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ASSET PURCHASE AGREEMENT

Asset Purchase Agreement

ASSET PURCHASE AGREEMENT | Document Parties: MEDIMMUNE, INC | ZLB BEHRING AG You are currently viewing:
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MEDIMMUNE, INC | ZLB BEHRING AG

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Title: ASSET PURCHASE AGREEMENT
Governing Law: Maryland     Date: 2/27/2007
Industry: Biotechnology and Drugs     Law Firm: Hogan Hartson;Ballard Spahr     Sector: Healthcare

ASSET PURCHASE AGREEMENT, Parties: medimmune  inc , zlb behring ag
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Exhibit 10.27

 

 

 

Confidential materials omitted and filed separately with

the Securities and Exchange Commission.

Asterisks denote omissions.

 

 

 

 

ASSET PURCHASE AGREEMENT

 

 

Between

 

 

MEDIMMUNE, INC. ,

as Seller,

 

and

 

ZLB BEHRING AG ,

as Purchaser,

 

Dated as of November 8, 2006

 

 

TABLE OF CONTENTS

 

 

 

 

 

 

Page

1.

 

SALE AND PURCHASE OF ASSETS.

 

1

 

 

1.1

 

Purchase and Sale.

 

1

 

 

1.2

 

Transfer of Assets.

 

1

 

 

1.3

 

Assumed and Excluded Liabilities.

 

3

 

 

1.4

 

Closing.

 

6

 

 

1.5

 

Purchase Deposit.

 

6

 

 

1.6

 

Purchase Price.

 

6

 

 

1.7

 

Milestone Payments.

 

7

 

 

1.8

 

Inventory Calculations.

 

10

 

 

1.9

 

Allocation of Purchase Price.

 

11

 

 

1.10

 

Prorations.

 

12

 

 

1.11

 

Risk of Loss.

 

12

 

 

 

 

 

 

 

2.

 

REPRESENTATIONS AND WARRANTIES OF SELLER.

 

13

 

 

2.1

 

Organization.

 

13

 

 

2.2

 

Due Authorization.

 

13

 

 

2.3

 

No Conflicts; Consents.

 

13

 

 

2.4

 

Title to Assets.

 

14

 

 

2.5

 

Intellectual Property.

 

14

 

 

2.6

 

Contracts.

 

14

 

 

2.7

 

Compliance with Laws.

 

15

 

 

2.8

 

Litigation.

 

15

 

 

2.9

 

Brokers or Finders.

 

16

 

 

2.10

 

Inventory.

 

16

 

 

2.11

 

Financial Statements.

 

16

 

 

2.12

 

Financial Records.

 

16

 

 

2.13

 

No Other Representations or Warranties.

 

17

 

 

 

 

 

 

 

3.

 

REPRESENTATIONS AND WARRANTIES OF PURCHASER.

 

17

 

 

3.1

 

Organization.

 

17

 

 

3.2

 

Authority; Execution and Delivery; Enforceability.

 

17

 

 

3.3

 

No Conflicts; Consents.

 

18

 

 

3.4

 

Brokers and Finders.

 

18

 

 

3.5

 

Litigation.

 

18

 

 

3.6

 

Financial Condition.

 

19

 

 

3.7

 

Limitations on Acquired Assets.

 

19

 

 

3.8

 

Governmental Authorizations.

 

19

 

 

3.9

 

Financial Statements.

 

20

 

 

3.10

 

No Other Purchaser Representations or Warranties.

 

20

 

 

 

 

 

 

 

4.

 

COVENANTS PRIOR TO CLOSING.

 

20

 

 

4.1

 

Access to Information.

 

20

 

 

4.2

 

Operation of Product-Related Business Prior to the Closing.

 

20

 

 

 

 

 

 

4.3

 

Consents and Approvals.

 

22

 

 

4.4

 

HSR Act.

 

22

 

 

4.5

 

Other Pre-Closing Covenants.

 

23

 

 

 

 

 

 

 

5.

 

ADDITIONAL COVENANTS.

 

24

 

 

5.1

 

Confidentiality; Publicity.

 

24

 

 

5.2

 

Availability of Records.

 

25

 

 

5.3

 

Revision of Marketing Materials; Use of Names.

 

25

 

 

5.4

 

Customer Notifications.

 

26

 

 

5.5

 

Product Returns, Rebates, Chargebacks and NDC Number.

 

26

 

 

5.6

 

Accounts Receivable.

 

28

 

 

5.7

 

Regulatory Approvals.

 

29

 

 

5.8

 

Tax Matters.

 

31

 

 

5.9

 

Government Multi-Product Contracts.

 

31

 

 

5.10

 

Inventory.

 

31

 

 

5.11

 

Further Assurances.

 

31

 

 

5.12

 

Post-Effective Time Cooperation.

 

32

 

 

5.13

 

No Active Solicitation of Returns.

 

32

 

 

5.14

 

Insurance.

 

32

 

 

5.15

 

Non-Competition.

 

33

 

 

 

 

 

 

 

6.

 

CONDITIONS PRECEDENT TO OBLIGATIONS OF SELLER.

 

33

 

 

6.1

 

Representations and Warranties.

 

33

 

 

6.2

 

Performance.

 

33

 

 

6.3

 

Legal Proceedings.

 

34

 

 

6.4

 

Consents.

 

34

 

 

6.5

 

Purchase Price.

 

34

 

 

6.6

 

Purchaser’s Certificates.

 

34

 

 

6.7

 

Assumption Agreement.

 

34

 

 

6.8

 

Ancillary Agreements.

 

34

 

 

6.9

 

Governmental Authorizations.

 

34

 

 

6.10

 

Purchaser Financial Information.

 

34

 

 

6.11

 

Parent Guaranty.

 

34

 

 

 

 

 

 

 

7.

 

CONDITIONS PRECEDENT TO OBLIGATIONS OF PURCHASER.

 

34

 

 

7.1

 

Representations and Warranties.

 

34

 

 

7.2

 

Performance.

 

35

 

 

7.3

 

Legal Proceedings.

 

35

 

 

7.4

 

Consents.

 

35

 

 

7.5

 

Seller’s Certificates.

 

35

 

 

7.6

 

Related Instruments.

 

35

 

 

7.7

 

Ancillary Agreements.

 

35

 

 

7.8

 

Governmental Authorizations.

 

35

 

 

7.9

 

Baxter/PPS Matters.

 

35

 

 

7.10

 

Product Removal Notice.

 

35

 

 

 

 

 

 

 

 

 

 

 

8.

 

SURVIVAL; INDEMNIFICATION.

 

36

 

 

8.1

 

Survival of Representations.

 

36

 

 

8.2

 

Indemnification by Seller.

 

36

 

 

8.3

 

Indemnification by Purchaser.

 

37

 

 

8.4

 

Calculation of Losses.

 

38

 

 

8.5

 

Termination of Indemnification.

 

38

 

 

8.6

 

Procedures.

 

38

 

 

8.7

 

Sole Remedy; No Additional Representations.

 

40

 

 

8.8

 

Limitations on Liability.

 

41

 

 

 

 

 

 

 

9.

 

TERMINATION.

 

41

 

 

9.1

 

Termination.

 

41

 

 

9.2

 

Effect of Termination.

 

42

 

 

 

 

 

 

 

10.

 

MISCELLANEOUS.

 

42

 

 

10.1

 

Amendment and Waivers.

 

42

 

 

10.2

 

Notices.

 

42

 

 

10.3

 

Definitions; Interpretation.

 

43

 

 

10.4

 

Descriptive Headings.

 

44

 

 

10.5

 

Counterparts.

 

44

 

 

10.6

 

Entire Agreement.

 

44

 

 

10.7

 

Fees And Expenses.

 

44

 

 

10.8

 

Governing Law.

 

44

 

 

10.9

 

Specific Performance.

 

44

 

 

10.10

 

Assignment.

 

44

 

 

10.11

 

Successors and Assigns.

 

44

 

 

10.12

 

Severability.

 

45

 

 

10.13

 

Consent to Jurisdiction.

 

45

 

 

10.14

 

Waiver of Jury Trial.

