Back to top

ASSET PURCHASE AGREEMENT

Asset Purchase Agreement

ASSET PURCHASE AGREEMENT | Document Parties: Fresenius USA Manufacturing, Inc You are currently viewing:
This Asset Purchase Agreement involves

Fresenius USA Manufacturing, Inc

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: ASSET PURCHASE AGREEMENT
Governing Law: Delaware     Date: 3/15/2007
Industry: Biotechnology and Drugs     Law Firm: Robinson Bradshaw;Nutter McClennen     Sector: Healthcare

ASSET PURCHASE AGREEMENT, Parties: fresenius usa manufacturing  inc
50 of the Top 250 law firms use our Products every day

Exhibit 10.35

[ ***** ] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

ASSET PURCHASE AGREEMENT

between

NABI BIOPHARMACEUTICALS

(the Seller)

and

FRESENIUS USA MANUFACTURING, INC.

(the Buyer)

Dated October 11, 2006

 

 

TABLE OF CONTENTS

 

 

         

ARTICLE I DEFINITIONS AND CONSTRUCTION

  

1

1.1

  

DEFINED TERMS

  

1

1.2

  

CONSTRUCTION

  

10

ARTICLE II CONTEMPLATED TRANSACTIONS

  

11

2.1

  

PURCHASE OF ASSETS

  

11

2.2

  

PURCHASED ASSETS

  

11

2.3

  

EXCLUDED ASSETS

  

13

2.4

  

ASSUMPTION OF LIABILITIES

  

14

2.5

  

CONSENT OF THIRD PARTIES

  

16

2.6

  

REGISTRATIONS AND APPLICABLE PERMITS

  

17

ARTICLE III PURCHASE PRICE AND CLOSING

  

17

3.1

  

PURCHASE PRICE

  

17

3.2

  

REPORTS; PAYMENTS

  

18

3.3

  

BOOKS AND RECORDS; AUDITS

  

19

3.4

  

PAYMENTS

  

19

3.5

  

ALLOCATION OF CLOSING PAYMENT

  

20

3.6

  

FREEDOM TO CONDUCT BUSINESS UNIMPAIRED

  

20

ARTICLE IV CLOSING

  

20

4.1

  

CLOSING

  

20

4.2

  

CLOSING OBLIGATIONS. AT THE CLOSING:

  

20



 

         

ARTICLE V REPRESENTATIONS AND WARRANTIES OF THE SELLER

  

22

5.1

  

ORGANIZATION AND GOOD STANDING

  

22

5.2

  

AUTHORITY RELATIVE TO THIS AGREEMENT

  

22

5.3

  

CONSENTS AND APPROVALS; NO VIOLATIONS

  

22

5.4

  

PURCHASED ASSETS

  

23

5.5

  

REAL PROPERTY. [INTENTIONALLY BLANK]

  

23

5.6

  

INTELLECTUAL PROPERTY

  

23

5.7

  

SOFTWARE

  

25

5.8

  

PERMITS

  

25

5.9

  

CONTRACTS

  

26

5.10

  

FINANCIAL STATEMENTS

  

27

5.11

  

BOOKS AND RECORDS

  

27

5.12

  

TAXES

  

27

5.13

  

LIABILITIES

  

27

5.14

  

PRODUCT LIABILITY; LITIGATION

  

27

5.15

  

LITIGATION

  

27

5.16

  

REGULATORY COMPLIANCE

  

28

5.17

  

COMPLIANCE

  

29

5.18

  

CLINICAL AND SCIENTIFIC DATA; GOOD PRACTICES

  

31

5.19

  

EXPORTS AND CUSTOMS

  

32

5.20

  

WARRANTY CLAIMS

  

32

5.21

  

SPECIFICATIONS

  

32

5.22

  

LABOR AND EMPLOYMENT MATTERS

  

32

5.23

  

EMPLOYEE BENEFIT PLANS; ERISA

  

33

5.24

  

ENVIRONMENTAL MATTERS

  

33



 

ii

 

         

5.25

  

INSURANCE

  

34

5.26

  

ABSENCE OF CHANGES OR EVENTS

  

34

5.27

  

CUSTOMERS AND SUPPLIERS

  

35

5.28

  

BUSINESS RELATIONSHIPS

  

35

5.29

  

INVENTORY; PRICING; CERTAIN COSTS

  

35

5.30

  

OVERPAYMENT

  

36

5.31

  

CERTAIN INTERESTS

  

36

5.32

  

COMMISSIONS

  

36

ARTICLE VI REPRESENTATIONS AND WARRANTIES OF THE BUYER

  

36

6.1

  

ORGANIZATION AND QUALIFICATION

  

36

6.2

  

AUTHORITY RELATIVE TO THIS AGREEMENT

  

36

6.3

  

CONSENTS AND APPROVALS; NO VIOLATIONS

  

36

6.4

  

LITIGATION

  

37

6.5

  

COMMISSION

  

37

ARTICLE VII PRE-CLOSING COVENANTS

  

37

7.1

  

CLOSING EFFORTS; HSR ACT

  

37

7.2

  

OPERATION OF BUSINESS

  

39

7.3

  

ACCESS

  

40

7.4

  

REPORTS

  

40

7.5

  

EXCLUSIVITY

  

40

7.6

  

NOTICE OF SUITS

  

41

7.7

  

EMPLOYEES

  

41

7.8

  

UPDATED SCHEDULES

  

41

7.9

  

SALES TAX

  

41

7.10

  

INVENTORY

  

42



 

iii

 

         

ARTICLE VIII POST-CLOSING COVENANTS

  

42

8.1

  

POST-CLOSING PAYMENTS

  

42

8.2

  

REPORTS

  

42

8.3

  

TAIL INSURANCE

  

42

8.4

  

INTELLECTUAL PROPERTY

  

43

8.5

  

ACCESS TO INFORMATION; RECORD RETENTION; COOPERATION; CONFIDENTIALITY

  

43

8.6

  

POST-EFFECTIVE TIME RECEIPTS AND PAYMENTS

  

45

8.7

  

USE OF NAME FOR TRANSITION PERIOD

  

45

8.8

  

WHOLESALER CHARGES AND REBATE CHARGES

  

46

8.9

  

ASSISTANCE WITH PROCEEDINGS

  

46

8.10

  

BUYER’S DILIGENCE OBLIGATIONS

  

46

8.11

  

NON-COMPETITION BY THE BUYER

  

49

8.12

  

SELLER’S DILIGENCE OBLIGATIONS

  

50

8.13

  

CERTAIN EXCLUDED LIABILITIES

  

50

8.14

  

ROXANE PROCEEDING

  

50

8.15

  

[ ******* ] AGREEMENT

  

50

8.16

  

EXCLUDED CONTRACTS

  

51

8.17

  

PART D AND COMMERCIAL REBATE CONTRACTS

  

51

ARTICLE IX CLOSING CONDITIONS

  

51

9.1

  

MUTUAL CONDITIONS

  

51

9.2

  

CLOSING CONDITIONS OF THE SELLER

  

52

9.3

  

CLOSING CONDITIONS OF THE BUYER

  

53



 

iv

 

         

ARTICLE X INDEMNIFICATION

  

54

10.1

  

SURVIVAL OF REPRESENTATIONS

  

54

10.2

  

SELLER’S AGREEMENT TO INDEMNIFY

  

55

10.3

  

BUYER’S AGREEMENT TO INDEMNIFY

  

55

10.4

  

PROCEDURE FOR THIRD-PARTY CLAIMS

  

56

10.5

  

PROCEDURE FOR DIRECT CLAIMS

  

58

10.6

  

LIMITATIONS ON INDEMNIFICATION.

