Market Access Plan | Consulting | Colombia

Offer for Skyline Medical, Inc. (the "Offer") | Prepared by: bioaccess.™

April 3, 2019

Offer No. SKY0012019

Attn.: Kevin Hungerford, Vice President of Sales and Marketing

Dear Kevin,

Thank you for considering bioaccess.™ for your market access needs in Colombia and the rest of Latin America. This Offer will enable bioaccess.™ to assist Skyline Medical, Inc. ("Skyline") with its interest in significantly increasing sales of its STREAMWAY System (the "Product") in Latin America.

This Offer has been customized to address the challenges for Skyline in Latin America that we identified during our most recent conference call, and they include,

  • Lack of understanding of the risks and opportunities that Latin America has to offer for medical capital equipment vendors in the fluid disposal segment.
  • Lack of local contacts to guide the company in a market access initiative in Colombia.
  • Lack of access to qualified distributors that are aligned with the company's values and business objectives.
  • With this Offer, we will research the Colombian market and develop for Skyline a strategic and tactical market access plan; this plan will position Skyline for success in Colombia (the "Plan").

    The Plan will require a comprehensive market access analysis after conducting face-to-face interviews with key stakeholders. This will give us the ability to propose strategies and tactics to have Skyline successfully penetrate the Colombian market.

    After delivery of the Plan, Skyline will be able to thoroughly understand the Colombian market for the Product, will know the right pricing, the reimbursement landscape (if applicable), how to generate demand, and the candidate in-country distribution partners.

    We look forward to getting started on this exciting project for Skyline.

    Thank you for your trust,


    Julio G. Martinez-Clark, bioaccess.™ CEO

    jmclark@bioaccessla.com | +1 (954) 903-7210

    CONFIDENTIALITY

    The Offer is subject to a mutually executed confidentiality agreement or clinical services agreement specifying full terms and conditions. By accepting this document, you agree that the information in this proposal shall not be disclosed, duplicated or used for any purpose other than to evaluate the Offer.

    All of the information contained in this document is provided on the basis of strict confidentiality for only your exclusive use and must not be disclosed to any other party. You should exercise no lesser security measures than those applied to their own confidential material including restricting the circulation of the information on a need to know basis.

    Why do you need a market access plan?

    Emerging markets are the engines of growth today, and, thus, performing in these markets is critical for the majority of pharmaceutical and medical technology companies


    Market access has gained considerable attention worldwide as countries try to contain their escalating healthcare expenditures amidst the global economic slowdown. This has resulted in governments adopting stricter measures for new product approval. Thus, pharmaceutical and medical technology companies are finding it increasingly difficult to successfully address the specific challenges posed by various government and regulatory agencies and stakeholders.

    The stagnant developed markets have forced pharmaceutical and medical technology companies to focus more on the emerging markets, which are touted as being the next engines of growth. Thus, growth for pharmaceutical and medical technology company will depend on its performance in these markets. A customized market access strategy integrated with the right processes and talent can help mitigate these challenges, allowing effective commercialization and increased drug or medical device accessibility for patients.

    Read more.

    Offer Summary

    Market access consulting in Colombia

    A turn-key solution for your market access needs in Colombia

    Many foreign medical technology companies are dependent primarily on local distributors to sell into the Latin American countries. Most of these companies poorly choose their distributors, don't conduct the necessary due-diligence on them. Most distributors in Latin America are small operations that are thinly capitalized; they may be good at accepting orders and service clients but are unable to invest in demand creation on your behalf.

    bioaccess.™ market access experts identify why certain companies succeed in a given market while others fail, pinpointing the forces that drive the market so we can make the best possible strategic recommendations. This market wisdom is the most valuable component of our medical device market access plans and is designed to bring our clients a competitive edge.

    Skyline Challenges

    bioaccess.™ Solution

    Benefit to Skyline

    Lack of understanding of the risks and opportunities that Colombia has to offer for medical capital equipment vendors in the fluid disposal segment.


    If Skyline doesn't address this, it will likely enter the market with the wrong information, and will make many mistakes along the way.

    A thorough market access plan to enter the Colombian market —one of the top Latin American economies and the door to the Pacific Alliance

    Access to updated verifiable information to make decisions, project revenue, and lower Skyline's risks in Colombia.

    Lack of local contacts to guide the company in a market access initiative in Colombia.


