Market Access Consulting

Colombia

Offer for Amenity Health, Inc. (the "Offer") | Prepared by: bioaccess.™

January 28, 2019

Offer No. AH0012019

Attn.: Aaron Clark, Co-Founder, CEO

Dear Aaron,

Thank you for considering bioaccess.™ for your market access needs in Colombia. This Offer will enable bioaccess.™ to assist Amenity Health, Inc. ("Amenity") on its interest in increasing sales of its MedCline Reflux Relief System device in Colombia (the "Device").

We will research the Colombian market and develop for Amenity a strategic and tactical market access plan; this plan will position Amenity for success in Colombia (the "Plan").

The Plan will require a market access analysis and proposed strategies after conducing face-to-face interviews with key opinion leaders, payers (insurance companies and private practices), and distributors of specialized medical devices.

With this Offer, Amenity will be able to understand the Colombian market for the Device, will find a reliable partner to fulfill demand for the Device, and will know how to generate demand and increase sales.

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

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.

Offer Summary

Market Access Consulting in Colombia

A turn-key solution for Amenity's market access needs in Colombia

Situation Summary

  • Amenity is a medical device company focused on developing novel, non-pharmacological solutions for those suffering with chronic medical conditions. Utilizing the many therapeutic benefits of positional therapy, its devices reduce nocturnal symptoms to promote quality, restorative sleep leading to a higher health-related quality of life.
  • Uncontrolled symptoms of gastroesophageal reflux disease (GERD) can lead to serious health consequences for patients globally. Lack of effective, economical treatment options for these conditions also contributes to the mounting economic burden of increased healthcare utilization and sky rocketing prescription costs. It’s time to change how these chronic conditions are treated.
  • Sleep positioning for the natural treatment of GERD dates back to the 1970s, when researchers began to explore the numerous benefits of (a) inclined sleep for increasing acid clearance time; and (b) left-lateral positioning to decrease reflux episodes.
  • Based on the compelling research of each sleep position independently, the engineering team at Amenity theorized – could adding an incline to left-side sleeping be more beneficial to each position alone? After (6) clinical trials, conducted by top gastrointestinal (GI) researchers across the US, this is exactly what was found.
  • The compounding therapeutic benefits of Amenity's MedCline Reflux Relief System positional therapy device provide unprecedented reflux symptom relief; superior reduction in damaging esophageal acid exposure; and increased patient satisfaction over expensive surgeries and/or anti-secretory medications linked to a growing list of serious side effects.
  • Amenity is successfully selling its product in the U.S. with a direct-to-consumer model.
  • Amenity is interested in exploring the possibility of entering the Latin American market but its Device has no brand recognition in the region.
  • Amenity considers the Colombian market a good test-market to penetrate in Latin America.
  • A medical device for the treatment of GERD is a novel idea and Colombia's benefits health plan still doesn't cover that type of medical technology.
  • In Colombia, patient out-of-pocket costs for medical devices and any healthcare technology in general is lower than in any other Latin America country.
  • Amenity has limited understanding of the Colombian market. Amenity needs market access experts in hopes of guiding it in the right strategic direction to executing a growth plan for its business in Colombia.
  • Amenity understands that it needs someone to objectively do local research and formulate a market access plan (the Plan as defined above) to successfully sell its Device in the country.
  • Thus, Amenity would like to hire bioaccess.™ team of expert market access consultants in Colombia to create the Plan to generate demand (and sales) for the Device.
  • Background

    The Colombian medical device market is complex and challenging. The Colombian medical devices market relies overwhelmingly on imports, which made up about 93% of the market during 2017. BMI Research estimates that Colombia will import USD $1.1 billion worth of medical devices 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 96% 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.

    The Device is not part of Colombia's healthcare system's benefits plan, and the only way for Amenity to sell the Device is through,

  • Partnerships with select health management organizations/insurance companies (aka Entidades Administradoras de Planes de Beneficios en Salud or E.A.P.B. in Colombia); and
  • A financially-solid distributor that can operationalize a direct-to-consumer sales strategy.
  • (the "Channel Partners")

    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 Amenity. It is critical for Amenity to identify the limitations that may prevent the sales of the Device in Colombia and to find ways to successfully enter the market.

    A market access plan for Amenity in Colombia will require comprehensive analysis including face-to-face interviews with the right stakeholders including payers (i.e., E.A.P.B.), key opinion leaders, and medical device distributors.

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

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

    Objective

    Our objective for this Offer:

    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 Device in Colombia.

