ASSET PURCHASE AGREEMENT

Asset Purchase Agreement

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ABBOTT CARDIOVASCULAR, INC. | ABBOTT JAPAN CO., LTD., | INVERNESS MEDICAL INNOVATIONS, INC.,

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Title: ASSET PURCHASE AGREEMENT
Governing Law: Illinois Date: 7/7/2005
Industry: Biotechnology and Drugs Law Firm: Goodwin Procter LLP Sector: Healthcare

Exhibit 2.1

ASSET PURCHASE AGREEMENT

dated as of May 28, 2005

by and among

ABBOTT LABORATORIES ,

ABBOTT CARDIOVASCULAR, INC.

ABBOTT JAPAN CO., LTD.,

INVERNESS MEDICAL INNOVATIONS, INC. ,

INVERNESS MEDICAL SWITZERLAND GmbH,

AND

INVERNESS MEDICAL JAPAN, LTD.

TABLE OF CONTENTS

ARTICLE I									DEFINITIONS

				1.1			Definitions

				1.2			Construction

				1.3			Performance of Obligations by Affiliates

ARTICLE II									PURCHASE AND SALE

			2.1					Agreements to Purchase and Sell

			2.2					Excluded Assets

			2.3					Assumed Liabilities

			2.4					Excluded Liabilities

			2.5					Contracts Transferred by Seller following the Closing Date

			2.6					Procedures for Contracts not Transferable

			2.7					Extraordinary Obligations

			2.8					Wrong Pockets

ARTICLE III									PURCHASE PRICE; CONSISTENT TREATMENT

		3.1					Purchase Price

		3.2					Purchase Price Allocation

ARTICLE IV									CLOSINGS

	4.1					Closing Date

	4.2					Closing

	4.3					Transactions at Closing

	4.4					Regulatory Matters in Japan

	4.5					Transfer of Marketing Registrations

	4.6					Distribution of the Products

	4.7					Inventory

	4.8					Cost-Flow Examples

ARTICLE V									REPRESENTATIONS AND WARRANTIES OF SELLER

	5.1				Organization

	5.2				Due Authorization

	5.3				Title

	5.4				Intellectual Property

	5.5	Litigation

	5.6	Contracts

	5.7	Employment Matters

	5.8	Employee Benefits

	5.9	Consents

	5.10	Brokers, Etc

	5.11	Marketing Registrations; Compliance with Laws

	5.12	Disclaimer

	5.13	Unaudited Financial Statements and Financial Information

	5.14	Absence of Certain Changes

	5.15	Warranty Matters

	5.16	Customers, Distributors and Suppliers

	5.17	Disclosure

ARTICLE VI			REPRESENTATIONS AND WARRANTIES OF BUYER

	6.1	Organization

	6.2	Due Authorization

	6.3	Consents

	6.4	Litigation

	6.5	Brokers, Etc

	6.6	Compliance with Laws

	6.7	Disclosure

	6.8	Valuation

ARTICLE VII			POST-CLOSING COVENANTS; OTHER AGREEMENTS

	7.1	Conduct of the Product Line Prior to the Closing

	7.2	Disclosure Supplements

	7.3	Records

	7.4	Use of Abbott Brands

	7.5	Japanese Employees

	7.6	Transfer Taxes

	7.7	Accounts Receivable

		7.8			Returns of Products

		7.9			Assistance with Transition of the Product and Manufacturing of Product

		7.10			Buyer’s Covenant Not to Sue

		7.11			Seller’s Covenant Not to Sue

		7.12			Product Diversion

		7.13			Further Assurances

		7.14			Non-Solicitation

		7.15			Financing

		7.16			Developing World Program

		7.17			Financial Information

		7.18			Use of Determine/Daina Screen Brand Names in United States

		7.19			Reagent Information Rights

		7.20			Inverness Japan

ARTICLE VIII							CONDITIONS TO CLOSING

		8.1		Conditions to Seller’s Obligations

		8.2		Conditions of Buyer’s Obligations

ARTICLE IX							TERMINATION

	9.1		Termination

	9.2		Procedure and Effect of Termination

ARTICLE X							INDEMNIFICATION AND SURVIVAL

	10.1		Indemnification by Seller

	10.2		Indemnification by Buyer

	10.3		Survival

	10.4		Exclusive Remedy

	10.5		Net Losses and Subrogation

	10.6		Third Party Claim Indemnification Procedures

ARTICLE XI						MISCELLANEOUS

	11.1		Assignment

	11.2		Public Announcements

	11.3		Confidentiality

iii

Exhibits and Schedules

Exhibits

Exhibit A	–	Assignment and Assumption Agreement
Exhibit B	–	Bill of Sale
Exhibit C	–	Master Secondment Agreement
Exhibit D	–	License and Material Transfer Agreement
Exhibit E	–	Manufacturing Support Services Agreement
Exhibit F	–	Patent Assignment
Exhibit G	–	Reagent Supply Agreement
Exhibit H	–	Supply of Products for the Humanitarian Program Agreement
Exhibit I	–	Trademark Assignment
Exhibit J	–	Trademark License Agreement
Exhibit K	–	Alternative Dispute
Exhibit L	–	Index of Documents
Exhibit M	–	Cost Flow Examples
Exhibit N	–	Noncompetition Agreement
Exhibit O	–	Press Release

Schedules

Schedule 1.1(j)	–	Regular Japanese Employees
Schedule 1.1(k)	–	Key Japanese Employees
Schedule 1.1(l)	–	Least Developed Countries
Schedule 1.1(o)	–	Labor and Overhead Payment
Schedule 1.1(p)	–	Products
Schedule 1.1(r)	–	Royalty Payments
Schedule 1.1(t)	–	Territory
Schedule 2.1(a)	–	Equipment
Schedule 2.1(c)(i)	–	Patents
Schedule 2.1(c)(ii)	–	Licensed Patents
Schedule 2.1(c)(iii	–	Marks
Schedule 2.1(c)(iv	–	Licensed Marks
Schedule 2.1(f)	–	Marketing Registrations
Schedule 2.1(k )	–	Reagents Exclusive to Product Line
Schedule 3.2	–	Allocation Schedule
Schedule 5.3	–	Operating Condition
Schedules 5.4(a), (b),
(e), (f) and (j)	–	Intellectual Property
Schedule 5.7(c)	–	Employment Matters
Schedule 5.8	–	Abbott Benefit Plan
Schedule 5.9	–	Seller’s Consent
Schedule 5.13(a)	–	Product Line Financial Statements

Schedule 5.13(d)	–	United States Closing Assets
Schedule 5.14	–	Absence of Changes
Schedule 5.15	–	Warranty Matters
Schedule 5.16	–	Customers, Distributors and Suppliers
Schedule 6.3	–	Buyer Consents
Schedule 7.5(a)(i)	–	Japanese Employees
Schedule 7.5(a)(ii)	–	Other Benefits
Schedule 7.5(b)	–	Copies of Employment Offers
Schedule 7.5(i)	–	Allocation of Bonus for 2005
Schedule 8.2(e	–	Other Employee
Schedule 10.2(a)	–	Third Party Patent Infringement Liability

ASSET PURCHASE AGREEMENT

THIS ASSET PURCHASE AGREEMENT, dated as of May 28, 2005 is entered into by and among Abbott Laboratories, an Illinois corporation (“ Abbott Laboratories ”), Abbott Cardiovascular, Inc., a Delaware corporation (“ Abbott Cardiovascular ”), Abbott Japan Co., Ltd., a Japanese corporation (“ Abbott Japan ”, and collectively with Abbott Laboratories and Abbott Cardiovascular, “ Seller ”), on the one hand, and Inverness Medical Innovations, Inc., a Delaware corporation (“ Parent ”), Inverness Medical Switzerland GmbH, a corporation organized under the laws of Switzerland (“ Inverness Switzerland ”), and Inverness Medical Japan, Ltd., a corporation organized under the laws of Japan (“ Inverness Japan ”, and collectively with Parent, and Inverness Switzerland, the “ Buyer ”), on the other hand. Seller and Buyer sometimes are referred to in this Agreement collectively as the “ Parties ” and individually as a “ Party ”.

WHEREAS, Seller wishes to sell and assign to Buyer, and Buyer wishes to purchase and assume from Seller, certain assets and liabilities relating to the design, development, manufacturing, registration, marketing, distribution and sale of its Determine ^® /Daina Screen ^® product line (“ Product Line ”); and

WHEREAS, Seller has agreed, as an inducement for Buyer to enter into this Agreement, to enter into the Noncompetition Agreement (as defined herein).

NOW, THEREFORE, in consideration of the premises and mutual covenants, agreements and provisions herein contained, the Parties hereto agree as follows:

ARTICLE I
Definitions.

1.1 Definitions . In addition to the terms defined above and other terms defined in other Sections of this Agreement, the following initially capitalized terms have the following meanings when used herein:

“ Abbott Benefit Plan ” means each Benefit Plan established, maintained or contributed to by Abbott Japan for the benefit of the Japanese Employees.

“ Abbott Brands ” means the trademarks or trade names “Abbott ^® ,” “Abbott Laboratories ^® ,” the stylized symbol “A ^® ,” and any variants of any of the foregoing presently used in connection with the Product Line.

“ Abbott Excluded Business ” means the design, development, manufacturing, registration, marketing, distribution and sale of products which test using Excepted Readers in hospitals, laboratories, blood banks or similar locations, other than in a Rapid Manner within the Field of Use, bodily fluids for evidence of infectious diseases (including HIV and hepatitis) of donors or patients.

