global mktg presentation 3.0

INTERNATIONAL MARKET DEVELOPMENT

VACCINES ,BIOLOGICS, SPECIALTY PHARMA, GENERICS, HOSPITAL SUPPLIES & DIAGNOSTICS

AmbianceVentures

OUR CAPABILITIES IN GLOBAL MARKETS

GOVERNMENT (Public) MARKETS

PRIVATE MARKETS

AmbianceVentures

International Distribution: Summary of Services

• Regulatory• Logistics: Customs, Warehousing & Cold Chain Storage• Local Order Processing• Collection, Accounts Receivables• Credit & Risk Management• Government and Private Sales• Repackaging & Labeling• Delivery & Transportation• Reverse Logistics – Returns, handling expired, obsolete product• Cross Docking• Sample Management• Pharmacovigilance – Follow-up and tracking• Bridging studies – Follow-up

AmbianceVentures

Terminology:

‘Approved’ / ‘Accredited’ / ‘Preferred Distributor’ ‘Govt. Authorized Agent’‘Clearing & Forwarding Agent’‘Warehousing Agent’

•Endorsement from Ministry of Health – ‘local’ bidders are preferred•Accredited bidders – Principal-to-Agent Agreement•Comply with paperwork for government tenders•Physical presence required during bid opening process•Negotiate bidding prices – 1 cent difference in price can win or lose tender!•Consolidation of local orders for differed deliveries, drop shipments.•Multiple agents for govt. bids, private markets , institutional markets•Staffing: 5 to 10 people specialized in customs , regulatory, tenders, logistics and other business functions. •Ward off competitors’ efforts for bids through counterproposals

AmbianceVentures

REGULATORY & LEGAL COMPLIANCE:

•Filing initial application for Product Registration•Obtain required certification, licenses•Follow-up on application through multiple agencies

•Submit samples, submit analytical, BE studies and clinical reports

•Initiate bridging studies, periodic stability tests done locally (follow-up and coordinate)

•Prepare dossiers per country laws•Registration with ‘local government’ (state / province)•Registration for private distribution in ‘cooperatives’

AmbianceVentures

REGULATORY & LEGAL COMPLIANCE:

•Labeling requirements; Local / regional language translation

•Periodic follow-up (weekly)

• Most Governments DO NOT OPEN Letters of Credit

•Customs documentation is CRITICAL

•Comply with specified product delivery criteria

•INCOMPLETE OR INACCURATE DOCUMENTATION CAN RESULT IN INORDINATE DELAYS IN PRODUCT LAUNCH, OR OUTRIGHT REJECTION

•Delays in product delivery and improper storage at govt. appointed facilities can result in damage, loss of potency , product obsolescence – write off, returned product and additional cost for disposal or reverse logistics

AmbianceVentures

PRIVATE MARKETS:

Influential in lobbying Federal and Provincial Governments, Regional Distributors

•Agent / Distributor plays a crucial role•Reputation in private market supply chain•Supply logistics, cold chain, customer service•Institutional : Large insurance companies, Hospital chains•Retail: Pharmacy chains•Wholesalers: Physician offices•National level programs through private clinics• Create Local Advisory Boards; Strong connections with KOLs

AmbianceVentures

ACCOUNTS RECEIVABLES, COLLECTIONS:

•Governments do not open Letters of Credit

•Terms vary from 90 – 180 days credit

•Sometimes bank guarantees can be obtained.

•Assuming the Financial Risk - Agents / Distributors are experienced in collections from both government and private buyers

•Private and institutional buyers want 90 – 120 days credit

AmbianceVentures

LOGISTICS:

•Customs clearance – proper documentation•Receiving shipments, ensuring cold-chain at port / airport•Deal with port authority, associated bureaucrats and labor unions•Reduce risk of product damage and obsolescence•Freight consolidation – in-bound and out-bound•Re-packaging, re-dressing or special labeling in controlled environment•Storage permits and licenses•Cold chain validation•Proof of delivery procedures•Documentation:•Packaging list, Invoice, CoA, Customs Duty, •Point to point delivery: inland distribution to multiple final destinations•Return of expired, damaged or defective product•Disposal of expired, damaged or defective product

AmbianceVentures

PHARMACOVIGILANCE:

While an agent or distributor does not undertake fulltime PV responsibility,they are the first responders within their specific region or country for AE’s and SAE’s

•Collecting defective product •Contacting reporting medical facility for liaison•Product recalls when necessary•Submit samples of ‘defective’ product to authorized labs.•Destruction of returned product if necessary

AmbianceVentures

Operational Objectives & Methodology:

(1) Discover: Data collection pertinent to Clients’ needs

(2) Diagnose: Analyze data and information to arrive at a cost-effective international strategy

(3) Design: Design the solution through application of strategy - a plan / proposal

(4) Deliver: Implement the solution through appropriate sales tactics.

