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AMENDED AND RESTATED CONTRIBUTION AGREEMENT

Contribution Agreement

AMENDED AND RESTATED CONTRIBUTION AGREEMENT | Document Parties: Inverness Medical Innovations, Inc | Procter & Gamble Company | PROCTER & GAMBLE INTERNATIONAL OPERATIONS, SA You are currently viewing:
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Inverness Medical Innovations, Inc | Procter & Gamble Company | PROCTER & GAMBLE INTERNATIONAL OPERATIONS, SA

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Title: AMENDED AND RESTATED CONTRIBUTION AGREEMENT
Governing Law: New York     Date: 5/23/2007
Industry: Biotechnology and Drugs     Law Firm: Covington Burling;Goodwin Procter     Sector: Healthcare

AMENDED AND RESTATED CONTRIBUTION AGREEMENT, Parties: inverness medical innovations  inc , procter & gamble company , procter & gamble international operations  sa
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Exhibit 2.2

Execution Copy

================================================================================

AMENDED AND RESTATED

CONTRIBUTION AGREEMENT

dated as of May 17, 2007

among

INVERNESS MEDICAL SWITZERLAND GMBH,

PROCTER & GAMBLE INTERNATIONAL OPERATIONS, SA

and

SPD SWISS PRECISION DIAGNOSTICS GMBH

================================================================================

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TABLE OF CONTENTS

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ARTICLE 1 FORMATION AND CONTRIBUTIONS.................................... 3

Section 1.1 Formation of the Company; Sale of Shares to PGIO....... 3

Section 1.2 Transfer of the Contributed CD Business................ 3

Section 1.3 Excluded Assets........................................ 5

Section 1.4 Assumption of Liabilities.............................. 7

Section 1.5 Liabilities Not Assumed by the Company................. 9

Section 1.6 Additional Contributions............................... 10

ARTICLE 2 CLOSING........................................................ 11

Section 2.1 Closing................................................ 11

Section 2.2 Closing Deliveries..................................... 11

ARTICLE 3 REPRESENTATIONS AND WARRANTIES OF IMS AND IMA.................. 13

Section 3.1 Organization and Existence............................. 13

Section 3.2 Power and Authority; Binding Agreement................. 14

Section 3.3 Noncontravention....................................... 14

Section 3.4 Compliance with Laws................................... 15

Section 3.5 Governmental Licenses.................................. 15

Section 3.6 Financial Statements................................... 16

Section 3.7 Absence of Changes or Events........................... 17

Section 3.8 Undisclosed Liabilities................................ 17

Section 3.9 Assets other than Real Property........................ 17

Section 3.10 [Reserved]............................................. 17

Section 3.11 Contracts.............................................. 17

Section 3.12 Intellectual Property.................................. 19

Section 3.13 Legal Proceedings...................................... 22

Section 3.14 Tax Matters............................................ 23

Section 3.15 Insurance.............................................. 23

Section 3.16 Benefit Plans.......................................... 23

Section 3.17 Employee and Labor Matters............................. 24

Section 3.18 Environmental Matters.................................. 25

Section 3.19 Transactions with Affiliates........................... 26

Section 3.20 Certain Business Practices............................. 26

Section 3.21 Regulatory Compliance.................................. 26

Section 3.22 Product Liability Claims; Product Recalls.............. 28

Section 3.23 Product Registrations.................................. 28

Section 3.24 Purchase for Investment................................ 29

Section 3.25 Brokers' Fees.......................................... 29

ARTICLE 4 COVENANTS...................................................... 29

Section 4.1 Filings................................................ 29

Section 4.2 Access and Investigation............................... 29

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Section 4.3 Conduct of Business.................................... 30

Section 4.4 Commercially Reasonable Efforts........................ 32

Section 4.5 Public Announcements................................... 33

Section 4.6 Enforcement............................................ 33

Section 4.7 Inventory.............................................. 33

Section 4.8 Transfer............................................... 33

Section 4.9 Further Assurances..................................... 34

Section 4.10 Accounts Receivable.................................... 35

Section 4.11 Expenses............................................... 35

Section 4.12 Confidentiality........................................ 35

Section 4.13 [Reserved]............................................. 36

Section 4.14 Preparation for Transition............................. 36

Section 4.15 Other Subsidiaries..................................... 36

Section 4.16 Compliance with Contractual Obligations................ 37

Section 4.17 Issuance of Shares..................................... 37

Section 4.18 Unipath Purchase....................................... 37

Section 4.19 Transition Assets...................................... 37

Section 4.20 Post-Closing Obligations with Respect to European

Product Registrations.................................. 39

Section 4.21 Disclosure Supplements................................... 41

ARTICLE 5 TAX MATTERS................................................... 41

Section 5.1 Cooperation............................................ 41

Section 5.2 Apportioned Obligations................................ 41

Section 5.3 Transfer Taxes......................................... 41

Section 5.4 Tax Payments........................................... 42

Section 5.5 Transaction Treated as a Contribution.................. 42

ARTICLE 6 CONDITIONS TO CLOSING.......................................... 42

Section 6.1 Conditions to Each Party's Obligations................. 42

Section 6.2 Conditions to the Company's Obligations................ 43

Section 6.3 Conditions to IMS's Obligations........................ 44

ARTICLE 7 INDEMNIFICATION................................................ 45

Section 7.1 Indemnification of PGIO................................ 45

Section 7.2 Indemnification of IMS................................. 46

Section 7.3 Indemnification Claims................................. 46

Section 7.4 Survival............................................... 48

Section 7.5 Sole and Exclusive Remedy.............................. 48

ARTICLE 8 TERMINATION.................................................... 49

Section 8.1 Termination............................................ 49

Section 8.2 Effect of Termination.................................. 49

Section 8.3 Amendment.............................................. 50

Section 8.4 Extension; Waiver...................................... 50

ARTICLE 9 GENERAL PROVISIONS............................................. 50

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Section 9.1 Notices................................................ 50

Section 9.2 Definitions............................................ 52

Section 9.3 Descriptive Headings; Certain Interpretations.......... 59

Section 9.4 Assignment............................................. 59

Section 9.5 Specific Enforcement................................... 59

Section 9.6 Entire Agreement....................................... 59

Section 9.7 No Third-Party Beneficiaries........................... 59

Section 9.8 Counterparts........................................... 59

Section 9.9 Governing Law.......................................... 60

Section 9.10 Arbitration............................................ 60

Section 9.11 Severability........................................... 61

Section 9.12 Nonassignable Contracts................................ 61

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INDEX OF DEFINED TERMS

<TABLE>

<S> <C>

Accounts Payable .......................................................... 10

Accounts Receivable ....................................................... 35

Affiliate ................................................................. 52

Agreement ................................................................. 1

Apportioned Obligations ................................................... 41

Arbitration Request ....................................................... 60

Assignment and Assumption Agreement ....................................... 11

Assumed Liabilities ....................................................... 7

Benefit Plans ............................................................. 23

Bond Indenture ............................................................ 43

Business Contract ......................................................... 52

Business Contributed Intellectual Property ................................ 5

Business Day .............................................................. 52

Business Intellectual Property ............................................ 19

Business Registered Intellectual Property ................................. 52

CD Business ............................................................... 1

CD Financial Statements ................................................... 16

CE Marking ................................................................ 52

Claim Notice .............................................................. 47

Closing ................................................................... 11

Closing Date .............................................................. 11

COBRA ..................................................................... 24

Code ...................................................................... 52

Company ................................................................... 1

Confidential Information .................................................. 35

Constitutive Documents .................................................... 52

Contingent Obligation ..................................................... 52

Contract .................................................................. 53

Contributed Assets ........................................................ 3

Contributed CD Business ................................................... 2

Contributed Note .......................................................... 10

Contributed US CD Business ................................................ 2

Control ................................................................... 53

Controlled ................................................................ 53

Distribution Arrangements ................................................. 2

EEA ....................................................................... 40

Environmental Law ......................................................... 53

Environmental Liability ................................................... 53

Environmental Permits ..................................................... 53

ERISA ..................................................................... 23

Exchange Act .............................................................. 15

Excluded Assets ........................................................... 5

Excluded Businesses ....................................................... 6

Excluded Contracts ........................................................ 6

Excluded Liabilities ...................................................... 9

FDA ....................................................................... 15

FDCA ...................................................................... 27

Financial Investor ........................................................ 53

Finished Product Purchase Agreement ....................................... 2

First Check Diagnostics Business .......................................... 54

GAAP ...................................................................... 16

General Limitations ....................................................... 14

Global Trademark Assignments .............................................. 13

Governmental Entity ....................................................... 54

Governmental Licenses ..................................................... 4

Guarantee ................................................................. 2

Hazardous Materials ....................................................... 54

House Marks ............................................................... 6

HSR Act ................................................................... 15

IMA ....................................................................... 1

IMA Audited Financial Statements .......................................... 16

IMA Balance Sheet Date .................................................... 16

IMA Facilities ............................................................ 54

IMA Financial Statements .................................................. 16

IMA Indemnified Party ..................................................... 46

IMA Indemnity Threshold ................................................... 46

IMA Interim Balance Sheet ................................................. 16

IMA License Agreements .................................................... 54

IMA Services Agreement .................................................... 54

IMA Transition Services Agreement ......................................... 54

IMA Unaudited Financial Statements ........................................ 16

IMS ....................................................................... 1

Indebtedness .............................................................. 54

Indemnified Party ......................................................... 55

Indemnifying Party ........................................................ 55

Intellectual Property ..................................................... 55

Intellectual Property Rights .............................................. 55

IP Liens .................................................................. 19

IRS ....................................................................... 24

Judgment .................................................................. 14

Knowledge ................................................................. 55

Kunz ...................................................................... 1

Labeling .................................................................. 27

Lanter .................................................................... 1

Law ....................................................................... 14

Legal Proceeding .......................................................... 8

License Agreements ........................................................ 55

Lien ...................................................................... 14

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Losses .................................................................... 56