“ Abbott Material Costs Incurred ” means: (a) during the term of the Manufacturing Support Services Agreement and while the Distribution Period is still in effect, the raw materials, labels and packaging materials portion of Products sold during each calendar month of the Distribution Period valued at the standard cost per the BPCS system in Matsudo, Japan as of December 1, 2004; provided , however , that during such term, Seller shall supply Reagents at a price equal to the Standard Manufacturing Cost per unit plus 15%, and (b) after the termination or expiration of the Manufacturing Support Services Agreement and while the Distribution Period is still in effect, the price charged by Buyer to Seller for Products purchased for distribution during each calendar month of the Distribution Period.

“ Accounts Receivable ” has the meaning set forth in Section 2.2(c) .

“ Acquired Assets ” has the meaning set forth in Section 2.1 .

“ Additional Assay Capabilities ” means the design, development, manufacturing, registration, marketing, distribution and sale of products manufactured by Buyer or its Affiliates which test for malaria Pf, malaria Pf/vivax, tuberculosis, Chagas disease, chlamydiasis, and multiple analytes; provided , however , that multiple analyte tests (which test for more than one of HIV1-2, hepatitis, syphilis or fecal occult blood) are expressly excluded.

“ Affiliate ” means, with respect to any Person, any other Person directly or indirectly controlling or controlled by, or under direct or indirect common control with, such Person; provided , however , that for the avoidance of doubt and subject to the following sentence, the term “Affiliate” shall exclude, with respect to Seller, TAP Pharmaceuticals Inc., a Delaware corporation, TAP Finance Inc., a Delaware corporation and TAP Pharmaceuticals Products Inc., a Delaware corporation and, with respect to Buyer, PBM-Selfcare LLC, a Delaware limited liability company. For purposes of this definition, a Person shall be deemed to control another Person if it owns or controls more than 50% of the voting equity of the other Person (or other comparable ownership if the Person is not a corporation).

“ Affiliate Variances ” means variances, which may be either positive or negative, related to Abbott Material Costs Incurred resulting from inventory loss due to obsolescence, damage,

loss or theft at any of Seller’s or any of its Affiliates’ distribution locations, unless such loss is due to Seller’s gross negligence, recklessness or willful misconduct.

“ Agreement ” means this Asset Purchase Agreement, including all Schedules and Exhibits hereto, as it may be amended from time to time in accordance with its terms.

“ Allocation Schedule ” has the meaning set forth in Section 3.2 .

“ Assignment and Assumption Agreement ” means the Assignment and Assumption Agreement between Abbott Laboratories, on the one hand, and Parent, on the other hand, the form of which is attached hereto as Exhibit A .

“ Assumed Liabilities ” has the meaning set forth in Section 2.3 .

“ Benefit Plan ” means any standard salary, sales incentive, variable payment, extra standard salary, extraordinary salary, bonus, deferred compensation, stock-based incentive, regular retirement allowance at the company rate, special retirement allowance, guaranteed “age 60” retirement allowance, 30 days’ notice period of termination or payment in lieu of such notice, housing allowance, cash gifts of congratulations and condolences, hospitalization or other medical, disability, life or other insurance, retirement plan, program, agreement, or arrangement and each other employee benefit plan, program, agreement or arrangement.

“ Bill of Sale ” means the Bill of Sale among Abbott Laboratories and Abbott Cardiovascular, on the one hand, and Inverness Japan, on the other hand, the form of which is attached hereto as Exhibit B .

“ Business Day ” means any day other than a day, which is Saturday or Sunday, or other day on which commercial banks in New York, New York are authorized or required to remain closed.

“ Buyer ” has the meaning set forth in the recitals hereof.

“ Buyer Indemnified Party ” has the meaning set forth in Section 10.1(a) .

“ Buyer Product Vendor ” has the meaning set forth in Section 7.12(a) .

“ Buyer’s Field of Use ” has the meaning set forth in Section 7.11 .

“ Cell Lines ” has the meaning set forth in the License and Material Transfer Agreement.

“ Closing ” means the closing of the purchase and sale of the Acquired Assets (subject to Sections 4.4, 4.5 and 4.6 ) and the assignment and assumption of the Assumed Liabilities, each as contemplated by this Agreement.

“ Closing Date ” has the meaning set forth in Section 4.1 .

“ Commission ” has the meaning set forth in Section 4.6(f) .

“ Competing Product ” has the meaning set forth in the Noncompetition Agreement.

“ Confidentiality Agreement ” means the Confidentiality Letter Agreement effective as of August 2, 2004 from Seller to Buyer.

“ Consent ” means any consent, approval, authorization, consultation, waiver, permit, grant, agreement, license, certificate, exemption, order, registration, declaration, filing or notice of, with or to any Person, in each case required to permit the consummation of any of the transactions contemplated hereby.

“ Consent Decree ” means the Amended Consent Decree of Permanent Injunction (Civil Action No. 99C7135) entered into between Seller and the United States dated November 2, 1999 and the Complaint for Injunction (Civil Action No. 99C7135) dated November 2, 1999.

“ Contracts ” means: (i) the distribution contracts covering only the distribution of the Products in one or more countries within the Territory that Seller or its Affiliates have entered into prior to the Closing Date, and (ii) those supply agreements and all other contracts related primarily to the Product Line that Seller or its Affiliates have entered into prior to the Closing Date.

“ Customers and Distributors ” has the meaning set forth in Section 5.16 .

“ Distribution Activities ” means the following activities to be performed by Seller or its Affiliates during the Distribution Period pursuant to the provisions of Section 4.6 : (i) the receipt and processing of purchase orders for the Products; (ii) providing warehousing services for the Products; (iii) shipping of Products to third party distributors and other customers; (iv) invoicing and collection of accounts receivable from third party distributors and other customers; (v) maintenance of third party distributor and customer accounts ( i.e., implementing the credit limits for sales of the Products established from time to time by Buyer); (vi) handling of third party distributor and customer complaints; (vii) processing returns of Products from third party distributors and other customers; (viii) reporting Net Sales of the Products in accordance with the

provisions of Section 4.6(c) ; (ix) conducting first line post-market surveillance; and (x) performing all other administration functions related to sales of the Products to third party distributors or other customers, including the submitting, processing and administering of all tender documentation for the Products within the Territory.

“ Distribution Period ” means the period during which Seller and its Affiliates distribute the Products in any country within the Territory in accordance with the provisions of Section 4.6(a) .

“ Encumbrance ” means any lien, mortgage, security interest, pledge, restriction on transferability, conditional sale agreement or other title retention agreement, or other charge or encumbrance of any nature whatsoever on any property or property interest.

“ Equipment ” has the meaning set forth in Section 2.1(a) .

“ Excepted Readers ” means any monitor or reader that is capable of reading more than ten tests before its disposal, provided further that, for the avoidance of doubt, IMx â , AxSYM â , Prism â , i-Stat â and Architect â products, in their current formats, are examples of Excepted Readers.

“ Excluded Assets ” has the meaning set forth in Section 2.2 .

“ Excluded Liabilities ” has the meaning set forth in Section 2.4 .

“ Exclusive Reagents ” means those reagents listed on Schedule 2.1(k) .

“ Exclusively Related Know-How ” means any Know-How that as of the Closing Date is (i) exclusively related to the Product Line, and (ii) exclusively used in connection with the Product Line.

“ FDA ” means the U.S. Food and Drug Administration or similar federal, state or local Governmental Authorities.

“ Field of Use ” means the design, development, manufacturing, registration, marketing, distribution and sale of single use disposable test strips using lateral flow immunoassay technology which are visually read without the aid of an Excepted Reader. For the avoidance of doubt, the Field of Use shall not include the Abbott Excluded Business.

“ Financing ” means the financing obtained by Buyer from its lenders lead by General Electric Capital Corporation in the amount of $56,500,000 (or in such lesser amount as is sufficient to consummate the transactions contemplated by this Agreement) and on the terms that Buyer may agree to in compliance with the provisions of Section 7.15 .

“ Finished Inventory ” means any stock of finished Products maintained by Seller or any of its Affiliates in any country within the Territory (except for finished Products at the Matsudo, Japan plant) at the end of the Distribution Period in such country. For the avoidance of doubt, any stock of finished Product maintained by Abbott Japan at the Matsudo, Japan plant shall be transferred to Inverness Japan upon the termination of the Manufacturing Support Services Agreement in accordance with the provisions contained therein.

“ Fiscal Year ” means the 12 month period commencing on December 1 of each calendar year and ending on November 30 of the immediately following calendar year.

“ GAAP ” means accounting principles generally accepted in the United States consistently applied from period to period and throughout any period in accordance with the past practices of Seller.

“ Governmental Authority ” means any nation or government, any state, local or other political subdivision thereof, and any entity, department, commission, bureau, agency, authority, board, court, official or officer, domestic or foreign, exercising executive, judicial, regulatory or administrative governmental functions.

“ Humanitarian Program ” means (i) a sale or donation of Determine ^® HIV 1-2 or, subject to the provisions of Sections 5.6 and 5.7 of the Manufacturing Support Services Agreement and Sections 2.9 and 2.10 of the Supply of Products for the Humanitarian Program Agreement, any similar test products that operate in a Rapid Manner for the detection of any infectious diseases (including HIV and hepatitis) in any of the Least Developed Countries for humanitarian purposes by Seller and its Affiliates provided that such product is not bundled with other products of Seller and its Affiliates other than for humanitarian purposes or sold as a loss leader or as an inducement to purchase other products of Seller and its Affiliates, or (ii) any research and development conducted by Seller, an Affiliate of Seller or any other Person relating to the operation of test products that operate in a Rapid Manner for the detection of infectious diseases (including HIV and hepatitis) for use in any of the Least Developed Countries, in each case as part of the Global Care Initiatives and HIV surveillance programs of Seller and its Affiliates. Notwithstanding the foregoing, for the period from the Closing Date through the 5th anniversary

of the Closing Date (or, if not enforceable in any country for such period or for any other reason, for the period or otherwise to the maximum extent as shall be enforceable in such country), Seller and its Affiliates shall not engage in any filing or submission necessary or appropriate to obtain any technical, medical, scientific, labeling or similar license, registration, authorization, permit or approval for the Products outside the Least Developed Countries under the Humanitarian Program.

