This document provides an overview of the Nerviano Site in Italy which is owned by Actavis. Some key points: - The site has about 450 employees and manufactures sterile injectable pharmaceutical products across 14 buildings spanning 300,000 square meters. - It has a long history dating back to 1969 and has changed ownership several times, most recently being acquired by Actavis in 2008. - The site focuses on manufacturing cytotoxic and non-cytotoxic injectables as well as packaging. It has 6 automated packaging lines and produces over 50 approved products with more in development. - It has received regular inspections from health authorities including the FDA and maintains certifications around quality, environmental and safety standards.

1. 1
Nerviano Site, Italy Operations
October 2016

2. 2
Actavis Injectable - Operations
Managing Director
Bogdan Mihai
Oghina
Manufacturing
Director
Fabio Augusto Bellia
Materials
Management
Director
Andrea Frigeri
Engineering
Maintenace & Utilities
Director
Claudio Zaninetti
Strategy & Technology
Transfer Director
Claudia Bianchi
Carnevale
Finance Director
Massimiliano
Bastianelli
Quality Operations
Director/QP
Vera Terragni
Human Resources &
General Services
Director
Cinzia Colzani
Regulatory Affairs
CMC Manager
Felicita Greco
Information
Technology Manager
Alessio Barenghi
Research &
Development Director
Lorena Muggetti
Environment Health &
Safety Manager
Romano Colombo
Legenda
report solid line
report dotted line

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LOCATION:
Nerviano (15km from Milan) Italy
TOTAL SITE PROPERTY:
300.000 m²
NUMBER OF EMPLOYEES:
About 450
OPERATIONS:
Pharmaceutical Manufacturing
Nerviano
About Nerviano

4. 4
4
Actavis Italy SpA
Via L. Pasteur, 10 – 20014 – Nerviano (MI) - Italy
About Nerviano

5. 5
Site Evolution
2015
1969: Farmitalia built Nerviano plant for animal health products
1975: Farmitalia transferred the production of antracyclines to Nerviano plant
1980: Farmitalia acquired Carlo Erba forming Farmitalia Carlo Erba (FICE)
1982: FICE moved the production of all injectables products and all R&D activities to Nerviano
1994: Kabi Pharmacia acquired FICE forming Pharmacia
1996: Pharmacia merged with Upjohn forming Pharmacia & Upjohn
2000: Pharmacia & Upjohn merged with Monsanto to create Pharmacia Corporation
2003: Pfizer acquired Pharmacia
2004: Pfizer sold NRV R&D center to Nerviano Medical Sciences (NMS)
2008: Actavis acquired Nerviano Plant
2012: Watson acquired Actavis
2015: Actavis acquired Allergan
2016: Teva acquired Actavis Generics
August3,2016TEVADAYONE

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Nerviano Personnel
6
Average employment years in the Company: 14 years
Turnover of employees: 3,4%
Of which 220 Direct and 232 Indirect
Production
Warehouse
QC
QA
Technical / Maintenance
R&D and RA
Others
Production
188
Warehouse
18
QC
84
QA
25
Technical / Maintenance
54
R&D and RA
19
Others
(Purchasing, Planning, Logistics, HR, Finance, EHS, Security,
Administrative, Factory Mgmt, IT, Tech. Transf.)
64
Total
452

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Workforce
Hierarchical Distribution
Top Management - 2%
Middle Management - 9%
Specialists - 34%
Operators - 44%
Assistants - 11%
-
10
20
30
40
50
49 50
40 41
43
A
v
e
r
a
g
e
A
g
e
Level
Average Age / Company Level
Top Management
Middle Management
Specialists
Operators
Assistants
Education
University - 18%
High School - 46%
Secondary School - 24%
Primary School - 12%
Gender Distribution
Male - 51%
Female - 49%

8. 8
Site Layout

9. 9
Markets 2016

10. 10
Nerviano Operations: current capabilities
Bulk Non Cyto
vials, FD, liquid,
amps
Bulk Cyto
vials, liquid, FD,
PFS
Bulk Cyto
vials liquid
Packaging
6 automatic lines

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Product portfolio
Nerviano portfolio includes:
•Sterile Cytotoxic parenterals, including freeze dried
•Sterile non Cytotoxic parenterals, including freeze dried
•Sterile biologic Freeze dried
•Injectable solutions
•Prefilled Syringes
Cytotoxic solution and FD
Non cytotoxic solution and FD
Packaging
Pre-filled syringe

