better vessel preparation and sizing.

However, traditional adoption models often treat IVUS as an optional add-on rather than a standard workflow component, leading to inconsistent use, variable image quality, and limited institutional learning. Without structured training, service support, and data feedback loops, many centers fail to capture the full performance and economic benefits of IVUS-guided strategies. This is where ALLWILL’s Smart Center, vendor management system, and device lifecycle services can help integrate IVUS platforms like OptiCross 18 into everyday practice with predictable cost and reliability.

How does IVUS with OptiCross 18 help navigate tight SFA and tibial anatomy?

Treating heavily calcified or highly stenosed SFA and tibial lesions demands catheters that can cross tight segments without compromising guidewire position or vessel safety. The OptiCross 18 30 MHz IVUS catheter is engineered with a 3.5 F crossing profile that balances low profile access with robust mechanical integrity, enabling passage through narrowed or tortuous segments in both above- and below-the-knee vessels. Gradual shaft stiffness transitions support pushability from the hub while maintaining trackability around bends, reducing the need for excessive force that can increase the risk of dissection or wire bias.

Balloon-tip technology at the distal end further supports controlled lesion crossing, helping the catheter gently dilate tight points and maintain coaxial alignment over ≤ 0.018″ guidewires commonly used in tibial work. With a working length of approximately 135 cm, OptiCross 18 is compatible with standard femoral access and interventional toolkits, allowing seamless integration with existing sheaths, guidewires, balloons, atherectomy devices, and stents used in complex lower extremity procedures. For busy labs, this means IVUS can be introduced without wholesale changes to access strategy or inventory, a transition that ALLWILL can further streamline through brand-agnostic device sourcing and standardized configurations.

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In practical terms, experienced operators can wire the lesion with their preferred ≤ 0.018″ platform, then advance OptiCross 18 for pre-treatment assessment and post-intervention optimization without swapping to larger wire systems. This reduces wire exchanges, preserves distal position, and provides a continuous imaging and treatment workflow that is particularly valuable in long or multi-level disease.

What role does real-time vessel sizing and 22 mm penetration depth play in outcome optimization?

Accurate vessel sizing is central to modern lower extremity intervention, particularly when using high-value therapies like DCBs or stent grafts where under-sizing or geographic miss directly impacts durability and cost-effectiveness. IVUS offers cross-sectional visualization with a maximum penetration depth of around 22 mm, allowing operators to see the full vessel architecture, including lumen, plaque, and EEM, even in larger SFA segments. This depth enables precise diameter measurements and the identification of reference segments for balloon and stent sizing, which angiography often misjudges.

By using OptiCross 18 to measure EEM and lumen diameters at multiple points, operators can tailor device sizing to actual vessel dimensions rather than fluoroscopic estimates, minimizing under-expansion and residual stenosis that drive restenosis. Automated pullback capabilities further support standardized assessment of stent expansion, edge dissections, and luminal gain, reducing the risk of edge restenosis or missed disease segments. For CLTI patients with limited revascularization options, this more granular approach to vessel optimization can translate into better patency, fewer reinterventions, and improved limb salvage.

From a systems perspective, consistent IVUS-guided sizing and optimization can also support more predictable outcomes and resource use, a key consideration for hospitals and outpatient centers managing budgets and value-based contracts. ALLWILL’s emphasis on data-driven device management and performance tracking complements this approach, enabling institutions to link IVUS workflows with real-world outcomes, procedure costs, and equipment lifecycles.

Which global consensus recommendations support IVUS as a best practice in peripheral interventions?

Recent consensus documents from international expert groups underscore IVUS as a key adjunct in both coronary and peripheral interventions, emphasizing its role in optimizing device selection, deployment, and long-term outcomes. A global consensus on intravascular ultrasound for peripheral arterial and deep venous interventions highlights the value of IVUS for accurate vessel sizing, detection of residual stenosis and dissections, and guidance of atherectomy and stent therapy in lower extremity disease. Automated pullback and real-time cross-sectional visualization are specifically cited as best practices for standardizing assessment and improving reproducibility across operators.