 

45

        •  

           

           

LIST OF EXHIBITS, SCHEDULES AND ANNEXES

Annex

 

Description

 

 

A

 

Definitions

 

 

 

Exhibits

 

Description

 

 

A

 

Assumption Agreement

B

 

Reserved

C

 

Trademark Assignment Agreement

D-1, D-2, D-3

 

Initial Press Releases

E

 

Transition Services Agreement

F

 

Escrow Agreement

G

 

Parent Guaranty

H

 

Bill of Sale

 

 

 

Schedules

 

Description

 

 

1.2(a)

 

Acquired Assets

1.2(a)(i)

 

Product Intellectual Property

1.2(a)(ii)

 

Governmental Authorizations

1.2(a)(iii)

 

Product Documentation and Product Records

1.2(a)(iv)

 

Marketing Material

1.2(a)(v)

 

Assigned Contracts

1.2(a)(vi)

 

Customer Lists

1.2(a)(vii)

 

Manufacturing Equipment

1.2(a)(viii)

 

Database Software

1.2(b)

 

Excluded Assets

1.3(a)

 

Assumed Liabilities

1.8

 

Estimated Inventory Value

1.9

 

Allocation Schedule

2.3(a)

 

No Conflicts

2.3(b)

 

Consents, Approvals and Filings

2.4

 

Title to Assets Exceptions

2.5

 

Intellectual Property Exceptions

2.6

 

Assigned Contracts Exceptions

2.7(a)

 

Compliance with Law Exceptions

2.7(b)(ii)

 

Notices from Governmental Entities

2.8

 

Litigation Exceptions

3.9(a)

 

Financial Statements

3.9(b)

 

Interim Financial Statements

3.9(c)

 

Financial Statements Exceptions

5.5(b)(iii)

 

Best Price

5.9

 

Pricing: Government Multi-Product Contracts

6.4

 

Required Consents

 

 

 

 

ASSET PURCHASE AGREEMENT

THIS ASSET PURCHASE AGREEMENT (this " Agreement ") is entered into as of November 8, 2006, (the " Agreement Date ") between MedImmune, Inc., a Delaware corporation (" Seller "), and ZLB Behring AG, a Swiss corporation (" Purchaser ").

Recitals

WHEREAS , Seller owns certain assets relating to the manufacture, distribution, marketing and sale of a biological product known as CytoGam® (cytomegalovirus immune globulin intravenous) (the " Product "), which assets are referred to herein as the Acquired Assets (as more particularly defined below); and

WHEREAS , Seller desires to sell to Purchaser, and Purchaser desires to purchase from Seller, the Acquired Assets (as defined below), and Purchaser has agreed to assume from Seller the Assumed Liabilities (as defined below), all on the terms and conditions set forth in this Agreement; and

WHEREAS , except as otherwise expressly provided, capitalized terms used herein shall have the meanings set forth in Annex A .

NOW, THEREFORE , in consideration of the foregoing and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:

        • 1.                                       SALE AND PURCHASE OF ASSETS.

1.1           Purchase and Sale.   On the terms and subject to the conditions of this Agreement, Seller shall sell, assign, transfer, convey and deliver to Purchaser, and Purchaser shall purchase, from Seller, as of the Effective Time, all the right, title and interest of Seller in, to and under the Acquired Assets in consideration for payment of the Purchase Price (as defined below) and the assumption by Purchaser of the Assumed Liabilities. The purchase and sale of the Acquired Assets and the assumption of the Assumed Liabilities are referred to in this Agreement collectively as the " Acquisition ."

1.2          Transfer of Assets.

(a)           Acquired Assets .  The term " Acquired Assets " means all Seller’s rights, title and interest in, to and under those certain assets set forth below and further described in Schedule 1.2(a) , subject to any limitations, restrictions or conditions imposed under the Assigned Contracts, the Assumed Liabilities or this Agreement:

        • (i)            the Product Intellectual Property;

          (ii)           the Governmental Authorizations;

          (iii)          the Product Documentation and Product Records;

           

           

          (iv)          the Marketing Material;

      (v)           the rights of Seller and its Affiliates under the contracts and agreements listed on Schedule 1.2(a)(v) (the " Assigned Contracts ");

      (vi)          the customer list for the Product and all historical customer lists prepared within the past five (5) years, which shall be delivered at the Closing as Schedule 1.2(a)(vi) ;

      (vii)         the manufacturing equipment identified on Schedule 1.2(a)(vii) ;

      (viii)        the Seller’s interest in the database software and the data identified on Schedule 1.2(a)(viii) ;

      (ix)           the Inventory;

      (x)            all goodwill relating to the Acquired Assets; and

      (xi)           all rights in and to all warranties, guarantees and indemnities with respect to the Acquired Assets or Assumed Liabilities, and, except as provided in Section 1.2(b)(vi) , all rights, claims or causes of action of Seller and/or any of its Affiliates relating to any Acquired Asset or any Assumed Liability, whether known or unknown, contingent or noncontingent.

(b)           Excluded Assets .  Notwithstanding anything to the contrary in Section 1.2(a) and elsewhere in this Agreement, all assets of Seller other than the Acquired Assets (the " Excluded Assets ") are not part of the Acquisition.  By way of clarification and not limitation, the following assets (as further described on Schedule 1.2(b) ) shall be Excluded Assets and shall remain the property of Seller after the Closing:

        • (i)            any real estate owned or leased by Seller or any of its Affiliates;

          (ii)           all cash and cash equivalents of Seller or any of its Affiliates;

          (iii)          the Names;

          (iv)          all Accounts Receivable;

          (v)           any refund or credit of Taxes attributable to any Excluded Tax Liability;

      (vi)          all rights, claims, causes of action and credits of Seller or any of its Affiliates, relating to any Excluded Asset or any Excluded Liability, including any such items arising under insurance policies, and all rights in and to all warranties, guarantees and indemnities and similar rights in favor of Seller or any of its Affiliates relating to any Excluded Asset or any Excluded Liability;

      (vii)         all rights of Seller or any of its Affiliates under this Agreement, the Related Instruments and the Ancillary Agreements; and

      (viii)        all Retained Information.

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(c)           Liens and Encumbrances .  Subject to any limitations or conditions imposed by the Assigned Contracts and as otherwise provided in this Agreement, Purchaser is acquiring the Acquired Assets free and clear of all liabilities, obligations and commitments of Seller or any of its Affiliates, other than the Assumed Liabilities, and free and clear of all Liens and Encumbrances, other than Permitted Liens.

1.3          Assumed and Excluded Liabilities.

(a)           Assumed Liabilities .  Upon the terms and subject to the conditions of this Agreement, Purchaser hereby assumes, and from and after the Effective Time Purchaser shall pay, perform, discharge and otherwise fully satisfy when due, any and all liabilities, obligations and commitments arising out of or related to the liabilities set forth below and further described in Schedule 1.3(a) (the " Assumed Liabilities "):

    • (i)            except to the extent set forth in Section 1.3(b)(i) , all liabilities, obligations and commitments arising out of or relating to any product liability, breach of warranty or similar claim for injury to person or property, if asserted following the Effective Time, to the extent that such liabilities, obligations or commitments (A) result from the use or misuse of Product included in any lot released by or on behalf of Purchaser after the Effective Time (" Purchaser Lot "), (B) otherwise relate to Product included in any Purchaser Lot (including all Proceedings relating to any such liabilities) or (C) subject to the Transition Services Agreement, relate to, or derive from, the sale, handling or distribution of the Product (including Product from any lot released by or on behalf of Seller prior to the Effective Time (" Seller Lot ")) after the Effective Time by or on behalf of Purchaser;

      (ii)           except to the extent specifically provided in Section 1.3(b)(ii) , all liabilities arising out of or relating to the ownership of the Governmental Authorizations from and after the Effective Time, including the responsibility for all product complaints, recalls, lookbacks, market withdrawals and field corrections with respect to any Product included in any Purchaser Lot;

      (iii)          subject to Section 5.5 below, all liabilities arising out of or relating to the return of any Product included in any lot from which Seller had not shipped any vials of Product prior to the Effective Time;

      (iv)          subject to Section 5.5 , all liabilities, obligations and commitments arising out of or relating to any rebates, chargebacks, or administrative fees related to any Product that are asserted or requested on or after [*****];

      (v)           all liabilities for Taxes arising out of or relating to, directly or indirectly, the Acquired Assets (including the Product), or the ownership, sale or lease of any of the Acquired Assets, other than the Excluded Tax Liabilities, and in each case only to the extent such Taxes relate to periods or transactions after the Effective Time;

3

 

 

    • (vi)          all liabilities arising on or after the Effective Time under or relating to, directly or indirectly, the Assigned Contracts, other than liabilities for breaches occurring prior to the Effective Time;

      (vii)         all other liabilities, obligations and commitments of whatever kind and nature, primary or secondary, direct or indirect, absolute or contingent, known or unknown, whether or not accrued, arising out of or relating to, directly or indirectly, the Acquired Assets (including the Product), or the ownership, sale or lease of any of the Acquired Assets, or the marketing, sale or distribution of the Product, or the conduct of the Product-Related Business, but in each case only to the extent arising after the Effective Time; and

      (viii)        except to the extent specifically provided in Section 1.3(b) , any and all other liabilities, obligations and commitments, of whatever kind and nature, primary or secondary, direct or indirect, absolute or contingent, known or unknown, whether or not accrued, arising out of or relating to, directly or indirectly, the Acquired Assets (including the Product), to the extent arising after the Effective Time.