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Products: approved or submitted I
Calcium Folinate 3 mg/mL (30/10) Injection
Calcium Folinate 10mg/mL (30/3, 100/10) Injection
Carboplatin 10 mg/mL (50/5, 150/15, 450/45, 600/60) Injection
Cisplatin 1 mg/mL (10/10, 50/50, 100/100) Injection
Cytarabine 100 mg/mL (100/1, 500/5, 1000/10, 2000/20) injection
Daptomycin 500 mg/vial freeze dried
Dexmedetomidine 100mcg/mL (200mcg/2) injection
Docetaxel 20 mg/mL (20/1, 80/4, 140/7, 160/8) Injection
Docetaxel Povidon free 20 mg/mL (20/1, 80/4) Injection
Doxorubicin 2 mg/mL (10/5, 20/10, 50/25, 100/50, 150/75, 200/100) Injection
Doxorubicin 10 mg/vial and 50 mg / vial freeze dried
Epirubicin 2 mg /mL (10/5, 20/10, 50/25, 100/50, 200/100) Injection
Epirubicin 10 mg/vial, 50 mg/vial freeze dried
Fludarabine 50 mg/2ml injection
Fulvestrant Copy PFS 50mg/ml (250mg/5ml) Injection
Gemcitabine 200 mg/vial, 1000 mg /vial, 2000mg/vial freeze dried
Gemcitabine 40 mg/mL (200/5, 1000/25, 2000/50) Injection
Gemcitabine Aqueous 40 mg/mL (200/5, 1000/25, 2000/50) Injection
Gemcitabine Aqueous 38 mg/mL (200/5,26, 1000/26,3, 2000/52,6) Injection
Irinotecan 20 mg/ml (40/2,100/5, 300/15, 500/25) Injection
Levoleucovorin 50 mg,175mg/vial freeze dried
Liposomal Doxorubicin 2 mg/ml (20/10, 50/25) Injection
Metotrexate PFS (2,5 mg/0,33 ml, 7,5 mg/0,30 ml,10 mg/0,40 ml, 12,5 mg/0,3125 ml, 15 mg/0,375 ml, 17,5 mg/0,4375
ml, 20 mg/0,50 ml, 22,5 mg/0,5625 ml, 25 mg/0,625 ml, 27,5 mg/0,6875 ml, 30 mg/0,75 ml) Injection
Methylnaltrexone 12mg/0,6ml – vial injection
Methylnatrexone PFS 8mg/0,4ml, 12mg/0,6ml

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Products: approved or submitted II
Oxaliplatin 100 mg/vial, 50 mg/vial freeze dried
Oxaliplatin 5mg/mL (50/10, 100/20, 200/40) Injection
Paclitaxel 6 mg/mL (30/5, 100/16.7, 150/25, 260/43.3, 300/50) Injection
Pantoprazole 40mg/vial freeze dried
Pemetrexed 25mg/mL (500/20, 1000/40) Injection
Rapilysin 10U/vial freeze dried
Vinorelbine 10 mg/mL (10/1 and 50/5) Injection
Voriconazole 200mg/vial freeze dried
Zoledronic Acid 4 mg/5 ml Injection

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Products: to be submitted
ABP 980 60mg/vial, 150 mg/vial 440 mg/vial freeze dried
ABP 980 diluent 1,1% benzylic acid WFI
Anidulafungin 200 mg/vial freeze dried
Carbamazepine product under R&D reformulation
Fondaparinux PFS 5mg/ml (2.5/0.5) Injection
Fondaparinux PFS 12.5mg/ml (5/0.4, 7.5/0.6, 10/0.8) Injection
Fosaprepitant 150 mg/vial freeze dried
Fulvestrant Novel PFS 50mg/ml (250/5) Injection
Micafungin 50 mg/vial 100mg/vial freeze dried
Pemetrexed 25mg/mL (500/20, 850/34, 1000/40) Injection-Product under R&D reformulation
Rifampin 600mg/vial freeze dried

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Regulatory approval and compliance
Last 5 years Regulatory inspection:
HEALTH AUTHORITY YEAR NOTE
AIFA-Italian Health Authority –
covers EU countries
2010, 2012,
2013 2015
2016
In 2010: A90/ A100 revamping;
In 2013 2 times: A200 revamping & GMP;
In 2015 2 times: biologic accreditation & GMP
In 2016: new laborarories
FDA-US
2011, 2013,
2015
ANVISA 2010, 2013 Inspection & accreditation
PMDA 2013, 2014 Accreditation & inspection
Nigeria Ministry of Health 2014
Kazakhstan Ministry of Health 2014
Kenya Ministry of Health 2013
GCC 2011
Turkish Ministry of Health 2011
Montenegro Ministry of Health 2011

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Our EH&S certifications

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