Document:

exv10w10

 

Exhibit 10.10

RESTORE MEDICAL, INC.

MANAGEMENT INCENTIVE PLAN

	1.	 	PURPOSES.

     (a) The purpose of the Plan is to provide a means by which selected Key Employees of the
Company may be given an opportunity to participate in the proceeds of a Change of Control
transaction.

     (b) The Company, by means of the Plan, seeks to retain the services of persons who are now Key
Employees of the Company, to secure and retain the services of new Key Employees, and to provide
incentives for such persons to exert maximum efforts for the success of the Company.

	2.	 	DEFINITIONS.

     (a) “Management Bonus” means an amount of cash and/or securities, determined pursuant to the
Plan, equal to twenty-five percent (25%) of the total amount of gross proceeds upon a Change of
Control, if any, in excess of $72,000,000, up to a maximum aggregate bonus of $3,300,000.

     (b) “Board” means the Board of Directors of the Company.

     (c) “Change of Control” means any consolidation or merger of the Company with or into another
corporation or entity (after which the pre-existing shareholders of the Company do not own a
majority of the outstanding shares of the surviving entity), an acquisition or sale of
substantially all of the assets of the Company or a sale of stock in a single transaction (or
several related transactions) to one person (or a group acting together) who, as a result of such
transaction, shall own more than 50% voting control of the Company, or any voluntary or involuntary
liquidation, dissolution or winding up of the affairs of the Company.

     (d) “Closing” means the closing of a transaction constituting a Change of Control.

     (e) “Company” means Restore Medical, Inc., a Minnesota corporation.

     (f) “Key Employee” means any current or former employee or consultant of the Company who is
designated by the Chief Executive Officer and approved by the Board from time to time as a Key
Employee. The individuals currently designated as Key Employees are set forth on Exhibit A of the
Plan.

     (g) “Plan” means this Restore Medical, Inc. Management Incentive Plan.

     (h) “Restated Articles” means the Amended and Restated Articles of Incorporation of Restore
Medical, Inc.

 

 

	3.	 	ADMINISTRATION.

     (a) The Plan shall be interpreted and administered by the Board, whose actions shall be final,
binding and conclusive on all persons, including the Key Employees. The Board may, in its sole
discretion, increase, decrease or eliminate a previously authorized percentage allocation to a Key
Employee upon a determination by the Board that such percentage is no longer reflective of the Key
Employee’s contributions to the Company. Any such increase of a percentage for a Key Employee
shall decrease the other percentages of Key Employees and any such decrease or elimination of a
percentage for a Key Employee by the Board shall increase the other percentages of Key Employees,
in each case, on a pro rata basis unless otherwise designated by the Chief Executive Officer and
approved by the Board.

     (b) The Board, in its sole discretion, shall have the power, subject to, and within the
limitations of, the express provisions of the Plan:

     (i) To approve from time to time which employees of the Company are designated by the
Chief Executive Officer as Key Employees entitled to participate in the Plan. This
authority shall also include the ability to approve the proposal by the Chief Executive
Officer and the Executive Chairman that one or more employees previously designated as Key
Employees shall no longer be entitled to participate in the Plan.

     (ii) To approve the percentage allocation of the cash or securities in the Management
Bonus to each of the Key Employees proposed by the Chief Executive Officer.

     (c) The Board may delegate some or all of its powers and responsibilities under the Plan to a
committee of the Board.

4. ALLOCATION OF MANAGEMENT BONUS.

     (a) The allocation of the Management Bonus to individuals designated as Key Employees as of
the date hereof shall be as set forth on Exhibit A, and subject to the terms of this Plan.

     (b) In the event that the Company’s outside accounting firm determines that a distribution to
a Key Employee under Section 5 would result in the imposition of a “parachute payment” excise tax
under Section 4999 of the Internal Revenue Code of 1986, as amended (the “Code”), the Chief
Executive Officer may reallocate the Management Bonus among Key Employees in a manner that reduces
or eliminates the amount of such excise tax.

     (c) Any percentage amounts that are unallocated at the time of a Change of Control shall be
allocated immediately prior to such Change in Control in accordance with the recommendation of the
Company’s Chief Executive Officer and approval of the Board. If no such recommendation is provided
and Board approval received, such unallocated percentage amounts shall be distributed on a pro-rata
basis among the existing Key Employees at such time.