For avoidance of doubt, nothing in this Section 1.3(a) is intended to, or shall be interpreted to, limit or otherwise reduce the Liabilities of Purchaser as they may occur and/or exist after the Effective Time by virtue of Purchaser’s ownership of the Acquired Assets or operation of the Product-Related Business, but rather, this Section 1.3(a) is solely intended to identify and provide for the assumption by Purchaser of those Liabilities of Seller that are specifically assumed by Purchaser hereunder and which, but for such assumption, would remain Liabilities of Seller.

(b)           Excluded Liabilities .  Notwithstanding any other provision of this Agreement or any Related Instrument, Purchaser is not hereby assuming any Excluded Liability, each of which shall be retained and paid, performed and discharged when due by Seller. The term " Excluded Liability " shall mean those liabilities which are not Assumed Liabilities, including:

    • (i)            all liabilities arising out of or relating to any product liability, breach of warranty or similar claim for injury to person or property, to the extent such liabilities, obligations or commitments (A) result from the use or misuse of Product included in any Seller Lot, or (B) otherwise relate to Product included in any Seller Lot (including all Proceedings relating to any such liabilities), except in the case of both (A) and (B) to the extent such liabilities relate to or derive from the sale, handling or distribution of such Product after the Effective Time by or on behalf of Purchaser;

      (ii)           all liabilities arising out of or relating to the ownership of the Governmental Authorizations prior to the Effective Time, including the responsibility for all product complaints, recalls, market withdrawals and field corrections with respect to any Product included in any Seller Lot;

4

 

 

    • (iii)          subject to Section 5.5 below, all liabilities arising out of or relating to the return of any Product included in any lot from which Seller had shipped at least one Product vial prior to the Effective Time, provided , that Purchaser maintains substantially the same Product return policies with respect to Product in any lots for which Seller retains return liability;

      (iv)          subject to Section 5.5 below, all liabilities, obligations and commitments arising out of or relating to any rebates, chargebacks, or administrative fees related to any Product that are asserted or requested prior to [*****];

      (v)           all liabilities arising out of or claims or complaints originating, occurring, arising or brought against Seller relating to or affecting the Product or the Product-Related Business with respect to any time prior to the Effective Time;

      (vi)          any Tax payable with respect to any business, asset, property or operation of Seller or any member of any affiliated group of which Seller is a member (including any Taxes relating to or arising out of the operation of the Acquired Assets) relating to any Pre-Effective Time Tax Period, other than any Tax for which Purchaser is responsible pursuant to Section 5.8 , provided that notwithstanding Section 5.8 , Purchaser shall not assume any liability for transfer Taxes to the extent such transfer Tax is measured by gain realized by Seller from the sale of the Acquired Assets (an " Excluded Tax Liability ") and, for this purpose, in the case of a taxable period that begins before and ends after the Effective Time (a " Straddle Period "), (i) any Tax that is based on income, revenue, sales, payments or wages shall be allocated between the portion of the Straddle Period that is a Pre-Effective Time Tax Period and the remainder of the Straddle Period, as if based on a closing of the books as of the Effective Time, (ii) and any other Tax shall be allocated in proportion to the number of the days of the Straddle Period ending before and after the Effective Time;

      (vii)         any liability of Seller or any of its Affiliates arising out of or relating to any Excluded Asset;

      (viii)        any liability of Seller or any of its Affiliates for royalties accrued in connection with the manufacture and sale of Product prior to the Effective Time;

      (ix)           any liability of Seller or any of its Affiliates for accounts payable incurred in connection with the manufacture and sale of Product prior to the Effective Time;

      (x)            except as otherwise expressly provided in this Agreement or the Transition Services Agreement, any liability for acts of Seller after the Effective Time; and

      (xi)           except to the extent specifically provided in Section 1.3(a) any and all other liabilities, obligations and commitments of whatever kind and nature, primary or secondary, direct or indirect, absolute or contingent, known or unknown, whether or not accrued, arising out of or relating to, directly or indirectly, the Acquired Assets (including the Product) but only to the extent related to any period prior to the Effective Time.

5

 

 

(c)           No Offset .  Each of Purchaser’s and Seller’s obligations under this Section 1.3 will not be subject to offset or reduction by reason of any actual or alleged breach of any representation, warranty or covenant contained in this Agreement or any Ancillary Agreement or Related Instrument or any right or alleged right to indemnification hereunder.

1.4          Closing.   The closing of the Acquisition provided for in this Agreement (the " Closing ") will take place at the offices of Seller’s counsel, Hogan & Hartson L.L.P. at 555 Thirteenth Street, N.W., Washington, D.C. at a mutually agreeable time on the date three (3) business days after the date on which all of the conditions precedent set forth in Sections 6 and 7 below are satisfied or waived (or such other date as Seller and Purchaser mutually agree).  The time of consummation of the transactions contemplated by this Agreement (" Effective Time ") is deemed to be at 12:01 a.m. Maryland time on the date on which the Closing occurs (the " Closing Date ").

1.5          Purchase Deposit.

(a)           Payment of Deposit .  Upon execution of this Agreement, Purchaser shall deliver to Seller a deposit of Five Million Dollars ($5,000,000) (the " Purchase Deposit "), to be held by Seller.  For purposes of calculating any accrued interest on the Purchase Deposit, the Parties agree to use an interest rate of [*****] per annum from and after the date of delivery.  The Purchase Deposit is a deposit against, and component of, the Purchase Price defined in Section 1.6 and shall be applied to the Purchase Price at the Closing.

(b)           Return of Deposit .  In the event that Purchaser terminates this Agreement as permitted pursuant to Section 9.1(c) , the Purchase Deposit shall be returned to Purchaser.  The Purchase Deposit shall also be returned to Purchaser in the event the Agreement is terminated by mutual agreement pursuant to Section 9.1(a) .  Interest on the Purchase Deposit shall be paid out to Purchaser when the Purchase Deposit is paid out.

(c)           Forfeit of Deposit .  The Purchase Deposit, plus accrued interest, shall be forfeited by Purchaser and be retained by Seller in the event that this Agreement is terminated by Seller pursuant to Section 9.1(b) , other than pursuant to either condition precedent Section 6.3 , Legal Proceedings, or Section 6.4 , Consents, in which case the Purchase Deposit, plus accrued interest, shall be returned to Purchaser.

1.6           Purchase Price .  In addition to any other amounts due hereunder, in consideration of the sale, assignment, conveyance, license and delivery of the Acquired Assets hereunder, Purchaser shall assume the Assumed Liabilities and pay to Seller, by wire transfer of immediately available funds directly to an account designated by Seller, when due, the following (subject to the adjustments set forth in this Section 1 , the " Purchase Price "):

(a)           Up-Front Payment .  An up-front component consisting of:

    • (i)            the Purchase Deposit paid pursuant to Section 1.5 ; and

      (ii)           Forty-Five Million Dollars ($45,000,000) (the " Cash Amount ") payable at Closing.

