Accident Prevention and Emergency Respotise Schwarz …Attachment J.1 Accident Prevention and Emergency Response Schwarz Pharma Ltd. Revised IPCL Application . A preliminary risk assessment

Attachment J.1 Accident Prevention and Emergency Response Schwarz Pharma Ltd. Revised IPCL Application

” .

‘,.

,’

Accident Prevention and Emergency Respotise

Schwarz Pharma .Ltd. Revised IPCL Application

Issue No 53836-003

. .

‘.

Attachment J.doc

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:14:13:33

Attachment J.l Accident Prevention and Emergency ResponSe Schwarz Pharma Ltd. Revised IPCL Application .

CONTENTS

Section Page No

1.

1.1.

2.

3.

3.1. 3.2. 3.2.1

EMERGENCY MANAGEMENT ....................................................................................... 2

Spill Response at Schwarz Pharma ................................................................................. 3 Emergency Equipment On Site.. ..................................................................................... .3 Equipment Maintenance.. ................................................................................................. .

4. PROVISION OF SECONDARY CONTAINMENT ............................................................ 4

5. MANAGEMENT OF MATERIALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*.............................................. 5

6. BUND INTEGRITY ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*......*.......................... 6

7. UNDERGROUND DRAINAGE SURVEYS . . . . . . . . . . . . . . . . . . . . ..*............................................... 6

8. FIREWATER RETENTION FACILITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

9. - a

10.

11. OUT OF HOURS ARRANGEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*.................................................. 9

ACCIDENT PREVENTION AND EMERGENCY RESPONSE . . . . . . . ,..... . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Accidental Emission Control Procedures. ........................................................................ 1

STANDARD PROCEDURES ........................................................................................... 1

EMERGENCY RESPONSE AND PdEPAREDNESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

ACCIDENTAL EMISSION REPORTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..m.*................ 8

Appendix J. 1 .I - SOPS relating to Accident Prevention and Emergency Response

Appendix J.1.2 - Firewater Retention Study

Attachment J.doc Page i

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:14:13:33

Attachment J.1 Accident Prevention and Emergency Respon’se Schwarz Pharrna Ltd. Revised IPCL Application .

I. ACCIDENT PREVENTION AND EMFRGENCY RESPONSE

1.1. Accidental Emission Control Procedures

Accidental emissions can occur due to minor accidents in handling of materials or, as a consequence of a major incident. In terms of avoidance of accidental emissions, the philosophy employed at Schwarz Pharma Ltd. is that prevention is better than cure. Day to day prevention is employed by training operating staff and by use of standard procedures. Prevention, at the point of adopting new processes or equipment, is by a systematic procedure called ‘Hazop’ which tries to identify and address all the real and potential deviations from procedure and practice which could cause an accident. In the event of a minor spillage, the standard procedure system is in place. Hazop procedures are developed for all processes and equipment and are therefore ongoing.

2. STANDARDPROCEDURES

The following Standard Operating Procedures, as applied to normal operation, refer to accidental emissions, in terms of controlling the risk of emission and consequence of any emission.

601.007

601.014

601.015

601.016

601.023

Environment Health & Safety Training for Contractors & Transport Companies.

Internal Accident/Incident/Near Miss Reporting

Accidental Release

External Accident/Incident Reporting

Accident I Incident Response

601.024 Accident Investigation

601.032 Management of Process Safety

601.033 Management of Occupational Injury I Illness *

602.077 Response To TOC Alarm Activation

605.002 Waste Disposal Contractor Control

605.044 Hazardous Waste Disposal I I

Accident Prevention and Emergency Response Page 1

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:14:13:34

Attachment J.1 Accident Prevention and Emergency Response Schwarz Pharma Ltd. Revised IPCL Application .

3. EMERGENCYMANAGEMENT

605.050

605.051

605.062

606.025

606.026

606.029

620.001

620.002

620.003

620.004

620.005

620.006

300.010

301.002

301.185.