  

60

10.7

  

TREATMENT OF INDEMNIFICATION PAYMENTS

  

61

10.8

  

CONSTRUCTION

  

61

10.9

  

INTEREST

  

61

10.10

  

REMEDIES

  

61

ARTICLE XI TERMINATION

  

61

11.1

  

TERMINATION

  

61

11.2

  

PROCEDURE AND EFFECT OF TERMINATION

  

62

ARTICLE XII MISCELLANEOUS PROVISIONS

  

62

12.1

  

JURISDICTION, VENUE AND SERVICE OF PROCESS

  

62

12.2

  

REMEDIES

  

62

12.3

  

ATTORNEYS’ FEES

  

63

12.4

  

PUBLICITY

  

63

12.5

  

EXPENSES

  

63

12.6

  

WAIVER OF COMPLIANCE; CONSENTS

  

63

12.7

  

NOTICES

  

64

12.8

  

BINDING AGREEMENT; ASSIGNMENT

  

64

12.9

  

INTERPRETATION

  

65



 

v

 

         

12.10

  

GOVERNING LAW

  

65

12.11

  

FURTHER ASSURANCES

  

65

12.12

  

SEVERABILITY

  

65

12.13

  

COUNTERPARTS; ELECTRONIC SIGNATURES

  

65

12.14

  

MERGER AND MODIFICATION; AMENDMENT

  

66



 

vi

SCHEDULES

 

 

     

2.2(a)

  

Assigned Registrations/NDAs

2.2(b)

  

Assigned Trademark Rights

2.2(c)

  

Assigned Patent Rights

2.2(e)

  

Assigned Contracts

2.2(g)

  

Brochures

2.2(i)

  

Customer, Supplier and Vendor Materials

2.2(j)

  

Sales Force Training Materials

2.2(k)

  

Assigned Permits

2.2(q)

  

Acquired Fixed Assets

2.2(r)

  

Acquired Telephone Numbers

2.3(e)

  

Excluded Assets, Rights and Properties

2.3(k)

  

Excluded Fixed Assets

2.3(l)

  

Excluded Telephone Numbers

2.4(a)

  

Excluded Liabilities

3.2

  

Form of New Formulation Net Sales Statement

3.5

  

Allocation of Closing Payment

4.2(a)(xi)

  

Delivered Software

5.3

  

Consents and Approvals

5.4(a)

  

Tangible Assets

5.4(c)

  

Sufficiency

5.6(b)

  

Marks

5.6(c)

  

Patents

5.6(d)

  

Copyrights

5.6(f)

  

Agreements With Other Persons

5.6(g)

  

Infringement

5.7

  

Software

5.8(a)

  

Permits

5.9(a)

  

Contracts

5.9(c)

  

Events of Default

5.9(e)

  

Seller Third Party Consents

5.10

  

Financial Statements

5.12

  

Taxes

5.14

  

Product Liability; Litigation

5.15

  

Litigation

5.16(c)

  

Notices from Medical Product Regulatory Authorities

5.16(f)

  

Approvals

5.17

  

Compliance

5.18(a)

  

Scientific Data

5.20

  

Warranty Claims

5.21

  

Specifications

5.22(a)

  

Employees

5.22(b)

  

Employment Agreements

5.23

  

Employee Benefit Plans; ERISA

5.24

  

Environmental Matters



 

vii

 

     

5.25(a)

  

Insurance

5.25(c)

  

Accident Reports

5.26

  

Absence of Changes or Events

5.27

  

Customers and Suppliers

5.29

  

Inventory Costs

5.30

  

Adjustments

7.1(c)

  

Form of Assignment Agreement

7.2

  

Operation of Business

7.7(a)

  

Excluded Employees

8.10

  

Countries with Diligence Obligations

9.2(f)

  

Seller’s Third Party Conditions

9.3(h)

  

Buyer Third Party Consents



EXHIBITS

 

 

     

Exhibit 4.2(a)(ii)

  

Noncompetition and Nonsolicitation Agreement

Exhibit 4.2(a)(iii)

  

Seller Registration Transfer Letter

Exhibit 4.2(a)(iv)

  

Bill of Sale

Exhibit 4.2(a)(v)

  

Patent Agreement

Exhibit 4.2(a)(vi)

  

Trademark Agreement

Exhibit 4.2(a)(vii)

  

Assumption Agreement

Exhibit 4.2(a)(viii)

  

Transition Services Agreement

Exhibit 4.2(b)(v)

  

Buyer Registration Transfer Letter

Exhibit 7.2(c)

  

Braintree Assignment Agreement

Exhibit 9.2(g)

  

Opinion of Counsel for Buyer

Exhibit 9.3(f)

  

Opinion of Counsel for Seller

Exhibit 9.3(g)

  

Employee Consent



 

viii

ASSET PURCHASE AGREEMENT

THIS ASSET PURCHASE AGREEMENT (this " Agreement "), dated October 11, 2006, is between Nabi Biopharmaceuticals , a Delaware corporation (the " Seller "); and Fresenius USA Manufacturing, Inc ., a Delaware corporation (the " Buyer ").

Background Statement

The Seller is engaged in, among other activities, the business of distributing, marketing and selling a line of phosphate binder calcium acetate products known as PhosLo ® products, which includes causing such products to be manufactured, inspected, packaged, inventoried and delivered to distributors and other purchasers (such business together with the Seller’s activities related to New Formulation Products is referred to herein as the " PhosLo Business ").

The Seller desires to sell to the Buyer, and the Buyer desires to purchase from the Seller, certain of the assets of the Seller used in the PhosLo Business, all on the terms and conditions set forth in this Agreement.

Statement of Agreement

In consideration of the premises and the mutual covenants herein contained, the receipt and sufficiency of which are hereby acknowledged, the parties hereto, for themselves, their successors and assigns, agree as follows:

ARTICLE I

DEFINITIONS AND CONSTRUCTION

1.1 Defined Terms . Except as otherwise specifically provided herein, the following terms shall have the meanings indicated below:

" Affiliate " means, with respect to any Person, each of the Persons that directly or indirectly, through one or more intermediaries, owns or controls, or is controlled by or under common control with, such Person. For the purpose of this definition, "control" means the possession, directly or indirectly, of the power to direct or cause the direction of management and policies of such Person whether through the ownership of voting securities, by contract or otherwise.

" Agreement " means this agreement, as amended or supplemented in accordance with the terms hereof, together with all Exhibits and Schedules attached hereto or incorporated herein by reference.

" Arbitration Dispute " has the meaning set forth in Section 10.5(a) .

" Arbitrators " has the meaning set forth in Section 10.5(c) .

" Assigned Contracts " has the meaning set forth in Section 2.2(e) .

" Assigned Permits " shall mean the Permits which are listed on Schedule 2.2(k) .

" Assumed Liabilities " has the meaning set forth in Section 2.4(a) .

" Assumption Agreement " has the meaning set forth in Section 4.2(a)(vii) .

" Bill of Sale " has the meaning set forth in Section 4.2(a)(iv) .

" Braintree " means Braintree Laboratories, Inc., a Massachusetts corporation.

" Braintree Purchase Agreement " has the meaning set forth in Section 5.9(f) .

" Business Day " means any day excluding Saturday, Sunday and any day that shall be a legal holiday in Massachusetts.

" Buyer " has the meaning set forth in the introductory paragraph of this Agreement.

" Buyer Certificate " has the meaning set forth in Section 9.2(c) .

" Buyer Damages " has the meaning set forth in Section 10.2(a) .

" Buyer Indemnified Parties " has the meaning set forth in Section 10.2(a) .

" CARE 2 Study " means the clinical study initiated by the Seller and designed to compare the relative rate of PhosLo and Renegal, with the addition of Lipitor, in slowing progression of cardiovascular calcification.

" Closing " has the meaning set forth in Section 4.1 .

" Closing Date " has the meaning set forth in Section 4.1 .

" Closing Payment " has the meaning set forth in Section 3.1(a) .

" CMS " means the Centers for Medicare and Medicaid Services, a division of the United States Department of Health and Human Services.

" COBRA " has the meaning set forth in Section 5.22(h) .

" Code " means the Internal Revenue Code of 1986, together with the regulations thereunder, in each case as in effect from time to time.

" Commercial Rebate Contract " means each Contract designated as such on Schedule 2.2(e) .

" Commercially Reasonable Discontinuance " has the meaning set forth in Section 8.10(d) .

 

2

" Competitive Product " means [*******].

" Compliance Program " means a provider compliance program of the type described in the compliance guidance published by the Office of Inspector General of the Department of Health and Human Services.

" Confidentiality Agreement " has the meaning set forth in Section 7.3(a) .

" Contract " means any legally binding obligation or agreement, whether oral or written, and specifically including any note, bond, mortgage, lease of real or personal property, license and other instrument.

" Copyright " means the legal right provided by the Copyright Act of 1976, as amended, to the expression contained in any work of authorship fixed in any tangible medium of expression together with any similar rights arising in any other country as a result of statute or treaty.

" CPR " has the meaning set forth in Section 10.5(b) .

" Damages " has the meaning set forth in Section 10.2(a) .

" Data Lock " means, in respect of a clinical trial in support of a new drug application, the time at which, in accordance with the trial protocol, no modifications will be made to the clinical trial data base.

" Deferred Payment Period " has the meaning set forth in Section 3.1(c) .

" Deferred Payments " has the meaning set forth in Section 3.1(c) .

" Demand " has the meaning set forth in Section 10.5(b) .

" Diligence Breach " has the meaning set forth in Section 8.10(a) .

" Discounts " means amounts claimed as discounts with respect to PhosLo Products sold (a) on or before the Closing Date or (b) under any Excluded Contract.

" Effective Time " means 12:01 a.m. on the Closing Date.