2

 

	5.	 	DISTRIBUTIONS.

     (a) If the conditions for distributions set forth in the Plan are satisfied, each Key Employee
shall be entitled to receive upon the Closing and simultaneously with payments to the Company’s
shareholders, a distribution equal to (i) such Key Employee’s allocation of the Management Bonus
times (ii) the aggregate dollar value of the Management Bonus, subject to the limitations set forth
in Section 4 above. Such distributions shall be made in cash and/or securities, as determined by
the Board, in its sole discretion. While generally each participant will receive his or her
distributive share of the Management Bonus in the same form or forms of payment and in the same
proportions paid by the purchaser(s) upon the Change of Control, the Board shall have the
discretion to restructure the form and timing of payment of such distributions to accommodate the
business objectives of the Company in the Change of Control, which may include, but not be limited
to, (x) consideration of the tax consequences to the Company, its shareholders, and the Plan’s
participants, (y) financial accounting consequences for the Company or the acquiror, and (z)
satisfaction of any applicable securities law requirements.

     (b) Any securities that are issued to the Key Employees pursuant to this Plan shall be subject
to the same or similar restrictions as imposed by a purchaser on the securities of the Company’s
shareholders as set forth in the agreement pursuant to which the Control of Control occurs.

     (c) Subject to any adjustments made under Section 5(a) above, if any, payments to Key
Employees under the Plan shall be made within 30 days of the Closing (provided that proceeds from
the Change of Control event shall have been made available to the Company within such period, or
otherwise immediately upon receipt of such proceeds from the Change of Control), except for
payments to be made with respect to contingent payments payable in connection with a Change of
Control, which shall be made as soon as administratively reasonable following the receipt by the
Company or its shareholders of such payments.

     (d) Key Employees must be employed as of the closing date of the Change of Control transaction
in order to be eligible to receive any payments pursuant to the Plan.

	6.	 	AMENDMENT OR TERMINATION OF THE PLAN.

     (a) The Board at any time, and from time to time prior to the Closing, may amend or terminate
the Plan, so long as such actions are approved after consultation with the Chief Executive Officer
and, subject to Section 3(a), do not adversely affect any beneficiary of this Plan.

     (b) The Plan shall automatically terminate upon the earliest to occur of (i) December 31,
2003, unless a Change of Control has occurred prior to such date, (ii) the Closing and completion
of all payments under the terms of the Plan, and (iii) the automatic conversion of all of the
Company’s outstanding preferred stock into common stock pursuant to Section 3.7 of the Restated
Articles (or any successor provision thereto).

3

 

	7.	 	NO GUARANTEE OF FUTURE SERVICE.

     Selection of an individual to participate in the Plan shall not provide any guarantee or
promise of continued service of the participant with the Company, and the Company retains the right
to terminate the employment of any employee at any time, with or without cause, for any reason or
no reason, except as may be restricted by law or contract.

	8.	 	TAX WITHHOLDING.

     The Company shall withhold from any distributions under the Plan any amount required to
satisfy the Company’s income and employment tax withholding obligations under any applicable
Federal and State laws.

	9.	 	COMPANY OBLIGATIONS.

     The Plan shall constitute a liability of the Company that shall be satisfied prior to any
distributions to shareholders of the Company. Further, the Company shall use its best efforts to
provide that a portion of the net proceeds from any transaction that results in a Change in Control
be distributed in substantial accordance with the terms of this Plan, subject to the fiduciary
duties applicable to the Company and the Board; provided, however, that failure by the Chief
Executive Officer to propose a reasonable initial recommendation of allocations for the Management
Bonus or failure by the Board to reasonably approve such initial recommendation shall not operate
to delay, block or otherwise impede the Company’s undertaking a Change of Control or making
payments to the Company’s shareholders resulting therefrom

	10.	 	CHOICE OF LAW.

     All questions concerning the construction, validation and interpretation of the Plan will be
governed by the law of the State of Minnesota.