Material Adverse Effect ................................................... 56

Most Recent Balance Sheet ................................................. 16

Most Recent Balance Sheet Date ............................................ 16

Nonassignable Contract .................................................... 61

Option Agreement .......................................................... 56

Ordinary Course of Business ............................................... 17

Original Agreement ........................................................ 1

Outside Date .............................................................. 49

Permitted IP Liens ........................................................ 56

Permitted Liens ........................................................... 56

Person .................................................................... 56

PGIO ...................................................................... 1

PGIO Indemnified Party .................................................... 45

PGIO License Agreements ................................................... 56

PGIO Services Agreement ................................................... 57

PGUS ...................................................................... 2

Post-Closing Tax Period ................................................... 41

PRC ....................................................................... 6

Pre-Closing Tax Periods ................................................... 23

Product ................................................................... 57

Product Agreement ......................................................... 57

Product Registrations ..................................................... 57

Purchase Agreement ........................................................ 2

Purchased Asset ........................................................... 57

Purchased CD Business ..................................................... 2

Regulatory Transition Agreement ........................................... 57

Representatives ........................................................... 57

Restructuring ............................................................. 1

Retained Accounts Receivable .............................................. 6

Retained Contracts ........................................................ 39

Retained Inventory ........................................................ 7

Returned Inventory ........................................................ 33

Scheduled Contracts ....................................................... 17

SEC ....................................................................... 15

Securities Act ............................................................ 29

Share ..................................................................... 57

Share Transfer Agreement .................................................. 1

Shareholder Agreement ..................................................... 1

Shareholders .............................................................. 57

Strategic Investor ........................................................ 57

Subsequent Transfer Date .................................................. 4

Subsidiary ................................................................ 58

Tax ....................................................................... 58

Tax Return ................................................................ 58

Technical File ............................................................ 58

Third Party Claim ......................................................... 58

Trademarks ................................................................ 58

Transaction Agreements .................................................... 58

Transfer .................................................................. 3

Transfer Taxes ............................................................ 41

Transferred Employee ...................................................... 58

Transition Assets ......................................................... 4

Transition Period ......................................................... 37

UK Newco .................................................................. 2

UK Newco Investment Agreement ............................................. 58

Unipath ................................................................... 2

Unipath Purchase Agreement ................................................ 2

US CD LLC ................................................................. 2

US Contribution Agreement ................................................. 2

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AMENDED AND RESTATED CONTRIBUTION AGREEMENT, dated as of May 17, 2007

(this "Agreement"), among Inverness Medical Switzerland GmbH, a Swiss

company ("IMS"), Procter & Gamble International Operations, SA, a

Swiss company ("PGIO") and SPD Swiss Precision Diagnostics GmbH, a

Swiss company (the "Company").

INTRODUCTION

The Company was formed on December 19, 2006 by Dominique Kunz ("Kunz")

and Marco Lanter ("Lanter"), each a resident of Switzerland, on behalf of IMS.

In connection with the formation of the Company, each of Kunz and Lanter, on

behalf of IMS, contributed CHF 10,000 to the Company and as consideration for

such contribution received one quota (one Share of the Company, representing,

immediately following such contribution, 50% of the outstanding Shares of the

Company).

Effective December 21, 2006, Kunz and IMS entered into a share

transfer agreement, pursuant to which Kunz sold to IMS and IMS purchased from

Kunz, one Share of the Company for a purchase price of CHF 10,000. Following the

consummation of such sale and purchase, each of Lanter, on behalf of IMS, and

IMS owned one quota (one Share of the Company, representing 50% of the

outstanding Shares of the Company).

On or prior to the date hereof, Lanter, on behalf of IMS, and PGIO

entered into a Share Transfer Agreement (the "Share Transfer Agreement"),

pursuant to which Lanter sold and PGIO purchased the Share of the Company owned

by Lanter, on behalf of IMS, for a purchase price of CHF 10,000. Immediately

following such sale and purchase, and effective upon the Closing, each of IMS

and PGIO own 50% of the Company's outstanding Shares.

On the Closing Date, PGIO, IMS and the Company will enter into a

shareholder agreement in a form to be mutually agreed upon (the "Shareholder

Agreement"), which shall establish the respective rights and obligations of PGIO

and IMS with respect to the Company.

IMS, Inverness Medical Innovations, Inc. ("IMA") and certain of their

Affiliates are in the business of developing, manufacturing, marketing, selling

and distributing human diagnostics and monitoring products for sale and

distribution through over-the-counter channels, including retail outlets and

emerging channels located in such retail outlets (the "CD Business").

Prior to the Closing Date, IMA and certain of its Subsidiaries

(including IMS) will restructure (the "Restructuring") their businesses.

IMS and its Affiliates contemplate selling certain assets and

contributing certain assets and liabilities of the CD Business, other than

assets used in, and liabilities arising from, the Excluded Fields (as defined in

the IMA License Agreements).

IMS, PGIO and the Company entered into a Contribution Agreement, dated

as of December 22, 2006 (the "Original Agreement"), to provide for the

contribution by IMS to the Company of certain assets of the CD Business, and the

assumption by the Company of certain liabilities of the CD Business, in each

case, as set forth in the Original Agreement.

 

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IMS, PGIO and the Company desire to enter into this Agreement to amend

and restate the Original Agreement and to provide for the contribution by IMS to

the Company on the Closing Date of (a) cash, (b) a promissory note in an

original principal amount of $22,326,000 and (c) certain assets of the CD

Business, and the assumption by the Company of certain liabilities of the CD

Business (the "Contributed CD Business"), in each case, subject to the terms set

forth in this Agreement (including with respect to the Excluded Assets and

Excluded Liabilities).

Concurrently with the execution of this Agreement, (a) PGIO is

entering into an Amended and Restated Asset Purchase Agreement (the "Purchase

Agreement") with IMS and the Company, pursuant to which PGIO will purchase from

IMS assets of the CD Business (the "Purchased CD Business") on terms and

conditions set forth in the Purchase Agreement. Such purchase and sale will be

consummated concurrently with the Closing hereunder, and simultaneously with the

Closing, PGIO will contribute the Purchased CD Business to the Company pursuant

to the PGIO Contribution Agreement (as defined in the Purchase Agreement); (b)

SPD Development Company, Ltd. ("UK Newco"), and Unipath Limited ("Unipath") are

entering into an Asset Purchase Agreement (the "Unipath Purchase Agreement"),

pursuant to which Unipath will sell and UK Newco will purchase certain assets of

the R&D Operations and the UK Call Center (each as defined in the Unipath

Purchase Agreement), and UK Newco will assume certain liabilities of the R&D

Operations and the UK Call Center, in each case, as set forth in the Unipath

Purchase Agreement (the "Purchased UK Operations"); and (c) IMA, Procter &

Gamble RHD, Inc., ("PGUS") and US CD LLC, a Delaware limited liability company

("US CD LLC"), are entering into a Contribution Agreement (the "US Contribution

Agreement") whereby IMA will contribute to the US CD LLC certain assets of the

US CD Business (as defined in the US Contribution Agreement), and the US Company

will assume certain liabilities of the US CD Business, in each case, as set

forth in the US Contribution Agreement (the "Contributed US CD Business").

On the Closing Date, IMA will execute a guarantee (the "Guarantee")

pursuant to which IMA guarantees all of IMS's obligations under this Agreement,

the Contributed Note and the Purchase Agreement, and all of IMS's and Unipath's

respective obligations under the Unipath Purchase Agreement.

On the Closing Date, the Company and IMA and certain of its

Subsidiaries will enter into a mutually agreeable finished product purchase

agreement (the "Finished Product Purchase Agreement"), pursuant to which IMA

and/or such Subsidiaries will manufacture and sell to the Company the products

described therein.

On and following the Closing Date, the Company and (a) certain

Affiliates of PGIO and (b) IMA or certain Affiliates of IMA will enter into

distribution and commissionaire arrangements pursuant to which such Affiliates

of PGIO or IMA, as applicable, will distribute and act as sales agents for

products of the Company (collectively, the "Distribution Arrangements").