" Employees " means the individuals employed by the Seller principally in the operation of the PhosLo Business.

" Employee Consent " means a consent by an Employee to the release of such Employee’s personnel files to the Buyer, substantially in the form of the Consent of Employee Regarding Transfer of Personnel Records attached hereto as Exhibit 9.3(g) .

" Environmental Laws " means any Legal Requirement relating to the protection of safety, human health or the environment, including any requirement pertaining to the manufacture, processing, distribution, use, treatment, storage, disposal, transportation, handling, reporting, licensing, permitting, investigation or remediation of materials that are or may constitute a threat to human health

 

3

or the environment. Without limiting the foregoing, each of the following is an Environmental Law: the Comprehensive Environmental Response, Compensation, and Liability Act (42 U.S.C. § 9601 et seq .), the Hazardous Material Transportation Act (49 U.S.C. § 5101 et seq .), the Resource Conservation and Recovery Act (42 U.S.C. § 6901 et seq .), the Federal Water Pollution Control Act (33 U.S.C. § 1251 et seq .), the Clean Air Act (42 U.S.C. § 7401 et seq .), the Toxic Substances Control Act (15 U.S.C. § 2601 et seq .), the Safe Drinking Water Act (42 U.S.C. § 300f et seq .), the Occupational Safety and Health Act (29 U.S.C. § 651 et seq .), and the Atomic Energy Act (42 U.S.C. § 2011 et seq .), and each similar Legal Requirement promulgated under such federal, state and local laws.

" EPICK Study " means the clinical study initiated by the Seller and designed to evaluate PhosLo’s ability to safely and effectively control serum phosphorus levels, parathyroid levels, serum calcium levels and calcium phosphorus product in chronic kidney disease, stage 4, patients.

" ERISA " means the Employee Retirement Income Security Act of 1974 (29 U.S.C. § 1001, et seq .).

" Excluded Assets " has the meaning set forth in Section 2.3 .

" Excluded Contracts " has the meaning set forth in Section 2.3(d) .

" Excluded Liabilities " has the meaning set forth in Section 2.4(b) .

" Family Member " means any of (i) a Person’s spouse, (ii) the natural or adoptive grandparents, parents, siblings, children or grandchildren of a Person or such Person’s spouse, (iii) the stepparents, stepchildren, stepbrothers or stepsisters of a Person or such Person’s spouse, (iv) the nieces, nephews, first cousins, aunts or uncles of a Person or such Person’s spouse, or (v) the spouse of any Person described in the foregoing clauses (i) through (iv).

" FDA " means the United States Food and Drug Administration.

" FDA Approval " means the approval, clearance or authorization of the FDA that allows the Buyer to make, sell, promote, market and distribute a pharmaceutical product for therapeutic use in humans on a lawful and commercial basis in the United States.

" FD&C Act " means the Food, Drug and Cosmetic Act, 21 U.S.C. 321, et seq., as amended, and the rules and regulations promulgated thereunder.

" Finished Goods Inventory " has the meaning set forth in Section 2.2(l) .

" Fixed Assets " means all equipment (including computer hardware and data processing and telecommunications equipment), machinery, furniture and furnishings, fixtures, tools, vehicles and other tangible personal property of every type, in each case that are used principally in the PhosLo Business, whether owned or leased, all contract rights with respect thereto, and all maintenance records and other documents relating thereto.

 

4

" Foreign Marketing Authorization " means the equivalent of an FDA Approval in each country of the Territory other than the United States.

" GAAP " means generally accepted accounting principles as recognized by the American Institute of Certified Public Accountants, as in effect from time to time, consistently applied and maintained on a consistent basis for the applicable Person (or Persons on a consolidated basis, as the case may be) throughout the period indicated and consistent with such Person’s prior financial practices.

" Good Practices " means compliance with the applicable requirements contained in "Good Laboratory Practices," "Investigational New Drug" and/or "current Good Manufacturing Practices" regulations as promulgated by the FDA.

" Governmental Authority " means any nation or government, any state or other political subdivision thereof, any municipal, local, city or county government, or any Person exercising executive, legislative, judicial, regulatory or administrative functions of or pertaining to government.

" Governmental Filings " has the meaning set forth in Section 7.1(a) .

" GPOs " has the meaning set forth in the definition of "Wholesaler Charges."

" Hazardous Material " means any substance or material meeting any one or more of the following criteria: (i) it is or contains a substance designated as a hazardous waste, hazardous substance, hazardous material, pollutant, contaminant or toxic substance under any Environmental Law; (ii) it is toxic, explosive, corrosive, reactive, ignitable, infectious, radioactive, mutagenic, dangerous or otherwise hazardous; (iii) its presence at some quantity requires investigation, notification or remediation under any Environmental Law or common law; (iv) it constitutes a danger, a nuisance, a trespass or a health or safety hazard to persons or property; or (v) it is or contains, without limiting the foregoing clauses (i)-(iv), asbestos, polychlorinated biphenyls, petroleum hydrocarbons, petroleum derived substances or waste, crude oil or any fraction thereof, nuclear fuel or waste, natural gas or synthetic gas.

" Healthcare Governmental Authority " means any Governmental Authority, whether created under any federal, state or local statute or regulation, which governs or has oversight over the delivery or reimbursement of healthcare services, including CMS and fiscal intermediaries and other agents acting on behalf of CMS, and the health department or health licensing department of any federal, state or local Governmental Authority.

" HSR Act " has the meaning set forth in Section 5.3(a) .

" Indemnified Party " has the meaning set forth in Section 10.4(a) .

" Indemnifying Party " has the meaning set forth in Section 10.4(a) .

" Information " has the meaning set forth in Section 8.5(a) .

 

5

" Inventory " means all inventories of pharmaceuticals, goods, materials and supplies used principally in the PhosLo Business.

" Know-How " means ideas, designs, concepts, compilations of information, methods, techniques, procedures and processes, inventions and discoveries, whether or not patentable.

" Knowledge of the Seller ," " Seller’s Knowledge " and similar phrases means the actual knowledge of any of the following Persons and the information available in the books, records and files of the Seller: [*******].

" Legal Requirement " means any statute, law, treaty, rule, regulation of any Governmental Authority or any Order applicable or binding upon the subject Person (including its business or the ownership or use of any of its assets), property or other asset.

" Liabilities " means all liabilities or obligations of any nature whatsoever, whether absolute or contingent, due or to become due, accrued or unaccrued, known or unknown, direct or consequential or otherwise.

" Lien " means any lien, charge, claim, pledge, security interest, conditional sale agreement or other title retention agreement, lease, mortgage, security agreement, right of first refusal, option, restriction, license, covenant or other encumbrance (including the filing of, or agreement to file any financing statement under the Uniform Commercial Code or statute or law of any jurisdiction).

"[*******] Agreement " has the meaning set forth in Section 2.2(p) .

" Mark " means any word, name, symbol or device used by a Person to identify its goods or services, whether or not registered, and any right that may exist to obtain a registration with respect thereto from any Governmental Authority and any rights arising under any such application. As used in this Agreement, the term "Mark" includes trademarks and service marks.

" Master Formulations " has the meaning set forth in Section 2.2(d) .

" Material Adverse Effect " means any change, including any damage, destruction or other casualty loss, that is or would reasonably be expected to be materially adverse to the Purchased Assets or the PhosLo Business including its financial condition or results of operations; provided however, (i) a "Material Adverse Effect" does not include any change caused by a change in any circumstance, political, economic or business conditions affecting the United States economy as a whole or the pharmaceutical sector of the United States economy specifically and (ii) in determining whether there has been a Material Adverse Effect, any change shall be considered both individually and together with all other changes.

" Medicaid " means that means tested entitlement program under Title XIX of the Social Security Act that provides federal grants to states for medical assistance based on specific eligibility criteria. (Social Security Act of 1965, Title XIX, P.L. 89 87; 42 U.S.C. 1396 et seq .).

 

6

" Medical Product Regulatory Authority " means any Governmental Authority that is concerned with the safety, efficacy, reliability, manufacture, investigation, sale or marketing of pharmaceuticals, medical products, biologics or biopharmaceuticals, including the FDA.

" Medicare " means that government sponsored entitlement program under Title XVIII of the Social Security Act that provides for a health insurance system for eligible elderly and disabled individuals. (Social Security Act of 1965, Title XVIII, P.L. 89-87 as amended, 42 U.S.C. 1395 et seq .).

" Milestone Payments " means the payments payable from the Buyer to the Seller pursuant to Sections 3.1(a)(i)-(vi)  upon the achievement of certain milestones.

" NDA Filing Date " has the meaning set forth in Section 5.16(a) .