    Secondary objectives:

  • 1.Identify market size and sales drivers for the Device in Colombia.
  • 2.Identify the critical success factors to create a value proposition to Channel Partners in Colombia around how the Device could reduce nocturnal symptoms to promote quality, restorative sleep leading to a higher health-related quality of life.
  • 3.Extract the opinions of key opinion leaders (i.e., gastroenterologists, internal medicine specialists, pulmonologists, and others) to determine how to have them incorporate into their practices the prescription of the Device.
  • 4.Identify the pathway —within the context of the national healthcare system— to significantly launch sales of the Device in Colombia through the Channel Partners.
  • 5.Quantify, identify, and select candidate distribution Channel Partners for the Device based on their national coverage, business structure, trained sales personnel, prestige, solid finances, and solid relationships with public and private insurance companies.
  • 6.Identify and name the ideal candidates to become Channel Partners for Amenity in Colombia.
  • 7.Operationalize the strategies and tactics suggested in the Plan.
  • Scope of Work

    The Offer includes the following activities divided in two phases:

    Phase I: Research

  • Creation of a list of relevant stakeholders to interview.
  • Interviews with leaders at two (2) insurance companies/E.A.P.B., administrators, leaders, and purchase managers.
  • Interviews with ten (10) key opinion leaders (KOLs).
  • Interviews with three (3) specialized medical device distributors.
  • Assemblage and opinion gathering from an advisory board/panel of experts (using the Delphi or similar) with five (5) KOLs.
  • Identification of Amenity's 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 Device market in Colombia to help us determine the industry's weaknesses and strengths).
  • Production of the Plan containing market drivers, critical success factors, strategies, and tactics to generate demand and increase sales of the Devices.
  • Identification of the ideal partnership agreement with the potential Channel Partners.
  • Identification of the ideal product distribution strategy and network.
  • Identification of the key success factors to sell the Devices to potential Channel Partners in Colombia.
  • Presentation (PowerPoint or similar format) of the Plan to Amenity.
  • Phase II: Implementation

  • Outreach to select insurance companies and hospitals that place emphasis on prevention and that show interest on disease management programs (the "Target Accounts").
  • Gather government data on quality indicators for insurance companies and hospitals.
  • Identify and map decision makers at the Target Accounts.
  • Meet and demonstrate to Target Accounts how the compounding therapeutic benefits of the Device could provide unprecedented reflux symptom relief; superior reduction in damaging esophageal acid exposure; and increased patient satisfaction over expensive surgeries and/or anti-secretory medications linked to a growing list of serious side effects.
  • Needs assessment, data gathering and analysis of proprietary data from Target Account.
  • Presentation of Amenity's value proposition to Target Accounts; centered around implementing Amenity-sponsored customized interventions such as the following (the "Amenity Programs"):
  • Real-world data studies
  • Hypertension disease management programs
  • Physician educational programs
  • Patient educational programs
  • Cost-savings epidemiological analysis
  • Observational studies (e.g., quality of life improvements)
  • Customize the Amenity Programs (as defined below) to each Target Account interested in working with Amenity
  • Negotiation and execution of agreements with the Target Accounts.
  • Outreach to candidate distributor Channel Partners.
  • Negotiation and execution of a distribution agreement with one distributor Channel Partner.
  • Deliverables

    We’ll know we’re successful when the following are manifested:

  • The Plan (produced in the form of a PowerPoint-type presentation to Amenity) including market research data, market drivers, critical success factors, strategies and tactics.
  • The facilitation of one or more agreements with the Target Accounts.
  • The facilitation of one agreement with a distributor that can implement a direct-to-consumer strategy to sell the Device.
  • Notes:

  • This Offer does not include the operationalization of the Amenity Programs at the Target Accounts (e.g., epidemiological design and conduction of an observational or real-world data study). This activity will be quoted on a case-by-case basis.
  • Timing

  • Phase I: Approximately 60 days from contract execution to delivery of the Plan.
  • Phase II: TBD
  • Access to this market 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, and Biomerica —among others— conduct trials, register their products, and/or formulate a winning market access strategy in Colombia. Learn more.

    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.

    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"). Amenity needs a thorough market research/analysis that will help us identify its problem statement, identify Amenity's opportunities, and provide Amenity 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 Amenity 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 Amenity 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:

  • Research: Identification of Amenity's barriers of entry that create the Problem for Amenity in Colombia.
  • Methodology: We will use our own research, paid interviews, and the creation of an advisory board; this will include all relevant stakeholders. We will assemble an advisory board with key members. This will give us the opportunity to obtain valuable insights so that we can discuss and validate them in real time.
  • Planning: Formulation of strategies and tactics to solve the Problem.
  • Implementation: Operationalization of the strategies and tactics as solutions to the Problem.
  • We will need four (4) 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 0.97 FTE* (6 resources) for the time indicated below.

    Phase I (Approx. 60 days)

    Team

    Role

    Hours/Week

    Full-Time-Equivalent (FTE)

    Total Hours

    Alfredo Spath, M.D., M.B.A.

    Market Access Expert Consultant

    15

    0.38

    135

    Adriana Rodriguez, EPI, M.R.M.

    Research Assistant

    15

    0.38

    135

    Monica C. Mora

    Project Manager / General & Administrative

    3

    0.08

    27

    Antonio J. Trujillo, Ph.D.