Capitalized terms shall have the meanings assigned to them in Section

9.2 or as otherwise provided in this Agreement.

 

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In consideration of the foregoing, the respective representations,

warranties, covenants and agreements set forth herein, and for other good and

valuable consideration, including a maximum of CHF 0.50, the receipt and

sufficiency of which are hereby acknowledged, the parties hereto agree as

follows:

ARTICLE 1

FORMATION AND CONTRIBUTIONS

Section 1.1 Formation of the Company; Sale of Shares to PGIO. Prior to

the date hereof, Kunz and Lanter, on behalf of IMS, formed the Company and each

made an initial contribution of CHF 10,000 to the capital of the Company in

exchange for 50% of the outstanding Shares of the Company (together, as of the

effective date of such contributions, Kunz and Lanter owned 100% of the

outstanding Shares of the Company). Prior to the date hereof, IMS purchased the

Share of the Company owned by Kunz for a purchase price of CHF 10,000. Following

the consummation of such sale and purchase, each of Lanter, on behalf of IMS,

and IMS owned one Share of the Company, which together represent 100% of the

outstanding Shares of the Company. On or prior to the date hereof, Lanter sold

to PGIO and PGIO purchased from Lanter, the Share of the Company owned by

Lanter, on behalf of IMS, subject to the terms and conditions of the Share

Transfer Agreement. Effective as of the closing of such purchase and sale, each

of IMS and PGIO owned 50% of the Shares of the Company.

Section 1.2 Transfer of the Contributed CD Business. Except for the

Excluded Assets as provided in Section 1.3 and without duplication of the

Purchased CD Business, at the Closing and with effect as of the Closing Date (or

such later date as provided under this Section 1.2), IMS shall, or shall cause

its Affiliates to, assign, transfer, convey and deliver to the Company, free and

clear of all Liens except Permitted Liens (the "Transfer"), and the Company

shall acquire from IMS, all of the right, title and interest of IMS in and to

any and all of the assets, properties, rights and business of the Contributed CD

Business of every kind, nature, type and description, real, personal and mixed,

tangible and intangible, whether known or unknown, fixed or unfixed, or

otherwise, whether or not specifically referred to in this Agreement and whether

or not reflected on the books and records of IMS (collectively, the "Contributed

Assets"), including the following:

(i) all tangible assets, furniture, fixtures and property, if any,

used by the Transferred Employees upon the hiring of such Transferred

Employees;

(ii) the Business Contracts (other than the Excluded Contracts) not

included within the Transition Assets;

(iii) the Business Contracts included within the Transition Assets,

which shall be transferred to the Company on the applicable Subsequent

Transfer Date;

(iv) the Product Registrations for all Products registered in the

United States;

(v) the Product Registrations for all Products registered in

jurisdictions other than the United States, including those listed in

Section 1.2(v) of the Disclosure Schedule, and any transferable rights in

respect of Product Registrations for Products registered in Japan and any

other jurisdiction, including those listed in Section 1.2(v) of

 

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the Disclosure Schedule, each of which shall be transferred to the Company

on the applicable Subsequent Transfer Date;

(vi) except for the Product Registrations (the transfer of which is

addressed in clauses (iv) and (v) above), all licenses, registrations,

notifications, franchises, qualifications, provider numbers, permits,

approvals, clearances and authorizations issued by any Governmental Entity

that relate to the Contributed CD Business or the Contributed Assets

(collectively, and together with the Product Registrations, the

"Governmental Licenses"), in each case, to the extent transferable or

assignable and subject to IMA retaining such of the foregoing as are

necessary for IMA and/or certain of its Subsidiaries to fulfill their

respective obligations under the Finished Product Purchase Agreement, the

IMA Transition Services Agreement, the Product Agreement, the Regulatory

Transition Agreement or as a distributor under the Distribution

Arrangements (the foregoing licenses, registrations, notifications,

franchises, qualifications, provider numbers, permits, approvals,

clearances and authorizations, all lists, documents, records, information

and other assets and rights of IMS or any of its Affiliates, in each case

excluding the Excluded Assets, necessary for IMA and/or its Subsidiaries to

perform such obligations being referred to hereunder as the "Transition

Assets"); provided that the Transition Assets shall be transferred to the

Company, without the payment of additional consideration by the Company,

upon the termination or expiration of the Finished Product Purchase

Agreement, the applicable Transition Period (as defined in the IMA

Transition Services Agreement) under the IMA Transition Services Agreement,

the Regulatory Transition Agreement or the term of the applicable

Distribution Agreement, as applicable (such applicable date, the

"Subsequent Transfer Date"), in each case to the extent transferable or

assignable;

(vii) all lists, documents, records, written information, computer

files and other computer readable media concerning present customers, and

to the extent reasonably available, past and potential customers, of goods

or services arising from or used in the Contributed CD Business, excluding

any of the foregoing included within the Transition Assets, which shall be

transferred to the Company on the applicable Subsequent Transfer Date;

(viii) all lists, documents, records, written information, computer

files and other computer readable media concerning present suppliers and

vendors of goods or services, and to the extent reasonably available, past

and potential suppliers and vendors, arising from or used in the

Contributed CD Business, excluding any such lists, records, written

information, computer files and other media included within the Transition

Assets, which shall be transferred to the Company on the applicable

Subsequent Transfer Date;

(ix) all product records, product data, correspondence with and to

customers of the CD Business, production records, contract files,

technical, accounting, and procedural manuals, studies, reports or

summaries relating to the general condition of the Contributed Assets, and

any confidential information which has been reduced to writing or

electronic form, to the extent that any of the foregoing relate to or arose

from the Contributed CD Business, which shall be transferred to the Company

on the applicable Subsequent Transfer Date;

 

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(x) all rights under express or implied warranties from the suppliers

and vendors relating to or arising out of the operation of the Contributed

CD Business, except for such rights arising out of or relating to the

manufacturing of any product of the CD Business;

(xi) to the extent related to an Assumed Liability, all claims,

warranties, guarantees, refunds, causes of action, rights of recovery,

rights of set-off and rights of recoupment of any kind and nature;

(xii) all currently outstanding unfilled purchase orders and proposals

(or portions thereof) received for the purchase of inventory of the

Contributed CD Business following the termination of the Transition Period;

(xiii) except for those Trademarks set forth in Section 3.12(a) of the

Disclosure Schedule as registered in the name of IMS, which will be

assigned, transferred and conveyed pursuant to the Purchase Agreement and

the PGIO Contribution Agreement, all (A) Intellectual Property owned by IMS

or any of its Affiliates that are exclusively used in the CD Business, and

(B) Trademarks (other than House Marks) owned by IMS or IMA or any of their

respective Subsidiaries that are not presently exclusively used by the CD

Business or any other business of IMS or such Affiliate but that were

exclusively used by the CD Business in the past, in each case including the

Business Registered Intellectual Property (the "Business Contributed

Intellectual Property");

(xiv) to the extent assignable, all rights under any non-disclosure

agreements, non-solicitation agreements and non-competition agreements

entered into with any parties, to the extent that any of the foregoing

relates to or arose from the Contributed CD Business;

(xv) all rights and claims, including refunds, to the extent that such

rights and claims relate to or arose from the Contributed CD Business;

(xvi) all insurance policies (to the extent separable and assignable)

with respect to the CD Business, and rights, benefits, claims and proceeds

thereunder arising from or relating to the Assumed Liabilities;

(xvii) other than Retained Inventory, all other tangible assets or

movable property used in connection with the Contributed CD Business, if

any; and

(xviii) all goodwill relating to the foregoing.

Section 1.3 Excluded Assets. Notwithstanding the provisions of Section

1.2, the parties hereto acknowledge and agree that the following are not

included among either the Contributed Assets or the Purchased Assets (as defined

in the Purchase Agreement) and are excluded from the Transfer (collectively, the

"Excluded Assets"):

(i) the assets, properties, Contracts and rights of IMS and its

Affiliates in the Excluded Fields (which shall include, for the avoidance

of doubt, the tangible assets and

 

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real property located at Stirling, Scotland) and the Intellectual Property

of IMS and its Affiliates in the Excluded Fields;

(ii) (A) Intellectual Property owned by third parties and licensed to

IMS or one or more of its Affiliates for use in the CD Business and which

are listed in Section 1.3(ii) of the Disclosure Schedule, (B) Intellectual

Property, other than Trademarks, not used exclusively in the CD Business,

and (C) Trademarks that have never been at any time exclusively used in the

CD Business (other than Trademarks that have been held for use in the CD

Business but have never been used by any business);

(iii) the assets, properties, Contracts and rights of IMS and its

Affiliates (including vendor and supplier contracts, information, files and

data) used in the manufacturing of the products of the CD Business,

including all tangible assets, properties, and contracts of IMS's or its

Affiliates' manufacturing facilities located in Bedford, England, Hangzhou,

People's Republic of China ("PRC") and Shanghai, PRC, excluding any product

specifications, product registrations or similar assets used in the conduct

of the CD Business;