“ Indemnified Claim ” has the meaning set forth in Section 10.6(h) .

“ Indemnified Party ” has the meaning set forth in Section 10.5(a) .

“ Indemnifying Party ” has the meaning set forth in Section 10.5(a) .

“ Initial Distribution Period ” has the meaning set forth in Section 4.6(a) .

“ Initial Inventory Report ” has the meaning set forth in Section 4.7(a) .

“ Inventory Acquisition Price ” has the meaning set forth in Section 4.7(b) .

“ Japan Marketing Authorization ” means the marketing authorization issued by the relevant Japanese prefectural government authority that is required for the marketing, distribution or importation of pharmaceutical products within Japan.

“ Japan Product Marketing Approval ” means the product marketing authorizations issued by the Minister of Health, Labor and Welfare of Japan that are required for the marketing, promotion, distribution or sale of each of the Products within Japan.

“ Japanese Employees ” has the meaning set forth in Section 7.5(a) .

“ Key Japanese Employees ” means the Japanese Employees listed on Schedule 1.1(k) .

“ Knowledge ” means, with respect to Buyer, the actual knowledge of any executive officer of Buyer, and with respect to Seller, the actual knowledge of any of David Akeroyd, Regina Anderson, Jeffery Barton, Marc Berendes, Paul Eck, Thomas Holden, Cathe Johnson, Dr. Sushil Devare, Kiyonori Karasawa, Haruyoshi Sakamoto, Mark Shaffar and Andy Schapals; provided, however , that “Knowledge” shall not include any opinion that is subject to any attorney/client, work product, or like privilege.

“ Know-How ” means all non-public information, proprietary or otherwise, owned, held or licensed (with the right to sublicense) by Seller or one of its Affiliates as of the Closing Date

which relates directly to the design, development, manufacturing, quality control, packaging, storage, registration, marketing, distribution or sale of the Product Line.

“ Launch ” means the date of the first commercial sale of one or more Products in the United States by Parent, its Affiliates or third-party distributors to any Person.

“ Labor and Overhead Payment ” means the aggregate amount of the labor and overhead cost portion of the number of units of raw materials, work-in-process and finished Products existing as of the Closing Date which shall be determined in accordance with the criteria set forth on Schedule 1.1(o) and in the manner set forth in Section 4.7(a) .

“ Law ” means each provision of any currently existing federal, state, local or foreign, civil and criminal law, statute, ordinance, order, code, rule, regulation or common law, promulgated or issued by any Governmental Authority, as well as any judgments, decrees, injunctions or agreements issued or entered into by any Governmental Authority.

“ Least Developed Countries ” means those countries listed on Schedule 1.1(l) , as such Schedule 1.1(l) may be modified from time to time in the event that the United Nations modifies or amends the listing of Least Developed Countries, as such listing is set forth on the United Nations website ( www.un.org ).

“ Liability ” means, with respect to any Person, any liability or obligation of such Person, whether known or unknown, absolute or contingent, accrued or unaccrued, disputed or undisputed, liquidated or unliquidated, secured or unsecured, joint or several, due or to become due, vested or unvested, executory, determined, determinable or otherwise, and whether or not the same is required to be accrued on the financial statements of such Person.

“ License ” has the meaning set forth in Section 2.1(k) .

“ License and Material Transfer Agreement ” means the License and Material Transfer Agreement between Abbott Laboratories and Parent, a copy of which is attached hereto as Exhibit D .

“ Licensed Marks ” has the meaning set forth in Section 2.1(c)(iv) .

“ Licensed Patents ” has the meaning set forth in Section 2.1(c)(ii) .

“ Losses ” has the meaning set forth in Section 10.1(a) .

“ Manufacturing Instructions ” means those manufacturing, packaging and labeling specifications for the Products used by Seller or Seller’s Affiliates in the production and supply of the Products, including: (i) the Product Specifications (as defined in the Manufacturing and Support Services Agreement), and (ii) the Product Specifications, Product formulae and materials that Seller and Seller’s Affiliates reasonably required for the manufacture, quality control and release of the Products immediately prior to the Closing Date.

“ Manufacturing Site License ” means the manufacturing site license to be issued in favor of Inverness Japan by the Prefecture in Japan having jurisdiction over the place where Inverness Japan shall manufacture the Products upon the termination of the Manufacturing Support Services Agreement.

“ Manufacturing Support Services Agreement ” means the Manufacturing Support Services Agreement among Abbott Laboratories and Abbott Japan, on the one hand, and Buyer, on the other hand, a copy of which is attached hereto as Exhibit E .

“ Marks ” has the meaning set forth in Section 2.1(c)(iii) .

“ Marketing Registrations ” means the European Union Conformity Marking (CE marks) issued by an European Union Notified Body and all other technical, medical, scientific, labeling and similar licenses, registrations, authorizations, permits and approvals of the Products (including marketing authorizations and labeling approvals) issued by the Regulatory Authorities of any country within the Territory other than Japan and held as of the Closing Date by Seller or Seller’s Affiliates or third party distributors (under rights of reservation of Seller or its Affiliates) that are required for the marketing, promotion, distribution or sale of the Products within any country of the Territory other than Japan, all of which are listed on Schedule 2.1(f) .

“ Master Secondment Agreement ” means the Master Secondment Agreement between Abbott Japan and Inverness Japan, the form of which is attached hereto as Exhibit C .

“ Material Adverse Effect ” means, with respect to the Product Line, any change or effect that, individually or in the aggregate, has or is reasonably likely to have a material adverse effect on the assets and liabilities (taken together) or operations or sales or operating results of the Product Line, taken as a whole; provided , however , that, none of the following shall be deemed (either alone or in combination) to constitute such change or effect: (i) (A) any adverse change attributable to the announcement or consummation of the transactions contemplated by this Agreement or (B) any adverse change attributable to or conditions generally affecting the United

States or Japanese economy or financial markets in general; or (ii) any action by Seller approved or consented to in writing by Buyer after the date hereof.

“ Minor Product Modification ” means any enhancement, improvement or alteration of a Product which (i) affects the appearance, form, function, packaging, storage, or use of such Product, but is not significant, with respect to performance, safety, regulatory compliance or compatibility with the Product Specifications, and (ii) does not require Buyer or its Affiliates or representatives to obtain a new marketing registration for the Products in the European Union or a new Japan product marketing approval, or manufacturing site license in Japan or make modifications to the then-existing Marketing Registrations, Japan Product Marketing Approval or Manufacturing Site License.

“ Modified Product ” means any enhancement, improvement or alteration of a Product which is not a Minor Product Modification and which is approved in writing by Seller.

“ Monthly Average Exchange Rate ” means, with respect to each country within the Territory, the average exchange rate of the prior calendar month used by Seller for financial reporting, generally as reported by Reuters at 9:00 a.m. on the penultimate Business Day of each calendar month.

“ Monthly Net Sales ” has the meaning set forth in Section 4.6(d) .

“ Monthly Payments ” have the meaning set forth in Section 4.6(e) .

“ Net Sales ” means, with respect to any Product, the aggregate gross invoice price of all units of such Product sold during the Distribution Period by Seller or its Affiliates to third parties in a given country within the Territory (other than for the purposes of the Humanitarian Program), plus any separately invoiced transportation, importation, shipping and other handling expenses, less the following deductions:

(d) provisions made in accordance with GAAP for discounts, credits, coupons, allowances, adjustments, rejections, recalls, and returns;

(e) price reductions or rebates imposed on Seller or its Affiliates by Governmental Authorities;

(f) sales, excise, turnover, value-added and similar Taxes assessed against Seller or its Affiliates on the sales of such units during such period;

(g) transportation, importation, shipping, other handling expenses, insurance and other third party handling expenses directly chargeable to the sale of such units during such period, in each case to the extent included in such invoiced price; and

(h) to the extent applicable, chargebacks granted to wholesalers or their customers in the case of sales to wholesalers where there are no direct shipments with respect to such Product to such customers by Seller or its Affiliates.

“ Noncompetition Agreement ” means the Noncompetition Agreement among Abbott Laboratories and Abbott Japan, on the one hand, and Parent, Inverness Switzerland and Inverness Japan, on the other hand, the form of which is attached hereto as Exhibit N .

“ Non-Exclusive Reagents ” means those Reagents which are not listed on Schedule 2.1(k) .

“ OraSure HIV ” means the rapid, point of care in vitro diagnostic products for the detection of HIV-1 and HIV-2 antibodies which are sold under the trade name OraQuick ^® ADVANCE™ Rapid HIV-1/2 Antibody Test, and any other rapid, point of care products of OraSure Technologies, Inc. that Abbott Laboratories and its Affiliates may distribute in the United States for an initial period ending on December 31, 2007, pursuant to the terms of that certain Supply and Distribution Agreement entered into as of February 11, 2005 between Abbott Laboratories and OraSure Technologies, Inc., as extended, modified or amended thereafter (the “ OraSure HIV Agreement ”); provided , however , that, except as otherwise provided in the Noncompetition Agreement with respect to the OTC Market (as defined in the Noncompetition Agreement), such extension, modification or amendment occurs prior to notice of any Launch.

“ Ordinary Course of Business ” means the usual and customary way in which Seller or its Affiliates have conducted: (i) the manufacturing of the Products; (ii) the Distribution Activities; or (iii) the evaluation, and if commercially appropriate, submission of offers to any significant tender opportunities in the Territory during the period 12 months prior to the date hereof.

