Little Island

T. +353 (0) 21 497 8919 F: +353 (0) 21 435 3589

Licensing Section Environmental Protection Age Johnstown Castle Estate, Co. Wexford Cork, Ireland

31 January 2007

1

Ref: IPPC Application, PO134-03, dated 17'h October 2006.

Dear SirlMadam,

Attached please find 3 copies of revised sections of our application for review of our IPC Licence PO134-02 to IPPC Licence, In line with recent discussions with the Agency Sections B. l and 1.2 have been revised following the sale of the company in November 2006 by Cambrex Corporation to International Chemical Investors Group, and a name change from January 2007.

The new company name is Corden Pharma Limited, trading as Corden PharmaChem and the associated certificate of incorporation and registration of business name are included in the revised application form sections.

In relation to the complete application document please read Cambrex and Cambrex Cork Ltd as Corden PharmaChem, as the change of ownership has not resulted in any change to the contents of all other sections of the original application on 17'h October, 2006.

This delivery includes 3 hard copies, an original and 2 copies and 1 electronic copy-also.

If you have any further queries please contact the undersigned at 021-4978919.

Yours Sincerely,

I , I

Sean Kenrick

021 4878919 '' EHS Manager r

Corden Pharma Ltd TIA Corden PharmaChern Little Island, Cork, Ireland. Registered Office: Directors:

Tel: t353 (0)21 497 8900 - Fax: +353 (0)21 435 3589 E-Mail: cork@cordenpharmachem.com - www.cordenpharmachem.com

90 South Mall, Cork,,lreland. Company No. 45559

Mr. P Burke, Mr. P. Schnitzer (Germany) Dr. A. Riemann (Germany)

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I

SECTION B GENERAL

B.1. Owner/Operator

* Review Applicants Name: Corden Pharma Limited

Address: Little Island, Co.Cork

Telephone N": 02 1-4978900 Fax N": 021-4353589

e-mail : sean.kenrick@cambrex. com

* This should be the name of the review applicant on the date the Review Application is lodged with the Agency. This should be the name of the legal entity (which can be a limited company or a sole trader). A trading/business name is not acceptable.

Address for correspondence : Corden PharmaChem

Little Island, Co.Cork (if different from above)

Address of Body Corporate : INTERNATIONAL CHEMICAL INVESTORS GROUP

(if applicable)

Contact e-mail address

An der Hauptwache 5

603 13 Frankfurt

Germany

: info@,ic-investors.com

Phone +49 (69) 506 999-0

Fax +49 (69) 506 999-1 1

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Confirm whether the information submitted in relation to the legal entity of the company has changed from that detailed in the original application or in the most recent review application.

Has information in relation to legal entity of thc company changed?

Yes Ix) No U

(a) (b) (c)

Certified Copy of Certificate of Incorporation Company’s Number in Company’s Registration Office and Particulars of Registered Office of the Company.

Copies of requested information included in Attachment No. B.l.

Supporting information should form Attachment Ng B.l.

Name and address of the proprietor(s) of the Land on which the Activity is situated (if different from review applicant named above).

Proprietor’s Name: As Above

Address:

Name and address of the owner(s) of the building and ancillary plant in which the activity is situated (if different from review applicant named above).

Name: As above

Address:

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2. Fit and Proper Person:

The EPA Acts, 1992 and 2003 (Section 83(5)(xi)) specifies that the Agency shall not grant a licence unless it is satisfied that the applicant or licensee or transferee as the case may be is a fit and proper person. Section 84(4) of the Act specifies the information required to enable a determination to be made by the Agency. In order for the Agency to make a determination the following is to be provided:

0 Indicate whether the applicant or other relevant person has been convicted under the PoE Act, the Waste Management Act 1996, the Local Government (Water Pollution) Acts 1977 and 1990 or the Air Pollution Act 1987.

Corden PharmaChem has not been convicted under any of the above mentioned Acts. Other relevant personnel and bodies include the senior personnel noted below and previous company names used a t Corden PharmaChem premises, Irish Fher Laboratories Ltd, Irotec laboratories Ltd, Cambrex Profarmaco Cork Ltd and Cambrex Cork Ltd. None of these bodies or persons have been convicted under any of the above mentioned Acts.

0 Provide details of the applicant’s technical knowledge and/or qualifications, along with that of other relevant employees.

Attached in Attachment No. I a re qualifications and experience of Senior Personnel on site L.

0 Managing director 0 EHSManager 0 Operations Manager

0 Environmental Officer R&D and Process Development Manager

0 Provide information to show that the person is likely to be in a position to meet any financial commitments or liabilities that may have been or will be entered into or incurred in carrying on the activity to which the application relates or in consequence of ceasing to carry out that activity.

Corden PharmaChem has a financial and operational record extending beyond thirty years which is unblemished. We have never sought a scheme of arrangement, either formally or informally with our creditors, and have traded without incident since inception.

See also Section H

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ATTACHMENT No. B.l.

