Who is Catalent?

1. Who is Catalent?

2. Module Instructions • This learning module includes reading onscreen slides, watching online videos, and completing a Learner Worksheet as you progress throughout the module. • Videos will load and play automatically. Do not progress to the next slide until the video has been fully watched. • Make sure that you have your volume turned up and speakers turned on or headphones plugged in. • At the end of the module, please turn in your completed Learner Worksheet to either a member of the Training Team or your Shadow Week Mentor.

3. Section 1 Complete the Section 1 questions on your Learner Worksheet as you progress through the following section.

4. Introduction Catalent Pharma Solutions is the world's #1 drug development and delivery partner in the world for drugs, biologics and consumer health products. But, what does that mean? Who are we? What are Catalent’s values? What do we do and how does it help people? What makes Catalent special? In this module, you’ll learn about Catalent’s history, purpose and products. You’ll examine what we believe and how we’re organized. You’ll also learn about how we help our customers and what differentiates us from the competition.

5. Goals The goal of this course is; to provide learners with an understanding of who Catalent is, it’s purpose, core values and history, to introduce learners to what Catalent does, and to explain how Catalent is organized and it’s global reach.

6. Learning Objectives At the end of this module, learners will be able to: • Briefly explain Catalent’s history • Restate Catalent’s core values in their own words • Briefly explain who Catalent is and what it does • List some of Catalent’s customers • Explain why a company would choose Catalent • Describe Catalent’s corporate organizational structure

7. Key Terminology • ADTAdvanced Delivery Technologies • API Active Pharmaceutical Ingredient • BU Business Unit • CFRCode of Federal Regulations • CPSCatalent Pharma Solutions • DEADrug Enforcement Administration • IPAIsopropyl Alcohol • Ops Operations Function • OTCOver the Counter • OTW Oral Technologies Winchester • PRProblem Report • QAQuality Assurance • QC Quality Control • SOP Standard Operating Procedure • SGSoftgel Technologies Just like any company, Catalent hasan alphabet soup of words, phrases, and acronyms that are part of our culture, but may be new to you. These are a few of the most used acronyms, but during your training you’ll be provided an additional reference document defining additional frequently seen terms and acronyms.

8. Who Is Catalent? Catalent is the #1 drug development and delivery partner in the world.

9. Who Is Catalent? Catalyst + Talent = Catalent Pharma Solutions formed in 2007 when the Blackstone Group acquired the Pharmaceutical Technologies and Services segment of Cardinal Health. The name Catalent was chosen to combine the ideas embodied in the words “catalyst” and “talent.” Our name signifies empowerment, progress, and our ability to transform customers’ ideas into viable, high-quality pharmaceutical products, creatively and dependably. We strive to be a catalyst for our customers’ success. Our dedicated people use their unique expertise and broad experience to propel our customers’ business, designing creative solutions to complex problems and producing, market-ready results that you can rely on.

10. Catalent Timeline 2012 Catalent purchases remaining 49% minority share ownership of the RP Scherer softgel subsidiary located in Eberbach, Germany. 2002 Cardinal Health acquires Magellan Labs, leader in analytical science services for U.S. pharmaceuticals 1998 Cardinal Health acquires R.P. Scherer Corp., leader in advanced oral drug delivery technologies 2014 Catalent Pharma Solutions becomes a public company and is listed on the New York Stock Exchange 1930’s Continuous rotary die encapsulation process for Softgel manufacturing first commercialized by RP Scherer 2007 Catalent Pharma Solutions formed when the Blackstone Group acquires the Pharmaceutical Technologies and Services segment of Cardinal Health. 2001 1980’s Vegicaps® vegetable-based softgel shell system introduced. Zydis® “fast-dissolve” dose form launched

11. Section 2 Complete the Section 2 questions on your Learner Worksheet as you progress through the following section.

12. We are dedicated to our customers’ success. That’s why we… Believe in relentlessly pursuing innovation and continuous improvement. Believe in being the best at what we do. Believe that the contribution of every person matters. Encourage creativity, curiosity & optimism. Are driven by a passion for growth and developing our people. Strive for excellence and speed, every day. Commit to uncompromising integrity, personal accountability, and respect for each other. • What Does Catalent Believe?

13. What Are Catalent’s Values?

14. How Does Catalent Help its Clients? Catalent provides leading development solutions, advanced delivery technologies and innovative supply solutions to the global pharmaceutical, biotech and consumer health industries. Catalent exists to provide innovative solutions that help improve people’s lives. Catalent has been involved in over 50% of all new drugs approved by the FDA, and launched in the US since 2004. That means if you’ve taken a drug product since then, there’s more than a 50% chance Catalent was involved with it.