APPROACH:

• Capabilities presentation to examine opportunities to market vaccineproducts in select global markets in accordance with your strategy.

• Identify potential partners / distributors for import of finished products or bulk vaccine for stockpile or re-distribution to private and public buyers in foreign markets

• Design a step approach for future marketing needs in international markets.

AmbianceVentures

AmbianceVentures USA

Principal Role: International Logistics & DistributionExports & Imports

Freight ConsolidationCustoms Documentation & Clearance

Product RegistrationRegulatory Filings

Bridging Studies, Bioequivalence StudiesStorage, Warehousing, Cold Chain Distribution.

Dependable source for Biologics, Pharmaceuticals, Diagnostic Products and Hospital Supplies

Who is……?

Our Operations in India


INTRODUCTION: How we handle global businessPennsylvania (USA) & Mumbai (India) based Global Business Development company with offices and operations in United States, United Kingdom, Philippines, Dubai and Affiliates in China.

Specialized in International Business Development and Exports of Life Science products – Vaccines, Generics, Biologics, Diagnostics, and pharmaceutical machinery End-to-end solution for:

– Formulation, Analytical Development– Export APIs, Finished Products, POC / In-vitro Diagnostics– Contract Manufacture– Neutral Label & Private Label Manufacture– Global Marketing Assistance– Complete Export Documentation – Registration, Customs, Regulatory


GLOBAL MARKETING, TRADE & BUSINESS STRATEGY

We market in the following countries:

North America: United States, Canada, Mexico

European Union: United Kingdom, Germany, Italy, Russia, Bulgaria, Hungary, Portugal, Spain, Ireland

Latin America / Central America: Argentina, Brazil, Chile, Bolivia, Peru, Panama, Caribbean Is., Guyana, Surinam, Colombia

Asia, West Asia & Pacific: Afghanistan, Bangladesh, Bhutan, Cambodia, China, Indonesia, Iran, Iraq, Jordan, Middle East Nations, Malaysia, Philippines, Sri Lanka, Taiwan, Turkey, Vietnam

Africa:Cameroons, Congo, Egypt, Ghana, Kenya, Libya, Mauritius, Morocco, Sudan, South Africa, Uganda, Zambia

CIS Countries:Ukraine, Russia, Kazakhstan, Uzbekistan, Armenia, Tajikistan


We Specialize in International Marketing:Diversity of Our Product Range:

•Branded and Generic Pharmaceuticals, Biologics, Biogenerics, •including Private Label, Neutral Label, Govt. Label•Biologics – Adult & Pediatric Vaccines, Sera and Anti-venoms•Our current focus: H1N1 (Swine Flu) Vaccine, Seasonal Flu Vaccine.•Hospital Supplies – Private Label and Generic •Pharmaceutical Ingredients: APIs, Empty Capsules, Excipients, •Fine Chemicals, Intermediates•Lab Supplies: Instrumentation, Reagents and Chemicals•Dental Products and supplies

•Packaging Materials: Vials, Ampoules, Bottles, Blister packs, Aluminum Foils

•Diagnostic Tests and Devices: HIV, Pregnancy, Diabetes, Malaria, STDs,

•OTC and Personal Care Products – Branded, Generic and Private Label – •Custom manufactured at our own facilities in Dubai Tax Free Zone or India


Outsource your Export Marketing, Regulatory and Customs formalities to us:

We have an established and reliable Worldwide infrastructure for Marketing and logistically sound Distribution, capable of handling large or small volumes.

