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ACCESS to EMERGING MARKETS We are a lean, skilled Market Development and Consulting company with a focus on Tier-1 and Tier-2 Emerging Markets…..especially those that are most receptive to new Life Science technologies, innovative healthcare products and new sciences such as Genomics and Personalized Medicine. Our offices in Brazil, Estonia, Finland, S. Korea and India are dexterous at handling operations in Latin America, Europe (EU, CEE), and Asia relating to licensing and franchising new business models. Our cordial relations with Government agencies enable us to expedite approvals for product launches and other business development needs. We are industry recognized experts with unique abilities to validate and bridge market needs with pragmatic solutions and offer actionable proposals for measuring returns on investment. Geographies & Connections: We have a strong presence in the following markets: Central & South America: Mexico, Brazil, Argentina, Paraguay, Uruguay, Peru, Chile, European Union, especially Scandinavia; Central / Eastern Europe including Russia CIS Markets, Turkey, Middle East (UAE) All of Asia-Pacific, especially S. Korea, Thailand, Philippines, Singapore, Japan, Australia, New Zealand Our Connections in all the above markets are our greatest assets. These include: Pharmaceutical and Biotechnology companies of repute; local and multinational Diagnostic and Testing Companies affiliated with Private and Public insurance Importers of US and European made Products who know how to market them Distributors and Marketing Agents with well-organized affiliations and sales teams GPOsand Government Tender agencies Hospitals: Specialty hospitals (e.g. Oncology, CV), Teaching Hospitals, Affiliates of Medical schools Federal and Provincial / State run Health Institutes and Authorities (equivalents of the US NIH, CDC) Regulatory Authorities (e.g. ANVISA Brazil, ANMAT Argentina, COFEPRIS Mexico) Taxation and IP Attorneys Key Opinion Leaders across multiple therapeutic areas Talent recruiters. PARTNERSHIPS We are advisers to Life Science companies in the United States, Europe, Asia and Australia. Our experience in multiple therapeutic areas in Product Development, Licensing and Global Marketing / Distribution render us versatile in providing services for In-licensing and Out-licensing of new molecules, drug delivery systems and novel diagnostics. This encompasses a gamut of services from Clinical Development to Technology Transfers, and Due Diligence to Term Sheets; with particular emphasis on Emerging Markets worldwide. We not only create strategic consortiums between global partners, but also coordinate and lead the Clinical Development and Marketing effort a total hand-holding and supportive process. Market Assessment and Due Diligence on the technical capabilities of potential partners is the cornerstone of our continued success. This cost and time efficient model is based on high level Scientific and Marketing expertise, without the bureaucracy of large companies to move forward in a fast- paced market environment.

Ambiance Ventures - Access to Emerging Markets

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Page 1: Ambiance Ventures - Access to Emerging Markets

ACCESS to EMERGING MARKETS We are a lean, skilled Market Development and Consulting company with a focus on Tier-1 and Tier-2 Emerging Markets…..especially those that are most receptive to new Life Science technologies, innovative healthcare products and new sciences such as Genomics and Personalized Medicine. Our offices in Brazil, Estonia, Finland, S. Korea and India are dexterous at handling operations in Latin America, Europe (EU, CEE), and Asia relating to licensing and franchising new business models. Our cordial relations with Government agencies enable us to expedite approvals for product launches and other business development needs. We are industry recognized experts with unique abilities to validate and bridge market needs with pragmatic solutions and offer actionable proposals for measuring returns on investment.

Geographies & Connections: We have a strong presence in the following markets:

Central & South America: Mexico, Brazil, Argentina, Paraguay, Uruguay, Peru, Chile,

European Union, especially Scandinavia; Central / Eastern Europe including Russia

CIS Markets, Turkey, Middle East (UAE)

All of Asia-Pacific, especially S. Korea, Thailand, Philippines, Singapore, Japan, Australia, New Zealand

Our Connections in all the above markets are our greatest assets. These include:

Pharmaceutical and Biotechnology companies of repute; local and multinational

Diagnostic and Testing Companies affiliated with Private and Public insurance

Importers of US and European made Products who know how to market them

Distributors and Marketing Agents with well-organized affiliations and sales teams

‘GPOs’ and Government Tender agencies

Hospitals: Specialty hospitals (e.g. Oncology, CV), Teaching Hospitals, Affiliates of Medical schools

Federal and Provincial / State run Health Institutes and Authorities (equivalents of the US NIH, CDC)

Regulatory Authorities (e.g. ANVISA – Brazil, ANMAT – Argentina, COFEPRIS – Mexico)

Taxation and IP Attorneys

Key Opinion Leaders across multiple therapeutic areas

Talent recruiters.