“ Other Agreements ” means, collectively, the Assignment and Assumption Agreement, the Bill of Sale, the License and Material Transfer Agreement, the Manufacturing Support Services Agreement, the Master Secondment Agreement, the Noncompetition Agreement, the Patent Assignment, the Reagent Supply Agreement, the Supply of Products for the Humanitarian Program Agreement, the Trademark Assignment, the Trademark License Agreement and other agreements entered into by Seller and Buyer in connection herewith on the date hereof.

“ Other Employee ” means the employee of Abbott Japan set forth in Schedule 8.2(e) .

“ Patents ” has the meaning set forth in Section 2.1(c)(i) .

“ Patent Assignment ” means the Patent Assignment among Abbott Laboratories and Abbott Cardiovascular, on the one hand, and Inverness Switzerland, on the other hand, the form of which is attached hereto as Exhibit F .

“ Person ” means any individual, corporation, partnership, joint venture, limited liability company, trust or unincorporated organization or government or any agency or political subdivision thereof.

“ PMA Product Application ” means the filing of a complete pre-market approval application with the FDA under Section 515 of the Federal Food, Drug and Cosmetic Act, as amended (or any successor provision thereto), in order for Buyer or one of its Affiliates to obtain the approval of the FDA to commercialize the Products in the United States to test for HIV 1-2.

“ Product ” or “ Products ” means those products identified on Schedule 1.1(p) (and for the avoidance of doubt does not mean specific units thereof).

“ Product Line ” has the meaning set forth in the recitals hereof.

“ Product Line Accountants ” has the meaning set forth in Section 7.17 .

“ Product Line Financial Statements ” has the meaning set forth in Section 5.13 .

“ Promotional Activities ” means those activities undertaken to encourage sales of the Products, including: journal advertising, broadcast advertising, direct mail programs, detailing, customer meetings, conventions and trade show exhibits, Product presentations, end user training, marketing plan development, ongoing post-market development, demand generation, symposia and other forms of advertising, promotion, sales and customer support.

“ Purchase Price ” has the meaning set forth in Section 3.1 .

“ Rapid Manner ” means the operation of a product which is competitive with the lateral flow technology utilized in the Products in terms of its performance and price. Further, Rapid Manner shall include only products:

(a) which perform and complete testing in substantially similar or less time than that of the comparable Products;

(b) that are self calibrating without direct operator intervention; and

(c) that are qualitative (i.e., simply positive or negative), rather than quantitative.

For the avoidance of doubt, Rapid Manner shall not include any products which test using Excepted Readers.

“ Reagents ” has the meaning set forth in the Reagent Supply Agreement.

“ Reagent Supply Agreement ” means the Reagent Supply Agreement among Abbott Laboratories, on the one hand, and Parent and Inverness Japan, on the other hand, the form of which is attached as Exhibit G .

“ Redbooks ” has the meaning set forth in Section 2.2(g) .

“ Regular Japanese Employees ” means the Japanese Employees listed on Schedule 1.1(j) .

“ Regulatory Authority ” means any Governmental Authority that is responsible for issuing technical, medical, scientific, labeling and similar licenses, registrations, authorizations, permits and approvals necessary for the manufacture, use, storage, import, transport, marketing or sale of the Products.

“ Regulatory Documentation ” means all applications, files and correspondence with Regulatory Authorities for the Japan Product Marketing Approvals, Manufacturing Site License and Marketing Registrations and all relevant pricing information and correspondence with Regulatory Authorities related to the Product Line, including the following: (i) approval letters; (ii) Product labeling files and artworks for each country, in paper and electronic format; (iii) validation of manufacturing processes and/or remediation studies and reports; (iv) complete copies of regulatory files; (v) copies of the Japan Product Marketing Approvals and the Marketing Registrations (including copies of cGMP certificates); (vi) copies of the variations and all correspondence related to them; (vii) copies of all labeling for all stock keeping units for the Product Line; (viii) copies of all expert reports, pre-clinical and clinical reports; (ix) a chart showing the renewal dates for the Japan Product Marketing Approvals and the Marketing Registrations; (x) copies of existing specifications (including copies of validation of analytical methods); (xi) a summary of any outstanding regulatory issues; (xii) copies of the complaints for 2003 and 2004 calendar years; and (xiii) any information on recalls for the 2003 and 2004 calendar years.

“ Required Consent ” has the meaning set forth in Section 2.6 .

“ Royalty Payments ” means any royalties on Net Sales paid during the Distribution Period by Seller and its Affiliates to any Person (other than Seller and its Affiliates) pursuant to the license or sublicense agreements listed on Schedule 1.1(r) .

“ SEC ” means the United States Securities and Exchange Commission.

“ Seller ” has the meaning set forth in the recitals hereof.

“ Seller Indemnified Party ” has the meaning set forth in Section 10.2(a) .

“ Seller Product Vendor ” has the meaning set forth in Section 7.12(b) .

“ Standard Manufacturing Cost ” means the standard manufacturing cost per the BPCS system in Matsudo, Japan and Delkenheim, Germany and per the AMM system in Lake County, Illinois as of December 1, 2004, for application in the applicable 2005 Fiscal Year, as increased or decreased on the first day of each applicable Fiscal Year during the term of the Manufacturing Support Services Agreement by an amount equal to the percentage increase or decrease in Seller’s standard costs of manufacturing the Reagents.

“ Suppliers ” has the meaning set forth in Section 5.16 .

“ Supply of Products for the Humanitarian Program Agreement ” means the Supply of Products for the Humanitarian Program Agreement, the form of which is attached hereto as Exhibit H .

“ Taxes ” means all taxes, charges, fees, duties, levies or other assessments, including, without limitation, income, gross receipts, net proceeds, ad valorem, turnover, real and personal property (tangible and intangible), sales, use, franchise, excise, value added, license, payroll, unemployment, environmental, customs duties, capital stock, disability, stamp, leasing, lease, user, transfer, fuel, excess profits, occupational and interest equalization, windfall profits, severance and employees’ income withholding and Social Security taxes imposed by the United States or any foreign country or by any state, municipality, subdivision or instrumentality of the Unites States or of any foreign country or by any other tax authority and such term shall include any interest, penalties or additions to tax attributable to such taxes.

“ Tax Indemnification ” has the meaning set forth in Section 10.3 .

“ Tax Return ” means any return, declaration, report, claim for refund or information return or statement relating to Taxes, including any schedule or attachment thereto, and including any amendment thereof.

“ Technical Information ” means all documents, drawings, specifications, computer software and any other documented information of whatever nature and wherever located which, in each case: (i) are owned or controlled by Seller and Seller’s Affiliates; and (ii) to the extent such documents relate to the design, development, validation, materials and components, biological compatibility, manufacture, processing, testing, storage, packaging, labeling, regulations, safety, quality or performance of the Product Line, including, periodic safety updated reports (“ PSURs ”) and information about adverse events reportable to Regulatory Authorities (real or alleged) received in the 2002, 2003 and 2004 Fiscal Years and all corrective and preventive action taken in such period; provided , however , that, with respect to such documents the absence of which would not materially: (a) impair the ability to manufacture the Products after the Closing, or (b) interfere with or prevent Buyer’s ability to receive any license, registration, authorization, permit or approval of the Products that is required to manufacture, market, promote, distribute or sell the Products, Seller and Seller’s Affiliates are required to deliver to Buyer only those documents that Seller and Seller’s Affiliates can deliver by using commercially reasonable efforts.

“ Territory ” means those countries listed on Schedule 1.1(t) .

“ Threshold Amount ” means $416,000.

“ Trademark Assignment ” means the Trademark Assignment among Abbott Laboratories and Abbott Cardiovascular, on the one hand, and Inverness Switzerland, on the other hand, the form of which is attached hereto as Exhibit I .

“ Trademark License Agreement ” means the Trademark License Agreement, between Abbott Laboratories and Parent, the form of which is attached hereto as Exhibit J .

“ Transfer Documents ” means (i) with respect to the Acquired Assets, such deeds, bills of sale, asset transfer agreements, endorsements, assignments affidavits and other instruments of sale, conveyance, transfer and assignment between Seller and Seller’s Affiliates, on the one hand, and Buyer and Buyer’s Affiliates or designees, on the other hand, as necessary under the Law of the relevant jurisdiction or contemplated by this Agreement in order to transfer all right, title and interest of Seller and Seller’s Affiliates in, to and under the Acquired Assets in accordance with the terms hereof, and (ii) with respect to the Assumed Liabilities, such

instruments of assumption between Seller and Seller’s Affiliates, on the one hand, and Buyer and Buyer’s Affiliates or designees, on the other hand, as necessary under the Law of the relevant jurisdiction or contemplated by this Agreement in order for the Assumed Liabilities to be effectively assumed by and transferred to Buyer and Buyer’s Affiliates or designees.

“ Transfer Price ” means the historic price that Seller or its Affiliates selling the Products charge to Affiliates of Seller or third party distributors or customers that purchase Products immediately prior to the Closing Date, subject to any price increases in the Ordinary Course of Business.

“ Transfer Taxes ” has the meaning set forth in Section 7.6 .

“ United States ” or “ US ” means the United States of America (including its territories and possessions).

“ United States Closing Assets ” has the meaning set forth in Section 5.13(d) .

“ Written Statement ” has the meaning set forth in Section 4.6(d) .