    If Skyline doesn't address this, it will have ill-prepared, inexperienced, and culturally-insensitive staff interacting with a different culture, in a different language, and will likely fail communicating its value proposition.

    Latin American market access experts, key opinion leaders, and other key stakeholders contributing to creating Skyline's market access plan in Colombia.

  • Contact information and personal links to all the key stakeholders for the Skyline business in Colombia.
  • The right input to formulate Skyline's market access plan for Colombia.
  • Lack of access to qualified distributors that are aligned with Skylines's values and business objectives.


    If Skyline doesn't address this, it won't conduct due diligence on its distributors, and will poorly choose them. This will mean wasted time and money in the process —the wrong distributor in a Latin American country costs a Medtech company about three years in lost sales.

    Skyline will have market access experts objectively conducting local research from primary and secondary sources to formulate a market access plan for Skyline in Colombia.

    Skyline will have access to a pool of qualified candidate distributors so that it can make the best decision as to its best partner to have in Colombia.

    Objectives

    With this Offer, we are focused to reaching the following objectives:

    Main objective:

  • To propose and implement winning strategies and tactics for brand positioning, sales, and product differentiation in the Plan to generate demand and successfully launch the sale of the Product in Colombia.
  • Secondary objectives:

  • Identify market size and sales drivers for the Product in Colombia.
  • Identify the critical success factors to create a value proposition to potential distributors in Colombia around how the Product could benefit patients, payers (if applicable), and end-users.
  • Extract the opinions of key opinion leaders about the Product.
  • Identify the pathway —within the context of the national healthcare system— to significantly launch sales of the Product in Colombia through the distributor.
  • Quantify, identify, conduct due diligence, and select candidate distributors for the Product based on their national coverage, business structure, trained sales personnel, prestige, solid finances, and solid relationships with public and private insurance companies and hospitals.
  • Identify and name the ideal candidates to become distributor for Skyline in Colombia.
  • The Scope of Work

    This Offer includes the following scope of work/activities:

  • Phase 1 (Market Access Plan Research)
  • Creation of a list of relevant stakeholders to interview.
  • Interviews with leaders at insurance companies (if applicable).
  • Interviews with key opinion leaders (KOLs).
  • Interviews with specialized distributors of medical products.
  • Assemblage and opinion gathering from an advisory board/panel of experts (using the Delphi or similar method) —if applicable.
  • Identification of Skyline' strengths and weaknesses, as well as its external opportunities and threats (SWOT analysis).
  • Identification of Porter's Five Forces (a model that will help us identify and analyze the five competitive forces that shape the Product market in Colombia to help us determine the industry's weaknesses and strengths).
  • Identification of the ideal partnership agreement with the potential distributors.
  • Identification of the ideal Product distribution strategy and network.
  • Production of the Plan containing market drivers, critical success factors, pricing, reimbursement, strategies, and tactics to generate demand and increase sales of the Products.
  • Phase 2 (Market Access Plan Creation)
  • Presentation (PowerPoint or similar format) of the Plan to EOS.
  • EOS Introduction to candidate distributors.
  • Phase 3 (Market Access Plan Implementation) — (Pricing Not Included in this Offer)
  • Follow up with the candidate distributors that have expressed a firm interest in working with Skyline. 
  • Facilitation of meetings (virtual or in-person) between distributors and Skyline leadership. 
  • Facilitation and management of the communication between Skyline and the new distributor, and support of all distributor needs.
  • Maintenance of awareness of industry, company, competitor, legislative and regulatory activities in the Latin American region that may affect positively or negatively Skyline's business in the region.
  • Handling and management of day-to-day requests and ongoing concerns and requests from distributors and end-buyers.
  • Constant interaction with Skyline leadership to build a firm sales and marketing strategy and business plan to execute on objectives.
  • Tracking of metrics to ensure achievement of goals/objectives by distributors are met.
  • Coordination of the regulatory registration of the STREAMWAY® System in the target countries.(1) 
  • Deliverables

    We will know we are successful when the following are manifested:

  • The Plan (produced in the form of a PowerPoint-type presentation).
  • Names and contact information for the candidate distribution distributors.
  • Transfer price calculator (you will be able to clearly see and understand the fees involved with importing the Product in Colombia, and will be able to negotiate pricing with your local distributor).
  • Names and contact information of key stakeholders including key opinion leaders, top customers, etc.
  • Timing

  • 90 to 120 days from contract execution to delivery of the Plan.

