licence transfer application form step 1: guidancethe certificate shall be retained by the public...

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Licence Transfer Application Form Step 1: Guidance Current Licensee Contact Name Simon Garrett Contact Position EHS&S Senior Manager Date 10/01/2017 Proposed Transferee Contact Name Liam Nagle Contact Position EHS Specialist Date 14/11/2017 Licence Transfer Application Report - P0016-02 Page 1 of 22 For inspection purposes only. Consent of copyright owner required for any other use. EPA Export 18-11-2017:03:47:33

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Page 1: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

Licence Transfer Application Form

Step 1: Guidance

Current Licensee

Contact Name Simon Garrett

Contact Position EHS&S Senior Manager

Date 10/01/2017

Proposed Transferee

Contact Name Liam Nagle

Contact Position EHS Specialist

Date 14/11/2017

Licence Transfer Application Report - P0016-02 Page 1 of 22

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Page 2: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

Step 2: Current Licensee

Licence Reg No P0016-02

Licensee Janssen Pharmaceutical

Licence County Cork

Site Location Wallingstown, Little Island, Cork

ELRA / CRAMP Review

Provide additional information on ELRA / CRAMPThe ELRA and CRAMP have been submitted to the EPA for approval.The EPA are currently reviewing hte ELRA and the CRAMP.

Request ELRA / CRAMP Status? ELRA/CRAMP Approved

Contact Information

Proposed Transferee Organisation Janssen Pharmaceutical Sciences UC

Proposed Transferee Contact Email [email protected]

Reason for licence transfer request

The transfer is requested due to a legal entity change. This is resulting in a name change but also a CRO number change. The transfer is requested to transfer the licence and all liabilities to the new entity.

Desired date for proposed transfer to take effect 18/11/2017

Confirm Enforcement Charges Paid Yes

Specify Outstanding Enforcement Charges €0.00

Additional Information

Additional Information Please find attached the EPA licence along with amendments A an B.

Licence Transfer Application Report - P0016-02 Page 2 of 22

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Page 3: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

Step 3: Proposed Transferee

Name Janssen Pharmaceutical Sciences UC

Address Little Island Industrial Estate, Little Island, T45 P663, Cork

Transfer Contact Liam Nagle

Additional Transfer Contacts

Name Position Home Phone Mobile Phone Email

General Background

Business Activity The production of pharmaceutical products including intermediates.

Date Established 02/01/2017

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

Management and Supervisory Details

Name Details of Relevant Education, Training and Experience Responsibilities

Pat Fitzgerald Degree and Masters in Science/Engineering subjects. EHS Manager

Kyran Johnson Degree Qualified General Manager

Licence Transfer Application Report - P0016-02 Page 3 of 22

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Page 4: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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

Additional Information

Financial Provision in place? Yes

Additional Information

Licence Transfer Application Report - P0016-02 Page 4 of 22

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Page 5: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

Step 4: Fees, Declaration and Submit

Payment Amount €2,000

Payment Method EFT

Payment Date 24/11/2017

Application Submission Date 17/11/2017

Licence Transfer Application Report - P0016-02 Page 5 of 22

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Page 6: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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Page 7: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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Page 8: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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Page 9: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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Page 10: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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Page 11: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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Page 12: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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Page 13: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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Page 14: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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Page 15: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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Page 16: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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Page 17: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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Page 18: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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Page 19: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

Short Certificate of Incorporation of a Company (Electronic Form, for Public Service Use only)

I hereby certify

Certified by me at Dublin, this Thursday, the 16th day of November, 2017.

( )69662F

Registrar of Companies

I make this Declaration for the benefit of

(name of public body) __________________________________________________

to whom I am furnishing the Certificate.

__________________ _______________________Signature of Applicant Date Forgery Act 1913, section 4 and 6

hereby declare that this is one and the same as the Certificate of Incorporation of the above company that was made available electronically, for public service use, at my request, by the registrar of companies. I further declare that to the best of my knowledge, information and belief, the said Certificate has not been altered or amended in any way. I acknowledge that it is a criminal offence to forge a public document with intent to defraud or deceive, and that it is an offence to utter a forged document with intent to defraud or deceive, in each case punishable with imprisonment for a term not exceding two years.

I, (name)of (address)

NoteThe above certificate of incorporation is furnished free of charge by the registrar of companies and is valid solely for public service use. A process has been put in place whereby, where necessary, the certificate may be verified by a public service body on inquiry to the registrar.

The applicant for any public service who is required to produce a certificate of incorporation must certify below that the certificate has not been tampered with in any way. The certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any wrongful use.

Companies Act 2014, section 216; Electronic Commerce Act 2000, sections 12 and 13

Tuesday, the 24th day of November, 2015.

572261that company number

as a Unlimited Company on

JANSSEN PHARMACEUTICAL SCIENCES UNLIMITED COMPANY

was Incorporated under the Companies Act 2014

Licence Transfer Application Report - P0016-02 Page 19 of 22

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Page 20: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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Page 21: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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Page 22: Licence Transfer Application Form Step 1: GuidanceThe certificate shall be retained by the public service organisation that requires its delivery and may be used as evidence of any

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