Lic

ence Reggister No

o. P01000

EXECUTIVE SUMMARY

IPPC licence Update

In May 2011 Elan Corporation plc (Elan) announced that Elan and Alkermes, Inc. entered into a merger agreement under

which Alkermes, Inc. would acquire the Elan Drug Technologies business of Elan (EDT) and combine it with the business of

Alkermes under a new holding company called, Alkermes plc.

On completion of the merger transaction in September 2011, the Athlone site was named as Alkermes Pharma Ireland

Limited (APIL) a subsidiary of Alkermes plc. In parallel with this merger transaction, IPPC Licence No. 100-02 was

transferred to Elan Corporation plc to Alkermes Pharma Ireland Limited (Alkermes).The Athlone site continues to operate

under the same management post transfer of the IPPC licence.

The following is noteworthy with regards to IPPC Licence No. 100-02:

A site inspection by the EPA took place on 06/03/2011, a report for which was issued on 06/05/2011. The inspection

resulted in a number of minor observations (all of which were subsequently followed up on via correspondence to the

EPA). There were no non-compliant findings arising from the inspection.

A site audit by the EPA took place on 14/09/2011, a report for which was issued on 12/10/2011. The audit resulted in a

number of minor observations, all of which were subsequently followed up on via correspondence to the EPA. There

were no non-compliant findings arising from the audit.

In June 2011, the sites environmental management system received certification to the ISO 140001 standard.

In November 2011, Alkermes requested changes to the IPPC Licence via a Technical Amendment to facilitate the

increase to the chloride ELV to sewers and the addition of new emission points due to the introduction of a new process

(N1821) to the site.

Overall Compliance with IPPC Licence & GHG Permit

The following provides a summary of the sites Environmental performance throughout 2011.

Alkermes achieved 99.8% compliance with wastewater emissions limits via non continuous monitoring.

Alkermes achieved 99.1% compliance with air emissions limits via non continuous monitoring.

Alkermes achieved 99.9% compliance with air emissions limits via continuous monitoring, noise emissions etc

Alkermes achieved 100% compliance with all other emissions limits of IPPC licence i.e. wastewater emissions limits via

continuous monitoring, noise emissions etc.

Alkermes achieved 100% compliance with GHG Permits conditions.

Emissions Trading & Energy Management

The sites Greenhouse Gas Emissions Permit was transferred to Alkermes Pharma Ireland Limited (Alkermes) in September

2011 due to the merger of Alkermes Inc. and Elan Drug Technologies in September 2011. Permit No. GHG011-05 was

issued by the EPA to the site under this transfer. The sites CO2 emissions for 2011 were 7,564 tonnes, versus an allocation

of 13,450 tonnes, while this is an increase (7.6%) on 2010s CO2 emissions, these are well within the sites yearly allocation

under the EU Emissions Trading Scheme.

Thus, while the sites overall energy usage increased in 2011 versus the 2010 energy usage, the sites energy management

programme in 2011 continued to contribute to maintaining energy levels below those of previous years. The maintenance of

energy consumption to such levels has significant environmental benefits and assists Alkermes in achieving its CO2 emission

targets under the Emissions Trading Directive.

Alkermes Operational Excellence Programme

In 2009, the site established an Operational Excellence (OE) programme to assist in achieving its competitiveness and

continuous improvement objectives. OE is the deployment of lean thinking in the provision of site activities such as

development, scale-up and manufacturing activities. It involves the philosophy of leadership, teamwork and problem solving

resulting in continuous improvement throughout the organisation by focusing on the needs of the customer, empowering

employees, and optimising existing activities in the process. The Environmental, Health & Safety and Security (EHSS)

Department have engaged in this programme with the benefit of improving on the sites environmental performance and

enhancing the many elements of the Environmental Management System.

In 2011, two projects had particular focus on environmental matters: i) CTO Operation; and ii) Waste Reduction and

Improvements in manufacturing. These were completed by utilising OE tools and have resulted in improved performance in

both areas.

Environmental Projects in the Local Community

In 2011 the site developed an on-site Corporate Social Responsibly (CSR) group to focus on projects which would be of

environmental benefit to the community.

In 2011 the site continued its involvement as a resource to local education facilities. The site facilitated training and

workshop sessions with transition year students throughout the year. As part of these workshops, environmental focussed

activities of the site were presented in order to demonstrate environmental control measures and environmental

management systems typical to the Pharma-Chem sector. The involvement in this scheme has shown to be both positive

and mutually beneficial to Alkermes and the local community. Alkermes continues to respond to requests to support local

environmental education programmes.

The site also supports the Lough Ree Fish Hatchery (located in Coosan, Athlone) which has continued under the supervision

of the Shannon Regional Fisheries Board since 2003. This provides a suitable breeding ground for trout, thus enhancing the

survival rate of the young trout in a controlled pollution-free environment.

The site supports and encourages all employees to get involved in recycling activities both on and away from the site. While

major schemes are in operation on the site to support recycling, to help encourage employees to use facilities away from

work, it was arranged that Alkermes would cover the entrance fee to the Athlone Recycling Centre. In 2011, this recycling

centre received 700 visits from Alkermes employees.

Waste Management & Recycling

The quantity of waste generated in 2011 was 738 tonnes

which was a decrease on the 2010 figure of 933 tonnes, a

decrease of 21%. In total, 54% of all waste generated at

the Alkermes facility was recovered or recycled.

510 tonnes of non-hazardous waste was produced in

2011; a significant decrease from the 2010 quantity of 725

tonnes (though the 2010 figure was higher due to

increased construction activity on site).

The quantity of non-hazardous waste recycled (which

would otherwise have gone to landfill) in 2011 was 311

tonnes, or 61 % of the total quantity of non-hazardous

waste. While this is a decrease on the non-hazardous

recycle rate achieved in 2010 (76%), this figure is an

increase on previous years (61% in 2009, 57% in 2008,

and 51% in 2007).

The quantity of hazardous waste increased marginally to

228 tonnes in 2011 (208 tonnes in 2010) of which 39%

was recovered off site and 60% treated via incineration

employing waste to energy technology.

TABLE OF CONTENTS

1.0 Introduction ........................................................................................................... 11.1 Facility Details ............................................................................................................................................... 11.2 Company Description ..................................................................................................................................... 11.3 Organisational Structure ................................................................................................................................. 31.4 Environmental Policy ..................................................................................................................................... 42.0 Summary Data ........................................................................................................ 52.1 Emissions to Sewer ........................................................................................................................................ 52.2 Surface Water Monitoring .............................................................................................................................. 82.3 Emissions to Atmosphere Summary ............................................................................................................... 92.4 Summary of Emissions for CTO By-Passes/Shutdowns .............................................................................. 102.5 Waste Management Summary Information ............................................................................................... 132.6 Resource Consumption ................................................................................................................................. 172.7 Environmental Non-compliances & Complaints .......................................................................................... 183.0 Environmental Management Programme (EMP) ............................................... 203.1 EMP- Report for 2011 .................................................................................................................................. 203.2 EMP -Proposal for