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Licence Transfer Application Form Step 1: Guidance Current Licensee Contact Name Niall McCaffrey Contact Position EHS Lead Date 16/09/2016 Proposed Transferee Contact Name mary hyland Contact Position Environmental Coordinator Date 21/09/2016 Licence Transfer Application Report - P0015-05 Page 1 of 23 For inspection purposes only. Consent of copyright owner required for any other use. EPA Export 25-09-2016:02:14:44

Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

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Page 1: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

Licence Transfer Application Form

Step 1: Guidance

Current Licensee

Contact Name Niall McCaffrey

Contact Position EHS Lead

Date 16/09/2016

Proposed Transferee

Contact Name mary hyland

Contact Position Environmental Coordinator

Date 21/09/2016

Licence Transfer Application Report - P0015-05 Page 1 of 23

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Page 2: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

Step 2: Current Licensee

Licence Reg No P0015-05

Licensee Schering-Plough (Ireland) Company

Licence County Wicklow

Site Location Rathdrum, Wicklow

ELRA / CRAMP Review

Provide additional information on ELRA / CRAMP N/A

Request ELRA / CRAMP Status? ELRA/CRAMP Approved

Contact Information

Proposed Transferee Organisation MSD International GmbH, Trading as MSD Ireland (Rathdrum)

Proposed Transferee Contact Email [email protected]

Reason for licence transfer request

Schering-Plough (Ireland) Company intends to sell and transfer certain assets and liabilities of its branch in Rathdrum(called SP Ireland (Rathdrum) Co) to the Irish branch of MSD International GmbH, a Swiss company, with a registered address at Weystrasse 20, 6000 Lucerne 6, Switzerland, registration number CHE-115.587.106, who has a branch located in Rathdrum (called MSD Ireland (Rathdrum)) and is registered in Ireland under the registration numbers 908473.

Desired date for proposed transfer to take effect 30/09/2016

Confirm Enforcement Charges Paid Yes

Specify Outstanding Enforcement Charges €0.00

Additional Information

Additional Information

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Page 3: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

Step 3: Proposed Transferee

Name MSD International GmbH, Trading as MSD Ireland (Rathdrum)

Address Rathdrum, Wicklow

Transfer Contact Mary Hyland

Additional Transfer Contacts

Name Position Home Phone Mobile Phone Email

General Background

Business Activity The production of pharmaceutical products (including intermediates)

Date Established 21/09/2016

Total Assets Value €

Turnover €

Profit €

State whether your organisation is a Holding Company No

Fit and Proper Person Checks

Environmental Protection Agency Act 1992 as amended? No

Waste Management Act 1996 as amended? No

Local Government Acts 1977 and 1990 or Air Pollution Act 1987? No

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Page 4: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

Management and Supervisory Details

Name Details of Relevant Education, Training and Experience Responsibilities

Stephen Scanlon

• MSc Operations Management. Dublin City University, Dublin, • PgDip Management Studies. Communications and Management Institute, • BEng Chemical & Bioprocess Engineering. University College Dublin,

Manager, Engineering, 2015 – 2016Company: MSD RathdrumRole: Decommissioning Project Lead / Energy LeadResponsible for leading the site decommissioning project providing guidance and leadership to outsourced engineering provider, and ensuring all delivery and cost targets are met.

Manager, Engineering, 2013 - 2015Company: MSD RathdrumRole: Utilities Lead / Water Team LeadResponsible for leading the site Utility Operations Team ensure compliance with GMP / EHS requirements, adherence to EPA license requirements, and also meet site KPIs. Managed the operation of Waste Water Treatment Plant, Liquid Vapour Incinerator, various Grades of Water (incl Highly Purified Water), Steam, Compressed Air, PSA Nitrogen, OF Nitrogen etc.