15. How Does Catalent Help its Clients? OK, that sounds great, but what does it actually mean? Development Catalent’s broad range of expert services – analytical, biologics, pre-formulation, and formulation, are all designed to drive faster, more efficient development timelines and produce better products for our customers. Delivery Catalent’s unique delivery technologies – including softgel solutions, Liqui-Gels® capsules, and Vegicaps® capsules, Zydis® fast dissolve, controlled release, and inhaled dose forms – improve how products work in and for patients. Supply Catalent partners with companies to become a seamless extension of their supply chain, by providing global, integrated manufacturing and packaging solutions to take products from design to clinical trial, plant, and pharmacy. Catalent manufactures oral, sterile, and inhaled dose forms, produces biologics for preclinical and clinical studies, and is the recognized leader in biotechnology product packaging.

16. How Does Catalent Help its Clients? Think of Catalent as a general contractor that also owns several useful assets (manufacturing facilities, analytical laboratories, and product testing facilities.) This enables clients to come to Catalent for a wide range of commercialization and development services, and pick and choose which services will be provided by Catalent, and which will be retained or outsourced elsewhere. • For example, • Catalent can take an API, develop a formulation, help meet regulatory approvals, scale up production of the product, and package it in a variety of drug delivery technologies. On the developmental side, Catalent can help scale up production of clinical-trial volumes of a candidate drug, then help the client work out full-scale production methods.

17. What Does Catalent Do?Softgel Technologies • Softgels are an oral dosage form for medicine similar to capsules. They consist of a gelatin based shell surrounding a liquid fill. • Catalent is the world leader of softgel drug delivery technologies. We are the originator of the RP Scherer softgel rotary die process and have more than 80 years of global manufacturing expertise. • Catalent locations that produce Softgels: • Aprilia, I​taly • Beinheim, France • Braeside, Australia • Buenos Aires, Argentina • Eberbach, Germany • Indaiatuba, Brazil • Haining, China • Kakegawa, Japan • St. Petersburg, FL • Somerset, N.J • Sorocaba, Brazil​

18. What Does Catalent Do?Advanced Delivery Technologies Modified Release Capabilities are delivery systems that release predetermined amounts of drug or hormone into the body over a specified period of time. Modified Release Locations Braeside, Australia Schorndorf, Germany Somerset, New Jersey Sorocaba, Brazil Swindon, UK Tokyo, Japan Winchester, Kentucky​ • Biologics encompasses cell-line engineering, biopharmaceutical analysis, biomanufacturing and fill-finish supply. • Biologics Locations • Emeryville, CA • Madison, WI • Morrisville/RTP, NC • Tokyo, Japan • Steri​le Technologies is made up of our blow-fill-seal, asceptic glass-free injectables, and pre-filled syringe capabilities. • Sterile Technologies Locations • Brussels, Belgium • Limoges, France • Woodstock, Illinois​ The Advanced Delivery Technologies business unit is made up of three focus areas: Biologics, Modified Release and Sterile Technologies. Advanced Delivery Technologies teams identify the optimal delivery platform for our client's molecules.

19. What Does Catalent Do?Development & Clinical Services Clinical Supply Services offerings span all facets of clinical trials, including clinical scale manufacturing​​, direct global comparator sourcing, clinical packaging and labeling, warehousing, distribution, and returns management. Clinical Supply Services Locations The development & analytical area ensures advancement of large or small molecule products through development and registration to commercialization. They design solutions to problems for virtually any dose form. Development & Analytical Locations Bathgate, U.K. Bolton, U.K. Boston, MA Deeside, Wales Kansas City, MO Morrisville/RTP, N.C. Philadelphia, PA Singapo​​re Shanghai, China Tokyo, Japan Kansas City, MO Morrisville/RTP, N.C. Somerset, N.J. Swindon, U.K. Dartford, U.K​ Development and analytical capabilities are those which deal with the science of obtaining, processing, and communicating information about the composition and structure of matter. Clinical Supply Services encompasses those services that may be needed to help support and facilitate a clinical trial.

20. Activity 1 – Your Catalent Elevator Speech The name “elevator pitch” reflects the idea that it should be possible to deliver the answer in the time span of an elevator ride, or approximately thirty seconds to one minute. • Since you’re taking this course, you’re probably new to Catalent. This scenario will likely happen or may have already happened to you. • One day after work, your (friend, spouse, significant other, or a complete stranger) who knows you just started a new job, asks “Who are you working for now?” After responding with something like, “Catalent Pharma in Winchester”, they ask what your new company does. You don’t have much time to answer their question, how should you respond? • This is a great situation for an "elevator pitch*." An elevator pitch is a short (typically less than 30 seconds), pre-prepared speech that explains who your new company is, what it does, and why it does it, simply and succinctly, in a way that someone with no pharmaceutical knowledge could understand.