" NDAs " has the meaning set forth in Section 2.2(a) .

" Net Sales Deductions " means all: [*******].

" New Formulation Net Sales " means the excess of (a) the gross amount invoiced by the Buyer or its subsidiaries or Affiliates or its or their licensees, successors and assignees from or on account of sales or other dispositions of any New Formulation Products to unaffiliated third parties who are not licensees or sublicensees over (b) any Net Sales Deductions. The Buyer and any such sublicensees, Affiliates, licensees, successors and assignees shall allocate Net Sales Deductions to the New Formulation Products in a manner consistent with the manner in which it allocates similar deductions to products in the balance of its business. For the avoidance of doubt, New Formulation Net Sales shall not result from any transfer between or among the Buyer and any of its subsidiaries or Affiliates or its or their licensees, successors and assignees for resale, but shall result from the sale or resale by any such subsidiary, Affiliate, licensee, successor or assignee.

" New Formulation Net Sales Statement " has the meaning set forth in Section 3.2(b) .

" New Formulation Products " means each and every [*******].

" New Formulation Rights " has the meaning set forth in Section 2.2(p) .

" Noncompetition and Nonsolicitation Agreement " has the meaning set forth in Section 4.2(a)(ii) .

" Order " means any award, decision, injunction, judgment, order, writ, decree, ruling, subpoena or verdict entered, issued, made or rendered by any Governmental Authority or arbitrator.

"Part D Rebate Contract " means each Contract designated as such on Schedule 2.2(e) .

" Patent " means any patent granted by the United States Patent and Trademark Office or by the comparable agency of any other country, and any renewal thereof, and any rights arising under any patent application filed with the United States Patent and Trademark Office or the comparable agency of any other country and any rights that may exist to file any such application, together with any divisionals, continuations or continuations in part with respect to any such patent applications, any re-examinations of any such patent, any reissues of any such patent and any amendments thereto as a result of reexamination.

 

7

" Patent Agreement " has the meaning set forth in Section 4.2(a)(v) .

" Permits " means all licenses, permits, authorizations, registrations, certifications, certificates of occupancy, franchises and approvals of any nature issued by any Governmental Authority and used in the operation of the PhosLo Business, including regulatory approvals and worldwide registrations.

" Person " means an individual, partnership, corporation, limited liability company, trust, decedent’s estate, joint venture, joint stock company, association, unincorporated organization, Governmental Authority or other entity.

" PhosLo Business " has the meaning set forth in the Background Statement to this Agreement.

" PhosLo GelCap " means the size 0 capsule dose of PhosLo (667 mg) or the size 2 (333.5 mg) capsule dose of PhosLo as approved in NDA 21-160.

" PhosLo Products " means the following products: PhosLo GelCap and PhosLo Tablets.

" PhosLo Tablets " means the round tablet dose of PhosLo (667 mg) as approved by NDA 19-976.

" Plan " means any employee pension, retirement, profit-sharing, stock bonus, incentive, deferred compensation, stock option, employee stock ownership, hospitalization, medical, dental, vacation, insurance, sick pay, disability, severance or other plan, fund, program, policy, contract or arrangement, whether arrived at through collective bargaining or otherwise, providing employee benefits, including any "employee benefit plan" as that term is defined in Section 3(3) of ERISA, currently maintained by, sponsored in whole or in part by, or contributed to by the Seller, for the benefit of employees, retirees, dependents, spouses, directors, independent contractors or other beneficiaries, whether created in writing, through an employee manual or similar document, or orally.

" Proceeding " means any action, arbitration, audit, hearing, investigation, litigation or suit (whether civil, criminal, administrative, investigative or informal) commenced, brought, conducted or heard by or before, or otherwise involving, any Governmental Authority or arbitrator.

" Proprietary Rights " means, cumulatively, Copyrights, Know-how, Marks, domain names, Patents, Trade Secrets and other intellectual property rights.

" Proprietary Software " has the meaning set forth in the definition of "Software."

" Purchased Assets " has the meaning set forth in Section 2.2 of this Agreement.

 

8

" Purchased Proprietary Rights " has the meaning set forth in Section 5.6(a) .

" Purchase Price " has the meaning set forth in Section 3.1 .

" Qualified Beneficiaries " has the meaning set forth in Section 5.22(h) .

" Rebate Charges " means amounts claimed by or under, and actually paid to or in respect of, Medicaid, state rebate programs, pharmaceutical benefit management organizations, managed care organizations, and other Persons as rebates under Contracts between such parties and the Seller or the Buyer, as the context requires.

" Registrations " has the meaning set forth in Section 2.2(a) .

" Restricted Period " has the meaning set forth in Section 8.11(a) .

" Retained Marks " has the meaning set forth in Section 8.7(a) .

" Roxane Proceeding " has the meaning set forth in Section 2.4(a)(iii) .

" Scientific Data " has the meaning set forth in Section 5.18(a) .

" Seller " has the meaning set forth in the introductory sentence of this Agreement.

" Seller Certificate " has the meaning set forth in Section 9.3(c) .

" Seller Damages " has the meaning set forth in Section 10.3(a) .

" Seller Disclosure Schedule " has the meaning set forth in Section 5 .

" Seller Indemnified Parties " has the meaning set forth in Section 10.3(a) .

" Software " means:

  • (a) every computer software program or portion thereof (including operating systems, application programs, software tools, firmware and software imbedded within any telecommunications, dialysis or other equipment, including both object code and source code versions thereof), including computer software programs purchased or licensed from third parties;

    (b) every computer software program that the Seller (including its employees and independent contractors) has designed or created and all electronic or written materials that explain any such computer software program or that were used in the development of any such computer software program or represent an interim step in the development of any such computer software program, including logic diagrams, flowcharts, procedural diagrams and algorithms, and all electronic or written materials used by the Seller or provided to any patient or physician in connection with the installation, customization or use of any of the computer software programs described above.

 

9

  • That portion of the Software that is owned by the Seller is referred to herein as the " Proprietary Software ," and that portion of the Software that is owned by any Person other than the Seller is referred to herein as the " Third-Party Software ."

" Specifications " has the meaning set forth in Section 5.21 .

" Taxes " means all taxes, and all charges, fees, levies or other assessments imposed in respect thereof, imposed by a Governmental Authority (whether federal, state, local or foreign), including income, gross receipts, excise, property, estate, sales, use, stamp, value added, transfer, license, payroll, franchise, ad valorem, withholding, social security and unemployment taxes; and such term shall include any interest, penalties and additions to such taxes, charges, fees, levies or other assessments.

" Tax Return " means, with respect to any Person, any report, return or schedule attached to a return (or any combination thereof) required to be supplied by such Person to any Governmental Authority in connection with Taxes.

" Territory " shall mean each country in the world.

" Third-Party Consents " has the meaning set forth in Section 7.1(a) .

" Third-Party Software " has the meaning set forth in the definition of the term "Software."

" Trade Secrets " means business or technical information of any Person including, but not limited to, customer lists and Know-How, that is not generally known to other Persons who are not subject to an obligation of nondisclosure and that derives actual or potential commercial value from not being generally known to other Persons.

" Trademark Agreement " has the meaning set forth in Section 4.2(a)(vi) .

" Transaction Agreements " has the meaning set forth in Section 4.2(c) .

" Transition Services Agreement " has the meaning set forth in Section 4.2(a)(viii) .

" Wholesaler Charges " means amounts claimed by wholesalers of the PhosLo Products as chargebacks or returns to the wholesaler under contracts between group purchasing organizations, FSS and PHS (collectively, " GPOs ") and the Seller and amounts claimed by GPOs as administrative or marketing fees under contracts between GPOs and the Seller.

1.2 Construction .

(a) The article and section headings contained in this Agreement are solely for the purpose of reference and convenience, are not part of the agreement of the parties, and shall not in any way limit, modify or otherwise affect the meaning or interpretation of this Agreement.

(b) References to "Sections" or "Articles" refer to corresponding Sections or Articles of this Agreement unless otherwise specified.

 

10

(c) Unless the context requires otherwise, (i) the words "include," "including" and variations thereof mean without limitation; (ii) the words "hereof," "hereby," "herein," "hereunder" and similar terms refer to this Agreement as a whole and not any particular section or article in which such words appear; (iii) words in the singular include the plural, words in the plural include the singular, and words importing any gender shall be applicable to all genders; (iv) a term defined as one part of speech (such as a noun) shall have a corresponding meaning when used as another part of speech (such as a verb); and (v) currency amounts referenced herein are in U.S. Dollars.

(d) Any reference herein to a Legal Requirement shall include any amendment thereof, any successor thereto and any rules, regulations and published interpretations promulgated thereunder by Governmental Authorities.