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Page 5: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

Niall Mccaffrey

• MSc Applied Environmental Sciences – Queens University Belfast • BEng (Hons) Civil Engineering – Queens University Belfast • Diploma in Occupational Safety & Health - NEBOSH

Date July 2012 – Present Company: Merck Sharp Dome (MSD), Rathdrum Role: EHS Lead - Associate Director

Ensuring that site systems are in place to maintain compliance with all Irish and EU Safety Regulations and MSD expectations and standards

Date: Jan 2010 – July 2012 Company: INTEL F14 and F24D Project / M+W Group Role: Project EHS Manager,Responsible for the EHS Management of a major, complex decontamination and de-installation project of a large-scale semi-conductor manufacturing facility.

Date: Feb 2009 – Jan 2010 Company: Covidien Role: Utilities and EHS Manager,Responsible for the Management of the Utilities and EHS Departments of a major pharmaceutical facility. A key element of this role involved mentoring and embedding EHS culture within the senior management team, through to all levels on-site

Paul Fenton

• B.Eng,(UCD) • M.Sc, (Heriot-Watt), • Postgrad Diploma Safety and Risk Management (Heriot-Watt),

Company: Schering-Plough/MSD (Rathdrum)Date: 1991-PresentRole: Engineering Director

25 years with Schering-Plough/MSD, 21 years with responsibility for Utilities operations during this time.

Licence Application History

Has the Proposed Transferee, their parent company or any relevant person had an application for a licence...

Granted? No

Rejected? No

Revoked? No

Transfer Refused? No

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Page 6: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

Additional Information

Financial Provision in place? Yes

Additional Information

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Page 7: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

Step 4: Fees, Declaration and Submit

Payment Amount €2,000

Payment Method EFT

Payment Date 28/09/2016

Application Submission Date 23/09/2016

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Page 8: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

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Page 9: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

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Page 10: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

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Page 11: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

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Page 12: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

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Page 13: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

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Page 14: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

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Page 15: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

örrrnrLrcHE URKUNDEPUBLIC DEED

über die Gründung deron the formation of

MSD fnternational GmbH

(nachfolgend die "Gesellschaft")( herei nafte r the " Com Pa n Y" )

mit Sitz in Luzern

with seat in Lucerne

Vor der unterzeichneten Urkundsperson des Kantons Zug, Birgit Urbons, Rechts-

anwältin, Baarerstrasse 8, 6301 Zug, ist heute die folgende Gründerin erschienen

bzw. vertreten:

Before the undersigned Civil Law Notary of the Canton of Zug, Birgit Urbons, At-

torney-at-Law, Baarerstrasse 8, 6301 Zug, the following founder has appeared

respectively has been represented:

Schering-Plough Ltd., eine Aktiengesellschaft unter Schweizer Recht, in

Weystrasse 20, CH-6000 Luzern

schering-Plough Ltd., a company timited by shares governed by swiss

law, at Weystrasse 20, CH-6000 Luzern;

ffix 19995538 doc

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Page 16: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

,lonal GmbH, Luzern

mit schriftlicher Vollmacht vertreten durch Dr. Daniela Fiorillo-Buonomano, c/o

Bär & Karrer AG Baarerstrasse 8, 6301 Zug und

represented through a written power of attorney by Dr, Daniela Fiorillo'

Buonomano, c/o Bär & Karrer AG Baarerstrasse 8, 6301 Zug; and

und hat erklärt:

and has declared:

Unter der Firma

Under the company name

MSD International GmbH

gründe ich gemäss den Bestimmungen des Schweizerischen Obligationenrechtes(OR) eine Gesellschaft mit beschränkter Haftung mit Sitz in Luzern.

and in accordance with the provisions of the Swiss Code of Obligations (CO), Ihereby found a limited liability company having its legal domicile in Lucerne.

II,

Ich habe den mir vorliegenden Entwurf der Gesellschaftsstatuten gelesen, als

richtig und verbindlich anerkannt und unterzeichnet. Ich erhebe ihn zum definiti-ven Statut der in Gründung begriffenen Gesellschaft. Die genehmigten Statutenliegen als wesentlicher U rku ndenbestandteil bei.

I.

ffi

2

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Page 17: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

I have read the tabled draft of the aftictes of association of the company, have

acknowledged it as being correct and binding, and have signed it. I declare these

articles of association to be the final articles of association of the company, The

approved articles of association are attached hereto as a material part of this

public deed.

ur.