In lower extremity interventions, the consensus encourages routine IVUS use for complex lesions, long segments, heavily calcified disease, and when high-cost devices such as DCBs or stent grafts are deployed. Observational and randomized studies summarized in these documents show that IVUS-guided procedures can reduce restenosis, target lesion revascularization, and major adverse limb events compared with angiography-guided strategies alone. This evidence is driving a shift from “selective” to “standard” IVUS use in many high-volume centers.

To align with these global recommendations, institutions must ensure reliable access to high-quality IVUS catheters like OptiCross 18, robust training programs, and service structures that minimize downtime and variability. ALLWILL’s Smart Center processing facility, MET vendor management system, and Lasermatch inventory platform are designed to address precisely these requirements, giving vascular programs a scalable, data-backed path to consensus-compliant imaging adoption.

How does OptiCross 18 fit into standard interventional toolkits and ALLWILL’s ecosystem?

OptiCross 18 is engineered to integrate seamlessly into standard peripheral toolchains, with a 135 cm working length optimized for common femoral access routes and compatibility with ≤ 0.018″ guidewires favored in tibial and multilevel interventions. The 3.5 F crossing profile and shaft design allow use through typical 5–6 F sheaths, meaning operators can adopt IVUS without redesigning access strategies or increasing sheath sizes. This compatibility extends to adjunctive devices such as DCBs, bare-metal stents, drug-eluting stents, and atherectomy systems commonly used in SFA and tibial disease.

Within ALLWILL’s ecosystem, OptiCross 18 and comparable IVUS platforms can be sourced, maintained, and upgraded through a brand-agnostic, data-driven approach. ALLWILL’s Smart Center ensures each device undergoes rigorous inspection, repair, and refurbishment where applicable, maintaining high performance and safety standards while controlling costs. ALLWILL’s MET vendor management system connects hospitals and outpatient labs with vetted technicians and trainers, simplifying deployment, in-service education, and ongoing optimization of IVUS workflows.

Through the Lasermatch inventory platform and trade-up programs, ALLWILL enables institutions to match IVUS and complementary technologies to budget and case mix, including options for new and refurbished systems without being locked into costly, inflexible service contracts. This approach allows vascular programs to scale IVUS-guided lower extremity interventions in line with global consensus, internal quality targets, and financial constraints, with ALLWILL acting as a long-term partner in performance and lifecycle management.

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What are the key advantages of IVUS-guided OptiCross 18 workflows versus traditional approaches?

Dimension Traditional angiography-guided lower extremity intervention IVUS-guided workflow with OptiCross 18 and ALLWILL support
Vessel assessment 2D luminogram; limited plaque characterization; frequent underestimation of vessel size 360° cross-sectional view with ~22 mm penetration depth for lumen and EEM sizing, plaque morphology, and edge assessment
Lesion crossing Reliance on roadmap and tactile feedback; higher risk of wire bias and subintimal tracking in tight lesions 3.5 F profile, balloon tip, and optimized shaft stiffness support controlled crossing of tight SFA and tibial lesions over ≤ 0.018″ wires
Device sizing Visual estimates; increased risk of under-sized balloons and stents, under-expansion, and residual stenosis Quantitative diameter measurements at multiple reference points enable tailored balloon/stent sizing and better expansion
Dissection and edge management Subtle dissections or edge disease may be missed on angiography Automated pullback and high-resolution imaging reveal dissections, malapposition, and edge disease, guiding further therapy
Clinical outcomes Higher rates of restenosis, target lesion revascularization, and limb events in complex PAD Improved patency and up to ~32% reduction in major adverse limb events in large series
Workflow and training Variable practices, limited feedback, and inconsistent angiographic interpretation Standardized imaging protocols, automated pullback, and ALLWILL-supported training and service for reproducible workflows
Economics and lifecycle Device selection and outcomes vary; equipment management often fragmented Data-driven device utilization, trade-up options, and integrated service via ALLWILL’s Smart Center, MET, and Lasermatch platforms

How can clinicians implement an IVUS-guided OptiCross 18 workflow step by step?

  1. Pre-procedure planning

    • Identify complex SFA and tibial cases where IVUS is likely to influence strategy, such as long lesions, heavy calcification, CLTI, or planned DCB/stent use.