1.2 Construction . The language in all parts of this Agreement is to be construed in all cases according to its fair meaning. Seller and Buyer acknowledge that each Party and its counsel have reviewed and revised this Agreement and that any rule of construction to the effect that any ambiguities are to be resolved against the drafting Party are not to be employed in the interpretation of this Agreement. Whenever used herein, the words “include,” “includes” and “including” mean “include, without limitation,” “includes, without limitation” and “including, without limitation,” respectively. The masculine, feminine or neuter gender and the singular or plural number are each deemed to include the other whenever the context so indicates. “Days” means calendar days unless otherwise specified. Whenever used herein, the words “Seller” and “Buyer” include their respective Affiliates whenever the context requires or to the extent applicable. The words “hereof”, “herein” and “hereunder” and words of similar import when used in this Agreement refer to this Agreement as a whole (including any Exhibits and Schedules hereto) and not to any particular provision of this Agreement, and all Article, Section, Schedule and Exhibit references are to this Agreement unless otherwise specified. Except as otherwise expressly provided herein all references to “Dollar” or “$” refer to the lawful money of the United States.

1.3 Performance of Obligations by Affiliates . Any obligation of Seller under or pursuant to this Agreement may be satisfied, met or fulfilled, in whole or in part, at Seller’s sole and

exclusive option, either by Seller directly or by any Affiliate or designee of Seller that Seller causes to satisfy, meet or fulfill such obligation, in whole or in part. Any obligation of Buyer under or pursuant to this Agreement may be satisfied, met or fulfilled, in whole or in part, at Buyer’s sole and exclusive option, either by Buyer directly or by any Affiliate or designee of Buyer that Buyer causes to satisfy, meet or fulfill such obligation, in whole or in part. With respect to any particular action, the use of the words “Seller shall” also means “Seller shall cause” the particular action to be performed, and the use of the words “Buyer shall” also means “Buyer shall cause” the particular action to be performed. Each of the Parties guarantees the performance of all actions, agreements and obligations to be performed by any Affiliates of such Party under the terms and conditions of this Agreement.

ARTICLE II
Purchase and Sale.

2.1 Agreements to Purchase and Sell . Except as otherwise provided in Sections 2.2 , 4.4, 4.5 and 4.7 of this Agreement, at the Closing, Seller shall, or shall cause Seller’s Affiliates to, grant, sell, transfer, convey, assign and deliver to Buyer or Buyer’s Affiliates, and Buyer or Buyer’s Affiliates shall purchase and accept from Seller or Seller’s Affiliates, all right, title, and interest of Seller and Seller’s Affiliates in and to all of the following assets of Seller and Seller’s Affiliates free and clear from any Encumbrances, in each case, unless expressly set forth otherwise in this Agreement, to the extent primarily related to the Product Line (collectively, the “ Acquired Assets ”):

(a) all of the rights to the fixed and other tangible personal property set forth on Schedule 2.1(a) , whether owned or leased by Seller or its Affiliates (collectively, the “ Equipment ”);

(b) copies of the documents and information included in the data room provided by Seller for review to Buyer during the negotiation of this Agreement, the index to which is attached hereto as Exhibit L , provided , however , that Seller may from time to time update certain documents and information included in the data room in respect of the period between preparation of the data room and the Closing Date, in which case Seller shall notify Buyer in writing of any such updates and promptly provide Buyer with a copy of any such document upon request. Notwithstanding the foregoing, nothing in this Section 2.1(b) shall modify Seller’s obligations that are otherwise set forth in this Agreement;

(c) (i) the patents and patent applications owned by Seller or its Affiliates which are listed on Schedule 2.1(c)(i) (the “ Patents ”); (ii) the patents licensed by Seller or its Affiliates which are listed on Schedule 2.1(c)(ii) (the “ Licensed Patents ”); (iii) the internet domain names (i.e., the domain names www.determine.biz and www.determine.info ), the trademarks, trade names and service marks owned by Seller or its Affiliates and all applications and registrations for the foregoing which are listed on Schedule 2.1(c)(iii) , together with all common law rights associated with the trademarks which are the subject of such registrations and applications and the goodwill associated therewith (the “ Marks ”); (iv) the trademarks, trade names and service marks licensed by Seller or its Affiliates which are listed on Schedule 2.1(c)(iv) (the “ Licensed Marks ”); (v) copyrights in (A) all design history files described in Section 2.1(g) , (B) the Manufacturing Instructions, and (C) the Technical Information, provided , however , that Buyer hereby grants to Seller and its Affiliates a sole and exclusive license in and to such copyrights outside the Field of Use; (vi) all the copyrights in the documents primarily related to the Product Line provided pursuant to Section 2.1(b) , provided , however , that Buyer hereby grants to Seller and its Affiliates a sole and exclusive license in and to such copyrights outside the Field of Use; (vii) trade dress, logos, packaging design, and slogans, copyrights in both published and unpublished works, including without limitation all compilations, in each case, solely if exclusively related to and used in connection with the Product Line; and (viii) customized databases and customized computer programs used to operate Equipment, manuals and other documentation and all copyrights and applications thereof, and all derivatives, translations, adaptations and combinations thereof, in each case, solely if exclusively related to and used in connection with the Product Line or the Acquired Assets;

(d) subject to the provisions of Section 2.5, 2.6 and 2.7 , the Contracts;

(e) subject to the provisions of Section 4.4 , the Japan Product Marketing Approvals;

(f) subject to the provisions of Section 4.5 , the Marketing Registrations supported by and including: (i) the original documents under the possession of Seller or Seller’s Affiliates (or that are accessible to Seller or Seller’s Affiliates using commercially reasonable efforts) evidencing the Marketing Registrations issued to Seller or Seller’s Affiliates by the Regulatory Authorities that are listed in Schedule 2.1(f) (or if the original is not available, certified copies of the portions thereof related to the Products), in each case to the extent assignable with or without the Consent of the issuing Regulatory Authority; (ii) all related Regulatory Documentation; provided , however , that if any Regulatory Documentation also covers the manufacturing, marketing or sale of other products of Seller or one of its Affiliates, Seller may elect to redact

those portions that pertain to such other products, or deliver certified copies of such materials un-redacted but subject to the confidentiality provisions of this Agreement; and (iii) all of Seller’s and Seller’s Affiliates rights of reservation in any Marketing Registrations under any agreement pursuant to which any Marketing Registrations are held in the name of a third party. The Parties hereby agree and covenant that Seller shall deliver to Buyer the originals or, if applicable, certified copies of the Marketing Registrations and copies of the Regulatory Documentation as soon as feasible after the Closing Date, but in any event no later than 60 days following the date hereof or 30 days after the Closing Date, whichever is later;

(g) copies of the design history files (including copies of any relevant research and development information out of the Redbooks) with respect to the Products. The Parties hereby agree and covenant that Seller shall deliver, at its own cost, copies of the design history files to Buyer within 6 months of the Closing Date, provided , however , that if any design history files also covers the design history files of other products of Seller or one of its Affiliates, Seller may elect to redact those portions that pertain to such other products or deliver copies of the design history files unredacted but subject to the confidentiality provisions of this Agreement;

(h) subject to the provisions of the License and Material Transfer Agreement, 2 ampoules of each cell line of the Cell Lines for use exclusively in the Field of Use;

(i) the Manufacturing Instructions and Technical Information. The Parties hereby agree and covenant that Seller shall deliver to Buyer copies of the Manufacturing Instructions and Technical Information as soon as feasible after the Closing Date, but in any event no later than 60 days following the date hereof or 30 days after the Closing Date, whichever is later;

(j) a listing of all customers of Seller and Seller’s Affiliates that have purchased an amount of Products (excluding Products distributed for purposes of the Humanitarian Program) greater than $100,000 during the 2004 Fiscal Year, together with copies of customer sales and marketing information files (including distribution and sales promotion and market research studies) for such customers which such copies Seller hereby covenants and agrees that Seller and its Affiliates shall provide Buyer, as soon as feasible after the Closing Date, but in any event not later than 60 days following the date hereof or 30 days after the Closing Date, whichever is the later; provided, however , that Seller and Seller’s Affiliates are required to deliver to Buyer only such documentation and information that Seller and Seller’s Affiliates can deliver using commercially reasonable efforts, and if any such materials in this Section 2.1(j) also cover the manufacturing, marketing or sale of other products of Seller or its Affiliates, Seller

and Seller’s Affiliates may elect to redact those portions that pertain to such other products or deliver copies of such materials un-redacted but subject to the confidentiality provisions of this Agreement. Seller hereby covenants and agrees that Seller and its Affiliates shall provide Buyer, as soon as feasible after the Closing Date, but in any event not later than 60 days following the date hereof or 30 days after the Closing Date, whichever is the later, with reasonable access to the sales and information files of any customers that have purchased an amount of Products (excluding Products for purposes of the Humanitarian Program) equal to or less than $100,000 during the 2004 Fiscal Year;

(k) a royalty-free, fully paid, worldwide, irrevocable, perpetual and assignable license (without the right to sublicense) under Seller’s intellectual property rights in and to the Know-How, Cell Lines and Reagents, including without limitation, the right to use the Know-How, Cell Lines and Reagents to make, have made, use, sell, have sold, offer for sale, have offered for sale, import and/or have imported products and/or services (the “ License ”); provided , however , that:

(i) with respect to the Know-How (other than the Exclusively Related Know-How), the License shall be non-exclusive within or outside the Field of Use;

(ii) with respect to the Exclusively Related Know-How, the License shall be exclusive within or outside the Field of Use;

(iii) with respect to (A) the Cell Lines related to the Non-Exclusive Reagents and (B) the Non-Exclusive Reagents, the License shall be non-exclusive within the Field of Use; and

(iv) with respect to (A) the Cell Lines related to the Exclusive Reagents and (B) the Exclusive Reagents, the License shall be exclusive within or outside the Field of Use, provided, however , that Buyer and its Affiliates shall not have the right to use the Cell Lines related to the Exclusive Reagents and the Exclusive Reagents within Abbott Excluded Business.