6

 

 

(b)           Equipment Payment .  The value of (i) the manufacturing equipment set forth on Schedule 1.2(a)(vii) and (ii) the plasma database software set forth on Schedule 1.2(a)(viii) (collectively, the " Equipment Payment ") payable at Closing.

(c)           Inventory Payment .  The Estimated Inventory Value calculated pursuant to Section 1.8 (the " Initial Inventory Payment ," and together with the Cash Amount and the Equipment Payment, the " Closing Payment ") payable at Closing and subject to adjustment for any Inventory Variance in accordance with Section 1.8 .

    • (d)           Milestone Payments .  The following Milestone Payments:

      (i)            [*****] (the " First Milestone Payment ") payable when Cumulative Net Sales reach [*****] (the " First Milestone ");

      (ii)           [*****] (the " Second Milestone Payment ") payable when Cumulative Net Sales reach [*****] (the " Second Milestone "); and

      (iii)          [*****] (the " Third Milestone Payment " and together with the First Milestone Payment and the Second Milestone Payment, the " Milestone Payments ") payable when Cumulative Net Sales reach [*****] (the " Third Milestone " and together with the First Milestone and the Second Milestone, the " Milestones ").

1.7          Milestone Payments.

(a)           Payment Procedures .

    • (i)            Within ten (10) days after the end of each calendar quarter in which Cumulative Net Sales have reached a Milestone, Purchaser shall deliver to Seller a written notice stating that a Milestone has been reached and that a Milestone Payment will be made by Purchaser within thirty (30) days after the end of such calendar quarter (the " Milestone Notice "). Such Milestone Notice need not include specific Cumulative Net Sales information.  Even if Purchaser or Seller determines, subsequent to delivery of a Milestone Notice, that a Milestone was not reached, delivery of such Milestone Notice by Purchaser based on its good faith belief that reaching a Milestone was imminent, and the payment by Purchaser of the Milestone Payment based thereon, shall not constitute a breach of this Agreement.

      (ii)           On or before thirty (30) days after the end of each calendar quarter, Purchaser shall deliver to Seller a report (the " Quarterly Sales Report ") setting forth (x) Product sales for such quarter and (y) Cumulative Net Sales as of the end of such quarter.  Purchaser shall pay each Milestone Payment to Seller within thirty (30) days of the end of the first such calendar quarter in which the Cumulative Net Sales exceed the applicable Milestone as set forth in the Quarterly Sales Report for such quarter or, even if Cumulative Net Sales have not exceeded such Milestone, within (30) days of the end of a calendar quarter for which a Milestone Notice was delivered by Purchaser.  Purchaser’s obligation to make the Milestone Payments shall not expire, regardless of the amount of time required for Cumulative Net Sales to exceed the applicable Milestones.

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(b)           Combination Products .  If Purchaser markets, distributes or sells a formulation of the Product or if any derivative thereof is present in combination with another substance (a " Combination Product "), the Net Sales of the Product for the purposes of calculating the Cumulative Net Sales shall be based on the amount of Product (or any derivative thereof) in the Combination Product, as follows:

    • (i)            the amount of the Product (or any derivative thereof) in the Combination Product shall be compared to the amount of the Product (or any derivative thereof) present as monotherapy, in order to identify the percentage of the monotherapy dose of the Product present in the Combination Product (such percentage being referred to as the " Product Percentage ").

      (ii)           the Product Percentage shall be multiplied by the sale price of the Combination Product and such product shall be deemed to be Net Sales of the Product for the purposes of calculating Cumulative Net Sales pursuant to this Section 1.7(b) .

(c)           Diligence .  Purchaser shall use its commercially reasonable efforts to commercialize the Product and generate maximum sales of Product for so long as any Milestone remains unachieved.  Each Party acknowledges that there is no assurance that the Milestones will be achieved.

(d)           Records; Audit .

    • (i)            Records Retention .  Purchaser, its Affiliates and sublicensees will maintain complete and accurate books, records and accounts in sufficient detail to confirm the accuracy of Cumulative Net Sales information reported to Seller (including the Monthly Sales Reports) (the " Sales Records "), which Sales Records will be retained by the applicable Party until all Milestone Payments have been paid in full.

      (ii)           Audit .  Seller will have the right, no more frequently than once per year, to have an independent certified public accounting firm of internationally recognized standing, reasonably acceptable to Purchaser (the " Independent Audit Accounting Firm "), to have access during normal business hours, and upon reasonable prior written notice, to such of the Sales Records of Purchaser, its Affiliates and sublicensees as may be reasonably necessary to verify the accuracy of information needed to calculate Milestone Payments required hereunder.  The Independent Audit Accounting Firm will disclose to the Parties only whether the Cumulative Net Sales reported by the Purchaser are correct or incorrect and the specific details concerning any discrepancies.  As between Seller and Purchaser, Seller will bear all costs of such audit, unless the audit reveals a discrepancy in Seller’s favor sufficient to trigger an unrealized Milestone Payment, in which case such audit shall not be counted for purposes of the once-per-year limitation of Seller’s audit rights.

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(e)           Security for Milestone Payments .  If at any time prior to the full payment of the Milestone Payments, based on Cumulative Net Sales reflected in a Quarterly Sales Report, a Milestone Notice or the results of an audit under Section 1.7(d)(ii) , the Purchaser fails to make any Milestone Payment when due, Seller shall notify Purchaser in writing of such failure to make a Milestone Payment, and Purchaser shall have fifteen (15) days from delivery of such written notice by Seller to pay to Seller the Milestone Payment then due.  If Purchaser fails to pay to Seller such Milestone Payment then due within such fifteen (15) day period, Purchaser shall within five (5) days after the expiration of such fifteen (15) day period (A) pay to Seller the Milestone Payment then due and (B) complete, execute and deliver an escrow agreement in substantially the form attached hereto as Exhibit F , with such changes as reasonably required by the Escrow Agent (the " Escrow Agreement ") and such related documents as are reasonbly required by the Escrow Agent in connection therewith, and deposit into an escrow account, pursuant to such Escrow Agreement, immediately available funds in the amount of the aggregate total unpaid Milestone Payments not then due (the " Escrow Deposit ").  The Escrow Agreement shall provide that a Milestone Payment shall be made from the Escrow Deposit to Seller upon (1) the joint instruction of the Parties, (2) Seller’s delivery of a statement of audit under Section 1.7(d)(ii) verifying Cumulative Net Sales in excess of a Milestone accompanied by Seller’s certification that Purchaser has failed to pay the corresponding Milestone Payment or (3) Seller’s delivery of a signed statement of the Independent Audit Accounting Firm indicating that it has been unable to complete an audit under Section 1.7(d)(ii) due to Purchaser’s failure to reasonably cooperate with any such audit for any ten-business day period (or periods).  The balance of the Escrow Deposit may be reduced to the amount of the unpaid Milestone Payments as future Milestone Payments are made.  The Escrow Deposit shall serve as security for the obligations of Purchaser to make Milestone Payments when due, and shall remain outstanding unless and until all such Milestone Payments have been received by Seller.

    • (f)            Acceleration of Milestone Payments .

      (i)            (A)          A Change of Control of Purchaser (including, without limitation, failure by Purchaser to provide Seller with written notice no less than one (1) business day prior to a Change of Control of Purchaser), (B) the failure of Purchaser to provide the Quarterly Sales Report within fifteen (15) days after written notice from Seller of such failure, (C) the failure of Purchaser to provide any Milestone Notice when due, (D) the failure of Purchaser to make a Milestone Payment required pursuant to clause (A) of the second sentence of Section 1.7(e) or the failure of Purchaser to deposit the Escrow Deposit in accordance with clause (B) of the second sentence of Section 1.7(e) , or (E) the failure of Purchaser to comply with the diligence requirements set forth in Section 1.7(c), shall each be referred to as a " Milestone Acceleration Event ."