(iv) the assets, properties, Contracts and rights arising from or used

in IMA and its Subsidiaries' professional diagnostics and nutritional

supplement businesses (collectively, the "Excluded Businesses");

(v) all accounts receivable, and notes receivable (if any), of any

nature arising from the Contributed CD Business existing on the Closing

Date (the "Retained Accounts Receivable");

(vi) all prepaid expenses and other deposits related to the

Contributed CD Business;

(vii) the Contracts arising from the CD Business set forth on Section

1.3(vii) of the Disclosure Schedule (the "Excluded Contracts");

(viii) the Trademarks or trade names "Inverness," and any variants

thereof that include "Inverness," internet domain names that include

"Inverness," and the Inverness "little man" logo (collectively, the "House

Marks");

(ix) real property, buildings, structures and improvements thereon,

whether owned or leased by IMS or its Affiliates, and all fixtures and

fittings attached thereto, including all manufacturing, distribution and

administration facilities of IMS and its Affiliates;

(x) rights to refunds of Taxes paid by or on behalf of IMS or any of

its Affiliates (other than those paid by the Company);

(xi) except as provided in Section 1.2(xvi), insurance policies and

rights and benefits and claims thereunder;

 

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(xii) tangible assets, properties, Contracts and Intellectual Property

of IMA or its Subsidiaries (including animals and cell lines) used in the

manufacturing, production and storage of reagents and other biological

materials used in the CD Business;

(xiii) all inventory, including all raw materials, work-in-process,

supplies and finished goods, including goods in transit, as sold, used or

held for use as part of the CD Business, wherever located (the "Retained

Inventory");

(xiv) all currently outstanding unfilled purchase orders and proposals

(or portions thereof) received for the purchase of inventory of the

Contributed CD Business during the period prior to the termination of the

Transition Period;

(xv) the services of any employees of IMA or its Subsidiaries (except

for Transferred Employees upon hiring of such Transferred Employees by the

Company or a Subsidiary of the Company) or assets of any employee benefit

plan, arrangement, or program maintained or contributed to by IMA or any of

its Subsidiaries with respect to any employees other than Transferred

Employees (upon the hiring of such Transferred Employees by the Company or

a Subsidiary of the Company);

(xvi) the assets, properties, Contracts and rights arising from or

used in the Purchased UK Operations, the Contributed US CD Business and the

First Check Diagnostics Business; and

(xvii) any other assets, tangible or intangible, wherever situated,

not included in the Contributed Assets, including those used in the

Excluded Businesses;

provided that IMS and its Affiliates, upon reasonable request and to the extent

IMS or any of its Affiliates has the right to so provide, will provide the

Company reasonable access during normal business hours to the Excluded Assets

that, prior to the Closing Date, were used in the CD Business and are not being

transferred pursuant to this Agreement or the Purchase Agreement, for the

Company's use to facilitate its manufacturing, research and development and

marketing, sales and distribution activities; provided, further, that with

respect to access to the Bedford, England, Hangzhou, PRC or Shanghai, PRC

manufacturing facilities, the terms of the Finished Product Purchase Agreement

shall control and this provision shall not expand the rights set forth therein.

Section 1.4 Assumption of Liabilities. At the Closing or, with respect

to liabilities arising out of any Transition Asset (including those transferred

under the Purchase Agreement), on the applicable Subsequent Transfer Date, the

Company shall assume, and shall agree to pay, perform and discharge according to

their respective terms (if any), the following (and only the following)

liabilities and obligations of IMS and its Affiliates arising primarily from or

related primarily to the Contributed CD Business and the Purchased CD Business,

and no other liabilities or obligations of IMS or its Affiliates (liabilities to

be assumed by the Company pursuant to this Section 1.4 being collectively

referred to as the "Assumed Liabilities"):

(i) all obligations of IMS or its Affiliates under the Business

Contracts (other than Excluded Contracts) that are part of the Contributed

CD Business or the Purchased

 

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CD Business that, by the terms of such Business Contracts, arise after the

Closing Date or, with respect to such Business Contracts, including those

that constitute part of the Purchased CD Business, included within the

Transition Assets (including those included within the Purchased CD

Business), the applicable Subsequent Transfer Date, relate to periods

following the Closing Date or, with respect to such Business Contracts

included within the Transition Assets (including those included within the

Purchased CD Business), the applicable Subsequent Transfer Date, and are to

be observed, paid, discharged, or performed, as the case may be, in each

case at any time after the Closing Date or, with respect to such Business

Contracts included within the Transition Assets (including those included

within the Purchased CD Business), the applicable Subsequent Transfer Date;

(ii) except to the extent related to or arising out of Retained

Inventory, any product warranty, product liability or product returns,

rebates, coupons, allowances or other discounting and promotional

commitments arising from any product line produced or sold by the

Contributed CD Business and the Purchased CD Business that has not been

discontinued prior to the date hereof;

(iii) except as set forth in Section 1.4(iii) of the Disclosure

Schedule or with respect to any matter involving Taxes or any Excluded

Assets, any liability, obligation, cost or expense of IMS or any of its

Affiliates arising out of or relating to any investigation, claim, action,

suit, complaint, dispute, audit, demand, litigation or judicial,

administrative or arbitration proceeding (collectively, "Legal

Proceeding"), as and to the extent it arose or arises from the Contributed

CD Business and the Purchased CD Business, to which IMS or any of its

Affiliates is or was a party whether it relates to any time prior to, at or

after the Closing (regardless of whether the Legal Proceeding is commenced

before or after the Closing), and any contingency reserve related thereto;

(iv) upon hiring of a Transferred Employee by the Company or a

Subsidiary of the Company, any liability or obligation with respect to such

Transferred Employee, including all liabilities for accrued vacation pay,

excluding any pension or similar liabilities;

(v) any liability, obligation or expense arising from the Business

Contributed Intellectual Property and Business Purchased Intellectual

Property (as defined in the Purchase Agreement) after the Closing Date; and

(vi) any liability or obligation arising from the conduct of the

Contributed CD Business and the Purchased CD Business (other than

liabilities or obligations related to the Retained Inventory, the Retained

Accounts Receivable, the Accounts Payable or the Transition Assets (in each

case, including such assets under the Purchase Agreement)) after the

Closing Date, and with respect to Transition Assets (including those

included within the Purchased CD Business), any liability or obligation

arising from the conduct of the Contributed CD Business and the Purchased

CD Business after the applicable Subsequent Transfer Date.

 

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Section 1.5 Liabilities Not Assumed by the Company. Notwithstanding

anything to the contrary in this Agreement, the Company shall not assume, or in

any way be liable or responsible for any, and IMS and its Affiliates shall pay,

perform and discharge all, obligations and liabilities of them, direct or

indirect, known or unknown, fixed or unfixed, choate or inchoate, liquidated or

unliquidated, secured or unsecured, accrued, absolute, contingent or otherwise,

except for the Assumed Liabilities (collectively, the "Excluded Liabilities"),

and IMS shall hold the Company harmless with respect to the Excluded

Liabilities. For the avoidance of doubt, the term Assumed Liabilities does not

include any of the Excluded Liabilities and the term Excluded Liabilities

includes all liabilities and obligations of IMS or any of its Affiliates

(including liabilities and obligations imposed by operation of Law) other than

the Assumed Liabilities. Without limiting the generality of the foregoing,

Excluded Liabilities shall include the following obligations and liabilities:

(i) any liability or obligation of IMS or any of its Affiliates

arising from or relating to the Excluded Businesses, or the business, if

any, of such entities in the Excluded Fields;

(ii) any liability or obligation of IMS or any of its Affiliates

arising out of or in connection with the negotiation and preparation of

this Agreement or any of the other Transaction Agreements or similar

agreements among Affiliates of IMS and PGIO in connection with US CD LLC or

the consummation and performance of the transactions contemplated hereby

and thereby, including any liability for Taxes so arising;

(iii) any liability or obligation (other than Assumed Liabilities)

arising under, relating to or resulting from any asset of IMS or its

Affiliates other than the Contributed Assets and the Purchased Assets;

(iv) any liability or obligation of IMS or any of its Affiliates

arising (A) from their failure to perform, or negligent performance of,

their obligations under, or (B) out of or relating to any breach or claim

of breach of a representation, warranty, covenant or agreement of IMS or

any of its Affiliates contained in, any of the Business Contracts;

(v) any liability, obligation or expense of any kind or nature

relating to Taxes owed by IMS or any of its Affiliates (including any

contractual liability with respect to Taxes of another Person); provided

that Transfer Taxes and Apportioned Obligations shall be paid in the manner

set forth in Sections 5.2 and 5.3 hereof;

(vi) any liability or obligation to any of the directors, officers or

Affiliates of IMS;

(vii) except for Legal Proceedings assumed pursuant to Section

1.4(iii), any liability, obligation, cost or expense of IMS or any of its

Affiliates arising out of or relating to any Legal Proceeding to which IMS

or any of its Affiliates is or was a party and that relates to any time at

or prior to the Closing (regardless of whether the Legal Proceeding is

commenced before or after the Closing), and any contingency reserve related

thereto;

 

