Exhibit 2.1
EXECUTION COPY
by and between
VICTORY PHARMA, INC.
and
XXXXXXXXXXX PHARMACEUTICALS, INC.
Dated as of May 14, 2010
TABLE OF CONTENTS
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ARTICLE 1 PURCHASE AND SALE |
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1 |
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1.1
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Transfer of Purchased Assets
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1 |
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1.2
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Excluded Assets
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1 |
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1.3
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Assumed Liabilities
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2 |
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1.4
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Excluded Liabilities
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3 |
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1.5
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Purchase Price
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1.6
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Purchase Price Allocation
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4 |
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1.7
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Deposit
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4 |
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1.8
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Escrow
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5 |
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1.9
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Adjustment Amount
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5 |
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1.10
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Risk of Loss
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5 |
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ARTICLE 2 CLOSING |
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6 |
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2.1
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Closing
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6 |
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2.2
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Transactions at Closing
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6 |
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ARTICLE 3 REPRESENTATIONS AND WARRANTIES OF THE SELLER |
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7 |
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3.1
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Existence and Power
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7 |
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3.2
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Authorization
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7 |
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3.3
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Enforceability
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3.4
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Governmental and Third-Party Notices and Consents
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8 |
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3.5
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Noncontravention
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8 |
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3.6
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Title; Assets
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8 |
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3.7
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Inventory
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8 |
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3.8
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Intellectual Property
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8 |
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3.9
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No Undisclosed Liabilities
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9 |
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3.10
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Material Contracts
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9 |
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3.11
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Suits
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9 |
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3.12
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Compliance with Laws; Authorizations
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10 |
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3.13
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Insurance
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10 |
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3.14
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Product Liability
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10 |
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3.15
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Taxes
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10 |
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3.16
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Regulatory Matters
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11 |
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3.17
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Government Product Contracts; Liability for Cost and Pricing Data
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11 |
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3.18
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Warranties
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11 |
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3.19
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Customers, Suppliers and Third Party Service Providers
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11 |
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3.20
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Recalls
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12 |
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3.21
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Product Treatments; Product Returns; Exporting and Manufacturing
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12 |
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ARTICLE 4 REPRESENTATIONS AND WARRANTIES OF THE PURCHASER |
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12 |
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4.1
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Existence and Power
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12 |
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4.2
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Authorization
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12 |
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4.3
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Enforceability
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4.4
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Financing
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13 |
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ARTICLE 5 COVENANTS PRIOR TO CLOSING |
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13 |
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5.1
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Bankruptcy Court Order
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13 |
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5.2
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Cure of Defaults; Assumption of Contracts
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13 |
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-II-
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5.3
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Access to Information; Reporting; Correspondence and Notices
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13 |
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5.4
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Conduct of the Businesses
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14 |
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5.5
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Required Filings
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5.6
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No Restriction
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5.7
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Notifications
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16 |
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5.8
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Keflex Validation; Sandoz
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16 |
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5.9
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Sales; Wholesaler Inventory
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16 |
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5.10
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Cardinal Co-Pay Vouchers
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16 |
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5.11
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Product Returns
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17 |
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5.12
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Wholesaler Payments
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17 |
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5.13
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Lilly Agreement
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17 |
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5.14
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Adequate Assurances
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17 |
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5.15
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Efforts to Cause the Closing
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17 |
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ARTICLE 6 CONDITIONS TO CLOSING |
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18 |
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6.1
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Conditions to Obligations of the Parties
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18 |
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6.2
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Conditions to the Purchaser’s Obligations
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18 |
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6.3
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Conditions to the Seller’s Obligations
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19 |
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ARTICLE 7 ADDITIONAL COVENANTS |
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7.1
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Confidentiality; Publicity
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7.2
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Availability of Records
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21 |
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7.3
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Notification of Customers
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21 |
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7.4
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Transfer of NDAs
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21 |
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7.5
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Product Returns, Rebates, Chargebacks and Vouchers
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22 |
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7.6
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Accounts Receivable
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7.7
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Regulatory Matters
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23 |
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7.8
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Website Information
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7.9
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Tax Matters
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23 |
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7.10
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Government Product Contracts
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24 |
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7.11
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Non-Disparagement
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7.12
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No Challenge
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7.13
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Non-Assertion
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7.14
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Excluded Inventory
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25 |
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7.15
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Further Assurances
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25 |
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ARTICLE 8 TERMINATION AND SURVIVAL |
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25 |
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8.1
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Termination
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25 |
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8.2
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Automatic Termination
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26 |
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8.3
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Effect of Termination
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26 |
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8.4
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Remedies
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26 |
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8.5
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Procedure for Termination
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27 |
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ARTICLE 9 MISCELLANEOUS |
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27 |
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9.1
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Notices
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27 |
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9.2
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Amendments and Waivers
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28 |
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9.3
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Expenses
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28 |
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9.4
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Successors and Assigns
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28 |
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9.5
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Governing Law
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28 |
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9.6
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Consent to Jurisdiction and Venue
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29 |
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9.7
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Counterparts
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29 |
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9.8
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No Third-Party Beneficiaries
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29 |
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9.9
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Entire Agreement; Schedules
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29 |
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-III-
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Page |
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9.10
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Captions
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29 |
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9.11
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Severability
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29 |
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9.12
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Interpretation
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29 |
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9.13
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Time of the Essence
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29 |
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9.14
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Signed Writings
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29 |
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9.15
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Business Days
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29 |
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9.16
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Disclaimer
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30 |
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9.17
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Construction
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30 |
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-IV-
LIST OF EXHIBITS
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Exhibit A
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— |
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Definitions |
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Exhibit B
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Depositary Agreement |
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Exhibit C
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Form of Escrow Agreement |
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Exhibit D
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—
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Form of Officer’s Certificate (Closing Conditions) |
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Exhibit E
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—
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Form of FIRPTA Certificate |
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Exhibit F
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—
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Form of Approval Order |
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Exhibit G
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—
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Forms of Patent Assignment, Trademark Assignment,
Copyright Assignment and Domain Name Assignment |
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Exhibit H
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—
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Form of Xxxx of Sale and Assignment and Assumption
Agreement |
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Exhibit I
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—
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Bid Procedures |
-V-
OTHER DISCLOSURE SCHEDULES
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Schedule A.1(a)
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—
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Acquired Inventory |
Schedule A.1(b)
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—
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Applicable Permits |
Schedule A.1(c)
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—
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Acquired Fixtures |
Schedule A.1(d)
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—
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Excluded Contracts |
Schedule A.1(e)
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—
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Knowledge |
Schedule A.1(f)
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—
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Assumed Contracts |
Schedule A.1(g)
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—
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Product Domain Names |
Schedule A.1(h)
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—
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Keflex Product Marks |
Schedule A.1(i)
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—
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Moxatag Product Marks |
Schedule A.1(j)
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—
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Product Patent Rights |
Schedule A.1(k)
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—
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Product Trade Dress |
Schedule A.1(l)
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—
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Promotional Materials |
Schedule A.1(m)
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—
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Purchased Assets |
Schedule A.1(n)
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—
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Regulatory Filings and Approvals |
Schedule 1.2(h)
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—
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Prepaid Items and Deposits |
Schedule 1.2(l)
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—
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Excluded Assets |
Schedule 1.3(h)
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—
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Purchaser Cure Amounts |
Schedule 1.3(i)
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—
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Assumed Liabilities |
Schedule 1.4(o)
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—
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Excluded Liabilities |
Schedule 5.3(c)(i)(A)
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—
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Identified Persons |
Schedule 7.5(a)(ii)
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—
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Best Price; AMP |
SELLER DISCLOSURE SCHEDULES
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Schedule 3.4
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—
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Government and Third Party Notices and
Consents |
Schedule 3.5
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—
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Noncontravention |
Schedule 3.6(a)
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—
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Title |
Schedule 3.6(b)
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—
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Assets |
Schedule 3.7
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—
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Inventory |
Schedule 3.8(a)(i)
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—
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Patents |
Schedule 3.8(a)(ii)
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—
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Copyrights, Marks, Trade Dress and Domain
Names |
Schedule 3.8(a)(iii)
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—
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Ownership of Product Intellectual Property |
Schedule 3.8(b)
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—
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Product Intellectual Property —
Restrictions and Disputes |
Schedule 3.8(c)
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—
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Product Intellectual Property — Infringement |
Schedule 3.9
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Undisclosed Liabilities |
Schedule 3.10
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—
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Material Contracts |
Schedule 3.11(a)
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—
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Suits |
Schedule 3.11(b)
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—
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Orders |
Schedule 3.12(a)(i)
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—
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Compliance with Laws |
Schedule 3.12(a)(ii)
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—
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Authorizations |
Schedule 3.12(a)(iii)
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—
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Notice of Violation |
Schedule 3.12(b)
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—
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Material Authorizations |
Schedule 3.13
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—
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Insurance Policies |
Schedule 3.14
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—
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Product Liability |
Schedule 3.18
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—
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Warranties |
Schedule 3.19
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—
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Customers, Suppliers and Third Party
Service Providers |
Schedule 3.21(a)
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—
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Promotional Allowances |
-VI-
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Schedule 3.21(b)
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—
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Seller’s Return Policy |
Schedule 3.21(c)
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—
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Product Returns |
Schedule 3.21(d)
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—
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Exporting/Manufacturing Activities |
-VII-
THIS
ASSET PURCHASE AGREEMENT (this “
Agreement”), dated as of May 13, 2010 (the
“
Execution Date”), is entered into by and between Victory Pharma, Inc., a
Delaware
corporation, having its principal offices at 00000 Xx Xxxxxx Xxxx, Xxxxx 000 Xxx Xxxxx, XX 00000
(the “
Purchaser”) and XxxxxxXxxxx Pharmaceuticals, Inc., a
Delaware corporation, having its
principal offices at 0 Xxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx, XX 00000 (the “
Seller” and
together with the Purchaser, the “
Parties”). Capitalized terms used herein and not
otherwise defined have the respective meanings ascribed to them in
Exhibit A.
WHEREAS, the Seller has commenced a case (the “
Case”) under Chapter 11 of Title 11 of
the United State Code, 11 U.S.C. Sections 101
et seq (the “
Bankruptcy
Code”) on April 30, 2010 by filing a voluntary petition with the United States Bankruptcy Court
for the District of
Delaware (the “
Bankruptcy Court”);
WHEREAS, subject to the terms and conditions of this Agreement and pursuant to Sections 105,
363 and 365 of the Bankruptcy Code, the Purchaser desires to purchase from the Seller, and the
Seller desires to sell to the Purchaser, all of the Seller’s right, title and interest in and to
the Purchased Assets;
WHEREAS, subject to the terms and conditions of this Agreement and pursuant to Sections 105,
363 and 365 of the Bankruptcy Code, the Seller desires to transfer to the Purchaser, and the
Purchaser desires to accept and assume from the Seller, the Assumed Liabilities; and
WHEREAS, the Seller and the Purchaser have determined that it is in their respective best
interests to consummate the foregoing transactions, and, in furtherance thereof, have approved this
Agreement and the transactions contemplated hereby.
NOW, THEREFORE, in consideration of the premises and the mutual covenants, representations,
warranties and agreements herein contained, the Parties hereby, intending to be legally bound,
agree as follows:
ARTICLE 1
PURCHASE AND SALE
1.1 Transfer of Purchased Assets. At the Closing, on the terms and subject to the
conditions hereof and subject to the approval of the Bankruptcy Court pursuant to Sections 105, 363
and 365 of the Bankruptcy Code, the Seller shall sell, convey, transfer, assign and deliver to the
Purchaser free and clear of all Claims, interests (as defined in Section 363 of the Bankruptcy
Code) and Liens, and the Purchaser shall purchase, take delivery of and acquire from the Seller,
all of the Seller’s right, title and interest in and to the Purchased Assets.
1.2 Excluded Assets. The Seller shall not sell, convey, transfer, assign or deliver
to the Purchaser, and the Purchaser shall not purchase, take delivery of or acquire from the Seller
the following assets, properties and rights of Seller (collectively, the “Excluded
Assets”):
(a) all leases for real property to which the Seller is or becomes a party that are used in
connection with any Product or any Business;
(b) all real property owned by the Seller that is used in connection with any Product or any
Business, other than the Acquired Fixtures;
(c) the Excluded Contracts;
(d) the Avoidance Actions and any Claims other than the Assumed Claims;
(e) all permits, approvals, licenses, franchises or authorizations other than the
Applicable Permits;
(f) any rights and assets related to any Benefit Plan;
(g) cash and cash equivalents and accounts receivable;
(h) the prepaid items and deposits set forth or described in Schedule 1.2(h);
(i) Tax Returns, Tax refunds and other Tax attributes;
(j) bank accounts and bank account records, corporate records and minute books,
(k) insurance policies and any unearned premiums or refunds under such policies; and
(l) the assets, properties and rights (contractual or otherwise) set forth or described in
Schedule 1.2(l).
1.3 Assumed Liabilities. At the Closing, on the terms and subject to the conditions
hereof and subject to the approval of the Bankruptcy Court pursuant to Sections 105, 363 and 365 of
the Bankruptcy Code, the Purchaser shall assume and pay, perform or otherwise discharge, in
accordance with their respective terms and subject to the respective conditions thereof, only the
following Liabilities of the Seller (collectively, the “Assumed Liabilities”):
(a) all Assumed Rebates and amounts owing in respect thereof;
(b) all credits and allowances verified and processed after the Effective Time that arise out
of or relate to the return of any Products, and all amounts owing in respect thereof;
(c) all quantity and trade discounts given by the Purchaser with regard to Product sold
following the Effective Time;
(d) all chargebacks and co-pay vouchers and checks processed after the Effective Time that
relate to any Product, and all amounts owing in respect thereof;
(e) all royalty Liabilities accrued on or after April 1, 2010 that the Seller owes under the
Lilly Agreement in respect of sales of the Keflex Product (“Assumed Keflex Royalty
Liabilities”);
(f) all Liabilities resulting from, relating to, or arising out of tort or other product
liability Claims arising with respect to the Purchased Assets or the use thereof after the
Effective Time;
(g) any Liability under any Assumed Contract, purchase order or sales order in respect of
services rendered, Products sold or other events or circumstances occurring or existing after the
Effective Time;
(h) all amounts specified, and only to the extent specified, in Schedule 1.3(h) (the
“Purchaser Cure Amounts”), which are payable pursuant to Section 365(b)(1)(A) or (B) of the
Bankruptcy Code, in order to effectuate, in whole or in part, the Seller’s assumption and
assignment to the Purchaser of certain Assumed Contracts under the Approval Order, in each case to
the extent not paid by the Seller prior to Closing in the Seller’s sole discretion; and
(i) any other Liability specified, and only to the extent specified, in Schedule
1.3(i);
-2-
provided, however, that the Purchaser does not assume and does not agree to pay, discharge or
perform any such Liabilities to the extent that they are specified as Excluded Liabilities.
1.4 Excluded Liabilities. Except as specifically set forth in Section 1.3 with
respect to the Assumed Liabilities, the Seller shall retain and shall be responsible for paying,
performing and discharging when due, and the Purchaser is not hereby assuming or having any
responsibility for any and all Liabilities of the Seller, whether relating to the Purchased Assets
or otherwise, including the following, which the Seller shall retain and which will remain the sole
obligation of the Seller (such obligations and liabilities not assumed hereunder, the “Excluded
Liabilities”):
(a) all Liabilities of the Seller (including any Liabilities that result from, relate to or
arise out of tort or other product liability Claims) that (i) arise with respect to any Business or
the Purchased Assets, or the use thereof, at or prior to the Effective Time, (ii) relate to periods
ending at or prior to the Effective Time or (iii) are to be observed, paid, discharged or performed
at or prior to the Effective Time, except, in the case to each of the foregoing clauses (i) through
(iii) (inclusive), to the extent that such Liabilities are otherwise expressly Assumed Liabilities;
(b) all quantity and trade discounts given by the Seller with regard to Product sold at or
prior to the Effective Time;
(c) all chargebacks and co-pay vouchers and checks processed at or prior to the Effective Time
that relate to any Product, and all amounts owing in respect thereof;
(d) any First Quarter Rebates and amounts owing in respect thereof;
(e) all credits and allowances verified or processed prior to the Effective Time that arise
out of or relate to the return of any Products, and all amounts owing in respect thereof;
(f) any amounts payable or owed by the Seller pertaining to any time period prior to the
Effective Time with respect to distribution services performed by McKesson Corporation,
AmerisourceBergen Corporation, Cardinal, Kinray, or H.D. Xxxxx or their respective Affiliates for
or on behalf of the Seller (“Pre-Closing Distribution Services Obligations”);
(g) any Liabilities of the Seller under the Par Agreement;
(h) all Liabilities that the Seller owes under the Lilly Agreement as of the Effective Time
other than the Assumed Keflex Royalty Liabilities;
(i) any penalties or interest resulting from failure to timely pay amounts due under any
Assumed Contracts to the extent relating to any time prior to the Effective Time;
(j) all amounts payable pursuant to Section 365(b)(1)(A) or (B) of the Bankruptcy Code, other
than the Purchaser Cure Amounts, in order to effectuate, pursuant to the Bankruptcy Code, the
Seller’s assumption and assignment to the Purchaser of the Assumed Contracts under the Approval
Order;
(k) all Liabilities related to litigation to which the Seller or any of its Affiliates are
party;
(l) all Employee Obligations;
(m) any Purchaser Cure Amounts paid by the Seller prior to Closing in the Seller’s sole
discretion;
(n) all Liabilities relating to any environmental, health or safety matter (including any
Liability or obligation arising under any Environmental Law) arising out of or relating to the
Seller’s
-3-
operation of any Business prior to the Effective Time or any other of the Seller’s businesses
or the Seller’s leasing, ownership or operation of real property; and
(o) any Liability set forth or described in Schedule 1.4(o).
1.5 Purchase Price. In consideration of the sale, conveyance, transfer, assignment
and delivery of the Purchased Assets hereunder, subject to the terms and conditions hereof, the
Purchaser:
(a) has delivered to the Depositary, by wire transfer of immediately available funds, and the
Depositary holds pursuant to Section 1.7, One Million Seven Hundred Ten Thousand U.S. Dollars
(U.S. $1,710,000) in cash (the “Deposit”);
(b) upon the Closing, shall pay, by wire transfer of immediately available funds, Fifteen
Million and Forty Thousand U.S. Dollars (U.S. $15,040,000), minus any Adjustment Amount (if agreed
to by the Parties prior to the Closing), to a bank account, which the Seller shall specify to the
Purchaser at least three (3) Business Days prior to the Closing Date (the “Closing
Payment”) (for purposes of clarification, a negative Adjustment Amount would result in an
increase in the Purchase Price);
(c) upon the Closing, shall pay, by wire transfer of immediately available funds to the Escrow
Account, an amount (such amount, the “Escrow Amount”) equal to Three Hundred and Fifty
Thousand U.S. Dollars (U.S. $350,000);
(d) upon the Closing, shall assume the Assumed Liabilities (the Assumed Liabilities and the
dollar amounts specified in this Section 1.5, collectively, as may be so adjusted, the
“Purchase Price”).
1.6 Purchase Price Allocation.
(a) Subject to the adjustments described in Section 1.9, the Purchase Price 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 Purchased Assets and the goodwill and going
concern value of the Businesses (the “Allocation”.
(b) Within five (5) days following the Closing Date, the Purchaser shall prepare and deliver
to the Seller an allocation schedule setting forth the Allocation (the “Allocation
Schedule”). The Seller shall review the Allocation Schedule and, to the extent the Seller
disagrees in good faith with the content of the Allocation Schedule, the Seller shall inform the
Purchaser of such disagreement within five (5) days after receipt of the Allocation Schedule, and
the Seller and the Purchaser shall attempt to resolve any such disagreement in good faith. If the
Seller and the Purchaser are unable to reach an agreement on the content of the Allocation Schedule
within twenty (20) days of the Closing Date, the Seller and the Purchaser shall submit such dispute
to the Bankruptcy Court for determination.
(c) In accordance with Section 1060 of the Code and the 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 Allocation Schedule, to file all Tax
Returns (including IRS Form 8594 and any supplemental or amended IRS Form 8594) in accordance with
the Allocation Schedule, and not to take any position inconsistent with the Allocation Schedule in
the course of any audit, examination, other administrative or judicial proceeding.
1.7 Deposit. The Depositary shall be obligated to hold and disburse the Deposit in
accordance with the terms of the Depositary Agreement attached to this Agreement as Exhibit B (the
“Depositary Agreement”), which the Purchaser, the Seller and the Depositary have executed
simultaneously with the execution of this Agreement.
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1.8 Escrow.
(a) The Escrow Agent shall be obligated to hold and disburse the Escrow Amount in accordance
with the terms of the Escrow Agreement in substantially the form attached to this Agreement as
Exhibit C (the “Escrow Agreement”).
(b) Subject to the terms of the Escrow Agreement, the Purchaser will be entitled to the Escrow
Funds to the extent equal to amounts paid by the Purchaser after the Closing on behalf of the
Seller, for amounts the Seller has failed to timely pay with respect to (i) co-pay vouchers
processed by Cardinal at or prior to the Effective Time, (ii) any First Quarter Rebates, (iii)
Verified Returns, (iv) any Wholesaler Credit Balance Payments, or (v) any Pre-Closing Distribution
Services Obligations.
1.9 Adjustment Amount.
(a) Promptly, but in no event later than 5:00 p.m. Eastern Time, following the close of
business on the Business Day prior to Closing, the Seller shall deliver to the Purchaser a
certificate signed by the Chief Executive Officer or Chief Financial Officer of the Seller,
certifying with respect to the accuracy and completeness of a report attached to such certificate
that sets forth (i) the monthly and aggregate unit and dollar sales (calculated at WAC) for each
Product for the Pre-Closing Period, (ii) any Purchaser Cure Amounts paid by the Seller prior to
Closing in the Seller’s sole discretion, together with reasonable evidence of such payments, and
(iii) the Adjustment Amount (as so calculated by the Seller, the “Seller Adjustment
Amount”), if any, which may be a negative or positive number.
(b) To validly object to the Seller’s calculation of the Seller Adjustment Amount, the
Purchaser must deliver to the Seller, on or prior to 12:00 a.m., Eastern Time, on the Closing Date,
written notice (the “Purchaser Adjustment Amount Statement”) indicating that the Purchaser
objects to the Seller Adjustment Amount, describing the basis for its objection, and providing its
own calculation of the Adjustment Amount (as so calculated by the Purchaser, the “Purchaser
Adjustment Amount”). If the Purchaser fails to provide a Purchaser Adjustment Amount Statement
in accordance with this Section 1.9(b), then the Seller Adjustment Amount shall become the
final and binding Adjustment Amount. If the Seller receives a Purchaser Adjustment Amount Statement
in accordance with this Section 1.9(b), the Parties shall seek in good faith to reach an
agreement with respect to the Adjustment Amount by 11:00 a.m., Eastern Time, on the Closing Date.
If the Parties are unable to reach an agreement with respect to the Adjustment Amount by such time,
then the Parties shall submit such dispute to the Bankruptcy Court for determination of the
Adjustment Amount.
(c) If the Parties (i) reach agreement on the Adjustment Amount prior to the Closing, any such
Adjustment Amount shall be subtracted from the Closing Payment at the Closing (provided, that, for
purposes of clarification, a negative Adjustment Amount would result in an increase in the Closing
Payment), or (ii) do not reach agreement on the Adjustment Amount prior to the Closing and submit
the determination of the Adjustment Amount to the Bankruptcy Court, then, within three (3) Business
Days after the Bankruptcy Court’s determination of any Adjustment Amount, either the Seller shall
pay the Purchaser an amount equal to any net positive Adjustment Amount or the Purchaser shall pay
the Seller an amount equal to any net negative Adjustment Amount. At the Purchaser’s election, in
its sole discretion, the Seller’s obligation to pay any Adjustment Amount pursuant to subsection
(ii) of this Section 1.9(c) may be satisfied from the Escrow Funds, and if the Purchaser
provides written notice to the Seller of such election, the Parties shall promptly execute and
deliver to the Escrow Agent joint written instructions to disburse the Adjustment Amount to the
Purchaser.
1.10 Risk of Loss. Until the delivery to the Purchaser pursuant hereto, following the
Effective Time, the Seller will be fully responsible for any loss of or damage to the Purchased
Assets from fire, flood, casualty or any other similar occurrence. As of the Effective Time, title
to the Purchased Assets will be transferred to the Purchaser.
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ARTICLE 2
CLOSING
2.1 Closing. The Parties shall consummate the Transactions (the consummation of such
Transactions, the “Closing”) at the offices of Xxxx Xxxxx LLP, 000 Xxxxxxxxx Xxxxxx, Xxx
Xxxx, XX 00000, at 11:00 a.m., local time, no later than the third (3rd) Business Day
after the satisfaction (or waiver, as provided herein) of the conditions set forth in Article
6 (other than those conditions that by their nature are to be or are capable of being satisfied
contemporaneously with the occurrence of the Closing), or such other time, date or place (or any of
the foregoing) as is agreed to in writing by the Parties. The Closing will be deemed to have
occurred at 12:01 a.m. Eastern Time on the day on which the Closing occurs (such time, the
“Effective Time”).
2.2 Transactions at Closing.
(a) Seller’s Actions and Deliveries. At the Closing, the Seller shall deliver or
cause to be delivered to the Purchaser:
(i) the Acquired Inventory, which the Seller shall deliver to Purchaser, at Purchaser’s
sole cost and expense, at the respective facilities of ICS and each of the Manufacturers, as
applicable to the Acquired Inventory in question;
(ii) a description of all Inventory quantities with respect to each Product by SKU as
of the Closing Date;
(iii) executed counterparts of each Other Agreement to which the Seller is a party;
(iv) all such filings and submissions (including in electronic format) of the Seller to
the FDA or any other Governmental Entity, duly executed by the Seller, as are necessary in
connection with the transfer of the rights to the NDAs included in the Regulatory Filings
and Approvals from the Seller to the Purchaser, to the extent so transferable, including the
letter to the FDA containing required information in accordance with 21 C.F.R. §314.72;
(v) a certificate, dated the Closing Date, signed on behalf of the Seller by an
executive officer of the Seller, in the form attached as Exhibit D;
(vi) a certificate from the Seller certifying, pursuant to Treasury Regulations Section
1.1445-2(b)(2), that such the Seller is not a foreign Person within the meaning of Sections
1445 and 897 of the Code, in the form attached as Exhibit E (such certificate, a
“FIRPTA Certificate”);
(vii) evidence, in form and substance satisfactory to the Purchaser, that the Seller
has paid all amounts owed by it under the Lilly Agreement relating to the four (4) quarterly
periods ended March 31, 2010;
(viii) written evidence of the grant by Xxx Xxxxx pursuant to Section 4.2 of the Lilly
Agreement of a license to the Licensed Technology (as such term is defined in the Lilly
Agreement) with respect to the manufacturing of Keflex in Austria as presently contemplated
with Sandoz;
(ix) all correspondence from the FDA to the Seller, and all correspondence from the
Seller to the FDA, in each case with respect to the Products or the Businesses, at the
Purchaser’s sole cost and expense;
(x) all tangible Product Records, at the Purchaser’s sole cost and expense; and
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(xi) such other documents and instruments as may be reasonably necessary to effect or
evidence the Transactions.
(b) Purchaser’s Actions and Deliveries. At the Closing, the Purchaser shall deliver
or cause to be delivered to the Seller:
(i) the Purchase Price (as described in and in accordance with Section 1.5);
(ii) executed counterparts of each of the Other Agreements to which it is a party;
(iii) all such filings and submissions of the Purchaser to the FDA or any other
Governmental Entity, duly executed by the Purchaser, as are necessary in connection with the
transfer of the rights to the NDAs included in the Regulatory Filings and Approvals from the
Seller to the Purchaser, to the extent so transferable, including the application form
containing certifications and required information in accordance with 21 C.F.R. §314.72;
(iv) a certificate, dated the Closing Date, signed on behalf of the Purchaser by an
executive officer of the Purchaser, in the form attached as Exhibit D; and
(v) such other documents and instruments as may be reasonably necessary to effect or
evidence the Transactions.
ARTICLE 3
REPRESENTATIONS AND WARRANTIES OF THE SELLER
The Seller represents and warrants to the Purchaser as follows:
3.1 Existence and Power.
(a) The Seller is an entity duly formed, validly existing and in good standing as a
corporation under the Laws of
Delaware.
(b) Subject to obtaining Bankruptcy Court approval pursuant to the Approval Order, the Seller
has full power and authority to enter into this Agreement and each Other Agreement to which it is
or will (as contemplated by this Agreement) become a party, to perform its obligations hereunder
and thereunder, and to consummate the Transactions.
(c) The Seller has all power and authority required to own, lease and operate its property and
to carry on the Businesses as presently conducted.
(d) The Seller is not in violation of any provision of its Organizational Documents.
3.2 Authorization. The execution and delivery by the Seller of this Agreement and each
Other Agreement to which it is or will (as contemplated by this Agreement) become a party, the
performance of its obligations hereunder and thereunder, and the consummation of the Transactions
by the Seller, have been duly and validly authorized by all necessary corporate action on the part
of the Seller and its board of directors.
3.3 Enforceability. This Agreement has been, and each Other Agreement to which the
Seller is or will (as contemplated by this Agreement) become a party has been or will be, duly and
validly executed and delivered by the Seller and (assuming (x) the due and valid authorization,
execution and delivery hereof or thereof, as the case may be, by the other parties hereto and
thereto, respectively, and (y) the approval hereof and of the Transactions by the Bankruptcy Court)
constitutes (or, with respect to such
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Other Agreements, will constitute) a valid and legally binding obligation of the Seller,
enforceable against the Seller in accordance with its terms, except as enforcement may be limited
by applicable bankruptcy, insolvency, reorganization, moratorium and other Laws affecting
creditors’ rights generally and except insofar as the availability of equitable remedies may be
limited by applicable Law.
3.4 Governmental and Third-Party Notices and Consents. Subject to obtaining
Bankruptcy Court approval pursuant to the Approval Order, except for any third-party approvals as
are specified on Schedule 3.4, (a) no Authorization is required to be made or obtained by or with
respect to the Seller in connection with the execution of, delivery of and performance under this
Agreement or any Other Agreement, or in connection with the consummation of the Transactions, and
(b) no consent, waiver, authorization or approval of or notice to any Person other than a
Governmental Entity is required to be obtained or made, respectively, by the Seller in connection
with the execution of, delivery of and performance under this Agreement or any Other Agreement, or
in connection with the consummation of the Transactions.
3.5 Noncontravention. Subject to obtaining the approval of the Bankruptcy Court
pursuant to the Approval Order, except for any violation, conflict, breach, default, right of
termination, modification, cancellation or acceleration, or right to impose additional obligations
that arises as a result of the commencement of the Case, and except as set forth in Schedule
3.5, the execution and delivery of this Agreement by the Seller does not, the execution and
delivery of each Other Agreement to which the Seller is or will (as contemplated by this Agreement)
become a party does not and will not, and the performance by the Seller of its obligations
hereunder and thereunder and the consummation of the Transactions will not (in each case, whether
with or without the giving of notice, the lapse of time or both), directly or indirectly: (a)
violate, conflict with or result in a breach of any provision of the Organizational Documents of
the Seller; (b) violate or conflict with any Law applicable to the Seller or give any Governmental
Entity or other Person the right to challenge any of the Transactions or to exercise any remedy,
obtain any relief under or revoke or otherwise modify any rights held under any such Law; (c)
violate, conflict with, result in a breach of, constitute a default under, an event of default
under or an event giving rise to (or otherwise give rise to) any right of termination,
modification, cancellation or acceleration, create in any Person the right to impose (or otherwise
result in the imposition of) any additional obligations on or the loss of any rights or benefits of
the Seller, or require any notice or consent under, any Contract (i) to which the Seller is a
party, (ii) of which the Seller is a beneficiary or (iii) by which the Seller is bound or to which
any Purchased Asset is subject; or (d) result in the creation of any Lien binding upon the Seller
or upon any Purchased Asset.
3.6 Title; Assets. Except as set forth on Schedule 3.6(a), the Seller has
(and, upon the consummation of the Transactions, the Purchaser will have) good, valid and
marketable title to the Purchased Assets, in each case free and clear of all Liens. Except as set
forth on Schedule 3.6(b), the Purchased Assets constitute all assets necessary and
sufficient to conduct the Businesses as presently conducted by the Seller.
3.7 Inventory. Schedule 3.7 sets forth the Inventory quantities with respect
to each Product by SKU as of the date hereof. Except for items of Inventory that are in the
possession or control of the Seller’s suppliers or ICS, the Inventory is in the physical possession
of the Seller at facilities at the addresses set forth on Schedule 3.7 or is in transit
from suppliers of the Seller.
3.8 Intellectual Property.
(a) Schedule 3.8(a)(i) sets forth all Patents licensed, owned or Controlled by the
Seller, including those Patents (A) used or held for use in the operation of any Business or
related to any Product, or (B) relating to (x) Moxatag or its use or manufacture, (y) Keflex or its
use or manufacture or (z) the Seller’s PULSYS technology. Schedule 3.8(a)(ii) sets forth
all Product Copyrights, Product Marks, Product Trade Dress and Product Domain Names licensed, owned
or Controlled by the Seller. Except as set forth in Schedule 3.8(a)(iii), (1) no Person
other than the Seller has any ownership interest
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in any Product Intellectual Property in which the Seller has an ownership interest, (2) the
Seller Controls all Product Intellectual Property, (3) neither the Seller nor any of its Affiliates
has granted any licenses to the Product Intellectual Property to third parties, and (4) neither the
Seller nor any of its Affiliates, nor to the Seller’s Knowledge, any other Person, is party to any
agreements with third parties that materially limit or restrict use of the Product Intellectual
Property or require any payments for their use.
(b) Except as set forth on Schedule 3.8(b), none of the Product Intellectual Property
is the subject of: (A) any pending adverse Order or Contract restricting (x) its use in connection
with any Product or any Business or (y) assignment or license thereof by the Seller; (B) to the
Seller’s Knowledge, any threatened Suit; (C) any pending Suit; (D) any requests for royalty
payments or offers for licenses to Intellectual Property that would relate to any Product or any
Business, in each case made in writing or, to the Seller’s Knowledge, made otherwise; or (E) to the
Seller’s Knowledge, any actual or threatened inventorship challenges, interferences declared or
assertions of invalidity with respect to any Patents included in the Product Intellectual Property.
(c) Except as set forth on Schedule 3.8(c), neither the Seller nor any of its
Affiliates has received written notice of a claim that the use or sale of the Product or the use of
the Product Intellectual Property by or behalf of the Seller infringe any valid intellectual
property right of any third party.
(d) All issuance, renewal, maintenance and other payments that are or have become due with
respect to the Product Intellectual Property have been timely paid by or on behalf of the Seller,
except as would not reasonably be expected to have a Material Adverse Effect.
3.9 No Undisclosed Liabilities. Except as set forth on Schedule 3.9, the
Seller has no Liabilities (and, to the Seller’s Knowledge, there is no Basis for any present or
future Suit against the Seller giving rise to any material Liability of the Seller) except for (a)
Liabilities fully reflected or reserved for on the Latest Balance Sheet and (b) current Liabilities
that have arisen since December 31, 2009 in the Ordinary Course of Business.
3.10 Material Contracts. Other than the Assumed Contracts and the Contracts listed on
Schedule 3.10, there is no Contract to which the Seller is a party that is material to the
either or both Products or either or both Businesses. Each Assumed Contract is in full force and
effect, and is a legal, valid and binding agreement of the Seller, and, to the Seller’s Knowledge,
the other party or parties thereto, except as enforcement may be limited by applicable bankruptcy,
insolvency, reorganization, moratorium and other Laws affecting creditors’ rights generally and
except insofar as the availability of equitable remedies may be limited by applicable Law. Except
as set forth on Schedule 3.10, the Seller has performed in all material respects all
obligations required to be performed by it under each Assumed Contract and has not received any
written notice of any default under or breach of any Assumed Contract. To the Seller’s Knowledge,
other than the commencement of the Case and except as disclosed on Schedule 3.10, no event
has occurred that (whether with or without the giving of notice, the lapse of time or both) would
constitute a material default under or material breach of or that would permit termination,
modification or acceleration of any Assumed Contract. To the Seller’s Knowledge, the other party
or parties to each Assumed Contract are not in default under or breach of the terms of such Assumed
Contract and no such party intends to terminate (whether for cause or convenience) or cause a
default under any Assumed Contract before its stated term. Except as set forth on Schedule
3.10, the Seller is not renegotiating any Assumed Contract and no other party to an Assumed
Contract has made a demand for such renegotiation.
3.11 Suits.
(a) Except for the Case and except as set forth in Schedule 3.11(a), no Suit is
pending or, to the Seller’s Knowledge threatened, against the Seller or with respect to any
Product, any Purchased Asset or any Business, in each case that is reasonably likely to give rise
to a material Liability of the Seller, and, to the Seller’s Knowledge, there is no Basis for any
such Suit.
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(b) Schedule 3.11(b) contains a list of all Orders to which the Seller is subject and,
to the Seller’s Knowledge, there is no Basis that could lead to any such other Order (except for
the Orders expressly referenced herein).
(c) None of the Suits and Orders set forth in Schedules 3.11(a) or 3.11(b)
could reasonably be expected to result in a Material Adverse Effect.
3.12 Compliance with Laws; Authorizations.
(a) Except as set forth on Schedule 3.12(a)(i), since December 31, 2008, the
Businesses have been conducted in compliance in all material respects with each applicable Law.
Except as set forth on Schedule 3.12(a)(ii), the Seller has obtained, and is currently
compliant with the requirements of, each Authorization necessary for the operation of each
Business, except where the failure to have or comply with any Authorization would not reasonably be
expected to have a Material Adverse Effect. Except as set forth on Schedule 3.12(a)(iii),
since December 31, 2008, the Seller has not received written notice from any Governmental Entity of
any violation or alleged violation by it of any applicable Laws.
(b) Schedule 3.12(b) sets forth a list of all Authorizations related to the Products.
No loss, suspension, withdrawal or limitation of any Authorization is pending or, to the Seller’s
Knowledge, threatened.
3.13 Insurance. Schedule 3.13 lists all of the insurance policies maintained
by the Seller that provide product liability insurance coverage in connection with any Business,
the Purchased Assets or Products, and for each indicates the insurer’s name, policy number,
expiration date, amount and type of coverage, and whether such coverage is provided on an
occurrence or claims-made basis. The Seller is not in breach or default under any provision
contained in any such policy, including with respect to the payment of premiums or the giving of
notices. No notice of cancellation or non-renewal with respect to any such policy has been
received by the Seller. To the Seller’s Knowledge, no event has occurred that (whether with or
without the giving of notice, the lapse of time or both) would constitute such a breach or default,
or that would permit termination, modification or acceleration of any such policy. No party to any
such policy has repudiated any provision thereof. The Seller has timely filed claims with insurers
with respect to all product liability claims relating to the Purchased Assets for which the Seller
believes it has coverage, and the Seller has not received notice from any insurance provider that
has claimed any reservation of rights or denied coverage with respect to such claims.
3.14 Product Liability. Except as set forth in Schedule 3.14, the Seller does
not have any Liability, and, to the Seller’s Knowledge there is no Basis for any Suit against the
Seller, arising out of any injury to Persons as a result of the use of any Product manufactured,
sold, or put into trade inventory by the Seller. Schedule 3.14 sets forth a complete and
accurate list of product liability claims that have been asserted or commenced against the Seller
within the past three years. Prior to the date hereof, the Seller has provided the Purchaser with
access to (a) a list of all serious adverse event reports and periodic adverse event reports with
respect to each Product that has been filed by the Seller since the initial launch of such
Product, including any material correspondence or other material documents relating thereto, (b)
all payouts made by the Seller since the initial launch of each Product to end-users in respect of
claims for injury relating to the use of Product and (c) all actual or threatened claims for injury
relating to the use of such Product made by end-users against the Seller since the initial launch
of such Product .
3.15 Taxes. There are no Liens for Taxes (other than statutory Liens for current
Taxes not yet due and payable) upon the Purchased Assets.
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3.16 Regulatory Matters.
(a) All existing Regulatory Filings and Approvals held by the Seller as of the date hereof are
set forth in Schedule A.1(n). The Seller is the sole and exclusive owner of the Regulatory
Filings and Approvals.
(b) Except as would not have a Material Adverse Effect, the Distribution, marketing and
promotion of the Products by the Seller has been conducted in material compliance with the
Regulatory Filings and Approvals and all applicable Laws, including the Act and the PDM Act.
(c) The Seller has not received any written or, to the Seller’s Knowledge, other notice of
proceedings from a Governmental Entity alleging that the Products or any of the Purchased Assets or
the ownership, manufacturing, operation, storage, Distribution, warehousing, packaging, labeling,
handling or testing thereof, or any of the foregoing is in material violation of any applicable
Law, including the Act and the PDM Act.
3.17 Government Product Contracts; Liability for Cost and Pricing Data.
(a) The Seller has made available to the Purchaser true and correct copies of all Government
Product Contracts.
(b) The Seller has made available to the Purchaser true and correct copies of the Seller’s
Non-FAMP calculations and submissions, with all supporting data, for the two (2) most recent
calendar quarters, as well as the Seller’s annual Federal Ceiling Price (“FCP”) calculation
and submission for the FCP currently in effect, with all supporting data.
(c) The Seller has made available to the Purchaser the FCP for each Product on the Seller’s
FSS Contract.
(d) No claim for Liability against the Seller by any Governmental Entity exists as a result of
incomplete or Product-related defective pricing data submitted by or on behalf of the Seller to any
Governmental Entity.
(e) The Seller has made available to the Purchaser all AMP and Best Price-related submissions
regarding sales of each Product during the period since January 1, 2008 by or on behalf of the
Seller, as submitted to the Centers for Medicare and Medicaid Services.
3.18 Warranties. Except as set forth on Schedule 3.18, the Seller has not
made any warranties to its customers with respect to the quality or absence of defects of the
Products that it has sold or that have been sold on its behalf that are in force as of the date
hereof or with respect to which Suits are outstanding as of the date hereof. The Seller has made
available to the Purchaser information, which is accurate in all material respects, regarding all
returns of defective or expired Products (other than Products damaged in transit) since January 1,
2009, and all credits and allowances for such defective or expired products given or promised to
customers during said period. The Seller has not paid or been required to pay any direct,
incidental or consequential damages to, and has not received a request or demand for such payment
from, any Person in connection with any Product.
3.19 Customers, Suppliers and Third Party Service Providers.
(a) Except as set forth on Schedule 3.19, since December 31, 2009, no supplier or
third-party service provider of the Seller providing goods or services to any Business has
indicated that it will stop, or materially decrease the rate of, providing materials, products or
services to the Seller.
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(b) Except as set forth on Schedule 3.19, the Seller has not granted rights to any
third-party with respect to Distribution of any Product nor appointed any third-party as a
licensee, distributor or subdistributor of any Product (a “Distributor”). Each Distributor
of any Product, to the Seller’s Knowledge, has obtained all material approvals and clearances
necessary to market such Product in any and all geographic areas in which they are marketed by or
on behalf of the Seller.
3.20 Recalls. To the Seller’s Knowledge, there is no Basis to impose upon the Seller
a duty to recall Product or to warn customers of a defect therein. There have been no recalls
ordered by any Governmental Entity with respect to any Product sold by or on behalf of the Seller.