(e) References to a number of days refer to calendar days unless Business Days are specified. Except as otherwise specified, whenever any action must be taken on or by a day that is not a Business Day, then such action may be validly taken on or by the next day that is a Business Day.

(f) All accounting terms used herein and not expressly defined herein shall have the meanings given to them under GAAP.

ARTICLE II

CONTEMPLATED TRANSACTIONS

2.1 Purchase of Assets . On the terms and subject to the conditions of this Agreement, on the Closing Date, effective as of the Effective Time, the Seller shall sell, convey, assign, and transfer to the Buyer (or one or more of its assignees), all of the Seller’s right, title and interest in and to the Purchased Assets, and the Buyer (or one or more of its assignees) shall purchase, acquire and accept the Seller’s right, title and interest in and to the Purchased Assets, free and clear of any Lien of any nature except for Liens for Taxes not yet due and payable.

2.2 Purchased Assets . For purposes of this Agreement, the term " Purchased Assets " shall mean all of the tangible and intangible assets, rights and properties used or held for use by the Seller principally in connection with the PhosLo Business, including the following assets, rights and properties, but excluding the Excluded Assets:

(a) all regulatory approvals, worldwide product registrations and associated materials (including the product dossier) relating to the PhosLo Business or the PhosLo Products (the " Registrations "), including the New Drug Applications (No. 19-976 and No. 21-160) issued by the FDA (together with all amendments, supplements and updates thereto (the " NDAs ")), and the other approvals, registrations, pending registrations and associated materials set forth on Schedule 2.2(a) hereto;

(b) the name "PhosLo" and any variant thereof, and the other Marks, trade names and domain names set forth on Schedule 2.2(b) hereto;

(c) the Patents set forth on Schedule 2.2(c) hereto;

 

11

(d) the intangible property rights that relate primarily to or are embodied in the PhosLo Products or the PhosLo Business (including phosphate binders generally or any product, device or service for the treatment of hyperphosphetemia, if any), whether or not patentable, including but not limited to Copyrights, Know-how, Trade Secrets, the goodwill associated with the PhosLo Business, master formulations for the PhosLo Products (" Master Formulations "), master processes used for manufacturing the PhosLo Products from the Master Formulations and other confidential business information;

(e) the Contracts related to the PhosLo Business that are listed on Schedule 2.2(e) hereto exclusive of the rights thereunder that relate to PhosLo Products sold prior to the Closing Date or the operation of the PhosLo Business prior to the Closing Date (the " Assigned Contracts ");

(f) the exclusive right to satisfy all unfilled purchase orders relating to the PhosLo Products from and after the Closing Date;

(g) all brochures and other promotional and printed materials, trade show materials (including displays), videos, advertising and/or marketing materials, including materials containing post-marketing clinical data, in the Seller’s possession or under its control used solely in connection with the sale of the PhosLo Products and/or the conduct of the PhosLo Business, including the materials listed on Schedule 2.2(g) ;

(h) all warranties and guarantees and other similar contractual rights made by third parties in favor of the Seller with respect to the PhosLo Products or the PhosLo Business included in the Assigned Contracts exclusive of those to the extent relating to PhosLo Products sold prior to the Closing Date or the operation of the PhosLo Business prior to the Closing Date;

(i) copies of all customer and supplier lists, account lists, call data, sales history, call notes, marketing studies, consultant reports, physician databases, and correspondence (excluding invoices and credit memos) principally relating to the PhosLo Products or the PhosLo Business to the extent maintained by the Seller, and all complaint files and adverse event files principally relating to the PhosLo Products or the PhosLo Business to the extent maintained by the Seller, including the materials listed on Schedule 2.2(i) ;

(j) all PhosLo specific training materials including an outline of training, quizzes and answers that accompany the written training materials to the extent maintained by the Seller, including the materials listed on Schedule 2.2(j) ;

(k) the Permits listed in Schedule 2.2(k) (the " Assigned Permits ");

(l) all PhosLo Products held by or on behalf of the Seller in inventory as finished goods (the " Finished Goods Inventory "), as well as all other Inventory;

(m) the Scientific Data, including any rights of access that the Seller has to the Scientific Data;

(n) copies of all financial records maintained by the Seller principally in connection with the sale of PhosLo Products relating to sales, accounts receivable, returns, chargebacks, rebates and discounts, redacted as necessary to delete all records and data respecting or including other products of the Seller and/or other aspects of its business;

 

12

(o) all rights of the Seller and its Affiliates to develop, make, have made, sell, distribute, promote, and use the PhosLo Products worldwide subject, in the case of Canada, to the rights of Genpharm Inc. pursuant to that certain Distribution Agreement between Genpharm Inc. and the Seller dated July 12, 2005;

(p) all rights of the Seller, and its Affiliates to [*******] (the " New Formulation Rights ") and all rights of the Seller and its Affiliates, if any, to develop and manufacture such products;

(q) the Fixed Assets listed on Schedule 2.2(q) ;

(r) all telephone numbers and listings in telephone directories maintained by third parties as listed on Schedule 2.2(r) ;

(s) copies of all other files, records, books, documents, data, plans and proposals of the Seller relating principally to the PhosLo Business or PhosLo Products, whether in written, electronic, visual or other form, redacted as necessary to delete all files, records, books, documents, data, plans and proposals respecting or including other products of the Seller and/or aspects of its business;

(t) [intentionally blank];

(u) all claims and rights relating principally to the Purchased Assets or the Assumed Liabilities, whether choate or inchoate, known or unknown, contingent or noncontingent, including all claims and rights of the Seller against third parties relating principally to the Purchased Assets or the Assumed Liabilities and including claims and rights under express or implied warranties but exclusive of those relating principally to PhosLo Products sold prior to the Closing Date or the operation of the PhosLo Business prior to the Closing Date; and

(v) the PhosLo Business as a going concern.

2.3 Excluded Assets . Notwithstanding anything in Section 2.2 to the contrary, the Purchased Assets shall not include any of Seller’s right, title or interest in or to the following assets, rights and properties (the " Excluded Assets "), all of which shall be retained by the Seller:

(a) [ intentionally blank ] ;

(b) all cash, cash equivalents and short-term investments of cash;

(c) all accounts receivable (billed and unbilled) in respect of sales of PhosLo Products made prior to the Closing Date;

(d) all Contracts and rights arising under any Contracts not specifically included in the Purchased Assets (the " Excluded Contracts ");

(e) the assets, rights and properties, if any, set forth on Schedule 2.3(e) ;

 

13

(f) any inter-company balances due to or from the Seller and any Affiliate;

(g) all interests in any real property, whether leased or owned;

(h) all Tax refunds and Tax deposits;

(i) any insurance policies;

(j) all Software;

(k) the Fixed Assets listed or described on Schedule 2.3(k) ;

(l) all telephone numbers and listings in telephone directories maintained by third parties other than those listed on Schedule 2.2(r) ; and

(m) all rights to receive payment of a license fee pursuant to Section 6.1(b) of the Distribution Agreement, dated as of July 12, 2005, between the Seller, Genpharm, Inc. and Prepharm, Inc.

2.4 Assumption of Liabilities .

(a) Assumed Liabilities . On the Closing Date, the Buyer shall assume, and shall thereafter timely pay and perform, the following Liabilities of the Seller (the " Assumed Liabilities "):

  • (i) the Liabilities of the Seller arising after the Effective Time under the Assigned Contracts (including in respect of all open purchase orders for PhosLo Products placed by customers with the Seller as of the Effective Time and all purchase orders and committed forecasts placed by the Seller with Braintree and Verdugt for the production or delivery of Inventory as of the Effective Time), excluding, however, any such Liabilities that arise from defaults or breaches under such Assigned Contracts based upon actions, omissions, circumstances or occurrences existing or occurring before the Closing Date (including for this purpose any event which, with notice or time, would constitute such a breach or default and any breach or default that occurs as a result of the Closing);

    (ii) all Liabilities under the Registrations and the Assigned Permits, if any, to the extent to be satisfied or performed, or arising out of acts or omissions of the Buyer, after the Closing Date; and

    (iii) any Liabilities arising from the Proceeding known as Nabi Biopharmaceuticals v. Roxane Laboratories, Inc ., filed in the United States District Court for the Southern District of Ohio (the " Roxane Proceeding "), based on acts, circumstances or omissions occurring after the Effective Time including the fees and expenses of counsel and experts and other third parties incurred in connection with the prosecution of the Roxane Proceeding after the Effective Time. Any such Liabilities based on acts, circumstances or omissions occurring prior to the Effective Time shall remain Liabilities of the Seller.

