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Confidential

AbbVie: A Leading Global Biopharmaceutical Company

TRADITIONAL PHARMA

BIOTECH

The expertise, financial stability and resources to effectively commercialize products

The focus, culture and innovative spirit to achieve breakthrough science

FOCUSED

PASSIONATE

REMARKABLE IMPACT

ABBVIE

A GLOBAL BIOPHARMACEUTICAL

COMPANY

BIOTECH TRADITIONAL PHARMA

AbbVie established independently from Abbott Laboratories in January 2013 A publically traded company (NYSE ticker ABBV)

2 AbbVie | Company Confidential © 2015

AbbVie: Corporate Overview

Sales: $19.96B (YE 2014)

Experience: Biopharmaceutical organization with leading scientific experience People: 28,000+ employees Global understanding: 30 commercial products in 170+ countries

>120+ years of pharmaceutical development and manufacturing

Offer both specialized and standard type manufacturing

Plants: 12 State-of the-art global manufacturing facilities

North America & Europe (Singapore under construction)

Reliability: Exceptional Quality, Regulatory and Delivery track record

Long term Vision: Investing in success

Therapeutic Areas of Focus: Immunology, Kidney Disease, Liver Disease, Neuroscience and Oncology


AbbVie: Toll Manufacturing

Embedded business unit built on a strong foundation and broad manufacturing capabilities.

Objective: Commercial manufacturing

Commitment: o Sales > $500 Million/year o More than 25 years of tolling

experience o Global Operation

Markets served: o Agrochemicals o Pharmaceuticals o Nutriceuticals/Dietary Supplements o Food Ingredients o Industrial Applications


AbbVie: Manufacturing Locations

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Ludwigshaven, Germany

Sligo, Ireland

Cork, Ireland

Campoverde, Italy

Lake County, Illinois, USA

North Chicago, Illinois, USA

Worchester, Mass., USA

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9

Wyandotte, Michigan, USA

Barcelonetta, Puerto Rico

Jayuya, Puerto Rico 10


AbbVie: North Chicago at a Glance

History: Started as Abbott manufacturing site in 1920’s and started fermentation in 1940’s.

Size: ~ 0.75 km2 (180 acres)

Purpose: - HQ for AbbVie Operations and Tolling - Fermentation Operations - Primary QA release site for region - Pharmaceutical R&D People: ~1,500 employees at the Site ~400 Employees Supporting Fermentation Products: Majority are for tolling customers ~40 Different Types of Products in Powder or Liquid Forms Customers: ~100 different customers served


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Raw Materials • Close proximity to natural raw material

sources • Rail spur for receipt of raw materials • On-site procurement and raw materials

testing on-site Solvents • On site bulk solvent tank farms with

storage of >2,000,000 Liters • On-site solvent recovery • Able to handle HAP solvents

Utilities • Access to Lake Michigan for cooling

water with back-up chillers • Double-ended grid supplied electricity • Natural gas supply • Steam generation

AbbVie | Company Confidential © 2015

Capabilities. Performance. Commitment. Site Infrastructure

Waste Treatment • Anaerobic and aerobic basins for

treatment prior to sending to public treatment

• On-Site Hazardous Waste Management • Odor control


Capabilities. Performance. Commitment. Cell Banks & Inoculum

Experience with many different types of organisms including: • Actinomycetes • E. coli • Fungi • Bacillus spp.

Currently manufacturing using genetically modified organisms:

• Institutional Biosafety Committee review per NIH guidelines • Organisms would need to meet GLSP criteria

Preparation of master and working cell banks:

• Compliant with ICH Q7 for API manufacturing • Cell Bank maintenance with backup and redundant equipment/controls

Inoculum process development:

• Streamlined, robust processes for consistent inoculum performance.

Strain improvement programs via:

• Classical techniques • Recombinant techniques

Fermentors

38 total fermentors

Sizes ranging from 19 – 135 m3

Total capacity > 3000 m3

Primary size is 135 m3

Additional Tankage

Seed tanks (1 to 12 m3)

Feed tanks

Formulation tanks •

Sterilizers

Media sterilizers (continuous)

Seed media sterilizer

Oil sterilizer


Capabilities. Performance. Commitment. Fermentation

Monitoring/Controls OSI-PI software for web based access Temp, agitation, pH, DO, off gas.