3.21 Product Treatments; Product Returns; Exporting and Manufacturing. Except as set
forth on Schedule 3.21(a), the Seller has not offered any promotional allowance (including
any voucher programs and co-pay assistance programs) to any customer nor has the Seller or its
agents provided any customer-specific packaging or value added services (other than displays) with
respect to the Products. The Seller has caused to be timely processed all material returns or
requests for returns of the Products. The Seller’s returns policy in effect during the period
beginning on the date that is one year prior to the Execution Date and ending on the date
immediately prior to the Closing Date is attached as Schedule 3.21(b). During the one-year
period prior to the Execution Date, (i) the Seller has processed or caused to be processed returns
consistent with such returns policy, and (ii) (A) the Seller has not refused to accept returns of
any Product in contravention of the returns policy and (B) no disputes arose with any customer of
the Seller regarding any attempted return to the Seller of any Product sold by the Seller. During
the one-year period prior to the Execution Date, no customer of the Seller has refused to accept
further shipments of any Product. The Seller does not have outstanding any authorization to any of
its customers to destroy any Product in lieu of returning such Product. Except as set forth on
Schedule 3.21(c), the Seller does not have outstanding any authorization to any of its
customers committing the Seller to a guaranteed sale/repurchase of the Product if not sold by such
customers. Except as set forth on Schedule 3.21(d), the Seller has not engaged in any
exporting or manufacturing activities of or relating to any Product or any Business.
ARTICLE 4
REPRESENTATIONS AND WARRANTIES OF THE PURCHASER
The Purchaser represents and warrants to the Seller as follows:
4.1
Existence and Power. The Purchaser is an entity duly formed, validly existing and
in good standing as a corporation under the Laws of
Delaware. The Purchaser has full power and
authority to enter into this Agreement and each Other Agreement to which it is or will (as
contemplated by this Agreement) become a party, to perform its obligations hereunder and
thereunder, and to consummate the Transactions.
4.2 Authorization. The execution and delivery by the Purchaser of this Agreement and
each Other Agreement to which it is or will (as contemplated by this Agreement) become a party, the
performance of its obligations hereunder and thereunder, and the consummation of the Transactions
by the Purchaser, have been duly and validly authorized by all necessary corporate action on the
part of the Purchaser and its board of directors, and each such authorization is and will remain in
full force and effect, and will not be amended, modified or rescinded (nor will the amendment,
modification or rescinding of such authorization be authorized).
4.3 Enforceability. This Agreement has been, and each Other Agreement to which the
Purchaser is or will (as contemplated by this Agreement) become a party has been or will be, duly
and validly executed and delivered by the Purchaser and (assuming (x) the due and valid
authorization, execution and delivery hereof or thereof, as the case may be, by the other parties
hereto and thereto, respectively, and (y) the approval hereof and of the Transactions by the
Bankruptcy Court) constitutes (or,
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with respect to such Other Agreements, will constitute) a valid and legally binding obligation
of the Purchaser, enforceable against the Purchaser in accordance with its terms, except as
enforcement may be limited by applicable bankruptcy, insolvency, reorganization, moratorium and
other Laws affecting creditors’ rights generally and except insofar as the availability of
equitable remedies may be limited by applicable Law.
4.4 Financing. The Purchaser acknowledges and agrees that its obligations under this
Agreement are not subject to any condition regarding the Purchaser’s ability to obtain financing
for the consummation of the Transactions or the terms of any financing being satisfactory to the
Purchaser or its Affiliates. At the Closing, the Purchaser will have sufficient funds available to
it to pay, in cash, the full Closing Payment and all other amounts payable pursuant to this
Agreement and the Other Agreements or otherwise necessary to consummate all of the Transactions.
ARTICLE 5
COVENANTS PRIOR TO CLOSING
5.1 Bankruptcy Court Order. The Seller shall file a motion to approve this Agreement
with the Bankruptcy Court promptly after the Execution Date. The Seller shall use its commercially
reasonable efforts to obtain prompt entry of the Procedures Order, including the approval of the
bidding procedures in the form attached hereto as Exhibit I. The Seller shall conduct the
Auction in accordance with, and on the terms and conditions provided in, the Procedures Order. The
Seller shall use its commercially reasonable efforts to obtain, through the filing with the
Bankruptcy Court of appropriate applications or motions, entry of the Approval Order not more than
five (5) Business Days after the Auction and following notice to creditors and parties in interest
in accordance with the Bankruptcy Code and Bankruptcy Rules.
5.2 Cure of Defaults; Assumption of Contracts. Subject to the Approval Order and any
other Order of the Bankruptcy Court, on or prior to the Closing or at such other time as ordered by
the Bankruptcy Court, (a) the Seller shall cure all monetary and other material defaults and
breaches under the Assumed Contracts, other than the Purchaser Cure Amounts, and satisfy all
material Excluded Liabilities under the Assumed Contracts, and (b) the Seller shall assume the
Assumed Contracts and assign them to the Purchaser in accordance with the provisions of Section 365
of the Bankruptcy Code and this Agreement.
5.3 Access to Information; Reporting; Correspondence and Notices.
(a) During the Pre-Closing Period, the Seller shall:
(i) afford the Purchaser and its Representatives access, during regular business hours
and at reasonable agreed-upon times, to the Seller’s personnel and properties pertaining to
any of the Purchased Assets, provided that such access does not unreasonably interfere with
the Seller’s normal business and operations;
(ii) provide or make available to the Purchaser and its Representatives(A) copies of
all Assumed Contracts and other documentation constituting Purchased Assets and (B) all
non-privileged information and records (financial and otherwise) relating to, or otherwise
used or useful in, any Business, and not otherwise included in the Purchased Assets, that
the Purchaser or its Representatives may reasonably request;
(iii) promptly provide the Purchaser with copies of all Regulatory Warning Notices and
any written communications related thereto between the Seller or its Affiliates, on the one
hand, and Governmental Entities, on the other;
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(iv) promptly provide the Purchaser with copies of any material reports, correspondence
and other notices related to any Product or any Business that the Seller (or any of its
Affiliates) receives from or sends to the FDA, the United States Department of Justice, the
United States Centers for Medicare & Medicaid Services, the United States Department of
Health & Human Services, or the European Medicines Agency; and
(v) promptly provide the Purchaser with copies of any material, non-privileged reports,
correspondence and other notices that the Seller (or any of its Affiliates) receives from or
sends to any third party relating to (A) any of the Manufacturing Facilities or their
ability to be used for the manufacture or storage of the Products, or (B) activities being
undertaken or proposed to be undertaken by any of the Manufacturers relating to any of the
Products or the making of any of the Products.
(b) Without limiting the generality of or being limited by Section 5.3(a), the Seller shall,
at its own cost and expense, provide to the Purchaser the following information and data with
respect to each Product on (1) the last Business Day of each calendar month occurring prior to
Closing, (2) the third (3rd) Business Day prior to Closing, and (3) the Closing Date:
(i) wholesale data comprised of (A) 852 Reports from each of McKesson Corporation,
Cardinal, and AmerisourceBergen Corporation for each Product, and (B) inventory balances as
reported in 852 Reports for each wholesaler for each Product;
(ii) data relating to finished Inventory of such Product held at ICS as well as bulk
and active pharmaceutical ingredient material Inventory, including the location, lot numbers
and expiration dates of such Inventory, as well as the Seller’s out-of-pocket cost (without
markup and appropriately supported and documented in accordance with GAAP) paid to
Manufacturers for all such units of such Product; and
(iii) unfilled firm purchase orders for the Products.
(c) The Seller shall promptly provide the Purchaser with complete copies of the following:
(i) all material, non-privileged notices, subpoenas, demands, complaints or similar
written or electronic communications received from, or sent by or behalf of the Seller to,
(A) the Persons identified on Schedule 5.3(c)(i)(A), (B) any party to an Assumed
Contract, and (C) to the extent such correspondence or other communications relates to any
Product or any Business, (I) the top five wholesalers of such Product and (II) any
Governmental Entity, including the FDA; and
(ii) all non-privileged correspondence, notices, subpoenas, requests, demands,
complaints or other written or electronic communications received from, or sent by or behalf
of the Seller to, any Person if such correspondence, notice, subpoena, request, demand,
complaint or other written or electronic communication relates to any action, event or
circumstance that constitutes, or that could reasonably be expected to constitute, a
Material Adverse Effect.
5.4 Conduct of the Businesses.
(a) During the Pre-Closing Period, the Seller shall advise the Purchaser promptly following
any material developments or changes, if any, with respect to the Purchased Assets, collectively,
any Product or any Business.
(b) During the Pre-Closing Period, except (x) as otherwise expressly required or permitted
hereunder or (y) with the prior written consent of the Purchaser, the Seller shall:
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(i) subject to Section 5.3, operate the Businesses only in the Ordinary Course of
Business, consistent with past practices, and preserve intact in all material respects the
Purchased Assets, the Products and the Businesses, and, to the extent that the Seller
currently has or currently purchases wholesale data in support of the Product, the Seller
shall maintain such wholesale data arrangements in all material respects; and
(ii) take such actions as may be necessary to satisfy the Seller’s covenants hereunder
(including the delivery to the Purchaser of the Purchased Assets pursuant to the terms
hereof) and the conditions to the Purchaser’s obligations hereunder.
(c) During the Pre-Closing Period, except (x) as otherwise expressly required or permitted
hereunder or (y) with the prior written consent of the Purchaser, the Seller shall not:
(i) fail to take, or delay taking, such actions as may be necessary to satisfy the
Seller’s covenants hereunder (including the delivery to the Purchaser of the Purchased
Assets pursuant to the terms hereof) and the conditions to the Purchaser’s obligations
hereunder;
(ii) except for breaches and defaults of the type referred to in Section 365(b)(2) of
the Bankruptcy Code, perform in all material respects all of its obligations under all
Assumed Contracts and other Contracts relating to or affecting any Purchased Asset or any
Business;
(iii) enter into any material Contracts relating to any Purchased Asset or any
Business;
(iv) terminate, amend or waive any rights under any Assumed Contract or fail to
exercise any right of renewal thereunder;
(v) change the price at which the Seller sells each Product;
(vi) transfer, or grant any rights or options in or with respect to, any of the
Purchased Assets, except for the transfer of Inventory in the Ordinary Course of Business
consistent with past practice;
(vii) make any claims or demands for breach against any party to any of the Assumed
Contracts, or threaten to take any such action;
(viii) take any action that could directly or indirectly impair in any material respect
any rights that the Purchaser or any of its Affiliates may have hereunder or under any Other
Agreement; or
(ix) commit or agree to take, whether or not in writing, any of the actions specified
in this Section 5.3(b).
5.5 Required Filings. As soon as reasonably practicable after the Execution Date, the
Parties shall make all filings required to be made in order to consummate the Transactions. The
Seller shall also provide reasonable assistance with respect to all filings that the Purchaser
elects to make that the Purchaser, in its reasonable discretion, deems legally necessary to make in
connection with the Transaction.
5.6 No Restriction. Nothing herein will be deemed to prevent the Seller or the board
of directors of the Seller from taking any action it is required to take to remain in compliance
with applicable Law.
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5.7 Notifications. During the Pre-Closing Period, each Party shall promptly notify
the other Party in writing of any fact, change, condition, circumstance or occurrence or
nonoccurrence of any event of which it is or becomes aware that has resulted in, or that will or is
reasonably likely to result in, (a) any of the conditions to the other Party’s obligation to
consummate the Transactions set forth in Article 6 becoming incapable of being satisfied or
(b) the inaccuracy of any of its representations or warranties in Article 3 (with respect
to the Seller) or Article 4 (with respect to the Purchaser). The delivery of any notice
pursuant to this Section 5.7 will not operate to amend or supplement the Seller Disclosure Schedule
and will not limit or otherwise affect the remedies available hereunder to a Party.
5.8 Keflex Validation; Sandoz.
(a) During the Pre-Closing Period, the Seller shall continue to reasonably cooperate with
Sandoz in seeking to obtain manufacturing validation of Keflex. The Seller shall provide the
Purchaser with bi-weekly updates, if any, regarding the progress toward validation of Sandoz’s
manufacture of Keflex, and, after the Seller receives a copy of the validation report from Sandoz
with respect to Keflex, the Seller shall promptly thereafter provide a copy thereof to the
Purchaser.
(b) The Seller shall use its commercially reasonable efforts to enter into the Sandoz
Agreement prior to the Closing and actively consult with the Purchaser regarding the foregoing;
provided, that the Seller shall not enter into the Sandoz Agreement unless the Purchaser has
provided its written consent to the form and substance thereof (which consent the Purchaser shall
not unreasonably withhold, delay or condition).
(c) During the Pre-Closing Period, the Seller shall (i) use its commercially reasonable
efforts to prepare and submit to the FDA a submission seeking approval to transfer the manufacture
of Keflex to the Sandoz Facility, (ii) provide the Purchaser with copies of, and an opportunity to
comment on, any such proposed filings prior to filing, and (iii) actively consult with the
Purchaser regarding all of the foregoing matters in subsections ((i) and (ii)).
5.9 Sales; Wholesaler Inventory.
(a) During the Pre-Closing Period, the Seller shall deliver to the Purchaser, a bi-weekly
report setting forth the aggregate unit sales for each Product SKU since the Execution Date, no
later than two (2) weeks since the last such report was delivered to the Purchaser.
(b) Without the Purchaser’s prior written consent, during the Pre-Closing Period, the Seller
shall not sell any Products: (i) (A) in calendar month May, June or July 2010, with an aggregate
value in excess of Four Hundred Thousand U.S. Dollars (U.S. $400,000) during any such calendar
month, (B) in calendar month August 2010, with an aggregate value in excess of Six Hundred Thousand
U.S. Dollars (U.S. $600,000) during such calendar month, or (C) in calendar months beginning with
September 2010 and later, with an aggregate value in excess of Seven Hundred Fifty Thousand U.S.
Dollars (U.S. $750,000) during any such calendar month, in each case ((A), (B) or (C)) calculated
based on the aggregate unit sales of Products during such month, multiplied by the applicable WAC
for such Products (which limitation shall be pro-rated for any partial calendar months during the
Pre-Closing Period), (with respect to a given calendar month, as applicable, the limitation imposed
by the foregoing (A), (B) or (C), the “Agreed Monthly Sales Limit”); and (ii) on the
Closing Date or during the two (2) Business Days immediately preceding the Closing Date (other than
to the Purchaser pursuant to the terms hereof).
5.10 Cardinal Co-Pay Vouchers. During the Pre-Closing Period, the Seller shall timely
pay all amounts that Cardinal or any of its Subsidiaries has billed the Seller, prior to the
Closing, under Cardinal’s co-pay voucher program for the Products. The Seller shall not issue any
instructions, or allow to remain any previously issued instructions, to cause Cardinal to stop or
delay processing of redemptions under Cardinal’s co-pay voucher program for the Products. Promptly
following the close of business on the Business Day prior to Closing, the Seller shall provide the
Purchaser with a report setting out co-pay
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vouchers redeemed as the close of business on the Business Day prior to Closing. Prior to the
Closing, the Seller shall (a) pay Cardinal for the estimated amounts due under the Cardinal co-pay
voucher program, based on such report and (b) provide evidence of such payment to Purchaser.
5.11 Product Returns.
(a) During the Pre-Closing Period, the Seller shall use its commercially reasonable efforts to
cause ICS to promptly and diligently process all returns with respect to the Products. The Seller
shall not issue any instructions, or allow to remain any previously issued instructions, to ICS to
slow down or halt processing returns with respect to any of the Products, and the Purchaser shall
not issue any instructions to ICS to expedite the processing of any returns with respect to any of
the Products. The Seller shall instruct ICS to promptly issue credit memos to the Seller’s
customers with respect to all returns of the Product processed prior to the Closing, in a manner
consistent with the Seller’s return policy as previously disclosed to the Purchaser.
(b) Two (2) Business Days prior to Closing, the Seller shall provide to the Purchaser
documentation that (a) reports the net balance for each wholesaler on the Seller’s accounts
receivable aging and (b) any net negative wholesaler account balances. Prior to Closing, subject
to Bankruptcy Court approval of such payments, the Seller shall (a) pay any net negative wholesaler
account balances (“Wholesaler Credit Balance Payments”), based on such report and (b)
provide evidence of such payments to Purchaser.
(c) Promptly following the close of business on the Business Day prior to Closing, the Seller
shall provide a report from ICS as of the close of business on the Business Day prior to Closing
summarizing verified but unprocessed returns (“Verified Returns”) of any Product. Prior to
the Closing, Seller shall apply the value of Verified Returns as a credit to customer accounts
receivable balances, and in cases where such applications result in or add to an already-existing
credit balance, Seller shall include such value(s) in corresponding Wholesaler Credit Balance
Payments.
5.12 Wholesaler Payments. During the Pre-Closing Period, subject to Bankruptcy Court
approval of such payments, the Seller shall timely pay all amounts invoiced by McKesson
Corporation, AmerisourceBergen Corporation, Cardinal, Kinray, or H.D. Xxxxx or their respective
Affiliates, prior to the Effective Time, for distribution services.
5.13 Lilly Agreement. Prior to the Closing, the Seller shall pay all amounts that it
owes under the Lilly Agreement in respect of dates prior to April 1, 2010, including any royalties
that the Seller owes thereunder with respect to the quarter ended March 31, 2010.
5.14 Adequate Assurances. During the Pre-Closing Period, the Purchaser shall, upon
the reasonable request of the Seller, use commercially reasonable efforts in communicating with
third parties to Assumed Contracts as may be reasonably necessary to assist the Seller in
establishing that the Purchaser has satisfied the requirement of adequate assurance of future
performance contained in Sections 365(b)(1)(C) and 365(f) of the Bankruptcy Code with respect to
such Assumed Contracts.
5.15 Efforts to Cause the Closing. Each Party shall use its commercially reasonable
efforts, in the most expeditious manner practicable, (i) to satisfy or cause to be satisfied all
the conditions precedent that are set forth in Article 6, as applicable to each of them,
and (ii) to cause the Transactions to be consummated.
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ARTICLE 6
CONDITIONS TO CLOSING
6.1 Conditions to Obligations of the Parties. The obligation of each Party to
consummate the Transactions is subject to the satisfaction on or prior to the Closing Date of the
following conditions:
(a) no Order preventing or restraining the consummation of the Transactions has been
instituted or threatened;
(b) no Law that makes the consummation of the Transactions illegal has been enacted or has
been deemed applicable to the Transactions; and
(c) the Approval Order is a Final Order.
6.2 Conditions to the Purchaser’s Obligations. The obligation of the Purchaser to
consummate the Transactions is subject to the satisfaction (or waiver in writing by the Purchaser
in its sole discretion) on or prior to the Closing Date of the following conditions:
(a) (i) each representation and warranty set forth in Article 3 that is qualified by
materiality is true and correct as written as of the date hereof and as of the Closing Date as if
made as of the Closing Date, except to the extent that such representation or warranty refers
specifically to an earlier date (other than the date hereof), in which case such representation or
warranty is true and correct in all respects as of such earlier date, and (ii) each representation
and warranty set forth in Article 3 that is not qualified by materiality is true and
correct in all material respects as of the date hereof and as of the Closing Date as if made as of
the Closing Date, except to the extent that such representation or warranty refers specifically to
an earlier date (other than the date hereof), in which case such representation or warranty is true
and correct in all material respects as of such earlier date;
(b) the Seller has performed and complied in all material respects with all obligations
required hereby to be performed or complied with by it at or prior to the Closing, including in
respect of the Seller’s obligations under Article 5;
(c) the Approval Order shall provide that the Lilly Agreement has been duly and validly
assumed by the Seller and that all of the Seller’s right, title and interest in and to the Lilly
Agreement has been duly and validly assigned to the Purchaser;
(d) the Seller has delivered (or caused to be delivered) to the Purchaser the items listed in
Section 2.2(a); and
(e) there shall not have occurred a Material Adverse Effect, including in respect of the
occurrence any of the following events that are, or could reasonably be expected to be,
individually or in the aggregate, materially adverse to the manufacture or supply of any Product,
the Regulatory Filings and Approvals for any Product, or the manufacture, use, sale or promotion of
any Product in reliance upon the Regulatory Filings and Approvals:
(i) any Regulatory Warning Notices that have been received by the Seller or a
Manufacturer that (A) cite GMP deficiencies with respect to the Stada Facility or Almac
Facility, (B) indicate the Stada Facility, Almac Facility and/or the Moxatag manufacturing
or packaging process or validation, product stability, analytical validation or prior
manufacturing has not or does not meet any minimum GMP requirements, or (C) otherwise
indicate any issues that would, or would be reasonably likely to, (1) result in the recall
of Moxatag, (2) require Stada to repeat manufacturing validation or analytical validation
with respect to Moxatag, (3) require Almac to
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repeat packaging validation with respect to Moxatag, or (4) cause any interruption in
the supply of Moxatag to the Seller (or to the Purchaser after the Effective Time);
(ii) any recall of any dosage strength or lot of any Product during the Pre-Closing
Period; or
(iii) any Force Majeure Event occurring during the Pre-Closing Period with respect to
any Manufacturing Facility or any building, facility or other site at which (A) Inventory
is, or during the Pre-Closing Period was, stored, (B) analytical testing is, or during the
Pre-Closing Period was, performed on or with respect to a Product, or (C) Product packaging
is, or during the Pre-Closing Period was, performed.
6.3 Conditions to the Seller’s Obligations. The obligation of the Seller to
consummate the Transactions is subject to the satisfaction (or waiver in writing by the Seller in
its sole discretion) on or prior to the Closing Date of the following conditions:
(a) (i) each representation and warranty set forth in Article 4 that is qualified by
materiality is true and correct as written as of the date hereof and as of the Closing Date as if
made as of the Closing Date, except to the extent that such representation or warranty refers
specifically to an earlier date (other than the date hereof), in which case such representation or
warranty is true and correct in all respects as of such earlier date, and (ii) each representation
and warranty set forth in Article 4 that is not qualified by materiality is true and
correct in all material respects as of the date hereof and as of the Closing Date as if made as of
the Closing Date except to the extent that such representation or warranty refers specifically to
an earlier date (other than the date hereof), in which case such representation or warranty is true
and correct in all material respects as of such earlier date;
(b) the Purchaser has performed and complied in all material respects with all obligations
required hereby to be performed or complied with by it at or prior to the Closing; and
(c) the Purchaser has delivered (or caused to be delivered) to the Purchaser the items listed
in Section 2.2(b).
ARTICLE 7
ADDITIONAL COVENANTS
7.1 Confidentiality; Publicity.
(a) The terms of the Confidentiality Agreement are hereby incorporated in this Agreement as
though fully set forth herein and shall apply during the Pre-Closing Period to any information
provided to the Seller or the Purchaser pursuant to this Agreement. Upon the Closing, the
Confidentiality Agreement shall expire and be of no further force and effect; provided, however,
such expiration of the Confidentiality Agreement shall in no way prejudice or adversely affect the
Seller’s or the Purchaser’s ability to seek damages, or any other remedy available to the Seller or
the Purchaser, as appropriate, with respect to a violation by such other Party (or its Affiliates
or Representatives) of the Confidentiality Agreement prior to the Closing.
(b) From and after the Closing, all Confidential Information exclusively concerning the
Products, the Purchased Assets and the Assumed Liabilities (the “Purchaser Confidential
Information”) shall be used by the Seller and its Affiliates solely as required to perform its
obligations, exercise or enforce its rights under this Agreement (or any Other Agreements), or
comply with applicable Law, and for no other purpose. The Seller shall not disclose, or permit the
disclosure of, any of Purchaser Confidential Information to any Person except those Persons to whom
such disclosure is necessary to permit the Seller to perform its obligations, exercise or enforce
its rights under this Agreement (or any
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Other Agreements), or comply with applicable Law. The Seller shall treat, and will cause its
Affiliates and the Representatives of the Seller or any of its Affiliates to treat, Purchaser
Confidential Information as confidential, using the same degree of care as the Seller normally
employs to safeguard its own confidential information from unauthorized use or disclosure, but in
no event less than a reasonable degree of care.
(c) From and after the Closing, all Confidential Information other than Purchaser Confidential
Information (the “Seller Confidential Information”) shall be used by the Purchaser solely
as required to perform its obligations, exercise or enforce its rights under this Agreement (or any
Other Agreements), or comply with applicable Law, and for no other purpose. The Purchaser shall
not disclose, or permit the disclosure of, any of the Seller Confidential Information to any Person
except those Persons to whom such disclosure is necessary to permit the Purchaser to perform its
obligations, exercise or enforce its rights under this Agreement (or any Other Agreements), or
comply with applicable Law. The Purchaser shall treat, and will cause its Affiliates and the
Representatives of the Purchaser or any of its Affiliates to treat, the Seller Confidential
Information as confidential, using the same degree of care as the Purchaser normally employs to
safeguard its own confidential information from unauthorized use or disclosure, but in no event
less than a reasonable degree of care.
(d) The Purchaser acknowledges and agrees that the Seller (and its Affiliates) may together
retain one (1) or more copies of all or part of the documentation (including written or electronic
records, files, manuals, filings, etc.), including any Purchaser Confidential Information contained
therein, that it delivers to the Purchaser as part of the Purchased Assets, in accordance with the
provisions of and solely for the purposes set forth in this Section 7.1; provided, however, that
the use of such documentation (including written or electronic records, files, manuals, filings,
etc.) does not constitute or otherwise facilitate, directly or indirectly, the development, use,
making or commercialization of any competitive product.
(e) From and after the Closing, in the event either Party is requested pursuant to, or
required by, applicable Law to disclose any of the other Party’s Confidential Information
(including Seller Confidential Information or Purchaser Confidential Information, as applicable),
it will notify the other Party in a timely manner so that such Party may seek, at its own expense,
a protective order or other appropriate remedy or, in such Party’s sole discretion, waive
compliance with the confidentiality provisions of this Agreement. Each Party will cooperate in all
reasonable respects, in connection with any reasonable actions to be taken for the foregoing
purpose. If, in the absence of any such protective order or other appropriate remedy or receipt of
a waiver from the other Party, the Party requested or required to disclose such Confidential
Information is nonetheless, in the opinion of its legal counsel, legally compelled to make such
disclosure, it may furnish such Confidential Information as requested or required pursuant to
applicable Law without liability hereunder, provided that such Party furnishes only that portion of
the Confidential Information which such Party is advised by its legal counsel is legally required,
and such Party exercises reasonable efforts to obtain reliable assurances that confidential
treatment will be accorded such Confidential Information.
(f) Notwithstanding anything else to the contrary in this Agreement or in the Confidentiality
Agreement, before issuing any publication, news release or other public announcement regarding, or
including or referencing in any regulatory or court filing (other than with respect to the Case),
or otherwise disclosing, this Agreement, any of the Other Agreements or any of the Transactions
(including the occurrence of the Closing and/or the identities of the parties to the Transactions
and/or any of their respective Affiliates) or any of the terms or conditions of the Transactions
(collectively, “Deal Related Information”), the issuing Party must first submit such
disclosure of Deal Related Information to the other Party for review and the other Party must have
consented thereto in writing (which consent the other Party is entitled to withhold in its sole
discretion); provided, however, that notwithstanding the foregoing or any contrary term contained
in the Confidentiality Agreement, (i) any disclosure of Deal Related Information that is
nonetheless, in the opinion of the disclosing Party’s legal counsel, legally compelled to be made
by the disclosing Party, may be made by the disclosing Party without the prior written consent of
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the other Party, provided that such disclosure is limited to only that which such disclosing
Party is advised by its legal counsel to be legally required to be disclosed, (ii) any Party may
issue a press release or public announcement without the prior written consent of the other Party
if all of the contents of such press release or public announcement have previously been made
public other than through a breach of this Agreement by the issuing Party, and (iii) prior to the
Closing, to the extent disclosure of Deal Related Information by the Purchaser is reasonably
necessary in connection with undertaking financing activities in support of the Transactions, the
Purchaser shall be permitted to make such disclosures; provided further, from and after the
Closing, the Purchaser shall be permitted to disclose Deal Related Information to any third party
or publicly make such disclosures when and in whatever manner the Purchaser deems necessary or
useful. With regard to disclosures made under the foregoing subsection (i): (X) to the extent
practicable, the disclosing Party shall give at least three (3) Business Days advance notice of any
such legally required disclosure to the other Party, and such other Party may, if applicable,
reasonably request that the disclosing Party request confidential treatment of such disclosure and
may otherwise provide any comments on the proposed disclosure (which comments, if reasonable, the
disclosing Party shall reflect in such disclosure) during such period and if not practicable, such
lesser practicable period, if any; and (Y) if a Party requests that the disclosing Party request
confidential treatment of any disclosure pursuant to subsection (X), the Parties shall cooperate,
each at its own expense, in such confidential treatment request and shall execute all documents
reasonably required in connection therewith.
7.2 Availability of Records. After the Closing, the Seller, on the one hand, and the
Purchaser, on the other hand, shall make available to each other Party and its Affiliates and
Representatives during normal business hours when reasonably requested, all Product Records in its
possession and shall preserve all such information, records and documents until the later of: (i)
six (6) years after the Closing; (ii) the expiration of all statutes of limitations for assessing
or collecting Taxes for periods ending on or prior to the Closing and periods including the Closing
Date, including extensions thereof applicable to the Seller or the Purchaser; or (iii) the required
retention period under any applicable Laws for all such information, records or documents (it being
understood that the Parties shall not be required to provide any Tax Returns to any Person, other
than as required by applicable Laws). The Purchaser and the Seller shall also make available for
consultation to each other during normal business hours, when reasonably requested, personnel
responsible for preparing or maintaining information, records and documents, in connection with Tax
matters, governmental contracts, litigation or potential litigation, each as it relates to any
Product, Business, Purchased Assets or Assumed Liabilities prior to the Closing Date (with respect
to the Seller) or from and after the Closing Date (with respect to the Purchaser), including
product liability and general insurance liability.
7.3 Notification of Customers. Promptly after the Closing, the Purchaser and the
Seller shall jointly notify all wholesale distributors of the Products (a) of the transfer of the
Purchased Assets to the Purchaser, (b) that all purchase orders for the Products received by the
Seller or any of its Affiliates on, prior to or after the Closing Date but not shipped prior to the
Effective Time will be transferred to the Purchaser (provided that to the extent that any purchase
order cannot be so transferred, the Seller and the Purchaser shall cooperate with each other to
ensure that such purchase order is filled and that the Purchaser receives the same economic benefit
and assumes the same Liability associated with filling such purchase order as if such purchase
order had been so transferred), and (c) that all purchase orders for the Product received after the
Closing Date should be sent to the Persons and addresses as directed by the Purchaser. Without the
prior written consent of the Seller, in no event shall the Purchaser or any of its Affiliates or
Representatives contact any of the Seller’s suppliers, wholesale distributors or other customers
prior to the Closing for any purpose related to or arising out of the Transactions.
7.4 Transfer of NDAs. After the Closing, if any NDA with respect to any of the
Products has not been transferred to the Purchaser, then the Seller shall use its commercially
reasonable efforts to transfer such NDA to the Purchaser and to maintain such NDA until transfer of
such NDA to the Purchaser has been completed. The Purchaser shall provide its required regulatory
submissions to the FDA in connection with the transfer of such NDAs.
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7.5 Product Returns, Rebates, Chargebacks and Vouchers.
(a) Government Rebates.
(i) The Seller acknowledges that the Purchaser will require certain information and
cooperation from the Seller to meet its obligations with regard to pricing and calculating
the rebates pursuant to any governmental rebate program (“Government Rebates”) for
Products bearing NDC numbers of the Seller or any of its Affiliates. Accordingly, from and
after the Closing Date until the date that is one calendar year after the expiration date of
the last lot of each Product produced with any NDC number of the Seller, the Seller shall
provide the Purchaser cooperation and assistance in connection with appropriately submitting
to the Centers for Medicare and Medicaid Services, the following information: (A) the Best
Price for each Product identified by NDC number; (B) the “average manufacturer price” (as
defined under the Social Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0(x)(0)) (“AMP”) for each
Product identified by the NDC number, (C) all data used by the Purchaser or the Seller to
calculate the AMP and Best Price for each Product identified by NDC number; and (D) any
additional pricing and/or claims data or other information related to such Medicaid issues
reasonably requested by the Purchaser. Without limiting the generality of the foregoing, or
being limited thereby, after the Closing, the Purchaser shall make all appropriate filings
and submissions with the Centers for Medicare and Medicaid Services in regard to all
Government Rebates for Products dispensed prior to the Effective Time for which such filings
or submissions have not previously been made by the Seller, including any filings covering
Products dispensed in any partial calendar quarter period leading up the Closing Date.
(ii) Schedule 7.5(a)(ii) sets forth the “Best Price” (as defined at 42 U.S.C.
§ 1396r-8(c)(1)(C)) (the “Best Price”) and AMP reported by the Seller for each
Product for the two most recently ended calendar quarters.
(iii) IN NO EVENT WILL THE PURCHASER BE OBLIGATED TO REIMBURSE THE SELLER FOR OR PAY
ANY GOVERNMENTAL ENTITY FOR ANY SELECTED GOVERNMENT REBATES THAT ARE NOT OWED BY THE SELLER
OR ARE NOT BASED UPON LEGALLY AND ACCURATELY CALCULATED INFORMATION SUBMITTED TO
GOVERNMENTAL ENTITIES BY THE SELLER.
(iv) If the Purchaser disputes any Government Rebate relating to a Product dispensed
prior to the Effective Time, then the Purchaser shall provide notice to the Seller, and,
upon receipt of such notice, the Seller shall notify the applicable Governmental Entity that
the Purchaser disputes such claim and the basis therefor. The Seller shall, to the extent
not part of the Purchased Assets, provide to the Purchaser, upon Purchaser’s reasonable
request, copies of any documents and records evidencing the original data relating to
Government Rebate calculations that are reasonably necessary to enable the Purchaser to
resolve such disputed amount. The Purchaser will be responsible for managing the dispute
and amount owed under any such disputed Government Rebate, and the Seller shall provide
reasonable assistance to the Purchaser in its dispute thereof.
(v) Notwithstanding the other provisions of this Section 7.5, the Parties acknowledge
that the VA National Acquisition Center must approve the addition of Products to the
Purchaser’s Federal Supply Schedule (“FSS”) Contract and the removal of the Product
from the Seller’s FSS Contract before the responsibility of processing chargebacks may be
transferred from the Seller to the Purchaser. The Parties shall cooperate with one another
to ensure the prompt completion of such approval. Upon request by the Purchaser, the
Seller shall provide the Purchaser, as promptly as practicable, with all information
reasonably related to the Product and the prices thereof that the Purchaser reasonably
requires in order to comply with applicable rules and regulations relating to P.L. 102-585
as it relates to the FSS.
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7.6 Accounts Receivable. The Parties acknowledge and agree that all accounts
receivable of the Seller are and shall after Closing remain the property of the Seller and the
Seller’s Affiliates and shall be collected by the Seller or the Seller’s Affiliates subsequent to
the Closing. In the event that, subsequent to the Closing, the Purchaser or the Purchaser’s
Affiliates receives any payments from any obligor with respect to an account receivable of the
Seller, then Purchaser shall within ten (10) Business Days of receipt of such payment remit the
full amount of such payment to the Seller. In the event that, subsequent to the Closing, the
Seller or the Seller’s Affiliates receives any payments from any obligor with respect to an account
receivable of the Purchaser, then Seller shall within ten (10) Business Days of receipt of such
payment remit the full amount of such payment to the Purchaser.
7.7 Regulatory Matters.
(a) From and after the Closing Date, the Purchaser, at its cost, shall be solely responsible
and liable for (i) taking all actions, paying all fees and conducting all communication with the
appropriate Governmental Entity required by Law in respect of the Regulatory Filings and Approvals,
including preparing and filing all reports (including adverse drug experience reports) with the
appropriate Governmental Entity (whether the Product is sold before or after transfer of such
Regulatory Filings and Approvals), (ii) taking all actions and conducting all communication with
third parties with respect to Product sold pursuant to such Regulatory Filings and Approvals
(whether sold before or after transfer of such Regulatory Filings and Approvals), including
responding to all complaints in respect thereof, including complaints related to tampering or
contamination, and (iii) investigating all complaints and adverse drug experiences with respect to
Product sold pursuant to such Regulatory Filings and Approvals (whether sold before or after
transfer of such Regulatory Filings and Approvals).
(b) From and after the Closing Date, the Purchaser, at its cost, shall be solely responsible
and liable for conducting all voluntary and involuntary recalls of units of the Product sold
pursuant to such Regulatory Filings and Approvals (whether sold before or after transfer of such
Regulatory Filings and Approvals), including recalls required by any Governmental Entity and
recalls of units of the Product sold by the Seller deemed necessary by the Seller in its reasonable
discretion.
7.8 Website Information. As soon as reasonably practicable following the Closing, the
Seller shall take all such commercially reasonable action required to transfer to Purchaser the
Product Domain Names and Other Domain Names, including all web sites and content therein at such
domain names as of the Effective Date.
7.9 Tax Matters.
(a) The Parties shall reasonably cooperate with one another to lawfully minimize all Transfer
Taxes arising out of the transfer of the Purchased Assets. Each Party shall bear one-half of any
Transfer Taxes resulting from the transfer of the Purchased Assets. The Parties shall cooperate to
timely prepare and file any Tax Returns relating to such Transfer Taxes, including any claim for
exemption or exclusion from the application or imposition of any Transfer Taxes. The Seller shall
pay all Transfer Taxes and shall file all necessary documentation and returns with respect to such
Transfer Taxes when due, and shall promptly, following the filing thereof, furnish a copy of such
return or other filing and a copy of a receipt showing payment of any such Transfer Tax to the
Purchaser, and the Purchaser shall promptly reimburse the Seller one-half thereof pursuant to the
first sentence of this Section 7.9(a). Each Party shall furnish or cause to be furnished to the
other, upon request, as promptly as practicable, such information and assistance relating to the
Purchased Assets as is reasonably necessary for filing of all Tax Returns, including any claim for
exemption or exclusion from the application or imposition of any Taxes or making of any election
related to Taxes, the preparation for any audit by any Taxing Authority and the prosecution or
defense of any Suit relating to any Tax Return.
(b) All real property Taxes, personal property Taxes and similar Taxes imposed on a periodic
basis levied with respect to the Purchased Assets for any taxable period that begins on or before
the
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Closing Date and ends after the Closing Date, whether imposed or assessed before or after the
Closing Date, shall be prorated between Parties as of the Closing Date. The Seller shall be
responsible for the payment of all Taxes incurred or accrued through the Closing Date and the
Purchaser shall be responsible for the payment of all Taxes incurred or accrued after the Closing
Date. If any such Taxes subject to proration are paid by the Purchaser, on the one hand, or the
Seller, on the other hand, then the proportionate amount of such Taxes paid (or in the event a
refund of any portion of such Taxes previously paid is received, such refund) shall be paid
promptly by (or to) the other Party after receipt by such other Party of evidence showing the
payment of such Taxes (or promptly following the receipt of any such refund).
(c) The Parties hereby waive compliance with any “bulk sales” Laws (including any requirement
to withhold any amount from payment of the Purchase Price) applicable to the sale to the Purchaser
of the Purchased Assets and the Inventory by the Seller.
7.10 Government Product Contracts.
(a) After the Effective Time, the Purchaser shall honor and perform all Liabilities of the
Seller arising after the Effective Time under and pursuant to each Government Product Contract with
respect to supplying the Product to the applicable party pursuant to such Government Product
Contract until such time as the VA permits the Purchaser add the Product to its FSS Contract. The
Seller agrees that, except as otherwise required by applicable Law, after the Effective Time it
will not take any action with respect to any Government Product Contract that would, to the
Seller’s Knowledge, extend the term of such Government Product Contract with respect to the Product
or otherwise adversely affect the Purchaser or any Business, without the prior consent of the
Purchaser. The Seller may enter into a separate agreement with such government party, provided
that such agreements do not contain any provisions relating to any Product or any Business.
(b) Seller shall provide the Purchaser with all information and data reasonably requested by
the Purchaser, to the extent not included in the Purchased Assets, necessary for the Purchaser to
add the Products to the Purchaser’s FSS Contract. The Seller shall terminate the rights and
obligations of the Seller with respect to the Products under each such Government Product Contract,
to the extent permitted by the terms thereof and to the extent permitted by, and in accordance
with, applicable Law, as soon as reasonably practicable after receipt of notification from the
Purchaser that the Product has been added to the Purchaser’s FSS Contract.
(c) Seller shall provide the Purchaser all data related to the Seller’s sales of Product
necessary for the Purchaser to calculate a new Federal Ceiling Price under the Veterans Health Care
Act, 38 U.S.C. § 8126.
7.11 Non-Disparagement. From and after the Effective Time, the Seller and the
Purchaser shall not, directly or indirectly, alone or in connection with any Person, engage in any
conduct or make any statement, whether in commercial or noncommercial speech, disparage or
criticize in any way the Purchaser or the Seller, as applicable, or any of its Affiliates, or any
products or services offered by any of them, and the Seller and the Purchaser shall not engage in
any conduct or make any other statement that could reasonably be expected to impair the goodwill of
any of these, or the reputation or marketing of any such party’s products or services, in each case
except to the extent required by Law, and then only after consultation with the party affected by
such conduct or statement.
7.12 No Challenge. From and after the Effective Time, the Seller and its Affiliates
shall not directly or indirectly initiate or prosecute any lawsuit or any other civil or
administrative Suit, or the making of any Claim or counterclaim, of any kind in any court,
tribunal, agency or Governmental Entity anywhere in the world challenging the validity or
enforceability of any Patents assigned to the Purchaser pursuant to the terms hereof. Nothing in
this Section 7.12 shall be construed as an admission or
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concession by the Purchaser that the Seller or its Affiliates has, or ever shall have, any
standing, right, or basis to challenge the validity or enforceability of any such Patents.
7.13 Non-Assertion. From and after the Effective Time, none of the Seller or its
Affiliates, or its or their successors and assigns, shall (a) xxx the Purchaser or any of its
Affiliates or sublicensees (or any of its or their successors or assigns) under or in connection
with or (b) commence, aid, prosecute, or cause to be commenced, aided or prosecuted any action or
other proceeding against any such Person for, in each case (subsections (a) and (b) of this Section
7.13), any infringement or misappropriation of any materials, information, data, know-how, Patents,
trade secrets or other intellectual property rights owned or otherwise controlled by the Seller
after the Effective Date that would be infringed or misappropriated by the development, use,
manufacture, commercialization, offering for sale, selling or importing any of the Products.
Without limiting any other right or remedy available to the Purchaser at law or in equity, the
Seller agrees and acknowledges that the foregoing covenant of the Purchaser in this Section
7.13 shall not act to limit or otherwise prejudice any suit, action or other proceeding to the
extent involving any breach or enforcement of other provisions of this Agreement.
7.14 Excluded Inventory. Promptly after the Closing, at its sole cost and expense,
the Seller shall destroy, or caused to be destroyed, all Excluded Inventory, and, promptly
thereafter, shall certify to the Purchaser in writing that all Excluded Inventory has been
destroyed.
7.15 Further Assurances. Subject to the terms and conditions herein, following the
Closing, the Seller shall execute and deliver to the Purchaser such instruments, assurances bills
of sale, endorsements, assignments and other documents, in form and substance reasonably
satisfactory to the Purchaser, and shall take such further action, in each case as the Purchaser
reasonably requests, (a) to vest in the Purchaser all of the Seller’s right, title and interest in
and to the Purchased Assets, (b) so that the Purchaser is placed in actual possession and operating
control of the Purchased Assets, (c) to assist the Purchaser in engaging independent contractors
and current or former employees of the Seller (d) to otherwise effect the Transactions.