Deep contacts and superior reputation within Governments and Private Markets resulting from 28 years of international business dealings

Dependable Agents / Distributors across all continents who will pro-activelypromote your products to focused target segments, Ministries of Health andnon-governmental entities at Federal, Provincial and Local levels

The Best of Logistics in terms of Warehousing, Cold Chain for timely deliveries.Expertise in Shipping, Scheduling, Consolidation for FCL shipments, Optimaluse of container space, Economical and timely Routing, Freight Insurance.World-class Air and Sea Connections

Efficient Customs handling including pre-shipment inspections of product, packaging, labeling, shipping marks


Former President of India – Dr. A.P.J. Kalam, and the Hon. President of the Philippines – Gloria Macapagal Arroyo preside over signing of agreement with Valerian Lobo (Feb 2006)

LOB International was appointed ‘Authorized Sourcing Agent’ by The Philippines Ministry of Health for supply of Pharmaceuticals, Biologics and Hospital supplies from India


Advantage – Ambiance Ventures:

U.S. Operations•By partnering with us, as a local producer, you will dominate with low prices,

efficient logistics and production capabilities.

•NEWEST PRODUCTS & FORMULATIONS – Far Superior to existing players!

•Marketing of Vaccines to Government & Private markets

•Rapid formulation, development and commercialization per US FDA standards

• Client will own the Intellectual Property for formulation, development and

manufacture.

•Leverage local know-how in India to deal with bureaucracy and the government

•Enjoy benefits of local manufacture and exports to other countries

•Import finished products in Generics, Diagnostics and APIs


OTHER SERVICES in Life sciences fromOur US Office:

Strategic Consulting & Market Development Services

Client Profile:Biotechnology, Pharmaceutical, Medical Device and Healthcare

Companies in US, Canada, Latin America, India & China.

Areas of Expertise:Contract Manufacture

Bulk Drugs, API ImportsGeneric Drug Formulation, Development & Validation

Alliance Management: Identify partners, Due Diligence, Venture CapitalCountry Representation: US, India, Latin America, Europe

Medical Conventions, Trade Shows, Speakership, Advisory Boards

Strategic Marketing, New Product CommercializationOutsource Clinical Trial Design, Site Management, BA/BE Studies

Thought Leader Development, Business IntelligenceExpertise in multiple therapeutic areas


CONTRACT MANUFACTURE – Why Outsource your Contract Manufacture to us in India?

•Reduce capital expenditure and costs of manufacturing operations

•Generic substitution, LOW COST, HIGH QUALITY, TIMELY PRODUCTION

•Need to access specialized, economical mfg technology and methods

•Have alternate mfg. sources in the event of supply interruptions

•Unforeseen increase in demand

•One-stop-shop for all PHARMA products and diagnostics needs

•Our 28-year experience in sourcing for generics, contract mfr, combined with buying power in India, China, Thailand, and other promising supply sources globally.


Our Contract Partners offer following STANDARDS OF MANUFACTURE & REGULATORY COMPLIANCE:

• ISO 9001

• ISO 13485

• cGMP

• ANVISA (Brazil)

• FDA (United States)

• EMEA (European Union)

• SAHRPA (South Africa)

• ANMAT (Argentina)


Popular Categories of products exported globally through our offices:

•Anti-retrovirals (HIV, AIDS), Anti-Virals (Oseltamivir, Zanamivir)•Anti-TB cocktails•Anti-Malaria cocktails•Biogenerics for Cancer•Cardiovascular•Antibacterials•Immunosuppressants•Hormonal, Infertility•Erectile Dysfunction•Sclerosants•Mucolytic agents•Anti-pyretics•Cough and Cold•Pediatric & Adult Vaccines•H 1 N 1 ( S w i n e F l u ) Va c c i n e - 2 0 1 0 - 1 1 S e a s o n


DISTRIBUTION & PRICING STRUCTURE“Right products at the right price, within your quality specs”

•Primary Consumption, Secondary Distribution•Specialists in Government Contracts, Private Market•Drop shipments•All Customs and Shipping Documentation•Labeling (in any language)

Pricing Variants:

Name of Product (if branded) or Generic NameIndicationChemical name or compositionForm of Product (tablet, capsule, liquid, gel, powder) / Bulk Strength (100mg, 250ml, etc.)Quantity per shipment (kgs., litres, units)Packaging (drums, bottles, strips) – MULTIDOSE, PRE-FILLSShipment Packaging requirementsLabeling Requirements – Regulatory Compliance


DIAGNOSTIC TEST KITS

•Blood Glucose •INFLUENZA•Pregnancy •HIV ( 1 & 2)•Hepatitis•Malaria•Dengue•Chikungunya•Syphillis•TB•Cardiac Markers•Dry Chemistry•Bio-chemistry•Hematology•Immunology, Rheumatology•ELISAs for Body Fluids

Ideal for Rural Clinics, Pharmacies; can be manufactured ‘Private Label’


OUR SPECIALTY: Brand MarketingLeverage low cost contract manufacture at our facilities!