Das Stammkapital der Gesellschaft beträgt cHF 20'000.- und ist eingeteilt in 200

Stammanteile mit einem Nominalwert von je CHF 100,-, welche zum Ausgabebe-

trag von CHF 1OO.- je Stammanteil wie folgt gezeichnet werden:

The company capital is CHF 2O,O0O.- and is divided into 200 quotas with nominal

vatueofCHFl00.'eachandanissueamountofCHFl00''each,whichareheldas follows:

Schering-Plough Ltd. 200 Stammeinlagen

200 quotas

von CHF 100.-

of CHF 1OO, -

cHF 20'000.-Total

Es bestehen weder statutarische Nachschuss- oder Nebenleistungspflichten noch

statutarische Konku rrenzverbote noch vorhand-, vorkaufs- und Kaufsrechte der

Gesellschafter oder der Gesellschaft noch Konventionalstrafen.

There is neither a statutory obligation for additional cover nor for any additional

obligation nor any statutory non-competition clauses nor any rights of first refus-

al, pre-emptive rights, and acquisition rights of the partners or the companY nor

any penalties,

dery§oY,:,\"O

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Page 18: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

IV.

Es sind folgende Einlage geleistet worden:

The following contribution has been made:

Total CHF 20'000.- in Geld, durch Hinterlegung bei der Credit Suisse, Zürich, als

dem Bundesgesetz über die Banken und Sparkassen unterstelltes Institut, ge-

mäss deren vorliegender schriftlichen Bescheinigung vom 8. April 2010, zur aus-

schliesslichen Verfü9un9 der Gesellschaft.

A total amount of CHF 20,000.- in cash, deposited with Credit Suisse, Zurich, an

institution under the Federal Law on Banks and Savings Banks, according to the

tabled written confirmation, dated I April 2010. The contribution in cash is at the

exclusive disposal of the company.

Dadurch ist die dem Ausgabebetrag aller Stammeinlagen entsprechende Einlage

vollständig erbracht.

The contribution corresponding to the issue price of all quotas has thereby been

fully paid up,

Ich stelle fest, dass:

I confirm that:

sämtliche Stammanteile gÜltig gezeichnet sind;

all company quotas have been validly subscribed;

die Einlage dem gesamten Ausgabebetrag entsprechen;

the contribution paid in corresponds to the issue price of all quotas;

die gesetzlichen und statutarischen Anforderungen an die Leistung der Ein-

lagen erfüllt sind;

the legal and statutory requirements for the payments of the contributions are

complied with;

V.

,

donäl GmbH. Lu2ern 4

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Page 19: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

keine statutarischen Nachschuss- oder Neben leistu ngspflichten bestehen.

There are no statutory obligation for additional contributions nor for any

add itiona I obligation.

Ich bestelle als Geschäftsführer mit Einzelu ntersch rift:

I appoint as Managing Directors with individual signatory power:

. Patrik Nietlispach, von von Beinwil (Freiamt) AG, in Risch

Patrik Nietlispach, of Beinwil (Freiamt) AG, residing in Risch

. Christoph Brombacher, von Basel, in Herrliberg

Christoph Brombacher, of Basel, residing in Herrliberg.

Die Unterschrift auf der Ha ndelsreg isteranmeldung gilt als Wahlannah meerklä-

run9,

The signature on the application for registration in the Commercial Register is

deemed as a declaration of acceptance.

Als Vorsitzenden der Geschäftsführer ernenne ich Patrik Nietlispach.

I appoint as chairman of the managing officers Patrik Nietlispach,

vI.

Als Revisionsstelle wähle ich Pricewaterhousecoopers AG, Bahnhofplatz 10, Post-

fach, 3001 Bern. Die Wah lan na hmeerklä ru ng liegt vor.

I etect as auditors Pricewaterhousecoopers AG, Bahnhofplatz 10, Po-Box, 3001

Berne. The declaration of the acceptance with respect to this election is present'

VII.

Das Domizil der Gesellschaft befindet sich in weystrasse 20, 6000 Luzern. Die

Gesellschaft hat eigene BÜros.