ARTICLE 8
TERMINATION AND SURVIVAL
8.1 Termination. Notwithstanding anything contained herein to the contrary, this
Agreement may be terminated and the Transactions may be abandoned at any time prior to the Closing:
(a) by mutual written consent of the Seller and the Purchaser;
(b) by either the Seller or the Purchaser if a Governmental Entity has issued a final and
non-appealable Order or taken any other final and non-appealable action, in any case having the
effect of permanently restraining, enjoining or otherwise prohibiting the Transactions;
(c) by either the Seller or the Purchaser if the Closing does not occur on or before October
15, 2010 (such date, the “Outside Date”); provided, however, that a Party
is not entitled to terminate this Agreement pursuant to this Section 8.1(c) if such Party’s
material breach of one or more of its covenants hereunder is the cause of or results in the failure
of the Closing to occur on or before the Outside Date;
(d) by the Purchaser if: (i)(A) the Seller breaches one or more of its covenants hereunder,
such that the condition set forth in Section 6.2(b) would not be satisfied, or (B) any
representation or warranty of the Seller is or hereafter becomes inaccurate (as if such
representation or warranty was made as of the date of determination of such inaccuracy rather than
as of the date hereof), such that the condition set forth in Section 6.2(a) would not be satisfied;
and (ii) such breach or inaccuracy, as the case may be, either (A) is not curable, (B) by its
nature or timing cannot reasonably be cured prior to the Outside Date or (C) if curable, is not
cured within ten (10) Business Days after the Purchaser provides
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written notice to the Seller of such breach or inaccuracy, respectively; provided,
however, that the Purchaser is not entitled to terminate this Agreement pursuant to this
Section 8.1(d) if (x) the Purchaser is in material breach of one or more of its covenants hereunder
or (y) at the time of such proposed termination, one or more of the Purchaser’s representations or
warranties hereunder is inaccurate in any material respect;
(e) by the Purchaser if: (i) the condition set forth in Section 6.2(e) is not satisfied at any
time during the Pre-Closing Period; and (ii) the failure to satisfy such condition either (A) is
not curable, (B) by its nature or timing cannot reasonably be cured prior to the Outside Date, or
(C) if curable, is not cured within fifteen (15) Business Days after the Purchaser provides written
notice to the Seller of the failure to satisfy such condition;
(f) by the Purchaser if:
(i) the Bankruptcy Court has not entered the Procedures Order on or before June 30,
2010;
(ii) after its entry, the Procedures Order fails to be in full force and effect or has
been stayed, reversed, modified, or amended in any respect without the prior written consent
of the Purchaser; or
(iii) the Bankruptcy Court has not entered the Approval Order on or before August 31,
2010.
(g) by the Seller if: (i)(A) the Purchaser breaches one or more of its covenants hereunder,
such that the condition set forth in Section 6.3(b) would not be satisfied, or (B) any
representation or warranty of the Purchaser is or hereafter becomes inaccurate (as if such
representation or warranty was made as of the date of determination of such inaccuracy rather than
as of the date hereof), such that the condition set forth in Section 6.3(a) would not be satisfied;
and (ii) such breach or inaccuracy, as the case may be, either (A) is not curable, (B) by its
nature or timing cannot reasonably be cured prior to the Outside Date or (C) if curable, is not
cured within ten (10) Business Days after the Seller provides written notice to the Purchaser of
such breach or inaccuracy, respectively; provided, however, that the Seller is not
entitled to terminate this Agreement pursuant to this Section 8.1(g) if (x) the Seller is in
material breach of one or more of its covenants hereunder or (y) at the time of such proposed
termination, one or more of the Seller’s representations or warranties hereunder is inaccurate in
any material respect.
8.2 Automatic Termination. This Agreement shall terminate automatically, without any
action on the part of any Party, if the Bankruptcy Court or other court of competent jurisdiction
enters an Order approving a proposal from a Person other than the Purchaser or any of its
Affiliates for the acquisition of any or all of the Purchased Assets.
8.3 Effect of Termination. If this Agreement is terminated pursuant to and in
accordance with this Article 8, then this Agreement will thereupon become void and of no
further force and effect, with no liability or obligation on the part of the Parties or their
respective Representatives or Affiliates, except as set forth in Section 8.4; provided,
however, that (a) this Section 8.3 (Effect of Termination), Article 9 (as
applicable for interpretation and administration of the foregoing) and the Depositary Agreement,
Escrow Agreement and Confidentiality Agreement will not be terminated thereby and (b) other than as
provided in this Article 8, such termination will not operate to relieve any Party from liability
with respect to such Party’s willful violation of any provision hereof prior to such termination.
8.4 Remedies. If (a) this Agreement is terminated by the Seller pursuant to Section
8.1(c), or (b) this Agreement terminates automatically pursuant to Section 8.2 and such acquisition
by any Person other than the Purchaser actually closes, then the Seller shall pay to the Purchaser
an amount in cash equal to (i) Four Hundred Thousand U.S. Dollars (U.S. $400,000) (the “Breakup
Fee”), plus (ii) the amount of
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the Purchaser’s Expenses up to a maximum amount of One Hundred Fifty Thousand U.S. Dollars
($150,000), by wire transfer of immediately available funds, within two (2) Business Days after
such termination of this Agreement pursuant to Section 8.1(c) or the closing of such acquisition by
a Person other than the Purchaser.
8.5 Procedure for Termination. In order for a Party to terminate this Agreement
pursuant to Section 8.1, such Party must provide written notice of such termination to the other
Party, and such termination will be effective at the time when such terminating Party has provided
such notice to the other Party.
ARTICLE 9
MISCELLANEOUS
9.1 Notices. To be effective for purposes of this Agreement, any notice, request,
demand, waiver, consent, approval or other communication (any of the foregoing, a “Notice”)
that is required or permitted hereunder must be in writing and will be deemed given: (a) on the
date established by the sender as having been delivered personally; (b) on the date delivered by a
private, internationally recognized, overnight courier as established by the sender by evidence
obtained from the courier; (c) on the date sent by facsimile, with confirmation of transmission, if
sent during normal business hours of the recipient (and, if not sent during normal business hours
of the recipient, then on the next Business Day); or (d) on the third (3rd) Business Day
after the date mailed, by certified or registered mail, return receipt requested, international
postage prepaid. Such communications, to be valid, must be addressed as follows:
If to the Seller, to:
XxxxxxXxxxx Pharmaceutical, Inc.
0 Xxxxxxx Xxxxxx
Xxxxx 000
Xxxxxxxx, XX 00000
Attn: Xxxx Xxxx
Facsimile: (000) 000-0000
With a required copy (the delivery of which will not constitute notice to the Seller) to:
Xxxxxx & Bird LLP
0000 Xxxx Xxxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attn: J. Xxxx Xxx
Facsimile: (000) 000-0000
If to the Purchaser, to:
Victory Pharma, Inc.
00000 Xx Xxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, XX 00000
Attn: Chief Executive Officer
Facsimile: (000) 000-0000
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With a required copy (the delivery of which will not constitute notice to the Purchaser) to:
Xxxx Xxxxx LLP
000 Xxxxxxxxx Xxxxxx
Xxx Xxxx, XX 00000
Attn: Xxxxxx Xxxxxx
Attn: Xxxx X. Xxxxxxxx
Facsimile: (000) 000-0000
Alternatively, a valid Notice may be delivered to such other address or to the attention of
such Person or Persons as the recipient Party has specified by prior written notice (in accordance
with this Section 9.1) to the sending Party (or, in the case of counsel, to such other readily
ascertainable business address as such counsel may hereafter maintain). If more than one method
for sending Notice as set forth above is used, the earliest notice date established as set forth
above will control for purposes of determining when such Notice is deemed to have been given.
9.2 Amendments and Waivers.
(a) Any provision of this Agreement may be amended or waived if, and only if, such amendment
or waiver is in writing and is signed, in the case of an amendment, by each Party, or, in the case
of a waiver, by the Party against which the waiver is to be effective. The waiver by any Party of
any right or privilege hereunder arising because of any breach, default or misrepresentation,
whether intentional or not, will not thereby extend and will not be deemed to thereby extend to any
prior or subsequent breach, default or misrepresentation by such Party or by another Party and will
not affect in any way any rights arising by virtue of any such prior to subsequent occurrence.
(b) No failure or delay by any Party in exercising any right or privilege hereunder will
operate as a waiver thereof, nor will any single or partial exercise thereof preclude any other or
further exercise thereof or the exercise of any other right, power or privilege.
9.3 Expenses. Except as otherwise expressly provided in this Agreement, each Party
shall bear its own costs and expenses in connection with this Agreement, the Other Agreements and
the Transactions, including all legal, accounting, financial advisory, consulting and all other
fees and expenses of third parties, whether or not the transactions contemplated hereunder are
consummated.
9.4 Successors and Assigns. Each Party shall not assign or delegate (or enter into
any Contract that would otherwise effect the assignment or delegation of) any of its rights or
obligations hereunder without the prior written consent of the other Party; provided, however, that
(a) without obtaining the consent of the Seller, the Purchaser may collaterally assign any of its
rights hereunder to any Person providing financing to the Purchaser in connection with the
Transactions (and the Seller hereby consents to any such assignment), and (b) from and after the
Escrow Release Date following the Closing, the Purchaser may assign this Agreement and/or the
rights and obligations relating to one or more of the Products or any Other Product Intellectual
Property, or grant any sublicenses thereunder, to any third party or an Affiliate of the Purchaser,
in each case without obtaining the consent of the Seller. The terms and conditions of this
Agreement shall be binding upon and shall inure to the benefit of the successors, heirs,
administrators and permitted assigns of the Parties. Any purported assignment in violation of this
Section 9.4 shall be null and void ab initio.
9.5
Governing Law. Except to the extent that the Bankruptcy Code mandatorily applies,
this Agreement is governed by, and is to be interpreted and enforced in accordance with, the
internal Laws of the State of
Delaware applicable to contracts entered into and performed entirely
within the State of
Delaware, without giving effect to any choice of Law or conflict of Laws rules
or provisions (whether of the State of
Delaware or any other jurisdiction) that would cause the
application of the Laws of any jurisdiction other than the State of
Delaware.
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9.6 Consent to Jurisdiction and Venue. Each Party irrevocably submits to the
exclusive jurisdiction of, and venue in, the Bankruptcy Court for the purposes of any Suit arising
out of this Agreement or any transaction contemplated hereby, and agrees to commence any such Suit
only in such court. Each Party further agrees that service of any process, summons, notice or
document by U.S. registered mail to such Party’s respective address set forth herein will be
effective service of process for any such Suit. Each Party hereby irrevocably and unconditionally
waives any objection to the laying of venue of any Suit arising out of this Agreement or the
Transactions in such court, and hereby irrevocably and unconditionally waives and agrees not to
plead or claim in such court that any such Suit brought in such court has been brought in an
inconvenient forum.
9.7 Counterparts. This Agreement may be executed in multiple counterparts, and any
Party may execute any such counterpart, each of which when executed and delivered will thereby be
deemed to be an original and all of which counterparts taken together will constitute one and the
same instrument. This Agreement will become effective as of the date first set forth above when
each Party has received one or more counterparts hereto signed by the other Parties. The delivery
of this Agreement, and the delivery of the Other Agreements and any other agreements and documents
at the Closing (except for the delivery of any negotiable instruments) may be effected by means of
an exchange of facsimile or portable document format (.pdf) signatures.
9.8 No Third-Party Beneficiaries. No provision of this Agreement is intended to
confer upon any Person other than the Parties, their respective successors and permitted assigns
any rights or remedies hereunder.
9.9 Entire Agreement; Schedules. This Agreement, the Other Agreements, the
Confidentiality Agreement and the other documents, instruments and agreements specifically referred
to herein or therein, or delivered pursuant hereto or thereto, (a) set forth the entire
understanding of the Parties with respect to the subject matter hereof and thereof the Transactions
and (b) supersede any and all previous agreements and understandings between or among the Parties
regarding the subject matter hereof or thereof, whether written or oral. All Schedules referred to
herein are intended to be and hereby are specifically made a part of this Agreement.
9.10 Captions. All captions contained in this Agreement are for convenience of
reference only, do not form a part of this Agreement and are not to affect in any way the meaning
or interpretation of this Agreement.
9.11 Severability. If any portion or provision of this Agreement is to any extent
declared illegal or unenforceable by a court of competent jurisdiction, then the remainder of this
Agreement, or the application of such portion or provision in circumstances other than those as to
which it is so declared illegal or unenforceable, will not be affected thereby, and each portion
and provision of this Agreement will be valid and enforceable to the fullest extent permitted by
Law.
9.12 Interpretation. The Parties have participated jointly in the negotiation and
drafting of this Agreement, and any rule of construction or interpretation otherwise requiring this
Agreement to be construed or interpreted against any Party by virtue of the authorship of this
Agreement is not to affect the construction and interpretation hereof.
9.13 Time of the Essence. Time is of the essence of this Agreement and of every part
hereof.
9.14 Signed Writings. Emails, including emails that bear an electronic “signature
block” identifying the sender, do not constitute signed writings for purposes of this Agreement.
9.15 Business Days. If any date for payment or notice under this Agreement falls on a
day other than a Business Day, then the referenced date will be deemed to refer to the first
Business Day following such date.
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9.16 Disclaimer. Except as otherwise expressly provided in Article 4, with respect to
the Seller, and Article 5, with respect to the Purchaser, neither Party is making or has made any
other representation or warranty, express or implied, written or oral, at law or in equity, in
respect of the Purchased Assets, the Assumed Liabilities, or the Products, including any implied
representation or warranty with respect to merchantibility, non-infringement, suitability or
fitness for any particular purpose.
9.17 Construction.
(a) For the purposes of this Agreement, except as otherwise expressly provided herein: (i)
where a word or phrase is defined herein, each of its other grammatical forms shall have a
corresponding meaning; (ii) the terms “hereof,” “herein,” “hereunder,” “hereby,” “hereto” and
“herewith” and words of similar import are to be construed to refer to this Agreement as a whole
and not to any particular provision of this Agreement; (iii) unless otherwise indicated, a
reference in this Agreement to an Article, Section, paragraph, Exhibit or Schedule is a reference
to an Article, Section, paragraph, Exhibit or Schedule, respectively, of or to this Agreement; (iv)
the words “include,” “includes,” and “including” when used in this Agreement are in all cases
deemed to be followed by the words “without limitation”; (v) the term “Dollars” and the symbol “$”
mean United States Dollars; and (vi) all accounting terms used and not defined herein have the
respective meanings given to them under US GAAP.
(b) Unless otherwise expressly provided herein, any reference (i) to an agreement (including
this Agreement) and all other contractual instruments is a reference to such agreement or
instrument (including all exhibits, schedules and appendixes thereto) as the same may be amended or
otherwise modified from time to time in accordance with the terms thereof and (ii) to a law is a
reference to all statutory and regulatory provisions consolidating, amending, replacing,
supplementing or interpreting such law.
(c) To the extent that an Entity has an obligation hereunder to not permit another Person from
taking any action, such Entity is deemed to have a concurrent obligation to cause such other
Person, to the extent such Entity is capable of exercising control over the actions of such other
Person, to cease taking such action (if applicable) and to refrain from taking such action.
(d) For purposes of this Agreement, the term “control,” as used with respect to any Person,
means the power to direct the management and policies of such Person, directly or indirectly,
whether through the ownership of voting Securities, by Contract or otherwise. The terms
“controlling” and “controlled” have meanings correlative to the foregoing.
[Signature page follows.]
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The Parties are signing this Agreement as of the Execution Date.
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VICTORY PHARMA, INC.
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By: |
/s/ Xxxxxx X. Xxxxxxx |
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Name: |
Xxxxxx X. Xxxxxxx |
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Title: |
VP of Finance / CAO |
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XXXXXXXXXXX PHARMACEUTICALS, INC.
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By: |
/s/ Xxxxx Xxxxxx |
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Name: |
Xxxxx Xxxxxx |
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Title: |
Chief Financial Officer and Acting CEO |
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Exhibit A
Definitions
As used herein, the following capitalized terms have the following meanings:
“852 Reports” means the electronic data interchange (EDI) 852 report, at a given time,
summarizing (a) outbound sales of Products from the Seller’s wholesalers to their retail customers
and (b) inventory of Products on hand at such wholesalers at such time.
“Acquired Fixtures” means the fixtures set forth on Schedule A.1(c).
“Acquired Inventory” means (i) all raw material Inventory (including bulk chemicals
and active pharmaceutical ingredients of the Products) and (ii) the Inventory of the finished
Products (and all rights thereto) described on Schedule A.1(a).
“Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended.
“Adjustment Amount” means: (a) the excess of (i) the dollar value of all unit sales of
Product during each calendar month of the Pre-Closing Period (calculated based on applicable WAC
for each Product) over (ii) the Agreed Monthly Sales Limit for such calendar month, aggregated
across all calendar months during the Pre-Closing Period; less (b) the aggregate of any Purchaser
Cure Amounts paid by the Seller prior to Closing (in the Seller’s sole discretion). For the
avoidance of doubt, the Adjustment Amount may be a negative or positive number, depending on the
relative magnitudes of the foregoing (a) and (b), and thereby result in a net increase or decrease,
respectively, in the Purchase Price. For further clarity, it is acknowledged and agreed that the
foregoing (a) may only be a positive number or zero.
“Affiliate” means, as to any Person and at a given time, any other Person that
directly, or indirectly through one or more intermediaries, controls, is controlled by, or is under
common control with, the specified Person at such time; provided, that Equity Group Investments
shall not be deemed to be an Affiliate of the Seller. The term “Affiliated” has a meaning
correlative to the foregoing.
“Agreed Monthly Sales Limit” has the meaning set forth in Section 5.9(b).
“Agreement” has the meaning set forth in the Preamble hereof.
“Allocation Schedule” has the meaning set forth in Section 1.6(a).
“Almac” means Almac Pharma Services Limited.
“Almac Facility” means 00 Xxxxxx Xxxxxxxxxx Xxxxxx, Xxxxxxxxx, XX00 0XX, XXXXXXX
(NORTHERN).
“AMP” has the meaning set forth in Section 7.5(a)(i).
“Applicable Permits” means, to the extent transferable under applicable Law, the
permits, approvals, licenses, franchises or authorizations, including the Regulatory Filings and
Approvals, from any Governmental Entities held by the Seller that relate primarily or exclusively
to any Product or any Business, including those set forth in Schedule A.1(b).
“Approval Order” means an Order in substantially the form attached as Exhibit
F.
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“Assumed Claims” means any Claims owned or held by the Seller relating to any of the
Purchased Assets.
“Assumed Contracts” means those Contracts identified in Schedule A.1(f).
“Assumed Keflex Royalty Liabilities” has the meaning set forth in Section
1.3(e).
“Assumed Liabilities” has the meaning ascribed to such term in Section 1.3.
“Assumed Rebates” means (i) all Selected Government Rebates, and (ii) any other
legally and accurately calculated rebates with respect to Products dispensed at or after the
Effective Time.
“Avoidance Actions” means any actions arising under Sections 541, 542, 544, 546, 547,
548, 549, 550 and 553 of the Bankruptcy Code.
“Auction” means the auction for the Purchased Assets to be conducted if a Qualified
Bid is submitted in accordance with the Procedures Order and as defined in the Bidding Procedures.
“Authorization” means any authorization, approval, consent, certificate, declaration,
license, permit, registration, filing, notice or franchise of, to or from any Governmental Entity
or pursuant to any Law.
“Bankruptcy Code” has the meaning ascribed to such term in the Recitals.
“Bankruptcy Court” has the meaning ascribed to such term in the Recitals.
“Bankruptcy Rules” means the Federal Rules of Bankruptcy Procedure.
“Basis” means any past or present fact, situation, circumstance, status, condition,
activity, practice, plan, occurrence, event, incident, action, failure to act or transaction that
forms or could form the basis for any specified consequence.
“Benefit Plan” means any employment, bonus, deferred compensation, incentive
compensation, stock ownership, stock purchase, stock appreciation, restricted stock, stock option,
“phantom” stock, performance, stock bonus, paid time off, perquisite, fringe benefit, vacation,
deferred compensation, retiree medical or life insurance, supplemental retirement, severance or
other benefit plans, programs or arrangements, and all employment, termination, severance,
retention or other contracts or agreements, or other program, policy or arrangement.
“Best Price” has the meaning set forth in Section 7.5(a)(ii).
“Bidding Procedures” means the bidding procedures for the Auction of the Purchased
Assets approved by the Bankruptcy Court pursuant to the Procedures Order.
“Xxxx of Sale and Assignment and Assumption Agreement” means the Xxxx of Sale and
Assignment and Assumption Agreement, in the form which shall be mutually agreed by the Parties and
then attached as Exhibit H.
“Breakup Fee” has the meaning set forth in Section 8.4.
“Business Day” means any day other than a Saturday, a Sunday or a day on which banks
in New York, New York, are authorized or obligated by Law to be closed.
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“Businesses” means, collectively, the Moxatag Product Line Business and the Keflex
Product Line Business, and the business of distributing, marketing, promoting, offering for sale,
selling, using, purchasing, importing, exporting, validating, manufacturing, packaging, labeling,
storing, warehousing, developing or commercializing any other antibiotic pharmaceutical drug
worldwide, together with all regulatory and other activities pertaining thereto, as conducted by
Seller.
“Cardinal” means Cardinal Health, Inc.
“Case” has the meaning set forth in the recitals.
“Claim” means a claim, counterclaim, credit, cause of action, chose in action, right
of recovery or right of setoff.
“Closing” means the closing of the purchase and sale of the Purchased Assets, and
assignment and assumption of the Assumed Liabilities contemplated by this Agreement.
“Closing Date” means the date on which the Closing occurs.
“Closing Payment” has the meaning set forth in Section 1.5(b).
“COBRA” means Section 4980B of the Code and Part 6 of Title I of ERISA.
“Code” means the United States Internal Revenue Code of 1986, as amended.
“Confidential Information” has the meaning given to such term in the Confidentiality
Agreement.
“Confidentiality Agreement” means the Confidentiality Agreement, dated as of July 29,
2009, by and between the Parties.
“Contract” means any agreement, contract, lease, sublease, license, sublicense,
commitment, purchase order, undertaking, instrument or other binding understanding, whether written
or oral.
“Control” or “Controlled by” means, with respect to Intellectual Property, the
ability of a Person (collectively with its Affiliate(s)), whether by ownership, license or
otherwise, to grant a license or sublicense.
“Copyright Assignment” means the Copyright Assignment, in the form attached as
Exhibit G.
“Deal Related Information” has the meaning set forth in Section 7.1(f).
“Deposit” has the meaning set forth in Section 1.5(a).
“Depositary” means SunTrust Bank.
“Depositary Agreement” has the meaning set forth in Section 1.7.
“Distribution” means activities related to the distribution, marketing, promoting,
offering for sale and selling of the Products, including advertising, detailing, educating,
planning, promoting, conducting reporting, packaging, storing, handling, shipping and communicating
with Governmental Entities and third parties in connection therewith.
“Distributor” has the meaning set forth in Section 3.19.
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“Domain Name Assignment” means the Domain Name Assignment, in the form attached as
Exhibit G.
“Effective Time” has the meaning set forth in Section 2.1.
“Xxx Xxxxx” means Xxx Lilly and Company, an Indiana corporation.
“Employee” means any employee of the Seller (whether salaried or hourly, and full-time
or part-time), whether or not actively employed on the date hereof, including employees on vacation
or leave of absence, including maternity, paternity, parental family, sick, military or disability
leave, but not including former employees of the Seller that terminated employment prior to the
date hereof.
“Employee Obligations” means (i) salary, wages, sick pay, accrued bonuses, incentive
pay, commissions, notice pay, severance pay, change in control or similar compensation or benefits,
or deferred compensation, (ii) Liabilities under or relating to any Benefit Plan (including any
claims with respect thereto), (iii) Liabilities of the Seller arising under or relating to COBRA,
(iv) Liabilities that might arise under WARN, under any Laws governing employee relations
(including anti-discrimination Laws, wage and hour Laws, labor relations Laws and occupational
safety and health Laws) or under any similar provision of any federal, state, regional, foreign or
local law, rule or regulation, in each case arising as a result of any employment losses occurring
prior to, on or after the Closing Date, (v) Liabilities with respect to and benefits under any
collective bargaining agreements, and (vi) Liabilities arising out of the employment by the Seller
(or the actual or constructive termination thereof) of any current or former employee or a
beneficiary or dependent thereof, and (vii) all other Liabilities of the Seller to its present or
former employees or retirees or spouses, dependents or other beneficiaries of such present or
former employees or retirees, arising prior to, on or after the Effective Time pursuant to
Contracts, plans or otherwise.
“Entity” means a Person that is not a natural Person.
“Environmental Law” means any Law or binding policy or guidance adopted by an
applicable Governmental Entity relating to protection of, or damage to, human health or the
environment (but not occupational health and safety), relating to Hazardous Substances, a Release,
a threat of a Release or Liability for, or cost of, actual or threatened damage to human health or
the environment (but not occupational health and safety).
“ERISA” means the Employee Retirement Income Security Act of 1974, as amended or any
successor law, and regulations and rules issued pursuant to that Act or any successor law.
“Escrow Agent” has the meaning set forth for such term in the Escrow Agreement.
“Escrow Agreement” has the meaning set forth in Section 1.8(a).
“Escrow Amount” has the meaning set forth in Section 1.5(c).
“Escrow Funds” means the amounts on deposit in the Escrow Account at any given time.
“Escrow Release Date” has the meaning set forth in the Escrow Agreement.
“Excess Product Sales” has the meaning set forth in Section 5.9(b)(i).
“Excluded Assets” has the meaning set forth in Section 1.2.
“Excluded Contracts” means any Contract that is not an Assumed Contract, including the
Contracts set forth in Schedule A.1(d).
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“Excluded Inventory” means all Inventory other than the Acquired Inventory.
“Excluded Liabilities” has the meaning set forth in Section 1.4.
“Execution Date” means the date set forth in the Preamble hereof.
“Expenses” means all reasonable, documented out-of-pocket expenses incurred by or on
behalf of a party in connection with or related to the investigation, due diligence examination,
authorization, preparation, negotiation, execution and performance of this Agreement and the Other
Agreements and the Transactions, any financing thereof, and the Closing.
“FCP” has the meaning set forth in Section 3.17(b).
“FDA” means the United States Food and Drug Administration, or any successor agency
thereto.
“Final Allocation” has the meaning set forth in Section 1.6(b).
“Final Order” means an Order of the Bankruptcy Court or other court of competent
jurisdiction that has not been reversed, vacated, modified or amended, is not stayed and remains in
full force and effect.
“Financial Statements” means (i) the Seller’s financial statements as filed in the
Seller’s SEC filings and (ii) financial statements that the Seller has provided to the Purchaser
for the quarterly period ended March 31, 2010.
“FIRPTA Certificate” has the meaning set forth in Section 2.2(a)(vi).
“First Quarter Rebates” means any rebates pursuant to any governmental rebate program
related to Products dispensed at any time on or prior to March 31, 2010.
“Force Majeure Event” means any: act of God; war, armed conflict, civil commotion or
action of any civil or military authorities (or economic dislocation resulting therefrom); embargo;
labor strike, lock-out or similar labor difficulty; shortages of labor, facilities or
transportation; epidemic; failure or default of public utilities or common carriers; destruction of
production facilities or materials by fire, earthquake, storm or like catastrophe; and Internet
slowdown or telecommunications failure or accidents.
“FSS” has the meaning set forth in Section 7.5(a)(v).
“GAAP” means United States generally accepted accounting principles.
“Government Product Contracts” means all Contracts to which the Seller is a party and
pursuant to which the Seller sells a Product to a Governmental Entity either singly or together
with other pharmaceutical products of the Seller.
“Government Rebates” has the meaning set forth in Section 7.5(a)(i).
“Governmental Entity” means any entity exercising executive, legislative, judicial,
regulatory or administrative functions of or pertaining to any federal, state or local government,
or any international, multinational or other government, and any department, commission, board,
agency, instrumentality, political subdivision, bureau, official or other regulatory,
administrative or judicial authority of any of the foregoing.
“Hazardous Substances” means any substances, including any and all substances (whether
solid, liquid or gas) defined, listed or otherwise classified as pollutants, contaminants,
hazardous wastes,
A-5
hazardous substances, chemical substances, substances of very high concern, hazardous
materials, extremely hazardous wastes or words of similar meaning or regulatory effect under any
present and future Environmental Laws or that may have a negative impact on human health or the
environment (including petroleum and petroleum products, asbestos and asbestos-containing
materials, polychlorinated biphenyls, artificial mineral fibers, and regulated radioactive
materials).
“ICS” means Integrated Commercial Solutions, Inc.
“IND” means Investigational New Drug Application Nos. 62,239; 62,425; 62,576; 70,876;
and 73,767.
“Intellectual Property” means, collectively: (a) all inventions (whether or not
reduced to practice), and all improvements thereto, and all Patents; (b) all Trademarks, all
goodwill associated therewith, and renewals or extensions in connection therewith; (c) all works of
authorship, all copyrights and moral rights relating thereto and all applications, registrations
and renewals in connection therewith (including Software); (d) all mask works and all applications,
registrations and renewals in connection therewith; (e) all trade secrets and confidential business
information (including confidential ideas, research and development, know how, show how, methods,
formulas, compositions, manufacturing and production processes and techniques, technical data,
designs, drawings, specifications, customer and supplier lists, pricing and cost information, and
business and marketing plans and proposals), invention disclosures, technology, discoveries,
improvements, specifications, designs, formulae, techniques, technical data and manuals, methods
and processes, and all other proprietary information and data; (f) all internet domain names and
registrations therefor; (g) all rights under Section 365(a) of the Bankruptcy Code arising from or
relating to the foregoing; (h) all copies and tangible embodiments of each of the foregoing (in
whatever form or medium) and all modifications, improvements and derivatives of each of the
foregoing; and (i) the right to seek past, present and future damages, including with respect to
third-party infringement and misappropriation.
“Inventory” means all materials, inventory and supplies, including raw materials,
work-in-process, finished goods, samples, packaging supplies, spare parts and other items, included
in the inventory of any Business or any Product, whether in stock, in transit or on order.
“IRS” means the Internal Revenue Service of the United States.
“Keflex” means the 250mg, 500mg and 750mg finished dosage strength of the oral dosage
formulation containing the active drug substance cephalexin, usp as its primary active ingredient,
including as currently marketed by the Seller as Keflex®, and such other dosage strengths thereof,
any reformulations or derivations of the same (whether or not utilizing the Product Patent Rights)
and any other product sold or distributed under the Product Marks for Keflex.
“Keflex NDA” means the new drug application covering Keflex (NDA No. 50-405),
including any supplements, amendments or modifications thereto, or divisions thereof, including all
correspondence under NDA No. 50-405 between the FDA and the Seller, in each case submitted to or
required by the FDA prior to the Effective Time.
“Keflex Product Line Business” means the business of distributing, marketing,
promoting, offering for sale, selling, using, purchasing, importing, exporting, validating,
manufacturing, packaging, labeling, storing, warehousing, developing or commercializing Keflex,
together with all regulatory and other activities pertaining thereto, as conducted by Seller.
“Knowledge” means, with respect to Seller, the knowledge, after reasonable inquiry, of
the Persons set forth on Schedule A.1(e) hereto.
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“Latest Balance Sheet” means the Seller’s balance sheet for the fiscal year ended
December 31, 2009.
“Law” means any constitution, law, statute, treaty, rule, directive, ordinance,
requirement, compact or agreement with or by any Governmental Entity, any Order and any rules or
regulations of any self-regulatory organization.
“Liabilities” means any and all liabilities, debts, claims, losses, expenses, damages,
fines, costs, royalties, deficiencies, obligations or commitments of any nature whatsoever (whether
asserted or unasserted, disclosed or undisclosed, direct or indirect, known or unknown, absolute or
contingent, determined or undeterminable, on- or off-balance sheet, liquidated or unliquidated,
accrued or unaccrued, matured or unmatured, due or to become due or otherwise, regardless of when
asserted and whether or not resulting from third-party claims), including any liability for Taxes
and any of the foregoing arising under any Law, Order or Contract.
“Lien” means any security interest (whether or not perfected), pledge, bailment (in
the nature of a pledge or for purposes of security), mortgage, deed of trust, grant of a power to
confess judgment, conditional sale, trust receipt or other title retention agreement (including any
lease in the nature thereof), lien, charge, encumbrance, claim, reservation, restriction (including
any limitation on a voting right), right of first refusal or first offer or other third-party
right, option, license, hypothecation, assessment, covenant, right-of-way, encroachment, easement,
tenancy, equity or other similar arrangement or interest in or with respect to real or personal
property (including any of the foregoing created by, arising under or evidenced by any conditional
sale or other title retention agreement, any financing lease having substantially the same economic
effect as any of the foregoing, or the filing of any financing statement naming the owner of the
asset to which such Lien relates as debtor under the Uniform Commercial Code or any comparable
Law).
“
Lilly Agreement” means the
Asset Purchase Agreement by and between the Seller (f/k/a
Advancis Pharmaceuticals) and Xxx Xxxxx and Company, dated June 30, 2004.
“Manufacturers” means Almac, Stada and Sandoz.
“Manufacturing Facilities” means the Almac Facility, Stada Facility and the Sandoz
Facility, collectively.
“Material Adverse Effect” means any effect or change that, individually or in the
aggregate, is or could reasonably be expected to be, materially adverse to (i) the manufacture or
supply of any Product, (ii) the Regulatory Filing and Approvals for any Product, or (iii) the
manufacture, use, sale or promotion of any Product in reliance upon the Regulatory Filing and
Approvals.
“Moxatag” means the 775 mg finished dosage strength of the once-daily oral dosage
formulation containing the active drug substance amoxicillin as its primary active ingredient
currently marketed by the Seller as Moxatag®, and such other dosage strengths thereof, any
reformulations or derivations of the same (whether or not utilizing the Product Patent Rights) and
any other product sold or distributed under the Product Marks for Moxatag.
“Moxatag NDA” means the new drug application covering Moxatag (NDA No. 50-518),
including any supplements, amendments or modifications thereto, or divisions thereof, including all
correspondence under NDA No. 50-518 between the FDA and the Seller, in each case submitted to or
required by the FDA prior to the Effective Time.
“Moxatag Product Line Business” means the business of distributing, marketing,
promoting, offering for sale, selling, using, purchasing, importing, exporting, validating,
manufacturing, packaging,
A-7
labeling, storing, warehousing, developing or commercializing Moxatag, together with all
regulatory and other activities pertaining thereto, as conducted by Seller.
“NDA” means a new drug application covering a Product, including any supplements,
amendments or modifications thereto, or divisions thereof, including all correspondence under a new
drug application covering a Product between the FDA and the Seller, in each case of the foregoing
submitted to or required by the FDA prior to the Effective Time.
“NDC” means the “National Drug Code”, which is the eleven digit code
registered by a company with the FDA with respect to a pharmaceutical product.
“Non-FAMP” has the meaning set forth in 38 U.S.C. § 8126 (h)(5).
“Notice of Objection” has the meaning set forth in Section 1.9(b).
“Order” means any award, injunction, judgment, decree, order, writ, determination,
ruling, subpoena or verdict or other decision issued, promulgated or entered by any Governmental
Entity of competent jurisdiction.
“Ordinary Course of Business” means, with respect to an action taken by or on behalf
of any Entity, an action that is both (a) consistent with the past practices of such Entity and is
taken in the ordinary course of the normal day-to-day operations of such Entity; and (b) similar in
nature and magnitude to actions customarily taken in the ordinary course of the normal day-to-day
operations of other Persons that are in the same line of business as such Entity.
“Organizational Documents” means, with respect to any Entity, its certificate of
incorporation, articles of incorporation, bylaws, articles of organization, constitution,
partnership agreement, limited liability company agreement, formation agreement, trust agreement
and other similar organizational documents of such Entity.
“Other Agreements” means, collectively, the Patent Assignment, Trademark Assignment,
Copyright Assignment, Domain Name Assignment, the Xxxx of Sale and Assignment and Assumption
Agreement, the Depositary Agreement, the Escrow Agreement and that certain guaranty letter, dated
May 7, 2010, with respect to the guarantee of the Purchaser’s obligations under this Agreement.
“Other Copyrights” means the copyrights owned, licensed, Controlled or otherwise
utilized by the Seller, other than the Product Copyrights.
“Other Domain Names” means the domain names and web sites (including source code and
layout) owned, licensed, Controlled or otherwise utilized by the Seller, other than the Product
Domain Names. For clarity, Other Domain Names shall include
xxxx://xxx.xxxxxxxxxxxxxxxxx.xxx.
“Other Know-How” means the know-how owned, licensed, Controlled or otherwise utilized
by the Seller, other than the Product Know-How.
“Other Intellectual Property” means the Other Patent Rights, Other Copyrights, Other
Know-How, Other Marks, and Other Trade Dress, and the Other Domain Names.
“Other Marks” means Trademarks as registered with the PTO or other equivalent
Governmental Entity, that are owned, licensed, Controlled or otherwise utilized by the Seller,
other than the Product Marks.
“Other Patents” means all Patents licensed, owned or Controlled by the Seller, other
than the Product Patent Rights.
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“Other Trade Dress” means the trade dress, package designs, product inserts, labels,
logos and associated artwork owned by, licensed to or otherwise held by the Seller, other than the
Product Trade Dress.
“Outside Date” has the meaning set forth in Section 8.1(c).
“Par Agreement” means the Development and Commercialization Agreement by and between
the Seller (f/k/a Advancis Pharmaceuticals) and Par Pharmaceutical, Inc., dated May 28, 2004, as
amended.
“Parties” has the meaning set forth in the Preamble hereof.
“Patent Assignment” means the Patent Assignment, in the form attached as Exhibit
G.
“Patents” means United States and non-United States patents, patent applications,
patent disclosures, invention disclosures and other rights relating to the protection of inventions
worldwide, and any and all right, title and interest related to any of the foregoing, including
without limitation all reissues, reexaminations, divisions, continuations, continuations-in-part,
extensions or renewals of any of the foregoing as well as supplementary protection certificates for
medicinal products provided under Council Regulation (EEC) No. 1768/92 of June 18, 1992, and their
equivalents.
“PDM Act” means the Prescription Drug Marketing Act of 1987, as amended.
“Person” means an individual, a corporation, a partnership, a limited liability
company, a trust, an unincorporated association, a Governmental Entity or any other entity or body.
“Petition Date” has the meaning set forth in the Recitals hereto.
“Pre-Closing Distribution Services Obligations” has the meaning set forth in
Section 1.4(f).
“Pre-Closing Period” means the period beginning on the Execution Date and ending at
the Effective Time.
“
Procedures Motion” means the Debtors’ Motion For An Order (I) Approving Bidding
Procedures For The Sale Of Substantially All Of Their Assets, (II) Approving The Form And Manner Of
Notice Of The Sale And Assumption And Assignment Of Executory Contracts And Leases, (III) Approving
The Form Of
Asset Purchase Agreement, (IV) Approving And Authorizing Sale Of Substantially All Of
The Debtors’ Assets To The Highest And Best Bidder(s) Free And Clear Of All Liens, Interests,
Claims And Encumbrances Pursuant To Sections 105, 363, And 365 Of The Bankruptcy Code, (V) Waiving
The Requirements Of Federal Rules Of Bankruptcy Procedure 6004(g) And 6006(d), (VI) Setting Auction
And Hearing Dates; and (VIII) Granting Related Relief filed in the Case.
“Procedures Order” means the Order of the Bankruptcy Court granting the Procedures
Motion and approving the Bidding Procedures.
“Product” means Keflex or Moxatag, as the case may be.
“Products” means Keflex and Moxatag, collectively.
“Product Copyrights” means the copyrights owned, licensed, Controlled or otherwise
utilized by the Seller primarily or exclusively related to any Product, any Business, Product Trade
Dress, one or more Product Marks, or Promotional Materials.
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“Product Domain Names” means the domain names and web sites (including source code and
layout) owned, licensed, Controlled or otherwise utilized by the Seller that primarily or
exclusively utilize the Product Marks, including those domain names and web sites identified in
Schedule A.1(g).
“Product Intellectual Property” means the Product Patent Rights, Product Copyrights,
Product Know-How, Product Marks, and Product Trade Dress, and the Product Domain Names.
“Product Know-How” means the know-how owned, licensed, Controlled or otherwise
utilized by the Seller primarily or exclusively related to any Product or any Business, including
research and development information, validation methods and procedures, unpatented inventions,
know-how, trade secrets, technical or other data or information, or other materials, methods,
systems, procedures, processes, materials, developments or technology, including all biological,
chemical, clinical, manufacturing and other information or data, other than such know-how which is
or becomes the subject of a Patent.
“Product Marks” means (a) with respect to Keflex, the Trademark “Keflex®” and such
other Trademarks as registered with the PTO or other equivalent Governmental Entity, that are
owned, licensed, Controlled or otherwise utilized by the Seller to identify Keflex, including those
that are identified in Schedule A.1(h), and (b) with respect to Moxatag, the Trademark
“Moxatag®” and such other Trademarks as registered with the PTO or other equivalent Governmental
Entity, that are owned, licensed, Controlled or otherwise utilized by the Seller to identify
Moxatag, including those that are identified in Schedule A.1(i).
“Product Patent Rights” means the Patents owned, licensed, Controlled or otherwise
utilized by the Seller primarily or exclusively related to any Product or any Business, including
those are identified in Schedule A.1(j).
“Product Records” means documentation or records, in whatever medium (including audio,
visual, print or electronic), relating to any Product or any Business or any of the foregoing: (i)
any and all data and correspondence supporting and/or utilized or made in connection with obtaining
and/or maintaining any of the Regulatory Filings and Approvals and/or the drug master file for the
Product; (ii) raw and/or analysis data for pivotal trials and integrated summaries (ISE/ISS) and
all bio-analytical data in SAS transport, PC SAS Version 6.06, or above, or other agreed format;
(iii) all clinical data (phase I — IV); (iv) all data from ongoing development of the compound
utilized in either or both of the Products (including marketing studies); (v) programs (analysis,
reports and supporting documentation) for trials for which data is provided; (vi) copies of SAS
libraries (with non-exclusive rights to use same) from the Seller’s analysis programs relating to
either or both of the Products; (vii) all books and records owned by the Seller relating to either
or both of the Products, including copies of all customer and supplier lists, account lists, call
data, sales history, call notes, research data, marketing studies, consultant reports, physician
databases, and correspondence (including invoices) with respect to either or both of the Products,
and all complaint files and adverse event reports and files; and (viii) all base line information
used by the Seller to calculate AMP and Best Price for each Product identified by NDC number during
calendar year 2009 as well as calendar year 2010 year-to-date through the Effective Time.
“Product Trade Dress” means the trade dress, package designs, product inserts, labels,
logos and associated artwork owned by, licensed to or otherwise held by the Seller and used
primarily or exclusively in connection with any Product or any Business, or the packaging therefor,
including that which is identified on Schedule A.1(k).
“Product Unit Demand” means, with respect to a Product SKU, retail extended unit (TRx)
consumption as measured by IMS NPA audit.
“Promotional Materials” means the advertising, promotional and media materials, sales
training materials (including any related outlines and quizzes/answers, if any), trade show
materials (including
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displays) and videos, including materials containing post-marketing clinical data, if any,
used primarily or exclusively for the commercialization of either or both of the Products by the
Seller (including Distribution and sales promotion information, market research studies and
toll-free telephone numbers), including those materials identified in Schedule A.1(l).
“PTO” means the United States Patent and Trademark Office.
“Purchase Price” has the meaning set forth in Section 1.5(c).
“Purchased Assets” means all of the assets, properties and rights of Seller
(contractual or otherwise), in each case other than the Excluded Assets, used or held for use in or
related to the operation of the Businesses, directly or indirectly, in whole or in part, of every
type and description, real, personal or mixed, tangible or intangible, wherever locater, whether or
not reflected on the books of Seller, and whether in existence on or after the Execution Date (but
prior to the Closing), including the following:
(i) the Assumed Contracts;
(ii) the Acquired Fixtures;
(iii) the Acquired Inventory;
(iv) the Promotional Materials;
(v) the Product Records (including any intangible rights in and to the Product Records);
(vi) the Applicable Permits, and all regulatory files (including correspondence with
Governmental Entities and regulatory authorities) relating to the Applicable Permits;
(vii) the Product Intellectual Property;
(viii) the Other Intellectual Property;
(ix) the assets, properties and rights (contractual or otherwise) set forth or described in
Schedule A.1(m); and
(x) the Assumed Claims.