      (ii)           Upon the occurrence of a Milestone Acceleration Event under Section 1.7(f)(i)(A) , Section 1.7(f)(i)(B) , Section 1.7(f)(i)(C) or Section 1.7(f)(i)(D) , or a Milestone Acceleration Event that remains uncured for a period of fifteen (15) days with respect to Section 1.7(f)(i)(E) , unless Seller otherwise notifies Purchaser in writing, all of the unpaid Milestone Payments shall immediately become due and payable, and in addition to any other remedies available at law or equity, Seller may pursue all available remedies pursuant to the Parent Guarantee, simultaneously with or in advance of pursuing remedies under this Agreement, provided that Seller may not pursue remedies under the Parent Guarantee for Milestone Payments paid to Seller pursuant to the Escrow Agreement from the Escrow Deposit.  For the avoidance of doubt, (A) in the event any Milestone Payment is paid to Seller from the Escrow Deposit by the Escrow Agent, Seller shall no longer be entitled to seek payment of such Milestone Payment from Purchaser or Guarantor and (B) Seller agrees to use reasonable efforts for ninety (90) days to fund any Milestone Payment which is due from the Escrow Deposit, prior to pursuing remedies under the Parent Guarantee.  Also, if Purchaser has fully funded the Escrow Deposit, any Milestone Payment that is paid to Seller by Purchaser or Guarantor directly, rather than by Escrow Agent from the Escrow Deposit, shall result in a prompt disbursement to Purchaser by the Escrow Agent from the Escrow Deposit in the amount of such Milestone Payment, and Seller agrees to execute any joint written instruction required to effect such disbursement.

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1.8          Inventory Calculations.

(a)           Inventory .  At least three (3) business days prior to the projected Closing Date, Seller shall deliver to Purchaser Schedule 1.8 which shall set forth an estimate of the amount of the value of the Inventory, determined in accordance with GAAP, as consistently applied by Seller (the " Estimated Inventory Value ") as of the Closing Date.  The final calculation of the value of the Inventory as of the Effective Time, determined in accordance with GAAP, as consistently applied by Seller (the " Inventory Value ") shall be determined, and a payment for the difference between the Inventory Value and the Estimated Inventory Value shall be made to Purchaser or Seller, as the case may be, as follows:

    • (i)            No later than twenty-one (21) days following the Closing, Seller shall examine its records to determine the quantities of Inventory existing as of the Effective Time and deliver a statement of Inventory Value to Purchaser (the " Statement of Inventory Value ").

      (ii)           Purchaser may dispute any amounts reflected on the Statement of Inventory Value on the basis that the Inventory Value was not accurate or correctly determined, and Purchaser shall have access to such Product Records, including Retained Information, as are reasonably necessary to support such determination; provided, however , that Purchaser shall have notified Seller in writing of each disputed item, specifying the amount thereof in dispute and setting forth, in reasonable detail, the basis for such dispute, within fifteen (15) days after Seller’s delivery of the Statement of Inventory Value to Purchaser.  In the event of such a dispute, Seller and Purchaser shall attempt to reconcile their differences, and any resolution by them as to any disputed amounts shall be final, binding and conclusive on the Parties.  If Seller and Purchaser are unable to resolve any such dispute within fifteen (15) days after Purchaser’s delivery of its notice of dispute to Seller, Seller and Purchaser shall submit the items remaining in dispute for resolution to a mutually acceptable independent accounting firm of national reputation (the " Independent Accounting Firm "), which shall, within twenty (20) business days after such submission, determine and report to Seller and Purchaser its determination of the payment obligation for such remaining disputed items, and such report shall be final, binding and conclusive on the Parties.  In acting under this Agreement, the Independent Accounting Firm shall be entitled to the privileges and immunities of arbitrators.

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(b)           Purchase Price Adjustment .  The Statement of Inventory Value shall be deemed final for the purposes of this Agreement upon the earlier of (x) the failure of Purchaser to notify Seller of a dispute within fifteen (15) business days after Seller’s delivery of the Statement of Inventory Value to Purchaser or (y) the resolution of all disputes pursuant to this Section 1.8 .  If the difference between the Estimated Inventory Value and the final Statement of Inventory Value (the " Inventory Variance ") exceeds two percent (2%) of the Estimated Inventory Value, then within five (5) business days of the Statement of Inventory Value being deemed final, a payment shall be made as follows:

    • (i)            if the amount of the Inventory Value reflected on the final Statement of Inventory Value is less than the Estimated Inventory Value, then Seller shall pay an amount equal to the Inventory Variance to an account designated by Purchaser by wire transfer in immediately available funds;

      (ii)           if the amount of the Inventory Value reflected on the final Statement of Inventory Value exceeds the Estimated Inventory Value, then Purchaser shall pay an amount equal to the Inventory Variance to an account designated by Seller by wire transfer in immediately available funds; or

      (iii)          if the Inventory Variance is less than two percent (2%) of the Estimated Inventory Value, no payment shall be made on account of the Inventory Variance.

(c)           Fees for Inventory Review .  The fees and disbursements of the Independent Accounting Firm shall be allocated to Purchaser in the same proportion as (x) the aggregate amount of such remaining disputed items so submitted to the Independent Accounting Firm that are unsuccessfully disputed by Purchaser (as finally determined by the Independent Accounting Firm) bears to (y) the total amount of such remaining disputed items so submitted, and the balance shall be paid by Seller.

1.9          Allocation of Purchase Price.   The Purchase Price shall be allocated in detail among the various Acquired Assets in accordance with this Section 1.9.

(a)           Initial Allocation .  Subject to the adjustments described in this Section 1.9 , the Purchase Price shall be allocated among the Acquired Assets as follows:

    • (i)            the Purchase Price minus the Estimated Inventory Value plus any Assumed Liabilities that are required to be treated as part of the purchase price for federal income tax purposes shall be allocated among the Acquired Assets (other than the Inventory) and the goodwill and going concern value of the Product-Related Business as set forth on Schedule 1.9 (the " Allocation Schedule "); and

      (ii)           the Estimated Inventory Value shall be allocated among the Inventory as set forth on the Allocation Schedule.

(b)           Revised Allocation .  Within fifteen (15) days after the determination of the Inventory Value, Seller shall prepare and deliver to Purchaser an amended Allocation Schedule prepared in accordance with Section 1060 of the Code and the regulations thereunder (the " Revised Allocation ") that reflects (i) the Inventory Value, which shall be allocated among the Inventory, and (ii) any adjustments in the allocation of the initial Purchase Price and Assumed Liabilities among the Acquired Assets reasonably necessary to reflect changes in the Acquired Assets between the Agreement Date and the Effective Time.

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(c)           Milestone Allocations .  Within thirty (30) days after the payment of each Milestone Payment, Seller and Purchaser shall agree on an amended Allocation Schedule (a " Milestone Allocation ") that reflects the payment of the Milestone Payment as additional Purchase Price and allocates such additional Purchase Price among the Acquired Assets in a manner consistent with the provisions of Section 1060 of the Code and the Treasury Regulations thereunder.

(d)           Tax Allocation .  In accordance with Section 1060 of the Code and Treasury Regulations thereunder, Purchaser and Seller agree, unless otherwise required pursuant to a "determination" within the meaning of Section 1313(a) of the Code, to be bound by the Revised Allocation and Milestone Allocation, to file all Tax Returns (including Internal Revenue Service (" IRS ") Form 8594 and any supplemental or amended IRS Form 8594) in accordance with the aforementioned allocations, and not to take any position inconsistent with the aforementioned allocations in the course of any audit, examination, other administrative or judicial proceeding; provided, however, that the provisions of this Section 1.9(d) shall apply only with respect to, and to the extent of any Tax Returns filed by Seller or Purchaser with a U.S. federal, state or local Tax authority and shall not prevent either Seller or Purchaser from seeking relief from the competent authorities under any treaties providing for avoidance of double taxation.

1.10        Prorations.

(a)           Prorations .  Subject to Sections 1.2 and 1.3 above, all royalties, contract payments, and other prepaid and deferred items relating to the Acquired Assets and Assumed Liabilities shall be prorated between Purchaser and Seller in accordance with the principle that (i) Seller shall be responsible for expenses relating to the manufacture and sale of the Products during the periods prior to the Effective Time and (ii) Purchaser shall be responsible for expenses relating to the manufacture and sale of units of Product during the periods after the Effective Time.

(b)           Timing of Payment .  Any prorations pursuant to this Section 1.10 will, insofar as feasible, be determined and paid on the Closing Date, and the Parties shall agree on a statement setting forth all such prorations as soon as practicable after the Closing.  Final settlement and payment by the appropriate Party of the net amount of prorations owing to the other Party shall occur no later than thirty (30) days after the actual amount becomes known.