PARTNERSHIPS We are advisers to Life Science companies in the United States, Europe, Asia and Australia. Our experience in multiple therapeutic areas in Product Development, Licensing and Global Marketing / Distribution render us versatile in providing services for In-licensing and Out-licensing of new molecules, drug delivery systems and novel diagnostics. This encompasses a gamut of services from Clinical Development to Technology Transfers, and Due Diligence to Term Sheets; with particular emphasis on Emerging Markets worldwide. We not only create strategic consortiums between global partners, but also coordinate and lead the Clinical Development and Marketing effort – a total hand-holding and supportive process. Market Assessment and Due Diligence on the technical capabilities of potential partners is the cornerstone of our continued success. This cost and time efficient model is based on high level Scientific and Marketing expertise, without the bureaucracy of large companies to move forward in a fast-paced market environment.

Page 2: Ambiance Ventures - Access to Emerging Markets

MAJOR ACCOMPLISHMENTS Business Development for Clients

We have developed long-standing relationships with private & public sector companies, Government

agencies and the scientific community in International markets to provide Licensing opportunities and

related services across the entire value chain to clients in Brazil, Argentina, S. Korea, China, India,

Malaysia & Singapore. Many of our clients in these markets approach us to fulfill such needs.

We have a track record of leadership in New Product Development, Translational studies, Market

Assessment, Business Planning, Positioning and subsequent stages of commercialization (including R&D)

for numerous new molecules and biologics. This includes preparing clinical protocols and commercialization

plans. These have culminated in consummation of new partnerships for launching Oncology and

Immunotherapeutic products in USA, BRAZIL, TURKEY, UAE, S.AFRICA and S.KOREA. Some examples:

o Influenza (Swine Flu), Dengue, Malaria, Pediatric Combination and Adult Vaccines.

o Serum Therapies, Plasma Proteins

o Transdermal Drug Delivery Technologies

o Influenza Diagnostic Tests

o Cancer therapies

We specialize in sourcing for new sciences and opportunities in Diagnostics, Pharma and Biotechnology

industries and Academia. We provide Market ‘Snapshots’, Commercial Assessments, Project Reports and

Business Plans through Qualitative and Quantitative Market Research, Physician Acceptance Studies,

Reimbursement Analyses, KOL Development and Competitive Intelligence. This results in preparing

actionable proposals for commercialization, potential acquisitions and business alliances (in-licensing and

out-licensing).

We have led new product and business development teams from ‘bench to customer’ by providing

marketing input for Clinical Trial Design throughout the life of the project, while working closely with cross-

functional teams (R&D, Medical, Regulatory, Intellectual Property and Manufacturing).

In cohort with our associates in overseas markets, we have developed product launch plans for Global

markets. We are experts in estimation of timelines for optimal time to market introduction vis-à-vis

competition, market size and prepared Sales Forecasts, while working closely with financial analysts to

develop P&Ls and Net Present Value estimates.

Global Commercial & Clinical Operations

We have prepared and implemented Flu Vaccine Launch plans for Direct and ex-Distributor Sales to Government, Provincial (Tenders) & Private Markets in Emerging Markets (Brazil, Rest of Mercosur, India, Singapore).

We have always worked with multi-functional teams (IP, Regulatory, Pharmacoeconomics, Manufacturing, R&D, Market Research, Logistics) to in-license new technologies and developed global marketing plans e.g…..novel Influenza vaccine technology

We have developed clinical protocols, and worked with vendors for Medical Writing, Data Management, and FDA, EMEA filings. Sourced for offshore services in lab analytics, BA / BE studies, validation and peri-clinical services for new products in Emerging Markets.

We continue to offer Business intelligence services to monitor impact from foreign Government Policy, tenders, Regulatory changes, and Intellectual Property vigilance.

Page 3: Ambiance Ventures - Access to Emerging Markets

CREATE A LASTING FOOTPRINT IN EMERGING MARKETS

Life Sciences markets in many areas of the world are getting saturated, especially developed and regulated markets. Global life sciences companies are now looking at Emerging Markets. However, most Life Science companies have not been able to get a major foothold there. According to Accenture, based on financials of the top-nine pharmaceutical companies, many of them have no more than 10% to 30% of their revenues coming from Emerging Markets. Opportunities also exist for small and medium sized Biotechnology and Pharmaceuticals.

Expertise in Emerging Markets Our global teams have high-level, influential connections. These relationships have been cultivated over the years that enable efficient deployment of precious resources for achievement of long-term goals in Tier-1 and Tier-2 Emerging Markets:

SUPPLY CHAIN: We identify and consolidate appropriate business partners for supply chain: Importers,

Distributors, Wholesalers, GPOs, Hospitals, Retail and Government procurement entities for tenders. MARKETING:

o Forge competent Marketing alliances to launch and consolidate brands, build equity, counter competition from local or multi-national companies and attain organic growth.

o Create and deploy pragmatic tactics that are actionable and offer ROIs which are commensurate with expectations of senior management.

o Identify and implement locally relevant media strategies to reach critical markets and sub-markets through astute use of resources based on 20+ years of experience.

MANUFACTURING: Locate and assess the right Manufacturing or assembly facilities if needed with proper infrastructure, approvals, tax breaks, and logistical conveniences.