“Purchaser” has the meaning set forth in the Preamble hereof.
“Purchaser Adjustment Amount Statement” has the meaning set forth in Section
1.9(b).
“Purchaser Adjustment Amount” has the meaning set forth in Section 1.9(b).
“Purchaser Confidential Information” has the meaning set forth in Section
7.1(b).
“Purchaser Cure Amounts” has the meaning set forth in Section 1.3(h).
“Qualified Bid” has the meaning given to such term in the Bidding Procedures.
“Regulatory Filings and Approvals” means the regulatory approvals, authorizations,
licenses, applications, rights of reference, permits, INDs, NDAs and other permissions held by the
Seller relating primarily or exclusively to any Product or any Business, including those set forth
on Schedule A.1(n), in each case issued by Governmental Entities to the Seller.
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“Regulatory Warning Notices” means Form FDA 483 Inspectional Observations,
Establishment Inspection Reports, warning letters, or their equivalents and any similar
correspondences received from the FDA or any other Governmental Entity having jurisdiction over a
Product or any Manufacturing Facility.
“Release” means any release, deposit, discharge, emission, leaking, leaching,
spilling, seeping, migrating, injecting, pumping, pouring, emptying, escaping, dumping, disposing
or other movement of Hazardous Substances into or in the environment.
“Representatives” means, with respect to any Person, the directors, managers,
employees, independent contractors, agents or consultants of such Person.
“Sandoz” means Sandoz GmbH.
“Sandoz Agreement” means a manufacturing agreement by and between the Seller and
Sandoz.
“Sandoz Facility” means that manufacturing facility owned and operated by Sandoz and
located at Xxxxxxxxxxxxxxxx 00, X0000 Xxxxx, Xxxxxxx.
“SEC” means the United States Securities and Exchange Commission.
“Selected Government Rebates” means any legally and accurately calculated rebates
pursuant to any governmental rebate program with respect to Products dispensed at any time on or
after April 1, 2010.
“Seller” has the meaning set forth in the Preamble hereof.
“Seller Adjustment Amount” has the meaning set forth in Section 1.9(a)(ii).
“Seller Confidential Information” has the meaning set forth in Section 7.1(c).
“Seller Disclosure Schedules” means those Disclosure Schedules referenced in
Article 3.
“SKU” means stock keeping unit.
“Stada” means Clonmel Healthcare Limited, a Subsidiary of STADA Arzneimittel AG.
“Stada Facility” means that manufacturing facility located at Xxxxxxxxx Xxxx, Xxxxxxx
Xxxxxx, Xxxxxxxxx, Xxxxxxx at which Stada manufactures Moxatag.
“Subsidiary” means, with respect to any Person, any Person controlled by such first
Person.
“Suit” means any investigation, charge, action, grievance, claim, proceeding (whether
administrative or otherwise), suit, arbitration or other dispute resolution proceeding or
litigation in each case by or before any court of Law or equity, Governmental Entity or arbitrator.
“Tax Return” means any return, declaration, form, report, claim or statement required
to be filed with any Governmental Entity with respect to Taxes, including any schedule or
attachment thereto or amendment thereof.
“Taxes” means all (a) taxes, charges, withholdings, fees, levies, imposts, duties and
governmental fees or other like assessments or charges of any kind whatsoever in the nature of
taxes imposed by any federal, state, local or other Taxing Authority (including those related to
income, net income, gross income, receipts, capital, windfall profit, severance, property,
production, sales, goods and services, use,
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business and occupation, license, excise, registration, franchise, employment, payroll
(including social security contributions), deductions at source, withholding, alternative or add-on
minimum, intangibles, ad valorem, transfer, gains, stamp, customs duties, estimated, transaction,
title, capital, paid-up capital, profits, occupation, premium, value added, recording, real
property, personal property, inventory and merchandise, business privilege, federal highway use,
commercial rent or environmental tax), and (b) interest, penalties, fines, additions to tax or
additional amounts imposed by any Taxing Authority in connection with (i) any item described in
clause (a) of this definition or (ii) the failure to comply with any requirement imposed with
respect to any Tax Return.
“Taxing Authority” means, with respect to any Tax or Tax Return, the Governmental
Entity that imposes such Tax or requires a Person to file such Tax Return and the agency (if any)
charged with the collection of such Tax or the administration of such Tax Return, in each case, for
such Governmental Entity.
“Trademark Assignment” means the Trademark Assignment, in the form attached as
Exhibit G.
“Trademarks” means trademarks, service marks, trade dress, trade names, company names,
logos, slogans and other indicia of source or origin, all registrations and applications for
registration of any of the foregoing, all renewals thereof, all translations, adaptations,
derivations and combinations of the foregoing, together with all goodwill associated with each of
the foregoing, in any jurisdiction throughout the world.
“Transactions” means, collectively, the transactions contemplated hereby and by the
Other Agreements.
“Transfer Taxes” means any and all transfer, documentary, sales, use, gross receipts,
stamp, registration, value added, recording, escrow and other similar Taxes and fees (including any
penalties, interest and additions thereto) incurred in connection with the Transactions (including
recording and escrow fees and any real property or leasehold interest transfer or gains tax and any
similar Tax).
“WAC” means wholesale acquisition cost per extended unit.
“WARN” means the Worker Adjustment and Retraining Notification Act, as amended.
X-00
Xxxxxxx X
Xxxxxxxxxx Xxxxxxxxx
X-0
EXECUTION COPY
DEPOSITARY AGREEMENT
THIS DEPOSITARY AGREEMENT (this “
Agreement”) is made and entered into as this 14th day
of May, 2010 (the “
Effective Date”), by and among VICTORY PHARMA, INC., a
Delaware
corporation (“
Purchaser”), XXXXXXXXXXX PHARMACEUTICALS, INC., a Delaware corporation
(“
Seller”), and SUNTRUST BANK, a Georgia banking corporation, as depositary (the
“
Depositary”).
Background
A. Purchaser and Seller are parties to that certain
Asset Purchase Agreement, dated May 14,
2010 (the “
Purchase Agreement”), providing for the purchase by Buyer of substantially all
of the assets relating to the Business. Capitalized terms not otherwise defined in this Agreement
have the meanings ascribed to such terms in the Purchase Agreement. A fully executed copy of the
Purchase Agreement will be provided to the Escrow Agent.
B. Purchaser will deposit cash in the amount of One Million Seven Hundred Ten Thousand Dollars
($1,710,000) (together with all interest and earnings thereon and as reduced by any disbursements,
amounts withdrawn, or losses on investments, the “Deposit Funds”) with the Depositary, upon
the terms set forth in the Purchase Agreement and this Agreement.
C. The Depositary is willing to accept the Deposit Funds and to hold and distribute the
Deposit Funds in accordance with the terms and conditions set forth in this Agreement and will rely
on the written direction of the authorized signers listed on Schedule I attached hereto.
Agreement
NOW, THEREFORE, in consideration of the mutual promises contained herein, and other good and
valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties
agree as follows:
1. Appointment of Depositary. Purchaser and Seller hereby designate and appoint
SunTrust Bank as the depositary, to receive, hold, invest and disburse the Deposit Funds in
accordance with the terms of this Agreement. SunTrust Bank hereby accepts its appointment as the
depositary and agrees to receive, hold, invest, and disburse the Deposit Funds in accordance with
the terms, conditions and provisions of this Agreement.
2. Delivery of Deposit. Simultaneously with the execution of the Purchase Agreement
and in accordance with Section 1.5(a) of the Purchase Agreement, Purchaser has delivered One
Million Seven Hundred Ten Thousand Dollars ($1,710,000) by wire transfer of immediately available
funds to the account designated by the Depositary (the “Deposit Account”). By its
execution and delivery of this Agreement, the Depositary acknowledges receipt of the Deposit Funds.
3. Investment of Deposit Funds. The Depositary shall invest the Deposit Funds as
jointly instructed by Purchaser and Seller, in writing from time to time, or as directed in
Schedule II attached hereto. In the absence of written instructions from Purchaser and
Seller, the Deposit Funds shall be invested in the SunTrust Bank Institutional Money Market
Account. The Depositary shall have no liability for any loss or diminution in the Deposit Funds
resulting from investments made in accordance with the provisions of this Agreement. The Depositary
is authorized to liquidate in accordance with its customary procedures any portion of the Deposit
Funds consisting of investments to provide for payments
required to be made under this Agreement, unless instructed otherwise by a joint written
instruction executed by Purchaser and Seller.
4. Distributions of Deposit Funds.
(a) The Depositary shall promptly disburse the Deposit Funds upon fulfillment of the
conditions specified in subsection (i), (ii), (iii), (iv) or (v), below, as provided in such
subsections.
(i) If Purchaser terminates the Purchase Agreement pursuant to any of Sections 8.1(a)
through (f) or 8.2 of the Purchase Agreement, then Purchaser shall deliver to the Depositary
(i) written notice of the termination, along with a statement setting forth the basis for
such termination in reasonable detail (a “Notice to Disburse”), together with (ii)
evidence of delivery (including a postal receipt, written receipt or delivery confirmation
from a delivery service or a facsimile confirmation) of a copy of such Notice to Disburse to
Seller. No Notice to Disburse may be delivered after the Closing (as defined below). The
Depositary shall disburse the Deposit Funds to Purchaser if the Depositary has not received,
within five (5) business days after the Depositary has received the Notice to Disburse from
Purchaser, a notice (a “Notice Contesting Disbursement”) from Seller (A) disputing
Purchaser’s termination of the Purchase Agreement and (B) setting forth, in reasonable
detail, the issues in controversy upon which Seller bases its assertion that Purchaser is
not entitled to receive the Deposit Funds. A Notice to Disburse and Notice Contesting
Disbursement may be referred to herein, individually or collectively, as the context
requires, as “Notice.”
(ii) If Seller terminates the Purchase Agreement pursuant to Section 8.1(g) of the
Purchase Agreement, then Seller shall deliver to the Depositary (i) a Notice to Disburse,
together with (ii) evidence of delivery (including a postal receipt, written receipt or
delivery confirmation from a delivery service or a facsimile confirmation) of a copy of such
Notice to Disburse to Purchaser. The Depositary shall disburse the Deposit Funds to Seller
if the Depositary has not received, within five (5) business days after the Depositary has
received the Notice to Disburse from Seller, a Notice Contesting Disbursement from
Purchaser.
(iii) If either Purchaser or Seller issue a Notice Contesting Disbursement, then
Purchaser and Seller shall submit such dispute to the Bankruptcy Court for determination.
If the Depositary receives a final binding order of the Bankruptcy Court to disburse the
Deposit Funds, then the Depositary shall disburse the Deposit Funds in accordance with such
order as soon as reasonably practicable. A final binding order of a court of competent
jurisdiction or a binding arbitration proceeding shall override any Notice received by the
Depositary under this Agreement, except to the extent the Depositary has, in good faith and
in compliance with this Agreement, already acted in compliance with such Notice.
(iv) If Purchaser and Seller agree that all conditions to the Closing have been
satisfied or waived in accordance with the Purchase Agreement, then Purchaser and Seller
shall execute and deliver joint written instructions to the Depositary, directing the
Depositary to disburse the Deposit Funds to Seller at the Closing. Upon receipt of such
joint written instructions from Purchaser and Seller, the Depositary shall disburse the
Deposit Funds in accordance with such instructions. A written instruction jointly signed by
both Purchaser and Seller shall override any Notice received by the Depositary under this
Agreement, except to the extent that Depositary has, in good faith and in compliance with
this Agreement, already acted in compliance with such Notice.
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(v) If Purchaser and Seller otherwise execute and deliver joint written instructions to
the Depositary, directing the Depositary to disburse the Deposit Funds, the Depositary shall
disburse the Deposit Funds in accordance with the terms and in the manner set forth in such
joint written instruction. A written instruction jointly signed by both Purchaser and Seller
shall override any Notice received by the Depositary under this Agreement, except to the
extent that Depositary has, in good faith and in compliance with this Agreement, already
acted in compliance with such Notice.
(b) The Depositary shall not be responsible for determining whether a Notice Contesting
Disbursement sets forth a reasonable basis for disagreement, and the Depositary is entitled to rely
on any Notice Contesting Disbursement that appears on its face to specify an issue in any level of
detail. If the Depositary receives a Notice Contesting Disbursement, the Depositary shall continue
to hold the Deposit Funds pending receipt of one of the items described in subsection (a)(iii) or
(a)(iv), above.
5. Obligations of Depositary.
(a) In performing its duties under this Agreement, or upon the claimed failure to perform its
duties, the Depositary shall have no liability except for the Depositary’s willful misconduct or
gross negligence. The Depositary’s sole responsibility shall be for the safekeeping and
disbursement of the Deposit Funds in accordance with the terms of this Agreement. In no event shall
the Depositary be liable for incidental, indirect, special, consequential or punitive damages.
(b) The Depositary shall have no implied duties or obligations and shall not be charged with
or be deemed to have any knowledge of any fact or circumstance not specifically set forth in this
Agreement or provided to the Depositary in writing strictly in accordance with the notice
provisions of this Agreement. The Depositary shall be entitled to rely upon and shall be protected
in acting upon any request, instructions, statement or other instrument, not only as to its due
execution, validity and effectiveness, but also as to the truth and accuracy of any information
contained therein, that the Depositary in good faith believes to be genuine, to have been signed or
presented by the person or parties purporting to sign the same and to conform to the provisions of
this Agreement.
(c) The Depositary shall not be obligated to take any legal action or to commence any
proceeding in connection with the Deposit Funds, any account in which the Deposit Funds are
deposited, or this Agreement, or to appear in, prosecute or defend any such legal action or
proceedings.
(d) The Depositary may consult legal counsel selected by it in the event of any dispute or
question as to the construction of any of the provisions of this Agreement or of the Depositary’s
duties under this Agreement, and shall incur no liability and shall be fully protected from any
liability whatsoever in acting in accordance with the advice, opinion or instruction of such
counsel.
(e) The Depositary shall have no liability with respect to the transfer or distribution of any
funds effected by the Depositary pursuant to wiring or transfer instructions provided to the
Depositary in accordance with the provisions of this Agreement.
6. Resignation or Removal of Depositary. The Depositary may resign from the
performance of its duties under this Agreement at any time by giving thirty (30) days’ prior
written notice to Purchaser and Seller or may be removed, with or without cause, by Purchaser and
Seller, acting jointly, at any time by the giving of ten (10) days’ prior written notice to the
Depositary. Such resignation or removal shall take effect upon the appointment of a successor
depositary as provided herein. Upon any such notice of resignation or removal, prior to the
expiration of the applicable notice period, Purchaser and Seller, acting jointly, shall appoint a
successor depositary, which shall be a commercial bank, trust
-3-
company or other financial institution with a combined capital and surplus in excess of
$100,000,000, unless otherwise agreed by Purchaser and Seller. Purchaser and Seller shall notify
the Depositary in writing, and upon receipt of such notice, the Depositary shall deliver all
Deposit Funds in its custody to such successor depositary, and all responsibility of the Depositary
under this Agreement shall terminate upon such delivery, other than any liability for actions taken
as Depositary under this Agreement prior to such succession. If Purchaser and Seller fail to
appoint a successor depositary within sixty (60) days after resignation or removal of the
Depositary, the Depositary shall deliver all Deposit Funds in its custody as Purchaser and Seller
shall jointly instruct in writing. Notwithstanding anything to the contrary provided in this
Agreement, in the event the Depositary resigns as depositary under this Agreement and, within sixty
(60) days, no successor Depositary has been designated and accepted appointment as successor
depositary, the Depositary shall have the right to deposit the Deposit Funds into the registry of
any court of competent jurisdiction and notify Purchaser and Seller of such deposit. Upon such
deposit, the Depositary shall be discharged from all further duties and responsibilities as
depositary under this Agreement.
7. Indemnification. Purchaser and Seller agree to jointly and severally indemnify and
hold the Depositary, its officers, directors, employees, affiliates and agents (collectively, the
“Indemnified Parties”) harmless against any and all actions, claims (whether or not valid),
losses, damages, liabilities, costs and expenses of any kind or nature whatsoever (including,
without limitation, reasonable attorneys’ fees, costs and expenses) incurred by or asserted against
any of the Indemnified Parties from and after the date hereof, as a result of, arising out of or
relating to any claim, demand, suit, action or proceeding (including any inquiry or investigation)
by any person (whether threatened or initiated), asserting a claim for any legal or equitable
remedy against any person under any statute or regulation, including, but not limited to, any
federal or state securities laws, or under any common law or equitable cause or otherwise, arising
directly or indirectly from or in connection with the negotiation, preparation, execution,
performance or failure of performance of this Agreement or any transactions contemplated by this
Agreement, whether or not any such Indemnified Party is a party to any such action, proceeding,
suit or is the target of any such inquiry or investigation; provided, however, that this indemnity
obligation shall not apply in the event of the willful misconduct, bad faith, gross negligence or
fraud of the Indemnified Parties or any of them. If any such action or claim is brought or
asserted against any Indemnified Party, such Indemnified Party shall promptly notify Purchaser and
Seller in writing, and Purchaser and Seller shall assume the defense thereof, including the
employment of counsel and the payment of all expenses. Such Indemnified Party shall, in its sole
discretion, have the right to employ separate counsel in any such action and to participate in the
defense thereof (with the fees and expenses of such counsel to be paid by such Indemnified Party),
unless (i) Purchaser and Seller agree to pay such fees and expenses, (ii) Purchaser or Seller fail
to assume the defense of such action or proceeding or fail, in the reasonable discretion of such
Indemnified Party, to employ counsel reasonably satisfactory to the Indemnified Party in any such
action or proceeding, or (iii) the named parties to any such action or proceeding (including any
impleaded parties) include both the Indemnified Party and Purchaser or Seller, and the Indemnified
Party shall have been advised by counsel that there may be one or more legal defenses available to
it that are different from or additional to those available to Purchaser or Seller. All such fees
and expenses payable by Purchaser or Seller pursuant to the foregoing sentence shall be paid from
time to time as incurred, both in advance of and after the final disposition of such action or
claim. No Indemnified Party shall settle any indemnifiable claim without the consent of Purchaser
and Seller, which consent shall not be unreasonably withheld. Neither Purchaser nor Seller will
settle any indemnifiable claim without the prior written consent of the Indemnified Party, which
consent will not be unreasonably withheld, unless the settlement provides for (i) no relief other
than monetary damages against which the Indemnified Party is fully indemnified, and (ii) an
unconditional release of the Indemnified Party. This indemnity obligation shall survive termination
of this Agreement and any resignation or removal of the Depositary.
-4-
8. Disputes. If, at any time, there shall exist any dispute between Purchaser and
Seller with respect to the holding or disposition of any portion of the Deposit Funds or any other
obligations of the Depositary under this Agreement, or if at any time the Depositary is unable to
determine, to the Depositary’s sole satisfaction, the proper disposition of any portion of the
Deposit Funds or the Depositary’s proper actions with respect to its obligations under this
Agreement, the Depositary shall be entitled to retain the Deposit Funds until the earlier of: (i)
receipt of joint written instructions from all of the parties in any such dispute, in which case
the Depositary shall disburse the Deposit Funds in accordance with such instructions, or (ii)
receipt of a final binding order of the Bankruptcy Court to disburse the Deposit Funds, in which
case the Depositary shall disburse the Deposit Funds in accordance with such order.
9. Compensation of Depositary.
(a) Purchaser and Seller shall compensation the Depositary for its services to be rendered
under this Agreement in accordance with Schedule III attached hereto and, in addition,
shall reimburse the Depositary for all reasonable out-of-pocket expenses, including attorneys’
fees, travel expenses, telephone and facsimile transmission costs, postage (including express mail
and overnight delivery charges), copying charges and the like.
(b) All of the compensation and reimbursement obligations set forth in this Section 9 shall be
payable promptly after the Depositary submits a statement for such fees and expenses and shall be a
joint and several obligation of Purchaser and Seller, but, solely as between Purchaser and Seller,
shall be paid fifty percent (50%) by Purchaser, on the one hand, and fifty percent (50%) by Seller,
on the other hand.
(c) Except as otherwise set forth in this Agreement, the Depositary hereby waives any and all
rights to offset claims it may have against any of the funds held by it under this Agreement,
including claims arising as a result of any claims, amounts, liabilities, costs, expenses, damages
or other losses that the Depositary may be entitled to collect from any party to this Agreement.
10. Tax Characterization. The parties to this Agreement agree that for all Federal,
state, local and foreign tax reporting purposes, all interest or other income earned from the
investment of the Deposit Funds in any calendar year shall (i) to the extent such interest or other
income is disbursed to any person pursuant to the terms of this Agreement during such calendar
year, be allocated to and reported by such person, and (ii) if no disbursement is made in any
calendar year, be allocated to and reported by Purchaser. The Depositary shall have no duty to
prepare or file any tax report or return with respect to the Deposit Funds.
11. Notice. All notices and other communications given or made pursuant to this
Agreement shall be in writing and shall be deemed effectively given: (a) upon hand delivery, (b)
when sent by confirmed facsimile, (c) when sent by confirmed electronic mail, (d) five (5) days
after deposit in the U.S. mail, by registered or certified mail, return receipt requested, postage
prepaid, or (e) one (1) day after deposit (with full payment) with a nationally recognized
overnight courier, in each case addressed as follows; provided, however, that notwithstanding
anything to the contrary in this Agreement, the Depositary shall only be deemed to have received
notice under this Agreement upon actual delivery to the Depositary:
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|
If to Purchaser: |
|
Victory Pharma, Inc.
00000 Xx Xxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, XX 00000
Attn: Chief Executive Officer
Facsimile: (000) 000-0000
E-mail: XXXX-xxxxxxx@xxxxxxxxxxxxx.xxx |
|
|
with a copy to: |
|
Xxxx Xxxxx LLP
000 Xxxxxxxxx Xxxxxx
Xxx Xxxx, XX 00000
Attn: Xxxxxx Xxxxxx
Attn: Xxxx X. Xxxxxxxx
Facsimile: (000) 000-0000
E-mail: XXxxxxx@XxxxXxxxx.xxx |
|
|
If to Seller: |
|
XxxxxxXxxxx Pharmaceutical, Inc.
0 Xxxxxxx Xxxxxx
Xxxxx 000
Xxxxxxxx, XX 00000
Attn: Xxxx Xxxx
Facsimile: (000) 000-0000
E-mail: xxxxx@xxxxxxxxxxxxxxxxx.xxx |
|
|
with a copy to: |
|
Xxxxxx & Bird LLP
0000 Xxxx Xxxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attn: Xxxxx Xxxxx
Facsimile: (000) 000-0000
E-mail: xxxxx.xxxxx@xxxxxx.xxx |
|
|
If to Depositary: |
|
SunTrust Bank
Escrow Services
000 Xxxx Xxxx Xxxxxx, 0xx Xxxxx
Xxxxxxxx, Xxxxxxxx 00000
Attention: Xxxxxxx Xxxxxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
E-mail: Xxxxxxx.Xxxxxxx@XxxXxxxx.xxx |
Any party may change his or its address with written notice to each of the other parties.
12. Applicable Law. The terms, conditions and other provisions of this Agreement and
any documents or instruments delivered in connection with it shall be governed and construed
according to the internal laws of the State of Delaware (other than the choice of law rules
thereof).
13. Consent to Jurisdiction and Venue. Each party to this Agreement irrevocably
submits to the exclusive jurisdiction of, and venue in, the Bankruptcy Court for the purposes of
any Suit arising out of this Agreement or any transaction contemplated hereby, and agrees to
commence any such Suit only in such court. Each party further agrees that service of any process,
summons, notice or document by U.S. registered mail to such party’s respective address set forth
herein will be effective service of process for any such Suit. Each party hereby irrevocably and
unconditionally waives any objection to the laying of
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venue of any Suit arising out of this Agreement in such court, and hereby irrevocably and
unconditionally waives and agrees not to plead or claim in such court that any such Suit brought in
such court has been brought in an inconvenient forum.
14. Execution of Form W-9 or Form W-8. On or before the execution and delivery of
this Agreement, Purchaser and Seller shall each complete and execute an Internal Revenue Service
Form W-9 or Form W-8, as applicable, and deliver an original of the same to the Depositary.
Notwithstanding anything to the contrary in this Agreement, the Depositary shall have no duty to
prepare or file any Federal or state tax report or return with respect to any funds held pursuant
to this Agreement or any income earned thereon.
15. Severability. It is the desire and intent of the parties to this Agreement that
the provisions of this Agreement be enforced to the fullest extent permissible under the laws and
public policies applied in each jurisdiction in which enforcement is sought. Accordingly, if any
particular provision of this Agreement shall be adjudicated by a court of competent jurisdiction to
be invalid, prohibited or unenforceable for any reason, such provision, as to such jurisdiction,
shall be ineffective, without invalidating the remaining provisions of this Agreement or affecting
the validity or enforceability of this Agreement or affecting the validity or enforceability of
such provision in any other jurisdiction. Notwithstanding the foregoing, if such provision could
be more narrowly drawn so as not to be invalid, prohibited or unenforceable in such jurisdiction,
it shall, as to such jurisdiction, be so narrowly drawn, without invalidating the remaining
provisions of this Agreement or affecting the validity or enforceability of such provision in any
other jurisdiction.
16. Counterparts. This Agreement may be executed in one or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute one and the same
instrument. Signatures on this Agreement delivered by facsimile shall be considered original
signatures for the purposes of effectiveness of this Agreement.
17. Entire Agreement. This Agreement (and the Purchase Agreement as to Purchaser and
Seller) constitutes the entire understanding and agreement of the parties to this Agreement with
respect to the subject matter of this Agreement and supersedes all prior and contemporaneous
agreements or understandings, inducements or conditions, express or implied, written or oral,
between the parties with respect to this Agreement.
18. Binding Upon Successors and Assigns. This Agreement and each and all of the
covenants, terms, provisions and agreements contained in this Agreement shall be binding upon, and
inure to the benefit of, the permitted successors, executors, heirs, representatives,
administrations and assigns of the parties to this Agreement.
19. Amendment. Except as otherwise set forth herein, this Agreement may be amended
only with the written consent of Purchaser, Seller and the Depositary. The Depositary shall not in
any way be bound or affected by a notice of modification or cancellation of this Agreement unless
notice thereof is given to the Depositary by Purchaser, nor shall the Depositary be bound by any
modification of its obligations hereunder unless the same shall be consented to by the Depositary
in writing.
20. Termination. This Agreement shall terminate upon the distribution by the
Depositary of all Deposit Funds held by the Depositary pursuant to the terms of this Agreement.
21. Purchase of Securities. The Depositary and any stockholder, director, officer,
agent or employee of the Depositary may buy, sell, and deal in any of the securities of Purchaser
and become
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pecuniarily interested in any transaction in which Purchaser may be interested, and contract and
lend money to Purchaser and otherwise act as fully and freely as though it were not Depositary
under this Agreement. Nothing herein shall preclude the Depositary from acting in any other
capacity for Purchaser or for any other entity.
[Signatures on Following Page]
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IN WITNESS WHEREOF, the undersigned have executed this Agreement as of the date first written
above.
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PURCHASER: |
VICTORY PHARMA, INC.
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By: |
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Name: |
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Title: |
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Federal Tax I.D. Number: |
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SELLER: |
XXXXXXXXXXX PHARMACEUTICALS, INC.
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By: |
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Name: |
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Title: |
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Federal Tax I.D. Number:
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DEPOSITARY: |
SUNTRUST BANK
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By: |
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Name: |
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Title: |
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[SIGNATURE PAGE TO DEPOSIT AGREEMENT]
Exhibit C
Form of Escrow Agreement
C-1
EXHIBIT C
ESCROW AGREEMENT
THIS ESCROW AGREEMENT (this “Agreement”), is made and entered into this
[_____] day of
[_____], 2010, by and among VICTORY PHARMA, INC., a Delaware corporation (the
“Purchaser”), XXXXXXXXXXX PHARMACEUTICALS, INC., a Delaware corporation (the
“Seller”), and SUNTRUST BANK, a Georgia banking corporation, as escrow agent (the
“Escrow Agent” and, collectively with the Purchaser and the Seller, the “Parties”).
Background
A. The Purchaser and the Seller have entered into an
Asset Purchase Agreement, dated as of May
14, 2010 (the “
Purchase Agreement”), pursuant to which, among other things, the Purchaser
has agreed to acquire the Purchased Assets (as defined in the Purchase Agreement) and assume the
Assumed Liabilities (as defined in the Purchase Agreement), in each case subject to the terms of
the Purchase Agreement. Capitalized terms not otherwise defined in this Agreement have the meanings
ascribed to such terms in the Purchase Agreement. A fully executed copy of the Purchase Agreement
will be provided to the Escrow Agent.
B. Pursuant to the Purchase Agreement, the Purchaser has delivered to the Escrow Agent, by
wire transfer of immediately available funds, an amount equal to Three Hundred Fifty Thousand
Dollars ($350,000) (such amount, together with any Interest (as defined in Section 12(b)),
less any payments or distributions made pursuant to Section 4, the “Escrow Funds”)
for deposit into the Escrow Account. By its execution and delivery of this Agreement, the Escrow
Agent acknowledges receipt of the Escrow Funds.
C. The Escrow Agent is willing to accept the Escrow Funds and to hold and distribute the
Escrow Funds in accordance with the terms and conditions set forth in this Agreement and will rely
on the written direction of the authorized signers listed on Schedule I attached hereto.
Agreement
NOW, THEREFORE, in consideration of the mutual promises contained herein, and other good and
valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties
hereby agree as follows:
1. |
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Appointment of Escrow Agent. The Purchaser and the Seller hereby appoint the SunTrust
Bank to act as escrow agent on the terms and conditions set forth herein, and SunTrust Bank hereby
accepts such appointment on such terms and conditions. |
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2. |
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Escrow Funds. The Escrow Agent shall hold, invest and distribute the Escrow Funds in
accordance with the terms and conditions hereof. The Escrow Agent shall not disburse the Escrow
Funds (including any Interest) other than pursuant to Section 4. |
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3. |
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Investment of the Escrow Funds. The Escrow Agent shall invest the Escrow Funds as
jointly instructed by the Purchaser and the Seller, in writing from time to time, or as directed in
Schedule II attached hereto. In the absence of written instructions from Purchaser and
Seller, the Escrow Funds shall be invested in the SunTrust Bank Institutional Money Market Account.
The Escrow Agent shall have no liability for any loss or diminution in the Escrow Funds resulting
from investments made in accordance with the provisions of this Agreement. The Escrow Agent is
authorized to liquidate in accordance with its customary procedures any portion of the Escrow Funds
consisting of investments to provide for payments required to be made under this Agreement, unless
instructed otherwise by a joint written instruction executed by Purchaser and Seller. |
4. |
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Disbursement of Escrow Funds and Procedures with Respect to Escrow Claims. |
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(a) |
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Release on Escrow Release Date. On the date (the “Escrow Release
Date”) that is forty-five (45) days after the Closing Date, the Purchaser and the
Seller shall execute and deliver a joint written instruction to the Escrow Agent
instructing the Escrow Agent to disburse to the Seller an amount equal to the Escrow
Funds as of the Escrow Release Date, minus the aggregate of Unpaid Seller Amounts as of
the Escrow Release Date (if any); provided, however, that, if the
aggregate of Unpaid Seller Amounts as of the Escrow Release Date equals or exceeds the
Escrow Funds as of the Escrow Release Date, then the Purchaser and the Seller will not
be required to so deliver such joint written instruction. If the Escrow Agent receives
the joint written instruction described in this Section 4(a), then it shall
promptly disburse the amount specified in such joint written instruction. |
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(b) |
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Distribution of Escrow Funds Pursuant to Joint Instruction. Promptly
following receipt by the Escrow Agent of joint written instructions signed by the
Purchaser and the Seller directing that all or a portion of the Escrow Funds be paid,
the Escrow Agent shall release all or such portion of the Escrow Funds in accordance
with such instructions. |
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(c) |
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Escrow Claims. |
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(i) |
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To validly claim that it is entitled to Escrow Funds, the
Purchaser must deliver to the Seller and the Escrow Agent, prior to the Escrow
Release Date, a written notice (such notice, an “Escrow Claim”) (A)
indicating that the Purchaser is entitled to Escrow Funds pursuant to the
Purchase Agreement, (B) describing the Purchaser’s basis therefor, (C)
specifying the amount that the Purchaser claims the Seller owes to the
Purchaser in respect thereof (which amount may exceed the Escrow Funds) (such
amount, a “Claim Amount”), and (D) providing evidence of payment of the
Claim Amount on behalf of the Seller. |
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(ii) |
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To validly object to a given Escrow Claim, the Seller must
deliver to the Purchaser and the Escrow Agent, on or prior to the date that is
ten (10) Business Days after the date on which the Seller receives or is deemed
to have received such Escrow Claim, a written notice (an “Escrow Claim
Objection Notice”) indicating that the Seller objects to the Escrow Claim,
describing the Seller’s basis for its objection, and specifying an alternative
amount (if any) owed by the Seller to the Purchaser in respect of such Escrow
Claim. |
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(iii) |
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If the Seller delivers an Escrow Claim Objection Notice in
accordance with Section 4(c)(ii), then the Purchaser and the Seller
shall seek in good faith to reach an agreement with respect to the Claim Amount
(or portion thereof) that is the subject of such Escrow Claim Objection Notice
on or before the date that is three (3) Business Days after the date on which
the Purchaser receives or is deemed to have received the Escrow Claim Objection
Notice. If the Purchaser and the Seller reach an agreement on or before such
date as to any Claim Amount owed by the Seller to the Purchaser, then they
shall deliver joint written instructions to the Escrow Agent instructing the
Escrow Agent to disburse to the Purchaser the agreed-upon Claim Amount in
accordance with Section 4(c)(v). If the Purchaser and the Seller are
unable to reach an agreement with respect to any Claim Amount (or portion
thereof) within such period, then the Purchaser and the Seller shall submit
such dispute to the Bankruptcy Court for determination of the final and binding
Claim Amount, if any (a “Final Claim Amount”). |
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(i) |
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If the Seller does not provide an Escrow Claim Objection Notice
in accordance with Section 4(c)(ii) with respect to all or a portion of
a Claim Amount specified in an Escrow Claim, then such Claim Amount will
thereby be deemed to be a Final Claim Amount. |
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(v) |
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Following the Escrow Agent’s receipt of an Escrow Claim, the
Escrow Agent shall disburse an amount from the Escrow Funds, to the extent of
the Escrow Funds at the time of such distribution, as follows: (A) if the
Purchaser and the Seller have delivered joint written instructions to the
Escrow Agent directing the Escrow Agent to disburse an agreed-upon Claim
Amount, such Claim Amount in accordance with the terms and in the manner set
forth in a joint written instructions; (B) if the Escrow Agent has not received
an Escrow Claim Objection Notice from the Seller within ten (10) Business Days
after the Escrow Agent has received an Escrow Claim, the Final Claim Amount
promptly to the Purchaser; or (C) if the Escrow Agent has received an order of
the Bankruptcy Court with respect to the determination of a Final Claim Amount,
such Final Claim Amount in accordance with such order as soon as reasonably
practicable. |
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(d) |
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The Escrow Agent shall not be responsible for determining whether an Escrow
Claim Objection Notice sets forth a reasonable basis for objection, and the Escrow
Agent is entitled to rely on any Escrow Claim Objection Notice that appears on its face
to specify an issue in any level of detail. If the Escrow Agent receives an Escrow
Claim Objection Notice, the Escrow Agent shall continue to hold the Escrow Funds
pending receipt of one of the items described in subsection (c)(v)(A) or (c)(v)(C),
above. |
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(e) |
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Payments in Excess of the Escrow Funds. If at any time a payment that
is required to be made by the Escrow Agent pursuant to this Section 4 exceeds
the Escrow Funds, then the Escrow Agent shall pay to the claiming party the entire
Escrow Funds. |
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(f) |
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No Limitation on Claims. Nothing herein (including any amount
specified in an Escrow Claim) or in the Purchase Agreement will operate (i) to limit to
the Escrow Funds the amount or nature of recourse to which the Purchaser is otherwise
entitled at Law or in equity or (ii) to prevent the Purchaser from receiving Escrow
Funds in respect of more than one Escrow Claim. |
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Obligations of Escrow Agent. |
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(a) |
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In performing its duties under this Agreement, or upon the claimed failure to
perform its duties, the Escrow Agent shall have no liability except for the Escrow
Agent’s willful misconduct or gross negligence. The Escrow Agent’s sole responsibility
shall be for the safekeeping and disbursement of the Escrow Funds in accordance with
the terms of this Agreement. In no event shall the Escrow Agent be liable for
incidental, indirect, special, consequential or punitive damages. |
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(b) |
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The Escrow Agent shall have no implied duties or obligations and shall not be
charged with or be deemed to have any knowledge of any fact or circumstance not
specifically set forth in this Agreement or provided to the Escrow Agent in writing
strictly in accordance with the notice provisions of this Agreement. The Escrow Agent
shall be entitled to rely upon and shall be protected in acting upon any request,
instructions, statement or other instrument, not only as to its due execution, validity
and effectiveness, but also as to the truth and accuracy of any information contained
therein, that the Escrow Agent in good |
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faith believes to be genuine, to have been signed or presented by the person or
parties purporting to sign the same and to conform to the provisions of this
Agreement. |
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(c) |
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The Escrow Agent shall not be obligated to take any legal action or to commence
any proceeding in connection with the Escrow Funds, any account in which the Escrow
Funds are deposited, or this Agreement, or to appear in, prosecute or defend any such
legal action or proceedings. |
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(d) |
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The Escrow Agent may consult legal counsel selected by it in the event of any
dispute or question as to the construction of any of the provisions of this Agreement
or of the Escrow Agent’s duties under this Agreement, and shall incur no liability and
shall be fully protected from any liability whatsoever in acting in accordance with the
advice, opinion or instruction of such counsel. |
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(e) |
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The Escrow Agent shall have no liability with respect to the transfer or
distribution of any funds effected by the Escrow Agent pursuant to wiring or transfer
instructions provided to the Escrow Agent in accordance with the provisions of this
Agreement. |
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Disputes. If, at any time, there shall exist any dispute between the Purchaser and
the Seller with respect to the holding or disposition of any portion of the Escrow Funds or
any other obligations of the Escrow Agent under this Agreement, or if at any time the Escrow
Agent is unable to determine, to the Escrow Agent’s sole satisfaction, the proper disposition
of any portion of the Escrow Funds or the Escrow Agent’s proper actions with respect to its
obligations under this Agreement, the Escrow Agent shall be entitled to retain the Escrow
Funds until the earlier of: (i) receipt of joint written instructions from all of the parties
in any such dispute, in which case the Escrow Agent shall disburse the Escrow Funds in
accordance with such instructions, or (ii) receipt of a final binding order of the Bankruptcy
Court, in which case the Escrow Agent shall disburse the Escrow Funds in accordance with such
order. |
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Indemnification. Purchaser and Seller agree to jointly and severally indemnify and
hold the Escrow Agent, its officers, directors, employees, affiliates and agents
(collectively, the “Indemnified Parties”) harmless against any and all actions, claims
(whether or not valid), losses, damages, liabilities, costs and expenses of any kind or nature
whatsoever (including, without limitation, reasonable attorneys’ fees, costs and expenses)
incurred by or asserted against any of the Indemnified Parties from and after the date hereof,
as a result of, arising out of or relating to any claim, demand, suit, action or proceeding
(including any inquiry or investigation) by any person (whether threatened or initiated),
asserting a claim for any legal or equitable remedy against any person under any statute or
regulation, including, but not limited to, any federal or state securities laws, or under any
common law or equitable cause or otherwise, arising directly or indirectly from or in
connection with the negotiation, preparation, execution, performance or failure of performance
of this Agreement or any transactions contemplated by this Agreement, whether or not any such
Indemnified Party is a party to any such action, proceeding, suit or is the target of any such
inquiry or investigation; provided, however, that this indemnity obligation shall not apply in
the event of the willful misconduct, bad faith, gross negligence or fraud of the Indemnified
Parties or any of them. If any such action or claim is brought or asserted against any
Indemnified Party, such Indemnified Party shall promptly notify the Purchaser and the Seller
in writing, and the Purchaser and the Seller shall assume the defense thereof, including the
employment of counsel and the payment of all expenses. Such Indemnified Party shall, in its
sole discretion, have the right to employ separate counsel in any such action and to
participate in the defense thereof (with the fees and expenses of such counsel to be paid by
such Indemnified Party), unless (i) the Purchaser and the Seller agree to pay such fees and
expenses, (ii) the |
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Purchaser or the Seller fail to assume the defense of such action or proceeding or fail, in
the reasonable discretion of such Indemnified Party, to employ counsel reasonably
satisfactory to the Indemnified Party in any such action or proceeding, or (iii) the named
parties to any such action or proceeding (including any impleaded parties) include both the
Indemnified Party and the Purchaser or the Seller, and the Indemnified Party shall have been
advised by counsel that there may be one or more legal defenses available to it that are
different from or additional to those available to the Purchaser or the Seller. All such
fees and expenses payable by the Purchaser or the Seller pursuant to the foregoing sentence
shall be paid from time to time as incurred, both in advance of and after the final
disposition of such action or claim. No Indemnified Party shall settle any indemnifiable
claim without the consent of the Purchaser and the Seller, which consent shall not be
unreasonably withheld. Neither the Purchaser nor the Seller will settle any indemnifiable
claim without the prior written consent of the Indemnified Party, which consent will not be
unreasonably withheld, unless the settlement provides for (i) no relief other than monetary
damages against which the Indemnified Party is fully indemnified, and (ii) an unconditional
release of the Indemnified Party. This indemnity obligation shall survive termination of
this Agreement and any resignation or removal of the Escrow Agent. |
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8. |
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Termination. Subject to Sections 5, 8 and 10, and except for
Sections 11 and 12, the obligations hereunder terminate upon the distribution
of all of the Escrow Funds pursuant to Section 4. |
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9. |
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Resignation or Removal of the Escrow Agent. The Escrow Agent may resign from the
performance of its duties under this Agreement at any time by giving thirty (30) days’ prior
written notice to the Purchaser and the Seller or may be removed, with or without cause, by
the Purchaser and the Seller, acting jointly, at any time by the giving of ten (10) days’
prior written notice to the Escrow Agent. Such resignation or removal shall take effect upon
the appointment of a successor escrow agent as provided herein. Upon any such notice of
resignation or removal, prior to the expiration of the applicable notice period, the Purchaser
and the Seller, acting jointly, shall appoint a successor escrow agent, which shall be a
commercial bank, trust company or other financial institution with a combined capital and
surplus in excess of $100,000,000, unless otherwise agreed by the Purchaser and the Seller.