301 .I89

305.008

305.007

306.001

306.002

311.003

Preparation of Drummed Waste for Shipment

Preparation of Bulk Waste for Shipment

Non-Process Waste Collection

Bund Management

Response to Emergency Conditions in the Waste Water Treatment Plant

Control of Critical Equipment For Effluent And Air

Emergency Equipment

Equipment Isolation

Emergency Response Team

Emergency Plan

Emergency Equipment Inventory

Efficiency Testing of the Emergency Evacuation Procedure

Performance Testing New Equipment

Maintenance Inspection of Nitric Acid Equipment Prior to Unloading

Bund Test Procedure

Underground Pipe Test Procedure

Equipment Maintenance Programme

Containment Booth Inspection

Fire alarm/sprinkler system isolation procedure

Checking Fire Alarm Sensor Sensitivity

Equipment Evaluation and Selection Report

* Schwarz Pharma Ltd. has conducted risk assessments and reviewed site operations at the facility in Shannon with regard to potential risks to the surrounding environment, in particular focussing on storage of chemicals, processing and packaging activities and waste management.


For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:14:13:34

Attachment J.l Accident Prevention and Emergency Response Schwarz Phaima Ltd. Revised IPCL Application

The company has implemented and employed high standards of safety and environmental protection equipment and measures on-site, to prevent and minimise accidental emissions to the environment, including:

.

.

.

.

.

.

. 0 .

.

Extensive fire alarms systems

Extensive sprinkler systems

Gas sensors (early detection systems)

Containment measures

Nitrogen blanketing (minimise potential for formation of explosive atmospheres)

Fully trained site Emergency Response Team (ERT)

Extensive emergency equipment resources

Thorough accident/incident investigation procedures

Thorough guidelines for dealing with accidental emissions

Furthermore, a comprehensive Emergency Response Plan comprising emergency response procedures prepared for potential emergencies, which may arise at the Schwarz Pharma Ltd. facility, is inoperation on-site, and documented in SOP 620.004.

3.1. Spill Response at Schwarz Pharma Ltd.

The company has prepared and implemented comprehensive spill response procedures to address the emergency action and remedial measures required in the event of a spillage on-site. Procedures are covered under SOP 601.015 designed to provide guidelines for dealing with accidental releases of liquids, solids and gases. This also

e includes a guidance table on how to respond to accidental releases of nitric acid, ammonia, bromine, HCI gas, solvents, solid active& corrosives, acids, bases and oils.

Mobile spill response equipment, as detailed in SOP 620.001, includes spill kits, drainblockers, gas tight suits and splash suits. Spill response kits are located in areas where spillage is most likely to occur and are inspected every 4 - 6 weeks approximately by an external supplier and topped up as necessary.

3.2. Emergdncy Equipment On Site 4

Schwarz Pharma Ltd. has a comprehensive stock of emergency response equipment stored on site. The overall structure of emergency response equipment (as shown below) is tested and maintained by designated personnel on a regular basis.

Accident Prevenlion and Emergency Response Page 3

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:14:13:34

Attachment J.l Accident Prevention and Emergency Response Schwarz Pharma Ltd. Revised IPCL Application .

3.2.1.

4.

MANUAL RESPONSE I::: :,.i.

Safety Shower 1x1 Foar

A record of emergency equipment, together with the test/maintenance frequency is contained in SOP 620.001.

Equipment Maintenance

Documented procedures are in place which cover the monitoring and measuring of all on- site activities and processes which significantly affect, or have the potential to significantly affect the environment. Monitoring and measurement activities on site are specifically covered under SOP 610.003, “Monitoring and Analysis Requirements”.

Schwarz Pharma Ltd. has in place an electronic system known as PEMAC which is used to track the maintenance histories of all plant items. The up-to-date maintenance history any plant item can thereby be accessed and reviewed at any time. The system is controlled under SOP 301.127 PEMAC Maintenance System.

Safety Critical Equipment is identified at the validation stage of all new equipment installations. The inspection frequency and spares requirements are defined as this point.