21. Activity 1 – Your Catalent Elevator Speech • One way to form a great elevator speech is by using the Why, How, What format. So far in this module, you’ve learned all about Why Catalent exists, How we help our customers and their patients, and What some of those products and services are that we use to help us carry out our purpose. • In the Activity 1 section on your Learner Worksheet, begin to craft your own elevator speech, by completing the following three phrases with information you’ve learned about Catalent before continuing with the module. • Remember: • Keep your answers brief and easy to understand. (Avoid pharma-speak!) • Think about your own “Why.” Why do you choose to work here and not somewhere else? What is it about what you do at Catalent that motivates you to get out of bed each day and come to work? • Catalent is a _______. At Catalent, we believe in/value… • Catalent carries out those beliefs/ values by… • A few of Catalent’s products and/or services that help us do that are…

22. Section 3 Complete the Section 3 questions on your Learner Worksheet as you progress through the following section.

23. Who Are Catalent’s Customers? As a global leader in development, delivery, and supply, Catalent has over 1000 customers and touches 80% of the top 200 drugs worldwide. If there’s a pharma name that you’ve heard of, chances are very good they’re one of Catalent’s customers. • Catalent’s customer’s include: • Large, mid-sized, and small pharma companies • Biotech companies • Virtual pharmaceutical companies • Generic companies • North American, European, Australian, Asia-Pacific & Latin America -based companies

24. Why Do Companies Choose Catalent? Catalent’s unrivaled experience, expertise, and track record of market success on a global scale. Catalent is the #1 industry partner in drug development and drug delivery technology with 80+ years of experience. Catalent partners with 48 of the top 50 pharma and 41 of top 50 biotech firms and hundreds of emerging innovators. Catalent serves 1,000+ customers at nearly 30 sites and 50+ clinical supply depots, supplying 7,000+ products in 80+ markets. Catalent touches 75% of the top-selling compounds and 50% of FDA approvals; currently partnering on 500+ new products. Why Choose Catalent? Catalent has invested over $1B in innovation, science, technology and additional capabilities and owns 1,100+ patents. Catalent’s 18 global R&D teams, 1,000+ scientists and accelerated development/ advanced delivery technologies result in better treatments. Catalent’s global scale and high standards of quality, its exemplary regulatory record, its global accreditations, and its LEAN operational excellence.

25. What Sets Catalent Apart?

26. Section 4 Complete the Section 4 questions on your Learner Worksheet as you progress through the following section.

27. Where Is Catalent?- Catalent’s Global Network Catalent’s global network of facilities provides scalable, cost-effective, customized manufacturing options for complex treatment solutions.Amarket leader in nearly every area of drug development, Catalent has broad and deep relationships throughout the globe, manufacturing nearly half of all new drug approvals and producing 30 doses every second.

28. Where Is Catalent?- Catalent’s Global Network North America Boston, MA Kansas City, MO Madison, WI Morrisville/RTP Philadelphia, PA Somerset, NJ* St. Petersburg, FL Winchester, KY Woodstock, IL Europe Aprilia, Italy Bathgate, Scotland Beinheim, France Bolton, UK Brussels, Belgium Cham, Switzerland Deeside, UK Eberbach, Germany Limoges, France Schorndorf, Germany Swindon, UK Asia/Pacific Haining, China Kakegawa, Japan Shanghai, China Singapore Tokyo, Japan Catalent employs approximately 8,400 people, at 30 facilities, on 5 continents. Latin America Buenos Aires, Argentina Indaiatuba, Brazil Montevideo, Uruguay Sorocaba, Brazil Australia Braeside, Australia *Corporate Headquarters

29. Somerset, NJ • Brussels, BE • Woodstock, IL • Philadelphia, PA • Bolton • Schorndorf, DE • Bolton, UK

30. Catalent Winchester Winchester, Kentucky is Catalent’s flagship location for modified-released and complex oral dose form manufacturing and related expert development services. • Winchester, KY

31. Catalent’s organizational structure Catalent uses a matrix organizational structure* and is organized into 3 Business Units and 8 Functions. • Functions • Operations • Quality • Sales & Marketing • Innovation • Finance • Information Technology (IT) • Human Resources (HR) • Legal • Business Units • Softgel Technologies • Advanced Delivery Technologies • Development & Clinical Services Each Business Unit is led by a President, reporting to the Catalent CEO. • John Chiminski • President & Catalent CEO • Aris GennadiosPresident, Softgel Technologies • Scott Houlton • President, Development & Clinical Services • Barry Littlejohns • President, Advanced Delivery Technologies *A matrix organizational structure is one in which people formally report to more than one manager.