1.11        Risk of Loss.   At the Effective Time, title to the Acquired Assets is hereby transferred to Purchaser and Purchaser shall hereafter bear all risk of loss associated with the Acquired Assets and be solely responsible for procuring adequate insurance to protect the Acquired Assets against any such loss.

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        • 2.                                       REPRESENTATIONS AND WARRANTIES OF SELLER.

Seller represents and warrants to Purchaser as of the date hereof as follows:

2.1          Organization.   Seller is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware.

2.2          Due Authorization.   Seller has the requisite corporate power and authority to execute, deliver and perform its obligations under this Agreement, the Ancillary Agreements, and the Related Instruments.  The execution and delivery of this Agreement, the Ancillary Agreements and the Related Instruments and the performance of all of its obligations hereunder and thereunder have been duly authorized by all requisite corporate action on the part of Seller.  This Agreement has been validly executed and delivered by Seller and, assuming that this Agreement has been duly authorized, executed and delivered by Purchaser, constitutes, and each Related Instrument and Ancillary Agreement that is to be executed and delivered by Seller will constitute when executed and delivered by Seller (assuming that such Related Instrument or Ancillary Agreement has been duly authorized, executed and delivered by the other parties thereto to the extent applicable), a valid and binding obligation of Seller, enforceable against Seller in accordance with its terms, except as may be limited by applicable bankruptcy, insolvency, reorganization or other laws of general application relating to or affecting the enforcement of creditor’s rights generally.

2.3          No Conflicts; Consents.

(a)           No Conflicts .  Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, the execution, delivery and performance of this Agreement, the Related Instruments or the Ancillary Agreements by Seller (i) are not prohibited or limited by, and will not result in the breach of or a default under, any provision of the Certificate of Incorporation or Bylaws of Seller, (ii) assuming all of the consents, approvals, authorizations and permits described in Section 2.3(b) have been obtained, all the filings and notifications described in Section 2.3(b) have been made and any waiting periods thereunder have terminated or expired, do not conflict with any Law applicable to Seller, and (iii) except as set forth on Schedule 2.3(a) , do not conflict with, result in a breach of, constitute a default under, result in the acceleration of obligations under, create in any party the right to terminate, modify or cancel, or require any notice, consent or waiver under, any material agreement or instrument binding on Seller or any applicable order, writ, injunction or decree of any court or Governmental Entity to which Seller is a party or by which Seller is bound or to which any of the Acquired Assets is subject.

(b)           Consents and Approvals .  Except for the requisite filings under the HSR Act and the expiration or termination of the waiting period thereunder, similar filings and approvals under foreign competition laws, and all of the filings and other actions listed on Schedule 2.3(b) (including the letter to the FDA contemplated by Section 5.7 and as may be necessary as a result of any facts or circumstances relating to Purchaser), no notice to, filing with, authorization of, exemption by, or consent of, any Person, including any Governmental Entity, is required for Seller to consummate the Acquisition, except where the failure to make such filings or notifications, or obtain such consents, approvals, authorizations or permits, would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

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2.4          Title to Assets.   Except as set forth on Schedule 2.4 , and except for the Product Intellectual Property (which is addressed in Section 2.5 ) and any limitations or conditions imposed by the Assigned Contracts or as provided in the Assigned Contracts, Seller has good and valid title to all the Acquired Assets, except in the case of the Acquired Assets that have been sold or otherwise disposed of in the Ordinary Course Of Business consistent with past practices and not in violation of this Agreement, in each case free and clear of all Liens and Encumbrances, other than Permitted Liens and any limitations or conditions imposed by the Assigned Contracts.  Except as set forth on Schedule 2.4 and except for human resources (including sales force, product representatives, quality assurance/quality control and/or supply chain personnel) used in lot release, stability, raw material sourcing and management, work-in-progress and finished Product logistics, sales and marketing of the Product, to the Knowledge of Seller, the Acquired Assets, along with the activities described in the Transition Services Agreement, constituted all of the assets and rights reasonably necessary for Seller to conduct the Product-Related Business before the Effective Time in accordance with recent past practice.

2.5          Intellectual Property.   Except as set forth on Schedule 2.5 or as provided in the Assigned Contracts:

(a)           Seller owns and possesses all right, title and interest in, to and under the Product Intellectual Property used in the sale and marketing of the Product and has the right to assign such Product Intellectual Property free and clear of any liens, encumbrances or other restrictions;

(b)           no claim by any third party contesting the validity, enforceability, use, possession or ownership of the Product Intellectual Property has been made and is currently outstanding against Seller, nor to the Knowledge of Seller, is any threatened;

(c)           Seller has not given notice to any third parties, asserting infringement by such third party of the Product Intellectual Property;

(d)           to the Knowledge of Seller, the manufacture, sale and/or marketing of the Product by Seller does not infringe, misappropriate or otherwise conflict with any rights of any third parties; and

(e)           except as would not individually or in the aggregate reasonably be expected to have a Material Adverse Effect, (i) Seller has not granted any licenses to the Product Intellectual Property to third parties; (ii) neither Seller nor to Seller’s Knowledge, any other Person, is party to any agreements with third parties that limit or restrict use of the Product Intellectual Property or require any payments for its use; and (iii) no other Person has any joint ownership or royalty interest in the Product Intellectual Property.

2.6           Contracts .  Except as set forth in Schedule 2.6 , all Assigned Contracts are in full force and effect and capable of assignment without any additional consents or approvals.  Seller has performed in all material respects all obligations required to be performed by it to date under the Assigned Contracts, and it is not (with or without the lapse of time or the giving of notice, or both) in breach or default in any respect thereunder and, to the Knowledge of Seller, (i) no other party to any Assigned Contract is (with or without the lapse of time or the giving of notice, or both) in material breach or default in any respect thereunder, and (ii) there is no outstanding material claim, demand, disagreement or other dispute asserted with respect to any Assigned Contract.

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2.7          Compliance with Laws.

(a)           Except as set forth on Schedule 2.7(a), (i) all Governmental Authorizations principally employed in, or necessary to the ongoing conduct of, the distribution of the Product as currently conducted by Seller or its Affiliates are in full force and effect, (ii) no Governmental Entity has served notice that Seller in connection with the Acquired Assets was or is in material violation of any law, statute, ordinance, rule, regulation or order in any jurisdiction, and (iii) Seller in connection with the Acquired Assets has not received written notice from any Governmental Entity that there are any circumstances currently existing that would reasonably be expected to lead to any loss of any Governmental Authorizations on terms less advantageous to Seller than the terms of those Governmental Authorizations currently in force.  Neither Seller nor any current or former member of Seller’s senior management has been cited by a Governmental Entity for violation of such Governmental Entity’s integrity policy, submission of false or misleading data or information, or been identified as a "Debarred Individual" or debarred by a Governmental Entity.

    • (b)           (i)            Seller has filed with the FDA all required notices, supplemental applications and annual or other reports, including adverse experience reports, with respect to each BLA that are material to the conduct of the marketing, distribution and sale of the Product as currently conducted by Seller.

      (ii)           Except as set forth on Schedule 2.7(b)(ii) , Seller has not received any notice that any Governmental Entity (including the FDA) has commenced, or, to the Knowledge of Seller, threatened to initiate any action to withdraw its approval or request the recall of any Product, or commenced or threatened to initiate any action to enjoin production of the Product at any facility.

      (iii)          Seller has made available to Purchaser copies of all material (A) reports of inspection observations and (B) establishment inspection reports.

      (iv)          Seller has not received any warning or untitled letters or other documents from the FDA relating to the Product that assert ongoing material lack of compliance with any material applicable laws or regulatory requirements (including those of the FDA) by Seller.

      (v)           At all times since January 1, 2001, Seller has fully complied with all Laws with respect to the ownership, operation and use of the Acquired Assets, conduct of the Product-Related Business and the sale of the Product, except for any non-compliance as would not reasonably be expected to have a Material Adverse Effect.

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2.8          Litigation.