The domicite of the company is at Weystrasse 20, 6000 Lucerne' The companY

has its own offices.

de{§o'7r:r\"o

5

4

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Page 20: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

VIII.

FernerbevollmächtigeichDanielaFiorillo-Buonomano,c/oBär&KarrerAG,Baarerstrasse 8,6301 Zug allfällige, wegen Beanstandung durch die Handels.

registerbehörde erforderliche Anderungen an den Statuten oder am Errich-

tungsakt, durch einen öffentlich zu beurkundenden Nachtrag namens der

Gründerin vorzunehmen.

Furthermore I authorize Daniela Fiorillo- Buonomano, c/o Bär & Karrer AG, Bahn-

hofstrasseS,630lZug,toundertakenecessarychangesofthearticlesofincor-poration or of the public deed by a notarized amendment in the name of the

founder, in case of any obiections of the commercial register authority'

rx.

Abschliessend erkläre ich die Gesellschaft den gesetzlichen vorschriften entspre-

chendalsgegrÜndetundermächtigedieGeschäftsführung,sieindasHandelsre-gister eintragen zu lassen.

FinaltyldectaretheCompanyasfoundedinaccordancewiththelegalrequire.ments and authorize the Managing Director to register the company with the

Commercial Register.

zug, 9. Aptil 2070

Die Gründerin / The founder:

Sche

mittels schriftlicher Vollmacht durch Dr.

Daniela Fiorillo-Buonomano / represented with

written proxy by Dr. Danieta Fiorillo'Buonomano)

ffi

6

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Page 21: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

örrerrucxE BEURKUNDUNG

Public Notarization

Die unterzeichnete Urkundsperson des Kantons Zug, Birgit Urbons, Rechtsanwäl-

tin, Baarerstrasse 8, 6301 Zug,

The undersigned Civil Law Notary of the Canton of Zug, Birgit Urbons, Attorney-

at-Law, Baarerstrasse 8, 6301 Zug,

beurkundet hlermit öffentlich / herewith certifies:

Diese Urkunde entspricht dem mir mltgeteilten Willen der Gründerin Schering-

Plough Ltd. Sie ist von der in der Urkunde genannten erschienenen Person gele-

sen, als richtig anerkannt und unterzeichnet worden.

This public deed corresponds to the will of the founder Schering-Plough Ltd. as

having been declared to me. It was read, confirmed as being accurate and has

been signed by the person having appeared before me as mentioned in the public

deed.

Alle in dieser Urkunde genannten Belege haben mir und der erschienenen Person

vorgelegen (Arl.777b Abs. 1 OR) und sind dleser Urkunde als integrierte Be-

standteile beigeheftet.

All documents mentioned in this public deed have been presented to me and to

the persons who have appeared before me (Art. 777b para. 1 CO) and are at'tached hereto as a material part of this public deed.

Diese Urkunde ist in 7 Exemplaren ausgefertigt, und zwar:

This public deed has been made out in 7 copies, namely:

2 Exemplare für die Urkundsperson / 2 copies for the Civil Law Notary

1 Exemplar für das Ha ndelsreg istera mt / 1 copy for the Commercial Register

1 Exemplar für die Revisionsstelle / .I copy for the auditors

3 Exemplare für die Gesellschatl / 3 copies for the company

Zug, 9. April 2010 ndsperson:

)nal 6mbH, Luzern ?

I

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Page 22: Licence Transfer Application Form Step 1: Guidance · Company: MSD Rathdrum Role: Decommissioning Project Lead / Energy Lead Responsible for leading the site decommissioning project

Dr. Stephen Rush Plant Manager

Tim Shanahan Supply Chain Lead

Tony Smyth Director of Finance

Niall Dunne IPT Lead

Liam Murray HR Lead

Paul Fenton Director of Engineering

Claire Doyle Director of Quality Operations

Niall McCaffrey Site EHS Lead

MSD Ireland (Rathdrum)

Site Organisation Chart

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Licence Transfer Application Report - P0015-05 Page 23 of 23

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