EU Authorised Representative Contract for Services
Exhibit 10.12
QUALITY FIRST INTERNATIONAL
This contract is between Restore Medical, Inc., 0000 Xxxxxx Xxxx, Xxxxxxxxx, Xxxxxxxxx 00000,
XXX (referred to in this contract as the Company) and Quality First International (referred to in
this contract as QFI) of: Xxxxxx 000/000, Xxxxxxx Xxxxxxxx Xxxxxx, 00 Xxxxxxx Xxxx, Xxxxxxxxx,
Xxxxxx, X00 0XX, Xxxxxx Xxxxxxx.
Contact for the Company: Xx. X. Xxxxxxxxxxx
Contact for QFI: H. Atchia
Date of commencement: 16 June 2003
Leading People — Leading Change
Quality First International is a trading name of Quality First International Limited, a company
registered in England No 03103506.
Registered Office 00 Xxxxxxxx Xxxx, Xxxxxxx xx Sea, Xxxx Xxxxxx, XX00 0XX, Xxxxxx Xxxxxxx
| 1.0 | Provision of QFI personnel |
1.1 QFI agree to act as the Company’s EU Authorised Representative.
1.2 The technical competence and necessary experience required by such a role will be
provided by Mr H Atchia, Technical Director currently registered with the appropriate
Competent Authorities as EU Authorised Representative, for the products covered by this
contract and referred to in QFI form Schedule A.
1.3 The administration of the services provided under this contract and responsibility for
liaising between the Company and QFI, and QFI and the Competent Authority will be provided
by the EU Authorised Representative Client Co-ordinator (EURCC), appointed by QFI from QFI’s
full-time staff.
| 2.0 | Services provided by QFI |
2.1 Interpretation of requirements.
2.2 Completion, review, approval and submission of all necessary documentation required by
the Competent Authority.
2.3 Registration of these matters on the Company’s behalf.
2.4 Safe keeping of all copies of the Company’s current listings of products registered by
QFI with the Competent Authority on the Company’s behalf covered by the Declaration of
Conformity.
2.5 Safe keeping of records relating to discussions with the Competent Authorities on the
Company’s behalf.
2.6 Receipt of information concerning incidents referred to in Article 10 of the Council
Directive 93/42/EEC (commonly known as the Medical Devices Directive) and/or Article 11 of
Council Directive 98/79/EC (commonly known as the In vitro Diagnostic Medical Devices
Directive) and 65/65/EEC (relating to medicinal products as applied to Blood Bags)
communication of such information to the Company.
| 3.0 | Responsibility of the Company |
3.1 The Company should ensure that the Medical Devices Vigilance system guidelines are made
known to persons responsible for placing devices on the market and any other agents
authorised to act on the Company’s behalf so that the Company’s responsibilities may be
fulfilled.
3.2 The Company must report all incidents fulfilling the notification criteria as well as
notifications such as Product Recall and Safety Alert notices to QFI.
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3.3 The Company shall institute documented procedures for alerting QFI of changes in
relevant company and product information in order for QFI to complete any registration or
re-registration of products/personnel with the Competent Authority.
3.3.1 Such information shall include the Company contact person for the purposes of
communication with QFI, product range (including new products and products to be
discontinued, change of intended use or other factors that alter the classification
of the product under the rules specified in Annex IX Council Directive 93/42/EEC as
relevant and any relevant compliance issues which could affect such registration).
3.3.2 The QFI Schedule A form (or agreed equivalent) shall be used for such
purposes.
| 4.0 | Timescale for the initial reporting of an incident or near incident |
4.1 Incidents ten (10) days.
4.2 Near incidents thirty (30) days.
4.3 The times given above are the maximum times for determining the relevant facts and
making an initial report to the appropriate Competent Authority.
4.4 Due to the strict reporting timetable requirements the Company must have a sound and
effective reporting mechanism in place between the Company’s end users, the Company’s
distributors and the Company’s own organisation which will allow speedy and complete
reporting to the Company’s EU Authorised Representative. Once the Company is aware of an
incident or near incident, it must ensure notification to QFI within twenty four (24) hours.
| 5.0 | Systematic recalls |
5.1 Any technical or medical reason for the systematic recall of a device is required by the
Directives to be notified by the manufacturer to the appropriate Competent Authority.
5.2 Copies of advisory notices implementing recalls should be sent by the manufacturer to
the appropriate Competent Authority before or at the same time as the notices are sent to
the relevant users.
| 6.0 | Commercial removal from the market |
6.1 Removals from the market for a purely commercial reason are not required to be reported
to the relevant Competent Authority but should be reported to QFI.
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| 7.0 | Labelling & packaging requirements |
7.1 The Company is obliged to list QFI’s details as agreed on all labels, packaging or user
instruction manuals/leaflets.