(a)           Except as set forth on Schedule 2.8 , and other than an investigation by a Governmental Entity (" Governmental Investigation "), there is no claim, action, or proceeding, including product liability claims (collectively, a " Proceeding "), pending or, to Seller’s Knowledge, threatened against Seller in respect of the Acquired Assets (including the Product) or the transactions contemplated by this Agreement, the Ancillary Agreements and each Related Instrument.  To Seller’s Knowledge, there is no Governmental Investigation pending or threatened.

(b)           There are no outstanding orders, injunctions or decrees of any Governmental Entity (other than the Governmental Authorizations) that apply to the Acquired Assets (or will apply to Purchaser after the Effective Time) that restrict the ownership, disposition or use of the Acquired Assets in any material respect.

2.9          Brokers or Finders.   No broker, investment banker, agent, finder or other intermediary acting on behalf of Seller or under the authority of Seller, except for UBS Securities LLC, is or will be entitled to any broker’s or finder’s fee or any other commission or similar fee directly or indirectly in connection with any of the Acquisition.

2.10        Inventory.   All finished Product that is included in the Inventory (i) is saleable in the ordinary course of business, (ii) to Seller’s Knowledge, has been produced or manufactured in accordance with the Product specifications and (iii) is free and clear of Liens and Encumbrances, other than Permitted Liens and any limitations or conditions imposed by the Assigned Contracts.

2.11        Financial Statements.   Each of the consolidated financial statements (including, in each case, any notes thereto) contained in Seller’s filings with the Securities and Exchange Commission, as amended, supplemented or restated, if applicable, was prepared in accordance with GAAP applied (except as may be indicated in such filings and, in the case of unaudited quarterly financial statements, as permitted by Form 10-Q under the Securities Exchange Act of 1934, as amended) on a consistent basis during the periods indicated (except as may be indicated in such filings), and each, as amended, supplemented or restated, if applicable, presented fairly, in all material respects, the consolidated financial position of Seller as of the respective dates thereof and the consolidated results of operations and cash flows of Seller for the respective periods indicated therein (subject, in the case of unaudited statements, to normal adjustments which, individually or in the aggregate, are not reasonably expected to have a Material Adverse Effect).

2.12        Financial Records.   All financial and sales records created less than three (3) years prior to the date of this Agreement are complete and, to Seller’s Knowledge, correct with respect to all information set forth therein and all time periods covered thereby, except for any incompleteness or inaccuracy as would not reasonably be expected to have a Material Adverse Effect.  For purposes of this Section 2.12, financial and sales records are those Product Records that contain information or data relating to Product revenue or Product cost of goods sold.   Except for any non-conformity as would not reasonably be expected to have a Material Adverse Effect, all financial and sales records created less than three (3) years prior to the date of this Agreement have been prepared and maintained, where applicable, in conformity with GAAP and in compliance with all applicable laws, regulations and other requirements.

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2.13        No Other Representations or Warranties.   Except for the representations and warranties contained in this Section 2 (including the Schedules), the Related Instruments, and the Ancillary Agreements, none of Seller, its Affiliates or any other Person makes any other express or implied representation or warranty on behalf of Seller or any of its Affiliates and Seller specifically disclaims any such warranty, including any such representation or warranty regarding:

(a)           The business prospects of the Product.

(b)           That any patents that claim, cover or relate to the Product are being assigned, transferred, licensed or sublicensed to Purchaser under this Agreement except the Product Patent Rights.

(c)           The manufacturing process, or the efficacy, efficiency or adequacy of the Acquired Assets for the purpose of manufacturing, marketing or selling the Product either before or after the Effective Time.

(d)           The efficacy or safety for human use of the Product, whether in the formulation heretofore manufactured and sold under the name "CYTOGAM" or in the form of any other formulation or variation or other derivative.

(e)           The legal and regulatory requirements that must be satisfied by Purchaser before Purchaser will be able lawfully to manufacture, market and sell the Product.

(f)            That any medical information provided by Seller or its Affiliates to Purchaser concerning the use of the Product is in accordance with sound medical practice or may be relied on by Purchaser or any other Person for any purpose.

(g)           That the Marketing Materials are current or in accordance with the Product labeling or can be used for any purpose other than historical reference.

        • 3.                                       REPRESENTATIONS AND WARRANTIES OF PURCHASER.

Purchaser represents and warrants to Seller as of the date hereof as follows:

3.1          Organization.   Purchaser is a Swiss corporation duly organized, validly existing and in good standing under the laws of Switzerland, and is an indirect wholly owned subsidiary of CSL Limited, an Australian Capital Territory corporation.  Purchaser has all requisite corporate power and authority to own, lease and operate its properties and to conduct its business as now being conducted.

3.2          Authority; Execution and Delivery; Enforceability.   Purchaser has the requisite power and authority to execute, deliver and perform its obligations under this Agreement, the Related Instruments and the Ancillary Agreements.  The execution and delivery of this Agreement, the Related Instruments and the Ancillary Agreements and the performance by Purchaser of its obligations hereunder and thereunder have been duly authorized by all requisite corporate action on the part of Purchaser.  This Agreement has been validly executed and delivered by Purchaser and, assuming that this Agreement has been duly authorized, executed and delivered by Seller, constitutes, and each Related Instrument and Ancillary Agreement that is to be executed and delivered by Purchaser will constitute when executed and delivered by Purchaser (assuming that such Related Instrument or Ancillary Agreement has been duly authorized, executed and delivered by the other parties thereto to the extent applicable), a valid and binding obligation of Purchaser, enforceable against Purchaser in accordance with its terms, except as may be limited by applicable bankruptcy, insolvency, reorganization or other laws of general application relating to or affecting the enforcement of creditor’s rights generally.

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3.3          No Conflicts; Consents.

(a)           No Conflicts .  The execution, delivery and performance of this Agreement, the Ancillary Agreements and the Related Instruments by Purchaser (i) are not prohibited or limited by, and will not result in the breach of or a default under, any provision of the Certificate of Incorporation or Bylaws of Purchaser, (ii) assuming all of the consents, approvals, authorizations and permits described in Section 2.3(b) have been obtained and all the filings and notifications described in Section 2.3(b) have been made and any waiting periods thereunder have terminated or expired, do not conflict with any Law applicable to Purchaser, and (iii) do not conflict with, result in a breach of, constitute a default under, result in the acceleration of obligations under, create in any party the right to terminate, modify or cancel, or require any notice, consent or waiver under, any material agreement or instrument binding on Purchaser or any applicable order, writ, injunction or decree of any court or Governmental Entity to which Purchaser is a party or by which Purchaser is bound, except in the case of clauses (ii) or (iii) for violations, breaches or defaults that would not have a material adverse effect on Purchaser’s ability to consummate the Acquisition or materially delay the consummation of the Acquisition.

(b)           Consents and Approvals .  Except for the requisite filings under the HSR Act and the expiration or termination of the waiting period thereunder, similar filings and approvals under foreign competition laws, and all of the filings and other actions contemplated set forth on Schedule 2.3 (including the letter to the FDA contemplated by Section 5.7 and as may be necessary as a result of any facts or circumstances relating to Seller), no notice to, filing with, authorization of, exemption by, or consent of, any Person, including any Governmental Entity, is required for Purchaser to consummate the Acquisition, provided, however, that the Parties have agreed that the Governmental Authorizations are not necessary for the consummation by Purchaser of the Acquisition, except where the failure to make such filings or notifications, or obtain such consents, approvals, authorizations or permits, would not, individually or in the aggregate, reasonably be expected to have a material adverse effect on Purchaser’s ability to consummate the Acquisition.

3.4          Brokers and Finders.   Neither Purchaser nor its Affiliates has retained any agent, broker, investment banker, financial advisor or other firm or Person, other than Merrill Lynch, that is or will be entitled to any brokers’ or finder’s fee or any other commission or similar fee in connection with any of the transactions contemplated by this Agreement, and there are no claims for any of the foregoing.

3.5          Litigation.   There is no Proceeding, pending or, to the Knowledge of Purchaser, threatened against Purchaser that would affect Purchaser’s ability to consummate the transactions contemplated by this Agreement and each Related Instrument.