PROVISION OF SECONDARY CONTAINMENT I

In accordance with the company’s commitment to the protection of the environment and EPA requirements, Schwarz Pharma Ltd. has implemented a programme for the provision of satisfactory containment at the facility. The main aims of the programme included the bunding of tank and drum storage areas.


For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:14:13:34


A preliminary risk assessment of material storage at the facility identified those areas requiring primary action and those storage areas requiring impervious surfaces to materials stored therein. In total, 30 bun& were identified for the purpose of this programme, and are listed in Attachment I of SOP 606.025 on Bund Management.

A chemical storage tank farm is located immediately to the west of the Nitration Plant and is approximately 208m’ in area. it holds 3 storage tanks for acetic acid, nitric acid, and acetyl anhydride and each ranges in size from 15 to 30m3. The tanks are fully bunded and closed so that any accidental spillages or leaks are contained. The associated transfer pumps are located within the bunded area. The solvents are hard-piped via a modified piperack to the Nitration Plant. An additional storage tank farm is located at the Main Production Building (BPS) which holds a further 13 tanks.

Schwarz Pharma Ltd. has defined a process whereby containment bunds are routinely inspected and drained of their contents in such a manner as to prevent any possibility of environmental damage either through spillage, leakage or the improper discharge of material to surface water drains or groundwater.

All materials drained from bunds are discharged directly to the drainage network which brings the effluent to the waste water treatment plant. The only exception to this rule is the discharge of nitration bunds. The contents of the nitration plant bunds are normally discharged to surface water and are only discharged to the wastewater treatment plant if contaminated. Before discharging liquid from the tank farm bunds, the bunds are checked for pH to ensure acidity is not a concern. Before discharging from the Mother Liquor Bunds, the liquid must be checked to ensure it does not contain solids or odour.

SOP 606.025 details Bund Management at the Schwarz Pharma Ltd. facility.

MANAGEMENT OF MATERIALS

Solid materials are received at the facility in either steel/fibre drums fitted with tamper proof closures or bags and are unloaded directly in the warehouse. The materials are firstly subject to quarantine and following satisfactory quality control checks, then stored in the warehouse, until requisitioned by the production department for processing. Movement of solid material externally on-site is by pallet truck or fork truck. Internal movements of the material is via lifts for floor to floor transfer or charged via stainless steel charge chute for transfer to equipment systems.

Liquid materials are transported on-site in steel drums and plastic containers, similar to the movements of solid materials. Within processing buildings, drums are charged from dedicated areas. Such areas incorporate closed drains for collection and containment purposes, which may be accessed to facilitate cleanup of any spillages.

External storage areas for liquid includes containment structures to provide the necessary bunding to satisfy IPC licence requirements. A copy of the most recent bund integrity assessment for the facility is contained in this attachment.


For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:14:13:34

/

Attachment J.l Accident Prevention and Emergency Response Schwarz Pharma Ltd. Revised IPCL Application .

Wastes arising on-site are segregated and stored ‘in accordance with dedicated site standard operating procedures. Designated waste storage locations on-site accommodate the storage of hazardous and non-hazardous waste. These areas are bunded and it is planned that these areas will be integrity tested in accordance with IPC licence requirements.

Finished products are stored in the Pharma warehouse. Documented standard operating procedures exist at Schwarz Pharma Ltd. for the storage, handling and transportation of materials and waste at the facility.

6. BUND INTEGRITY ASSESSMENT

Full integrity tests of bunds takes place at a maximum frequency of 3 years and records relating to the testing are held by the Engineering Department at Schwarz Pharma Ltd..

A copy of the most recent bunding report for the Schwarz Pharma Ltd. Ireland facility is included in Attachment H. This also includes a report on non-compliant bunds, which Schwarz Pharma Ltd. are currently upgrading and re-testing.

7. UNDERGROUND DRAINAGE SURVEYS

In accordance with present IPC licence requirements, Schwarz Pharma Ltd. commissioned external consultants to undertake an underground drain and pipeline survey on-site. This survey also comprises the necessary reports on process, foul sewer and stormwater pipeline systems on-site, and provide associated drainage drawings.