32. Catalent’s organizational structure Business Units are responsible for producing Catalent’s revenue and profit. Communication and collaboration between Functions and Business Units are critical success. Softgel Technologies Advanced Delivery Technologies Development and Clinical Services • Operations • Finance • Quality • Information Technology (IT) • Sales & Marketing • Human Resources (HR) • Legal • Innovation Functions enable the Business Units to be successful.

33. Catalent’s organizational structureThe Operations Function The Operations Function is the largest of Catalent’s functions. • Operations Function • Large portion of Catalent’s employees in Operations • Operations owns Catalent’s sites/plants • Corporate Centers of Excellence • Procurement and EH&S • Operational Excellence • Supply Chain • Strategic Operations • Site Operations Talent • Site General Managers (Director Ops) • Engineering & Maintenance • Site EH&S and Procurement • Technical Services • Operators • Drives Execution Excellence • KPI’s • On Time Delivery • Lean execution • Capex • Inventory management • Supply chain management • Maintenance & Repair • Technical Transfers

34. Catalent’s organizational structureCatalent’s Executive Leadership Team • BARRY LITTLEJOHNS • PRESIDENT, ADVANCED DELIVERY TECHNOLOGIES • SCOTT HOULTON • PRESIDENT, DEVELOPMENT & CLINICAL SERVICES • MATTHEW WALSH • EVP, CHIEF FINANCIAL OFFICER • ARIS GENNADIOSPRESIDENT, SOFTGEL • MARK BISSETPRESIDENT, ASIA PACIFIC • JOHN CHIMINSKI • PRESIDENT & CEO • STEVEN FASMAN • SVP, GENERAL COUNSEL • MICHAEL DEL PRIORE • CHIEF INFORMATION • OFFICER • WILL DOWNIE • SVP, GLOBAL SALES & MARKETING, EUROPEAN COMMERCIAL OFFICER • SHARON JOHNSON • SVP, QUALITY, PRODUCT DEVELOPMENT & REGULATORY AFFAIRS • STEVE LEONARD • SVP, GLOBAL OPERATIONS • LANCE MIYAMOTO • SVP, HUMAN RESOURCES • DANIEL COHEN • VP, CORPORATE DEVELOPMENT • ROY SATCHELL • SVP, BUSINESS • TRANSFORMATION • CORNELL STAMORANVP, CORPORATE DEVELOPMENT & STRATEGY • . • CHARLES SILVEY • VP, INTERNAL AUDIT & FINANCE OPERATIONS

35. Catalent Winchester Site Leadership Team Solid Line Reporting (or Direct Reporting)– This relationship provides direct supervision and also provides primary guidance to the employee to discharge his functions . This supervisor conducts Performance reviews. Dotted Line Reporting (or Indirect Reporting) –This relationship provides additional supervision and guidance. This supervisor provides inputs to the solid line reporting for Performance review. Barry Littlejohns President- Advanced Delivery Technologies Steve Leonard Global VP Operations Jonathan Arnold VP/ GM Advanced Delivery Technologies Vijay Surapaneni VP Global Operations Steve Havel General Manager Solid Line Reporting Dotted Line Reporting Cheryl Flack Exec. Admin. Assistant Kay Schmidt VP, Global R&D, ADT Ritchie Davis Director Operations Jim Lauterbach Dir., Engineering Harry Cocolas Manager, MS&T & NPIX Larry Lawless Director Project Mgmt. Linda Hlavac VP HR Global Site Operations David Thomas Dir. Business Integration Greg Easterling Manager, EHSS Jason Luring Area HR Director Jeremy Huneau VP Finance ADT Jason Ilari Director Finance Sapan Periwal Mgr. Operations Prgms. Michael Broaddus Dir. Cont. Imp. & Technology Kristie Lauterbach Director, Quality Systems Scott Gunther VP, Quality ADT Chris Abney Mgr. Process Optimization Sunil Nair Director, Supply Chain

36. Conclusion • Please remember to turn in your completed Learner Worksheet to either a member of the Training Team or your Shadow Week Mentor. Hopefully, you now have a much better understanding of who Catalent is, what we believe, how we help our customers, and what we do. In another module, you will learn more about what it is we do here at Catalent Winchester.

37. discover more. CATALENT PHARMA SOLUTIONS14 SCHOOLHOUSE ROADSOMERSET, NJ 08873 + 1 866 720 3148 www.catalent.com