Broth Separation

Scroll Decanters

Microfiltration

Disk Stack Centrifuges

Belt Filter


Capabilities. Performance. Commitment. Downstream Processing

Extraction

Whole Broth Extraction

Podbielniak Liquid-Liquid Extractors

Westfalia Liquid-Liquid Extractors

Concentration

Reverse Osmosis

Thin Film Evaporation

Flash Evaporators

Mechanical Vapor Recompression (MVR)

Reactors

Large, agitated and jacketed

reactors with sizes ranging

from (1-10 m3)



Purification

Chromatography

Ion Exchange (Adsorption)

Ultrafiltration

Decolorization

Sweco Sifters



Drying/Bulk Packaging

Blender Dryers

Fluid Bed Dryers

Tray Dryer

Filter Dryer

Milling

Dry Blending



Filtration & Isolation

Cartridge and Depth Filtration

Crystallization

Filter Press

Basket Centrifugation

Filter Pot

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AbbVie offers the full spectrum of fermentation development capabilities including:

Robust & Efficient

Manufacturing Process and

Product

Strain Development and

Improvement

Method Development

Recovery Process Development

Fermentation Process

Development and Characterization

• Strain improvement via classical and recombinant techniques

• Process development and characterization at lab and pilot scales from 10 L – 750 L

• Customizable recovery process development for extraction, crystallization, blending, drying, and milling.

• Method development and validation for analytical, microbiological and cleaning methods

60+ years developing and optimizing fermentation manufacturing processes


Capabilities. Performance. Commitment. Technical Transfer and Development

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Capabilities 88 pilot scale (55 L) fermenters Permanent staff dedicated to pilot plant operations Identical software as commercial production (OSI PI):

• Temperature, agitation, pH, DO and off-gas.

• Frequently scale directly from 55 L to 100,000 L commercial scale

Expertise Personnel are expert in process development and scale-up, running hundreds of pilot batches every year Average experience at the pilot plant is 20+ years


Capabilities. Performance. Commitment. Pilot Plant

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HPLC (reverse/normal phase and ion exchange, with UV/Vis, RI, fluorescence, ECD and ELS detection)

GC (direct injection and headspace analysis with FID and TCD detection)

Ion Chromatography

GC-MS and LC-MS

Spectroscopy (FT-IR, UV/Vis and AA)

ICP-OES and ICP-MS

Powder X-Ray Diffraction, TGA and DSC

Optical and Electron Microscopy

Surface Area and Particle Size Analysis

ICH and Development Stability Chambers

Cleaning Methods (LC and TOC)

Microbiology Lab for product testing and facility environmental testing.

Highly experienced staff provide method development, validation and transfer services, as well as submission, audit and manufacturing support


Capabilities. Performance. Commitment. Analytical and Microbiological Testing

Environmental Health & Safety

• OSHA Recordable

• Lost Time Injuries

• Near Misses

• Spills

• Loss of Primary Containment

• EPA Notice of Violations

Quality

• Right the First Time

• Lot Non-Conformances

• Number of Exceptions

• Exceptions Closed On-Time

• Number of Complaints

• Complaint Closure Rate

Scheduling

• On-Time Delivery to Approved Stock

• On-Time Purchase and Receipt of Materials

• On-Time Start

• On-Time Finish

• On-Time Release

Capabilities. Performance. Commitment. Measuring Excellence

Productivity

• Titer by Product

• Recovery Yield by Product

• Foreign Growth

• Equipment Utilization

• Labor Utilization

Equipment Maintenance

• % Repair Related Downtime

• % PM Scheduling

• PM Completion On-Time

• Spare Parts Availability

GOAL: On-Time, Consistent Supply to Our Customers

AbbVie | Company Confidential © 2015 17

Capabilities. Performance. Commitment. EH&S

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1

2

3

4

5

2013 2014 2015 YTD

Nu

mb

er

of

Occ

urr

en

ces

OSHA Recordable

Lost Time Injuries



• November 2013 - IEPA Air Inspection , 1 day – no findings

• June 2013 - IEPA Storm Water Inspection, 1 day – no findings

• March 2013 - IEPA Air Inspection, 1 day – no findings

• November 2012 - IEPA Air Inspection, 1 day – no findings

• August 2012 - IEPA Air Inspection, 1 day – no findings

• July 2012 - IEPA Storm Water Inspection, 1 day – no findings

• May 2012 - IEPA Air Inspection of Emissions Reduction Market System (ERMS), 1 day – no findings