This report will be available by the end of 2004.

8. FIREWATER RETENTION FACILITIES

The Schwarz Pharma Ltd. facility is protected by the following systems:

Tank Farm and Drum Store *

Schwarz has installed a fixed foam system designed primarily to protect the Tank Farm and Drum Store area. This system comprises a 2500 litre foam concentrate tank, a dedicated 100m3 water tank, and fire pumps. It is activated manually following the sensing of a fire by a series of flame detectors in the Tank Farm and Drum Store areas.


..: .

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:14:13:34

Attachment J.1 Accident Prevention and Emergency Responke Schwarz Pharma Ltd. Revised IPCL Application

The system has a dedicated underground foam main which serves two fixed and one mobile foam monitor.

Main Production Building (BPC)

An automatic sprinkler system protects the Production Building. There are 203 sprinkler heads in the 2 storey Production Building. In addition, there are individual sprinkler heads protecting specific vessels.

Pharma Building, Pharma Warehouse and Main Warehouse

A high pressure automatic sprinkler system protects these buildings. The system is fed from an on-site water tank of 450m3 capacity.

Fire Hydrants

A site wide fire hydrant system can provide water for fire fighting at 13 locations around the site. These hydrants can be used by Schwarz Pharma Ltd. staff or Shannon Fire Brigade personnel to supply water to fire hoses or to mobile foam making equipment.

Mobile Equipment

Schwarz Pharma Ltd. have a mobile fire pump. This pump can be used to apply foam to areas of the plant which are not accessible by the fixed or mobile foam monitors.

Fire Brigade Assistance

The Fire Brigade crew at Shannon Fire Station operate on a call out basis. The station maintains 2 appliances and a 1000 litre mobile foam container. The response time from a call out to an incident at the Schwarz Pharma Ltd. plant would be in the range 5-8 minutes.

The most recent Firewater Retention Study for Schwarz Pharma Ltd. is included in Appendix J.1.3. A new study has been commissioned at the time of writing to be complete by Q4 2004.

9. EMERGENCY RESPONSE AND PREPAREDNESS

Schwarz Pharma Ltd. has adopted and implemented procedures to identify foreseeable emergencies through the systematic analysis of its on site operations. An Emergency Plan has been developed to provide an organised response to such emergencies and procedures are also in place which test and review the emergency plan.

As part of the Emergency Preparedness at Schwarz Pharma Ltd. drills and exercise; are carried out on a routine basis as per SOP 620.007 “Emergency Systems Test Procedure”. All accidents/incidents on site are documented via the Accident/Incident reporting system, which is, covered under SOP 601.014 “Internal Accident/Incident/Near Miss Reporting” and potential accidents and emergency situations are identified using methodologies outlined in:


For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:14:13:34


. SOP 601.031”Preliminary Hazard Assessment” for the identification and assessment of major hazard scenarios.

. SOP 601.006 “HAZOP Procedure and follow-up”.

. SOP 610.014 “Environmental Health and Safety Change Control” which is used to determine the Safety and Environmental implications of change before it is

introduced onto the site. This procedure is the primary method used to monitor and control change.

An Emergency Plan which is outlined in SOP 620.004 has been developed which details planned responses at Schwatz Pharma Ltd. in the event of an emergency situations such as fire, accidental releases, explosions and other situations which have the potential to cause damage to personnel, buildings, equipment and the environmental damage. An Accidental Release Procedure (SOP 601.015) is in place which, details the steps to be taken following the occurrence of a Chemical Spill or release.

A specialist Emergency Response service is also in place on site. This service consists of teams trained in advanced emergency techniques such as fire fighting, spillage clean up and search/rescue. The ERT has comprehensive site knowledge and is trained in the, steps required to shutdown specific site buildings required in the event of an emergency. The ERT (Emergency Response’Team) provide cover for the facility 24 hrs a day and specific procedures are in place which cover the operation of the ERT i.e. SOP 620.003 Emergency Response Team duties, a documented list of all Fire equipment on site is maintained as per SOP 620.005 “Emergency Equipment Inventory”.

