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Safety Training Document for contractors working at the Boehringer Ingelheim sites in Ingelheim, Biberach, Dortmund and Hannover As at: 25.09.2017

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Safety Training Document

for contractors working at the Boehringer Ingelheim sites in Ingelheim, Biberach,

Dortmund and Hannover

As at: 25.09.2017

Tables of contents

• The sites in Ingelheim, Biberach and Dortmund

• Why training is necessary

• Prerequisites for admission to Company premises

• Behaviour on Company premises: some general points

• What to do if a building alarm is sounded

• What to do in an emergency

• What to do in the event of an accident at work

• Protective measures

• Environmental protection

• Information about data protection

• Names of contacts

As at: 25.09.2017 2

The sites in IN, BC, DO and HA

Ingelheim Administration Prescription Medicines Consumer Health Care Animal Health Pharmaceutical Manufacture Chemicals Development Medicine

Biberach Research and Development Medicine Biopharmaceuticals Administration

Dortmund Boehringer Ingelheim microParts GmbH Special microsystem technology (e.g. Respimat® Soft Mist Inhaler)

Hannover Veterinary Research Center

As at: 25.09.2017 3

Why training is necessary

•The people at these sites work in chemical/pharmaceutical plants, laboratories, workshops and offices.

•There are many different potential hazards on Company premises

•As a chemical-pharmaceutical company, Boehringer Ingelheim is obliged to meet particularly stringent safety requirements.

•The aim of training is to familiarise personnel with the main safety precautions and rules of conduct in place at BI, and to highlight potential hazards.

As at: 25.09.2017 4

Prerequisites for admission to Company premises

• Advance registration: The constructor is required to register all his employees as well the the ones from his sub contractor

• The Contractor must explain the rules of conduct to all personnel before admission to the Company, using this presentation.

• Training must be repeated once a year. Proof of this must be provided. A company ID badge will be issued for a maximum of one year.

• Staff members of partners can be asked for some questions concerning the safety rules – you might repeat the test. This test can be repeated once. Any personnel who fail the test will be denied entry to Company premises. In such cases, the BI representative should be informed. Any costs incurred as a result of waiting times or as a result of personnel having to come to the company again will be borne by the Contractor.

As at: 25.09.2017 5

Prerequisites for admission to Company premises

• By accepting the ID badge, Contractor personnel verify that they have been trained on the rules of conduct.

• The Contractor guarantees that all legal requirements and the directives of the German Employer's Liability Insurance Association and any special work-related requirements will be met by personnel.

• The Contractor undertakes to check that all personnel meet the above requirements.

• The ID badge must be worn open and visible at all times.

• The drive-in permit must be on prominent display in the vehicle.

As at: 25.09.2017 6

Behaviour on Company premises: some general points

• Smoking ban (also in vehicles)

• No alcohol permitted anywhere on Company premises

• Fire, naked flames and hot work (e.g. welding, grinding, blowtorch) prohibited; permitted outdoors only with permit

• No photography or filming permitted.

• Use of mobile telephones prohibited in specially marked areas. Also applies to explosion-proof devices.

• No animals permitted on Company premises

As at: 25.09.2017 7

Behaviour on Company premises: some general points

• Show consideration to other drivers

• Observe speed limits, especially in the marked traffic calmed zone

• Park only in designated parking areas.

• It is prohibited to stop under pipe bridges, over hydrants, fire-extinguishing equipment, manhole covers or areas bearing road markings.

• Particular care is required in loading areas and on narrow roads and building sites

• Use only roadworthy bicycles

As at: 25.09.2017 8

Behaviour on Company premises: some general points

• Keep escape and rescue routes clear

• Observe the fire safety regulations (in particular, use designated assembly point)

• Keep emergency equipment areas clear

• Notice the escape and rescue plan while entering the building, so that admits the escape and emergency routes/collecting station is! As at: 25.09.2017 9

What to do if a building alarm is sounded

• Leave building

• Go to assembly point (see fire safety regulations for exact location)

• Close fire doors

• Use fire-fighting equipment

• Use stairs

As at: 25.09.2017 10

What to do in an emergency

Dial emergency number (from company telephone): 112

Dial emergency number (from mobile phone): Ingelheim: (06132) 77 – 112 Biberach: (07351) 54 – 112 Hannover: (06132) 77 – 112 Dortmund: (06132) 77 – 112

• Give your name • Say where the emergency has occurred • Say what has happened • Say how many people are injured • Explain what injuries they have • WAIT to answer any further questions.

Also inform BI representative of all work-related accidents on Company premises!

As at: 25.09.2017 11

What to do in the event of an accident at work

Minor injuries: Take injured person(s) to Works Medical Service

Serious injuries: Ring emergency number (company telephone: 112)

Always seek medical advice after an electrical accident, electric shock, etc. (even if you feel well)

Use emergency equipment on site

Inform BI representative (Host)

Eye-wash fountain Emergency shower

Mobile phone: Ingelheim: (06132) 77 – 112 Biberach: (07351) 54 – 112 Hannover: (06132) 77 – 112 Dortmund: (06132) 77 – 112

As at: 25.09.2017 12

Protective measures

• Eliminate or reduce the source of the hazard

• Safety measures

• Organizational measures

• Use personal protective equipment (PPE) The Contractor should bring its own personal protective equipment to the Company. It must be used it in accordance with the relevant instructions. This includes regular testing.