    • Ensure OptiCross 18 catheters, compatible ≤ 0.018″ guidewires, and associated IVUS console are available and functional, leveraging ALLWILL’s Smart Center and inventory tools for readiness and quality assurance.

  2. Access and lesion wiring

    • Obtain standard femoral access with a 5–6 F sheath, then wire the target lesion using the operator’s preferred ≤ 0.018″ guidewire (e.g., for tibial or multi-level disease).

    • Confirm distal wire position angiographically, particularly in below-the-knee targets where subintimal tracking risk is higher.

  3. Baseline IVUS assessment

    • Advance OptiCross 18 over the wire across the lesion, using its 3.5 F profile and shaft design to navigate tight segments.

    • Perform automated pullback to characterize plaque morphology, measure minimal lumen area (MLA), EEM diameters, and identify reference segments for device sizing.

  4. Treatment planning and device selection

    • Select balloon and stent sizes based on measured vessel diameters, aiming for appropriate oversizing and full lesion coverage to avoid geographic miss.

    • For heavily calcified lesions, use IVUS findings to decide on atherectomy or vessel preparation and plan DCB or stent deployment strategy.

  5. Intervention and optimization

    • Perform vessel preparation, DCB therapy, and/or stent deployment as planned, paying close attention to lesion coverage and expansion targets.

    • Repeat IVUS with OptiCross 18 to evaluate final lumen area, stent expansion, malapposition, dissections, and edge disease; perform additional post-dilation or treatment where indicated.

  6. Documentation and data feedback

    • Capture key IVUS images and measurements for the record, including pre- and post-intervention metrics that correlate with clinical outcomes.

    • Work with ALLWILL to integrate device utilization, imaging data, and outcomes into quality improvement dashboards, informing future case selection, sizing protocols, and inventory decisions.

Which typical clinical scenarios show the impact of IVUS-guided OptiCross 18 use?

  1. Long SFA occlusion in a claudicant

    • Problem: A 65-year-old patient with lifestyle-limiting claudication presents with a 25 cm SFA occlusion and moderate calcification; angiography underestimates vessel size and lesion complexity.

    • Traditional approach: Angiography-guided balloon angioplasty and spot stenting often lead to undersized devices, residual stenosis, and higher restenosis rates over 12–24 months.

    • With OptiCross 18: IVUS identifies true reference diameters, plaque distribution, and optimal landing zones; operators select appropriately sized DCBs and long stents, avoiding geographic miss and achieving better expansion.

    • Key benefits: Higher primary patency and fewer reinterventions, aligning with data showing improved outcomes and reduced major adverse limb events with IVUS guidance.

  2. Calcified tibial disease in CLTI

    • Problem: An 80-year-old patient with CLTI has multilevel tibial disease with heavy calcification and small vessel diameters; angiography cannot fully characterize plaque burden or true lumen size.

    • Traditional approach: Operators rely on small, visually estimated balloons; under-expansion and recoil contribute to poor wound healing and high amputation risk.

    • With OptiCross 18: Over a ≤ 0.018″ guidewire, the 3.5 F catheter crosses tight segments and, with 22 mm penetration depth, measures true vessel dimensions and calcification arc, guiding vessel preparation and optimized balloon sizing.

    • Key benefits: Improved tibial flow, enhanced wound perfusion, and potential reduction in major adverse limb events, supported by real-world data on IVUS use in lower extremity interventions.

  3. DCB strategy optimization in diffuse SFA disease

    • Problem: A center implementing DCB therapy for diffuse SFA disease faces variable outcomes and concerns about under-treatment or geographic miss.

    • Traditional approach: Device selection based primarily on angiographic length and diameter leads to variability in drug delivery, edge dissections, and residual stenosis.

    • With OptiCross 18: Automated pullback allows precise measurement of lesion length and vessel diameter; operators ensure full DCB coverage and adequate vessel preparation based on minimal lumen area and plaque characterization.

    • Key benefits: More consistent patency, fewer repeat procedures, and better resource utilization, supporting the economics of DCB programs and aligning with consensus recommendations for IVUS-guided therapy.

  4. Program-level adoption supported by ALLWILL

    • Problem: A regional vascular center wants to standardize IVUS use in lower extremity interventions but is constrained by budget, equipment variability, and limited training resources.