The Purchaser and the Seller shall notify the Escrow Agent in writing, and upon receipt of
such notice, the Escrow Agent shall deliver all Escrow Funds in its custody to such successor
escrow agent, and all responsibility of the Escrow Agent under this Agreement shall terminate
upon such delivery, other than any liability for actions taken as Escrow Agent under this
Agreement prior to such succession. If the Purchaser and the Seller fail to appoint a
successor escrow agent within sixty (60) days after resignation or removal of the Escrow
Agent, the Escrow Agent shall deliver all Escrow Funds in its custody as the Purchaser and the
Seller shall jointly instruct in writing. Notwithstanding anything to the contrary provided
in this Agreement, in the event the Escrow Agent resigns as escrow agent under this Agreement
and, within sixty (60) days, no successor escrow agent has been designated and accepted
appointment as successor escrow agent, the Escrow Agent shall have the right to deposit the
Escrow Funds into the registry of any court of competent jurisdiction and notify the Purchaser
and the Seller of such deposit. Upon such deposit, the Escrow Agent shall be discharged from
all further duties and responsibilities as escrow agent under this Agreement. |
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Fees and Expenses. |
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(a) |
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The Purchaser and the Seller shall compensation the Escrow Agent for its
services to be rendered under this Agreement in accordance with Schedule III attached
hereto and, in addition, shall reimburse the Escrow Agent for all reasonable
out-of-pocket expenses, including attorneys’ fees, travel expenses, telephone and
facsimile transmission costs, |
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postage (including express mail and overnight delivery charges), copying charges and
the like. |
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(b) |
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All of the compensation and reimbursement obligations set forth in this Section
9 shall be payable promptly after the Escrow Agent submits a statement for such fees
and expenses and shall be a joint and several obligation of the Purchaser and the
Seller, but, solely as between the Purchaser and the Seller, shall be paid fifty
percent (50%) by the Purchaser, on the one hand, and fifty percent (50%) by the Seller,
on the other hand. |
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(c) |
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Except as otherwise set forth in this Agreement, the Escrow Agent hereby waives
any and all rights to offset claims it may have against any of the funds held by it
under this Agreement, including claims arising as a result of any claims, amounts,
liabilities, costs, expenses, damages or other losses that the Escrow Agent may be
entitled to collect from any party to this Agreement. |
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For tax reporting purposes, all Interest shall, as of the end of each calendar
year and to the extent required by Law, be reported as having been earned by the Party
to which such Interest were actually disbursed; provided, that, if no disbursement is
made in any calendar year, Interest is to be reported as having been earned by the
Purchaser. |
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(b) |
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The Escrow Agent shall have no duty to prepare or file any tax report or return
with respect to the Escrow Funds. |
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Notices. To be effective for purposes hereof, any notice, request, demand,
waiver, consent, approval or other communication (any of the foregoing, a “Notice”)
that is required or permitted hereunder must be in writing and will be deemed given: (i) on
the date established by the sender as having been delivered personally; (ii) on the date
delivered by a private, internationally recognized, overnight courier, as established by the
sender by evidence obtained from the courier; (iii) on the date sent by facsimile, with
confirmation of transmission, if sent during normal business hours of the recipient (and, if
not sent during normal business hours of the recipient, then on the next Business Day); (iv)
on the date sent by confirmed electronic mail, or (v) on the fifth (5th) day after the date
mailed, by certified or registered mail, return receipt requested, international postage
prepaid. Such communications, to be valid, must be addressed as follows; provided, however,
that notwithstanding anything to the contrary in this Agreement, the Escrow Agent shall only
be deemed to have received notice under this Agreement upon actual delivery to the Escrow
Agent: |
If to the Seller, to:
XxxxxxXxxxx Pharmaceutical, Inc.
0 Xxxxxxx Xxxxxx
Xxxxx 000
Xxxxxxxx, XX 00000
Attn: Xxxx Xxxx
Facsimile: (000) 000-0000
E-mail: xxxxx@xxxxxxxxxxxxxxxxx.xxx
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With a required copy (the delivery of which will not constitute notice to the Seller) to the
Escrow Agent and to:
Xxxxxx & Bird LLP
0000 Xxxx Xxxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attn: Xxxxx Xxxxx
Facsimile: (000) 000-0000
E-mail: xxxxx.xxxxx@xxxxxx.xxx
If to the Purchaser, to:
Victory Pharma, Inc.
00000 Xx Xxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, XX 00000
Attn: Chief Executive Officer
Facsimile: (000) 000-0000
E-mail: XXXX-xxxxxxx@xxxxxxxxxxxxx.xxx
With a required copy (the delivery of which will not constitute notice to the Purchaser) to
the Escrow Agent and to:
Xxxx Xxxxx LLP
000 Xxxxxxxxx Xxxxxx
Xxx Xxxx, XX 00000
Attn: Xxxxxx Xxxxxx
Attn: Xxxx X. Xxxxxxxx
Facsimile: (000) 000-0000
E-mail: XXxxxxx@XxxxXxxxx.xxx
If to the Escrow Agent, to:
SunTrust Bank
Escrow Services
000 Xxxx Xxxx Xxxxxx, 0xx Xxxxx
Xxxxxxxx, Xxxxxxxx 00000
Attention: Xxxxxxx Xxxxxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
E-mail: Xxxxxxx.Xxxxxxx@XxxXxxxx.xxx
Alternatively, a valid Notice may be delivered to such other address or to the attention of
such Person or Persons as the recipient Party has specified by prior written notice (in
accordance with this Section 11(a)) to the sending Party (or, in the case of
counsel, to such other readily ascertainable business address as such counsel may hereafter
maintain). If more than one method for sending Notice as set forth above is used, then the
earliest notice date established as set forth above will control for purposes of determining
when such Notice is deemed to have been given.
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Amendments and Waivers. |
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(i) |
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Any provision hereof may be amended or waived if, and only if,
such amendment or waiver is in writing and is signed, in the case of an
amendment, by each Party, or, in the case of a waiver, by the Party against
which the waiver is to |
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be effective. The Escrow Agent shall not in any way be bound or affected by
a notice of modification or cancellation of this Agreement unless notice
thereof is given to the Escrow Agent by Purchaser, nor shall the Escrow
Agent be bound by any modification of its obligations hereunder unless the
same shall be consented to by the Escrow Agent in writing. The waiver by any
Party of any right or privilege hereunder arising because of any breach,
default or misrepresentation, whether intentional or not, will not thereby
extend and will not be deemed to thereby extend to any prior or subsequent
breach, default or misrepresentation by such Party or by another Party and
will not affect in any way any rights arising by virtue of any such prior to
subsequent occurrence. |
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(ii) |
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No failure or delay by any Party in exercising any right or
privilege hereunder will operate as a waiver thereof, nor will any single or
partial exercise thereof preclude any other or further exercise thereof or the
exercise of any other right, power or privilege. |
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(c) |
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Successors and Assigns. Except as provided in Section 8, each Party
shall not assign or delegate (or enter into any contract that would otherwise effect
the assignment or delegation of) any of its rights or obligations hereunder without the
prior written consent of the other Parties, and any such purported assignment without
obtaining such written consent will be void ab initio; provided, however, that, without
obtaining the consent of the Seller or the Escrow Agent, the Purchaser may collaterally
assign any of its rights hereunder to any Person providing financing to the Purchaser
in connection with the Transactions (and the Seller and the Escrow Agent each hereby
consents to any such assignment). |
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(d) |
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Governing Law. Except to the extent that the Bankruptcy Code
mandatorily applies, this Agreement is governed by, and is to be interpreted and
enforced in accordance with, the internal Laws of the State of Delaware applicable to
contracts entered into and performed entirely within the State of Delaware, without
giving effect to any choice of Law or conflict of Laws rules or provisions (whether of
the State of Delaware or any other jurisdiction) that would cause the application of
the Laws of any jurisdiction other than the State of Delaware. |
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(e) |
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Consent to Jurisdiction and Venue. Each Party irrevocably submits to
the exclusive jurisdiction of, and venue in, the Bankruptcy Court for the purposes of
any Suit arising out of this Agreement or any transaction contemplated hereby, and
agrees to commence any such Suit only in such court. Each Party further agrees that
service of any process, summons, notice or document by U.S. registered mail to such
Party’s respective address set forth herein will be effective service of process for
any such Suit. Each Party hereby irrevocably and unconditionally waives any objection
to the laying of venue of any Suit arising out of this Agreement in such court, and
hereby irrevocably and unconditionally waives and agrees not to plead or claim in such
court that any such Suit brought in such court has been brought in an inconvenient
forum. |
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Counterparts. This Agreement may be executed in multiple counterparts,
and any Party may execute any such counterpart, each of which when executed and
delivered will thereby be deemed to be an original and all of which counterparts taken
together will constitute one and the same instrument. This Agreement will become
effective as of the date first set forth above when each Party has received one or more
counterparts hereto signed by the other Parties. The delivery of this Agreement may be
effected by means of an exchange of facsimile or portable document format (.pdf)
signatures. |
-8-
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No Third-Party Beneficiaries. No provision of this Agreement is
intended to confer upon any Person other than the Parties, their respective successors
and permitted assigns any rights or remedies hereunder. |
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Entire Agreement; Schedules. This Agreement and, as between the
Purchaser and the Seller, the Purchase Agreement collectively, (i) set forth the entire
understanding of the Parties with respect to the subject matter hereof and (ii)
supersede any and all previous agreements and understandings between or among the
Parties regarding the subject matter hereof or thereof, whether written or oral. All
Schedules referred to herein are intended to be and hereby are specifically made a part
hereof. |
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(i) |
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Captions. All captions contained herein are for convenience of
reference only, do not form a part hereof and are not to affect in any way the meaning
or interpretation hereof.(j) Severability. If any portion or provision hereof
is to any extent declared illegal or unenforceable by a court of competent
jurisdiction, then the remainder of this Agreement, or the application of such portion
or provision in circumstances other than those as to which it is so declared illegal or
unenforceable, will not be affected thereby, and each portion and provision hereof will
be valid and enforceable to the fullest extent permitted by Law. |
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Interpretation. The Parties have participated jointly in the
negotiation and drafting of this Agreement, and any rule of construction or
interpretation otherwise requiring this Agreement to be construed or interpreted
against any Party by virtue of the authorship of this Agreement is not to affect the
construction and interpretation hereof. |
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Specific Performance. Each Party acknowledges that the rights of each
other Party hereunder are special, unique and of extraordinary character and that, if a
Party violates or fails and refuses to perform any covenant made by it herein, then
each other Party may be without an adequate remedy at Law. Each Party agrees,
therefore, that, if it violates or fails and refuses to perform any covenant that it
makes hereunder, each other Party may, except to the extent the satisfaction of such
covenant been has been waived by such other Party in accordance with the terms hereof,
in addition to any remedies hereunder for damages or other relief, institute and
prosecute an action in any court of competent jurisdiction (subject to Section 11(d))
to enforce specific performance of such covenant or agreement or seek any other
equitable relief. |
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Time of the Essence. Time is of the essence of this Agreement and of
every part hereof. |
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(n) |
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Signed Writings. Emails, including emails that bear an electronic
“signature block” identifying the sender, do not constitute signed writings for
purposes of this Agreement. |
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(o) |
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Business Days. If any date for payment or notice hereunder falls on a
day other than a Business Day, then the referenced date will be deemed to refer to the
first Business Day following such date. |
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Conflicts. Nothing herein shall be construed to modify, vitiate,
narrow or expand the terms and conditions of the Purchase Agreement. To the extent
there is any conflict between any provisions of this Agreement and any provisions of
the Purchase Agreement, as between the Purchaser and the Seller, the provisions of the
Purchase Agreement will control. |
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Purchase of Securities. The Escrow Agent and any stockholder, director,
officer, agent or employee of the Escrow Agent may buy, sell, and deal in any of the
securities of the Purchaser and become pecuniarily interested in any transaction in
which the Purchaser may be interested, and contract and lend money to the Purchaser and
otherwise act as fully and freely as though it were not Escrow Agent under this
Agreement. Nothing herein shall preclude the Escrow Agent from acting in any other
capacity for the Purchaser or for any other entity. |
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(r) |
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Construction. For the purposes hereof, except as otherwise expressly provided
herein: |
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the terms “hereof,” “herein,” “hereunder,” “hereby,” “hereto”
and “herewith” and words of similar import are to be construed to refer to this
Agreement as a whole and not to any particular provision of this Agreement; |
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unless otherwise indicated, a reference herein to a Section,
paragraph, or Schedule is a reference to a Section, paragraph, or Schedule,
respectively, of or to this Agreement; |
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the words “include,” “includes,” and “including” as used
herein are in all cases deemed to be followed by the words “without
limitation”; |
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(iv) |
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the symbol “$” means United States Dollars; |
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(v) |
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any reference to an agreement (including this Agreement) and
all other contractual instruments is a reference to such agreement or
instrument (including all exhibits, schedules and appendixes thereto) as the
same may be amended or otherwise modified from time to time in accordance with
the terms thereof; and |
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any reference to a law is a reference to all statutory and
regulatory provisions consolidating, amending, replacing, supplementing or
interpreting such law. |
13. |
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Certain Defined Terms. |
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Capitalized terms used but not otherwise defined herein have the respective
meanings ascribed to them in the Purchase Agreement. |
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(b) |
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“Interest” means any amounts earned from the investment of, as interest
on or otherwise as income on the Escrow Funds. |
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(c) |
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“Unpaid Claim Amount” means (i) an Unresolved Claim Amount or (ii) a
Final Claim Amount that has not been paid to the Purchaser from the Escrow Funds. |
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(d) |
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“Unpaid Seller Amount” means (i) an Unpaid Claim Amount or (ii) an
amount with respect to which the Purchaser has duly made an election pursuant to
Section 1.9(c) of the Purchase Agreement but that has not been disbursed to the
Purchaser from the Escrow Account. |
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(e) |
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“Unresolved Claim Amount” means a Claim Amount, or portion thereof,
that is not a Final Claim Amount. |
[Signature page follows.]
-10-
The Parties have executed this Agreement as of the date first written above.
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VICTORY PHARMA, INC.
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By: |
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Name: |
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Title: |
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XXXXXXXXXXX PHARMACEUTICALS, INC.
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By: |
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Name: |
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Title: |
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SUNTRUST BANK
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By: |
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Name: |
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Title: |
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Signature Page to Escrow Agreement
-11-
Exhibit D
[VICTORY PHARMA, INC.] /
[XXXXXXXXXXX PHARMACEUTICALS, INC.]
OFFICER’S CERTIFICATE
[ ], 2010
Reference is hereby made to that certain
Asset Purchase Agreement, dated as of April
[_____],
2010 (the “
Agreement”), by and between Victory Pharma, Inc., a Delaware corporation (the
“
Purchaser”) and XxxxxxXxxxx Pharmaceuticals, Inc., a Delaware corporation (the
“
Seller”). Capitalized terms used herein and not otherwise defined have the respective
meanings ascribed to them in the Agreement.
The undersigned hereby certifies that [he]/[she] is the duly appointed, qualified and acting
[title] of the [Purchaser]/[Seller] and that [he]/[she] is authorized to execute this Certificate
and deliver this Certificate to the [Seller]/[Purchaser]. The undersigned hereby further
certifies, pursuant to Section [2.2(a)(v)]/[2.2(b)(iv)] of the Agreement, in [his]/[her] corporate
capacity and not in [his]/[her] individual capacity, as follows:
1. |
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(i) each representation and warranty set forth in [Article 4]/[Article 3] of the Agreement
that is qualified by materiality is true and correct as written as of the Execution Date and
as of the Closing Date as if made as of the Closing Date, except to the extent that such
representation or warranty refers specifically to an earlier date (other than the Execution
Date), in which case such representation or warranty is true and correct in all respects as of
such earlier date, and (ii) each representation and warranty set forth in [Article 4]/[Article
3] of the Agreement that is not qualified by materiality is true and correct in all material
respects as of the Execution Date and as of the Closing Date as if made as of the Closing
Date, except to the extent that such representation or warranty refers specifically to an
earlier date (other than the Execution Date), in which case such representation or warranty is
true and correct in all material respects as of such earlier date; and |
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the [Purchaser]/[Seller] has performed and complied in all material respects with all
obligations required by the Agreement to be performed or complied with by it at or prior to
the Closing. |
[Signature Page Follows]
D-1
The undersigned is signing this Officer’s Certificate as of the date first written above.
D-2
Exhibit E
Non-Foreign Seller Certificate
(FIRPTA Affidavit)
Section 1445 of the Internal Revenue Code of 1986, as amended (the “Code”), provides
that a transferee of a U.S. real property interest must withhold tax if the transferor is a
foreign person. For U.S. tax purposes (including Section 1445 of the Code), the owner of a
disregarded entity (which has legal title to a U.S. real property interest under local law) will
be the transferor of the property and not the disregarded entity. To inform Victory Pharma, Inc.,
a Delaware corporation (“Transferee”) that withholding of tax is not required upon the
disposition of a U.S. real property interest by XxxxxxXxxxx Pharmaceuticals, Inc.
(“Transferor”), the undersigned hereby certifies the following on behalf of Transferor:
1. Transferor is not a foreign corporation, foreign partnership, foreign trust, or foreign
estate (as those terms are defined in the Code and Income Tax Regulations);
2. Transferor is not a disregarded entity as defined in Treasury Regulations Section
1.1445-2(b)(2)(iii);
3. Transferor’s U.S. employer identification number is 00-0000000; and
4. Transferor’s office address is 0 Xxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx, Xxxxx 00000.
Transferor understands that this certification may be disclosed to the Internal Revenue
Service (the “IRS”) by Transferee and that any false statement contained herein could be
punished by fine, imprisonment, or both.
Under penalties of perjury I declare that I have examined this certification and to the best
of my knowledge and belief it is true, correct and complete, and I further declare that I have
authority to sign this document on behalf of Transferor.
Dated:
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XxxxxxXxxxx Pharmaceuticals, Inc.,
a Delaware corporation
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By: |
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Name: |
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Title: |
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NOTICE TO TRANSFEREE (BUYER): You are required by law to retain this Certificate until the end
of the fifth tax year following the tax year in which the transfer takes place and make the
Certificate available to the IRS if requested to do so during that period.
E-1
Exhibit F
Form of Approval Order
X-0
XXXXXXX X
XXXXXX XXXXXX BANKRUPTCY COURT
DISTRICT OF DELAWARE
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In re:
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Chapter 11 |
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XXXXXXXXXXX PHARMACEUTICALS,
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) |
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Case No. 10-11485 (MFW) |
INC.,1
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Ref. Docket No:
_____
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) |
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Debtor.
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) |
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ORDER PURSUANT TO SECTIONS 105(a), 363 AND 365 OF THE
BANKRUPTCY CODE, BANKRUPTCY RULES 2002, 6004, 6006, AND
9014, AND LOCAL RULES 2002-1 AND 6004-1, APPROVING THE
SALE OF ASSETS, INCLUDING THE ASSUMPTION AND ASSIGNMENT OF
CONTRACTS, FREE AND CLEAR OF ALL LIENS, CLAIMS, AND INTERESTS
Upon the motion, dated May , 2010 (the “Motion”), of XxxxxxXxxxx Pharmaceuticals, Inc. (the
“Debtor”), pursuant to Sections 105(a), 000, xxx 000 xx Xxxxx 00, Xxxxxx Xxxxxx Code (the
“Bankruptcy Code”), Rules 2002, 6004, 6006, and 9014 of the Federal Rules of Bankruptcy Procedure
(the “Bankruptcy Rules”), and Rules 2002-1 and 6004-1 of the Local Bankruptcy Rules for the
District of Delaware (the “Local Rules”) requesting entry of a bidding procedures order (the
“Bidding Procedures Order”) and sale order authorizing the sale (the “Sale”) of the Purchased
Assets2 to the highest and/or best Qualifying Bidder; and the Court having approved the
bidding procedures proposed in the Motion and entered the Bidding Procedures Order on June ,
2010; and the Debtor having received timely bids from interested parties; and the Debtor, in
consultation with the official committee of unsecured creditors (the “Committee”), having
determined which of such bids were Qualifying Bids pursuant to the Bidding Procedures Order; and
the Debtor having held an Auction on July , 2010, to determine which Qualifying Bid was the
highest and/or otherwise best offer for the Purchased Assets (the “Successful Bid”); and
(the “Purchaser”) having submitted the Successful Bid as
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1 |
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The last four digits of the Debtor’s taxpayer
identification number are 8264. The Debtor’s mailing address is 0 Xxxxxxx
Xxxxxx, Xxxxx 000, Xxxxxxxx, Xxxxx 00000. |
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Capitalized terms used but not defined herein shall have
the meanings ascribed to such terms in the Motion. |
determined at the Auction; and the Sale Hearing having been held on July
_____
, 2010, to consider
approval of the Sale of the Purchased Assets to the Purchaser; and due and proper notice of the
Motion having been provided to (i) the Office of the United States Trustee for the District of
Delaware (the “U.S. Trustee”), (ii) counsel to the Purchaser, (iii) counsel to the Committee, and
(iv) all parties requesting notice pursuant to Bankruptcy Rule 2002 and Local Rule 2002- 1(b); and
due and proper notice of the Sale and the assumption and assignment of the Assumed Contracts
otherwise having been provided to any other parties required to be noticed pursuant to the Bidding
Procedures Order; and it appearing that no other or further notice need be provided; all parties in
interest having been heard, or having had the opportunity to be heard, regarding the approval of
the Bidding Procedures Order, the Sale and all transactions contemplated thereunder; and the Court
having reviewed and considered the Motion and any objections thereto, and the arguments of counsel
and evidence adduced related thereto; and upon the record of the hearings for consideration of the
Bidding Procedures Order and the Sale and the full record of these cases; and the Court having
determined that the relief sought in the Motion is in the best interests of the Debtor, its estate
and creditors, and all parties in interest, and the legal and factual bases set forth in the
Motion, and the record establish just cause for the relief granted herein; and after due
deliberation and sufficient cause appearing therefor,
IT IS HEREBY FURTHER FOUND AND DETERMINED AS FOLLOWS:
A. The findings and conclusions set forth herein constitute the Court’s findings of fact and
conclusions of law pursuant to Bankruptcy Rule 7052, made applicable to this proceeding pursuant to
Bankruptcy Rule 9014.
B. To the extent any of the following findings of fact constitute conclusions of law, they are
adopted as such. To the extent any of the following conclusions of law constitute findings of
fact, they are adopted as such.
C. Notice of the Motion and of the Sale Hearing was given in accordance with the directive of
the Court and as otherwise required by applicable law, as evidenced by the affidavits of service on
file with the Clerk of the Court.
D. Notice of the Sale Motion and of the Sale Hearing was adequate and sufficient under the
circumstances.
E. Unless otherwise defined herein, capitalized terms used herein shall have the meanings
ascribed to them in the Motion or the Agreement.
F. The procedures set forth in the Bidding Procedures Order were substantively fair and
procedurally fair to all parties. The Debtor conducted the sale process (including the Auction) in
accordance with the Bidding Procedures Order.
G. The highest and best offer for the Purchased Assets was submitted by Purchaser pursuant to
the terms of the Agreement and in accordance with the bid procedures previously approved by the
Court.
H. The Agreement was negotiated and proposed, and has been entered into by the parties in good
faith within the meaning of Section 363(m) of Xxxxx 00, Xxxxxx Xxxxxx Code (the “Bankruptcy Code”),
at arm’s length bargaining positions, and without collusion; the Purchaser is a good faith
purchaser of the Purchased Assets (as defined in the Agreement) within the meaning of Section
363(m) of the Bankruptcy Code and entitled to the protections thereof; the legal and factual bases
set forth in the Motion establish just cause for the relief granted herein; and the relief granted
herein is in the best interests of Debtor and its estate.
I. The Purchased Assets are property of the Debtor and title thereto is vested in the Debtor.
J. Except as otherwise expressly provided in the Agreement, no further consents or approvals
are required for the Debtor to consummate the Sale of the Purchased Assets other than the consent
and approval of this Court. Although the parties have agreed under the terms of the Agreement to
obtain certain additional consents or approvals, as conditions to the closing of the Sale of the
Purchased Assets, the Court makes no finding as to whether any of these additional consents or
approvals is necessary for approval and authorization of the Sale by the Court. Neither the
execution of the Agreement nor the consummation of the Sale of the Purchased Assets in accordance
with the terms of the
Agreement will constitute a violation of any provision of the organizational documents of the
Debtor or any other instrument, law, regulation, or ordinance by which any Debtor is bound.
K. The consideration to be paid by the Purchase to the Debtor for the Purchased Assets
pursuant to the Agreement (i) is fair and reasonable; (ii) is the highest and/or otherwise best
offer for the Purchased Assets; and (iii) constitutes reasonably equivalent value and fair
consideration under the Bankruptcy Code and the Uniform Fraudulent Conveyance Act and the Uniform
Fraudulent Transfer Act and any and all similar laws of any state or jurisdiction whose law is
applicable to the Sale and transaction contemplated thereby.
L. All objections thereto having been resolved, other than for amounts escrowed by the Debtor
for unresolved Claimed Cure Amounts, the amounts set forth on Exhibit A to the Notice of Assumption
and Assignment, dated , 2010 (the “Cure Amounts”), are deemed the necessary amounts to
“cure” all “defaults” under Section 365(b) of the Bankruptcy Code.
IT IS HEREBY ORDERED AS FOLLOWS:
1. The Motion is granted to the extent provided herein. All objections to the Motion that
have not been withdrawn, waived, settled, or specifically addressed in this Order, and all
reservations of rights included in such objections, are overruled in all respects on the merits and
denied.
2. The Debtor is hereby authorized and empowered to enter into the Agreement and the Agreement
is hereby approved in its entirety and incorporated herein by reference, and it is further ordered
that all amounts payable under the Agreement shall be payable without the need for any application
therefor or a further order of the Court.
3. Pursuant to Section 363(f) of the Bankruptcy Code, all of the Purchased Assets shall be
sold free and clear of any and all mortgages, security interests, conditional sales or title
retention agreements, pledges, hypothecations, liens, judgments, encumbrances or claims of any kind
or nature (including, without limitation, any and all “claims” as defined in Section 101(5) of the
Bankruptcy Code), whether arising by agreement, any statute or otherwise and whether arising
before, on or after the date on which this Chapter 11 case was commenced (collectively, the
“Liens”), with such Liens to attach to the
proceeds and consideration (whether in the form of cash or otherwise) payable to or at any
time received by the Debtor under the Agreement with the same validity, force and effect as the
same had with respect to the assets at issue, subject to any and all defenses, claims and/or
counterclaims or setoffs that may exist.
4. The Debtor and the Purchaser, and each of their respective officers, employees and agents,
are hereby authorized to take such actions necessary and appropriate to implement the Agreement and
to close the transactions contemplated thereby without the necessity of a further order of this
Court as provided by the Agreement, including, but not limited to, the assumption and assignment of
the Assumed Contracts, all in accordance with the terms of the Agreement.
5. All of the transactions contemplated by the Agreement and the closing of the sale of the
Purchased Assets and assignment of the Assumed Contracts shall be protected by Section 363(m) of
the Bankruptcy Code in the event that this Order is reversed or modified on appeal.
6. The Purchaser shall not be liable for any claims against the Debtor other than as expressly
provided for in the Agreement. Without limiting the generality of the other provisions of this
Order, the Purchaser, under no circumstances, shall be deemed to be a successor of the Debtor.
Accordingly, the Purchaser shall have no successor or vicarious or other liabilities of any kind
with respect to the Debtor or the Purchased Assets, and all persons and entities shall be hereby
enjoined from asserting any such claims against the Purchaser.
7. The provisions of this Order and the Agreement and any actions taken pursuant hereto or
thereto shall survive entry of any order which may be entered confirming or consummating any plan
of reorganization of the Debtor, or which may be entered converting Debtor’s case from Chapter 11
to Chapter 7, and the terms and provisions of the Agreement as well as the rights and interests
granted pursuant to this Order and the Agreement shall continue in this or any superseding case and
shall be binding upon the Debtor, the Purchaser and their respective successors and permitted
assigns, including any trustee or other fiduciary hereafter appointed as a legal representative of
the Debtor under Chapter 7 or 11 of the Bankruptcy Code. Any trustee appointed in the case shall
be and hereby is authorized and
directed to operate the business of Debtor to the fullest extent necessary to permit
compliance with the terms of this Order and the Agreement and the Purchaser and the trustee shall
be and hereby are authorized to perform under the Agreement upon the appointment of a trustee with
the need for further order of this Court.
8. To the extent, if any, anything contained in this Order conflicts with a provision in the
Agreement, this Order shall govern and control.
9. The Agreement or any document relating thereto may be modified, amended, or supplemented by
the parties thereto, in a writing signed by such parties and in accordance with the terms thereof,
without further order of the Court, provided that any such modification, amendment, or supplement
does not have a material adverse effect on the Debtor or its estate.
10. Any party having the right to consent to the assumption or assignment of the Assumed
Contracts pursuant to the Agreement that has failed to object to such assumption or assignment is
deemed to have consented to such assumption and assignment, as required by Section 365(c) of the
Bankruptcy Code. In addition, adequate assurance of future performance has been demonstrated by or
on behalf of Purchaser with respect to the Assumed Contracts.
11. There shall be no rent accelerations, assignment fees, increases, or any other fees
charged to Debtor or to the Purchaser or its affiliates or designees as a result of the assumption
and assignment by the Debtor to the Purchaser of the Assumed Contracts, and the validity of such
assumption or assignment shall not be affected by any dispute between the Debtor and any
counterparty to any Assumed Contract, and the Assumed Contracts, upon assignment to Purchaser,
shall be deemed valid and binding and in full force and effect in accordance with their terms.
12. This Order shall be binding on all creditors (whether known or unknown) of the Debtor, all
successors and assigns of the Purchaser, Debtor, its affiliates and any subsequent trustee(s)
appointed in Debtor’s Chapter 11 case or upon a conversion to Chapter 7 under the Bankruptcy Code
and shall not be subject to rejection or revocation.
13. Consistent with, but not in limitation of the foregoing, each and every federal, state,
and local government agency or department is hereby directed to accept any and all documents and
instruments necessary and appropriate to consummate the Sale.
14. In the event that the Purchaser fails to consummate the transactions contemplated by the
Agreement in accordance with this Order and the Agreement, the Debtor and the next highest bidder
at the Auction may consummate a sale in accordance with the terms and conditions of such Next
Highest Bid without further notice or order of the Court.
15. Except as otherwise set forth in this Order, this Court shall retain exclusive
jurisdiction with regard to all issues on disputes in connection with this Order and the relief
provided for herein, and to resolve any disputes related to the Agreement or the implementation
thereof.
16. This Sale Order shall take effect immediately and shall not be stayed pursuant to
Bankruptcy Rules 6004(g), 6006(d), 7062, or otherwise, and the Debtor may take any action and
perform any act authorized under this Order immediately.
Dated: July , 0000
Xxxxxxxxxx, Xxxxxxxx
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THE XXXXXXXXX XXXX XXXXXXX |
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UNITED STATES BANKRUPTCY JUDGE |
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Exhibit G
Forms of Patent Assignment, Trademark Assignment,
Copyright Assignment and Domain Name Assignment
G-1
EXHIBIT G
PATENT ASSIGNMENT
THIS PATENT ASSIGNMENT (this “Assignment”) is made and is effective this
[ ], 2010 (the “Effective Date”), by and between XxxxxxXxxxx
Pharmaceuticals, Inc., a Delaware corporation, having its principal offices at 0 Xxxxxxx Xxxxxx,
Xxxxx 000, Xxxxxxxx, XX 00000 (“Assignor”) and Victory Pharma, Inc., a Delaware
corporation, having its principal offices at 00000 Xx Xxxxxx Xxxx, Xxxxx 000 Xxx Xxxxx, XX 00000
(“Assignee”).
WHEREAS, upon the terms and subject to the conditions set forth in that certain
Asset Purchase
Agreement, dated as of May 14, 2010, by and between Assignor and Assignee (the “
Asset Purchase
Agreement”), Assignor has agreed to sell, convey, transfer, assign and deliver to Assignee all
of Assignor’s right, title and interest in and to the Product Patent Rights and Other Patents (in
each case as defined in the Asset Purchase Agreement); and
WHEREAS, Assignee has agreed to acquire the Product Patent Rights and Other Patents.
NOW, THEREFORE, in consideration of the foregoing and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the parties provide
and agree as follows:
1. Capitalized Terms. Capitalized terms used but not otherwise defined herein shall
have the respective meanings ascribed to such terms in the Asset Purchase Agreement.
2. Assignment. As of the Effective Date, Assignor hereby sells, conveys, transfers,
assigns, and delivers to Assignee, and Assignee hereby accepts, all of Assignor’s right, title, and
interest in and to the Product Patent Rights and Other Patents, including more specifically, but
without limitation, those patents and patent applications set forth on Schedule A attached hereto
and any and all rights related thereto, including all direct and indirect divisions, continuations,
continuations-in-part of such patents and patent applications, any and all Letters Patent in the
United States and all foreign countries which may be granted therefore and thereon, and reissues,
reexaminations, extensions, and renewals of any of the foregoing, including the right to bring any
cause of action arising from, and recover damages accrued for, infringement of such patents or
patent applications prior to the date of this Assignment.
3. Regulatory Authorities. Assignor hereby authorizes the Commissioner for Patents of
the U.S. Patent and Trademark Office and other empowered officials of relevant patent and
industrial property offices and other governmental or regulatory authorities in each jurisdiction
other than the United States, to record the transfer of the Product Patent Rights and Other Patents
to Assignee as the assignee of Assignor’s entire right, title and interest therein, and to issue
all future registrations and other rights relating to such Product Patent Rights and Other Patents
to Assignee.
4. Further Acts.
4.1 Assignor shall duly execute and deliver, or cause to be duly executed and
delivered, any additional documents or instruments and do and cause to be done, such further
necessary and useful acts and things as Assignee may reasonably request at any time in the
future to enable Assignee to protect, perfect, enforce, or otherwise secure Assignee’s
rights in, and/or ownership of, the Product Patent Rights and Other Patents.
4.2 Following the Effective Date of this Assignment and subject to Assignor’s
obligations set forth in Section 4.1, Assignee shall be responsible for the drafting,
execution and filing of any such further instruments, documents, assignments and agreements
as may be necessary in order to prosecute, maintain, enforce and defend the intellectual
property rights assigned to Assignee pursuant to this Assignment.
4.3 Without limiting the foregoing, Assignor shall:
(a) promptly forward to Assignee any correspondence or other communication from
any patent office or any counsel employed by Assignor in connection with any of the
patents or patent applications set forth on Schedule A; and
(b) if Assignee institutes a legal proceeding with respect to any patent or
patent application set forth on Schedule A that requires, to initiate or maintain
such proceeding, that Assignor be joined as a named party to the proceeding, Assignor
agrees to be named to such proceeding at Assignee’s expense.
5. Miscellaneous.
5.1 Controlling Document. This Assignment may not be amended, supplemented or
otherwise modified except by an instrument in writing signed by all the parties hereto.
This Assignment and the Asset Purchase Agreement contain the entire agreement of the parties
hereto with respect to the Assignment, superseding all negotiations, prior discussions and
preliminary agreements made prior to the Effective Date. In the event of any conflict or
inconsistency between the terms, provisions and conditions of this Assignment and the Asset
Purchase Agreement, the terms, provisions and conditions of the Asset Purchase Agreement
shall govern.
5.2 Binding Effect. This Assignment shall be binding upon and inure to the
benefit of the Assignor and Assignee, and their representatives, successors and permitted
assigns, in accordance with the terms of the Asset Purchase Agreement.
5.4 Governing Law. Except to the extent that the Bankruptcy Code mandatorily
applies, this Assignment is governed by, and is to be interpreted and enforced in accordance
with, the internal Laws of the State of Delaware applicable to contracts entered into and
performed entirely within the State of Delaware, without giving effect to any choice of Law
or conflict of Laws rules or provisions (whether of the State of Delaware or any other
jurisdiction) that would cause the application of the Laws of any jurisdiction other than
the State of Delaware.
5.5 Consent to Jurisdiction and Venue. Each Party irrevocably submits to the
exclusive jurisdiction of, and venue in, the Bankruptcy Court for the purposes of any Suit
arising out of this Assignment or any transaction contemplated hereby, and agrees to
commence any such Suit only in such court. Each Party further agrees that service of any
process, summons, notice or document by U.S. registered mail to such Party’s respective
address set forth herein will be effective service of process for any such Suit. Each Party
hereby irrevocably and unconditionally waives any objection to the laying of venue of any
Suit arising out of this Assignment or the Transactions in such court, and hereby
irrevocably and unconditionally waives and agrees not to plead or claim in such court that
any such Suit brought in such court has been brought in an inconvenient forum.
5.6 Counterparts. This Assignment may be executed manually or by facsimile by
the parties, in any number of counterparts, each of which shall be considered one and the
same agreement
and shall become effective when a counterpart hereof shall have been signed by each of
the parties and delivered to each of the other parties.
[SIGNATURE PAGES FOLLOW]
Assignor has executed this Assignment as of the Effective Date.
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ASSIGNOR:
XXXXXXXXXXX PHARMACEUTICALS, INC.
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By: |
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Name: |
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Title: |
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) ss.:
On this
_____
day of , 2010, before me, a Notary Public duly commissioned, qualified
and acting, within and for the County and State, appeared in person the within named
to me personally known, who stated that he is the
of XxxxxxXxxxx Pharmaceuticals, Inc. and is duly authorized in that
capacity to execute the foregoing instrument for and in the name and on behalf of the corporation,
and further stated and acknowledged that he has so signed, executed and delivered the foregoing
instrument for the consideration, uses and purposes therein mentioned.
In testimony whereof, I have hereunto set my hand and official seal this
_____
day of
, 2010.
Assignee has executed this Assignment as of the Effective Date.
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ASSIGNEE:
VICTORY PHARMA, INC.
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By: |
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Name: |
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SCHEDULE A
Assigned Patents
See attached list of patents.
TRADEMARK ASSIGNMENT
THIS TRADEMARK ASSIGNMENT (this “Assignment”) is made and is effective this
[ ], 2010 (the “Effective Date”), by and between XxxxxxXxxxx
Pharmaceuticals, Inc., a Delaware corporation, having its principal offices at 0 Xxxxxxx Xxxxxx,
Xxxxx 000, Xxxxxxxx, XX 00000 (“Assignor”) and Victory Pharma, Inc., a Delaware
corporation, having its principal offices at 00000 Xx Xxxxxx Xxxx, Xxxxx 000 Xxx Xxxxx, XX 00000
(“Assignee”).
WHEREAS, upon the terms and subject to the conditions set forth in that certain Asset Purchase
Agreement, dated as of May 14, 2010, by and between Assignor and Assignee (the “Asset Purchase
Agreement”), Assignor owns and has agreed to sell, convey, transfer, assign and deliver to
Assignee all of Assignor’s right, title and interest in and to the Product Marks and Other Marks
(in each case as defined in the Asset Purchase Agreement), including the trademarks and trademark
applications and registrations as shown in Schedules A, B and C attached hereto (the
“Applications and Registrations”), and the goodwill associated therewith (together with the
trademarks and the Applications and Registrations, the “Marks”).
NOW, THEREFORE, for good and valuable consideration as set out in the Asset Purchase
Agreement, the receipt and sufficiency of which is hereby acknowledged, the parties agree as
follows:
1. Assignor hereby assigns unto Assignee all right, title and interest in and to the Marks,
together with any common law rights and the goodwill of the business symbolized therewith, as well
as the right (but not the obligation) to assert the Marks and to collect for all past, present and
future infringements, and claims for damages and the proceeds thereof, including, without
limitation, license royalties and proceeds of infringement suits and all rights corresponding
thereto throughout the world by reason of any past and future acts of infringement that have
occurred or may occur.
2. The portion of Assignor’s business to which the Marks pertain is an ongoing and existing
business.
3. Assignee is the successor to the portion of Assignor’s business to which the Marks pertain.
4. This document may be executed in two counterparts, each of which shall be deemed to be an
original and all such counterparts shall constitute but one and the same instrument.
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XXXXXXXXXXX PHARMACEUTICALS, INC.
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By: |
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Name: |
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Title: |
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VICTORY PHARMA, INC.
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By: |
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Name: |
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Title: |
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SCHEDULE A
U.S. Applications and Registrations
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XXXX |
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APP. NO. |
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REG. NO. |
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APP. DATE |
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REG. DATE |
Design Only (Green Capsule) |
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76670824 |
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3354517 |
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2006-12-26 |
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2007-12-11 |
KEFLEX |
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72311361 |
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0881598 |
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1968-11-05 |
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1969-12-02 |
KEFLEX 250 MG & Design |
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76670776 |
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3259839 |
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2006-12-26 |
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2007-07-10 |
KEFLEX 333 MG & Design |
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76670775 |
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n/a |
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2006-12-26 |
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n/a |
KEFLEX 500 MG & Design |
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76670777 |
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3259840 |
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2006-12-26 |
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2007-07-10 |
KEFLEX 750 MG & Design |
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76670823 |
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3259841 |
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2006-12-26 |
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2007-07-10 |
m1 (Stylized) |
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77625855 |
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n/a |
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2008-12-03 |
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n/a |
XXXXXXXXXXX |
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76671793 |
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3379090 |
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2007-01-25 |
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2008-02-05 |
XXXXXXXXXXX PHARMACCEUTICALS
(Stylized) |
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76675269 |
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3379091 |
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2007-04-10 |
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2008-02-05 |
MOX10 |
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77673511 |
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n/a |
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2009-02-19 |
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n/a |
MOXAKIT |
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77673517 |
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n/a |
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2009-02-19 |
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n/a |
MOXATAG |
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77683106 |
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3627404 |
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2007-10-18 |
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2009-05-26 |
MOXATAG 1 (Stylized) |
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77625829 |
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3706773 |
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2008-12-03 |
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2009-11-03 |
MOXATAG PAK (Stylized) |
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77906187 |
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n/a |
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2010-01-06 |
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n/a |
MOXATAG PAK |
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77934413 |
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n/a |
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2010-02-12 |
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n/a |
MOXATEN |
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77673515 |
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n/a |
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2009-02-19 |
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n/a |
MOXPAK |
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77693797 |
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n/a |
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2009-03-18 |
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n/a |
MOX-PAK |
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77673512 |
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n/a |
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2009-02-19 |
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n/a |
MOXPAK 1 (Stylized) |
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77850590 |
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n/a |
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2009-10-16 |
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n/a |
PULSYS |
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78077941 |
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3220454 |
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2001-08-07 |
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2007-03-20 |
REDEFINING THE PARADIGM |
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78285866 |
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2932810 |
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2003-08-11 |
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2005-03-15 |
SCHEDULE B
Canadian Applications
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XXXX |
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APP. NO. |
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REG. NO. |
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APP. DATE |
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REG. DATE |
MOX10 |
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1447969 |
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n/a |
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2009-08-12 |
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n/a |
MOXAKIT |
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1447976 |
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n/a |
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2009-08-12 |
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n/a |
MOXATAG |
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1420994 |
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n/a |
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2008-12-08 |
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n/a |
MOXATEN |
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1447975 |
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n/a |
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2009-08-12 |
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n/a |
MOX-PAK |
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1447974 |
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n/a |
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2009-08-12 |
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n/a |
PULSYS |
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1420993 |
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n/a |
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2009-12-08 |
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n/a |
SCHEDULE C
Mexican Applications and Registration
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XXXX |
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APP. NO. |
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REG. NO. |
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APP. DATE |
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REG. DATE |
MOX10 |
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1027154 |
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n/a |
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2009-08-17 |
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n/a |
MOXAKIT |
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1027152 |
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1135589 |
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2009-08-17 |
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2009-12-14 |
MOXATAG |
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980171 |
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103963 |
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2008-12-16 |
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2009-04-13 |
MOXATEN |
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1027151 |
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1135588 |
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2009-08-17 |
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2009-12-14 |
MOX-PAK |
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1027153 |
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n/a |
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2009-08-17 |
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n/a |
PULSYS |
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980170 |
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1226716 |
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2008-12-16 |
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2009-10-22 |
PULSYS |
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980169 |
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1144756 |
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2008-12-16 |
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2010-02-23 |
COPYRIGHT ASSIGNMENT
THIS COPYRIGHT ASSIGNMENT (this “Assignment”) is made and is effective this
[ ], 2010 (the “Effective Date”), by and between XxxxxxXxxxx
Pharmaceuticals, Inc., a Delaware corporation, having its principal offices at 0 Xxxxxxx Xxxxxx,
Xxxxx 000, Xxxxxxxx, XX 00000 (“Assignor”) and Victory Pharma, Inc., a Delaware
corporation, having its principal offices at 00000 Xx Xxxxxx Xxxx, Xxxxx 000 Xxx Xxxxx, XX 00000
(“Assignee”).