    Advisor 1

    1

    0.03

    9

    Carlos Enriquez

    Advisor 2

    2

    0.05

    18

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

    Project Leader

    2

    0.05

    18


    Total

    38

    0.97

    342

    Phase II (monthly)

    Team

    Role

    Hours/Week

    Full-Time-Equivalent (FTE)

    Total Hours

    Alfredo Spath, M.D., M.B.A.

    Senior Medial Scientific Liaison

    10

    0.25

    40

    Adriana Rodriguez, EPI, M.R.M.

    Epidemiologist

    10

    0.25

    40

    Monica C. Mora

    Project Manager / General & Administrative

    3

    0.08

    12

    Antonio J. Trujillo, Ph.D.

    Advisor 1

    1

    0.03

    4

    Carlos Enriquez

    Advisor 2

    1

    0.03

    4

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

    Project Leader

    1

    0.03

    4


    Total

    26

    0.67

    104

    *FTE: Full time equivalent

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

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    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

    Julio has been working with US medical device companies for over 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 has a B.S. degree in electronics engineering and a masters in business administration (MBA).


    Antonio J. Trujillo, Ph.D.

    Director of Projects, Market Research and Market Access

    Dr. Trujillo, is currently an associate professor, at the Health Systems Program, Department of International Health, Johns Hopkins Bloomberg School of Public Health. He is an economist from the Catholic University in Caracas, Venezuela, holds a Masters in Public Policy from Columbia University in New York, and a PhD from the University of North Carolina, Chapel Hill. Dr. Trujillo has been a consultant for the Inter-American Development Bank, and the World Bank, and several life science companies. Dr. Trujillo has has won significant honors, awards, and research grants, has published 48 peer-reviewed journals articles, seven book chapters and reports, and has been an international speaker in over 35 events.

    Dr. Trujillo is the director of the Master of Health Science (MHS) in Health Economics degree program at Johns Hopkins Bloomberg School of Public Health. He teaches an advanced econometrics course on program impact evaluation using observational data and a course on behavioral economics and public health. Read more.


    Alfredo Spath, M.D., M.B.A.

    Project Leader, Senior Market Access Expert

    Dr. Spath is physician, surgeon, internal medicine specialist, and has broad clinical experience in the treatment of cancer patients. Dr. Spath has an MBA from Instituto de Empresa in Madrid, Spain. He has over fifteen years of experience in the biopharmaceutical Industry. His main expertise is in oncology and hematology drugs, as well as internal medicine products from companies like Pfizer Novartis and Jazz Pharmaceuticals. He has been the medical leader of critical projects related to medical and regulatory affairs, market access, health economics, clinical research, and core medical strategies for complex and hyper-competitive markets such as Spain, Portugal, Central America, Colombia, and other countries in the Caribbean. Dr. Spath has been part of several medical and scientific activities that involved external stakeholders (e.g., regulatory authorities, key opinion leaders, CROs, advisory boards, patient advocacy groups, etc.), internal stakeholders (i.e., clinical research, translational medicine, global medical affairs, marketing, health economics and outcomes research), and internal decision committees.

    Dr. Spath has led several market access and HEOR projects in Spain, Portugal, Central America, the Caribbean, and other countries in Latin America. His work has been instrumental for Pfizer, Jazz, and Novartis, to reach exponential sales growth for drugs to treat solid tumors (breast, lung, renal and gastrointestinal cancer), and leukemia.


    Carlos Enriquez

    Senior Market Access Expert

    Carlos has worked opening new market for several globally-renowned companies such as Cadbury Schweppes, Proctor & Gamble, Walmart, and Omron Healthcare, among others. From 2008 to 2018 Carlos was the Latin American & Caribbean Senior Business Development & Sales Manager for Omron Healthcare —a global manufacturer of consumer home health monitoring equipment with $7B in annual sales. While at Omron, he tripled sales in the region to over $11M, developed sales and marketing strategies to expand Omron products from specialty to consumer products; and lead the consumer, channel, pricing, competitive positioning and marketing plans for all product categories. He also lead the expansion of Omron products into new channels and new countries, created innovative marketing strategies, supported the regulatory registration process across all markets, and trained and continuously lead Omron's regional sales team to surpass Omron’s sales goals. Carlos was honored with three Omron awards and two trade association awards for workplace excellence. Carlos is based in the Miami, FL area and has a Bachelor of Arts in finance and international business from Florida International University.


    Adriana P. Rodriguez, EPI, M.R.M.

    Project Manager, Researcher

    Adriana has a bachelor's degree in bacteriology, a master's degree in quantitative research methods in epidemiology, and is a PhD. candidate in epidemiology at the Autonomous University of Madrid, Spain. Adriana worked for the National Institute of Health in Colombia (2004-2005, 2008-2009), and assists bioccess.™managing a myriad of projects.


    Monica C. Mora

    Vice President of Operations

    Monica leads the company's operations, 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 and graduate studies in business management.

    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.
  • 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:
  • 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.
  • 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.
  • 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.
  • Delivery times are estimates and may vary. bioaccess.™ is not responsible for lack of performance due to major events beyond its control.
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