10. ACCIDENTAL EMISSION REPORTING

The overall objective at Schwarz Pharma Ltd. is to conduct operations on site in a manner which strives to protect the environment and safety of all personnel. However, in the event of an accidental emission the results and information provided need to be continuously monitored and assessed as they give valuable information regarding areas on site which may be prone to accidental emissions and identify areas for improvement.

Statistics on accident and incident information are compiled and reviewed by the Safety & Environment Department. These results are used to assist in making decisions on improving the environmental health and safety management system. Accident and incident analysis is specifically addressed under SOP 601.014 “Internal Accident/Incident Near Miss Reporting”.


For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:14:13:35

Attachment J-1 Accident Prevention and Emergency Response Schwarz Pharma Ltd. Revised IPCL Application .

11. OUT OF HOURS ARRANGEMENT

During normal hours of working, the person in charge is the head of QA and support services from the point of view of emergencies or accidental emissions. During hours when the process is manned on a shift work basis, the person in charge is the Site Coordinator. At any other time, e.g. Christmas, or in a summer shutdown, a security presence is maintained, based at the main site. A security person visits Bay 130 for inspections regularly.

In the event of fire alarm being set off by the detection equipment, a remote response system is in place. This remote response station is maintained 24 hours per day, seven days a week. There are members of the aforementioned Emergency Response Team (ERT) present on each production shift who are trained to respond to all emergencies and accidental emissions which may arise on site.

The ERT provide cover for the facility 24 hrs a day and specific procedures are in place which cover the operation of the ERT i.e. SOP 620.003 .Emergency Response Team duties, a documented list of all Fire equipment on site is maintained as per SOP 620.005 Emergency Equipment Inventory.

Since the main site is manned all year round, arrangements are in place, that at any time a telephone call to the main site number is received from the public, it will be dealt with.


For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:14:13:35

S Ireland

Public Liability Section - Claims-Made l%asis ‘. Section Definitions

Claim

‘Claim’ means any intimation of a claim or of an intention to claim against the Insured or any event which is likely to lead to a claim against the Insured

Damage e $

‘Damage’ means ..-

4 physical loss of or damage to tangible property including attendant loss of use of such property

b) nuisance trespass or interference with any easement right of air light water or way

Financial Loss

‘Financial Loss’ means financial loss unaccompanied by either

a) Injury or

b> Damage

Limit of Indemnity

‘Limit of Indemnity’ means the amount stated in the Section Schedule and applies to compensation payable in respect of any one occurrence or all occurrences of a series consequent on or attributable to one source or original cause

Where the Limit of Indemnity is less than the total amount of the Insured’s liability costs and expenses payable ’ under Section Cover shall be limited to the proportion that the Limit of Indemnity bears to the total amount of such liability

Products

‘Products’ means anything (including containers packaging instructions or labels) manufactured sold supplied hired out repaired serviced altered installed erected processed tested treated stored or transported by or on behalf of the Named Insured in connection with the Business after they have ceased to be in the custody or control of the Named Insured

Retroactive Date

‘Retroactive Date’ means the date stated in the Section Schedule

Cover

The Company will indemnify the Insured subject to the Limits of Indemnity in respect of all sums which the Insured shall become legally liable to pay as compensation arising out of any Claim for accidental Injury or Damage

4

b)

first made against the Insured and

notified to the Company

during the Period of Insurance and arising in connection with the Business

IN1 Public Liability 3.2002 (Claims Made)

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:14:13:35

S

The Company will also indemnify the Insured against

legal 1 iability for c Iaimants’ c osts and expenses in c onnection with the i ndemnity p rovided under this Section

‘4 costs incurred with the Company’s written consent of legal representation at any

i) coroner’s inquest or other inquiry in respect of any death

4

ii) proceedings in any court in regpect of any act or omission causing or relating to any occurrence

<.- other costs and expenses incurred with the Company’s written consent in relat;on to any matter which may be the subject of indemnity this Section