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(viii) any liability or obligation of IMS or its Affiliates with

respect to any Indebtedness or Contingent Obligations (including any

accrued interest, fees and any penalties thereon);

(ix) any liability or obligation of IMS or its Affiliates to or with

respect to employees, former employees, consultants and former consultants

and Benefit Plans and other employee and employment-related liabilities,

including any liability for severance, incentive, bonus or other

compensation, health, welfare and other benefit plans of IMS or IMA or any

of their respective Subsidiaries whether arising prior to or after the

Closing;

(x) all unpaid liabilities and obligations, including trade accounts

payable, of the Contributed CD Business (including all payables to IMS or

any of its Affiliates), and other similar current liabilities of the

Contributed CD Business (collectively, the "Accounts Payable");

(xi) to the extent related to or arising out of Retained Inventory,

any product warranty, product liability or product returns, rebates,

coupons, allowances or other discounting and promotional commitments

arising from any product line produced or sold by the Contributed CD

Business that has not been discontinued prior to the Closing Date;

(xii) any product warranty, product liability or product returns,

rebates, coupons, allowances or other discounting and promotional

commitments with respect to any product line of the CD Business that was

discontinued prior to the Closing Date;

(xiii) any liability or obligation of IMS or its Affiliates arising

out of or relating to the failure of IMS or its Affiliates to obtain any

Governmental Licenses material to or necessary for the conduct of the CD

Business;

(xiv) any liability or obligation of IMS or its Affiliates arising out

of or relating to IMA Facilities under applicable Environmental Laws;

(xv) any liability or obligation of IMS or its Affiliates to fund or

finance any pension or similar liabilities; and

(xvi) all liabilities and obligations of IMS or its Affiliates under

this Agreement, the other Transaction Agreements or similar agreements

among Affiliates of IMS and PGIO in connection with US CD LLC.

Section 1.6 Additional Contributions. At the Closing, IMS shall

contribute to the Company, in addition to any other contributions made

hereunder, (a) cash in the amount of CHF 990,000, which amount shall increase

the amount of Company's share capital held by IMS to CHF 1,000,000, (b) cash in

the amount of $11,269,050, which amount shall be allocated to the capital

surplus of the Company, and (c) a promissory note of IMS in favor of the Company

in an original principal amount of $22,326,000 (the "Contributed Note"). In

consideration of the contribution by IMS of CHF 990,000, on the Closing Date,

the Company shall increase the share capital of IMS to CHF 1,000,000.

 

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ARTICLE 2

CLOSING

Section 2.1 Closing. The closing of the transactions contemplated by

this Agreement (the "Closing") shall be held at the offices of Covington &

Burling LLP, 1201 Pennsylvania Avenue, NW, Washington, DC, at 10:00 a.m. on the

date as soon as practicable, and in any event not later than two Business Days,

following satisfaction of all conditions and taking of all other actions (other

than those that by their terms are to be satisfied or taken at the Closing) set

forth in Article 6 (or, to the extent permitted by Law, waived by the parties

hereto entitled to the benefits thereof), or on such other date, and at such

other time or place, as PGIO and IMA may mutually agree in writing. The date on

which the Closing occurs is referred to in this Agreement as the "Closing Date."

Section 2.2 Closing Deliveries. (a) At the Closing, the Company shall

deliver or cause to be delivered to IMS and PGIO:

(i) a certified copy of the current extract from the commercial

register of the Company;

(ii) the Shareholder Agreement, executed by the Company;

(iii) a public deed evidencing that IMS is the legal owner of one

quota (representing, on the Closing Date, 50% of the Company's outstanding

shares);

(iv) a public deed evidencing that PGIO is the legal owner of one

quota (representing, on the Closing Date, 50% of the Company's outstanding

shares);

(v) two quota holders resolutions approving the ownership as evidenced

per clauses (iii) and (iv) above;

(vi) a copy of the share register of the Company, evidencing the

ownership by PGIO and IMS of one quota each;

(vii) an assignment and assumption agreement (the "Assignment and

Assumption Agreement") reasonably satisfactory to PGIO, the Company and IMS

under which the Company assumes the Assumed Liabilities, executed by the

Company;

(viii) the Distribution Arrangements for the United States, executed

by the Company;

(ix) the License Agreements, executed by the Company;

(x) the Finished Product Purchase Agreement, in a form mutually agreed

by the parties, executed by the Company;

(xi) the Regulatory Transition Agreement, executed by the Company;

(xii) the IMA Transition Services Agreement, executed by the Company;

 

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(xiii) the IMA Services Agreement, executed by the Company;

(xiv) the PGIO Services Agreement, executed by the Company;

(xv) the Global Trademark Assignment (in a form reasonably

satisfactory to PGIO) between PGIO and the Company, executed by the

Company; and

(xvi) the other Transaction Agreements (other than Distribution

Arrangements for territories other than the United States) to which the

Company is a party.

(b) At the Closing, IMS shall deliver or cause to be delivered to the

Company and PGIO:

(i) the Contributed Note, executed by IMS;

(ii) the cash contributions to the Company required under Section 1.6;

(iii) the Shareholder Agreement, executed by IMS;

(iv) the Assignment and Assumption Agreement, executed by IMS;

(v) the IMA License Agreements, executed by IMA, IMS and such other

Affiliates of IMA or IMS as are parties thereto;

(vi) the Finished Product Purchase Agreement, in a form mutually

agreed by the parties, executed by certain Affiliates of IMS as set forth

therein;

(vii) the IMA Transition Services Agreement, executed by IMA and

certain Subsidiaries of IMA as set forth therein;

(viii) the IMA Services Agreement, executed by IMA and certain

Subsidiaries of IMA as set forth therein;

(ix) the Regulatory Transition Agreement, executed by IMS;

(x) the Share Transfer Agreement, executed by Lanter;

(xi) the other Transaction Agreements (other than Distribution

Arrangements for territories other than the United States) to which IMS or

any of its Affiliates is a party;

(xii) the Guarantee, in a form reasonably acceptable to PGIO, under

which IMA guarantees all of the obligations of IMS hereunder, under the

Contributed Note and under the Purchase Agreement;

(xiii) complete copies of all Technical Files maintained by IMA, IMS

or any of their respective Affiliates related to the Product Registrations;

 

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(xiv) an instrument of sale, assignment or contribution in a form

reasonably satisfactory to PGIO transferring to the Company all of IMS and

its Affiliates' right, title and interest in and to the Contributed Assets;

(xv) the Trademark Assignment (in a form reasonably satisfactory to

PGIO) between IMS and PGIO, executed by IMS; and the Trademark Assignment

(in a form reasonably satisfactory to PGIO), between PGIO and the Company

(collectively, the "Global Trademark Assignments"); and

(xvi) such other bills of sale, endorsements, assignments and other

instruments of transfer, conveyance and assignment (in a form reasonably

satisfactory to PGIO) as shall be required by Law or necessary in the

reasonable judgment of PGIO or the Company to transfer, convey and assign

the Contributed Assets to the Company.

(c) At the Closing, PGIO shall deliver or cause to be delivered to the

Company and IMS:

(i) cash contributions to the Company in the amounts of CHF 990,000

and $11,269,050, pursuant to the PGIO Contribution Agreement;

(ii) the Shareholder Agreement, executed by PGIO;

(iii) the Share Transfer Agreement, executed by PGIO;

(iv) the PGIO Services Agreement, executed by PGIO;

(v) the Regulatory Transition Agreement, executed by PGIO;

(vi) the PGIO License Agreements, executed by PGIO and such Affiliates

of PGIO that are parties thereto;

(vii) the Global Trademark Assignments, executed by PGIO; and

(viii) the other Transaction Agreements (other than Distribution

Arrangements for territories other than the United States) to which PGIO or

any of its Affiliates is a party.

ARTICLE 3

REPRESENTATIONS AND WARRANTIES OF IMS AND IMA

IMS represents and warrants to the Company and PGIO as follows, as of

December 22, 2006 and as of the Closing:

Section 3.1 Organization and Existence. Each of IMS and the Company is

duly organized and validly existing under the Laws of Switzerland, has all

requisite power and authority to carry on the CD Business as now being conducted

and is duly qualified or licensed to do business and in good standing in each

jurisdiction in which the nature of the CD Business or the ownership, leasing or

operation of its properties makes such qualification or licensing

 

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necessary, except for those jurisdictions where the failure to be so qualified

or licensed would not have a Material Adverse Effect. Other than wholly-owned

Subsidiaries, IMA has no Subsidiaries that conduct the CD Business or own

Contributed Assets other than Inverness Medical (Shanghai), Co., Ltd.