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3.6          Financial Condition.   Purchaser has sufficient immediately available funds to pay in cash at the Closing the Closing Payment and all other amounts payable pursuant to this Agreement, the Ancillary Agreements or the Related Instruments at Closing or otherwise necessary to consummate the Acquisition.  Purchaser is not subject to or bound by any Agreement that would restrict or prevent the payment of any amounts payable under this Agreement (including the Milestone Payments).  Upon the consummation of the Acquisition, (a) Purchaser will not be insolvent, (b) Purchaser will not be left with insufficient capital for the conduct of its business and the Product-Related Business, (c) Purchaser will not have incurred debts beyond its ability to pay such debts as they mature and (d) the capital of Purchaser will not be impaired.

3.7          Limitations on Acquired Assets.

(a)           Purchaser acknowledges and agrees that the Acquired Assets are being acquired subject to any limitations, restrictions or conditions imposed by the Assigned Contracts, including any licenses therein, and as described herein (including the Schedules hereto).

(b)           Purchaser has conducted its own thorough due diligence review and analysis, as Purchaser determines necessary and appropriate, of the Acquired Assets and of the business prospects of the Product.  Purchaser is not relying on any forecasts, marketing data, projections, estimates, offering brochures or materials, conversations with employees, management, or consultants, agents or brokers of Seller, market assessments, representations or warranties or other materials whether oral or written from Seller or Seller’s agents, brokers or consultants as to the business prospects or potential of the Product or any other representations or warranties, express or implied, except as expressly set forth herein.

(c)           Purchaser acknowledges and agrees that (i) Seller does not manufacture the Product, and (ii) Seller does not guarantee or warrant that (A) any supplier of the Product or any component of the Product shall continue to supply such items or (B) that any such third party shall supply or continue to supply such items on the pricing or other terms currently available to Seller.

(d)           Purchaser further acknowledges that Seller does not manufacture, package or test the Product and is dependent upon third parties for manufacturing, packaging and testing of such Products.  Purchaser acknowledges and agrees that Seller does not guarantee or warrant that any such third party will continue to manufacture, package, test or supply such Products.  Purchaser further acknowledges and agrees that Seller makes no representations or warranties with respect to the manufacturing practices or manufacturing facilities of such third parties.

(e)           Purchaser is acquiring the Products pursuant to this Agreement subject to the foregoing acknowledgements and limitations.

3.8          Governmental Authorizations.   Purchaser is fully qualified and meets all applicable requirements of Governmental Entities to accept the transfer of the Governmental Authorizations as contemplated herein.  Neither Purchaser nor any current or former member of Purchaser’s senior management has been cited by a Governmental Entity for violation of such Governmental Entity’s integrity policy, submission of false or misleading data or information or identified as a "Debarred Individual" or debarred by a Governmental Entity.  Purchaser has no reason to believe that any Governmental Entity will withhold consent to the transfer of the Governmental Authorizations as contemplated hereunder.

 

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3.9           Financial Statements.   Purchaser has provided Seller with true and complete copies of its audited balance sheet as of the last day of its most recently completed fiscal year, and the related statements of earnings and cash flows (collectively, the " Financial Statements "), copies of which are attached hereto as Schedule 3.9(a) .  Purchaser has provided Seller with true and correct copies of its balance sheet as of its fiscal quarter ended September 30, 2006, and related statements of earnings and cash flows (collectively, the " Interim Financial Statements "), copies of which are attached hereto as Schedule 3.9(b) .  Except as set forth in Schedule 3.9(c) , the Financial Statements and the Interim Financial Statements have been prepared in accordance with Australian generally accepted accounting principles, applied on a basis consistent with prior periods, and fairly presents in all material respects the financial condition of the Purchaser as of the represented dates thereof, the results of its operations and its cash flows for the period covered thereby, except that with respect to the Interim Financial Statements for certain year-end adjustments and financial statement footnotes which have been omitted.

3.10        No Other Purchaser Representations or Warranties.   Except for the representations and warranties contained in this Section 3 , the Ancillary Agreements and the Related Instruments neither Purchaser nor any other Person makes any other express or implied representation or warranty on behalf of Purchaser.

        • 4.                                       COVENANTS PRIOR TO CLOSING.

4.1          Access to Information.   Between the Agreement Date and the Closing Date, Seller shall, subject to any applicable Law, the Confidentiality Agreement and the terms of any contract by which Seller is bound (i) afford Purchaser and its Representatives access, during regular business hours and upon reasonable agreed-upon times, to Seller’s personnel, properties and records pertaining in material part to the Product or Product-Related Business, Assigned Contracts, Governmental Authorizations, the Product Records and all other information and materials pertaining in material part to the Product-Related Business, provided that such access shall not unreasonably interfere with Seller’s business and operations.

4.2          Operation of Product-Related Business Prior to the Closing.

(a)           Affirmative Covenants Pending Closing .  Seller shall, through the earlier of the Effective Time or the Termination Date, use its commercially reasonable efforts to conduct the Product-Related Business in the Ordinary Course of Business, and on a basis consistent with past practice, (i) preserve the Acquired Assets and the Product-Related Business, including preserving Seller’s present relationships with suppliers, consultants, customers and any other third parties having business relations with Seller that relate to the Product and Acquired Assets, (ii) advertise, promote, and market the Product, (iii) perform and comply in all material respects with the Assigned Contracts, and (iv) maintain, and comply in all material respects with, all Governmental Authorizations and any applicable law.

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(b)           Negative Covenants Pending Closing .  Except (i) as contemplated by this Agreement or (ii) as reasonably required or advisable to carry out its obligations under this Agreement, Seller shall, through the earlier of the Effective Time or the Termination Date, conduct the Product-Related Business only in the Ordinary Course of Business and, in addition, Company shall not, without Purchaser’s written consent:

    • (i)            enter into any material written agreement with respect to the manufacture, use, or sale of the Product (other than sales of the Product in the Ordinary Course of Business);

      (ii)           place, or allow to be placed, any material Encumbrance on any of the Acquired Assets, other than Permitted Encumbrances; or

      (iii)          sell, assign, license or transfer any material Acquired Asset other than sales of Product from Inventory in the Ordinary Course of Business.

(c)           Material Adverse Change .  Seller shall notify Purchaser promptly of the occurrence of any event that would reasonably be expected to have a Material Adverse Effect of which it has Knowledge including, without limitation, information and copies of all pertinent documents concerning all Proceedings instituted, threatened or asserted against or affecting the Product or any material Acquired Asset at law or in equity, before or by any court or governmental authority and which may relate to any such Claim.

(d)           Records and Reports .  Seller shall keep customary records relating to the manufacture and sale of the Product in accordance with generally accepted accounting principles applied on a basis consistent with prior periods, and shall supply to Purchaser monthly reports relating to the Product-Related Business, as soon as practicable (and no later than thirty (30) calendar days) after the end of each month, and such other documents (financial or otherwise) as Purchaser shall reasonably request.

(e)           Consultation Regarding Significant Developments .  Seller shall inform and consult with Purchaser regarding any significant developments or transactions proposed to be entered into relating to the Product prior to the earlier of the Effective Time or the Termination Date.

(f)            No Control of Seller’s Business .  Purchaser acknowledges and agrees that:  (i) nothing in this Agreement shall give Purchaser, directly or indirectly, the right to control or direct Seller’s operation of the Product-Related Business prior to the Effective Time, (ii) prior to the Effective Time, each of Seller and Purchaser shall exercise, consistent with the terms and conditions of this Agreement, complete control and supervision over its and its subsidiaries’ respective operations, and (iii) notwithstanding anything to the contrary set forth in this Agreement, no consent of Purchaser shall be required with respect to any matter set forth in this Section 4.2 or elsewhere in this Agreement to the extent the requirement of such consent would, upon advice of counsel, violate applicable antitrust Law.

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4.3          Consents and Approvals.   As soon as reasonably practicable after the Agreement Date, the Parties shall make all filings required to be made in order to consummate the transactions contemplated hereby, including all filings under the HSR Act in accordance with Section 4.4 .  Seller shall use its commercially reasonable efforts to obtain all third party consents required for assignment of the Assigned Contracts.

4.4          HSR Act.

(a)           If required pursuant to applicable Law, each Party shall file as soon as practicable, and in any event no later than fifteen (15) business days after the Agreement Date a Notification and Report Form under the HSR Act with the United States Federal Trade Commission and the Antitrust Division of the United States Department of Just


 
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