NEUTRAL LABEL, PRIVATE LABEL CONTRACT MANUFACTURE:

Hospital Supplies, Vaccines, Generics, Cosmetics, Diagnostics, FMCGPhysician Office Supplies

Custom Packaging – For Re-distribution

Neutral (‘generic drug’) labeling per Ministry of Health requirementsof numerous Countries in multiple languagesIn Portuguese / English / Spanish / French / Cyrillic / German / Arabic

Private labeling with your own Brand Name, Company Identity, Compliant with regulations – Pharmacies, HMOs, Export, or forSecondary Distribution


A Division of Ambiance Ventures

Distribution Offices in Mumbai (Bombay), India:•Fully staffed office (52 FT employees)•5000 sq. feet of Warehouse space•Cold Chain refrigerated facility: 1500 sq. feet

Sales and Logistics Office in Manila, Philippines:We are Authorized Purchasing Agents for the Govt. of Philippines•All requirements from India by Philippines Ministry of Health are purchasedthrough us – ‘one-stop-shop’ for vaccines, generics, hospital products from multiple suppliers.•All logistics is coordinated by our Manila office. •All Philippine Govt. tenders are routed through us.

Affiliate Offices in China:Sourcing offices in Guangzhou, Yiwu, Shenzhen, Hong Kong, Shanghai

OTC, Dental Hygiene Contract Manufacturing Plant in Dubai


Our Business Model – The Power of Bulk Buying and Bulk Freighting

•28 Years of international business with integrity and efficiency

•One-stop-shop for multiple products resourced from numerous mfrs.

•We specialize in small orders and shipments - consolidated into container loads

•Not all mfrs supply all your requirements. We source for you and consolidate smaller shipments for FCL rates

•Helps your customers to minimize paperwork and transactions with multiple buyers – e.g. multiple letters of credit, multiple bills of lading

•We take on the ‘headaches’ of logistics and excise /customs at port of origin even for smaller shipments to combine loads into affordable freight rates


Our Business Model – The Power of Bulk Buying and Bulk Freighting

•Our volumes enable us to buy in bulk – hence better pricing, than if you were to direct buy from the manufacturer!

•We pass the benefits on to you!

•We represent manufacturers from India, China, Thailand, Europe, United States

•All clients we represent are WHO, cGMP compliant, and many are ANVISA, US-FDA or EMEA approved

•We work with you for Due Diligence including your visits to mfg. facilities in Asia for monitoring regulatory compliance, inspections

•You can leverage low cost contract manufacturing at our facilities


Affiliate of Ambiance Ventures USA

We are your Office Address in India

As our Partner / Client, you may use our Offices and Warehouse facilities in Mumbai (Bombay) as your own:

On your WebsiteOn Letterheads

In Correspondence and ApplicationsDuring visits to India by you or your clients

Separate Phone and Fax lines for your company

Assign a designated rep to respond on your behalf

Govt. Market H1N1: Brazil’s Ministerio da Saude is buying a total of 83 million doses of vaccine against influenza A virus (H1N1), which will be used in a vaccination campaign planned for the period March to April 2010 – FIRST ROUND

Supply contracts: GSK, Sanofi Pasteur - 33 Million doses from Sanofi at $7.60 /dose via Instituto Butantan for first responders and susceptible population

PAHO to provide 10 Million doses later(??)

Potential for at least 5-6 Million more doses if price is right!(Priority groups such as pregnant women, health workers involved in patient care, children from 6 months to 2 years, indigenous people and people with chronic pre-existing conditions (cardiac, pulmonary, renal, metabolic, etc.) Details of strategy will be announced early February).

Private Market H1N1: 12-15 Million dosesSeasonal: Public: 17 Million doses; Private: 3 Million doses

BRAZIL - Update


Region Main Cities PopulationSE: 1-Sao Paulo 10.434.252

Metro area: 20.237.000 2-Rio de Janeiro 6.136.652 3-Belo Horizonte 2.399.920

SO: 4-Curitiba 1.788.559 5-Porto Alegre 1.440.939

NE: 6-Recife: 1.515.052 7-Salvador: 2.711.372 8-Fortaleza: 2.416.920

FD: 9-Brasilia: 2.363.108

Total: 41,009,522GDP/Capita $13,400Spain 40,397,842 GDP/Capita $25,600

• Population: 191.297.098

• Age structure: 0-14 years: 25.8% male 24,6M / female 23,7M

15-64 years: 68.1% male 63,5M / female 64,6M

65 years and over: 6.1% male 4,7M / female 6,7M (2006 est.)