 

14

(b) Liabilities Not Assumed . Except for the Liabilities specifically assumed pursuant to Section 2.4(a) , the Buyer shall not assume, shall not take subject to and shall not be liable for, any Liabilities of the PhosLo Business, the Seller or any Affiliate of the Seller (the " Excluded Liabilities "). Without limiting the generality of the foregoing and notwithstanding anything in Section 2.4(a) to the contrary, the Excluded Liabilities shall include the following:

  • (i) any Liabilities incurred or arising in connection with the operation of the PhosLo Business, the condition of the Seller’s assets or the ownership of the Purchased Assets prior to the Effective Time, including any claims made by or against the Seller or any Affiliate of the Seller, whether before or after the Closing Date, that arise out of actions, omissions, circumstances or occurrences existing or occurring before the Closing Date;

    (ii) any claim, lawsuit or Liability of any kind or nature whatsoever (including any Liabilities relating to malpractice, tort or breach of contract claims asserted by any customer, patient, former patient, employee or any other party) that is based on PhosLo Products sold prior to the Effective Time, the sale after the Effective Time of Finished Goods Inventory existing as of the Effective Time, or marketing practices or marketing materials for PhosLo Products used prior to the Effective Time;

    (iii) any Liabilities to refund or repay, and all Liability associated with, any unreconciled payments, overpayments, duplicate payments, refunds, discounts, rebates or adjustments due to Medicare, Medicaid, Blue Cross Blue Shield, or any other healthcare reimbursement or payment program or intermediary third-party payor, any states, the Veterans Administration, other governmental programs or any other Person in respect of PhosLo Products sold prior to the Effective Time, including any Liabilities to repay any amounts for failure to report correctly average manufacturing price or best price in violation of any Contract or Permit, including the Seller’s Medicaid Rebate Agreement, Pharmaceutical Provider Agreement with the Veterans Administration, or 340B Agreement, in violation of any Legal Requirement with respect to the calculation of reported prices, or any Liabilities for rebates or discounts for PhosLo Products bearing the Seller’s NDC number arising under Part D Rebate Contracts and Commercial Rebate Contracts assigned to the Buyer pursuant to Section 8.17 ;

    (iv) any Liabilities relating to investigations of the Seller or any Affiliate of the Seller by any Governmental Authority or relating to any noncompliance by the Seller or any Affiliate of the Seller with Legal Requirements, including applicable healthcare laws and regulations;

    (v) any Liabilities arising out of or relating to the conduct of the CARE 2 Study or the EPICK Study prior to the Effective Time;

    (vi) any Liabilities (whether assessed or unassessed) of the Seller or any Affiliate of the Seller for any Taxes, including any Taxes arising by reason of the transactions contemplated herein;

 

15

  • (vii) all Liabilities with respect to the Wholesaler Charges and Discounts in respect of PhosLo Products sold prior to the Effective Time;

    (viii) any product liability relating to or arising out of the sale of PhosLo Products prior to the Effective Time or the sale after the Effective Time of the Finished Goods Inventory existing as of the Effective Time;

    (ix) all Liabilities arising out of or relating to the recall, replacement or return of, or any claim for breach of warranty in respect of or for refund of the purchase price of, the PhosLo Products sold prior to the Closing Date;

    (x) all Liabilities of the Seller or its predecessors arising under any Environmental Laws;

    (xi) any Liabilities attributable to any period prior to the Closing Date that arises out of any Contract, including Assigned Contracts, so long as such Liabilities do not arise as a result of the performance or non-performance of such Assumed Contract by the Buyer after the Closing Date;

    (xii) except as specifically set forth in this Agreement, any Liabilities to former or current officers, directors, employees, shareholders or Affiliates of the Seller or any Affiliate of the Seller, including any Liabilities of the Seller or any Affiliate of the Seller in connection with any Plans or collective bargaining, labor or employment agreement or other similar arrangement, any obligations in respect of retiree health benefits, and any accrued employee paid time off, including for vacation and sick leave;

    (xiii) any Liabilities of the Seller or any Affiliate of the Seller incurred or arising in connection with this Agreement, including any fees or expenses of the Seller or any Affiliate of the Seller incurred in connection with the transactions contemplated herein; and

    (xiv) any Liabilities relating to Excluded Assets.

2.5 Consent of Third Parties . On the Closing Date, the Seller shall assign to the Buyer, and the Buyer shall assume, the Assigned Contracts to the extent provided in this Agreement. To the extent that the assignment of all or any portion of any Assigned Contract shall require the consent of the other party thereto or any other third party, this Agreement shall not constitute an agreement to assign any such Assigned Contract if an attempted assignment without any such consent would constitute a breach or violation thereof. In order, however, to seek to provide the Buyer the full realization and value of every Assigned Contract of the character described in the immediately preceding sentence (i) as soon as practicable after the Closing, the Seller and the Buyer shall cooperate, in all reasonable respects, to obtain any necessary consents to the assignment of the Assigned Contracts, provided that neither party shall be required to make any payments or agree to any material undertakings in connection therewith, and (ii) until all such consents are obtained or all such Assigned Contracts expire or are terminated, the Seller and the Buyer shall cooperate, in all reasonable respects, to provide to the Buyer the benefits under the Assigned Contracts (with the Buyer entitled to all the gains and responsible for all the losses, Taxes and Liabilities thereunder). In connection with clause (ii) of this Section 2.5 , the Seller shall seek to enforce at

 

16

the cost of and for the benefit and risk of the Buyer all claims or rights of the Seller arising under the Assigned Contracts to the extent such claims or rights are included in the Purchased Assets, and the Buyer shall perform and comply with, at the Buyer’s cost, all of the Seller’s obligations under the Assigned Contracts, to the extent such obligations are Assumed Liabilities as if the Buyer was the Seller thereunder. Nothing in this Section 2.5 shall in any way diminish the conditions in Article IX of this Agreement.

2.6 Registrations and Applicable Permits . On the Closing Date, the Seller shall assign or transfer to the Buyer, and the Buyer shall assume, the Registrations and Assigned Permits to the extent provided in this Agreement to the extent that they are assignable, provided, however, that the Buyer will reimburse the Seller on the Closing Date for the portion of the fees paid by the Seller in respect of periods after the Effective Time under the Prescription Drug User Fee Act. To the extent that the assignment or transfer of all or any portion of any Registration or Permit shall require the consent of the other party thereto or any other third party, this Agreement shall not constitute any agreement to assign or transfer any such Registration or Permit if an attempted assignment or transfer without any such consent would constitute a breach or violation thereof. In order, however, to seek to provide the Buyer the full realization and value of every Registration and Permit of the character described in the immediately preceding sentence (i) as soon as practicable after the Closing, the Seller and the Buyer shall cooperate, in all reasonable respects, and use best efforts to obtain, at the earliest possible date, any necessary consents to the assignment or transfer of the Registrations and Permits, provided that neither party shall be required to make any payments or agree to any material undertakings in connection therewith, and (ii) until all such consents are obtained or all such Registrations and Permits expire or are terminated, the Seller and the Buyer shall cooperate, in all reasonable respects, to provide to the Buyer the benefits under the Registration and Permits (with the Buyer entitled to all the gains and responsible for all the losses, Taxes and Liabilities thereunder). In such event, the Buyer shall perform and comply with, at the Buyer’s cost, all of the Seller’s obligations under the Registrations and Permits to the extent such obligations are Assumed Liabilities, as if the Buyer was the Seller thereunder. Nothing in this Section 2.6 shall in any way diminish the conditions in Article IX of this Agreement.