  • (1) bioaccess provides regulatory product registration services in Colombia (and also in Brazil, Mexico with the help of a local partner).  

    Access to this market [Colombia] is not easy for newcomers. The market is mature and competitive, with many foreign firms selling medical equipment and medical products.

    — U.S. Department of Commerce, Colombia Export Guide

    About us

    bioaccess.™ is a US-based contract research (CRO), regulatory, and market access consulting company that delivers a full spectrum of offerings from bench to commercialization so that foreign medical device companies can have long-term success in Colombia and the rest of Latin America.

    Our promise is for US or EU medical device companies that believe that Latin America offers untapped potential to test and sell their products. We focus on forward-looking medical device companies that want to conduct first-in-man clinical trials and want to have long-term sales growth in the region.

    We promise that by engaging with us as your CRO, regulatory, and market access consultants, your company will cost-effectively get the clinical data it needs and will be able to increase its sales in Colombia and the rest of Latin America.

    bioaccess.™ has helped companies like Avinger, Mitralign, and MitraSpan, SANUWAVE, ClarVista Medical, CeloNova BioSciences, Abiomed, Volcano, Mount Sinai's Center For Personalized Cancer Therapeutics, Libella Gene Therapeutics, Medimaps Group, WEP Clinical, Hancock Jaffe Laboratories, Omron Healthcare, IDx, LumiThera, and Biomerica —among others— conduct trials, register their products, and/or formulate a winning market access strategy in Colombia.

    Learn more.

    Omron Selects bioaccess.™ for its Market Access Plan in Colombia

    [ORLANDO, FL, July 6, 2018] - Omron Healthcare, Inc. ("Omron") has appointed bioaccess.™ as its market access consultants in Colombia. bioaccess.™ will help Omron formulate a market access strategy and implementation plan in Colombia so that more hypertensive patients have access to Omron's automated home blood pressure (BPM) monitors in Colombia; thus, making it easier for patients to monitor their blood pressure at home and reducing their risk of heart attacks and strokes. 

    Read more.

    Methodology

    Proven methods to deliver results!

    The execution strategy must incorporate proven methodologies, extremely qualified personnel, and a highly responsive approach to managing deliverables.

    We first need to craft your problem statement in Colombia. A problem statement is a concise description of an issue to be addressed or a condition to be improved upon. It identifies the gap between the current (problem) state and the desired (goal) state. Focusing on the facts, the problem statement should be designed to address the 5 W’s – who, what, where, when, and why.

    The first condition of solving a problem is understanding the problem, which can be done by way of a problem statement. Only after the problem statement is written and agreed upon should the solution(s) be discussed and the resulting course of action determined.

    Before the problem statement can be crafted, the problem must be defined. It is human nature to want to begin working on a solution as soon as possible and neglecting the definition of the true problem to be solved. However, a poorly defined problem increases the risk of implementing a solution that does not fully meet the expected results. A problem cannot be solved if it is not completely understood.

    The process of defining the problem is often a group effort. It starts with meeting with the stakeholders, customers, and/or users affected by the issue (if possible) and learning about their pain points. Once the problem is understood and the circumstances driving the project initiation are clear, it is time to write the problem statement.

    A poorly crafted or incorrect problem statement will lead to a faulty solution, as well as wasted time, money, and resources. A good problem statement will address the following areas: a) the ideal situation, the reality, the consequences of not solving the problem, and the potential solutions.

    There is an underlying problem related to access to the Colombian medical device market that we need to find and address that will prevent the Device from being sold in Colombia (the "Problem").

    Skyline needs a thorough market research/analysis that will help us identify its problem statement, identify Skyline's opportunities, and provide it with a well-thought-out and effective Plan.

    Once we find the Problem, then we will be able to come up with the right solutions (strategies and tactics) as part of the Plan for Skyline in Colombia.

    In order to find the Problem and achieve the objectives of this Offer, we strongly believe that we need to obtain insights from multiple stakeholders. This will allow us and Skyline evaluate and validate multiple access alternatives in Colombia that will contribute to a stronger Plan with more probability of being implemented with a successful outcome.