• Population growth rate: 1.04% (2006 est.) ;• Birth rate: 16.56 births/1,000 population (2006 est.) • Death rate: 6.17 deaths/1,000 population (2006 est.)

Demographic data:


Field Force

Medical Reps: 50

Sales Coordinators: 02

Sales National Manager: 01

Product Manager: 01

Total: 54

Sales Force Structure: Our Operations in Brazil

Field Force Distribution


Brazilian Vaccines Market

Estimating a CARG 6.5%/Year: The Market in 2008 $ 330 million (US$ =2.00)AmbianceVentures USA

Latin America Business Development Model

1- Regional (multinational) Innovative Partnership [ Win-Win Project – WWP]

1- A new core product is located by one of the partners (PA, PB, PC. PD…)2- The International Project Team is activated (country representatives)3- Marketing, Sales and Regulatory evaluation is performed in each country by the team.4- The Regional Dossier with Regulatory, MKT & Sales potential is provided to the Global Company5- Contract is signed and the Registration and Pre-MKT activities are started

Brazil Mexico Argentina Colombia ChileUS$ 20.5 billion US$ 19.2 billion US$ 4.2 billion US$ 2.1 billion US$ 1.6 billion

MexicoUMBr ChileArgentina

PA PC PD PE PFPB PG PH

Colombia

PJPI

Our connections in Mercosur govts., and rest of Latin America (for swine flu & seasonal vaccines).



Strong Market Leadership in Brazil, Argentina, Mexico (75% population of Latin America)

M a r k e t D e v e l o p m e n t :

Stage 1: Brazil, Mexico, Argentina

Stage 2: Colombia, Chile, Bolivia, Venezuela, Central America

Stage 3: Other LatAm countries

LATIN AMERICA


LATIN AMERICA

Therapeutic Areas / Markets of interest:

Vaccines – Complete Portfolio

Cardiovascular

Anaphylaxis and Emergency Care

Plasma-derived Therapeutics

AntiVenoms


INDIA: Government Licensed Importer, Distributor with strong network.28 years in Pharma, Biotech Distribution, Imports and ExportsHigh level connections

ASEAN Countries: Government Authorized Sourcing agents in Philippines, ASEAN Nations

Marketing / Distribution set - up in:

• ASEAN (14 countries)• Russia, Other CIS countries, Central Eastern Europe• Eurasia & PacRim• Middle East• Africa

ASIA, MIDDLE EAST, CIS, AFRICA


GLOBAL MARKETING, TRADE & BUSINESS STRATEGY

We market in the following countries:

North America: United States, Canada, Mexico

European Union: United Kingdom, Germany, Italy, Russia, Bulgaria, Hungary, Portugal, Spain, Ireland

Latin America / Central America: Argentina, Brazil, Chile, Bolivia, Peru, Panama, Caribbean Is., Guyana, Surinam, Colombia

Asia, West Asia & Pacific: Afghanistan, Bangladesh, Bhutan, Cambodia, China, Indonesia, Iran, Iraq, Jordan, Middle East Nations, Malaysia, Philippines, Sri Lanka, Taiwan, Turkey, Vietnam

Africa:Cameroons, Congo, Egypt, Ghana, Kenya, Libya, Mauritius, Morocco, Sudan, South Africa, Uganda, Zambia

CIS Countries:Ukraine, Russia, Kazakhstan, Uzbekistan, Armenia, Tajikistan


Contact: Jay NadkarniAmbiance Ventures, USA

P.O. Box 622, Swiftwater, Pennsylvania 18370 (USA)Tel: 570/ 460-1804

[email protected]; www.AmbianceVentures.com

Contact: Valerian LoboLOB International, India

G-6 Khira Industrial Estates, B.M. Bhargava Rd.Santa Cruz (W), Mumbai 400 054 (INDIA)

Tel: 9122- 2661-5006, [email protected]; www.lobin.com

http://www.ambianceventures.com/

mailto:[email protected]

http://www.lobin.com/

global mktg presentation 3.0

Documents

business strategywe marketin

middle east nations

west asia

swine flu

finished products

neutral label

business model

trade