ARTICLE III

PURCHASE PRICE AND CLOSING

3.1 Purchase Price . In consideration of the transfer to the Buyer of the Purchased Assets and the covenants of the Seller set forth herein, and subject to the terms and conditions of this Agreement, the Buyer shall pay or cause to be paid to the Seller the following amounts (together, the " Purchase Price "):

(a) $65,000,000 in cash on the Closing Date (the " Closing Payment ");

(b) the following amounts payable within ten (10) Business Days of notification of the achievement of each of the following Milestones; provided, however, that the payment due in connection with the achievement prior to the Closing Date of the Milestone in Section 3.1(b)(i) shall be payable on the Closing Date or within five (5) Business Days after the Closing Date:

  • (i) $5,000,000 upon completion of Data Lock related to the EPICK Study;

 

17

  • (ii) $2,500,000 upon submission to the FDA of an application seeking FDA Approval to market PhosLo GelCaps for use by chronic kidney disease, stage 4 patients, which application meets the requirements of 21 CFR Part 3.14 and other relevant FDA guidance and has been prepared in accordance with normally accepted industry standards for such applications, but only if such application is submitted by December 31, 2009;

    (iii) $2,500,000 upon FDA Approval to market a PhosLo Product for use by chronic kidney disease, stage 4 patients, but only if such FDA Approval is obtained by the tenth anniversary of the date hereof;

    (iv) $2,500,000 upon presentation of the CARE 2 Study abstract at the American Society of Nephrology 2006 meeting or cancellation of the meeting by ASN;

    (v) $2,500,000 upon acceptance and publication of the CARE 2 Study by a mutually agreed upon third party peer reviewed medical journal, but only if published by December 31, 2010;

    (vi) $5,000,000 within ten Business Days after the first commercial sale of a New Formulation Product by the Buyer or its Affiliates or their licensees or assignees, but only if such first commercial sale is made by the tenth anniversary of the date hereof; and

(c) deferred payments (the " Deferred Payments ") equal to [*******] of the annual New Formulation Net Sales in excess of $32,000,000 in each such calendar year during the period (the " Deferred Payment Period ") from the Closing Date through the earlier to occur of (a) receipt by the Seller of Closing Payments, Milestone Payments and Deferred Payments totaling $150,000,000, and (b) the tenth anniversary of the Closing Date. Notwithstanding the foregoing, the $32,000,000 threshold for the calendar year that includes the tenth anniversary of the Closing Date shall be prorated and reduced by multiplying $32,000,000 by a fraction equal to the total number of days between January 1, 2016 and the tenth anniversary of the Closing Date (inclusive) divided by 366. In no event shall the Buyer be obligated to pay the Seller Closing Payments, Milestone Payments and Deferred Payments of more than $150,000,000.

(d) The Buyer agrees that it shall have no right to set-off or apply against any Milestone Payment or Deferred Payment that the Buyer is obligated to make to the Seller under this Agreement after the Closing any amounts owed to the Buyer or its Affiliates by the Seller (including, without limitation, any indemnification obligation of the Seller under Section 10.2 ) unless and until such amount(s) shall have been reduced to an arbitration award or judgment.

3.2 Reports; Payments .

(a) Each party shall notify the other in writing whenever it believes that the Buyer has earned a Milestone Payment (including the Milestone in Section 3.1(b)(i) ), together with reasonably detailed information supporting the achievement of the corresponding Milestone. Except with respect to the Milestone in Section 3.1(b)(i) , the Seller shall not notify the Buyer of the achievement of any Milestone before the Closing Date. Except as otherwise provided in Section 3.1(b)(i) , within ten (10) Business Days of the notice of

 

18

achievement of a Milestone, the Buyer shall either pay the Seller the Milestone Payment or, if the Buyer disputes whether the Seller has earned the Milestone Payment, provide the Seller with written notice of its objections to payment of the Milestone Payment, with reasonably detailed supporting information.

(b) The Buyer shall deliver to the Seller, within forty-five (45) days after the last day of each calendar quarter (or partial quarter) that ends during the Deferred Payment Period, a statement in the form attached hereto as Schedule 3.2 (each, a " New Formulation Net Sales Statement "), setting forth (i) the gross amount of invoiced sales for each New Formulation Product (including unit quantities) for the year to date and the quarter then ended, (ii) the Net Sales Deductions for each such period (which deductions shall be aggregated by category), and (iii) the calculation of the related Deferred Payment then due, if any. For the avoidance of doubt the Seller agrees that no Deferred Payments shall be due in respect of any quarter unless the New Formulation Net Sales Statement delivered for such quarter establishes that the New Formulation Net Sales for the period from January 1 of such year through the end of such quarter exceed $32,000,000. If a New Formulation Net Sales Statement shall establish that Deferred Payments are due, then the Buyer shall pay such Deferred Payments to the Seller within ten days of its receipt of such New Formulation Net Sales Statement. The parties agree that the first Deferred Payment hereunder and the associated statement shall be made by the Buyer with respect to the quarter ending after the first commercial sale of a New Formulation Product.

(c) Any disputes regarding the right to receive any of the foregoing payments that cannot be settled amicably between the parties shall be resolved by arbitration in accordance with the arbitration procedures set forth in Sections 10.5(b) through 10.5(i) .

3.3 Books and Records; Audits . For a period of not less than three years after the relevant calendar year, the Buyer and its subsidiaries and Affiliates and its and their licensees that sell PhosLo Products and New Formulation Products shall keep full, true and accurate books of account sufficient to determine the amounts payable pursuant to Section 3.1 . The Seller shall have the right, not more than once during any calendar year, to have the books and records of the Buyer, its subsidiaries and Affiliates and its and their licensees audited by a qualified independent accounting firm of the Seller’s choosing, subject to the Buyer’s approval, which approval shall not be unreasonably withheld or delayed, under appropriate confidentiality provisions, to ascertain the accuracy of the reports and payments under Section 3.2 and compliance by the Buyer with its obligations under Section 3.1 . Such audit shall be conducted upon at least ten days’ advance notice during normal business hours and in a manner that does not interfere unreasonably with the business of the audited entity. Subject to the Buyer’s right to dispute such amounts, any underpayment determined by such audit shall promptly be paid by the Buyer. The Seller shall pay for the costs of such audit unless such audit shall establish an underpayment to the Seller in any calendar year of more than the greater of (i) 10% of the correct Deferred Payment and (ii) $50,000, in which event the Buyer shall reimburse the Seller for not more than $20,000 of the Seller’s out-of-pocket costs incurred in connection with conducting such audit.

3.4 Payments . Payments of Purchase Price shall be made by wire transfer to an account or accounts designated by the Seller at least two Business Days prior to the payment due date.

 

19

3.5 Allocation of Closing Payment . The parties shall allocate the Closing Payment among the Purchased Assets and the Seller’s covenants as indicated on Schedule 3.5 . The parties agree to report the transactions contemplated by this Agreement for income Tax purposes in accordance with such allocation pursuant to Section 1060 of the Code and the regulations thereunder, and agree not to take, in any filing with or accompanying any Tax Return reporting any part of the transactions contemplated herein, a position inconsistent with such allocations.

3.6 Freedom to Conduct Business Unimpaired . Subject to the terms of this Agreement, including Sections 8.10 and 8.11 , the Seller acknowledges and agrees that the Buyer and its Affiliates shall be free to pursue their respective business goals and that New Formulation Net Sales may be affected thereby. Accordingly, this Agreement shall not be deemed to impose any express or implied obligation on the Buyer or any of its Affiliates to maximize New Formulation Net Sales for all or any portion of the Deferred Payment Period or to impair the freedom of the Buyer and its Affiliates to conduct their respective businesses as they deem appropriate.

ARTICLE IV

CLOSING

4.1 Closing . The closing of the purchase and sale of the Purchased Assets and the consummation of the other transactions contemplated herein (the " Closing ") shall take place on October 18, 2006, or, if all of the conditions to the obligations of the parties to consummate the transactions contemplated hereby (excluding the delivery of any documents to be delivered at the Closing by any of the parties, it being understood that the occurrence of the Closing shall remain subject to the delivery of such documents) have not been satisfied in full or waived by such date, on such mutually agreeable later date as soon as practicable (but in no event more than three Business Days) after the first date on which the conditions to the obligations of the parties to consummate the transactions contemplated hereby (excluding the delivery of any documents to be delivered at the Closing by any of the parties, it being understood that the occurrence of the Closing shall remain subject to the delivery of such documents) have been satisfied or waived (the " Closing Date "), at the offices of Nutter McClennen & Fish LLP, in Boston, Massachusetts, beginning at 10:00 a.m., local time. The Closing shall be effective as of the Effective Time.

4.2 Closing Obligations . At the Closing:

(a) The Seller shall deliver (or cause to be delivered) to the Buyer:

  • (i) the various certificates, instruments and documents required to be delivered under Section 9.3 ;

    (ii) a Non-solicitation and Non-competition Agreement in the form attached hereto as Exhibit 4.2(a)(ii) (the " Noncompetition and Nonsolicitation Agreement ")

    (iii) a letter from the Seller in the form attached hereto as Exhibit 4.2(a)(iii) , notifying the FDA of the transfer of the rights to the Registrations to the Buyer;

 

20

  • (iv) a Bill of Sale in the form attached hereto as Exhibit 4.2(a)(iv) (the " Bill of Sale ");

    (v) a Patent Assignment Agreement in the form attached hereto as Exhibit 4.2(a)(v) (the " Patent Agreement ");

    (vi) a Trademark Assignment Agreement in the form attached hereto as Exhibit 4.2(a)(vi) (the " Trademark Agreement ");

    (vii) an Assignment and Assumption Agreement in the form attached hereto as Exhibit 4.2(a)(vii) (the " Assumption Agreement ");

    (viii) a Transition Services Agreement in the form attached hereto as Exhibit 4.2(a)(viii) (the " Transition Services Agreement ");

    (ix) such other instruments of conveyance, consent, and acknowledgement as may be required to convey all of the Purchased Assets to the Buyer, to permit the Buyer to record or register all registrable Purchased Proprietary Rights and to put the Buyer in possession and control of all of the Purchased Assets of a tangible nature, including documents and data in electronic formats, to the extent that such documents and data are in electronic formats;

    (x) original executed versions of the Assigned Contracts except for those that are not in the Seller’s possession, as indicated on Schedule 2.2(e) ; and

    (xi) copies of the Software listed on Schedule 4.2(a)(xi) (the Buyer acknowledging that such copies of Software will be provided by the Seller without any representation or warranty of any kind including as to any title or right of the Seller or the Buyer to use such Software).