    In order to gather the information needed to create the Plan, we must diligently take action under the following framework:

    The bioaccess.™ Framework

    Our framework to guide our clients consists of three phases to ensure a successful market entry in each Latin American country.


    Objective

    Benefit

    Actions

    Phase 1

    Market Access Plan Research

  • To identify the barriers of entry that create the Problem.
  • To identify the market drivers of the local business.
  • To identify the best access strategies and tactics to penetrate the local market.
  • You will have insights, key opinion leaders, potential buyers of your product, and distributors.

  • Interviews with key stakeholders to obtain valuable insights.
  • Creation of an advisory board (e.g., Delphi Method) with key stakeholders.
  • Phase 2

    Market Access Plan Creation

    To create a document outlining the research findings and recommend strategies and tactics to solve the Problem.

    You will know exactly what strategies and tactics you need to implement to succeed in the local market.

    Data analysis and formulation of strategies and tactics to create a thorough market access plan.

    Phase 3

    Market Access Plan Implementation

    To operationalize the strategies and tactics in the market access plan that solve the Problem.

    You will have a local team of experienced medical device business development, marketing, and sales experts driving your business in Colombia.

    Implementation of the market access plan and management of the local business.


    We will need several team members to execute this project simultaneously in the top four (4) Colombian cities (Bogota D.C, Medellin, Cali, and Barranquilla). This project will need a team of experts engaged for the time indicated below.

    Market Access Plan (90 days)

    Team

    Role

    Juan J. Muñoz

    Project Leader/In-Region Market Access Expert

    Monica C. Mora

    Project Manager/General & Administrative

    Alejandro Infante

    Advisor 1

    Julio G. Martinez-Clark, M.B.A.

    Advisor 2


    Benefits

    The benefits that our solution will provide Skyline

    Due diligence on a pool of qualified distributors in Colombia

    A foothold on the Pacific Alliance (Mexico, Colombia, Peru, and Chile) —a market with over 210 million people that represents the 7th economy in the world

    A thorough understanding of market drivers of the Colombian medical equipment business

    A team of qualified experts taking you by the hand and guiding you to make the right decisions on the challenging Latin American market


    London-based WEP Clinical Selects bioaccess.™ As Market Access Consultant to Enter the Colombian Market and Provide Patients Access to Life-Savings Drugs

    [Orlando, FL, August 22, 2018] — WEP Clinical —a London-based drug sourcing, and distribution company— has selected bioaccess.™ as its market access, regulatory and business development consultant to enter the Colombian market for hard-to-find drugs. For hospitals or health management organizations (HMOs) that want to provide a life-saving and hard-to-find drug to their patients, WEP Clinical offers an efficient, end-to-end product distribution model. From the required regulatory filings, through to product handling and delivery, WEP Clinical is well positioned to support patient's needs.

    Read more.

    TEAM

    Our team is comprised of international senior market access, healthcare, health economics, business development, sales & marketing, and regulatory professionals specialized in the life science industry with extensive experience in Latin America. They have a proven record of developing and implementing market access, healthcare, regulatory and business strategies in the region.


    This engagement will be led by,


    Julio G. Martinez-Clark, M.B.A.

    CEO

    Orlando, FL USA

    Podcast

    Julio has been working with US medical device companies for about 10 years helping them design and implement successful clinical trial, regulatory, and market access strategies. Julio is a recognized medical device expert, and his insights on the medical device industry have been featured on the industry-leading Med Device Online publication. Julio is also the host of the LATAM Medtech Leaders Podcast: A weekly conversation with Medtech leaders who have succeeded in Latin America. Julio has a B.S. degree in electronics engineering and a masters in business administration (MBA).


    Alejandro Infante

    Miami, FL USA

    Project Leader, Senior Market Access Expert

    Alejandro is a global senior executive with over 30 years of experience in healthcare including P&L management, go to market strategy, setting up new operations and building organizations overseas. He has a unique background in international markets for pharmaceuticals, generics, medical devices and nutritional products. He also has experience managing a large generics and medical devices business in the US.

    Prior to founding Procursum Medical, he held the position of President of International with Hill-Rom where, as a member of the executive leadership team, he managed a $500M business with focus on improving profitability in Europe and driving sustained and profitable growth in emerging markets.