Notwithstanding the foregoing, nothing in this License shall prevent or otherwise restrict or limit the right of Seller and its Affiliates to use (A) the Exclusively Related Know-How, (B) the Cell Lines related to the Exclusive Reagents and (C) the Exclusive Reagents now or in the future to make, have made, use, sell, have sold, offer for sale, have offered for sale, import and/or export products and/or services outside the Field of Use or with respect to products that operate other than in a Rapid Manner.

Buyer acknowledges and agrees that Seller represents that the Exclusive Reagents listed on Schedule 2.1(k) are related exclusively to the Product Line and the Non-Exclusive Reagents are not exclusively related to the Product Line. For the avoidance of doubt, the Parties hereby agree that the grant of the License to the Know-How, Cell Lines and Reagents shall be governed solely by the terms and conditions of the License and Material Transfer Agreement; and

(l) all goodwill with respect to the Products and the Product Line.

If an application for a Japan Product Marketing Approval or a Marketing Registration is pending on the Closing Date, Buyer may elect, at its sole and exclusive cost, to have Seller continue with the pending Japan Product Marketing Approval or Marketing Registration, in which event Seller shall use commercially reasonable efforts to obtain such Japan Product Marketing Approval or Marketing Registration, or if the pending Japan Product Marketing Approval or Marketing Registration is assignable, to have Seller assign to Buyer any rights that Seller may have with respect to the pending Japan Product Marketing Approval or Marketing Registration. Seller shall not be liable to or have any obligation to indemnify Buyer if all or any of the pending Japan Product Marketing Approval or Marketing Registrations are delayed or are not issued for any reason by any Regulatory Authority, other than on account of Seller’s gross negligence, recklessness or willful misconduct, or its material failure to comply with applicable Law, this Agreement or the applicable Other Agreements, other than at the request of Buyer.

For the avoidance of doubt, Buyer hereby agrees and acknowledges that nothing in this Agreement shall limit or restrict the right of Seller, its Affiliates and other Persons to whom Seller may from time to time grant such right to make, have made, use, offer to sell, sell, import and export: (i) the Products or, subject to the provisions of the Manufacturing Support Services Agreement and the Supply of Products for the Humanitarian Program Agreement, any similar products that operate in a Rapid Manner for the detection of infectious diseases (including HIV and hepatitis) in any of the Least Developed Countries, in each case, solely for the purposes of the Humanitarian Program, (ii) subject to Section 2.1(c) of the Noncompetition Agreement, OraSure HIV or any replacement product manufactured by or on behalf of Buyer or its Affiliates and distributed in lieu of OraSure HIV anywhere in the United States, and (iii) subject to Section 2.1(d) of the Noncompetition Agreement, any Additional Assay Capabilities or any replacement product manufactured by or on behalf of Buyer or its Affiliates and provided in lieu of any previously provided Additional Assay Capability anywhere in the world. Notwithstanding the definition of Abbott Excluded Business, for the avoidance of doubt, Seller acknowledges that Buyer, Buyer’s Affiliates and any Person acting on Buyer’s behalf shall not be limited from promoting, marketing, distributing or selling the Products to any customer or end user, including

any hospitals, laboratories, blood banks or similar locations, provided that such Products are not promoted, marketed, distributed or sold for use outside of the Field of Use.

2.2 Excluded Assets . Notwithstanding anything to the contrary in this Agreement, Seller shall not, nor shall it cause Seller’s Affiliates to, sell, transfer or assign, and Buyer or Buyer’s Affiliates shall not, nor shall Buyer or Buyer’s Affiliates have any right to, purchase or otherwise acquire, any right, title or interest of Seller or Seller’s Affiliates in any of the following assets (such assets being collectively referred to hereinafter as the “ Excluded Assets ”):

(a) the Abbott Excluded Business;

(b) rights of Seller and Seller’s Affiliates arising under this Agreement or the Other Agreements or from the consummation of the transactions contemplated hereby or thereby;

(c) all accounts receivable and notes receivable and intercompany receivable balances related to Net Sales generated by sales of the Products by Seller and its Affiliates that either exist as of the Closing Date or at any time prior to the termination of the Distribution Period for the relevant country within the Territory (subject in this case to the provisions of Section 4.6(b) ), including any value added Taxes or similar Taxes levied on such accounts receivable, any unpaid interest accrued on any such accounts receivable and any security or collateral related thereto, and any payments received with respect thereto before or after the termination of the Distribution Period for the relevant country within the Territory (collectively, the “ Accounts Receivable ”);

(d) all cash (including cash on hand and cash in transit), cash equivalents, bank deposits and marketable securities;

(e) all books (including corporate minute books), documents, records (including stock records), files and Tax Returns of Seller and Seller’s Affiliates as may exist on the Closing Date (other than such books, records or files that are covered in Section 2.1 above) which: (i) were prepared in connection with or relating to the transactions contemplated by this Agreement, including bids received from other Persons and analyses relating to the Acquired Assets, the Assumed Liabilities or the Product Line; or (ii) are maintained by Seller, its Affiliates and/or their representatives, agents or licensees in connection with their respective tax, legal, regulatory or reporting requirements;

(f) the manufacturing site license of Abbott Japan;

(g) design notebooks (including those commonly referred to by Seller as “redbooks”) related to the Product Line and the Products (“ Redbooks ”), except as otherwise provided in Section 2.1(g) ;

(h) all intellectual property of Seller and any of its Affiliates of any kind which is not specifically included in Section 2.1 , including the Abbott Brands;

(i) real property, buildings, structures and improvements thereon, whether owned or leased by Seller or Seller’s Affiliates, and all fixtures and fittings attached thereto, including those in Matsudo, Japan, including all manufacturing, distribution and administration facilities of Seller but not including any of the Equipment;

(j) all of the rights to equipment and other tangible personal property, whether owned or leased by Seller or its Affiliates, not listed on Schedule 2.1(a) attached hereto;

(k) rights to refunds of Taxes paid by or on behalf of Seller (but not paid by Buyer) or any of its Affiliates for periods or partial periods ending prior to the termination of the Distribution Period for the relevant country within the Territory;

(l) insurance policies and claims thereunder;

(m) intercompany account balances, including those related to the Product Line;

(n) aliquots of cell lines related to the Products, except to the extent provided in Section 2.1(h) ;

(o) except for the Japanese Employees, the services of all other employees of Seller or Seller’s Affiliates;

(p) all assets of Abbott Benefit Plans;

(q) subject to Section 4.7 , the amount of raw materials, work-in-process and finished Products held by Seller and its Affiliates as of the Closing Date and the amount of Finished Inventory held by Seller and its Affiliates upon the termination of the Distribution Period; and

(r) any assets, tangible or intangible, wherever situated, not included in the Acquired Assets.

2.3 Assumed Liabilities . On the Closing Date, Buyer shall assume, or shall cause Buyer’s Affiliates to assume, only the Liabilities of Seller and Seller’s Affiliates specifically identified below in this Section 2.3 (the “ Assumed Liabilities ”), unless otherwise specifically excluded under Section 2.4 :

(a) (i) all Liabilities related to the Japanese Employees who accept employment with Inverness Japan incurred after the Closing Date, and (ii) those Liabilities related to the Japanese Employees incurred before or on the Closing Date but solely to the extent provided in Section 7.5 ;

(b) all executory non-monetary Liabilities under the Contracts, and all monetary Liabilities under the Contracts if and to the extent they accrue after the Closing Date; provided , however , that Buyer shall have no obligation to perform or pay any Liabilities arising out of or resulting from any breach of or default under any provision of any Contract by Seller or any of its Affiliates before or on the Closing Date;

(c) Taxes relating to the Products, the Product Line or the Acquired Assets attributable to any period or partial period beginning after the Closing Date or that are otherwise the responsibility of Buyer pursuant to Section 7.6 or Section 11.4 of this Agreement;

(d) subject to the Other Agreements, any and all claims, causes of action and litigation, including without limitation warranty and product liability claims, involving Product units to the extent (i) arising out of or related to any actions taken or omitted to be taken after the Closing Date by Buyer or any of its Affiliates or (ii) related to Product units sold after the Closing Date; and

(e) without limiting anything else in this Section 2.3 , any and all Liabilities, obligations, claims, causes of action or litigation involving the Products, the Equipment, the Contracts or the ownership or use of the Acquired Assets based upon, relating to or arising out of acts, omissions or events occurring after the Closing Date, except those obligations, liabilities and commitments described in Section 2.4, Section 4.4 , Section 4.5 , Section 4.6 and Section 4.7 .

2.4 Excluded Liabilities . Neither Buyer nor Buyer’s Affiliates shall assume, nor shall they become responsible for any Liabilities of Seller or Seller’s Affiliates (collectively, the “ Excluded Liabilities ”) other than the Assumed Liabilities, which Excluded Liabilities shall include, without limitation, the following Liabilities, all of which shall remain the Liabilities of Seller or Seller’s Affiliates:

(a) all Liabilities of Seller and Seller’s Affiliates arising under this Agreement or the Other Agreements or from the consummation of the transactions contemplated hereby or thereby;

(b) all accounts payable, including all intercompany payable balances owing by Seller or Seller’s Affiliates;

(c) all Liabilities related to the Japanese Employees incurred or arising on or before the Closing Date, except to the extent provided for in Section 7.5 ;

(d) subject to the Other Agreements, any and all claims, causes of action and litigation, including without limitation warranty and product liability claims, involving the Products to the extent arising out of any events occurring, or actions taken or omitted to be taken by Seller or its Affiliates, on or before the Closing Date;

(e) any Taxes relating to the Products or the Product Line or the Acquired Assets attributable to any period or partial period ending on or before the Closing Date (other than any Taxes that are the responsibility of Buyer pursuant to Section 2.3(c) );

(f) any Liabilities under or in connection with any Excluded Assets;

(g) subject to the terms and conditions of the Other Agreements, any Liabilities relating to, or arising from, the Humanitarian Program; and

(h) except to the extent of the Assumed Liabilities, all Liabilities related to the Products or operation of the Product Line or Acquired Assets to the extent accruing or arising on or before the Closing Date. For the avoidance of doubt, any Liability resulting from the manufacture or sale of a Product or due to any breach of warranty relating to the sale of Product prior to or on the Closing Date shall be the responsibility of Seller, and any Liability resulting from the manufacture or sale of a Product or due to any breach of a warranty relating to the sale of a Product after the Closing Date shall be the responsibility of Buyer.