• Behaviour-related measures

As at: 25.09.2017 13

Protective measures: permit-to-work

Permits-to-work are required for dangerous work:

• Work involving ignition hazard, e.g. welding or grinding

• Climbing into tanks and confined spaces / driving vessels

• Work that involves risk of falling (e.g. work on roofs or shaft constructions)

• Shutdowns

• Work involving special hazards

• Work involving starter power

• Work involving road closures, use of truck-mounted crane

• Excavation and digging work

The BI representative shall provide a permit-to-work and explain how it is used. It must be on display at the place of work.

As at: 25.09.2017 14

Protective measures: hazardous symbols

15 As at: 25.09.2017

Protective measures: hazardous symbols

• Warning indicating explosive atmosphere:

Use of non explosion-proof mobile telephones not permitted Use of electrical devices allowed only with permit-to-work

• Warning indicating electromagnetic fields

• Not permitted for persons with pacemakers or implants, e.g. insulin pumps

• Warning indicating radioactive rays

• Warning indicating biological or genetically engineered substances

As at: 25.09.2017 16

Protective measures: protecting against falls

Principle

• Risk of falling must be eliminated

• Collective measures, e.g. three-part side protection, before individual measures

• Only scaffolding that has been approved by scaffolding erector should be entered

As at: 25.09.2017 17

Protective measures: hygiene

• Hygiene in laboratory, warehouse and production, etc.

• No eating or drinking permitted in work areas

• Keep street and work clothing separate

• Clean any dirt from body or clothing before each visit to toilet or before each break

• Use appropriate washing facilities

As at: 25.09.2017 18

Protective measures: working hours

General requirements:

• Notice must be given of any work to be done outside normal working hours.

• Plant Security must be informed of any work to be done after 7 pm or at weekends and on public holidays – to be agreed via company representative.

• Permit to work on Sundays and public holidays is issued by contractor and by relevant office responsible for work safety and is agreed with BI representative!

• Special approval to be presented to BI representative.

As at: 25.09.2017 19

Health

Safety & Security

Environmental Protection

EHS Vision

We aspire to be one of the safest and most environmentally responsible pharmaceutical companies in Germany

EHS – Environmental Protection, Health & Safety

As at: 25.09.2017 20

Scope and responsibilities: applicable for all German sites and the BI companies and units operating there.

Compliance: we meet all legal requirements

EHS management system: Our integrated EHS management system is based on the requirements of the ISO 14001, ISO 50001 und OHSAS 18001. Thereby a systematic compliance will be ensured and the continuous improvement process will be preserved.

Commitment: We are committed to reduce as much as possible the impact of our activities and products on people and environment. We are also committed to strive for continous improvement and optimization.

Employees and public: We mantain an open dialogue with employees, authorities, media, neighbourhood …

Business partner

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EHS Policy – Site Germany

As at: 25.09.2017 21

Environmental protection and nergy

Our Commitment:

• to use natural resources, raw materials and energy economically and to increase efficiency continuously

• the procurement of energy services, products and facilities that improve our energy performance

• to reduce the environmental impact of all activities as much as possible

It is therefore the task of our business partners to contribute to the efficiency improvement by economical use of resources and energy.

The business partners shall instruct their employees to use energy economically and to protect the environment.

The contribution to the efficiency improvement by economical use of resources and energy is a criterion for the selection and evaluation of business partners.

As at: 25.09.2017 22

• Do not discharge left-over paint, solvents or fuel, etc. into sewage system (painted red). The disposal of the materials takes place outside of the firm area unless there is an agreement with BI concerning the disposal on BI area.

• Never discharge dirty water or chemicals into storm sewer (painted green).

• Inform Security Headquarters of any accidents.

Emergency number (landline): 112

Emergency number (mobile phone):

Environmental protection: water pollution control

Ingelheim: (06132) 77 – 112 Biberach: (07351) 54 – 112 Hannover: (06132) 77 – 112 Dortmund: (06132) 77 – 112

As at: 25.09.2017 23

Environmental protection: waste disposal

• Do not put waste into waste skips on Company premises.

• Providing approval has been obtained from responsible person at BI, take waste to disposal facilities on sites

• Dispose of your own waste properly!

As at: 25.09.2017 24

Pharmacovigilance – what should you report?

Should you have problems, like e.g. an adverse event (e.g. itching), overdose, fragile tablets or missing leaflet, with a Boehringer Ingelheim (BI) Drug or should you be informed about that another person experienced a problem with a BI Drug , please inform immediately the following department :

Pharmacovigilance Germany

Phone: +49 (0)6132-77-2604 Fax: +49 (0)6132-72-141522

E-Mail (internal): zrPV local Germany

E-Mail (external): [email protected]

Please report as much information as you can, e.g. your name/contact details, name of the BI Drug, information regarding the problem, e.g. adverse event, patient information (age, gender), date of awareness.

Please always report in case of doubt !

As at: 25.09.2017 25

Information about data protection:

Data protection statement: Please be advised that personal data (name, company address, photograph and telephone number) and information on the relevant activity (“in” and “out” times, comments on events, names of supervisors, and information about attendance of training courses) obtained in the course of our business relations will be recorded and saved in accordance with the legal requirements and Boehringer Ingelheim’s regulations.

If you have any questions about data protection, please contact our Data Protection Officer on 06132/77-6464 or by e-mail at [email protected]:

As at: 25.09.2017 26

Names of contacts

If you have any questions on this subject, please contact:

Questions on Registering Plant Security Germany Phone +49 6132 77 81 44

Questions on Safety Training Occupational Safety Germany

Phone +49 6132 77 80 63

As at: 25.09.2017 27

Thank you for your attention