WHEREAS, upon the terms and subject to the conditions set forth in that certain Asset Purchase
Agreement, dated as of May 14, 2010, by and between Assignor and Assignee (the “Asset Purchase
Agreement”), Assignor owns and has agreed to sell, convey, transfer, assign and deliver to
Assignee all of Assignor’s right, title and interest in and to the Product Copyrights and Other
Copyrights (in each case as defined in the Asset Purchase Agreement), including the copyrighted
works and the registrations therefore set forth on Schedule A attached hereto (the “Copyrighted
Works”).
NOW, THEREFORE, for good and valuable consideration as set out in the Asset Purchase
Agreement, the receipt and sufficiency of which is hereby acknowledged, the parties agree as
follows:
1. Assignor hereby assigns unto Assignee the entire, full and exclusive right, title and
interest in and to the Copyrighted Works, and the right (but not the obligation) to assert the
Copyrighted Works and to collect for all past, present and future infringements, and claims for
damages and the proceeds thereof, including, without limitation, license royalties and proceeds of
infringement suits and all rights corresponding thereto throughout the world by reason of any past
and future acts of infringement that have occurred or may occur.
2. This document may be executed in two counterparts, each of which shall be deemed to be an
original and all such counterparts shall constitute but one and the same instrument.
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XXXXXXXXXXX PHARMACEUTICALS, INC.
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By: |
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Name: |
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Title: |
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VICTORY PHARMA, INC.
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By: |
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Name: |
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Title: |
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SCHEDULE A
Copyrighted Works
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Title |
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Reg. No. |
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Reg. Date |
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Type |
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Claimant |
How PULSYS products
work-animation 2003
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PAu002824256
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2004-01-30
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CD-ROM
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Advancis
Pharmaceutical
Corp. |
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How PULSYS products
work : illustrations 2003
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VAu000628176
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2004-01-30
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Art originals
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Advancis
Pharmaceutical
Corp. |
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KEFLEX Packaging
Insert
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TX0006982104
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2009-01-14
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Text
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XxxxxxXxxxx
Pharmaceuticals,
Inc. |
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Pulsys drug
delivery animation
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PAu002783288
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2002-10-11
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Motion picture
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Advancis
Pharmaceutical
Corp. |
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MOXATAG Packaging
Insert
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TX0006981796
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2009-01-14
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Text
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XxxxxxXxxxx
Pharmaceuticals,
Inc. |
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Moxatag Website
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VA0001668154
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2009-04-30
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Text, visual
material
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XxxxxxXxxxx
Pharmaceuticals,
Inc. |
DOMAIN NAME ASSIGNMENT
THIS DOMAIN NAME ASSIGNMENT (this “Assignment”) is made and is effective this
[ ], 2010 (the “Effective Date”), by and between XxxxxxXxxxx
Pharmaceuticals, Inc., a Delaware corporation, having its principal offices at 0 Xxxxxxx Xxxxxx,
Xxxxx 000, Xxxxxxxx, XX 00000 (“Assignor”) and Victory Pharma, Inc., a Delaware
corporation, having its principal offices at 00000 Xx Xxxxxx Xxxx, Xxxxx 000 Xxx Xxxxx, XX 00000
(“Assignee”).
WHEREAS, upon the terms and subject to the conditions set forth in that certain Asset Purchase
Agreement, dated as of May 14, 2010, by and between Assignor and Assignee (the “Asset Purchase
Agreement”), Assignor owns and has agreed to sell, convey, transfer, assign and deliver to
Assignee all of Assignor’s right, title and interest in and to the Product Domain Names and Other
Domain Names (in each case as defined in the Asset Purchase Agreement), including the domain name
registrations set forth on Schedule A attached hereto including all registrations and registration
applications relating to such domain name registrations (the “Domain Names”).
NOW, THEREFORE, for good and valuable consideration as set out in the Asset Purchase
Agreement, the receipt and sufficiency of which is hereby acknowledged, the parties agree as
follows:
1. Assignor hereby assigns unto Assignee the entire, full and exclusive right, title and
interest in and to the Domain Names, together with all proceeds, benefits, privileges, causes of
action, and remedies relating to such domain name registrations, all rights to bring an action,
whether at law or in equity, for infringement, dilution or misuse of such domain name registrations
against any third party, all rights to recover damages, profits and injunctive relief for all past,
present or future infringement, dilution or misuse of such domain name registrations.
2. This document may be executed in two counterparts, each of which shall be deemed to be an
original and all such counterparts shall constitute but one and the same instrument.
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XXXXXXXXXXX PHARMACEUTICALS, INC.
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By: |
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Name: |
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Title: |
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VICTORY PHARMA, INC.
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By: |
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Name: |
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Title: |
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SCHEDULE A
Domain Names
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xxxxxx-xxxxxxxxxxx.xxx
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XXXXXX.XX |
xxxxxx-xxxxxxxx.xxx
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XXXXXXXXXXXXXXXX.XXX |
xxxxxx.xxx
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XXXXXXXXXXX-XXXXXX.XXX |
xxxxxx000.xxx
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XXXXXXXXXXXXXXXXXXXXXXXX.XXX |
xxxxxx000.xxx
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XXXXXXXXXXXXXXXXXXXXXXXXXX.XXX |
xxxxxx000.xxxx
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XXXXXXXXXXX-XXXXXXXXXXXXXXX.XXX |
xxxxxx000.xxx
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XXXXXXXXXXXXXXXXXXXXXXXXXX.XXXX |
xxxxxx000.xxx
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XXXXXXXXXXXXXXXXXXXXXXXXXX.XXX |
xxxxxx000.xx
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XXXXXXXXXXXXXXXXXXXXXXXXXX.XXX |
xxxxxx000.xx.xxx
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XXXXXXXXXXXXXXXXXXXXXXXXXX.XX |
xxxxxxxx.xxx
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xxxxxxxxxxxxxxxxx.xxx |
xxxxxxxxxxxx.xxx
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xxxxxxxxxxxxxxxxx.xxxx |
xxxxxxxxxxxx.xxx
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xxxxxxxxxxxxxxxxx.xxxx |
xxxxxxxxxxxx.xxxx
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xxxxxxxxxxxxxxxxx.xxx |
xxxxxxxxxxxx.xxx
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xxxxxxxxxxxxxxxxx.xxx |
xxxxxxxxxxxx.xxx
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xxxxxxxxxxxxxxxxx.xx |
xxxxxxxxxxxx.xx
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xxxxxxxxxxxxxxxxxxxxxxxxx.xx.xx |
xxxxxxxx.xxx
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xxxxxxxxxxxxxxxxxxxxxxxxx.xxxx |
xxxxxxxx.xxx
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xxxxxxxxxxxxxxxxxxxxxxxxxx.xx.xx |
xxxxxx-xxxxx-xxxxxxxxxxxx.xx.xx
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xxxxxxxxxxxxxxxxxxxxxxxxxx.xxxx |
xxxxxxxxxxx-xxxxx.xx.xx
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xxxxxxx.xxx |
xxxxxxxxxxx-xxxxx.xxxx
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xxxxxxx.xxxx |
xxxxxxxxxxx-xxxxxx.xx.xx
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xxxxxxx.xxx |
xxxxxxxxxxx-xxxxxx.xxxx
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xxxxxxx.xxx |
xxxxxxxxxxx-xxxxxxxxxxxxxx.xx.xx
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xxxxxxx.xx.xxx |
xxxxxxxxxxx-xxxxxxxxxxxxxx.xxxx
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xxxxxxx.xxxx |
xxxxxxxxxxx-xxxxxxxxxxxxxxx.xx
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xxxxxxx.xx.xxx |
xxxxxxxxxxx-xxxxxxxxxxxxxxx.xx.xx
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xxxxxxx.xx.xxx |
xxxxxxxxxxx-xxxxxxxxxxxxxxx.xxxx
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xxxxxx.xxx |
xxxxxxxxxxxxxxxx.xx.xx
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xxxxxx.xxxx |
xxxxxxxxxxxxxxxx.xxxx
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xxxxxx.xxx |
xxxxxxxxxxxxxxxxx.xxx
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xxxxxx.xx |
xxxxxxxxxxxxxxxxx.xx.xx |
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Exhibit H
XXXX OF SALE AND ASSIGNMENT AND ASSUMPTION AGREEMENT
THIS XXXX OF SALE AND ASSIGNMENT AND ASSUMPTION AGREEMENT, dated as of [ ], 2010 (this
“Agreement”), is made and entered into by and between Victory Pharma, Inc., a Delaware
corporation (the “Purchaser”) and XxxxxxXxxxx Pharmaceuticals, Inc., a Delaware corporation
(the “Seller” and, collectively with the Purchaser, the “Parties”), to be effective
as of the Effective Time.
WHEREAS, the Seller and the Purchaser are parties to that certain Asset Purchase Agreement,
dated as of April 30, 2010 (the “Purchase Agreement”);
WHEREAS, pursuant to the Purchase Agreement, the Seller has agreed to sell, convey, transfer,
assign and deliver to the Purchaser free and clear of all Claims, interests (as defined in Section
363 of the Bankruptcy Code) and Liens, and the Purchaser has agreed to purchase, take delivery of
and acquire from the Seller, all of the Seller’s right, title and interest in and to the Purchased
Assets; and
WHEREAS, pursuant to the Purchase Agreement, the Purchaser has agreed to assume and pay,
perform or otherwise discharge, the Assumed Liabilities, in accordance with their respective terms
and subject to the respective conditions thereof.
NOW, THEREFORE, for and in consideration of the mutual covenants contained herein and in the
Purchase Agreement, and for other good and valuable consideration, the receipt, adequacy and legal
sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
1. |
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Definitions. Unless otherwise indicated, capitalized terms used and not defined
herein have the respective meanings ascribed to them in the Purchase Agreement. |
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2. |
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Sale and Transfer of Purchased Assets. The Seller hereby sells, conveys,
transfers, assigns and delivers to the Purchaser all of the Seller’s right, title and interest
in and to the Purchased Assets, effective as of the Effective Time. For the avoidance of
doubt, the Parties acknowledge that the Seller is not hereby selling, conveying, transferring,
assigning or delivering to the Purchaser the Excluded Assets. |
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3. |
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Assignment and Assumption of Assumed Liabilities. Effective as of the
Effective Time, the Purchaser hereby assumes and agrees to pay, perform or otherwise
discharge, the Assumed Liabilities, in accordance with their respective terms and subject to
the respective conditions thereof. For the avoidance of doubt, the Parties acknowledge that
the Purchaser is not hereby assuming and is not hereby agreeing to pay, perform or otherwise
discharge, the Excluded Liabilities. |
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4. |
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Controlling Provisions. This Agreement and the rights, obligations and liabilities
of the Parties provided herein are subject in all respect to the terms of the Purchase
Agreement. Nothing herein in any way supersedes, enlarges, narrows or modifies, or shall be
deemed to supersede, enlarge, narrow or modify, any provision of the Purchase Agreement. In
the event of any conflict or inconsistency between the terms of the Agreement and the terms
hereof, the terms of the Purchase Agreement will control. |
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5. |
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Further Actions. The Parties covenant and agree, at their own expense, to execute
and deliver, at the request of the other Party hereto, such further instruments of transfer
and assignment and to take such other action as such other Party may reasonably request to
more effectively consummate the transfers, assignments and assumptions contemplated by this
Agreement. |
H-1
5. |
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Incorporation of Provisions in the Agreement. The following provisions of the
Purchase Agreement are hereby incorporated by reference as if set forth in full herein,
mutatis mutandis: Sections 9.1 (Notices), 9.2 (Amendments and Waivers), 9.4 (Successors and
Assigns) 9.5 (Governing Law), 9.6 (Consent to Jurisdiction), 9.7 (Counterparts), 9.8 (No
Third-Party Beneficiaries), 9.10 (Captions), 9.11 (Severability), 9.12 (Interpretation), 9.14
(Signed Writings) and 9.17 (Construction) of the Purchase Agreement are hereby incorporated by
reference as if set forth in full herein, mutatis mutandis. |
[Signature Page Follows]
H-2
Each Party is signing this Xxxx of Sale and Assignment and Assumption Agreement as of the date
first above written.
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VICTORY PHARMA, INC.
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By: |
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Name: |
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Title: |
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XXXXXXXXXXX PHARMACEUTICALS, INC.
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By: |
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Name: |
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Title: |
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H-3
Exhibit I
Bidding Procedures
I-1
BIDDING PROCEDURES
The following procedures (collectively, the “Bidding Procedures”)3 shall govern the
proposed sale (the “Sale”) of the assets (collectively, the “Assets”) of XxxxxxXxxxx
Pharmaceuticals, Inc. (the “Debtor”), as more fully set forth in that certain Asset Purchase
Agreement (the “APA”), dated as of May 14, 2010, by and between Victory Pharma, Inc., a Delaware
corporation (the “Purchaser”), and the Debtor.
Asset Purchase Agreement
On May 14, 2010 (the “Execution Date”), the Debtor entered into the APA with the Purchaser
pursuant to which Purchaser proposes to acquire substantially all of the Assets (the “Purchased
Assets”) and assume certain assumed liabilities (the “Assumed Liabilities”). The Purchased Assets
would include, among other things, all Real Property, Leaseholds, Equipment, Fixtures, Inventory,
and Intellectual Property in which the Debtor has an interest, and all proceeds and products
thereof. As set forth in more detail the APA, the Purchased Assets and the Assumed Liabilities
shall not include certain excluded assets (the “Excluded Assets”) and certain excluded liabilities
(the “Excluded Assets”).
Pursuant to the terms of the APA, Purchaser would provide cash consideration in an amount
equal to Seventeen Million and One Hundred Thousand U.S. Dollars (U.S. $17,100,000), the Purchase
Price set forth in Section 1.5 of the APA, plus assumption of the Assumed Liabilities.
Sale Motion
On or before the date that is five (5) business days after the Execution Date, the Debtor
shall file a motion (the “Sale Motion”) for orders (A)(I) approving the Bidding Procedures to be
employed in connection with the Proposed Sale of the Purchased Assets, (II) scheduling an auction
(the “Auction”) and the hearing (the “Sale Hearing”) to consider approval of (a) the Sale, (b) the
assumption and assignment of certain executory contracts and unexpired leases (collectively, the
“Assigned Agreements”) in connection with the Sale, and (c) certain related relief, and (III)
approving the notice of the respective dates, times, and places for the Auction and the Sale
Hearing, and (B)(I) authorizing and approving an asset purchase agreement between the Debtor and
Purchaser, or such other purchaser(s) providing higher or otherwise better offer(s), (II)
authorizing the Sale of the Purchased Assets, free and clear of all liens, claims, encumbrances,
and other interests, (III) authorizing the assumption and assignment of the Assigned Agreements and
the rejection of other executory contracts, (IV) authorizing the Debtor to consummate all
transactions related to the above, and (V) granting other relief, filed in the United States
Bankruptcy Court for the District of Delaware (the “Bankruptcy Court”).
The Bidding Procedures shall be approved and authorized by a Bankruptcy Court order (the
“Bidding Procedures Order”) dated no later than June 30, 2010.
|
|
|
3 |
|
All capitalized terms not otherwise defined herein shall
have the meaning ascribed to them in the Sale Motion. |
-1-
Due Diligence
Due to the complexity of the proposed transactions and the Debtor’s duty to maximize
recoveries from the Sale, the Debtor shall deliver the Sale Motion to all parties who are known to
have expressed an interest in acquiring the Assets and any other entity that requests service of
the Sale Motion (the “Potential Bidders”). The Sale Motion will invite all Potential Bidders to
participate in the Sale.
The Debtor may afford any Potential Bidder the time and opportunity to conduct reasonable due
diligence; provided such Potential Bidder enters into a confidentiality agreement (the
“Confidentiality Agreement”) limiting its use of such information and demonstrates sufficient
financial wherewithal, in the Debtor’s discretion, to consummate the Sale. Any Potential Bidder
may obtain a copy of the Confidentiality Agreement from Gleacher & Company (“Gleacher”), the
Debtor’s financial advisor. Gleacher and the Debtor may, on their own initiative, also send a copy
of the Confidentiality Agreement to those parties who have not yet executed one but whom Gleacher
or the Debtor has identified as being likely to be interested in making an offer to purchase the
Assets and participating in the Auction.
Thereafter, the Debtor and Gleacher shall entertain any further reasonable requests for
additional information and due diligence from any party who has executed the Confidentiality
Agreement and provided the required satisfactory evidence of financial wherewithal. The Debtor, in
its discretion, may deny any such requests for additional information, if, after taking into
account, among other things, business factors (such as whether or not the Potential Purchaser is
currently a competitor of the Debtor), legal, regulatory, and other considerations, it determines
that doing so would not be in the best interests of its estate and creditors or is otherwise
contrary to the goals of the Auction and the Sale. If any due diligence material has not
previously been provided to the Purchaser, then the Debtor shall simultaneously provide such
material to the Purchaser.
Participation Requirements
To participate in the Auction, a Potential Bidder must become a “Qualified Bidder.” Unless
otherwise ordered by the Bankruptcy Court, for cause shown, or as otherwise determined by the
Debtor, each Potential Bidder must have delivered to (a) Gleacher & Company, 1290 Avenue of the
Xxxxxxxx, Xxxxxx Xxxxx, Xxx Xxxx XX 00000, Attn: Xxxx Xxxxxx, (b) Xxxxxx & Bird LLP, 0000 Xxxx
Xxxxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxx 00000-0000, Attn: Xxxxx Xxxxx, Esq., and (c) Victory Pharma,
Inc., 00000 Xx Xxxxxx Xxxx, Xxxxx 000 Xxx Xxxxx, XX 00000, with a copy to Xxxx Xxxxx LLP, 000
Xxxxxxxxx Xxxxxx, Xxx Xxxx, XX 00000 Attn: Xx. Xxxxxx Xxxxxx and Xx. Xxxx Xxxxxxxx (but with
respect to Victory Pharma, Inc., only Item No. iii(c), below, shall be sent to Victory Pharma,
Inc.) the following information such that such information is received no later than 4:00 pm
prevailing Eastern Time on the date that is at least five (5) business days before the date set for
the Auction (the “Bidding Deadline”), a written bid (a “Competing Bid”) that contains the
following:
|
(i) |
|
An executed Confidentiality Agreement; |
|
|
(ii) |
|
Current audited financial statements (or such other form of financial
disclosure and credit-quality support or enhancement acceptable to the Debtor) of the
Potential Bidder or of those entities that will guarantee the obligations of the
Potential Bidder; |
-2-
|
(iii) |
|
A bid letter including a written expression of the Potential Bidder’s
initial bid that includes: (a) such bidder’s initial bid (an “Initial Bid”), (b) a
statement that such bidder is willing to proceed as a buyer on a basis substantially
similar to that of Purchaser, and (c) a binding, definitive, and irrevocable executed
copy of the APA marked with interlineations indicating any modifications thereto
required by such Potential Bidder (which agreement shall not contain the provisions
set forth in Section 8.4 of the APA or otherwise entitle such bidder to any
Termination Fee or the other Bidding Procedures set forth therein); |
|
|
(iv) |
|
Provide an xxxxxxx money deposit equal to 10% of the Potential Bidder’s
Initial Bid, which deposit shall be no less than $1.7925 million (the “Bid Deposit”);
and |
|
|
(v) |
|
Provide sufficient indicia that such Potential Bidder or its representative
is legally empowered, by power of attorney or otherwise (i) to bid on behalf of the
Potential Bidder and (ii) to complete and sign, on behalf of the bidder, a binding and
enforceable APA. |
A Qualified Bidder is a Potential Bidder that delivers a Competing Bid and that the Debtor
determines is reasonably likely (based on financial information submitted by the Potential Bidder,
the availability of financing, experience and other considerations deemed relevant by the Debtor)
to submit a bona fide offer and to be able to consummate the proposed transaction if selected as a
Winning Bidder (defined below) within the time frame provided by the APA and the Sale Motion.
The Debtor may request additional information from a Potential Bidder to evaluate the bidder’s
ability to consummate the Sale and to fulfill its obligations in connection therewith, and such
bidder will be obligated to provide such information as a precondition to participating further in
the Auction.
As promptly as practicable after a Potential Bidder delivers all of the materials required of
a Competing Bid, and in no event later than five (5) days before the Auction, the Debtor shall
determine, in consultation with the unsecured creditors committee if/after one is appointed in the
Bankruptcy Case (the “Committee”), and shall notify each Potential Bidder and the Purchaser in
writing, whether such Potential Bidder is a Qualified Bidder. Notwithstanding the foregoing,
Purchaser shall be deemed a Qualified Bidder for purpose of the Auction. Each Qualified Bidder
participating in the Auction will be required to confirm that it has not engaged in any collusion
with respect to the bidding process or the Sale.
The Bid Deposit shall be in the form of a wire transfer to the account of an escrow agent
selected by the Debtor (the “Escrow Agent”), pursuant to instructions to be provided upon request.
The Bid Deposit, together with any interest earned thereon, shall be returned to any Bidder whose
Bid is not accepted by the Debtor within three (3) business days of the conclusion of the Sale
Hearing, except that in the case of the party who submits the Alternate Winning Competing Bid (as
such term is defined herein) the Debtor reserves the right to retain such bidder’s Bid Deposit
until three (3) business days after the transaction with the Winning Competing Bidder has been
consummated. If the entity that makes the Winning Competing Bid (as such term is defined below)
fails to consummate the purchase of the Assets, and such failure to consummate the purchase is the
result of a breach by the Winning Competing Bidder, such bidder’s deposit shall be forfeited to the
Debtor and the Debtor specifically reserves the right to seek all available damages from the
defaulting offeror.
-3-
An Initial Bid of a Qualified Bidder shall not provide a purchase price that is less than
Seventeen Million and Nine Hundred and Twenty-Five Thousand U.S. Dollars (U.S. $17,925,000) in cash
plus an additional amount in cash equal to the Purchaser Cure Amounts (if any) paid by the Seller
prior to such point in time (collectively, the “Initial Competing Bid Amount”), such amount being
the sum of the (i) Sixteen Million and Seven Hundred and Fifty Thousand U.S. Dollars (U.S.
$16,750,000), the Purchase Price set forth in Section 1.5(a) and (b) of the APA, (ii) Three Hundred
and Fifty Thousand U.S. Dollars (U.S. $350,000), the Escrow Amount set forth in Section 1.5(c) of
the APA; (iii) Four Hundred Thousand U.S. Dollars (U.S. $400,000) (the “Breakup Fee”), (iv) One
Hundred Fifty Thousand U.S. Dollars ($150,000) on account of the Purchaser’s actual expenses
incurred (the “Expense Reimbursement Fee”), (v) Purchaser Cure Amounts paid by the Seller prior to
such point in time, and (vi) Two Hundred Seventy-Five Thousand U.S. Dollars (U.S. $275,000) (the
“Initial Bid Increment”), plus assumption of at least the Assumed Liabilities.
Each Competing Bid must also: (a) specify the portion of the consideration to be paid in cash
and the portion to be paid in any other form of value (if any), including specifying any liability
of the Debtor that the such bidder intends to assume in connection with the Sale above and beyond
the Assumed Liabilities; (b) if any consideration above and beyond the assumption of the Assumed
Liabilities is to be provided in a form other than cash, provide information concerning such
consideration to permit the Debtor to accurately assess the value of such consideration; (c) if the
Competing Bid contemplates a purchase of less than all of the Purchased Assets, provide sufficient
detail concerning which of the Purchased Assets would not be purchased thereby; (d) not contain any
contingencies to closing that are not set forth in Article VI of the APA, including, without
limitation, contingencies for financing, diligence, board approval, or similar contingencies or
condition; (e) identify with particularity each and every executory contract or unexpired lease the
assumption and assignment of which is a condition to closing, to the extent different from the
Assigned Agreements proposed to be assumed under the APA; (f) require the Qualified Bidder to
consummate the Sale on substantially the same timing as set forth in the APA; and (g) fully
disclose the identity of the entities, if any, which shall be acquiring directly or indirectly a
portion of the Assets under or in connection with the Competing Bid.
Competing Bids submitted on or prior to the Bidding Deadline, as same may be modified by a
bidder at the Auction, shall remain open and irrevocable until the Sale Hearing. Acceptance of a
Bid shall, in all respects, be subject to entry of an order by the Court that, among other things,
authorizes the Debtor to consummate a sale to the Winning Competing Bidder (as defined below).
Following the Sale Hearing, if Purchaser or any Winning Competing Bidder (as the case may be) fails
to consummate an approved sale because of a breach or failure to perform on its part, the next
highest or otherwise best Qualified Bid, as disclosed at the Auction (the “Alternate Winning
Competing Bid”), shall be deemed to be the Winning Competing Bid, and the Debtor shall be
authorized, but not required, to consummate the Sale with the Qualified Bidder submitting such bid
(i) without the need for further notice or order of the Court and (ii) without prejudice to the
Debtor’s right to seek all available damages from the defaulting offeror.
The Auction and Selection of the Winning Bid
If one or more Competing Bids (other than Purchaser’s) are received, the Auction will be
conducted at the offices of Xxxxxx & Xxxx XXX, Xxx Xxxx, Xxx Xxxx 00000, or at another location as
may be timely disclosed by the Debtor to Qualified Bidders and Purchaser, on or about 10:00 a.m. on
[ ] , 2010 (the “Auction Date”).
The Auction will be conducted openly and all creditors will be permitted to attend. Additionally,
the Auction will be transcribed by a court reporter, or videotaped at the Debtor’s discretion. If,
-4-
however, no such Competing Bids are received by the Bidding Deadline (unless the Debtor has
extended such deadline in accordance with the terms hereof), then the Auction will not be held,
Purchaser will be deemed the Winning Competing Bidder, and the Debtor may seek approval thereof at
the Sale Hearing.
All Qualified Bidders must appear in person at the Auction, or through a duly authorized
representative. At or prior to the commencement of the Auction, the Debtor will notify all
Qualified Bidders, including Purchaser, of the then highest and best Qualified Bid received by that
time (the “Highest and Best Bid”).
Initial bidding shall begin at the Auction with the Highest and Best Bid. Each subsequent bid
(each, a “Subsequent Overbid”) must have a purchase price that exceeds the purchase price of the
previous highest bid by at least Two Hundred and Fifty Thousand U.S. Dollars (U.S. $250,000).
Unless otherwise specified by the Debtor, in consultation with the Committee, the Auction shall be
completed on the Auction Date. Except as otherwise set forth herein, the Debtor may conduct the
Auction in the manner it determines will result in the highest, best or otherwise financially
superior offer(s) for the Acquired Assets. Any such rules must provide that: (A) the procedures
will be fair and open, with no participating Qualified Bidder disadvantaged in any material way as
compared to any other Qualified Bidder; (B) the true identity of each bidder will be fully
disclosed to all other bidders and all material terms of each Qualified Bid will be fully disclosed
to all other bidders throughout the entire Auction; and (C) each Qualified Bidder will be permitted
a fair, but limited, amount of time to respond to the previous bid at the Auction.
Unless otherwise specified by the Debtor, in consultation with the Committee, the Auction will
continue in one or more rounds of bidding and shall conclude after each participating bidder has
had an opportunity to submit an additional Subsequent Overbid, after being advised of the then
highest bid and the identity of the party making such next highest bid.
In considering every bidder’s bids, the Debtor shall take into account the Breakup Fee and
Reimbursement Fee. Purchaser shall be entitled to make a revised higher or better offer at any
time prior to the conclusion of the Auction.
The Debtor further reserves the right to (a) amend and/or impose additional terms and/or
conditions at or prior to the Auction that they believe will better promote the goals of the
Auction and do not otherwise conflict with the terms and requirements set forth in the APA, (b)
extend the deadlines set forth in the Bidding Procedures and/or adjourn the Auction at the Auction
and/or the Sale Hearing in open court or on the Bankruptcy Court’s calendar on the date scheduled
for said hearing without further notice to creditors or parties-in-interest, and (c) to withdraw
the Sale Motion at any time prior to the conclusion of the Sale Hearing.
Upon conclusion of the Auction, the Debtor shall (i) review each Qualified Bid or bids (as and
to the extent such bids were increased at the Auction) on the basis of financial and contractual
terms and the factors relevant to the Sale Process, including those factors affecting the speed and
certainty of consummating the Sale, and (ii) identify the highest and otherwise best offer for the
Purchased Assets as the winning competitive bid (“Winning Competing Bid”) and such entity
submitting the Winning Qualified Bid will be the winning competing bidder (“Winning Competing
Bidder”).
-5-
Supplement
To the extent that the Initial Bid embodied in the APA is not the Winning Competing Bid at the
Auction, the Debtor will file with the Court a supplement (the “Supplement”) that will inform the
Bankruptcy Court of the results of the Auction and the highest or best bid for the Assets. The
Supplement will identify, among other things, (a) the Winning Competing Bidder, as the proposed
purchaser of the Assets, (b) the consideration to be paid by such purchaser for the Assets, and (c)
any executory contracts and unexpired leases to be assumed and assigned to the purchaser in
connection with the Sale (to the extent different from the Assigned Agreements proposed to be
assumed and assigned to the Purchaser under the APA). In addition, the Debtor will attach to the
Supplement, as exhibits, (a) any revised proposed order approving the Sale and (b) copies of the
asset purchase agreement entered into by the Debtor and the Winning Competing Bidder. The Debtor
will file and serve the Supplement as promptly as is reasonably practicable prior to the Sale
Hearing.
The Debtor will serve the Supplement on (i) the U.S. Trustee, (ii) counsel to the Committee,
(iii) counsel to the Purchaser, (iv) any party who timely submitted a Competing Bid, (v) any
parties entitled to notice under Local Rule 2002-1(b), and (vi) any person who submits a written
request therefor to Xxxxxx & Bird LLP, 0000 Xxxx Xxxxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxx 00000-0000,
Attn: Xxxxx Xxxxxx, Esq., (E-mail, xxxxx.xxxxxx@xxxxxx.xxx; Facsimile: 404.253.8521).
-6-
Pursuant to Item 601 (b)(2)
of Regulation S-K, the Seller Disclosures Schedules listed on pages VI to VII to the Asset Purchase
Agreement have been omitted. The registrant agrees to furnish supplementally a copy of all omitted schedules to the
Securities and Exchange Commission upon request.
OTHER DISCLOSURE SCHEDULES
TO
ASSET PURCHASE AGREEMENT
BY AND BETWEEN
VICTORY PHARMA, INC.
and
XXXXXXXXXXX PHARMACEUTICALS, INC.
Dated as of May 14, 2010
OTHER DISCLOSURE SCHEDULES
TO THE ASSET PURCHASE AGREEMENT
DATED AS OF MAY 14, 2010 (THE “AGREEMENT”)
BY AND BETWEEN
VICTORY PHARMA, INC. (THE “PURCHASER”)
AND XXXXXXXXXXX PHARMACEUTICALS, INC. (THE “COMPANY”)
1. Capitalized terms used in these Other Disclosure Schedules but not defined herein shall have the
meanings ascribed to such terms in the Agreement.
2. Headings and captions in these Other Disclosure Schedules are for convenience of reference only
and shall in no way affect or be considered in construing or interpreting any information provided
herein.
3. These Disclosure Schedules are qualified in their entirety by reference to specific provisions
of the Agreement and is not intended to constitute, and shall not be construed as constituting
representations and warranties of the Purchaser or the Seller or agreements by the Purchaser or the
Seller except as and to the extent provided in the Agreement. Inclusion of information herein
shall not be construed as an admission that such information is material to the business, financial
condition or results of operations of the Seller, that the Seller has violated any Laws or that the
Seller breached any of its agreements or obligations, except to the extent that such information in
included in this Other Disclosure Schedule to qualify a representation for any such purpose.
4. The information disclosed herein is subject to the provisions of the Confidential Disclosure
Agreement, dated July 29, 2009, between the Purchaser and the Company.
Schedule A.1(a)
Acquired Inventory
See attached list of Acquired Inventory.
Whs. L93
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unit |
|
|
Exp. |
|
|
Sell By |
|
|
Sum of |
|
|
Sum of |
|
|
Sum of |
|
|
Total |
|
Description |
|
Lot |
|
|
Cost |
|
|
Date |
|
|
Date |
|
|
Retention |
|
|
Saleable |
|
|
Total |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CNA9001A |
|
|
$ |
12.87236 |
|
|
|
12/31/2011 |
|
|
|
7/1/2011 |
|
|
|
6 |
|
|
|
1,012 |
|
|
|
1,012 |
|
|
$ |
13,026.83 |
|
Keflex 250mg 100 capsules Ea Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6 |
|
|
|
1,012 |
|
|
|
1,012 |
|
|
$ |
13,026.83 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CNA9002A |
|
|
$ |
16.92446 |
|
|
|
12/31/2011 |
|
|
|
6/30/2011 |
|
|
|
6 |
|
|
|
2,855 |
|
|
|
2,855 |
|
|
$ |
48,319.32 |
|
Keflex 500mg 100 Capsules Ea Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6 |
|
|
|
2,855 |
|
|
|
2,855 |
|
|
$ |
48,319.32 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Keflex 750mg 50 capsules Ea |
|
|
CNA9003A |
|
|
$ |
7.58236 |
|
|
|
12/31/2011 |
|
|
|
7/1/2011 |
|
|
|
5 |
|
|
|
39,005 |
|
|
|
39,010 |
|
|
$ |
295,787.76 |
|
Keflex 750mg 50 capsules Ea Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5 |
|
|
|
39,005 |
|
|
|
39,010 |
|
|
$ |
295,787.76 |
|
Moxatag 775mg 30 Tablets EA |
|
|
93407 |
|
|
$ |
10.92954 |
|
|
|
4/30/2012 |
|
|
|
5/1/2011 |
|
|
|
24 |
|
|
|
18,480 |
|
|
|
18,504 |
|
|
$ |
202,240.25 |
|
Moxatag 775mg 30 Tablets EA |
|
|
93609 |
|
|
$ |
10.90185 |
|
|
|
5/31/2012 |
|
|
|
6/1/2011 |
|
|
|
24 |
|
|
|
18,120 |
|
|
|
18,144 |
|
|
$ |
197,803.11 |
|
|
|
|
93810 |
|
|
$ |
10.90185 |
|
|
|
5/31/2012 |
|
|
|
6/1/2011 |
|
|
|
24 |
|
|
|
18,240 |
|
|
|
18,264 |
|
|
$ |
199,111.33 |
|
|
|
|
93811-4008 |
|
|
$ |
10.90185 |
|
|
|
5/31/2012 |
|
|
|
6/1/2011 |
|
|
|
24 |
|
|
|
18,288 |
|
|
|
18,312 |
|
|
$ |
199,634.62 |
|
|
|
|
93812-5440 |
|
|
$ |
10.92763 |
|
|
|
5/31/2012 |
|
|
|
6/1/2011 |
|
|
|
24 |
|
|
|
18,312 |
|
|
|
18,336 |
|
|
$ |
200,369.01 |
|
Moxatag 775mg 30 Tablets EA Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
120 |
|
|
|
91,440 |
|
|
|
91,560 |
|
|
$ |
999,158.32 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,356,292.23 |
|
Whs. L93
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Description |
|
Lot |
|
|
Exp. Date |
|
|
Unit Cost |
|
|
Sell By Date |
|
|
Total Units |
|
|
Total Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
W004572 |
|
|
|
6/30/2011 |
|
|
$ |
0.89460 |
|
|
|
12/29/2010 |
|
|
|
533,975 |
|
|
$ |
477,696.09 |
|
|
|
|
W004573 |
|
|
|
8/31/2011 |
|
|
$ |
0.90150 |
|
|
|
3/1/2011 |
|
|
|
554,365 |
|
|
$ |
499,759.75 |
|
|
|
|
W004574 |
|
|
|
8/31/2011 |
|
|
$ |
0.92468 |
|
|
|
3/1/2011 |
|
|
|
541,220 |
|
|
$ |
500,457.67 |
|
|
|
|
W005218 |
|
|
|
9/30/2011 |
|
|
$ |
0.89696 |
|
|
|
4/3/2011 |
|
|
|
543,875 |
|
|
$ |
487,836.66 |
|
Moxatag 775mg
Samples |
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EACH Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,173,435 |
|
|
$ |
1,965,750.17 |
|
XxxxxxXxxxx Pharmaceuticals, Inc. Bulk Tablets Inventory—
12110-00
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Beginning |
|
|
Ending |
|
|
Expiration Dates |
|
|
|
Invoice# |
|
|
Lot# |
|
|
Qty |
|
|
Cost |
|
|
Balance |
|
|
Balance |
|
|
Blister |
|
|
Bottle |
|
Moxatag Tablets |
|
|
92005212 |
|
|
|
94818 |
|
|
|
553,492 |
|
|
$ |
0.2991 |
|
|
$ |
165,539.58 |
|
|
$ |
165,539.58 |
|
|
Nov-11 |
|
May-12 |
Moxatag Tablets |
|
|
92005203 |
|
|
|
94817 |
|
|
|
554,484 |
|
|
$ |
0.2991 |
|
|
$ |
165,836.27 |
|
|
$ |
165,836.27 |
|
|
Feb-12 |
|
Aug-12 |
Moxatag Tablets |
|
|
92005200 |
|
|
|
94816 |
|
|
|
548,788 |
|
|
$ |
0.2991 |
|
|
$ |
164,132.69 |
|
|
$ |
164,132.69 |
|
|
Feb-12 |
|
Aug-12 |
Moxatag Tablets |
|
|
92005192 |
|
|
|
94313 |
|
|
|
551,007 |
|
|
$ |
0.2991 |
|
|
$ |
164,796.36 |
|
|
$ |
164,796.36 |
|
|
Nov-11 |
|
May-12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Moxatag Tablets |
|
|
92007119 |
|
|
|
93501T |
|
|
|
549,697 |
|
|
$ |
0.2890 |
|
|
$ |
158,848.46 |
|
|
$ |
158,848.46 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
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|
|
|
|
|
|
|
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|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Balane at |
|
|
3/31/2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
819,153.36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
819,153.36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XxxxxxXxxxx Pharmaceuticals, Inc.