(b) The Buyer shall deliver (or cause to be delivered) to the Seller:

  • (i) The various certificates, instruments and documents required to be delivered under Section 9.2 ;

    (ii) The Assumption Agreement;

    (iii) The Noncompetition and Nonsolicitation Agreement;

    (iv) The Transition Services Agreement;

    (v) A letter from the Buyer to the FDA in the form attached hereto as Exhibit 4.2(b)(v) , notifying the FDA of the transfer of the Registrations to the Buyer; and

    (vi) The Closing Payment.

 

21

(c) The agreements and instruments referred to in Sections 4.2(a)(ii) through (viii)  and Section 4.2(b)(v) , together with this Agreement, are referred to herein as the " Transaction Agreements ."

ARTICLE V

REPRESENTATIONS AND WARRANTIES OF THE SELLER

Except as disclosed on Schedule 5 hereto (the " Seller Disclosure Schedule ") the Seller represents and warrants to the Buyer the following:

5.1 Organization and Good Standing . The Seller is a corporation duly organized, validly existing and in good standing under the laws of its state of incorporation, as indicated in the introductory paragraph of this Agreement. The Seller has full corporate power and authority necessary to enable it to own, lease or otherwise hold its properties and assets (including the Purchased Assets) and to carry on the PhosLo Business as presently conducted. The Seller is duly qualified to do business as a foreign corporation in all the states, provinces and jurisdictions in which such qualification is necessary because of the operation of the PhosLo Business, the ownership or use of the Purchased Assets or otherwise.

5.2 Authority Relative to this Agreement . The Seller has full corporate or other power and authority to execute, deliver and perform this Agreement and the other Transaction Agreements and to consummate the transactions contemplated hereby and thereby. The execution, delivery and performance by the Seller of the Transaction Agreements and the consummation of the transactions contemplated thereby have been duly and validly authorized by all necessary corporate or other action on its part and no other further authorization or consent of the Seller or its board of directors, lenders or stockholders will be necessary. This Agreement has been, and each other Transaction Agreement will be, duly executed and delivered by the Seller and constitutes, and such other Transaction Agreement will constitute, the legally valid and binding obligation of the Seller, enforceable against the Seller in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency or other laws of general applicability affecting creditors’ rights and by general principles of equity.

5.3 Consents and Approvals; No Violations .

(a) Subject to compliance with the applicable requirements of the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the " HSR Act "), there is no requirement applicable to the Seller to make any filing with, or to obtain any permit, authorization, consent or approval of, any Governmental Authority as a condition to the lawful consummation of the transactions contemplated hereby.

(b) The execution, delivery and performance of each Transaction Agreement by the Seller and the Seller’s compliance with the terms thereof will not: (i) conflict with any provision of the articles of incorporation, bylaws or other governing documents of the Seller; (ii) conflict with, result in a breach of, constitute (with or without due notice or lapse of time or both) a default under, result in the acceleration of obligations under, create in any party the right to terminate or modify, result in the loss of any rights under, or require any notice, consent or waiver under, any Assigned Contract or any Assigned Permit; (iii) contravene, conflict with, violate, or

 

22

give any Governmental Authority or other Person the right to challenge any of the transactions contemplated hereby or exercise any remedy (including revocation, withdrawal, suspension or modification of any Permit) or obtain any relief under, any Legal Requirement applicable to the Seller; (iv) violate any Order specifically naming the Seller or any of its properties or assets; or (v) result in the creation or imposition of any Lien of any nature upon any of the Purchased Assets.

5.4 Purchased Assets .

(a) Tangible Assets . Schedule 5.4(a) lists or describes, as of the Closing Date, each item of the Purchased Assets that is tangible personal property (other than Inventory). The Fixed Assets listed on Schedule 2.2(q) are all of the Fixed Assets owned or leased by the Seller that are used primarily in connection with the PhosLo Business. All such Purchased Assets are in good working order and condition, reasonable wear and tear excepted.

(b) Title . The Seller has the right to sell and transfer to the Buyer good title to the Purchased Assets, free and clear of all Liens except for Liens for Taxes not yet due and payable. The delivery to the Buyer of the instruments of transfer of ownership contemplated by this Agreement will vest good title to the Purchased Assets in the Buyer, free and clear of all Liens except for Liens for Taxes not yet due and payable and Liens arising solely by actions or failures to act of the Buyer.

(c) Sufficiency . Except for the Excluded Assets and for the Seller’s assets that are used in connection with the provision of the corporate overhead and administrative services and the assets listed or described in Schedule 5.4(c) , the Purchased Assets constitute all of the assets necessary for the continued conduct of the PhosLo Business by the Buyer after the Closing in substantially the same manner as conducted by the Seller prior to the Closing. The telephone numbers and telephone directory listings listed on Schedule 2.2(r) are all of the telephone numbers and telephone directory listings that are used by the Seller primarily in connection with the PhosLo Business.

5.5 Real Property . [Intentionally Blank] .

5.6 Intellectual Property .

(a) Ownership and Right to Use . The Seller owns or has the right to use on a worldwide basis all of the Proprietary Rights included within the Purchased Assets (the " Purchased Proprietary Rights "). The Purchased Proprietary Rights include all of the Proprietary Rights necessary for the continued conduct of the PhosLo Business by the Buyer after the Closing in substantially the same manner as conducted by the Seller prior to the Closing. None of the Purchased Proprietary Rights will lapse, be terminable, be diminished or limited or be subject to any additional restrictions as a result of the Closing and the assignment of the Purchased Proprietary Rights to the Buyer. Each Person under Seller’s control, if any, who has participated in the creation, development, testing, modification or documentation of any PhosLo Product or New Formulation Product has entered into an enforceable agreement with the Seller assigning to the Seller, or is required by Legal Requirement to assign to the Seller, any of such Person’s rights in the Purchased Proprietary Rights.

 

23

(b) Marks and Trade Names . Schedule 5.6(b) lists each Mark, trade name and domain name that has been used by the Seller since August 4, 2003 to identify the PhosLo Business or the PhosLo Products and lists each registration that has been filed or obtained by the Seller with respect to any such Marks. All such pending and registered Marks are valid. To the Knowledge of the Seller, no other Person is using a confusingly similar Mark to describe products that are similar to the PhosLo Products.

(c) Patents . Schedule 5.6(c) lists each Patent owned or licensed by the Seller and used in or in connection with the PhosLo Business, specifies whether each such Patent is owned or licensed by the Seller and lists each country in which each such issued Patent has been issued. Each such issued Patent is valid and enforceable with regard to its coverage of the applicable PhosLo Product. Each Contract pursuant to which the Seller licenses any Patent included within the Purchased Proprietary Rights grants the Seller the unrestricted right to carry on any business within the scope of the inventions covered by such Patent in the countries in which the Patent is valid. Neither the Seller nor, to the Knowledge of the Seller, anyone acting on its behalf in a representative capacity, has knowledge of any material misrepresentation made to any Governmental Authority in connection with the procurement of any Patent included in the Purchased Proprietary Rights.

(d) Copyrights . Schedule 5.6(d) lists each Copyright registration included within the Purchased Proprietary Rights.

(e) Trade Secrets . The Seller has taken efforts that are reasonable under the circumstances to prevent the unauthorized disclosure to any other Person of such portions of the Seller’s Trade Secrets included in the Purchased Assets as would enable any other Person to compete with the Seller within the scope of the PhosLo Business as now conducted and as presently proposed to be conducted. Each current or former Employee and independent contractor of the Seller engaged principally in the operation of the PhosLo Business has executed a confidentiality agreement with the Seller or is subject to an obligation of confidentiality.

(f) Agreements with Other Persons . Schedules 5.6(c) and 5.6(f) list each Contract pursuant to which the Seller


 
SITE SEARCH

AGREEMENTS / CONTRACTS

Document Title:

Entire Document: (optional)

Governing Law:(optional)


Try our advanced search >>
 

CLAUSES

Search Contract Clauses >>

Browse Contract Clause Library>>

Get Email Updates
Email:
This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more