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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
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Page
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1.
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SALE AND PURCHASE OF ASSETS.
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1
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1.1
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Purchase and Sale.
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1
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1.2
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Transfer of Assets.
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1
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1.3
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Assumed and Excluded Liabilities.
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3
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1.4
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Closing.
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6
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1.5
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Purchase Deposit.
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6
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1.6
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Purchase Price.
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6
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1.7
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Milestone Payments.
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7
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1.8
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Inventory Calculations.
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10
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1.9
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Allocation of Purchase Price.
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11
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1.10
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Prorations.
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12
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1.11
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Risk of Loss.
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12
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2.
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REPRESENTATIONS AND WARRANTIES OF
SELLER.
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13
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2.1
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Organization.
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13
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2.2
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Due Authorization.
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13
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2.3
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No Conflicts; Consents.
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13
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2.4
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Title to Assets.
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14
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2.5
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Intellectual Property.
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14
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2.6
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Contracts.
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14
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2.7
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Compliance with Laws.
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15
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2.8
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Litigation.
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15
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2.9
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Brokers or Finders.
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16
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2.10
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Inventory.
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16
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2.11
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Financial Statements.
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16
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2.12
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Financial Records.
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16
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2.13
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No Other Representations or
Warranties.
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17
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3.
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REPRESENTATIONS AND WARRANTIES OF
PURCHASER.
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17
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3.1
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Organization.
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17
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3.2
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Authority; Execution and Delivery;
Enforceability.
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17
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3.3
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No Conflicts; Consents.
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18
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3.4
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Brokers and Finders.
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18
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3.5
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Litigation.
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18
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3.6
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Financial Condition.
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19
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3.7
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Limitations on Acquired Assets.
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19
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3.8
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Governmental Authorizations.
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19
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3.9
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Financial Statements.
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20
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3.10
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No Other Purchaser Representations or
Warranties.
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20
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4.
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COVENANTS PRIOR TO CLOSING.
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20
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4.1
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Access to Information.
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20
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4.2
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Operation of Product-Related Business Prior to
the Closing.
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20
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4.3
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Consents and Approvals.
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22
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4.4
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HSR Act.
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22
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4.5
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Other Pre-Closing Covenants.
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23
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5.
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ADDITIONAL COVENANTS.
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24
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5.1
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Confidentiality; Publicity.
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24
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5.2
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Availability of Records.
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25
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5.3
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Revision of Marketing Materials; Use of
Names.
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25
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5.4
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Customer Notifications.
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26
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5.5
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Product Returns, Rebates, Chargebacks and NDC
Number.
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26
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5.6
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Accounts Receivable.
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28
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5.7
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Regulatory Approvals.
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29
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5.8
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Tax Matters.
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31
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5.9
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Government Multi-Product Contracts.
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31
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5.10
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Inventory.
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31
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5.11
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Further Assurances.
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31
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5.12
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Post-Effective Time Cooperation.
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32
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5.13
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No Active Solicitation of Returns.
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32
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5.14
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Insurance.
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32
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5.15
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Non-Competition.
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33
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6.
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CONDITIONS PRECEDENT TO OBLIGATIONS OF
SELLER.
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33
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6.1
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Representations and Warranties.
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33
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6.2
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Performance.
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33
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6.3
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Legal Proceedings.
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34
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6.4
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Consents.
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34
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6.5
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Purchase Price.
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34
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6.6
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Purchaser’s Certificates.
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34
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6.7
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Assumption Agreement.
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34
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6.8
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Ancillary Agreements.
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34
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6.9
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Governmental Authorizations.
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34
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6.10
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Purchaser Financial Information.
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34
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6.11
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Parent Guaranty.
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34
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7.
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CONDITIONS PRECEDENT TO OBLIGATIONS OF
PURCHASER.
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34
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7.1
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Representations and Warranties.
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34
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7.2
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Performance.
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35
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7.3
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Legal Proceedings.
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35
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7.4
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Consents.
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35
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7.5
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Seller’s Certificates.
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35
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7.6
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Related Instruments.
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35
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7.7
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Ancillary Agreements.
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35
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7.8
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Governmental Authorizations.
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35
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7.9
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Baxter/PPS Matters.
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35
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7.10
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Product Removal Notice.
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35
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8.
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SURVIVAL; INDEMNIFICATION.
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36
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8.1
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Survival of Representations.
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36
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8.2
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Indemnification by Seller.
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36
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8.3
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Indemnification by Purchaser.
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37
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8.4
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Calculation of Losses.
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38
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8.5
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Termination of Indemnification.
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38
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8.6
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Procedures.
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38
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8.7
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Sole Remedy; No Additional
Representations.
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40
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8.8
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Limitations on Liability.
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41
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9.
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TERMINATION.
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41
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9.1
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Termination.
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41
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9.2
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Effect of Termination.
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42
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10.
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MISCELLANEOUS.
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42
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10.1
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Amendment and Waivers.
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42
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10.2
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Notices.
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42
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10.3
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Definitions; Interpretation.
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43
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10.4
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Descriptive Headings.
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44
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10.5
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Counterparts.
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44
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10.6
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Entire Agreement.
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44
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10.7
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Fees And Expenses.
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44
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10.8
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Governing Law.
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44
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10.9
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Specific Performance.
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44
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10.10
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Assignment.
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44
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10.11
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Successors and Assigns.
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44
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10.12
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Severability.
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45
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10.13
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Consent to Jurisdiction.
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45
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10.14
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Waiver of Jury Trial.
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45
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LIST OF EXHIBITS, SCHEDULES AND
ANNEXES
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Annex
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Description
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A
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Definitions
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Exhibits
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Description
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A
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Assumption Agreement
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B
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Reserved
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C
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Trademark Assignment Agreement
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D-1, D-2, D-3
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Initial Press Releases
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E
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Transition Services Agreement
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F
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Escrow Agreement
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G
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Parent Guaranty
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H
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Bill of Sale
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Schedules
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Description
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1.2(a)
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Acquired Assets
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1.2(a)(i)
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Product Intellectual Property
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1.2(a)(ii)
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Governmental Authorizations
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1.2(a)(iii)
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Product Documentation and Product
Records
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1.2(a)(iv)
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Marketing Material
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1.2(a)(v)
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Assigned Contracts
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1.2(a)(vi)
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Customer Lists
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1.2(a)(vii)
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Manufacturing Equipment
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1.2(a)(viii)
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Database Software
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1.2(b)
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Excluded Assets
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1.3(a)
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Assumed Liabilities
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1.8
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Estimated Inventory Value
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1.9
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Allocation Schedule
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2.3(a)
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No Conflicts
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2.3(b)
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Consents, Approvals and Filings
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2.4
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Title to Assets Exceptions
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2.5
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Intellectual Property Exceptions
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2.6
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Assigned Contracts Exceptions
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2.7(a)
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Compliance with Law Exceptions
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2.7(b)(ii)
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Notices from Governmental Entities
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2.8
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Litigation Exceptions
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3.9(a)
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Financial Statements
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3.9(b)
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Interim Financial Statements
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3.9(c)
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Financial Statements Exceptions
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5.5(b)(iii)
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Best Price
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5.9
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Pricing: Government Multi-Product
Contracts
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6.4
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Required Consents
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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:
1.1
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:
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(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:
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(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.
2
(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 "):
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(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
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(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.
7
(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.
8
(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.
9
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.
10
(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.
11
(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.
12
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.
13
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.
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(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.
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.
4.1 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:
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(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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