Section Clauses

Indemnity to Principal

The definition of ‘Insured’ extends to include at the request of the Named Insured

a> any public or local authority company firm or other principal for whom the Named Insured is carrying out a contract or agreement for the performance of work

b) any owner of plant in by the Named Insured

but only to the extent required by the c onditions o f t he c ontract or a greement and a lways provided that the principal shall be subject to and comply with the terms and conditions of herein This clause shall in no way operate to increase any Limit of Liability stated herein

Motor Contingent Liability

Notwithstanding Section Exclusion 5 the Company will indemnify the Named Insured and no other for the purposes of this Paragraph against legal liability arising from or caused by any motor vehicle not the property of nor provided by the Insured and being used in connection with the Business provided that the Company will not provide indemnity in respect of liability

4 for loss of or damage to such vehicle or property conveyed therein or thereon

‘4

4

for which indemnity is provided by any other insurance

arising or caused whilst such vehicle is being

0 driven by the Insured

ii) driven with the general consent oft he Insured or his representative by any person who to the knowledge of the Insured or such representative does not hold a licence to drive such vehicle unless such person has held and is not disqualified from holding or obtaining such a licence

iii) used elsewhere than in the Republic of Ireland Great Britain Northern Ireland the Isle of Man or the Channel Islands

Overseas Personal Liability

The Company will indemnify the Insured up to the Limit of Indemnity against legal liability for damages in respect of accidental Bodily Injury to any person or accidental loss of or damage to tangible property happening during any Period of Insurance and incurred in a personal capacity whilst temporarily outside the Republic of Ireland Great Britain Northern Ireland the Isle of Man or the Channel Islands in connection with the Business

IN1 Public Liability 3.2002 (Claims Made) 2

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:14:13:35

provided that the Company will not provide indemnity

4 where indemnity is provided by another insurance

b) in respect of liability assumed by the Named Insured under any contract or agreement unless liability would have attached in the absence of such contract or agreement

c) in respect of liability arising from or caused by

9 the ownership or occupation of land or buildings

ii)

iii)

the carrying on of any busines% profession trade or employment e

.,- the ownership possession or use by or on behalf of the Named Ins&d of horse drawn vehicles or animals other than domestic pets

Property in the Insured’s Custody or Control

Section Exclusion 1 c) will not apply to

6

4

b)

the personal effects (including vehicles and their contents) of any visitor or director partner or Employee of the Named Insured

premises (including their fixtures fittings and contents) not owned by or leased rented or hired to the Named Insured which are temporarily occupied by the Insured for the purposes of carrying out work therein or thereon

premises (including their fixtures and fittings) leased rented or hired to the Named Insured provided that the Company will not provide indemnity in respect of

9 liability assumed by the Insured under a tenancy or other agreement unless liability would have attached in the absence of such agreement P

ii) the fast e320 of each and every occurrence of loss or damage caused other than by fire or explosion

Section Exclusions

The indemnity provided by this Section does not apply to

6 1 the cost of making good loss of or damage to property

a) belonging to the Named Insured or

b) being that part of any property worked upon by the Insured and arising out of such work or

4 in the Named Insured’s care custody or control

2 liability attaching by virtue of any agreement or contract but which would n ot have attached in the absence of such agreement or contract unless the Company shall have signified its general approval to the form of such contract or agreement by endorsement hereon

3 liability arising from Products

4 liability arising from the ownership possession use or control of any aircraft or self-propelled waterborne craft

INI Public Liability 3.2002 (Claims Made) 3

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:14:13:35

S

5

6

7

8

9

10

11

12

13

14

15

Ireland

liability arising from or caused by the ownership possession or use by or on behalf of the Insured of any mechanically propelled vehicle or plant except

any vehicle or plant

9 not requiring a licence for road use or a certificate of motor insurance or other security

b)

ii) being used as a tool of trade at any Premises or on the site of any contract where the Insured is working