(a) Certified Copy of Certificate of Incorporation, Cambrex Profarmaco Cork Ltd and Cambrex Cork Ltd.

Corden business name.pdf Corden Cert of 1ncorporation.pdf

(b) Company's Number in Company's Registration Office and Particulars of 3

"Company details 20071. pdf" Registered Office of the Company.

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Registration of Business Names Act, 1963 CERTIFICATE: OF REGISTRATION

Rusiness Nainr

I'rincipal I'lacc of Busmess LITTLE ISLAND INDVSTKI.;\L, ESTATE LITTLE ISI,AKI) CO. CORK

I HEREBY CERTIFY that a Stateinent of Particulars in Respect ot'thc above Business Naine pursuant to Section 4 of the above mentioiled Act wab registered on 6th Ilecemher, 2006

Dated this 6th December, 2006

Person who h3s registered this business name : C'OKDEN Pt i . l l lMA I.IMITED

Section 7 of the above Act iequircs that wlicnevci a change is made oi occuis in any 01 the particulars registered in respect of an> person, that person shall, uithin one month after tho change furnish by sending by post or dclivering to the iegistrar a statement i n hriting in the prescribed foriii specifying the nature and ddte ofthc change signed and U h a c necessaiy \erified in

lihc nianner as the stateiiient iequircd on registration

Section 8 (2) provides that "a ceitificatc ofregistrdtion shdll be kcpr ekhibited in J

conspicuous position at, in the case o f d firm or individual. the principal place of busincss and in fhc case of J body corporate. ifs registered or principal office in ihc Starc and i n every cdse, in evcry branch office or place where the business is normally carried on, and i f not kept so exhibiicd. the person registercd or. in the cdsc 01 a film. etcry partner in thc firin shall be liable on suinniarj conbiction to D fine not exceedinge 12: "

Section 12 (I)--- "If a person registeicd uiidcr this Act in respect ofa busincss name ccascs to carry on business uiidcr that name, i l shnll be the duty of (Iiai person or. in fhe cast of dn iiidi! idual who dies. of his personal representatibe or, in the Lase of J firm, of every person who as a partner in the firm at thc tmc &hen it ceased 10 carry on business undei that name. and alba in the case o f a body corporate. of any liquidator. within three inonths thereafter to send b! post or deliver to the registrar a sratcmcnl in the prescribed form to that effect, and if he makes default in doing so hl: shall be Iidblc on sumin~ry conviction to a fine not exceedingEl 27 "

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ti; 'P A

Certificate of Incorporation on change of name

1 heruby certify that

C:\ 31 RKE X CORK I. IM IT F, 11

ha\ ing. by a Special Resolution of the Coiiipany. and \+it11 the apprmal of the Registrar of Companies, changed its name, is no\\ incorporatecl as a liinitrd cornpan) under thc lliiliie

and I have entered S U C ~ niinie on tlic Kegistcr accordingly.

Ciivcn under iny h a n d it1 Duhliii, this

Tuesday, the 5 t h clay of December, 2006

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Company Registration Number 45559

Secretary and Registered Office

Mr. Vincent O’Driscoll 90 South Mall Cork

Corden Pharrna Ltd TIA Corden PharmaChem Ltttle Island. Cork, Ireland. Tel: +353 (0)21 497 8900 - Fax: +353 (0)21 435 3589 €-Mail: cork@cordenpharmachern.com ~ www.cordenpharmachem.com

Directors: Mr. P. Burke, Mr. P. Schnitzer (Germany) Dr. A. Riemann (Germany)

Registered Office: 90 South Mall, Cork. Ireland. Company No. 45559

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ATTACHMENT No. I

0 Managing director

"Curriculum Vitae Paudie.doc"

0 EHSManager a') 'I

"CURRICULUM V ITE S Kenrick.doc"

0 Operations Manager

"IPPC Curriculum Vitae.doc"

0 R&D and Process Development Manager

"Curriculum VitaeJA 0 Neill.doc"

0 Environmental officer

"Peter Keegan cv.doc"

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Mr. Sean Kenrick, Corden PharmaChem .

I

' I

1978-1 982

1982-1 984

1985-1 989

1990-1 992

1992-1 996

1997-2001

2001 - 2005

2006

2007

B.E.(Chemical), from University College Dublin

Lecturer in Chemical Technology at Cork Regional Technical College.

Shift Supervisor at Irish Fher Laboratories, Little Island Co. Cork.

Project Engineer, Irish Fher Laboratopries, Little Island, Co. Cork

Engineering Section Head, lrotec Laboratories, Little Island. Co. Cork.

Technical Services Manager, lrotec Laboratories Ltd, Little Island, Co. Cork.