EU Authorised Representative
QUALITY FIRST INTERNATIONAL
00 Xxxxxxxx Xxxx
Xxxxxxx xx Xxx
Xxxx Xxxxxx
XX000XX
Xxxxxx Xxxxxxx
QUALITY FIRST INTERNATIONAL
00 Xxxxxxxx Xxxx
Xxxxxxx xx Xxx
Xxxx Xxxxxx
XX000XX
Xxxxxx Xxxxxxx
Telephone: x00-000-000-0000
Telefax: x00-000-000-0000
Telefax: x00-000-000-0000
7.2 Copy artwork of the EU Authorised Representative details must be sent to QFI for
approval before going to print.
7.3 QFI guarantees that the address, telephone and fax details will not change without a
sufficient period of notice to be agreed, save for any changes in area code as may be made
by the telephone companies.
7.4 Any variation in the appearance and details on labels, packaging and user instruction
manuals or leaflets must be agreed between the Company and QFI.
| 8.0 | Confidential information |
8.1 QFI will not disclose confidential information relating to the services under this
contract to any third party. This does not affect the obligation of QFI to provide
information under civil or criminal law.
| 9.0 | Work records |
9.1 QFI will keep records of all work done under the contractual terms in accordance with
QFI’s standard approved procedures.
| 10.0 | Fees |
10.1 Where this contract is first entered into between QFI and the Company a First
registration fee of US $195 (one hundred and ninety-five Dollars US) payable on return of
the signed contract by the Company.
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10.2 Annual fee for undertaking the role of EU Authorised Representative, is US $3245 (three
thousand two hundred and forty-five Dollars US) for the contract period of TWELVE (12)
months from the date of signature by the Company, payable on return of the signed contract,
covering up to TEN (10) reported incidents or other notifications to the Competent Authority
within that TWELVE (12) month period.
10.2.1 QFI will maintain the annual fee for undertaking the role of EU Authorised
Representative for a period of three (3) years commencing the execution of this
contract
10.2.2 Registration of additional products and changes to an existing, registered
product attracts a unit charge of US $125 (one hundred and twenty-five Dollars US)
for each product.
10.3 Any additional reported incidents or other notifications will be charged at an
individual rate of US $125 (one hundred and twenty-five Dollars US) each as an additional
unit fee.
10.3.1 QFI will maintain the additional unit fee for a period of three (3) years
commencing the execution of this contract.
10.4 The Company agrees to make all payments by bank transfer.
10.4.1 Payment by bank transfer shall be made nett of charges to Quality First
International Limited’s account at HSBC Plc, Hastings Branch, Hastings, Xxxx Xxxxxx,
XX00 0XX, Xxxxxx Xxxxxxx, Bank swift code 40-05-15, account 00000000 605837285-561,
IRAN XX00 XXXX 0000 0000 0000 00, BIC XXXXXX00.
10.4.2 The Company shall ensure all bank charges for transfers are paid and that
nett amounts are received in QFI’s account
10.5 Banking wire transfer charges per transfer of US $45 (forty-five Dollars US).
10.6 All amounts due must be received gross by QFI.
| 11.0 | Extra charges |
11.1 The Company will be responsible for all additional charges incurred by QFI as a result
of the provision of services where the Competent Authority requires work of QFI which is not
part of the normal reporting procedure.
11.2 QFI will keep the Company informed when this occurs and where possible inform the
Company in advance of the likely cost of this additional requirement from the Competent
Authority.
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| 12.0 | Payment terms |
12.1 Invoices requesting First Registration Fee and the Annual Fee must be paid in full
before QFI will undertake the provision of the above services.
12.2 Where the Company forwards details of any additional reported incidents or other
notifications to QFI over and above the agreed TEN (10) (as referred to in Section 10.2
above) the Company shall at the same time forward to QFI the additional unit fee (as
referred to in Section 10.3)
| 13.0 | Advice & information |
13.1 The EU Authorised Representative Contract in principle is for QFI to act as a receiving
and forwarding communications representative between the Company and the Competent
Authority.
13.2 The reporting time requirements are the responsibility of the Company through the
creation of suitable systems and procedures to ensure notification of adverse incidents
meeting the notification criteria of the Medical Device Vigilance system (MDVs) guidelines.
13.2.1 Where necessary, the Company’s procedures for MDVs notification shall be
harmonised to ensure QFI’s turnaround time for completion of such notification can
be fulfilled.
13.2.2 The Company will ensure that any adverse incident notification submissions
are communicated to QFI in finished from no less than one working day before the
expiry of the relevant reporting time requirement for notification to the Competent
Authority by QFI.
13.2.3 QFI will implement documented procedures to ensure notification time
requirements of the MDVs guidelines are achievable.