Raw Materials — 12100-00
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Beginning |
|
|
Units |
|
|
Units |
|
|
Ending |
|
|
Expiry |
|
|
|
Vendor |
|
|
Invoice# |
|
|
Qty |
|
|
U/M |
|
|
Cost |
|
|
Balance |
|
|
Received |
|
|
Sold/Used |
|
|
Balance |
|
|
Date |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amox API @ Stada |
|
Stada |
|
|
91834063 |
|
|
|
9,416 |
|
|
ST |
|
$ |
45.00 |
|
|
$ |
423,720.00 |
|
|
|
— |
|
|
|
— |
|
|
$ |
423,720.00 |
|
|
Feb-14 |
Amox API @ DSM |
|
Stada |
|
|
91834052 |
|
|
|
8,200 |
|
|
ST |
|
$ |
49.03 |
|
|
$ |
402,046.00 |
|
|
|
— |
|
|
|
(8,200.00 |
) |
|
$ |
— |
|
|
|
|
|
Packaging Components-Base |
|
Almac |
|
|
S1501280 |
|
|
|
7,874 |
|
|
kg |
|
$ |
8.13 |
|
|
$ |
63,990.13 |
|
|
|
— |
|
|
|
— |
|
|
$ |
63,987.72 |
|
|
|
|
|
Packaging Components-Foil |
|
Almac |
|
|
S1501280 |
|
|
|
2,314 |
|
|
kg |
|
$ |
24.33 |
|
|
$ |
56,302.17 |
|
|
|
— |
|
|
|
— |
|
|
$ |
56,302.17 |
|
|
|
|
|
Packaging Components-Carton/Leaflet |
|
Almac |
|
|
S1501280 |
|
|
|
501,770 |
|
|
Units |
|
$ |
0.10 |
|
|
$ |
49,117.02 |
|
|
|
— |
|
|
|
— |
|
|
$ |
49,117.02 |
|
|
|
|
|
Packaging Components-Shipper |
|
Almac |
|
|
S1501280 |
|
|
|
17,779 |
|
|
Units |
|
$ |
0.51 |
|
|
$ |
9,136.10 |
|
|
|
— |
|
|
|
— |
|
|
$ |
9,136.10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
3/31/2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
602,263.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Per GL |
|
|
602,263.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Difference |
|
$ |
(0.00 |
) |
|
|
|
|
Fixed Assets Ledger
Mfg. Equipment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Placed |
|
|
|
|
|
|
Net Book |
|
|
|
|
|
Short |
|
|
|
Date |
|
|
in |
|
|
|
|
|
Value (as of |
|
|
|
Asset ID |
|
Description |
|
Location |
|
Aquired |
|
|
Service |
|
|
Cost Basis |
|
|
3/31/10) |
|
|
Purpose/Use |
CO001 |
|
MP-6 |
|
IR |
|
|
5/31/05 |
|
|
|
09/01/06 |
|
|
|
318,750.00 |
|
|
|
204,531.25 |
|
|
Fluid bed coater |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
for coating the |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
delayed-release |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pellets. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CO001 |
|
MP-6 |
|
IR |
|
|
6/1/07 |
|
|
|
06/01/07 |
|
|
|
1,293,681.90 |
|
|
|
927,138.70 |
|
|
Fluid bed coater |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
for coating the |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
delayed-release |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pellets. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CO001 |
|
MP-6 |
|
IR |
|
|
7/1/07 |
|
|
|
07/01/07 |
|
|
|
226,738.10 |
|
|
|
164,385.13 |
|
|
Fluid bed coater |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
for coating the |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
delayed-release |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pellets. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CO002 |
|
Vibrac tourque |
|
IR |
|
|
12/15/08 |
|
|
|
12/15/08 |
|
|
|
20,862.00 |
|
|
|
18,080.40 |
|
|
Tests the closure |
|
|
tester |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
torque on the |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
bottles of tablets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CO003 |
|
Manesty Tablet |
|
IR |
|
|
11/1/09 |
|
|
|
11/01/09 |
|
|
|
41,229.63 |
|
|
|
39,511.73 |
|
|
In-process testing |
|
|
Press-testing equip |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
for tablets as they |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
come off the tablet |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
press. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD072 |
|
Ackly printer |
|
IR |
|
|
6/1/07 |
|
|
|
06/01/07 |
|
|
|
150,013.00 |
|
|
|
107,509.31 |
|
|
Will not be used |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
for commercial |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
process after we |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
switch to debossed |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
tablets (subject of |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FDA filing with |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alt. API |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
qualification) for |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
any batches |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
produced later this |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
year and beyond. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD027 |
|
TDG-80G |
|
IR |
|
|
10/1/04 |
|
|
|
01/01/05 |
|
|
|
235,028.00 |
|
|
|
58,757.00 |
|
|
Used for extrusion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
in granulation and |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
core pelet |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
production. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD028 |
|
Installation work |
|
IR |
|
|
1/19/05 |
|
|
|
01/19/05 |
|
|
|
15,887.15 |
|
|
|
3,971.81 |
|
|
Used to process |
|
|
for QJ-700 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
core pellets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD028 |
|
QJ-700 |
|
IR |
|
|
10/1/04 |
|
|
|
01/01/05 |
|
|
|
101,400.00 |
|
|
|
25,350.03 |
|
|
Used to process |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
core pellets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD028 |
|
Shipping and import |
|
IR |
|
|
11/30/04 |
|
|
|
01/01/05 |
|
|
|
10,653.58 |
|
|
|
2,663.39 |
|
|
Used to process |
|
|
on equipment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
core pellets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Placed |
|
|
|
|
|
|
Net Book |
|
|
|
|
|
Short |
|
|
|
Date |
|
|
in |
|
|
|
|
|
Value (as of |
|
|
|
Asset ID |
|
Description |
|
Location |
|
Aquired |
|
|
Service |
|
|
Cost Basis |
|
|
3/31/10) |
|
|
Purpose/Use |
PD028 |
|
QJ-700 |
|
IR |
|
|
12/1/04 |
|
|
|
01/01/05 |
|
|
|
1,572.00 |
|
|
|
393.10 |
|
|
Used to process |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
core pellets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XX000 |
|
XX-000 Xxxxx filler |
|
IR |
|
|
11/30/04 |
|
|
|
5/1/05 |
|
|
|
92,680.00 |
|
|
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XX000 |
|
XX-000 final |
|
IR |
|
|
4/1/05 |
|
|
|
4/1/05 |
|
|
|
26,480.00 |
|
|
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD029 |
|
Installation for |
|
IR |
|
|
8/5/05 |
|
|
|
8/5/05 |
|
|
|
16,442.25 |
|
|
|
0.00 |
|
|
|
|
|
LA160 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XX000 |
|
XX-000 Xxxxx filler |
|
IR |
|
|
2/1/05 |
|
|
|
2/1/05 |
|
|
|
145,640.00 |
|
|
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD029 |
|
set up technican |
|
IR |
|
|
3/31/05 |
|
|
|
3/31/05 |
|
|
|
10,000.00 |
|
|
|
0.00 |
|
|
|
|
|
for XX-000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XX000 |
|
Model 20 fluid bed |
|
IR |
|
|
11/30/04 |
|
|
|
6/1/05 |
|
|
|
187,411.20 |
|
|
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD030 |
|
model 20 fluid bed |
|
IR |
|
|
12/1/04 |
|
|
|
6/1/05 |
|
|
|
93,705.60 |
|
|
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD030 |
|
Model 20 Fluid bed |
|
IR |
|
|
12/1/04 |
|
|
|
6/1/05 |
|
|
|
31,235.20 |
|
|
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,019,409.61 |
|
|
$ |
1,552,291.85 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Schedule A.1(b)
Applicable Permits
See Schedule A.1(n)
Maryland Manufacturing/Distribution Licenses
|
|
|
|
|
State |
|
License Number |
|
Expiration |
Minnesota
|
|
361507
|
|
5/31/2010 |
|
|
|
|
|
Louisiana (Department of Health and
Hospitals)
|
|
10236-D
|
|
6/30/2010 |
|
|
|
|
|
New Hampshire
|
|
4963
|
|
6/30/2010 |
|
|
|
|
|
North Dakota
|
|
229
|
|
6/30/2010 |
|
|
|
|
|
Ohio
|
|
WMAN.011459900-02
|
|
6/30/2010 |
|
|
|
|
|
Pennsylvania
|
|
7200000537
|
|
6/30/2010 |
|
|
|
|
|
West Virginia
|
|
WD0558568
|
|
6/30/2010 |
|
|
|
|
|
Xxx Xxxx
|
|
000000
|
|
8/31/2010 |
|
|
|
|
|
Oklahoma
|
|
88-M-1346
|
|
8/31/2010 |
|
|
|
|
|
Oregon
|
|
M-0001897
|
|
9/30/2010 |
|
|
|
|
|
Xxxxxxxxxx
|
|
XXXX.XX.00000000
|
|
0/00/0000 |
|
|
|
|
|
Xxxxxxx
|
|
00000
|
|
10/31/2010 |
|
|
|
|
|
Alabama
|
|
193133
|
|
12/31/2010 |
|
|
|
|
|
Arkansas
|
|
16927
|
|
12/31/2010 |
|
|
|
|
|
Illinois
|
|
4002739
|
|
12/31/2010 |
|
|
|
|
|
Iowa
|
|
6712
|
|
12/31/2010 |
|
|
|
|
|
Louisiana (Board of Wholesale Drug
Distributors)
|
|
3909
|
|
12/31/2010 |
|
|
|
|
|
Maine
|
|
WH70000894
|
|
12/31/2010 |
|
|
|
|
|
Maryland
|
|
D02278
|
|
12/31/2010 |
|
|
|
|
|
North Carolina
|
|
728
|
|
12/31/2010 |
|
|
|
|
|
South Dakota
|
|
600-0969
|
|
12/31/2010 |
|
|
|
|
|
Florida
|
|
40445
|
|
5/13/2011 |
|
|
|
|
|
Texas
|
|
77946
|
|
6/27/2011 |
|
|
|
|
|
Xxxxxxx
|
|
XXXX000000
|
|
6/30/2011 |
|
|
|
|
|
Xxxxx Xxxxxxxx
|
|
00000
|
|
6/30/2011 |
|
|
|
|
|
New Mexico
|
|
WD00010451
|
|
12/31/2011 |
Texas Manufacturing/Distribution Licenses
|
|
|
|
|
State |
|
License Number |
|
Expiration |
New Jersey
|
|
5003774
|
|
01/31/2010 (Per NJ Department of
Health, XxxxxxXxxxx renewal
application has not been received,
4/21/10). |
|
|
|
|
|
Xxxxxxxxx
|
|
000000
|
|
5/31/2011 |
|
|
|
|
|
Pennsylvania
|
|
2000002726
|
|
5/31/2010 |
|
|
|
|
|
New Hampshire
|
|
4992
|
|
6/30/2010 |
|
|
|
|
|
North Dakota
|
|
663
|
|
6/30/2010 |
|
|
|
|
|
Ohio
|
|
WMAN. 011979850
|
|
6/30/2010 |
|
|
|
|
|
Oklahoma
|
|
88-M-2276
|
|
7/31/2010 |
|
|
|
|
|
Oregon
|
|
M-001914
|
|
9/30/2010 |
|
|
|
|
|
Alabama
|
|
193819
|
|
12/31/2010 |
|
|
|
|
|
Arkansas
|
|
WD03675
|
|
12/31/2010 |
|
|
|
|
|
Iowa
|
|
6863
|
|
12/31/2010 |
|
|
|
|
|
Louisiana
|
|
6266
|
|
12/31/2010 |
|
|
|
|
|
Maryland
|
|
D02865
|
|
12/31/2010 |
|
|
|
|
|
New Mexico
|
|
WD00011052
|
|
12/31/2010 |
|
|
|
|
|
North Carolina
|
|
397
|
|
12/31/2010 |
|
|
|
|
|
South Dakota
|
|
600-1614
|
|
12/31/2010 |
|
|
|
|
|
Texas
|
|
1000088
|
|
4/26/2011 |
|
|
|
|
|
Xxxxxxx
|
|
XXXX000000
|
|
6/30/2011 |
|
|
|
|
|
Xxx Xxxx
|
|
00000
|
|
6/30/2012 |
Corporate Qualifications
Alabama
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
District Of Columbia
Florida
Georgia
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana
Nebraska
Nevada
New Hampshire
New Jersey
New Mexico
New York
North Carolina
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
Tennessee
Texas
Utah
Xxxxxxxx
Xxxxxxxxxx
West Virginia
Wisconsin
Schedule A.1(c)
Acquired Fixtures
See attached list of Acquired Fixtures.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Placed |
|
|
|
|
|
|
Net Book |
|
|
|
|
|
Short |
|
|
|
Date |
|
|
in |
|
|
|
|
|
Value (as of |
|
|
|
Asset ID |
|
Description |
|
Location |
|
Aquired |
|
|
Service |
|
|
Cost Basis |
|
|
3/31/10) |
|
|
Purpose/Use |
CO001 |
|
MP-6 |
|
IR |
|
|
5/31/05 |
|
|
|
09/01/06 |
|
|
|
318,750.00 |
|
|
|
204,531.25 |
|
|
Fluid bed coater |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
for coating the |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
delayed-release |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pellets. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CO001 |
|
MP-6 |
|
IR |
|
|
6/1/07 |
|
|
|
06/01/07 |
|
|
|
1,293,681.90 |
|
|
|
927,138.70 |
|
|
Fluid bed coater |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
for coating the |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
delayed-release |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pellets. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CO001 |
|
MP-6 |
|
IR |
|
|
7/1/07 |
|
|
|
07/01/07 |
|
|
|
226,738.10 |
|
|
|
164,385.13 |
|
|
Fluid bed coater |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
for coating the |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
delayed-release |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
pellets. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CO002 |
|
Vibrac tourque |
|
IR |
|
|
12/15/08 |
|
|
|
12/15/08 |
|
|
|
20,862.00 |
|
|
|
18,080.40 |
|
|
Tests the closure |
|
|
tester |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
torque on the |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
bottles of tablets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CO003 |
|
Manesty Tablet |
|
IR |
|
|
11/1/09 |
|
|
|
11/01/09 |
|
|
|
41,229.63 |
|
|
|
39,511.73 |
|
|
In-process testing |
|
|
Press-testing equip |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
for tablets as they |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
come off the tablet |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
press. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD072 |
|
Ackly printer |
|
IR |
|
|
6/1/07 |
|
|
|
06/01/07 |
|
|
|
150,013.00 |
|
|
|
107,509.31 |
|
|
Will not be used |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
for commercial |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
process after we |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
switch to debossed |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
tablets (subject of |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FDA filing with |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alt. API |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
qualification) for |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
any batches |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
produced later this |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
year and beyond. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD027 |
|
TDG-80G |
|
IR |
|
|
10/1/04 |
|
|
|
01/01/05 |
|
|
|
235,028.00 |
|
|
|
58,757.00 |
|
|
Used for extrusion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
in granulation and |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
core pelet |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
production. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD028 |
|
Installation work |
|
IR |
|
|
1/19/05 |
|
|
|
01/19/05 |
|
|
|
15,887.15 |
|
|
|
3,971.81 |
|
|
Used to process |
|
|
for QJ-700 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
core pellets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD028 |
|
QJ-700 |
|
IR |
|
|
10/1/04 |
|
|
|
01/01/05 |
|
|
|
101,400.00 |
|
|
|
25,350.03 |
|
|
Used to process |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
core pellets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD028 |
|
Shipping and import |
|
IR |
|
|
11/30/04 |
|
|
|
01/01/05 |
|
|
|
10,653.58 |
|
|
|
2,663.39 |
|
|
Used to process |
|
|
on equipment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
core pellets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD028 |
|
QJ-700 |
|
IR |
|
|
12/1/04 |
|
|
|
01/01/05 |
|
|
|
1,572.00 |
|
|
|
393.10 |
|
|
Used to process |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
core pellets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XX000 |
|
XX-000 Xxxxx filler |
|
IR |
|
|
11/30/04 |
|
|
|
5/1/05 |
|
|
|
92,680.00 |
|
|
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XX000 |
|
XX-000 final |
|
IR |
|
|
4/1/05 |
|
|
|
4/1/05 |
|
|
|
26,480.00 |
|
|
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Book |
|
|
|
|
|
Short |
|
|
|
Date |
|
|
Placed |
|
|
|
|
|
Value (as of |
|
|
|
Asset ID |
|
Description |
|
Location |
|
Aquired |
|
|
in Service |
|
|
Cost Basis |
|
|
3/31/10) |
|
|
Purpose/Use |
PD029 |
|
Installation for |
|
IR |
|
|
8/5/05 |
|
|
|
8/5/05 |
|
|
|
16,442.25 |
|
|
|
0.00 |
|
|
|
|
|
LA160 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XX000 |
|
XX-000 Xxxxx filler |
|
IR |
|
|
2/1/05 |
|
|
|
2/1/05 |
|
|
|
145,640.00 |
|
|
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD029 |
|
set up technican |
|
IR |
|
|
3/31/05 |
|
|
|
3/31/05 |
|
|
|
10,000.00 |
|
|
|
0.00 |
|
|
|
|
|
for XX-000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XX000 |
|
Model 20 fluid bed |
|
IR |
|
|
11/30/04 |
|
|
|
6/1/05 |
|
|
|
187,411.20 |
|
|
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD030 |
|
model 20 fluid bed |
|
IR |
|
|
12/1/04 |
|
|
|
6/1/05 |
|
|
|
93,705.60 |
|
|
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PD030 |
|
Model 20 Fluid bed |
|
IR |
|
|
12/1/04 |
|
|
|
6/1/05 |
|
|
|
31,235.20 |
|
|
|
0.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,019,409.61 |
|
|
$ |
1,552,291.85 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Schedule A.1(d)
Excluded Contracts
Par Agreement
Promotion Agreement, dated February 3, 2010, by and between the Company and XxxxxxXxxxxxxxx.xxx,
Inc.
Addendum dated March 12, 2010, by and between the Company and XxxxxxXxxxxxxxx.xxx, Inc. to the
Promotion Agreement, dated February 3, 2010, by and between the Company and XxxxxxXxxxxxxxx.xxx,
Inc.
Any other agreements by and between the Seller and XxxxxxXxxxxxxxx.xxx, Inc.
Any and all agreements by and between the Seller and United States Global Partners, Ltd.
Any other Contract that is not an Assumed Contract
Schedule A.1(e)
Knowledge
Xxxxx Xxxxxx
Xxxx Xxxx
Xxxxx Xxxxxxx
Xxxxx Xxxxxx
Xxxxxx X. Xxxxxx, Ph.D.
Schedule A.1(f)
Assumed Contracts
See attached list of Assumed Contracts.
Schedule A.1(f)
ASSUMED CONTRACTS
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
Almac Pharma Services
|
|
Xxxxxxx Xxxxxx
|
|
Primary & secondary
packaging of
amoxicillin trihydrate
tablets
|
|
Proforma Quotation
|
|
5/27/2008 |
|
|
Almac Pharma Services
|
|
Xxxxxxx Xxxxxx
|
|
Tolling, qualification
(IQ/QQ) and process
validation for the
primary and secondary
packaging of
amoxicillin trihydrate
tablets
|
|
Proforma Quotation
|
|
6/5/2008 |
|
|
Almac Pharma Services
|
|
Xxxxxxx Xxxxxx
|
|
Tolling, qualification
(IQ/QQ) and process
validation for the
primary and secondary
packaging of
amoxicillin trihydrate
tablets
|
|
Proforma Quotation
|
|
6/17/2008 |
|
|
Almac Pharma Services
|
|
Xxxxx Xxxxxxx
|
|
Possible business
transaction between the
parties
|
|
Confidentiality
|
|
8/13/2008
|
|
8/13/2015 |
Almac Pharma Services
|
|
Xxxxxx XxXxxxxx
|
|
Packing and Supply —
Moxatag
|
|
Packaging and Supply
|
|
12/17/2008
|
|
12/17/2011 |
Almac Sciences Limited &
Alhow Laboratories
|
|
Xxxxxxx Xxxx
|
|
Evaluating possible
business transactions
between the parties
|
|
Confidentiality
|
|
2/21/2005
|
|
2/21/2012 |
Xxxxxx Xxxxxx Corporation
|
|
Xxx Xxxxxx
|
|
Evaluating possible
business transactions
between the parties
|
|
Confidentiality
|
|
4/27/2005
|
|
4/27/2012 |
|
|
|
|
|
|
|
|
|
|
|
Block, Xxxx, M.D.
|
|
Xxxx Block, M.D.
|
|
Consulting on pediatric
Pharyngitis program
|
|
Consulting
|
|
10/18/2008
|
|
10/18/2009 |
Butterworth Laboratories
|
|
Xxxxx Xxxxxxxxxxx
|
|
Business transaction
between the parties
|
|
Confidential
Disclosure
|
|
10/27/2006 |
|
|
Cardinal Health
|
|
Xxxxxxx Xxxx
|
|
Quality Agreement for
contract packaging
services with regard to
Keflex capsules, 250mg,
333mg, 500mg, 750mg.
|
|
Quality Agreement
|
|
6/7/2006 |
|
|
Cardinal Health
|
|
Xxxx Xxxxxxxx
|
|
Keflex Physician Sample
1’s Blisters
|
|
Quotation
|
|
8/10/2006 |
|
|
Cardinal Health
|
|
Xxxx Xxxxxxxx
|
|
Keflex Physician Sample
1’s Blister — Version
01
|
|
Quotation
|
|
8/10/2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
Cardinal Health
|
|
Xxxx Xxxxxx
|
|
Related to copay
voucher program
|
|
Patient co-pay
voucher program
agreement
|
|
7/1/2009 |
|
|
CEPH International
Corporation
|
|
Xxxxx Xxxxxxx
|
|
CEPH to manufacture and
sell certain cephalexin
pharmaceutical products
|
|
Commercial Supply
Agreement
|
|
12/3/2004 |
|
|
CEPH International
Corporation
|
|
Xxxxxxxx Visp
|
|
CEPH to manufacture and
sell certain cephalexin
pharmaceutical products
|
|
Commercial Supply
Agreement
|
|
12/3/2004 |
|
|
CEPH International
Corporation
|
|
Xxxxxxxx Xxxxxxx
(Ms.)
|
|
Manufacturing and
testing of several
doses of cephalexin and
Keflex
|
|
Quality Agreement
|
|
3/7/2006 |
|
|
CEPH International
Corporation
|
|
Xxxxxx Xxxxxxx
|
|
Transfer from Patheon
Puerto Rico to VWR
|
|
Method Transfer
Consent
|
|
12/22/2008 |
|
|
CEPH International
Corporation
|
|
Xxxxxxxx Xxxxxxx
(Ms.)
|
|
Manufacturing and
testing of several
doses of Keflex brand
only
|
|
Quality Agreement
|
|
3/7/2006 |
|
|
CEPH International
Corporation & VWR
Advanced Instruments LLC
|
|
Xxxxxx Xxxxxxx
(Ceph); Xxx Xxxxx
(VWR)
|
|
Confidentiality and
consent re: transfer
from Patheon Puerto
Rico to VWR
|
|
Confidentiality &
Consent
|
|
12/4/2008 |
|
|
Clonmel Healthcare
|
|
Xxxxxxx Xxxxxxx
|
|
The parties have
significant interest in
entering into an
agreement to
collaborate in the
manufacturing and
supply of Company’
amoxicillin PULSYS
product.
|
|
Letter of Intent
and Authorization
to Begin Purchasing
|
|
10/11/2004 |
|
|
Clonmel Healthcare Limited
|
|
Xxxx X’Xxxxxxx
|
|
Commercial supply
agreement/pivotal
agreement
|
|
Heads of Agreement
|
|
11/29/2004
|
|
11/29/2009 |
Clonmel Healthcare Limited
|
|
|
|
Development & Clinical
Manufacturing Agreement
|
|
Development &
Clinical
Manufacturing
Agreement
|
|
4/18/2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
Clonmel Healthcare Limited
|
|
|
|
Manufacturing & Supply
Agreement
|
|
Manufacturing &
Supply Agreement
|
|
4/18/2005 |
|
|
Clonmel Healthcare Limited
|
|
Xxxxx Xxxxxx
|
|
Facility Build-Out
Agreement
|
|
Facility Build-Out
Agreement
|
|
4/19/2005 |
|
|
Clonmel Healthcare Ltd.
|
|
Xxxxxxx X. Xxxxxxx
|
|
antibiotic projects
sponsored by Advanced
Pharma
|
|
Non Disclosure
|
|
6/8/2000 |
|
|
Colorcon
|
|
Xxxxxx X. Xxxxxxxx
|
|
Business relationship
between the parties
which will involve
Company evaluating the
Colorcon product for
potential commercial
use by Company and
Colorcon evaluating
Company products solely
for the purpose of
allowing Colorcon to
assistant Company in
the development and
commercialization of
products
|
|
Confidentiality
|
|
8/6/2004
|
|
Shall indefinitely
survive the
conclusion of the
Project between the
parties |
Covance Central
Laboratory Services
|
|
Xxxxxx Xxxxxxx
|
|
To generate and report
the laboratory data for
111.301: Tonsillitis/Pharyngitis
Phase III
APC-111
|
|
Laboratory Services
Statement of Work
|
|
9/8/2004
|
|
Upon completion of
services |
Covance Central
Laboratory Services
|
|
Xxx Xxxxx
|
|
To generate and report
the laboratory data for
231.301: Tonsillitis/Pharyngitis
Phase III
APC-231
|
|
Laboratory Services
Statement of Work
|
|
11/19/2004 |
|
|
Covance Central
Laboratory Services
|
|
Xxxxxx Xxxxxxx
|
|
To generate and report
the laboratory data for
111.301: Tonsillitis/Pharyngitis
Phase III
APC-111
|
|
Amendment to
Laboratory Services
Statement of Work
|
|
3/22/2005 |
|
|
Covance Central
Laboratory Services
|
|
Xxx Xxxxx
|
|
To generate and report
the laboratory data for
231.301: Tonsillitis/Pharyngitis
Phase III
APC-231
|
|
Amendment to
Laboratory Services
Statement of Work
|
|
3/22/2005 |
|
|
Covance Central
Laboratory Services
|
|
Xxx Xxxxx
|
|
To generate and report
the laboratory data for
Protocol 111.302: Tonsillitis/Pharyngitis
Phase III APC-111
|
|
Laboratory Services
Statement of Work
|
|
10/5/2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
Covance Central
Laboratory Services
|
|
Xxx Xxxxx
|
|
To generate and report
the laboratory data for
Protocol 111.302: Tonsillitis/Pharyngitis
Phase III APC-111
|
|
Laboratory Services
Statement of Work
|
|
11/17/2005 |
|
|
Covance Central
Laboratory Services Inc.
|
|
Xxxxxx Xxxxx
|
|
AVNC Protocol 231.301
|
|
Quote for Services
|
|
12/1/2004 |
|
|
Covance Health Economics
& Outcomes Services, Inc.
|
|
Xxxx X. Xxxxx
|
|
Evaluating possible
business transactions
between them regarding
AVNC’s product
portfolio of
anti-infectives
|
|
Confidentiality
|
|
2/9/2004
|
|
2/9/2011 |
|
DSM Anti-Infectives
|
|
X.X. Xx Xxxx; N. H.
Gerardu
|
|
Evaluating possible
business transaction
between the parties
|
|
Confidentiality
|
|
6/23/2004
|
|
6/23/2011 |
DSM Gist B.V.
|
|
T Xxxx
|
|
Antibiotic projects
sponsored by API,
specifically the drugs
of interest are,
Amoxicillin and
Clavulanate — but can
be expanded to other
anti-infectives.
|
|
Non Disclosure
|
|
6/8/2000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Xxx Lilly & Company
|
|
|
|
Keflex — Asset
Purchase Agreement
|
|
Purchase Agreement
|
|
6/30/2004 |
|
|
Xxx Xxxxx & Company
|
|
Xx. Xxxxxxx Xxxxxx
|
|
Keflex — Quality
Agreement
|
|
Quality Agreement
|
|
7/29/2004 |
|
|
Xxx Xxxxx & Company
|
|
Xxxxxxx Xxxxxx
|
|
Keflex — Quality
Agreement
|
|
Addendum to Quality
Agreement
|
|
11/17/2005 |
|
|
Xxxxxx, Xxxxx
|
|
Xxxxx Xxxxxx
|
|
Will provide certain
services to Xxx Lilly
and Co., and AVNC
related to reporting of
certain information
pertaining to the
pricing of Keflex sold
under 4 NDC.
|
|
Letter of Agreement
|
|
10/30/2004
|
|
9/30/2005 |
Xxxxxx, Xxxxx
|
|
Xxxxx Xxxxxx
|
|
Will provide certain
services to Xxx Lilly
and Co., and AVNC
related to reporting of
certain information
pertaining to the
pricing of Keflex sold
under 4 NDC.
|
|
Letter of Agreement
Amendment
|
|
10/1/2005
|
|
9/30/2006 |
MOVA Pharmaceutical
Corporation
|
|
Illegible (Vice
President, Business
Development)
|
|
Anti-infective projects
sponsored by API
|
|
Non-Disclosure
|
|
5/18/2001
|
|
5/18/2011 |
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
MOVA Pharmaceutical
Corporation
|
|
Xxxx X. Xxxxxxxx
|
|
Affirm the
Non-Disclosure
Agreement remains in
full force and effect;
and to give notice that
Company has changed its
corporate address from
Xxxxxxx to Seneca
Xxxxxxx address
|
|
Amendment to
Non-Disclosure
Agreement
|
|
3/29/2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Niro, Inc.
|
|
Xxxxxx X. Xxxxxx
|
|
Advanced Pharma’s
certain proprietary
information and
concepts relating to
pharmaceutical
products. Niro’s
experience in
processing
pharmaceutical
products.
|
|
Confidentiality
|
|
5/4/2000
|
|
5/4/2005 |
Niro, Inc.
|
|
Xxxxxx X. Xxxxxx
|
|
Advanced Pharma’s
certain proprietary
information and
concepts relating to
pharmaceutical
products. Niro’s
experience in
processing
pharmaceutical
products.
|
|
Confidentiality
|
|
5/4/2005
|
|
5/4/2010 |
Patheon, Inc.
|
|
Xxxxxxx Xxxxxx
|
|
Service Proposal
#ADV07-07 — Keflex
250mg and 500mg
Validation
|
|
Service Proposal
|
|
9/13/2007 |
|
|
Patheon, Inc.
|
|
X. Xxxx
|
|
Service proposal for
artwork changes to
Keflex 750mg bottles
and blisters
|
|
Service Proposal
|
|
5/6/2008 |
|
|
Patheon, Inc.
|
|
X. Xxxx
|
|
Commercial pricing
proposal for Keflex
750mg bottles and
blisters
|
|
Commercial Pricing
|
|
5/14/2008 |
|
|
PPD
|
|
Xxxxx Xxxxxxx
|
|
Renewal of drug safety/medical
information
contract
|
|
Amendment No. 10 to
Project Addendum
|
|
10/22/2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
PPD Development
|
|
Illegible
|
|
LC/MS/MS partial
validation of
clarithromycin in EDTA
mouse plasma
|
|
Research
|
|
9/20/2002
|
|
Termination with 30 days prior written notice |
PPD Development
|
|
Xxxxxx Xxxxx
|
|
Bioanalytical and
Pharmacokinetic Volume
Credit Agreement
|
|
Bioanalytical and
Pharmacokinetic
Volume Credit
Agreement
|
|
7/1/2004
|
|
6/30/2005 |
PPD Development
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
services in support of
Amoxicillin Study
111/106
|
|
Clinical
Pharmacology
Proposal
|
|
7/22/2004
|
|
Quote/pricing valid
for 90 days |
PPD Development
|
|
Xxx X. Xxxxxxxx
|
|
XX/MS/MS Analysis of
Amoxicillin in EDTA
Human Plasma
|
|
Revised
Bioanalytical
Proposal No.
R408D05.1
|
|
8/12/2004 |
|
|
PPD Development
|
|
Xxx X. Xxxxxxxx
|
|
XX/MS/MS Analysis of
Amoxicillin in ETA
Human Plasma
|
|
Bioanalytical
Proposal No.
R409R13
|
|
9/16/2004
|
|
CANCELLED |
PPD Development
|
|
Xxx X. Xxxxxxxx
|
|
XX/MS/MS Analysis of
Amoxicillin in ETA
Human Plasma
|
|
Revised
Bioanalytical
Proposal No.
R408D34.1
|
|
9/16/2004 |
|
|
PPD Development
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
services in support of
Amoxicillin Study
111.111
|
|
Clinical
Pharmacology
Proposal
|
|
9/24/2004 |
|
|
PPD Development
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
services in support of
Amoxicillin Study
111.110
|
|
Clinical
Pharmacology
Proposal
|
|
10/12/2004 |
|
|
PPD Development
|
|
Xxx X. Xxxxxxxx
|
|
XX/MS/MS Analysis of
Amoxicillin in ETA
Human Plasma
|
|
Bioanalytical
Proposal No.
R409R13.1
|
|
10/14/2004
|
|
CANCELLED |
PPD Development
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
services in support of
Amoxicillin Study
231.103
|
|
Clinical
Pharmacology
Proposal
|
|
10/15/2004
|
|
CANCELLED |
PPD Development
|
|
Xxxxxxxx Xxxxxx
|
|
LC/MS/MS Analysis of
Amoxicillin in ETA
Human Plasma
|
|
Revised
Bioanalytical
Proposal No.
R411D03.1
|
|
11/5/2004 |
|
|
PPD Development
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
services in support of
Amoxicillin Study
111.109
|
|
Revised Clinical
Pharmacology
Proposal
|
|
11/18/2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
PPD Development
|
|
Xxxxx Xxxxx
|
|
Analysis of
Amoxicillin, Augmentin,
Clarithromycin, and
Azithromycin in
Chinchilla Plasma
|
|
Early Preclinical
Development
Proposal No.
M0412S02
|
|
12/6/2004 |
|
|
PPD Development
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
services in support of
Amoxicillin Study
231.104
|
|
Clinical
Pharmacology
Proposal
|
|
12/27/2004 |
|
|
PPD Development
|
|
Xxxxxxxx X. Xxxxxx
|
|
XX/MS/MS Analysis of
approx 504 human EDTA
plasma samples for
Amoxicillin at $62 per
sample
|
|
Bioanalytical
Proposal No.
R0501D01
|
|
1/3/2005 |
|
|
PPD Development
|
|
Xxxxx Xxxxx
|
|
Analysis of
Amoxicillin, Augmentin,
Clarithromycin, and
Azithromycin in
Chinchilla Plasma —
Proposal No. M0412S02
|
|
Early Preclinical
Development
|
|
1/12/2005 |
|
|
PPD Development
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
Services in support of
amoxicillin study
111.112
|
|
Clinical
Pharmacology
Proposal
|
|
4/14/2005 |
|
|
PPD Development
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
Services in support of
amoxicillin study
111.109
|
|
Clinical
Pharmacology
Proposal
|
|
4/14/2005 |
|
|
PPD Development
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
Services in support of
amoxicillin study
111.110
|
|
Clinical
Pharmacology
Proposal
|
|
4/14/2005 |
|
|
PPD Development
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
Services in support of
Amoxicillin study
111.111
|
|
Clinical
Pharmacology
Proposal
|
|
4/14/2005 |
|
|
PPD Development
|
|
Xxxxx Xxxxx
|
|
Analysis of Amoxicillin
in Chinchilla Plasma —
Proposal No. M0504S11
|
|
Early Preclinical
Development
Proposal
|
|
4/28/2005 |
|
|
PPD Development
|
|
Xxxxx Xxxxx
|
|
Method Transfer/Dev.
And Preclinical Testing
Services: Clavulanic
Acid in Brain/Heart
Infusion Media —
Proposal No. M0504S13
|
|
Early Preclinical
Development
Proposal
|
|
4/28/2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
PPD Development
|
|
Xxxxxxxx X. Xxxxxx
|
|
XX/MS/MS analysis of
cephalexin in human
EDTA plasma
|
|
Bioanalytical
Proposal No.
R0510D34
|
|
11/2/2005 |
|
|
PPD Development
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
services in support of
cephalexin study
103.102
|
|
Revised Clinical
Pharmacology
Proposal
|
|
11/3/2005 |
|
|
PPD Development
|
|
Xxxxxxxx X. Xxxxxx
|
|
XX/MS/MS analysis of
approximately 1,000
human EDTA plasma
samples for amoxicillin
at $60 per sample
|
|
Bioanalytical
Proposal No.
R0510D33.1
|
|
11/17/2005 |
|
|
PPD Development
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
services in support of
Amoxicillin Study
111.116
|
|
Clinical
Pharmacology
Proposal
|
|
11/28/2005 |
|
|
PPD Development
|
|
Xxxxxxxx X. Xxxxxx
|
|
XX/MS/MS analysis of
approximately 1,200
human EDTA human plasma
samples at $60 per
sample
|
|
Bioanalytical
Proposal No.
R0601D11.1
|
|
1/22/2006 |
|
|
PPD Development
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
services in support of
amoxicillin study
111.115
|
|
Clinical
Pharmacology
Proposal
|
|
1/23/2006 |
|
|
PPD Development
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
services in support of
cephalexin study
103.103
|
|
Clinical
Pharmacology
Proposal
|
|
1/23/2006 |
|
|
PPD Development
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
services in support of
Amoxicillin Study
231.104
|
|
Clinical
Pharmacology
Proposal
|
|
10/3/2006 |
|
|
PPD Development
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
services in support of
Amoxicillin Study
111.112
|
|
Clinical
Pharmacology
Proposal
|
|
10/3/2006 |
|
|
PPD Development
|
|
Xxxxxx Xxxxxx
|
|
Amendment to Project
Addendum
|
|
Amendment 4 to
Project Addendum
|
|
1/1/2008 |
|
|
PPD Development
|
|
Xxxxxxxx X. Xxxxxx
|
|
XX/MS/MS analysis of
approximately 832 human
EDTA human plasma
samples at $60 per
sample
|
|
Bioanalytical
Proposal No.
R0601D10
|
|
1/13/2006 |
|
|
PPD Development, Inc.
|
|
Xxxxx Xxxxxxxx, R.N.
|
|
Antibiotic projects
sponsored by API
|
|
Non Disclosure
|
|
2/1/2001
|
|
2/1/2011 |
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
PPD Development, LP
|
|
Xxxxxxxxx
Xxxxxxxxx, Ph.D.
|
|
Possible business
transaction between the
parties
|
|
Confidentiality
|
|
11/12/2003
|
|
11/12/2010 |
PPD Development, LP
|
|
Xxxx Xxxxxxxxx
|
|
Medical information
support, post-marketing
pharmacovigilance
support and medical
writing support
services — Keflex
|
|
Letter of Agreement
(services)
|
|
11/2/2004 |
|
|
PPD Development, LP
|
|
Xxxx X. Xxxxxxxxx,
MD
|
|
Development,
manufacture,
distribution and sale
of pharmaceutical
products
|
|
Master Service
Agreement
|
|
1/12/2005 |
|
|
PPD Development, LP
|
|
Xxxx Xxxxxxxxx
|
|
Medical information
support, post-marketing
pharmacovigilance
support and medical
writing support
services — Keflex
|
|
Project Addendum
|
|
2/10/2005 |
|
|
PPD Development, LP
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Clinical
pharmacology/PK
Services in support of
Amoxicillin study
111.116
|
|
Clinical
Pharmacology
Proposal
|
|
11/28/2005 |
|
|
PPD Development, LP
|
|
Xxxxxx Xxxxxx
|
|
Medical information
support, post-marketing
pharmacovigilance
support and medical
writing support
services — Keflex
|
|
Project Addendum
|
|
12/20/2005 |
|
|
PPD Development, LP
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
Change Order
|
|
Clinical
Pharmacology
Proposal Change
Order
|
|
4/4/2006 |
|
|
PPD Development, LP
|
|
J. Xxxxxxx Xxxxxxxxx
|
|
A Phase I, Single
Center, Open-Label,
Randomized Single Dose
2-Way Crossover Study
to Characterize the
Pharmacokinetics of 3
combinations of
individual pulse
mini-tablet formations
of APC103 under fed
conditions in healthy
subjects
|
|
Clinical
Pharmacology
Proposal
|
|
4/6/2006 |
|
|
PPD Development, LP
|
|
Xxxxxxxx X. Xxxxxx
|
|
Proposal # R0604D18:
LC/MS/MS analysis of
approx. 676
K3EDTA human
plasma samples for
cephalexin at $60 per
sample
|
|
Bioanalytical
Proposal
|
|
5/28/2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
PPD Development, LP
|
|
Xxxxxxxx X. Xxxxxx
|
|
Proposal # R0606R21:
Bioanalytical support
of 232.101
|
|
Bioanalytical
Proposal
|
|
6/13/2006 |
|
|
PPD Development, LP
|
|
Xxxxxx X. Xxxxxxx
|
|
XX/MS/MS analysis of
approx. 1,152
K3EDTA human
plasma samples for
cephalexin at $60 per
sample
|
|
Bioanalytical
Proposal
|
|
9/21/2006 |
|
|
PPD Development, LP
|
|
Xxxxxx X. Xxxxxxx
|
|
XX/MS/MS analysis of
approx. 2,400
K3EDTA human
plasma samples for
cephalexin at $60 per
sample
|
|
Bioanalytical
Proposal
|
|
9/21/2006 |
|
|
PPD Development, LP
|
|
Xxxxxxxx X. Xxxxxx
|
|
Clinical
pharmacology/PK
Services in support of
Cephalexin Study
103.106 “A Pilot, Phase
I, Single Center,
Open-Label, Randomized,
Single-Dose, 4-way
Crossover Study to
Characterize and
compare the
Pharmacokinetics of
Four Composite
Formulations of APC-103
Under Fed Conditions in
healthy subjects.
|
|
Clinical
Pharmacology
Proposal
|
|
9/25/2006 |
|
|
PPD Development, LP
|
|
Xxxxxxxx X. Xxxxxx
|
|
Clinical
pharmacology/PK
Services in support of
Cephalexin study
103.105 “A pilot, Phase
I, Single Center,
Open-Label, Randomized,
Single Dose, 4-way
Crossover Study to
characterize and
compare the
pharmacokinetics of
four composite
formulations of APC-103
under fasted conditions
in healthy subjects”
|
|
Clinical
Pharmacology
Proposal
|
|
9/25/2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
PPD Development, LP
|
|
Xxxxxxxx X. Xxxxxx
|
|
Clinical
pharmokology/PK
services in support of
Amoxicillin studies
Generation of SAS
datasets and data
definition tables for
the following studies:
|
|
Clinical
Pharmacology
Proposal
|
|
10/10/2006 |
|
|
|
|
|
|
111.109; 111.110;
111.111; 111.112 |
|
|
|
|
|
|
PPD Development, LP
|
|
Xxxxxxxx X. Xxxxxx
|
|
Clinical
pharmokology/PK
services in support of
Amoxicillin studies
111.109; 111.110;
111.111; 111.112
|
|
Clinical
Pharmacology
Proposal
|
|
10/11/2006 |
|
|
PPD Development, LP
|
|
Xxxxxx Xxxxxx
|
|
Amendment No. 3 to
Project Addendum dated
February 10, 2005
|
|
Project Addendum
|
|
1/1/2007 |
|
|
PPD Development, LP
|
|
Xxxxx X. Xxxxxx
|
|
Consulting on Clinical
projects and reviewing
materials, including
protocols, as requested
by the Company
|
|
Consulting
|
|
3/1/2007 |
|
|
PPD Development, LP
|
|
Xxxxxx Xxxxxx
|
|
Amendment No. 5 to
Project Addendum dated
February 10, 2006
|
|
Amendment to
Project Addendum
|
|
4/4/2008 |
|
|
PPD Development, LP
|
|
Xxxxxx Xxxxxx
|
|
Amendment No. 6 to
Project Addendum dated
February 10, 2006
|
|
Amendment to
Project Addendum
|
|
4/21/2008 |
|
|
PPD Development, LP
|
|
Xxxxxx Xxxxxx
|
|
Amendment No. 7 to
Project Addendum dated
February 10, 2005
|
|
Amendment to
Project Addendum
|
|
7/19/2008 |
|
|
PPD Development, LP
|
|
Xxxxxx Xxxxxx
|
|
Amendment No. 8 to
Project Addendum dated
February 10, 2005
|
|
Amendment to
Project Addendum
|
|
9/1/2008 |
|
|
PPD Development, LP
|
|
Xxxxxx Xxxxxx
|
|
Amendment No. 9 to
Project Addendum to
Master Services Agmt
dated February 10, 2005
|
|
Amendment to
Project Addendum
|
|
1/1/2009 |
|
|
PPD Medical Communications
|
|
Xxxx Xxxxxxxxx
|
|
Medical Information
Support, Post-Marketing
Pharmacovigilance
Support and Medical
Writing Support
Services
|
|
Letter of Agreement
|
|
11/2/2004 |
|
|
Quintiles Inc.
|
|
Xxxxx X. Xxxxxx
|
|
Evaluating possible
business transaction
between the parties
|
|
Confidentiality
|
|
10/29/2003
|
|
10/29/2010 |
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
Quintiles Phase I Services
|
|
Xxxxxx X. Xxxxxxx
|
|
Antibiotic projects
sponsored by Advanced
Pharma, Inc.
|
|
Non Disclosure
|
|
2/1/2001
|
|
2/1/2010 |
Quintiles, Inc.
|
|
Xxxxxxx Xxxxx
|
|
Company Protocol
111.301, Streptococcal
Tonsillitis/Pharyngitis
Study
|
|
Authorization to
Proceed w/Study
|
|
7/9/2004 |
|
|
Quintiles, Inc.
|
|
Xxxxx X. Xxxxxx
|
|
Company’ Protocol
231.301, Pediatric
Tonsillitis/Pharyngitis
Study
|
|
Authorization to
Proceed with Study
|
|
9/27/2004 |
|
|
Quintiles, Inc.
|
|
Xxxxx X. Xxxxxx
|
|
Quintiles will perform
Clinical Protocol No.
111.301
|
|
General Services
Agreement
|
|
10/22/2004 |
|
|
Quintiles, Inc.
|
|
Xxxxx X. Xxxxxx
|
|
Protocol APC.111
|
|
Authorization to
Proceed
|
|
11/15/2004 |
|
|
Quintiles, Inc.
|
|
Xxxxx X. Xxxxxx
|
|
Company’ Protocol
231.301, Pediatric
Tonsillitis/Pharyngitis
Study
|
|
Amended and
Restated
Authorization to
Proceed
|
|
12/17/2004 |
|
|
Quintiles, Inc.
|
|
Xxxxx Xxxxxx
|
|
Clinical Protocol
231.301
|
|
Change Order Form
|
|
1/19/2005 |
|
|
Quintiles, Inc.
|
|
Xxxxx Xxxxxx
|
|
Clinical Protocol
231.301 (Pediatric)
|
|
General Services
Agreement
|
|
2/3/2005 |
|
|
Quintiles, Inc.
|
|
Xxxxx X. Xxxxxx
|
|
Protocol No. 111.301
|
|
Change Order Form
|
|
2/4/2005 |
|
|
Quintiles, Inc.
|
|
Xxxxx X. Xxxxxx
|
|
Planning, preparation
and implementation of
two marketing
applications in CTD
Format for Protocols
APC-111 and APC-231
|
|
Authorization to
Proceed
|
|
2/24/2005 |
|
|
Quintiles, Inc.
|
|
Xxxxx X. Xxxxxx
|
|
AVNC Protocol 111.302,
Streptococcal
Tonsillitis/Pharyngitis
Study
|
|
Authorization to
Proceed
|
|
9/19/2005 |
|
|
Quintiles, Inc.
|
|
Xxxxx X. Xxxxxx
|
|
Protocol No. 111.301
|
|
Change Order Form
|
|
10/25/2005 |
|
|
Quintiles, Inc.
|
|
Xxxxx X. Xxxxxx
|
|
Quintiles will perform
Clinical Protocol No.
111.302
|
|
General Services
Agreement
|
|
10/31/2005 |
|
|
Quintiles, Inc.
|
|
Xxx Xxxxxx
|
|
Quintiles will provide
misc. services
pertaining to
regulatory submission
and execution, and
regulatory strategy for
Company compounds.
|
|
Consulting
|
|
4/27/2006
|
|
7/27/2007 |
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
Quintiles, Inc.
|
|
Xxx Xxxxxx
|
|
APC 231-301
|
|
Change Order Form
|
|
6/2/2006 |
|
|
Quintiles, Inc.
|
|
Xxxxx Xxxxx
|
|
APC-111 MP Tablet
|
|
Change Order Form
|
|
10/24/2006 |
|
|
Quintiles, Inc.
|
|
Xxxxx Xxxxx
|
|
Quintiles will provide
writing, publishing,
submission and
regulatory services for
the Adolescent/Adult
(APC-11) CTD as
directed by Company
|
|
General Services
Agreement
|
|
11/17/2006 |
|
|
Quintiles, Inc.
|
|
Xxxxx Xxxxx
|
|
Protocol No. 111.302
|
|
Change Order Form
|
|
1/16/2007 |
|
|
Quintiles, Inc.
|
|
Xxxxxxx Xxxxx
|
|
Protocol review
consulting to Clinical
Dept.
|
|
General Consulting
|
|
4/22/2009 |
|
|
Quintiles, Inc. — J
Xxxxx Research Inc.
|
|
Xxx Xxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
Advanced Clinical
Research
|
|
Xxxxx Xxxxx Merwe,
MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
Advanced Clinical
Research
|
|
Xxxx Xxxxxx, MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Advanced Clinical
Research
|
|
Xxxx Xxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Advanced Clinical
Research
|
|
Xxx Xxxxxx,, MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Xxxxxx
Clinical Research
|
|
Xxxxxx X Xxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
Arapahoe Internal
Medicine
|
|
Xxxx X Xxxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
Biokinetics, Inc.
|
|
X X Xxxxx III, MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
Biomedical Research
Associates LLC
|
|
Xxxxxx X Xxxxxxx DO
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — C&L
Research
|
|
Xxxxxxx Xxxxxxxxx,
MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Central
Phoenix Medical Clinic
LLC
|
|
Xxxxx Xxxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Coastal
Medical Research Group
Inc.
|
|
Xxxxx Xxxxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Conyers
Medical Clinic
|
|
Xxxxxx Xxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Xxxxx
Family Physicians
|
|
Xxxxx Xxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Xx.