B d

the loading or unloading or the bringing to or taking away of a load from any mechanically propelled vehicle or plant

provided that the Company will not grant indemnity

4 in respect of liability which is compulsorily insurable under any road traffic legislation

b) if indemnity is provided by any other insurance

liability arising out of Pollution or contamination unless caused by a sudden identifiable unintended and unexpected event which takes place in it’s entirety at a specific time and place during the Period of Insurance All Pollution or contamination which arises out of one incident shall be deemed to have occurred at the time such incident takes place

For the purpose of this exclusion Pollution or contamination shall mean

4 all Pollution or contamination of buildings or other structures or of water or land or the atmosphere and

b) all Financial Loss or Damage or Injury directly or indirectly caused by such Pollution or contamination

.\ b..

liability arising Tom the libel or slander of an Employee to another Employee arising out of and in the course of his / her employment or by any partner or member of a partnership or joint venture to any other partner or member thereof

liability in respect of loss of information or the provision of wrong information in or from computer programmes tapes or data recording equipment unless as a direct consequence of physical loss of or damage to tangible property

liability in respect of Bodily Injury sustained by an Employee and arising out of and in the course of his employment by the Insured

fines liquidated damages or specified damages under any agreement contract or penalty clause

awards or damages of a punitive or exemplary nature whether in the form of tines penalties multiplication of compensatory awards or damages or in any other form whatsoever

liability for Financial Loss

liability in respect of any manual work a way from the Insured’s P remises other than c ollection and delivery

liability arising directly or indirectly from advice designs or specifications provided by the Insured for a fee or in circumstances where a fee would normally be charged

liability for any Injury or Damage which occurred prior to the Retroactive Date

INI Public Liability 3.2002 (Claims Made) 4

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:14:13:35

S Ireland

16 liability for any Claim

e

4 notified by the Insured under any insurance which was in force prior to the inception of this Policy

b) known or which in the reasonable opinion of the company ought to have been known to the Insured at the inception of this Policy

Option&Endorsements t’

The following endorsements shall only apply if they are shown as being operative in the Schedulg W

1 Work Away

It is hereby declared and agreed that Section Exclusion 13 is deemed to be deleted but the indemnity provided under this Section does not apply to liability arising from the use of electric oxyacetylene or similar welding or cutting equipment blow lamps or blow torches away from the Named Insured’s own premises

2 Hot Work Away

It is hereby declared and agreed that Section Exclusion 13 is deemed to be deleted It is however warranted that in respect of the use away from the Named Insured’s own premises of electric oxyacetylene or similar welding or cutting equipment blow lamps or blow torches the following precautions will be complied with

4 the immediate area in which the work is to be carried out is to be segregated by the use of screens constructed of incombustible material

b) in the area where the work is to be carried out all combustible materials must be removed at % least 6 meters away from the work or protected by overlapping sheets of incombustible materials

cl combustible floors in the segregated area will be covered with sand or protected by overlapping sheets of incombustible materials

4 suitabl&fire extinguishing appliances will be kept available in the work area for immediate use i

* 4 before ‘burning off metal work built into or projecting through walls or partitions the Named

Insured will make an examination to confirm that the other end of the metal is not in a hazardous proximity to combustible material which may be ignited by the conduction of heat

f) a thorough examination of the area of work will be undertaken 1 hour after the termination of each period of work

3 North American Jurisdiction

Notwithstanding the Jurisdiction Clause under the General Conditions of this Policy the Indemnity provided in respect of legal liability to pay compensation (including claimants’ and defence costs and expenses) extends to apply to the laws of the United States of America or Canada (or to any order made anywhere in the world to enforce such judgement award or settlement either in whole or in part) provided that

a> the Limits of Indemnity stated in the Schedule are inclusive of claimants’ and defence costs and expenses

b) the Company will not be liable for claims for or arising out of Pollution

IN1 Public Liability 3.2002 (Claims Made) 5

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 25-07-2013:14:13:35

Documents

Accident Prevention and Emergency Respotise Schwarz …Attachment J.1 Accident Prevention and Emergency Response Schwarz Pharma Ltd. Revised IPCL Application . A preliminary risk assessment