13.3 The accuracy of the details of any reported incident and/or notification are the
responsibility of the Company.
13.3.1 QFI will implement documented procedures to ensure review of adverse incident
reports and will confirm completion of notifications made to the Competent Authority
within one (1) working day to the Company.
13.3.2 QFI will implement documented procedures to ensure review and communication
of relevant adverse incident communications from the Competent Authority within one
(1) working day to the Company.
13.4 The provision of advice and/or information by QFI is in confidence.
13.5 Liability other than death or personal injury as the result of the provision of advice
and/or information by QFI, is hereby excluded.
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| 14.0 | Renewal |
14.1 Upon the anniversary of the date of commencement, continuation of the EU Authorised
Representative Contract may be entered into subject to:
(a) satisfactory annual technical documentation review of the Company’s file.
(b) the receipt by QFI of the fees for the forthcoming years service.
| 15.0 | Termination |
15.1 This contract will terminate upon a breach of condition by either party where the
injured party elects not to continue with the contract
15.2 By the Company serving written notice on QFI stating that
(1) QFI details have been removed from all Company labels and
(2) that QFI is no longer the EU Authorised Representative of the. Company.
15.3 By QFI serving written notice on the Company stating that
(1) QFI no longer acts as the Company EU Authorised Representative and
(2) stating that QFI requires the Company to remove all QFI details from all Company
labels.
15.4 The period of written notice as referred to in 15.2 and 15.3 shall be a reasonable
period taking into account the length of time the contract period has to run. Where there
is a dispute as to length of written notice, term 16.1 shall apply.
| 16.0 | Arbitration |
16.1 In the event of any dispute whether as to law or fact or mixed law and fact between the
Company and QFI, the parties agree to resolve the dispute amicably failing which the dispute
will be referred to an arbitrator appointed by the Chartered Institute of Arbitrators. The
arbitrator’s decision shall be final.
| 17.0 | Start date |
17.1 QFI will consider itself bound by the terms of this contract for the contract period
from 1 January 2005 upon signature by the Company.
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| 18.0 | Acceptance |
As agent for QFI
|
/s/ H. Atchia | |||
Title:
|
Technical Director | |||
Name:
|
H A R D Atchia | |||
Date:
|
January 25, 2005 | |||
| Accepted on the terms herein stated: | ||||
As
agent for the Company:
|
/s/ Xxxxxx X. Xxxxxxxxxxx | |||
| Title: Vice President Regulatory/Clinical Affairs | ||||
| Name: Xxxxxx X. Xxxxxxxxxxx | ||||
Date: February 9, 2005 |
||||
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EU Authorized Representative Contract for Services
Annual renewal of EU authorized representative contact
In accordance with the Renewal term 14.1 (a) and (b), please sign below and confirm:
(1) that you will provide QFI with the following:
(i) updates for various products you sell bearing the CE marking of conformity to update the
Product Registration File we have notified to the Competent Authority.
(ii) Copies of the latest versions of the following information for all products placed on the
market since initial CE marking by your company plus any new product (as agreed):
a) Description of each product,
b) Intended use of each product, including an example of unit and outer labels and
Instructions for Use or equivalent),
c) Declaration of Conformity,
d) CE and Quality System Certificates,
e) Date of commencement of manufacture of each product,
f) A list of all technical documentation and related certificates,
g) Breakdown of complaints, corrective and preventive action performed for these
complaints plus complaints analysis,
h) Hazard evaluation (risk analysis), including the Risk Management File according
to EN 1441/EN ISO 14971,
i) “technical” file or summary of content,
j) List of design changes since First Placement of the Product on the Market with
the CE marking of conformity,
k) Copies of the relevant registration letters, authorisations and Certificates
issued by regulatory authorities and other inspection bodies for the device.
l) 27 original letters of appointment of QFI as EUAR for the Company.
for US manufacturers, please would also send the following documents with FDA:
a) Establishment Registration,
b) Device listing.
(iii) Summary of clinical data for each product according to Article 15/Annex X Council Directive
93/42/EEC
so that the annual technical documentation review of your company’s file may be conducted.
(2) that the amount of $3245.00 will be forwarded to QFI by return, together with the transfer
charge of $45 in accordance with term 10.4.
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As agent for QFI
|
/s/ H. Atchia | |||
Title:
|
Technical Director | |||
Name:
|
H A R D Atchia | |||
Date:
|
January 25, 2005 | |||
| Accepted on the terms herein stated: | ||||
As
agent for the Company:
|
/s/ Xxxxxx X. Xxxxxxxxxxx | |||
| Title: Vice President Regulatory/Clinical Affairs | ||||
| Name: Xxxxxx X. Xxxxxxxxxxx | ||||
Date: February 9, 2005 |
||||
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