• December 2010 - IEPA Air Inspection, 1 day – no findings

• November 2010 - IEPA Air Inspection of Emissions Reduction Market System (ERMS) , 1 day – no findings

• August 2009 - IEPA Air Inspection of Pharmaceutical MACT, 1 day – no findings

• July 2009 - IEPA Storm Water Inspection, 1 day – no findings

• July 2009 - IEPA Resource Conservation and Recovery Act (RCRA) Inspection, 1 day – no findings


Capabilities. Performance. Commitment. Environment

Capabilities. Performance. Commitment. Quality

• Greater than 1000 fermentation runs per year • Excludes fermentation runs lost due to foreign growth

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2013 2014 2015 YTD

Number of Non-Conforming Lots

98.0%

98.5%

99.0%

99.5%

100.0%

2013 2014 2015 YTD

% Right the First Time


Capabilities. Performance. Commitment. Productivity

• Greater than 1000 fermentation runs per year

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

2013 2014 2015 YTD

% Foreign Growth


Capabilities. Performance. Commitment. Scheduling

• Greater than 1000 fermentation runs per year

85.0%

88.0%

91.0%

94.0%

97.0%

100.0%

2013 2014 2015 YTD

% On-Time Delivery to Approved Finished Goods


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Capabilities. Performance. Commitment. Business Excellence

Class A Certification (2007/2011/2014) Based on Oliver Wight manufacturing philosophy

KPIs to ensure performance

Master production schedule conformance

Supply plan achievement

Data accuracy

New product introduction milestone achievement

Perfect index

Right the first time

EHS index

Customer service

Days on hand

Business Processes established

New product introduction

Master production scheduling

Material ordering and inventory management

Supply and operations planning meetings

Monthly management reporting system

Continuous Improvement Tools Utilized Kaizen Root Cause Problem Solving 5S Six Sigma

Dedicated Internal Business Excellence Organization AbbVie | Company Confidential © 2015

Physical

24/7 On-site Security

Gated Site

Video Surveillance

Badge Access For Each Building

Cell Banks Are Under Lock and Key with Restricted Access

Manufacturing Documents in Controlled File Area

Personnel

Policies and routine training on handling of confidential information

Employees required to sign a confidential agreement upon hiring.

Capabilities. Performance. Commitment. Security

AbbVie has many layers to ensure your proprietary information is safe:

Cyber

All computers are virus protected

All shared sites password protected with restricted access


Proposal Stage:

Initial evaluation for site fit

• EH&S

• Organism

• Scale

• Commercial

Process Evaluation for equipment fit

• Commercial pricing estimate

• Capex estimates

Tech Transfer Proposal

• Tailored to customers needs; can include detailed activities with sub-stages

• Timelines

• Defined success criteria

Letter of Intent/Supply Agreement

• LOI enables immediate transfer

• Project governance

Program execution:

Manage the successful implementation of products into manufacturing

• Develop project plan and schedule

• Form project team

• Kick-off meeting

• Facilitate team meetings

• Track progress against milestones

• Report to Governance Committee

Communication • Routine meetings

• Face to face visits/telecon/webex

• Sharepoint site development

• Elevation strategy

• Engaged senior leadership

Capabilities. Performance. Commitment. Customer Experience


• Stable and committed partner with 25+ years tolling experience

• 65+ years of classical fermentation expertise and know-how

• Established site infrastructure to ensure reliable supply

• Proven ability to consistently meet delivery commitments

• Robust compliance and business processes

• Excellent environmental, health and safety record

• Strong culture of continuous improvement

• Trusted partner to maintain confidentiality


Capabilities. Performance. Commitment. AbbVie Fermentation – Your Preferred Partner

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