2.5 Contracts Transferred by Seller following the Closing Date . Within 60 days following the date hereof or 30 days after the Closing Date, whichever is later, Seller shall furnish Buyer with complete copies of all Contracts. As soon as practicable following the termination of the Distribution Period for the relevant country within the Territory, Seller shall assign to Buyer or Buyer’s Affiliates all rights and interest of Seller or Seller’s Affiliates to any and all Contracts for such country within the Territory. Within 60 days following the date hereof

or 30 days after the Closing Date, whichever is later, Seller shall provide Buyer with the contact information of any third party distributors with whom Seller or Seller’s Affiliates have contracts for the distribution of the Products together with other products of Seller. Within 60 days following the Closing Date, Seller shall, in writing, notify such third party distributors that Seller has divested the Product Line and Seller shall act as distributor of the Products on behalf of Buyer during the Distribution Period in accordance with the pertinent terms of this Agreement. Buyer hereby acknowledges and agrees that although the Contracts cannot be formally assigned to Buyer or an Affiliate of Buyer until the termination of the Distribution Period in accordance with the provisions of Section 2.6(b) , with respect to the Seller, Buyer shall enjoy all of the benefits and assume all of the Liabilities under the Contracts if and to the extent they arise or accrue after the Closing Date, other than as a result of Seller’s or its Affiliates or a designee’s gross negligence, recklessness or willful misconduct, or its material failure to comply with applicable Law, this Agreement or the applicable Other Agreements, other than at the request of Buyer.

2.6 Procedures for Contracts not Transferable . If any Consent which is required of one or more Persons to transfer a Contract (each, a “ Required Consent ”) cannot be obtained prior to the termination of the Distribution Period for the relevant country within the Territory, this Agreement and the related Transfer Documents shall not constitute an assignment or transfer of such Contract. Instead, Seller shall use commercially reasonable efforts, at its own expense, to obtain such Required Consent as soon as possible after the termination of the Distribution Period for the relevant country within the Territory. In addition, if any Required Consent is not obtained prior to the termination of the Distribution Period for the relevant country within the Territory, then subject to the applicable Law and the terms and conditions of this Agreement: (a) Seller shall hold such Contract in trust for Buyer; (b) Buyer shall provide all goods and services, bear all costs and perform all other actions necessary to complete Seller’s or Seller’s Affiliate’s obligations under such Contract at Buyer’s expense; (c) Seller shall hold for Buyer’s account or for the account of one of Buyer’s Affiliates and promptly remit to Buyer or one of Buyer’s Affiliates all amounts received with respect to such Contract; and (d) Seller shall take all other reasonable actions with respect to such Contract as directed by Buyer, at Buyer’s sole cost and expense, for a period of time not to exceed 1 year after the termination of the Distribution Period for the relevant country within the Territory. Seller shall not be liable to or have any obligation to indemnify Buyer in connection with the failure to obtain any Required Consents unless the failure to obtain such Required Consent was caused by Seller’s failure to exercise commercially reasonable efforts to obtain such Required Consents.

2.7 Extraordinary Obligations . If (i) one or more of the Contracts which are not referenced in Exhibit L (Index of Documents) contains an obligation to be assigned to Buyer hereunder that would, if assigned, impose a liability on Buyer greater than $50,000 individually, or $100,000 in the aggregate, whether in or outside the ordinary course, for the design, development, manufacture, marketing, distribution and sale of the Product Line, or that would impair Buyer’s ability to fulfill its obligations to the Seller with respect to the Humanitarian Program, or (ii) any agreements which are not listed on Schedule 1.1(r) impose an obligation to pay any royalty in connection with the Product Line, such Contracts or agreements may be reassigned by Buyer to Seller, together with the reassignment of any and all net benefits previously obtained by Buyer in connection with such Contracts or agreements, Buyer shall notify Seller of the obligation within 15 Business Days following the date that Seller has provided, at its sole and absolute discretion, to Buyer either (i) detailed summaries of the main terms and conditions of the Contracts or agreements, or (ii) English versions of the redacted Contracts or agreements which are not referenced in Exhibit L (Index of Documents) or in Schedule 1.1(r) . Notwithstanding the foregoing, nothing in this Section 2.7 shall increase or expand the Liabilities assumed by Buyer pursuant to Section 2.3 .

2.8 Wrong Pockets . Subject to Section 4.4 and Section 4.5 , to the extent that the Acquired Assets do not include any trademark, copyright or material tangible capital asset which is reasonably necessary for the manufacture and packaging of the Products and which: (i) was owned by Seller or any of its Affiliates on the date hereof; and (ii) was used by Seller or any of its Affiliates exclusively in connection with the Products or the Product Line prior to Closing, Seller agrees, to the extent commercially practicable and subject to Section 2.6 , to, without further consideration, transfer, convey, or assign such asset so that Buyer has substantially similar benefits (subject to the burdens) of such asset in relation to the manufacture and packaging of the Products as did Seller prior to Closing.

ARTICLE III
Purchase Price; Consistent Treatment.

3.1 Purchase Price . The total purchase price for the Acquired Assets, excluding any inventory anywhere in the world, is $56,500,000 (the “ Purchase Price ”) plus any Japanese consumption Taxes or similar Taxes applicable under Japanese Tax Law, which shall be paid in accordance with Section 4.2 , plus the assumption of the Assumed Liabilities.

3.2 Purchase Price Allocation . Attached hereto as Schedule 3.2 (the “ Allocation Schedule ”) is the schedule setting forth the Acquired Assets to which the Purchase Price has

been allocated. Seller and Buyer shall sign and submit all necessary forms to report this transaction for federal, national, state, local and foreign income tax purposes in accordance with the Allocation Schedule and shall not take a position for Tax purposes inconsistent therewith. The Parties shall treat the transactions contemplated by this Agreement in all filings with Governmental Authorities for all Tax purposes (including consumption Taxes) consistently with the Allocation Schedule and this Section 3.2 .

ARTICLE IV
Closings.

4.1 Closing Date . On the terms and subject to the conditions of this Agreement, the Closing shall take place at the offices of Baker & McKenzie, 130 East Randolph Drive, Chicago, Illinois, on the last Business Day (based on local time in Chicago) of the month in which the last to be fulfilled or waived of the conditions set forth in Article VIII shall be fulfilled or waived in accordance with this Agreement or at such other time, date or place as the Parties may mutually agree (the “ Closing Date ”). The Parties to this Agreement shall exchange (or cause to be exchanged) at the Closing the funds, certificates and other documents, and do, or cause to be done, all of the things respectively required of each Party as specified in Sections 4.3(a) and (b) .

4.2 Closing . At the Closing, Buyer shall pay to Seller the Purchase Price plus any Japanese consumption Taxes or similar Taxes under Japanese Tax Law by a wire transfer of immediately available funds with value as of the Closing Date in accordance with written instructions provided by Seller to Buyer prior to the date hereof. For purposes of this Agreement, but subject to Section 4.4 and Section 4.5 , the Closing shall be deemed effective as of 11:59 p.m. local time in Chicago on the Closing Date.

4.3 Transactions at Closing . At the Closing, subject to the terms and conditions hereof:

(a) Seller’s Actions and Deliveries . Subject to Section 4.4 , Section 4.5 , Section 4.6 and Section 4.7 , Seller or its Affiliates shall: (i) transfer and convey, or cause to be transferred and conveyed, to Buyer all of the Acquired Assets; and (ii) execute and deliver to Buyer the Other Agreements.

(b) Buyer’s Actions and Deliveries . In consideration for the transfer of the Acquired Assets, Buyer shall: (i) pay to Seller the Purchase Price by wire transfer of immediately available funds in accordance with the provisions of Section 3.1 and Section 4.2 ; and (ii) execute and deliver to Seller the Other Agreements. As soon as practicable following the Closing Date,

Buyer shall deliver to Seller for execution such other Transfer Documents as are reasonably necessary to transfer to Buyer good and valid title to the Patents and the Marks.

4.4 Regulatory Matters in Japan . (a) Seller and Buyer hereby acknowledge and agree that, due to the requirements of the regulatory Laws of Japan and for other business reasons, Abbott Japan shall continue being the responsible legal entity for regulatory matters: (i) with respect to the marketing and distribution of the Product until the Japan Product Marketing Approvals have been transferred to, or newly issued in the name of, Inverness Japan upon the termination of the Distribution Period for the country of Japan, and Inverness Japan has obtained a Japan Marketing Authorization; and (ii) with respect to the manufacturing of the Product, until Inverness Japan has obtained a Manufacturing Site License upon the termination of the Manufacturing Support Services Agreement.

