+ All Categories
Home > Documents > Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application...

Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application...

Date post: 04-Jun-2020
Category:
Upload: others
View: 2 times
Download: 0 times
Share this document with a friend
17
Licence Transfer Application Form Step 1: Guidance Current Licensee Contact Name Mr. Tomas McCarthy Contact Position EHS Specialist Date 26/07/2016 Proposed Transferee Contact Name Mr. John Dee Contact Position EHS Specialist Date 23/08/2016 Licence Transfer Application Report - P0005-02 Page 1 of 17 For inspection purposes only. Consent of copyright owner required for any other use. EPA Export 17-09-2016:01:50:38
Transcript
Page 1: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

Licence Transfer Application Form

Step 1: Guidance

Current Licensee

Contact Name Mr. Tomas McCarthy

Contact Position EHS Specialist

Date 26/07/2016

Proposed Transferee

Contact Name Mr. John Dee

Contact Position EHS Specialist

Date 23/08/2016

Licence Transfer Application Report - P0005-02 Page 1 of 17

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 17-09-2016:01:50:38

Page 2: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

Step 2: Current Licensee

Licence Reg No P0005-02

Licensee Schering-Plough (Ireland) Company

Licence County Cork

Site Location Brinny, Innishannon, Cork

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 (Brinny)

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 Brinny(called SP Ireland (Brinny) 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 Brinny (called MSD Ireland (Brinny)) and is registered in Ireland under the registration numbers 908472.

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

In relation to Licence Transfer process for Licence P0005-02, Schering-Plough (Ireland) Company, the EPA have notified the site (22.08.2016) that all relevant assessments of the ELRA and/or CRAMP have been approved

Licence Transfer Application Report - P0005-02 Page 2 of 17

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 17-09-2016:01:50:38

Page 3: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

Step 3: Proposed Transferee

Name MSD International GmbH, trading as MSD Ireland (Brinny)

Address Brinny, Innishannon, T12RD82, Cork

Transfer Contact John Dee

Additional Transfer Contacts

Name Position Home Phone Mobile Phone Email

General Background

Business Activity Pharmaceutical production of both API and Drug product

Date Established 21/06/2016

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

Licence Transfer Application Report - P0005-02 Page 3 of 17

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 17-09-2016:01:50:38

Page 4: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

Management and Supervisory Details

Name Details of Relevant Education, Training and Experience Responsibilities

John Dee

• Relevant Education – Bsc Environmental Science, Cert. Occ H& S, Safety Diploma, • Training - DGSA, PSCS, WWTP, Six Sigma.• Professional memberships – IEMA, IOSH and CIWM.• Experience – since 2004 has worked in various EHS roles including Environmental Officer/Coordinator/Specialist for industries including food and drinks, waste and pharma. These positions included EHS operational (e.g. WWTP, air abatement), organisational (management systems, procedures) and permit/licensing.

EHS Specialist

Jean Nyhan

Relevant Education:• 1997 University of Limerick – BSc in Environmental Science – 1.1• 1998 Queens University of Belfast – MSc in Environmental Engineering – Distinction• 2005 UCD – Certificate in Safety, Health and Welfare at Work• 2007 UCC – HDip in Safety, Health and Welfare at Work - Distinction

Training and Experience:• Almost 20 years EHS experience in EHS consultancy and in the adhesive, pharmaceutical, medical devices and biotechnology sectors

EHS Site Lead

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

Licence Transfer Application Report - P0005-02 Page 4 of 17

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 17-09-2016:01:50:38

Page 5: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

Additional Information

Financial Provision in place? Yes

Additional Information

Licence Transfer Application Report - P0005-02 Page 5 of 17

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 17-09-2016:01:50:38

Page 6: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

Step 4: Fees, Declaration and Submit

Payment Amount €2,000

Payment Method EFT

Payment Date 21/09/2016

Application Submission Date 16/09/2016

Licence Transfer Application Report - P0005-02 Page 6 of 17

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 17-09-2016:01:50:38

Page 7: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

Lice

nce

Tran

sfer

App

licat

ion

Rep

ort -

P00

05-0

2

Pag

e 7

of 1

7

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 17-09-2016:01:50:38

Page 8: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

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

Licence Transfer Application Report - P0005-02 Page 8 of 17

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 17-09-2016:01:50:38

Page 9: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

,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

Licence Transfer Application Report - P0005-02 Page 9 of 17

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 17-09-2016:01:50:38

Page 10: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

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

Licence Transfer Application Report - P0005-02 Page 10 of 17

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 17-09-2016:01:50:38

Page 11: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

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

Licence Transfer Application Report - P0005-02 Page 11 of 17

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 17-09-2016:01:50:38

Page 12: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

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

Licence Transfer Application Report - P0005-02 Page 12 of 17

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 17-09-2016:01:50:39

Page 13: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

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

Licence Transfer Application Report - P0005-02 Page 13 of 17

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 17-09-2016:01:50:39

Page 14: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

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

Licence Transfer Application Report - P0005-02 Page 14 of 17

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 17-09-2016:01:50:39

Page 15: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

Licence Transfer Application Report - P0005-02 Page 15 of 17

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 17-09-2016:01:50:39

Page 16: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

Organisation Chart

(MSD International GmbH, trading as MSD Ireland (Brinny))

Site

Manager

Matt

Corcoran

Technology Lead –

Barry

Mulcahy

Sterile IPT Lead – Donal

Kelleher

API IPT Lead –

Matt Maher

Site EHS

Lead –

Jean Nyhan

Site Quality

Lead –

Kevin

Dwane

Finance

Lead -

Majella

Cronin/Jean

O’Brien (JS)

SCM Lead –

Sarah

Prendergast

Environmental

Technicians

Tomás McCarthy

EHS Specialist

(Environment)

Maria Delea EHS

Specialist

Marcus Austin EHS

Specialist

Licence Transfer Application Report - P0005-02 Page 16 of 17

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 17-09-2016:01:50:39

Page 17: Licence Transfer Application Form Step 1: Guidance · 2016-09-17 · Licence Transfer Application Report - P0005-02 Page 2 of 17 For ... Bsc Environmental Science, Cert. Occ H& S,

Lice

nce

Tran

sfer

App

licat

ion

Rep

ort -

P00

05-0

2

Pag

e 17

of 1

7

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 17-09-2016:01:50:39


Recommended