	11.	 	SUCCESSORS; THIRD PARTY BENEFICIARIES.

     This Plan shall be binding upon any successor to the Company. The Company acknowledges that
the Key Employees will rely on the provisions of this Plan and therefore agrees that the Key
Employees shall be deemed to be third parties beneficiaries hereof.

	12.	 	SEVERABILITY.

     If any provision of this Plan is held by a court of competent jurisdiction to be invalid, void
or unenforceable, the remaining provisions shall nevertheless continue in full force and effect
without being impaired or invalidated in any way and shall be construed in accordance with the
purposes, tenor and effect of this Plan.

	13.	 	HEADINGS.

     The headings in the Plan are inserted for convenience only and shall not be deemed to
constitute a part hereof nor to affect the meaning thereof.

4

 

     The Plan has been adopted by the Board of Directors of the Company effective as of the
12th day of June, 2003

	 	 	 	 	 
	 	RESTORE MEDICAL, INC.

 	 
	 	By:  	/s/ Susan L. Critzer
 	 
	 	 	Name:  	Susan L. Critzer 	 
	 	 	Title:  	President and Chief Executive Officer 	 

5

 

	 	 	 	 	 

EXHIBIT A

	 	 	 	 	 
	Name of Key Employee	 	Percent of Management Bonus
	Mark B. Knudson

	 	 	10.0	%
	Susan L. Critzer

	 	 	14.0	%
	Bob Campbell

	 	 	10.0	%
	Ed Numainville

	 	 	7.5	%
	Tim Conrad

	 	 	3.0	%
	Robert S. Nickoloff

	 	 	3.0	%
	Brian Erickson

	 	 	3.0	%
	Phil Radichel

	 	 	3.0	%
	John Sopp

	 	 	3.0	%
	Jim Kruse

	 	 	3.0	%
	Dale Noel

	 	 	3.0	%
	Lisa Asper

	 	 	3.0	%
	Dean Horstman

	 	 	3.0	%
	Dave Coleman

	 	 	3.0	%
	Glen Peterson

	 	 	3.0	%
	Brett Biener

	 	 	3.0	%
	New Sales Representative

	 	 	3.0	%
	All Other Employees

	 	 	15.0	%
	 
	 	 	 	 
	TOTAL:

	 	 	100.0	%

A-1exv10w12

 

Exhibit 10.12

QUALITY FIRST INTERNATIONAL

EU Authorised Representative Contract for Services

This contract is between Restore Medical, Inc., 2800 Patton Road, Roseville, Minnesota 55113,
USA (referred to in this contract as the Company) and Quality First International (referred to in
this contract as QFI) of: Suites 317/318, Burford Business Centre, 11 Burford Road, Stratford,
London, E15 2ST, United Kingdom.

Contact for the Company: Mr. E. Numainville

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 20 Eversley Road, Bexhill on Sea, East Sussex, TN40 1HE, United Kingdom

 

 

	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.

 2 of 10

 

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.

 3 of 10

 

	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

20 Eversley Road

Bexhill on Sea

East Sussex

TN401HE

United Kingdom

Telephone: +44-208-221-2361

Telefax:      +44-208-221-1912

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.

 4 of 10

 

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, East Sussex,
TN34 1HW, United Kingdom, Bank swift code 40-05-15, account 39157053 605837285-561,
IRAN GB10 MIDL 4005 1539 1570 53, BIC MIDLGB22.

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.

 5 of 10

 

	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.

 6 of 10

 

	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.

 7 of 10

 

	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/ Edward W. Numainville	 
	 

	 	 	 	 

	 	 	 	 	 
	 
	 	 	 	 
	Title: Vice President Regulatory/Clinical Affairs	 	 
	 
	 	 	 	 
	Name: Edward W. Numainville	 	 
	 
	 	 	 	 
	Date: February 9, 2005
	 	 	 	 

 8 of 10

 

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.

 9 of 10

 

	 	 	 	 	 
	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/ Edward W. Numainville
	 

	 	 	 	 

	 	 	 	 	 
	 
	 	 	 	 
	Title: Vice President Regulatory/Clinical Affairs	 	 
	 
	 	 	 	 
	Name: Edward W. Numainville	 	 
	 
	 	 	 	 
	Date: February 9, 2005
	 	 	 	 

 10 of 10

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00099-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00099-of-00352.parquet"}]]