    Before joining Hill-Rom, Alejandro had several executive positions with Hospira including President of the Americas where he was responsible for the medical device and specialty pharmaceutical segments with a total revenue of $2.5B; he also held the positions of Vice President and General Manager of International Commercial Operations and Regional Director for Hospira in Latin America. Prior to joining Hospira, at the time of the spin off from Abbott Laboratories, he held numerous management roles within Abbott, including General Manager in Mexico and Poland.

    Alejandro has extensive experience building multifunctional organizations in international markets for both direct and indirect operations. He develops successful go to market strategies and build effective teams based on strong leadership and a diverse background in various segments of healthcare products and geographies. Read more.


    Juan J. Muñoz, M.B.A.

    Bogota, D.E., Colombia

    In-Region Senior Market Access Expert

    Juan is an experienced international life sciences and healthcare business development, sales, marketing, and management executive. Juan had leadership positions at Baxter Laboratories and Boston Scientific creating, managing, and leading profitable sales operations in Colombia, Venezuela, Ecuador and Peru. Juan is an expert at formulating market access strategies that allow foreign Medtech companies successfully penetrate the challenging Latin American market. Juan has a B.S. in microbiology from Javeriana University and an M.B.A. degree from ICESI; both leading universities in Bogota, Colombia. Learn more.


    Monica C. Mora

    Orlando, FL USA

    Vice President of Operations

    Monica leads the company's operations including project management, logistics, accounting, human resources and general corporate and project-related administrative matters. Monica has worked for global companies including Alcatel-Lucent and Toshiba. She has a B.S. degree in computer sciences from Universidad del Norte —the leading university in Colombia's Caribbean coast— and graduate studies in business management. Learn more.

    BUDGET

    United States dollars (USD)

    Terms & Conditions

    Terms and Conditions

  • Validity: This Offer is valid for 30 days.
  • Payment terms: Upon acceptance of the Offer, bioaccess.™ will invoice 50% of the professional fees upon contract execution and the remaining 50% upon presentation of the Plan. Upon commencement of Phase II, bioaccess.™will invoice you (in advance) 100% of the proposed monthly fee, and will continue to invoice you until the end of the engagement. Invoices are payable upon receipt.
  • The Plan: The Plan will be created in the Spanish language, and it will be translated to English before delivery to you. The cost of the translation will be a pass-thru expense of the project.
  • Acceptance of the Offer: You will accept the Offer subject to bioaccess.™ and you (the “Parties”) executing a formal services agreement (the “Agreement"). It being understood that if you accept the Offer, the Parties shall in good faith use their best efforts to execute the Agreement as soon as possible.
  • Your responsibilities:
  • Designate a project leader to act as a liaison and main contact between you and bioaccess.™
  • Timely approve and provide any request of information and documentation.
  • Ongoing availability and collaboration to participate in scheduled meetings and project management activities.
  • Facilitate meetings with key personnel and decision makers.
  • Provide us with your sales expectations or forecasts.
  • Provide us with the technical file of any product involved in a sales opportunity and other sales-related documentation including sales and customer data if applicable.
  • Exclusions of the Offer:
  • Regulatory registration/market clearance of your product at INVIMA in Colombia. This service will be quoted separately. Learn more.
  • The prices in the "Pass-Thru Expenses" section are provided for your convenience, for informational purposes, and to help you budget your total project investment. bioaccess.™ makes no claims about the accuracy of these expenses nor that these will be the actual expenses that bioaccess.™ will incur while performing under this Offer.
  • Third-party fees or compensation. bioaccess.™ will invoice these items as they occur. bioaccess.™ may require payment in advance of pass-thru expenses based on the projected amounts. bioaccess.™ will provide supporting documentation of pass-thru expenses and will adjust your account balance accordingly.
  • Translations of documents (including the Plan) from English to Spanish or vice versa.
  • bioaccess.™'s compensation under this Offer are its professional fees and exclude,
  • Project-related expenses such as national and international shipping & handling, courier services, photocopying, printing.
  • Travel-related expenses such as airfare, lodging, ground transportation, meals.
  • Translations of letters, certificates, technical and legal documents (bioaccess.™ will invoice translations at bioaccess.™'s standard rate of USD $0.25/word in Spanish).
  • Filing fees imposed by government agencies.
  • Contract templates and legal fees related to the drafting and execution of legal agreement between you and a third-party.
  • Delivery times are estimates and may vary. bioaccess.™ is not responsible for lack of performance due to major events beyond its control.
  • About Colombia

    Opportunity

    Colombia is the third largest health market in Latin America.