Section 3.2 Power and Authority; Binding Agreement. Each of IMS and

the Company has all requisite power and authority to execute and deliver this

Agreement, to consummate the transactions contemplated hereby and to perform its

obligations hereunder, and has, or on the Closing Date will have, the requisite

power and authority to enter into each of the Transaction Agreements to which it

is a party and to perform its obligations thereunder. This Agreement is a valid

and binding obligation of each of IMS and the Company, enforceable against each

of them in accordance with its terms, except as the same may be limited by

bankruptcy, insolvency, reorganization, moratorium or other Laws affecting the

rights of creditors generally and subject to the rules of Law governing (and all

limitations on) specific performance, injunctive relief and other equitable

remedies (the "General Limitations"). When executed, each other Transaction

Agreement to which it is a party will be the valid and binding obligation of

each of IMS and the Company enforceable against each of them in accordance with

its terms, except as the same may be limited by the General Limitations. Except

as set forth in Section 3.2 of the Disclosure Schedule, no other act, approval

or proceedings on the part of IMS or the Company is, or will be, required to

authorize the execution and delivery of this Agreement and the other Transaction

Agreements to which either of them is a party or the consummation of the

transactions contemplated hereby and thereby.

Section 3.3 Noncontravention. (a) Except as set forth in Section

3.3(a) of the Disclosure Schedule, the execution and delivery by IMS or the

Company of this Agreement and the other Transaction Agreements to which either

of them is a party, and the consummation of the transactions contemplated hereby

and thereby and the compliance by either of them with the provisions hereof and

thereof do not and will not result in the creation of any lien, pledge, claim,

charge, mortgage, encumbrance or other security interest of any kind, whether

arising by Contract or by operation of Law (a "Lien"), in or upon any of the

properties or assets of IMS or its Affiliates that are material to the conduct

of the CD Business. Except as set forth in Section 3.3(a) of the Disclosure

Schedule, the execution and delivery by IMS or the Company of this Agreement and

the other Transaction Agreements to which either of them is a party, and the

consummation of the transactions contemplated hereby and thereby and the

compliance by either of them with the provisions hereof and thereof do not and

will not (i) conflict with or result in any violation or default (with or

without notice or lapse of time or both) under, (ii) give rise to a right of, or

result in, termination or cancellation of, or acceleration of any obligation

under, (iii) result in a loss of a material benefit under, or (iv) give rise to

any increased, additional, accelerated or guaranteed rights or entitlements

under, any provision of (A) the Constitutive Documents of IMS or the Company,

(B) any material Business Contract to which IMS or any of its Affiliates or the

Company is a party or is bound by, or any Contributed Assets are bound by or

subject, or under which IMS or any of its Affiliates or the Company has material

rights or benefits or (C) subject to the governmental filings and other matters

referred to in Section 3.3(b), any constitution, act, statute, law (including

common law), ordinance, treaty, rule or regulation of any Governmental Entity (a

"Law") or any judgment, order or decree (a "Judgment"), in each case applicable

to IMS or any of its Affiliates or the Contributed Assets or the Purchased

Assets, or the Company.

 

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(b) No consent, approval, license, permit, order or authorization of,

registration, declaration or filing with, or notice to, any Governmental Entity

is required by or with respect to IMS or the Company in connection with the

execution and delivery of this Agreement, the other Transaction Agreements to

which either of them is a party, the consummation of the transactions

contemplated hereby or thereby or the compliance by IMS or the Company with the

provisions hereof and thereof, except (i) for filings required under, and

compliance with other applicable requirements of, the Hart Scott Rodino

Antitrust Improvements Act of 1976 (the "HSR Act"), and any similar competition

filing with any Governmental Entity, if applicable to this Agreement, the other

Transaction Agreements and the transactions contemplated hereby and thereby;

(ii) the filing with the Securities and Exchange Commission ("SEC") of such

reports under the Securities Exchange Act of 1934, as amended (the "Exchange

Act"), as may be required in connection with this Agreement and the other

Transaction Agreements and the transactions contemplated hereby and thereby;

(iii) filings with, and notices and submissions to, the United States Food and

Drug Administration (the "FDA"); (iv) such filings as may be required to

transfer the ownership of Intellectual Property Rights; and (v) such other

consents, approvals, orders, authorizations, registrations, declarations,

filings and notices, the failure of which to be obtained or made individually or

in the aggregate would not impair in any material respect the ability of IMS or

the Company to perform its obligations under this Agreement or prevent or

materially impede or delay the consummation of the transactions contemplated

hereby.

Section 3.4 Compliance with Laws. Except as set forth in Section 3.4

of the Disclosure Schedule, IMS and its Affiliates are in compliance in all

material respects with all applicable Laws and Judgments. Except as set forth in

Section 3.4 of the Disclosure Schedule, since January 1, 2004 neither IMS nor

any of its Affiliates has received a written notice from a Governmental Entity

alleging a possible violation by it of any applicable Law or Judgment applicable

to the CD Business. Notwithstanding the foregoing, this Section 3.4 shall not

constitute a representation or warranty as to intellectual property, tax,

employee benefit plan, environmental or the specific regulatory matters covered

in Sections 3.21, 3.22 and 3.23 which are limited to those representations and

warranties set forth in Sections 3.12, 3.14, 3.16, 3.17, 3.18, 3.21, 3.22 and

3.23, respectively.

Section 3.5 Governmental Licenses. IMS and its Affiliates validly hold

and have in full force and effect all Governmental Licenses that are material to

the conduct of the CD Business, and neither IMS nor any of its Affiliates is in

violation (other than an immaterial violation) of, or default (with or without

notice or lapse of time or both) (other than an immaterial default) under, or

event giving to any other Person any right of termination, amendment or

cancellation of, any Governmental License material to the conduct of the CD

Business. Each of IMS and its Affiliates is in compliance in all material

respects with the terms and conditions of all Governmental Licenses issued to or

held by it that are material to the CD Business, and such Governmental Licenses

will not be subject to suspension, modification, revocation or nonrenewal as a

result of the execution and delivery of this Agreement or the other Transaction

Agreements to which either of them is a party or the consummation of the

transactions contemplated hereby and thereby. No proceeding is pending or, to

the Knowledge of IMS or IMA, threatened seeking the revocation or limitation of

any Governmental License that is material to the conduct of the CD Business.

Section 3.5 of the Disclosure Schedule lists each Governmental License held by

IMS or its Subsidiaries that is material to the conduct of the CD Business,

except for any licenses related to, or necessary for, the manufacture or storage

of

 

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the products of the CD Business. Except as set forth therein, all of the

Governmental Licenses listed in Section 3.5 of the Disclosure Schedule are held

in the name of IMS or its Affiliates, and none are held in the name of any

current or former director, officer, employee, independent contractor or

consultant of IMS or its Affiliates or agents or otherwise on behalf of IMS or

its Affiliates. Except for those Governmental Licenses retained pursuant to

Section 1.2(vi) hereof in order to perform the obligations under the Finished

Product Purchase Agreement or as set forth in Section 3.5 of the Disclosure

Schedule, all Governmental Licenses that are material to the conduct of the CD

Business are transferable to the Company. Notwithstanding the foregoing, this

Section 3.5 shall not constitute a representation or warranty as to the specific

regulatory matters covered in Sections 3.21 and 3.23.

Section 3.6 Financial Statements. (a) Section 3.6(a) of the Disclosure

Schedule refers to the audited consolidated balance sheets of IMA as of December

31, 2005 (the "IMA Balance Sheet Date"), and December 31, 2004 and audited

statements of income and cash flows of IMA for each of the fiscal years ending

on such dates, together with any notes thereto and accountant's reports thereon

(collectively, the "IMA Audited Financial Statements"), and the unaudited

consolidated balance sheet of IMA as of September 30, 2006 and the unaudited

statement of income of IMA for the period ending on such date (collectively, the

"IMA Unaudited Financial Statements" and together with the IMA Audited Financial

Statements, the "IMA Financial Statements"). Except as disclosed in Section

3.6(a) of the Disclosure Schedule, the IMA Financial Statements fairly present,

in all material respects, the consolidated financial position and results of

operations and cash flows of IMA for the periods and as of the dates referred to

in the IMA Financial Statements, all in accordance with United States generally

accepted accounting principles, consistently applied ("GAAP") (except, in the

case of the IMA Unaudited Financial Statements, for the absence of footnotes and

normal year-end adjustments that are not material individually or in the

aggregate). The IMA Financial Statements are consistent in all material respects

with the books and records of IMA, subject, in the case of the IMA Unaudited

Financial Statements, to normal year-end adjustments that are not material

individually or in the aggregate.

(b) Section 3.6(b) of the Disclosure Schedule sets forth the unaudited

pro forma balance sheet (the "Most Recent Balance Sheet") of CD Business as of

September 30, 2006 (the "Most Recent Balance Sheet Date"), and the unaudited pro

forma statements of revenues and direct expenses of the CD Business for the

period then ended (the financial statements collectively, the "CD Financial

Statements"). Except as set forth in Section 3.6(b) of the Disclosure Schedule,

the CD Financial Statements (i) are consistent with the books and records of IMS

and IMA, (ii) have been prepared in accordance with GAAP and (iii) present

fairly the pro forma financial condition, results of operations of the CD

Business as of the respective dates thereof and for the periods referred to

therein, subject to normal year-end adjustments that are not material

individually or in the aggregate.