TAXATION: Advise on tax strategy through our local tax attorney partners KOL NETWORKS: Form partnerships with Academia, Research Hospitals, Government Healthcare entities

(equivalents of NIH) and develop a supportive network of KOLs in therapeutic areas of interest. REGULATORY: Develop and nurture respectable relationships with Regulatory agencies for favorable

dispositions to current and future initiatives through our partners. TALENT: Hire the brightest local talent and create a motivated workforce with niche skills to handle

operations with minimal supervision.

Page 4: Ambiance Ventures - Access to Emerging Markets

Why entrust your Emerging Market Development needs to us?

We have access to sources of New Technology and IP Assets. We will lead the Identification, Evaluation

and Due Diligence for such assets and technologies aimed at helping our Clients achieve strategic

objectives. We are focused on complex projects including innovative products in Diagnostics and Drug

Delivery Technologies. We specialize in identifying potentially complex new product opportunities aligned

with your company's growth drivers, and assist you across the value chain.

Our strong connections in Global markets among Life Science intelligentsia (KOLs) will be your asset to

identify opportunities for collaborations (in-licensing and out-licensing). We focus on the United States, and

Tier-1 and Tier-2 markets in Latin America, Eastern Europe, Asia, and Middle East.

We work closely with your BD teams, and act as a deal ‘sponsor’ to structure and execute M&A, JV or

licensing deals while recommending the right business model for the foreign market of interest.

We conduct thorough reviews of our clients’ franchise mandates to determine timeframe, funding

limitations, risk management, procedures for accomplishing projects, staffing requirements and astute

allotment of available resources to multiple projects. We will represent your interests as your representative

office in the South America (Brazil), EU (Finland, Estonia), India (Mumbai), and APAC (S.Korea)

We manage global cross-functional teams through evaluation of opportunities and various interactions with

potential partners. We also work closely with your BD team to develop proposals for structuring and

negotiating deals and deliver presentations to Senior Management to develop a business case.

We will work with your Finance teams to develop models for forecasting sales and financial performance of

a potential new product line or business. This includes contributions to revenue, expenditures, income and

NPV analysis when required.

We will offer our expertise in analyzing records of present and past operations, trends, costs, realized

revenues, estimated revenues, administrative commitments and obligations incurred to project future

revenues, expenditures and net income.

We will participate on your behalf in Industry conferences, Medical Conventions and Speakership in the

Emerging Markets as subject matter experts.

Our Definition of Emerging Markets:

While the World Bank defines Emerging economies in terms of absolute GDP growth, our criteria for qualifying a country as an Emerging Market are based on value growth of Life Sciences industries and Healthcare services:

Investments by Federal and Provincial Governments in Life Sciences and Healthcare infrastructure.

Sophistication in medical treatment and quality of care i.e. above and beyond just basics (generics).

Patient demand for more than mere ‘unmet medical needs’; i.e., High quality of care and medicines.

Actual expansion / growth of healthcare infrastructure. Number of hospital beds and clinics added.

Government Investment in Life Sciences R&D for innovative medicines; e.g., Research grants to

industry and academia, creation of institutions dedicated to improvisation of medicine and care.

Private sector involvement and investment in R&D, Healthcare, academia and overall interest.

Page 5: Ambiance Ventures - Access to Emerging Markets

Tier-1 Emerging Markets Tier-2 Emerging Markets Tier-3 Emerging Markets

India, Brazil,

China (incl. Hong Kong)

Argentina, Mexico, Poland, Russia,

CEE, S.Africa, Turkey, Middle-

East, Singapore, Malaysia, S.Korea

CIS Countries, Indonesia,

Philippines, Vietnam, Thailand,

Colombia, Panama

OPPORTUNITIES IN GENOMICS & PRECISION MEDICINE Unprecedented opportunities exist to foray into Personalized Medicine in Emerging Markets given the growing interest in Genetic Testing, Companion Diagnostics and algorithm-based software for prognosis. The US FDA is stressing the co-development of drug and diagnostics. This will spur molecular test developers to partner with pharma companies, since the future aims toward the provision of genetic testing at low costs. $210 million have been allocated to develop a database to genetically profile over 1 million individuals by the Obama administration. Many Emerging markets have welcomed initiatives of American and European Personalized Medicine companies and have begun to offer full support in terms of insurance coverage. The effect of this will directly flow through manufacturers and service provider companies….an unprecedented business opportunity for a resourceful Diagnostics company.

HISTORY Ambiance Ventures is a 12 year old niche market development and consulting firm led by Jay Nadkarni, an industry veteran of 20 years. Jay is also Managing Partner at Molecule Market in Estonia. He is a frequent guest speaker at international medical and biopharmaceutical conventions. Jay’s corporate career with Sanofi (9 years) and Procter & Gamble (7 years) was primarily in international marketing of new products and business development. His deep connections, global partnerships and vast experience across multiple disease and therapeutic areas will be at your disposal.

CONTACT

Jay Nadkarni Partner / Principal Consultant - Market Access P.O.Box 622, Swiftwater, PA 18370 (United States) Mobile: 570.460.1804; Fax: 570.619.8811; Skype: jay.nadkarni [email protected]

www.linkedin.com/in/jaynadkarni