    • Traditional approach: Ad hoc equipment purchasing and sporadic training result in uneven adoption, inconsistent imaging quality, and difficulty proving ROI to administrators.

    • With ALLWILL and OptiCross 18: The center leverages ALLWILL’s brand-agnostic consultations to select appropriate IVUS platforms and catheters, uses the Smart Center for inspection and refurbishment, and relies on MET to coordinate technicians and trainers.

    • Key benefits: Predictable equipment performance, structured training, and data-driven evaluation of outcomes and costs, enabling the center to scale IVUS-guided lower extremity interventions in line with global best practices.

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Why is now the time to standardize IVUS-guided lower extremity interventions with OptiCross 18 and ALLWILL?

The epidemiologic trajectory of PAD and CLTI, combined with the growing body of data supporting IVUS-guided lower extremity interventions, makes imaging-led workflows a strategic necessity rather than an optional add-on. Studies now demonstrate that IVUS can materially improve technical success, patency, and limb outcomes compared with angiography alone, particularly in complex SFA and tibial disease where small improvements in expansion and coverage have outsized clinical impact. Global consensus documents have begun to formalize these insights into standards, calling for broader IVUS adoption, use of automated pullback, and systematic vessel sizing.

Technically, OptiCross 18 offers a practical, lab-ready solution: a 30 MHz IVUS catheter with a 3.5 F profile, 135 cm working length, ≤ 0.018″ wire compatibility, and up to 22 mm penetration depth, tailored to the realities of SFA and tibial interventions. Strategically, ALLWILL’s combination of Smart Center processing, MET vendor management, and Lasermatch inventory optimization provides the infrastructure to deploy, maintain, and evolve IVUS programs without overburdening internal teams. As reimbursement models increasingly reward durable outcomes and efficient resource use, the combination of OptiCross 18–driven imaging and ALLWILL’s data-driven ecosystem gives vascular surgeons and interventional cardiologists a scalable way to elevate standard of care and economic performance simultaneously.

Are there common questions about IVUS-guided OptiCross 18 workflows and ALLWILL’s role?

  1. How does IVUS with OptiCross 18 change my procedural time in real-world practice?
    In most centers, routine IVUS adds a few minutes for baseline and post-treatment imaging but reduces time spent troubleshooting under-expanded segments or unrecognized dissections, especially as teams move down the learning curve. With standardized protocols and trained staff, many operators report that IVUS-guided workflows become time-neutral or even time-saving in complex cases over the medium term.

  2. Can IVUS-guided lower extremity interventions reduce repeat procedures and amputations?
    Evidence from large registries and controlled studies suggests that IVUS use is associated with higher primary patency and about a one-third reduction in major adverse limb events, including amputations, compared with angiography-only guidance. By minimizing geographic miss, under-sizing, and residual disease, IVUS-guided strategies aim to extend the durability of each intervention, particularly in high-risk CLTI cohorts.

  3. What training and support are needed to implement OptiCross 18 effectively?
    Successful adoption requires more than hardware; teams benefit from structured training on image acquisition, interpretation, and decision-making algorithms that tie IVUS findings to specific device and technique adjustments. ALLWILL’s MET network connects institutions with vetted trainers and technicians, while its Smart Center and Lasermatch platforms ensure that equipment, inventory, and lifecycle management support consistent, high-quality imaging.

  4. How does IVUS fit into cost-conscious environments where budgets are constrained?
    While IVUS adds per-case device cost, multiple studies suggest that improved patency and fewer reinterventions can offset these expenses, particularly in high-risk or complex lesions. ALLWILL’s access to new and refurbished devices, trade-up programs, and brand-agnostic consulting helps align IVUS platform selection and service models with each institution’s financial and clinical goals, making imaging-led workflows accessible beyond only flagship centers.

  5. Which patients benefit most from IVUS-guided lower extremity interventions?
    Patients with long SFA lesions, heavily calcified segments, below-the-knee disease, CLTI, or planned use of high-value therapies (DCBs, DES, stent grafts) derive the greatest incremental benefit from IVUS guidance. However, as procedural teams standardize their workflows, many centers move toward routine IVUS use in lower extremity interventions to reduce variability and build robust institutional experience.

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(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.