(c) IMA maintains a system of internal accounting controls sufficient

to provide reasonable assurance that: (i) transactions are executed in

accordance with management's general or specific authorizations; (ii)

transactions are recorded as necessary to permit preparation of financial

statements in accordance with GAAP and to maintain asset accountability; (iii)

access to assets is permitted only in accordance with management's general or

specific authorization; and (iv) the recorded accountability for assets is

compared with the

 

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existing assets at reasonable intervals and appropriate actions are taken with

respect to any differences.

Section 3.7 Absence of Changes or Events. Since the IMA Balance Sheet

Date, (a) except as set forth in Section 3.7 of the Disclosure Schedule, the CD

Business has been conducted only in the ordinary course of business consistent

with past practice (the "Ordinary Course of Business"), (b) there has occurred

no Material Adverse Effect, and (c) other than as set forth in Section 3.7 of

the Disclosure Schedule, none of IMA and its Subsidiaries has taken any actions

that, if taken after the date of this Agreement, would constitute a breach of

any of the covenants set forth in Section 4.3(a), (b) and (c).

Section 3.8 Undisclosed Liabilities. Except with respect to their

respective obligations under this Agreement, the Purchase Agreement, the other

Transaction Agreements and the Contributed Note, neither IMS nor IMA has

liabilities or obligations relating to the CD Business (in each case whether

known, absolute, contingent, accrued or otherwise), except for such liabilities

and obligations (a) to the extent shown on the Most Recent Balance Sheet, (b)

incurred in the Ordinary Course of Business since the Most Recent Balance Sheet

Date, (c) under the Business Contracts, other than liabilities and obligations

due to any material breaches or non-performance thereunder, or (d) listed in

Section 3.8 of the Disclosure Schedule.

Section 3.9 Assets other than Real Property. Except as set forth in

Section 3.9 of the Disclosure Schedule, (a) each of IMS and IMA owns outright

and has good and marketable title to, or has valid leasehold interests in, all

of the tangible Contributed Assets free and clear of all Liens; (b) other than

the Excluded Assets and together with the assets acquired by the Company

pursuant to the Purchase Agreement, the Company's rights under the IMA License

Agreements, the Finished Product Purchase Agreement, the Distribution

Arrangements and the IMA Transition Services Agreement, the Contributed Assets

constitute all of the assets, properties, permits, rights, agreements and other

Contract rights and interests that are necessary to enable the Company after the

Closing to operate the CD Business in a manner consistent with the manner in

which the CD Business is currently being operated; and (c) the Transfer will

vest good and marketable title in and to the tangible Contributed Assets in the

Company free and clear of all Liens except for Permitted Liens. To the Knowledge

of IMS or IMA, the tangible Contributed Assets are in good operating condition

and repair and none of such tangible assets that are material to the conduct of

the CD Business is in need of maintenance or repairs except for ordinary,

routine maintenance and repairs that are not material in nature or cost.

Section 3.10 [Reserved].

Section 3.11 Contracts. (a) Section 3.11(a) of the Disclosure Schedule

sets forth a true, accurate and complete list of each Business Contract

(collectively, "Scheduled Contracts") to which IMA, IMS or any of their

respective Subsidiaries is a party that (x) is material to the CD Business; (y)

provides for aggregate annual payments, or has a value in excess, of fifty

thousand dollars ($50,000); or (z) falls within one or more of the following

categories:

(i) Contracts under which IMA, IMS or any of their respective

Subsidiaries own, have under license, have a right to acquire (by option or

otherwise), have a right to use or exercise (including any covenant not to

sue or other similar right of forbearance),

 

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<PAGE>

or otherwise Control, or have any other right or interest in or to any

Intellectual Property that is necessary to the conduct of the CD Business

as currently conducted;

(ii) Contracts with any labor union or similar representative covering

any Transferred Employee;

(iii) Contracts under which products of the CD Business are

manufactured or distributed by IMA, IMS or any of their respective

Subsidiaries, including any distribution agreements, wholesalers,

manufacturing and supply agreements and Contracts with managed care

organizations or Governmental Entities; and

(iv) Contracts limiting or restraining IMA, IMS or any of their

respective Subsidiaries in any material respect from engaging or competing

in any business of the CD Business with any Person or from purchasing any

products, services or inventory from any third parties.

Notwithstanding the foregoing, neither IMA nor IMS shall be required to set

forth on the aforementioned Section 3.11(a) of the Disclosure Schedule any

Contract relating to IMA's and certain of its Subsidiaries' manufacturing of

products of the CD Business, including Contracts to purchase raw materials,

components or supplies, Contracts to supply or procure reagents or other

biological components and Contracts with subcontractors, suppliers or service

providers used in the conduct of such manufacturing activity.

(b) Except as indicated in Section 3.11(b) of the Disclosure Schedule,

IMA has delivered or made available to PGIO complete and correct copies of all

written Scheduled Contracts, including all amendments, modifications and

material waivers relating thereto.

(c) Each Scheduled Contract is in full force and effect in accordance

with the terms thereof and constitutes a legal, valid and binding agreement of

IMA, IMS or one or more of their respective Subsidiaries, as applicable, and is

enforceable in accordance with its terms by IMA, IMS or such Subsidiaries, as

applicable, against each counterparty thereto, except as the same may be limited

by General Limitations. IMA, IMS and their respective Subsidiaries, as

applicable, have performed in all material respects all of their obligations,

and are not in default under, any Business Contract. To IMS's or IMA's

Knowledge, except as indicated in Section 3.11(c) of the Disclosure Schedule, no

other party to any Business Contract is in material breach of or default under

such Business Contract.

(d) Except as set forth in Section 3.11(d) of the Disclosure Schedule,

neither IMA nor IMS has any Knowledge that any party to any Scheduled Contract

(i) intends to either terminate or not renew such Scheduled Contract, or (ii)

has or intends to submit to IMA, IMS or any of their respective Subsidiaries any

claim of material breach by any such party with respect to the performance of

its obligations under any such Scheduled Contract.

(e) Section 3.11(e) of the Disclosure Schedule sets forth a true,

accurate and complete list of the Scheduled Contracts for which third party

consents are required to assign such Business Contracts to the Company. Subject

to the receipt of the third party consents listed on Section 3.11(e) of the

Disclosure Schedule and Closing, the Company will succeed to all rights, title

and interests of IMA, IMS or their respective Subsidiaries under each such

Contract

 

18

<PAGE>

without the necessity to obtain the consent of any other Person(s) to the

assignment of such Contract.

(f) None of the Business Contracts have been entered into by IMA, IMS

or any of their respective Subsidiaries other than in its or their Ordinary

Course of Business (other than agreements in settlement of Legal Proceedings

listed on Section 3.13 of the Disclosure Schedule) and other than on an arm's

length basis.

(g) Except as set forth in Section 3.11(g) of the Disclosure Schedule,

the Scheduled Contracts do not contain any provision that provides for automatic

termination upon the occurrence of the transactions contemplated hereby or for

the right of any party to any such Contract to terminate, accelerate or receive

any payment or other more favorable terms and conditions upon occurrence of the

transactions contemplated hereby.

(h) Except as set forth in Section 3.11(h) of the Disclosure Schedule,

there are no Persons holding a power of attorney on behalf of IMS, IMA or any of

their respective Subsidiaries that would enable such Persons to sell, lease or

otherwise encumber any of the Contributed Assets.

Section 3.12 Intellectual Property. (a) Section 3.12(a) of the

Disclosure Schedule sets forth, as of the date hereof, a complete and accurate

list of all Business Registered Intellectual Property. "Business Intellectual

Property" means (i) Business Contributed Intellectual Property, (ii) Business

Purchased Intellectual Property (as defined in the Purchase Agreement) and (iii)

all other Intellectual Property constituting Inverness Licensed IP and Inverness

Licensed Trademarks (each as defined in the IMA License Agreements). Except to

the extent indicated in Section 3.12(a) of the Disclosure Schedule, all Business

Intellectual Property is either (x) owned by, or subject to an obligation of

sole and exclusive assignment to, IMS or IMA or one of their respective

Subsidiaries free and clear of all Liens or other exceptions to title that

affect such Business Intellectual Property or restrict the use by IMS or IMA or

any of their respective Subsidiaries of the Business Intellectual Property in

any way or require IMS or IMA or any of their respective Subsidiaries to make

any payment or give anything of value as a condition to its use in any way of

such Business Intellectual Property (collectively, "IP Liens"), except in each

case for Permitted IP Liens or (y) Controlled but not owned by IMS or IMA or one

of their respective Subsidiaries pursuant to a license from, or a similar

agreement with, a third party free and clear, to the Knowledge of IMS and IMA,

of all IP Liens except for Permitted IP Liens. To the Knowledge of IMS or IMA,

with respect to all Business Intellectual Property owned by IMS or IMA or one of

their respective Subsidiaries that are United States patents or applications

subject to a terminal disclaimer against another patent or application, each

such patent or application has been and remains commonly owned with the patent

or application it is terminally disclaimed against since the terminal disclaimer

was filed with the United States Patent Office. Except to the extent indicated

in Section 3.12(a) of the Disclosure Schedule, IMS or IMA or one of their

respective Subsidiaries is (A) the sole owner of all Business Contributed

Intellectual Property and all Business Purchased Intellectual Property and (B)

the sole owner or sole and exclusive licensee (as the case may be) of all

Inverness Licensed IP and Inverness Licensed Trademarks. There are no actions

pending or, to the Knowledge of IMS or IMA, threatened with regard to the

ownership or Control by IMS or IMA or one of their respective Subsidiaries of

any Business Intellectual Property. Except as specified in Section 3.12(a) of

the

 

19

<PAGE>

Disclosure Schedule, each of IMS and IMA has the legal power to convey or

license (as applicable) to the Company all of its or its Subsidiaries' right,

title and interest that is being conveyed or licensed in and to the Business

Intellectual Property. No Business Intellectual Property will terminate or cease

to be valid Intellectual Property by reason of the execution and delivery of

this Agreement by IMS and IMA, the performance of IMS and IMA of their

obligations hereunder, or the consummation by IMS and IMA of the transactions

contemplated hereby.