  • In 2013, total healthcare spending reached 26 billion U.S. dollars. Colombia spent 6.8% of its gross domestic product (GDP) on healthcare in 2017. It is forecasted that spending will increase to around 32 billion U.S. dollars until 2021.
  • Colombia is the third largest healthcare market in Latin America with USD 24.1 billion for 2017 and 46 million affiliates to the healthcare system representing about 95% of its population.
  • Colombia's healthcare system is ranked #1 in Latin America and #22 worldwide according to the World Healthcare Organization. Part of this top spot in the charts is explained by the low burden of payments for patients: For 2017, 76% of the total healthcare expenditure was public and the remaining 24% private, where out of pocket expenses are very low. The rest of Latin America presents different proportions, reporting an average of 56% and 44% of government and private spend respectively.
  • U.S. imports make up the largest share of the Colombian medical equipment market, accounting for 31.8% of all medical equipment imports, followed by China (13.3%), Germany (8.4%), Ireland (4.8%) and Switzerland (4.5%); with China quickly increasing market share.
  • The Government of Colombia is the main buyer and U.S. companies can find public tender opportunities in the Colombia Compra Eficiente web site. Colombia Compra Eficiente is the government’s public procurement system, and it offers participants tools to facilitate the tender process in Colombia.
  • There are many high-quality hospitals and clinics located throughout Colombia that provide both general and specialized medical services. According to the U.S. Department of Commerce, there will be upcoming tenders in Bogota for five hospital projects: two new hospitals will be constructed, and three hospitals will have major upgrades and overhauls. Four of these projects will be public private partnerships and one will be done through public works. These projects will add 1,272 beds and nearly 670,000 square feet of infrastructure to Colombia’s health system.
  • The best approach to enter the Colombian market is through a local partner such as a distributor, as Colombian companies prefer to buy from companies located in Colombia that can provide after-sales services. However, some of the country’s largest end-users do import equipment and supplies directly.

  • Healthcare expenditure in Colombia

    Source: Business Monitor International

    Background

    The Colombian medical equipment market is complex and challenging; it relies overwhelmingly on imports, which made up about 93% of the market during 2017. BMI Research estimates that Colombia imported USD $1.2 billion worth of medical equipment in 2018. Since the implementation of the U.S.-Colombia Trade Promotion Agreement (TPA) with the United States in 2012, 96% of U.S. medical equipment exports to Colombia receive duty free treatment.

    The country’s healthcare infrastructure is adequate in the larger urban areas but is generally in need of modernization and expansion. The Colombian government provides a universal medical system known as the “General System of Social Security in Health” (SGSSS, or Sistema General de Seguridad Social en Salud), which currently covers about 95% of the population thanks to Law 100 of 1993, whereby all citizens, irrespective of their ability to pay, are entitled to a comprehensive health benefit package.

    At this moment, the most cost-effective way for Skyline to sell the Product in Colombia is through a financially-solid distributor with experience selling hospital capital equipment preferably in the fluid disposal segment.

    The Colombian market is desirable, is unique in terms of favorable legislation for patients’ rights, and has ample coverage of the population. Colombia may represent millions in sales for Skyline. It is critical for Skyline to identify the limitations that may prevent the sales of the Product in Colombia and to find ways to successfully enter the market.

    A market access plan for Skyline in Colombia will require comprehensive analysis including face-to-face interviews with the right stakeholders including key opinion leaders, distributors of medical equipment, and select insurance companies (if applicable for the Product.

    The market access plan for Skyline should explore topics such as pricing, reimbursement landscape, distribution network, market size, competitive differentiation, key sales drivers, technology preferences, patient needs, packaged services, etc.; it must identify Skyline's challenges in Colombia, identify Skyline's opportunities, and provide Skyline with a well-thought-out and effective Plan.

    bioaccess.™ has a team of expert market access consultants that can help Skyline conduct primary and secondary market research, and design and implement cost-effective strategies and tactics —as part of the Plan— to help Skyline reach its sales goals in Colombia.

    TAKEOFF FOR COLOMBIA?

    bioaccessla.com| info@bioaccessla.com

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