(b) Seller and Buyer hereby further acknowledge and agree that upon the termination of the Distribution Period for the country of Japan, and subject to first obtaining the Consent of the Minister of Health, Labor and Welfare of Japan, Abbott Japan shall transfer the Japan Product Marketing Approvals to Inverness Japan without additional consideration to Seller and its Affiliates. Until the Japan Product Marketing Approvals are transferred to Inverness Japan, Abbott Japan shall hold the Japan Product Marketing Approvals in trust for the sole and exclusive benefit and cost of Inverness Japan and shall follow the reasonable instructions of Inverness Japan in connection with the Japan Product Marketing Approvals provided that such reasonable instructions are in compliance with all applicable Laws and regulatory requirements. Inverness Japan shall be solely responsible for obtaining the Consent of the Ministry of Health, Labor and Welfare of Japan for the transfer of the Japan Product Marketing Approvals to Inverness Japan on or before the termination of the Distribution Period and shall bear all risks if such Consent is denied. In accordance with the terms of Section 7.9 , Abbott Japan shall provide to Inverness Japan with the necessary support and assistance, including promptly providing Inverness Japan with reasonable access to any of Abbott Japan’s employees necessary, for the transfer of the Japan Product Marketing Approvals to Inverness Japan 3 months prior to the termination of the Distribution Period for the country of Japan provided , however , that Inverness Japan shall be responsible for all costs and expenses relating to the transfer of the Japan Product Marketing Approvals to Inverness Japan.

(c) Parent and Inverness Japan shall be solely responsible for obtaining the Japan Product Marketing Approvals (to the extent they cannot be transferred to Inverness Japan), the Japan Marketing Authorization and the Manufacturing Site License and shall bear all risks associated with the failure to timely obtain such Japan Product Marketing Approvals, Japan

Marketing Authorization and Manufacturing Site License. In accordance with the terms of Section 7.9 , Seller and its Affiliates shall use commercially reasonable efforts to assist Parent and Inverness Japan, to the extent applicable, with the transfer of the Japan Product Marketing Approvals.

4.5 Transfer of Marketing Registrations .

(a) Seller and Buyer further acknowledge that, on the Closing Date, legal title to the Marketing Registrations in certain countries within the Territory shall remain with Seller or its Affiliates or third party distributors due to the requirements of applicable regulatory local Laws and the need, if applicable, for the Consent of the Regulatory Authorities for the transfer to or the issuance of new Marketing Registrations in the name of Buyer or Buyer’s Affiliate or designee. Seller and Buyer further acknowledge that, notwithstanding the foregoing, (i) to the extent permitted by relevant local Laws, beneficial ownership of the Marketing Registrations shall vest with Buyer on the Closing Date and remain with Buyer until legal ownership vests with Buyer, and (ii) until such time as the Marketing Registrations for such countries can be transferred to (or issued in the name of) or assumed by Buyer or Buyer’s Affiliate or designee, Seller or its Affiliates or third party distributors shall hold such Marketing Registrations in trust for the sole and exclusive benefit and cost of Buyer. Unless expressly provided otherwise in this Agreement, Seller and Buyer shall each bear its own costs and expenses in connection therewith without the requirement of payment of any further consideration. Notwithstanding the foregoing, Seller and its Affiliates shall not be required to bear any cost or expense (including internal costs) in connection with the transfer to or the issuance of new Marketing Registrations in the name of Buyer or Buyer’s Affiliate or designee that require material effort, expenditures or time on the part of Seller or any of its Affiliates, except to the extent Buyer and its Affiliates are unable to perform actions necessary to satisfy such requirements, in which event, at Buyer’s request, Seller and its Affiliates shall use commercially reasonable efforts to assist Buyer to satisfy such requirements at Seller’s cost; provided , further , however , that (A) in no event shall Seller or its Affiliates be obligated to perform material product registration activities or services other than on arm’s-length terms; and (B) Buyer shall pay, or indemnify Seller for, all filing and transfer costs required in connection with transfers to Buyer or Buyer’s Affiliates or designees of, or applications for new, Marketing Registrations.

(b) As soon as possible after the Closing Date, but in no event later than 60 days following the Closing Date, or if such 60-day period is not feasible in light of the requirements for the transfer of the Marketing Registrations under applicable Law, as soon as possible thereafter, subject to the other provisions of this Article IV , Seller or its Affiliates (or, if

applicable, Seller or its Affiliates jointly with Buyer or its Affiliates) shall, at Buyer’s sole cost and expense, apply to each of the relevant Regulatory Authorities for the transfer of, or issuance of new, Marketing Registrations to Buyer or Buyer’s Affiliate or designee. Buyer hereby acknowledges and agrees that Seller shall not be obligated to indemnify Buyer if, for any reason (other than on account of Seller’s gross negligence or willful misconduct), any Regulatory Authority of any country within the Territory denies its Consent to the transfer or issuance of new Marketing Registrations in the name of the Buyer or one of its Affiliates or designees and Buyer shall bear all risks as a result thereof. If the Laws of any applicable country permit election between the transfer of an existing Marketing Registration or the cancellation and issuance of a new Marketing Registration, Buyer shall be entitled to make such election at its sole discretion provided that Buyer assumes all of the consequences arising from Buyer’s election, including, but not limited to, the denial of the transfer or issuance of new Marketing Registrations and any fees or penalties levied by the Regulatory Authorities. Seller and its Affiliates shall, in accordance with the terms of Section 7.9 , provide Buyer or Buyer’s Affiliate or designee with the necessary assistance, support and reasonable access for the preparation, notarization and legalization of the documents required to cause existing Marketing Registrations to be assigned to Buyer or Buyer’s Affiliate or designee, or to cause new Marketing Registrations to be issued to Buyer or Buyer’s Affiliate or designee, as the case may be. Prior to the transfer of the Marketing Registrations in the name of Buyer or its Affiliates or designees, Seller shall (i) comply with the requirements of each of the Marketing Registrations, (ii) use commercially reasonable efforts to maintain such Marketing Registrations in full force and effect (including, as applicable, obtaining any renewals or extensions thereof); provided , however , that Buyer shall reimburse Seller for all costs (including reasonable internal costs directly related thereto) incurred by Seller in doing so, and (iii) in the case of each applicable country, comply with any reasonable instructions of Buyer to request a price increase from the relevant Regulatory Authorities; provided , however , that such price increase requested by Buyer is permissible under applicable Law. Upon the transfer to or issuance of new Marketing Registrations to Buyer or its Affiliates or designees, Buyer shall bear all costs, expenses and consequences arising from such transfers or issuances, including costs associated with obsolete and distressed inventory and any changes in the label and packaging of the Products. Seller shall have the obligation to hold any of the Marketing Registrations in trust for the sole and exclusive benefit and cost of Buyer only for a maximum, non-renewable period of 18 months from the Closing Date. If after the expiration of such 18-month period any of the Marketing Registrations are not transferred to Buyer or its Affiliate or designee for any reason, Seller and its Affiliates may elect to discontinue holding any such Marketing Registrations on behalf of Buyer and

relinquish its duties as the responsible entity for regulatory purposes under such Marketing Registrations, and Seller shall not have any obligation to indemnify Buyer as a result thereof.

(c) Until such time as the Japan Product Marketing Approvals and the Marketing Registrations have been transferred to, and the Japan Marketing Authorization and the Manufacturing Site License have been issued in the name of, Buyer or Buyer’s Affiliate or designee, Buyer shall indemnify, defend and hold Seller and its Affiliates harmless against and in respect of any Losses resulting from, arising out of or relating to any of the (i) Assumed Liabilities, (ii) the manufacturing of the Products pursuant to the Manufacturing Support Services Agreement, (iii) the Distribution Activities; or (iv) any regulatory matters; provided , however , that Buyer shall not be required to indemnify Seller and its Affiliates to the extent any such Losses arise out of or result from the gross negligence, recklessness or willful misconduct of Seller or its Affiliates or designees, or its material failure to comply with applicable Law, this Agreement or the applicable Other Agreements, other than at the request of Buyer.

(d) As soon as possible following the Closing Date, Seller and Buyer shall each nominate one representative with sufficient experience to coordinate, to the extent permitted by local Law, on behalf of each Party all regulatory matters until the date of the transfer to or issuance of new Marketing Registrations, the Japan Product Marketing Approvals, the Japan Marketing Authorization and the Manufacturing Site License in the name of Buyer or a Buyer’s Affiliate or designee. Each representative shall, to the extent permitted by local Law, maintain regular and cooperative contact with the other representative to aid and facilitate a smooth and prompt transition from Seller to Buyer with respect to regulatory matters. Upon the transfer or issuance of new Marketing Registrations, the Japan Product Marketing Approvals, Japan Marketing Authorization or the Manufacturing Site License, as applicable, in the name of Buyer or its Affiliate or designee for each applicable country within the Territory, Buyer shall assume full responsibility for regulatory compliance with respect to such countries.

(e) Buyer hereby covenants and agrees that after the Closing Date, Seller and its Affiliates or designees shall continue to distribute the Products within the Least Developed Countries for purposes of the Humanitarian Program and if Seller and its Affiliates or designees require a Marketing Registration in order to be able to continue marketing, promoting, distributing and selling the Products after the Closing Date in all or any of the Least Developed Countries for purposes of the Humanitarian Program, then Buyer, at its sole discretion, may elect between having the Marketing Registration for such Least Developed Country remain with Seller or a Seller’s Affiliate or designee instead of such Marketing Registration being transferred to Buyer or to duly notify the Regulatory Authorities of any such Least Developed Countries

through letters of authorization and/or other appropriate means that Seller and its Affiliates and designees are duly authorized to continue marketing, promoting, distributing and selling Products after the Closing Date for purposes of the Humanitarian Program.

4.6 Distribution of the Products .

(a) Buyer hereby appoints Seller, its Affiliates and designees as its sole and exclusive distributor for the distribution of the Products within the Territory for a period

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