Operations Manager, Cambrex Cork Ltd, Little Island Co. Cork

Environment, Health & Safety and Process Engineering Manager, Cambrex Cork Ltd, Little Island, CO, Cork

Environment, Health & Safety and Process Engineering Manager, Corden PharmaChem, Little Island, CO, Cork

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Peter Keegan Environmental Officer Corden PharmaChem

0214978973

Work Experience

Corden PharmaChem Position: Environmental Officer July 06-Date

0 Management of EMS 0 Comliance with Licence 0 Env auditing, training and awareness

Costello Agricultural Consultants Position: Agricultural Consultant

Feb ’06 - June ‘06

Advising clients on REPS and other environmental schemes. Liaising with clients on a daily basis monitoring progress and developments.

Nestle Foods, Australia Position: Environmental/Safety Consultant

Jan ‘05-0ct ‘05

Set up and implemented safety management systems, IS018001 in a number of different Nestle sites across Australia. Set up Environmental Management Systems, I S 0 14001, in the same Nestle sites. Reviewed operations of wastewater treatment plants at Nestle sites in Melbourne, namely Mulgrave and Pakenham.

Vector Facilities Management Honeywell March ‘04 - Oct ‘04 Position: Environmental Engineer

Reviewed and optimised operations of wastewater treatment plant at Honeywell

Vector Facilities Management Hewlett Packard Dec ‘01 - March ‘04 Position Environmental Engineer

Maintained and updated EMS for Hewlett Packard Set up EMS for Vector FM Reviewed and optimised treatment of wastewater treatment plant Ensured compliance with IPC licence and other applicable environmental legislatiodregulations Implemented Energy reduction measures as part of the Energy Reduction Team

Education

Queens University of Belfast Sept ‘00 - ‘Oct 01

Title: MSc Environmental Engineering

University of Limerick

Title: BSc Environmental Science

Sept ‘96 -June ‘00

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Curriculum Vitae

John Anthony O'Neill, B.Sc., Ph.D. C. Chem. MRSC

Positions Held

Corden PharmaChem, Co. Cork (2001 to present) Research and Development Manager.

Pfizer Pharmaceuticals, Loughbeg, Co. Cork (1995 to 2001) (formerly Warner-Lambert and Hickson PharmaChem) Process Development Chemist Departmental Supervisor Technology Transfer Manager

Manro Products Ltd., Stalybridge, England (1 989-1990) Senior Development Chemist

Beecham Pharmaceuticals, Epsom, England (1987 to 1989) Process Development Chemist

Academic Qualifications

BioResearch Ireland/ University College Cork, Ireland (1 994 to 1995) Post-Doctorate Research

University of Bristol/AgroEvo (1 990 to 1993) Industrially sponsored Ph.D. in organic synthesis and bio-synthetic studies

University of Limerick (1983 to 1987) B.Sc. in Industrial Chemistry

Publications

J. A. O'Neill, T. J. Simpson and C. L. Willis, "Biosynthesis of Colletodiol and Related Polyketide Macrodiolides in Cytospora sp. ATCC 20502: Synthesis and Metabolism of Advanced Intermediates", J Chem. Soc., Chem. Comm., 1993,738

J. A. O'Neill, T. J. Simpson and C. L. Willis, "Structures of Bartanol and Iso-bartanol, Novel Macrodiolide Metabolites from Cylospora sp ATCC 20502", J. Chem. Soc., Perkin Trans. 1, 1994, 2493-2497

J. A. O'Neill, S. D. Lindell, T. J. Simpson and C. L Willis, "A Simple Enantioselective Synthesis of g- Valerolactone", Tetrahedron Asymmetry, 1994, 5, 1 17-1 18

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Education

1987-1991

Curriculum Vitae

Gary Collins, Cambrex Cork Ltd.

B. E. (Chemical) (Hons) University College Dublin

Experience

Merck & Co., Inc., Virginia, USA.

199 1-1995

1995-1998

1998-200 1

200 1-2004

Technical Operations - Engineer, Staff Engineer

Organic Synthesis (Fl) - Project Engineer, Superintendent

Bulk Sterile Antibiotic (F7) - Department Head

Materials Management - Planning Manager, Procurement Manager, Area Head (Acting)

Capital Projects/Engineering - Capital Team Leader 2004-2005

' Cambrex Cork Ltd., Cork.

2005-6 Operations - Operations Manager

Corden PharmaChem, Cork

2007 Operations - Operations Manager

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Curriculum Vitae

Name:

Date of Birth:

Nationality:

Qualifications:

1981 - 1985

1989

1999

Employment:

1985 - 1989

1989 - 1992

1992 - 1997

1997 - 2001

2002 to 2006

2007

Patrick Burke, Cambrex Cork Ltd.

24/07/63

Irish

B. Commerce, U.C.C., Cork. Ireland.

1989 Member of Institute of Chartered Accountants in Ireland (ICAI)

1999 Fellow of ICAI

Audit Senior, KPMG, Cork.

Accounting Section Head, Irotec Laboratories Limited, Cork.

Financial Controller, Irotec Laboratories Limited, Cork.

Site Manager, Irotec Laboratories, Cork.

Managing Director, Cambrex Cork Ltd., Cork.

Managing Director, Corden PharmaChem, Cork.

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