(b) Except as disclosed in Section 3.12(b) of the Disclosure Schedule,

to the Knowledge of IMS or IMA, there is no unauthorized use, infringement,

misappropriation or violation of any of the Business Intellectual Property by

any Person.

(c) Except as disclosed in Section 3.12(c) of the Disclosure Schedule,

there are no pending or, to the Knowledge of IMS or IMA, threatened written

claims that the CD Business has infringed or is infringing any Intellectual

Property of any Person. Except for any third-party Intellectual Property

referred to in Section 3.12(c) of the Disclosure Schedule, to the Knowledge of

IMS or IMA, there are no patents or patent applications of any third party that

claim the same subject matter as a patent or patent application included in the

Business Intellectual Property that could reasonably serve as the basis for an

interference proceeding involving a patent or patent application included in the

Business Intellectual Property.

(d) (i) The patent applications owned by IMS or IMA or one of their

respective Subsidiaries and included in the Business Intellectual Property and,

to the Knowledge of IMS or IMA, the patent applications licensed by any third

party to IMS or IMA or one of their respective Subsidiaries and included in the

Business Intellectual Property, are pending and have not been abandoned, and

have been and continue to be prosecuted. All patents, registered Trademarks and

applications for Trademarks owned by IMS or IMA or one of their respective

Subsidiaries and included in the Business Intellectual Property and, to the

Knowledge of IMS or IMA, all patents, registered Trademarks and applications for

Trademarks licensed by any third party to IMS or IMA or one of their respective

Subsidiaries and included in the Business Intellectual Property, have been duly

registered or filed with or issued by the appropriate Governmental Entity, all

necessary affidavits of continuing use have been timely filed, and all necessary

maintenance fees timely paid to continue all such rights in effect. Except as

set forth in Section 3.12(d)(i) of the Disclosure Schedule, none of the patents

owned by IMS or IMA or one of their respective Subsidiaries and included in the

Business Intellectual Property and, to the Knowledge of IMS or IMA, none of the

patents licensed by any third party to IMS or IMA or one of their respective

Subsidiaries and included in the Business Intellectual Property, have expired or

been declared invalid, in whole or in part, by any Governmental Entity. Except

as set forth in Section 3.12(d) of the Disclosure Schedule, there are no ongoing

interferences, oppositions, reissues, or reexaminations or other proceedings

that could result in a loss or limitation of a patent right or claim involving

any of the patents or patent applications owned by IMS or IMA or one of their

respective Subsidiaries and included in the Business Intellectual Property. To

the Knowledge of IMS or IMA, there are no ongoing interferences, oppositions,

reissues, or reexaminations or other proceedings that could result in a loss or

limitation of a patent right or claim involving any of the patents or patent

applications licensed by any third party to IMS or IMA or one of their

respective Subsidiaries and included in the Business Intellectual Property.

 

20

<PAGE>

(ii) To the Knowledge of IMS or IMA, (A) the patents

included in the Business Intellectual Property have not been declared

invalid or unenforceable by any court, (B) there is no reason to believe

that any patent included in the Business Intellectual Property and material

to the CD Business would be declared invalid or unenforceable by a court,

and (C) each of IMS and IMA has met its duty of candor as required under 37

C.F.R. 1.56 and complied with analogous Laws outside the United States

requiring disclosure of references. To the Knowledge of IMS or IMA, each of

the patents and patent applications included in the Business Intellectual

Property that were filed by IMS or IMA or one of their respective

Subsidiaries properly identifies each and every inventor of the claims

thereof as determined in accordance with the Laws of the jurisdiction in

which such patent is issued or such patent application is pending.

(iii) Each inventor named on the patents and patent

applications included in the Business Intellectual Property that were filed

by IMS or IMA or one of their respective Subsidiaries, alone or together

with any joint owners, has executed an agreement agreeing to assign or

actually assigning his or her entire right, title and interest in and to

such patent or patent application, and the inventions embodied and claimed

therein, to IMS or IMA or such Subsidiary, alone or together with any joint

owners as appropriate, except as indicated in Section 3.12(a) of the

Disclosure Schedule. To the Knowledge of IMS or IMA, no such inventor has

any contractual or other obligation that would preclude any such assignment

or otherwise conflict with the obligations of such inventor to IMS or IMA

or such Subsidiary.

(e) Section 3.12(e) of the Disclosure Schedule sets forth a true,

complete and accurate list of all Contracts with respect to any options, rights,

licenses or interests of any kind relating to Business Intellectual Property

that have been granted (i) by a third party to IMS or IMA or any of their

respective Subsidiaries, or (ii) by IMS or IMA or any of their respective

Subsidiaries to any other Person (in the case of either clauses (i) or (ii)

above, other than agreements commonly generated in the Ordinary Course of

Business (including software licenses for generally available software, employee

assignment agreements, nondisclosure agreements, consulting agreements, material

transfer agreements, clinical trial agreements and evaluation agreements) that

individually and in the aggregate have not caused and would not reasonably be

expected to cause a Material Adverse Effect). In addition, Section 3.12(e) of

the Disclosure Schedule sets forth a true, complete and accurate list of all

Contracts under which IMS or IMA or any of their respective Subsidiaries is

obligated to make to, or receives from third parties payments (in any form,

including royalties, license fees, milestones and other contingent payments) for

use of any Business Intellectual Property. Other than as set forth on Section

3.12(e) of the Disclosure Schedule, no royalties, license fees or other payment

obligations are owed to any Person in connection with the exercise of

Intellectual Property Rights in the conduct of the CD Business after the Closing

Date by IMS or IMA or any of their respective Subsidiaries under any Contract

(other than Contracts relating to "off the shelf" commercially available

software) to which any of them are a party. Each of IMS and IMA and their

respective Subsidiaries is in compliance in all material respects with the terms

of all Contracts set forth on Section 3.12(e) of the Disclosure Schedule and, to

the Knowledge of IMS or IMA, each of the licensees and licensors, as the case

may be, is in compliance in all material respects with all such Contracts, and

there are no material disputes or proceedings threatened or pending regarding

the same.

 

21

<PAGE>

(f) The Business Intellectual Property constitutes all the

Intellectual Property necessary and sufficient to conduct the CD Business as

currently conducted; provided, that this Section 3.12(f) shall not constitute a

non-infringement representation (which non-infringement representation is the

subject of Section 3.12(g) below).

(g) Except as disclosed in Section 3.12(g) of the Disclosure Schedule,

to the Knowledge of IMS or IMA, the operation of the CD Business does not, and

as a result of Closing will not, infringe on or violate the rights of any Person

under any Intellectual Property.

(h) Each of IMS and IMA and their respective Subsidiaries has taken

reasonable steps to protect the confidentiality of the confidential information

and trade secrets included in the Business Intellectual Property, including by

entering into Contracts that generally require licensees, contractors and other

third persons with access to such trade secrets to keep such trade secrets

confidential.

(i) Each of IMS and IMA uses reasonable procedures designed to ensure

the recording and maintenance of all know-how that is included in the Business

Intellectual Property and material to the conduct of the CD Business.

(j) All former and current employees, consultants and contractors of

IMS or IMA or any of their respective Subsidiaries (i) having access to the

Business Intellectual Property have executed and delivered to IMS or IMA or the

relevant Subsidiary an agreement regarding the protection of the confidential

information included in the Business Intellectual Property and (to the extent

required by any customer or business partner or IMS or IMA) confidential

information of IMS's or IMA's customers or business partners made available to

such employees, consultants or contractors and (ii) who were involved in, or who

contributed to, the creation or development of any Business Intellectual

Property have executed and delivered to IMS or IMA or the relevant Subsidiary an

agreement regarding the assignment by such employees, consultants and

contractors to IMS or IMA (or the relevant Subsidiary) of any and all Business

Intellectual Property; and true and complete copies of all such agreements have

been made available to PGIO. Each of IMS and IMA and their respective

Subsidiaries has secured, from all former and current employees, consultants and

contractors w


 
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