Xxxxx Xxxx, PC Family
Practice
|
|
Xxxxx Xxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
Quintiles, Inc. — Xxxxxxx
Family Medicine
|
|
Xxxxxx X Xxxxxx, MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Gain
Medical Centre
|
|
Xxxxxx Xxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — HCI
Metromedic
|
|
Xxxxxx Xxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Health
Research of Hampton
|
|
Xxxxxxx X Xxxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Hear of
America Research
Institute
|
|
Xxxxx X. Xxxxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
Heartland Research
Associates
|
|
Xxxxxxx X Xxxxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
Heartland Research
Associates LLC
|
|
Xxxxx X Xxxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
Hillcrest Clinical
Research LLC
|
|
Xxxxxx Broker MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Xxxxxxx
Medical Group
|
|
Xxxxxx Xxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Xxxxxxx
Medical Group PC
|
|
Xxxxx X., Xxxxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Xxxxxxx
Medical Group PC
|
|
Xxxxx X Xxxxxxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Hope
Research Group LLC
|
|
Xxxxxx Trainer, DO
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
Kentucky Pediatric/Adult
Research
|
|
Xxxxxxx X. Block, MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
Xxxxxxxx Clinic, Inc.
|
|
Xxxx X. Xxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Xxxxx
Research, Inc.
|
|
Xxxxx X.
Xxxxxxxxxxx, MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Liberty
Clinical Research
|
|
Xxxxx X. Xxxxxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Manna
Research
|
|
Xxx Xxxxx, MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Med
Investigations
|
|
Xxxx Xxxxxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Mercury
Street Medical Group
|
|
Xxxx Xxxxxxx MD,
FACP
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Milford
Emergency Associates,
Inc.
|
|
Xxxxxxx X. Xxxxxxx,
MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Novabyss
|
|
Xxxxxxx Xxxxxx, MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
Quintiles, Inc. —
Pinnacle Medical Research
|
|
Xxxxxxxx X. Xxxxxx,
MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
Plymouth Meeting Family
Medicine
|
|
Xxxx Xxxxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Primary
Care Specialists, Inc.
|
|
Xxxxxx X. Xxxxxxxx,
MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
Professional Research
Network of Kansas, LLC
|
|
Xxxxxxx X. Xxxxx, DO
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Quest
Clinical Trials
|
|
Xxxxxx Xxxxxxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
Regional Clinical
Research, Inc.
|
|
Xxxxx XxXxxx, MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — River
Region Research LLC
|
|
Xxxxx Xxxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — SFM
Clinical Trials
|
|
Xxxxxxx Xxxxxx, MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
TriValley Primary Care —
Lower Salford
|
|
Xxxxxxx Xxxxxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
University Clinical
Research DeLand Inc.
|
|
Xxxxx X. Xxxxxx,
DO, CCTI
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
Wenatchee Valley Medical
Center
|
|
Xxxxxx X. Xxxxxx, MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. —
Westside Family Medical
Center PC
|
|
Xxxx Xxxxx MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc. — Zoom
International Inc
|
|
Xxxx Xxxxxxx, MD
|
|
Protocol No. 111.302
|
|
Clinical Trial
Agreement
|
|
9/23/2005 |
|
|
Quintiles, Inc./Advanced
Clinical Research (Xx.
Xxxxxx)
|
|
Xxxx Xxxxxx, M.D.
|
|
Protocol No. 111.301
|
|
Clinical Study
|
|
10/19/2004 |
|
|
Quintiles, Inc./Advanced
Clinical Research (Xx.
Xxxxxx)
|
|
Xxx Xxxxxx, M.D./Xxxxx
Xxxxxxx, M.D.
|
|
Protocol No. 111.301
|
|
Clinical Study
|
|
10/19/2004 |
|
|
Quintiles, Inc./Advanced
Clinical Research (Xx.
Xxxxxxxx)
|
|
Illegible
|
|
Protocol No. 111.301
|
|
Clinical Study
|
|
10/19/2004 |
|
|
Quintiles, Inc./Advanced
Clinical Research (Xx.
Xxxxxxx)
|
|
Xxxxx Xxxxxxx, M.D.
|
|
Protocol 111.301,
Streptococcal
Tonsillitis/Pharyngitis
Study
|
|
Clinical Study
|
|
10/19/2004 |
|
|
Quintiles, Inc./Advanced
Clinical Research (Xx.
Xxxx)
|
|
Illegible
|
|
Protocol No. 111.301
|
|
Clinical Study
|
|
10/19/2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
Quintiles, Inc./nTouch
Research Corporation
|
|
Xxxxxx Xxxxxxxxx,
M.D.
|
|
Protocol No. 111.301
|
|
Clinical Study
|
|
12/9/2004 |
|
|
Quintiles/Advanced
Clinical Research Inc.
|
|
Illegible
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
2/9/2005 |
|
|
Quintiles/Advanced
Clinical Research Inc.
|
|
Xxxxx Xxxxx Merwe,
MD
|
|
Protocol No. 111.302:
Adolescents and Adults
|
|
Clinical Study
|
|
11/29/2005 |
|
|
Quintiles/Advanced
Clinical Research Inc.
|
|
John Crites, MD
|
|
Protocol No. 111.302:
Adolescents and Adults
|
|
Clinical Study
|
|
11/29/2005 |
|
|
Quintiles/Advanced
Clinical Research Inc.
|
|
John Eck, MD
|
|
Protocol No. 111.302:
Adolescents and Adults
|
|
Clinical Study
|
|
11/29/2005 |
|
|
Quintiles/Advanced
Clinical Research Inc.
|
|
Kim Heaton, MD
|
|
Protocol No. 111.302:
Adolescents and Adults
|
|
Clinical Study
|
|
11/29/2005 |
|
|
Quintiles/Biokinetics Incorporated
|
|
W. Manford Gooch,
M.D.
|
|
Protocol 111.302: Adult
Patients
|
|
Clinical Study
|
|
10/31/2005 |
|
|
Quintiles/Bock Clinical
Research, Inc.
|
|
Christine M.
Zador-Silverman
|
|
Protocol 111.301
|
|
Clinical Study
|
|
9/23/2004 |
|
|
Quintiles/Boston
University Medical Center
|
|
Joseph Barabino/Thomas
Moore, M.D.
|
|
Protocol No. 231.301
|
|
Clinical Study
|
|
12/10/2004 |
|
|
Quintiles/Central
Kentucky Research Assoc.
|
|
Illegible (two
names)
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
12/22/2004 |
|
|
Quintiles/Central Ohio
Primary Care Physicians,
Inc.
|
|
Jonathan Thorne,
M.D./ Thomas Bishop
|
|
Protocol No. 111.301
|
|
Clinical Study
|
|
12/13/2004 |
|
|
Quintiles/Children’s
Hospital of Pittsburgh of
UPMC
|
|
A. Hoberman, M.C.
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
3/25/2005 |
|
|
Quintiles/Children’s
Memorial Hospital
|
|
1st
Signature
Illegible/ 2nd
Signature —
Phillip V. Spina,
CRA
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
3/11/2005 |
|
|
Quintiles/Clinical
Research Advantage
|
|
Ernie Riffer, MD
|
|
Protocol No. 111.302:
Adolescents and Adults
|
|
Clinical Study
|
|
11/29/2005 |
|
|
Quintiles/Coastal Medical
Research Group, Inc.
|
|
Frank Mazzone, M.D.
|
|
Protocol 111.301
|
|
Clinical Study
|
|
10/19/2004 |
|
|
Quintiles/Coastal Medical
Research Group, Inc.
|
|
Frank Mazzone, M.D.
|
|
Protocol 111.302: Adult
Patients
|
|
Clinical Study
|
|
10/13/2005 |
|
|
Quintiles/Dr. Senders and
Associates, Pediatrics
|
|
Shelly David Senders
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
3/1/2005 |
|
|
Quintiles/East Louisville
Pediatrics
|
|
Lawrence M. Jones
|
|
Protocol 111.301
|
|
Clinical Study
|
|
9/23/2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
Quintiles/Health Research
of Hampton Roads, Inc.
|
|
Chester Fisher, M.D.
|
|
Protocol 111.301
|
|
Clinical Study
|
|
12/1/2004 |
|
|
Quintiles/Health Research
of Hampton Roads, Inc.
|
|
Chester Fisher, M.D.
|
|
Protocol 111.302: Adult
Patients
|
|
Clinical Study
|
|
11/16/2005 |
|
|
Quintiles/Heartland Research Associates
|
|
Scott Myers, MD
|
|
Protocol No. 111.302:
Adolescents and Adults
|
|
Clinical Study
|
|
11/16/2005 |
|
|
Quintiles/Heartland Research Associates
|
|
Timothy Koehler, MD
|
|
Protocol No. 111.302:
Adolescents and Adults
|
|
Clinical Study
|
|
11/16/2005 |
|
|
Quintiles/Heartland Research Associates, LLC
|
|
Kathy Stoddard
|
|
Protocol 111.301
|
|
Clinical Study
|
|
10/19/2004 |
|
|
Quintiles/Heartland Research Associates, LLC
|
|
Kathy Stoddard
|
|
Protocol No. 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
2/15/2005 |
|
|
Quintiles/Heritage
Physician Group Children
and Youth Clinic
|
|
James Hughes, MD
|
|
Protocol No. 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
2/9/2005 |
|
|
Quintiles/Heritage
Physician Group Children
and Youth Clinic
|
|
Joseph W. Cenac
Jr., MD
|
|
Protocol No. 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
2/9/2005 |
|
|
Quintiles/Hillcrest
Clinical Research, LLC
|
|
Robert E. Broker,
M.D.
|
|
Protocol No. 111.302:
Adult Patients
|
|
Clinical Study
|
|
11/1/2005 |
|
|
Quintiles/Holston Medical
Group PC
|
|
James Louthan, MD
|
|
Protocol No. 111.302:
Adolescents and Adults
|
|
Clinical Study
|
|
11/16/2005 |
|
|
Quintiles/Holston Medical
Group, P.C.
|
|
J Miller
|
|
Protocol No. 111.301
|
|
Clinical Study
|
|
9/23/2004 |
|
|
Quintiles/Holston Medical
Group, P.C.
|
|
J Miller
|
|
Protocol No. 111.301
|
|
Clinical Study
|
|
9/23/2004 |
|
|
Quintiles/Holston Medical
Group, P.C.
|
|
J Miller
|
|
Protocol No. 111.301
|
|
Clinical Study
|
|
9/23/2004 |
|
|
Quintiles/Holston Medical
Group, P.C.
|
|
Joyce Caldwell
|
|
Protocol 111.302: Adult
Patients
|
|
Clinical Study
|
|
11/1/2005 |
|
|
Quintiles/Holston Medical
Group, PC
|
|
James Schrenker
|
|
Protocol No. 111.302:
Adolescents and Adults
|
|
Clinical Study
|
|
11/16/2005 |
|
|
Quintiles/Hope Research
Group LLC
|
|
Dr. Marlin Trainer,
DP
|
|
Protocol No. 111.302:
Adolescents and Adults
|
|
Clinical Study
|
|
11/16/2005 |
|
|
Quintiles/J Lewis
Research, Inc.
|
|
Dan Henry, MD
|
|
Protocol No. 111.302:
Adolescents and Adults
|
|
Clinical Study
|
|
11/1/2005 |
|
|
Quintiles/J Lewis
Research, Inc.
|
|
Shane Christensen,
MD
|
|
Protocol No. 111.302:
Adolescents and Adults
|
|
Clinical Study
|
|
11/1/2005 |
|
|
Quintiles/J. Lewis
Research, Inc./Supervised
by Dan C.
Henry, MD
|
|
Janet Lewis
|
|
Protocol 111.301
|
|
Clinical Study
|
|
10/19/2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
Quintiles/J. Lewis
Research, Inc./Supervised
by Dan C.
Henry, MD
|
|
Janet Lewis
|
|
Protocol No. 111.301:
|
|
Clinical Study
|
|
1/31/2005 |
|
|
Quintiles/J. Lewis
Research, Inc.;
Supervised by Dan C.
Henry, MD
|
|
Janet Lewis
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
1/31/2005 |
|
|
Quintiles/J. Lewis
Research, Inc.;
Supervised by Randall L.
Watson, MD
|
|
Janet Lewis
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
1/31/2005 |
|
|
Quintiles/J. Lewis
Research, Inc.;
Supervised by Renee M.
Scheidell, MD
|
|
Janet Lewis
|
|
Protocol 231.301:
iPediatric Patients
|
|
Clinical Study
|
|
1/31/2005 |
|
|
Quintiles/J. Lewis
Research, Inc.;
Supervised by Shane Glade
Christensen, MD
|
|
Janet Lewis
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
1/31/2005 |
|
|
Quintiles/Kernodle
Clinic, Inc.
|
|
Mark Doner, M.D.
|
|
Protocol No. 111.302:
Adolescents and Adults
|
|
Clinical Study
|
|
11/1/2005 |
|
|
Quintiles/McKenzie
Medical Center
|
|
Bryan H. Merrick, MD
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
2/3/2005 |
|
|
Quintiles/Meera Dewan, MD
|
|
Meera Dewan, MD
|
|
Protocol No. 111.302:
Adolescents and Adults
|
|
Clinical Study
|
|
11/16/2005 |
|
|
Quintiles/National
Allergy, Asthma &
Urticaria Centers of
Charleston, PA
|
|
Ned Rupp, M.D.
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
1/6/2005 |
|
|
Quintiles/Pediatric
Clinical Trials
International Inc.
|
|
John Niles
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
1/26/2005 |
|
|
Quintiles/Pediatric
Clinical Trials
International, Inc.
|
|
John Niles, CEO
|
|
Protocol 111.301
|
|
Clinical Study
|
|
10/19/2004 |
|
|
Quintiles/Pediatric
Clinical Trials
International, Inc.
|
|
John Niles, CEO
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
1/28/2005 |
|
|
Quintiles/Pharmaceutical Research Organization
|
|
David S. Johnson
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
2/9/2005 |
|
|
Quintiles/Pharmaceutical Research Organization
|
|
Michael P.
Husseman, MD
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
2/9/2005 |
|
|
Quintiles/Pharmaceutical Research Organization
|
|
Paul S. Lei, MD
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
2/9/2005 |
|
|
Quintiles/Pharmaceutical Research Organization
|
|
James H. Rees, M.D.
|
|
Protocol 111.302: Adult
Patients
|
|
Clinical Study
|
|
11/1/2005 |
|
|
Quintiles/Pinnacle
Medical Research
|
|
Bruce Short
|
|
Protocol No. 111.301
|
|
Clinical Study
|
|
12/7/2004 |
|
|
Quintiles/Pinnacle
Medical Research
|
|
Lawrence Riffel,
M.D.
|
|
Protocol 111.302: Adult
Patients
|
|
Clinical Study
|
|
11/2/2005 |
|
|
Quintiles/Primary Care
Specialists, Inc. &
DataPharm, Inc.
|
|
Denise L.
Bobovnyik, M.D.
|
|
Protocol 111.302: Adult
Patients
|
|
Clinical Study
|
|
10/26/2005 |
|
|
Quintiles/Progressive
Clinical Research
|
|
J LaRata
|
|
Protocol 111.301
|
|
Clinical Study
|
|
10/19/2004 |
|
|
Quintiles/ProMed
Healthcare; ProMed
Pediatrics
|
|
1st
Signature
Illegible; 2nd
Signature — John
Spitzer, M.D.
|
|
Protocol 231.301
|
|
Clinical Study
|
|
3/8/2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
Quintiles/ProMed
Healthcare; ProMed
Pediatrics
|
|
1st
Signature
Illegible; 2nd
Signature — John
Spitzer, M.D.
|
|
Protocol 111.301
|
|
Clinical Study
|
|
3/9/2005 |
|
|
Quintiles/Radiant Research
|
|
Kate Leonard; Laird
Vermont, M.D.
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
3/10/2005 |
|
|
Quintiles/Regional Clinical Research/Endwell
Family Physicians
|
|
Debra Gabrielson
|
|
Protocol 111.301
|
|
Clinical Study
|
|
12/1/2004 |
|
|
Quintiles/Regional Clinical Research/United
Medical Associates
|
|
Peter LaFoso
(Quintiles)/Debra
Gabrielson
(RCR)/Illegible
(United Medical
Assoc.)
|
|
Protocol No. 111.301
|
|
Clinical Study
|
|
12/7/2004 |
|
|
Quintiles/Research Solutions
|
|
Dr. Westbrook; 2nd
— Janet Bailey;
3rd signature
illegible
|
|
Protocol No. 231.301
|
|
Clinical Study
|
|
2/16/2005 |
|
|
Quintiles/Research Solutions LLC
|
|
1st
Signature
Illegible; 2nd
Signature —
William Geffen
|
|
Protocol No. 111.301
|
|
Clinical Study
|
|
10/5/2004 |
|
|
Quintiles/Research Solutions LLC
|
|
1st
Signature
Illegible; 2nd
Signature —
William Geffen
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
3/11/2005 |
|
|
Quintiles/Research Solutions w/Metro Pediatrics
|
|
Dr. Matthews
|
|
Protocol No. 231-301:
Pediatric Patients
|
|
Clinical Study
|
|
2/16/2005 |
|
|
Quintiles/Research
Solutions w/Willis
Knighton — Portico
Pediatrics
|
|
Dr. Parker
|
|
Protocol No. 231-301:
Pediatric Patients
|
|
Clinical Study
|
|
2/16/2005 |
|
|
Quintiles/Research Solutions, LLC w/All for
Kids
|
|
1st
Signature
Illegible; 2nd
Signature — Janet
Bailey
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
2/16/2005 |
|
|
Quintiles/Research
Solutions, LLC w/Medical
Center of Hart County
|
|
1st
Signature
Illegible; 2nd
Signature — S.M.
Hemmer, M.D.
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
2/16/2005 |
|
|
Quintiles/River Region Research LLC
|
|
Jimmy D. Durden,
M.D.
|
|
Protocol 111.302: Adult
Patients
|
|
Clinical Study
|
|
11/16/2005 |
|
|
Quintiles/Sterling
Research Group, Ltd.
|
|
Eli M. Roth, M.D.
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
2/15/2005 |
|
|
Quintiles/Sterling
Research Group, Ltd.
|
|
Julie A. Mullen,
D.O.
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
2/15/2005 |
|
|
Quintiles/Unifour Medical
Research Associates, LLC
|
|
Dr. John Earl
|
|
Protocol 231.301:
Pediatric Patients
|
|
Clinical Study
|
|
2/15/2005 |
|
|
Quintiles/United Medical
Associates
|
|
Peter Lofaso, M.D.
(UMA); Debra
Gabrielson (RCR)
|
|
Protocol 111.302:
Adolescent and Adult
Patients
|
|
Clinical Study
|
|
11/1/2005 |
|
|
Quintiles/United Medical
Associates & Regional
Clinical Research, Inc.
|
|
Peter Lofaso, M.D.
(UMA); Debra
Gabrielson (RCR)
|
|
Protocol 111.302: Adult
Patients
|
|
Clinical Study
|
|
11/1/2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
Quintiles/University Clinical Research
|
|
Bruce G. Rankin,
DP, CCTI
|
|
Protocol No. 111.302:
Adolescents and Adults
|
|
Clinical Study
|
|
11/16/2005 |
|
|
Quintiles/Walla Walla Clinic
|
|
Illegible
|
|
Protocol 111.301
|
|
Clinical Study
|
|
10/15/2004 |
|
|
Quintiles/Wenatchee Valley Medical Center
|
|
Steven Kaster, M.D.
|
|
Protocol 111.302: Adult
Patients
|
|
Clinical Study
|
|
10/21/2005 |
|
|
Quintiles/Westside Family
Medical Center, PC
|
|
Illegible
|
|
Protocol 111.301
|
|
Clinical Study
|
|
12/1/2004 |
|
|
Quintiles/Westside Family
Medical Center, PC
|
|
Gary Ruoff, M.D.
|
|
Protocol 111.302: Adult
Patients
|
|
Clinical Study
|
|
11/16/2005 |
|
|
Reading Scientific
Services Ltd.
|
|
Richard J. Pond
|
|
Evaluating possible
business transactions
between them
|
|
Confidentiality
|
|
1/17/2005
|
|
1/17/2012 |
Rohm America, Inc.
|
|
Rodger Cram
|
|
EUDRAGITâ FS30D
and anti-infective
projects sponsored by
API
|
|
Confidentiality
|
|
5/22/2001
|
|
5/22/2011 |
Rx Sample Solutions
|
|
David Youmans
|
|
Use of Point of Sale
Check Rebate to
produced printed
promotional materials
|
|
Voucher Project
|
|
1/5/2009
|
|
Expires on the
later of final
fulfillment of all
pharmacy
reimbursement
claims received
under the POS
system from last
date of authorized
redemptions |
Rx Sample Solutions
|
|
David Youmans
|
|
Possible business
transaction between the
parties
|
|
Confidentiality
|
|
1/15/2009
|
|
1/15/2016 |
Sandoz GmbH
|
|
Elmar Dolejsi &
Petra Saf
|
|
Use of Company’
proprietary delivery
systems for Sandoz’s
oral antibiotic
substances
|
|
Confidentiality
|
|
7/19/2004
|
|
7/19/2011 |
Sandoz GmbH
|
|
F Fucus; E Docessi
|
|
Possible business
transactions between
the parties
|
|
Confidentiality
|
|
10/10/2006
|
|
10/10/2013 |
STADA Arzneimittel AG
|
|
Wolfgang Jeblonski
|
|
Clonmel Build-out —
Clonmel wholly owned
subsidiary of Stada AG
|
|
Guaranty of
Performance
|
|
4/19/2005 |
|
|
Stada Pharmaceuticals Inc
|
|
Paul J Evans
|
|
Clarithromycin
|
|
Confidentiality
|
|
5/20/2003
|
|
5/20/2010 |
STADA R&D GmbH
|
|
Dr. K.-P Reich,
M.D.; Dr. S. Dienel
|
|
Amoxicillin PULSYS
|
|
Confidentiality
|
|
3/29/2005
|
|
3/29/2012 |
|
|
|
|
|
|
|
|
|
|
|
Company |
|
Signed By |
|
Purpose |
|
Agreement Type |
|
Commencement Date |
|
Termination Date |
STADA Arzneimittel AG
|
|
Pat Magner
|
|
Letter from Stada
confirming that MBRK is
the owner of specific
equipment at the
Antibiotic Plant in
Ireland
|
|
Letter
|
|
5/11/2010 |
|
|
STADA Arzneimittel AG
|
|
Pat Magner
|
|
Letter from Stada
confirming that MBRK is
the owner of specific
equipment at the
Antibiotic Plant in
Ireland
|
|
Letter
|
|
5/11/2010 |
|
|
STADA Production Ireland
|
|
Lorraine Henry, Joe
Donohoe
|
|
Update to previous
Qualtiy Agreement
|
|
Quality Agreement
|
|
5/5/2010 |
|
|
STADA Production Ireland
|
|
Lorraine Henry, Joe
Donohoe
|
|
Define/clarify
responsibilties among
the Parties
|
|
Three way Technical
Agreement
|
|
5/5/2009
|
|
12/17/2001 |
Almac Pharma Services
|
|
Ian Markwell |
|
|
|
|
|
|
|
|
Schedule A.1(g)
Product Domain Names
|
|
|
xxxxxx-xxxxxxxxxxx.xxx
|
|
XXXXXX.XX |
xxxxxx-xxxxxxxx.xxx
|
|
XXXXXXXXXXXXXXXX.XXX |
xxxxxx.xxx
|
|
XXXXXXXXXXX-XXXXXX.XXX |
xxxxxx000.xxx
|
|
XXXXXXXXXXXXXXXXXXXXXXXX.XXX |
xxxxxx000.xxx
|
|
XXXXXXXXXXXXXXXXXXXXXXXXXX.XXX |
xxxxxx000.xxxx
|
|
XXXXXXXXXXX-XXXXXXXXXXXXXXX.XXX |
xxxxxx000.xxx
|
|
XXXXXXXXXXXXXXXXXXXXXXXXXX.XXXX |
xxxxxx000.xxx
|
|
XXXXXXXXXXXXXXXXXXXXXXXXXX.XXX |
xxxxxx000.xx
|
|
XXXXXXXXXXXXXXXXXXXXXXXXXX.XXX |
xxxxxx000.xx.xxx
|
|
XXXXXXXXXXXXXXXXXXXXXXXXXX.XX |
xxxxxxxx.xxx
|
|
xxxxxxxxxxxxxxxxx.xxx |
xxxxxxxxxxxx.xxx
|
|
xxxxxxxxxxxxxxxxx.xxxx |
xxxxxxxxxxxx.xxx
|
|
xxxxxxxxxxxxxxxxx.xxxx |
xxxxxxxxxxxx.xxxx
|
|
xxxxxxxxxxxxxxxxx.xxx |
xxxxxxxxxxxx.xxx
|
|
xxxxxxxxxxxxxxxxx.xxx |
xxxxxxxxxxxx.xxx
|
|
xxxxxxxxxxxxxxxxx.xx |
xxxxxxxxxxxx.xx
|
|
xxxxxxxxxxxxxxxxxxxxxxxxx.xx.xx |
xxxxxxxx.xxx
|
|
xxxxxxxxxxxxxxxxxxxxxxxxx.xxxx |
xxxxxxxx.xxx
|
|
xxxxxxxxxxxxxxxxxxxxxxxxxx.xx.xx |
xxxxxx-xxxxx-xxxxxxxxxxxx.xx.xx
|
|
xxxxxxxxxxxxxxxxxxxxxxxxxx.xxxx |
xxxxxxxxxxx-xxxxx.xx.xx
|
|
xxxxxxx.xxx |
xxxxxxxxxxx-xxxxx.xxxx
|
|
xxxxxxx.xxxx |
xxxxxxxxxxx-xxxxxx.xx.xx
|
|
xxxxxxx.xxx |
xxxxxxxxxxx-xxxxxx.xxxx
|
|
xxxxxxx.xxx |
xxxxxxxxxxx-xxxxxxxxxxxxxx.xx.xx
|
|
xxxxxxx.xx.xxx |
xxxxxxxxxxx-xxxxxxxxxxxxxx.xxxx
|
|
xxxxxxx.xxxx |
middlebrook-pharmaceuticals.cc
|
|
xxxxxxx.xx.xxx |
xxxxxxxxxxx-xxxxxxxxxxxxxxx.xx.xx
|
|
xxxxxxx.xx.xxx |
xxxxxxxxxxx-xxxxxxxxxxxxxxx.xxxx
|
|
xxxxxx.xxx |
xxxxxxxxxxxxxxxx.xx.xx
|
|
xxxxxx.xxxx |
xxxxxxxxxxxxxxxx.xxxx
|
|
xxxxxx.xxx |
xxxxxxxxxxxxxxxxx.xxx
|
|
xxxxxx.xx |
xxxxxxxxxxxxxxxxx.xx.xx |
|
|
Schedule A.1(h)
Keflex Product Marks
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Registration |
|
|
Mark |
|
Country |
|
Status |
|
|
Reg. No. |
|
|
Serial No. |
|
or Fling Date |
|
Goods/Services |
GREEN CAPSULE DESIGN
|
|
US
|
|
Registered
|
|
|
3,354,517 |
|
|
76/670,824
|
|
12/11/2007
|
|
Antibiotics;
namely,
cephalosporin |
KEFLEX
|
|
US
|
|
Registered
|
|
|
881,598 |
|
|
72/311,361
|
|
12/02/1969
|
|
Broad spectrum
antibiotic |
KEFLEX 250 MG (and Design)
|
|
US
|
|
Registered
|
|
|
3,259,839 |
|
|
76/670,776
|
|
07/10/2007
|
|
Antibiotics |
KEFLEX 333 MG (and Design)
|
|
US
|
|
Pending
|
|
|
|
|
|
76/670,775
|
|
12/26/2006
|
|
Antibiotics |
KEFLEX 500 MG (and Design)
|
|
US
|
|
Registered
|
|
|
3,259,840 |
|
|
76/670.777
|
|
07/10/2007
|
|
Antibiotics |
KEFLEX 750 MG (and Design)
|
|
US
|
|
Registered
|
|
|
3,259,841 |
|
|
76/670,823
|
|
07/10/2007
|
|
Antibiotics |
REDEFINING THE
PARADIGM
|
|
US
|
|
Registered
|
|
|
2,932,810 |
|
|
78/285866
|
|
03/15/2005
|
|
Pharmaceutical drug
research and
development
services; drug
discovery services |
Schedule A.1(i)
Moxatag Product Marks
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Registration |
|
|
Mark |
|
Country |
|
Status |
|
|
Reg. No. |
|
|
|
Serial No. |
|
|
or Fling Date |
|
Goods/Services |
m1 (Stylized)
|
|
US
|
|
Pending
|
|
|
|
|
|
|
77/625,855 |
|
|
12/03/2008
|
|
Antibiotics |
MIRAMOX
|
|
US
|
|
Abandoned
|
|
|
|
|
|
|
76/683,107 |
|
|
10/18/2007
|
|
Antibiotics |
MOX10
|
|
Canada
|
|
Pending
|
|
|
|
|
|
|
1447969 |
|
|
08/12/2009
|
|
Antibiotics |
MOX10
|
|
Mexico
|
|
Pending
|
|
|
|
|
|
|
1027154 |
|
|
|
|
Antibiotics |
MOX10
|
|
US
|
|
Pending
|
|
|
|
|
|
|
77/673,511 |
|
|
02/19/2009
|
|
Antibiotics |
MOXAKIT
|
|
Canada
|
|
Pending
|
|
|
|
|
|
|
1447976 |
|
|
08/12/2009
|
|
Antibiotics |
MOXAKIT
|
|
Mexico
|
|
Registered
|
|
|
1135589 |
|
|
|
1027152 |
|
|
12/14/2009
|
|
Antibiotics |
MOXAKIT
|
|
US
|
|
Pending
|
|
|
|
|
|
|
77/673,517 |
|
|
02/19/2009
|
|
Antibiotics |
MOXATAG
|
|
Canada
|
|
Allowed
|
|
|
|
|
|
|
1420994 |
|
|
12/08/2008
|
|
Pharmaceutical
preparations;
namely, antibiotics |
MOXATAG
|
|
Mexico
|
|
Registered
|
|
|
1-03963 |
|
|
|
980171 |
|
|
12/16/2008
|
|
Antibiotics |
MOXATAG
|
|
US
|
|
Registered
|
|
|
3,627,404 |
|
|
|
76/683,106 |
|
|
05/26/2009
|
|
Antibiotics |
MOXATAG 1 (Stylized)
|
|
US
|
|
Registered
|
|
|
3,706,773 |
|
|
|
77/625,829 |
|
|
11/03/2009
|
|
Antibiotics |
MOXATAG PAK
(Stylized)
|
|
US
|
|
Pending
|
|
|
|
|
|
|
77/906,187 |
|
|
01/06/2010
|
|
Antibiotics and
associated
packaging |
MOXATAG PAK (Word Mark)
|
|
US
|
|
Pending
|
|
|
|
|
|
|
77/934,413 |
|
|
0212/2009
|
|
Antibiotics and
associated
packaging |
MOXATEN
|
|
Canada
|
|
Pending
|
|
|
|
|
|
|
1447975 |
|
|
08/12/2009
|
|
Antibiotics |
MOXATEN
|
|
Mexico
|
|
Registered
|
|
|
1135588 |
|
|
|
1027151 |
|
|
12/14/2009
|
|
Antibiotics |
MOXATEN
|
|
US
|
|
Published
|
|
|
|
|
|
|
77/673,515 |
|
|
02/19/2009
|
|
Antibiotics |
MOXPAK
|
|
US
|
|
Published
|
|
|
|
|
|
|
77/693,797 |
|
|
03/18/2009
|
|
Antibiotics |
MOX-PAK
|
|
Canada
|
|
Pending
|
|
|
|
|
|
|
1447974 |
|
|
08/12/2009
|
|
Antibiotics |
MOX-PAK
|
|
Mexico
|
|
Pending
|
|
|
|
|
|
|
1027153 |
|
|
|
|
Antibiotics |
MOX-PAK
|
|
US
|
|
Published
|
|
|
|
|
|
|
77/673,512 |
|
|
02/19/2009
|
|
Antibiotics |
MOXPAK 1 (Stylized)
|
|
US
|
|
Pending
|
|
|
|
|
|
|
77/850,590 |
|
|
10/16/2009
|
|
Antibiotics |
PULSYS
|
|
Canada
|
|
Pending
|
|
|
|
|
|
|
1420993 |
|
|
12/08/2008
|
|
Antibiotics |
PULSYS
|
|
Mexico
|
|
Registered
|
|
|
1144756 |
|
|
|
980169 |
|
|
12/16/2008
|
|
Antibiotics |
PULSYS
|
|
Mexico
|
|
Registered
|
|
|
1126716 |
|
|
|
980170 |
|
|
10/22/2009
|
|
Technology
development for use
in pharmaceutical
fields for
pulsatile release
of pharmaceutical
substances |
PULSYS
|
|
US
|
|
Registered
|
|
|
3220454 |
|
|
|
78/077,941 |
|
|
03/20/2007
|
|
Compositions and
systems for
delivery of
pharmaceuticals;
namely, in a
pulsatile release
manner (Cl. 5); and
development of and
preparation
services for
pharmaceutical
formulation
technologies for
the pulsatile
release and
delivery of
pharmaceutical
substances |
Schedule A.1(j)
Product Patent Rights
See attached list of Product Patent Rights.
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
01 |
|
206200.065 |
|
CON |
|
Granted |
|
10/320,113 |
|
16-Dec-2002 |
|
6,929,804 |
|
16-Aug-2005 |
|
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App.Title: |
|
ANTI-FUNGAL COMPOSITION |
|
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|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 2 |
|
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|
Case Number:
|
|
09/791,906 |
Title:
|
|
ANTIVIRAL PRODUCT, USE AND FORMULATION THEREOF |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Open |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
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Sub |
|
Client |
|
Case |
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|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
|
|
206200.020 |
|
CIP |
|
Granted |
|
09/791,906 |
|
22-Feb-2001 |
|
6,541,014 |
|
01-Apr-2003 |
|
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App.Title: |
|
ANTIVIRAL PRODUCT, USE AND FORMULATION THEREOF |
|
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|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 3 |
|
|
|
Case Number:
|
|
09/792,092 |
Title:
|
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Open |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
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Sub |
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Client |
|
Case |
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Application |
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Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
|
|
206200.019 |
|
CIP |
|
Granted |
|
09/792,092 |
|
22-Feb-2001 |
|
6,544,555 |
|
08-Apr-2003 |
|
|
|
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|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
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|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 4 |
|
|
|
Case Number:
|
|
10/027,366 |
Title:
|
|
LEVOFLOXACIN ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
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Sub |
|
Client |
|
Case |
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|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
|
|
206200.030 |
|
CIP |
|
Granted |
|
10/027,366 |
|
20-Dec-2001 |
|
6,667,057 |
|
23-Dec-2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
LEVOFLOXACIN ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 5 |
|
|
|
Case Number:
|
|
10/027,609 |
Title:
|
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Open |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
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|
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|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Sub Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
|
|
206200.035 |
|
CIP |
|
Granted |
|
10/027,609 |
|
20-Dec-2001 |
|
6,669,948 |
|
30-Dec-2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION |
|
|
|
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|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 6 |
|
|
|
Case Number:
|
|
10/027,837 |
Title:
|
|
FLUROQUINILONE ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Open |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
|
|
206200.034 |
|
CIP |
|
Granted |
|
10/027,837 |
|
20-Dec-2001 |
|
6,667,042 |
|
23-Dec-2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
FLUROQUINILONE ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 7 |
|
|
|
Case Number:
|
|
10/027,866 |
Title:
|
|
METRONIDAZOLE ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Open |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
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|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
|
|
206200.031 |
|
CIP |
|
Granted |
|
10/027,866 |
|
20-Dec-2001 |
|
6,663,890 |
|
16-Dec-2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
METRONIDAZOLE ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 8 |
|
|
|
Case Number:
|
|
10/028,590 |
Title:
|
|
TETRACYCLINE ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Open |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Sub Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
|
|
206200.032 |
|
CIP |
|
Granted |
|
10/028,590 |
|
20-Dec-2001 |
|
6,730,320 |
|
04-May-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
TETRACYCLINE ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 9 |
|
|
|
Case Number:
|
|
10/028,595 |
Title:
|
|
ERYTHROMYACIN ANTIBIOTIC PRODUCT, USE AND
FORMULATION THEREOF |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Open |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
|
|
206200.033 |
|
CIP |
|
Granted |
|
10/028,595 |
|
20-Dec-2001 |
|
6,663,891 |
|
16-Dec-2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ERYTHROMYACIN ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 10 |
|
|
|
Case Number:
|
|
10/092,811 |
Title:
|
|
CEPHALOSPORIN-METRONIDAZOLE ANTIBIOTIC
COMPOSITION |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
|
|
206200.046 |
|
CIP |
|
Granted |
|
10/092,811 |
|
07-Mar-2002 |
|
6,623,758 |
|
23-Sep-2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
CEPHALOSPORIN-METRONIDAZOLE ANTIBIOTIC COMPOSITION |
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 11 |
|
|
|
Case Number:
|
|
10/092,854 |
Title:
|
|
AMOXICILLIN-DICLOXACILLIN ANTIBIOTIC COMPOSITION |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
|
|
206200.045 |
|
CIP |
|
Granted |
|
10/092,854 |
|
07-Mar-2002 |
|
6,627,222 |
|
30-Sep-2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
AMOXICILLIN-DICLOXACILLIN ANTIBIOTIC COMPOSITION |
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 12 |
|
|
|
Case Number:
|
|
10/092,858 |
Title:
|
|
CIPROFOXACIN-METRONIDAZOLE ANTIBIOTIC COMPOSITION |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
|
|
206200.043 |
|
CIP |
|
Granted |
|
10/092,858 |
|
07-Mar-2002 |
|
6,632,453 |
|
14-Oct-2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
CIPROFOXACIN-METRONIDAZOLE ANTIBIOTIC COMPOSITION |
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 13 |
|
|
|
Case Number:
|
|
10/093,214 |
Title:
|
|
TETRACYCLINE-DOXYCYCLINE ANTIBIOTIC COMPOSITION |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
|
|
206200.041 |
|
CIP |
|
Granted |
|
10/093,214 |
|
07-Mar-2002 |
|
6,638,532 |
|
28-Oct-2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
TETRACYCLINE-DOXYCYCLINE ANTIBIOTIC COMPOSITION |
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 14 |
|
|
|
Case Number:
|
|
10/093,321 |
Title:
|
|
AMOXICILLIN-CLARITHROMYCIN ANTIBIOTIC COMPOSITION |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
|
|
206200.044 |
|
CIP |
|
Granted |
|
10/093,321 |
|
07-Mar-2002 |
|
6,610,328 |
|
26-Aug-2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
AMOXICILLIN-CLARITHROMYCIN ANTIBIOTIC COMPOSITION |
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 15 |
|
|
|
Case Number:
|
|
10/211,039 |
Title:
|
|
MULTIPLE-DELAYED RELEASED ANTIBIOTIC PRODUCT,
USE AND FORMULATION THEREOF |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
Australia |
|
|
|
206200.137 |
|
PCT |
|
Granted |
|
2003261339 |
|
01-Aug-2003 |
|
2003261339 |
|
24-Sep-2009 |
|
01-Aug-2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
MULTIPLE-DELAYED RELEASED ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canada |
|
|
|
206200.136 |
|
PCT |
|
Pending |
|
2494015 |
|
01-Aug-2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
App.Title: |
|
MULTIPLE-DELAYED RELEASED ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
European Patent Convention |
|
|
|
206200.138 |
|
PCT |
|
Published |
|
037670858 |
|
01-Aug-2003 |
|
|
|
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App.Title: |
|
MULTIPLE-DELAYED RELEASED ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
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|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
United States of America |
|
01 |
|
206200.024 |
|
RCE |
|
Granted |
|
10/211,039 |
|
02-Aug-2002 |
|
7,025,989 |
|
11-Apr-2006 |
|
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App.Title: |
|
MULTIPLE-DELAYED RELEASED ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
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|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 16 |
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Case Number:
|
|
10/211,682 |
Title:
|
|
DELAYED RELEASE ANTI-FUNGAL PRODUCT, USE AND
FORMULATION THEREOF |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
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Sub |
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Client |
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Case |
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Application |
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Filing |
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Patent |
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Issue |
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Expiration |
Country |
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Case |
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Matter # |
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Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
01 |
|
206200.037 |
|
RCE |
|
Granted |
|
10/211,682 |
|
02-Aug-2002 |
|
7,157,095 |
|
02-Jan-2007 |
|
|
|
|
|
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|
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App.Title: |
|
DELAYED RELEASE ANTI-FUNGAL PRODUCT, USE AND FORMULATION THEREOF |
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|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 17 |
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Case Number:
|
|
10/211,729 |
Title:
|
|
DELAYED RELEASE ANTI-VIRAL PRODUCT, USE AND
FORMULATION THEREOF |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
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Sub |
|
Client |
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Case |
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Application |
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Filing |
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Patent |
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Issue |
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Expiration |
Country |
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Case |
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Matter # |
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Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
01 |
|
206200.039 |
|
RCE |
|
Granted |
|
10/211,729 |
|
02-Aug-2002 |
|
7,074,417 |
|
11-Jul-2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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App.Title: |
|
DELAYED RELEASE ANTI-VIRAL PRODUCT, USE AND FORMULATION THEREOF |
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|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 18 |
|
|
|
Case Number:
|
|
10/288,000 |
Title:
|
|
ANTIVIRAL PRODUCT, USE AND FORMULATION THEREOF |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
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Sub |
|
Client |
|
Case |
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Application |
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Filing |
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Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America |
|
01 |
|
206200.060 |
|
RCE |
|
Granted |
|
10/288,000 |
|
05-Nov-2002 |
|
6,984,401 |
|
10-Jan-2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIVIRAL PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States of America |
|
02 |
|
206200.171 |
|
CON |
|
Granted |
|
11/273,661 |
|
14-Nov-2005 |
|
7,282,221 |
|
16-Oct-2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIVIRAL PRODUCT, USE AND FORMULATION THEREOF |
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|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 19 |
|
|
|
Case Number:
|
|
10/292,617 |
Title:
|
|
ANTIFUNGAL PRODUCT, USE AND FORMULATION THEREOF |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
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|
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Sub |
|
Client |
|
Case |
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|
Application |
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Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America
|
|
|
02 |
|
|
|
206200.061 |
|
|
RCE
|
|
Published
|
|
10/292,617
|
|
12-Nov-2002 |
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
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|
|
|
|
|
Owner: |
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
|
|
App.Title: |
|
ANTIFUNGAL PRODUCT, USE AND FORMULATION THEREOF |
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|
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|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 20 |
|
|
|
Case Number:
|
|
10/325,780 |
Title:
|
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
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|
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Sub |
|
Client |
|
Case |
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|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America
|
|
|
|
|
206200.066 |
|
|
CON
|
|
Granted
|
|
10/325,780
|
|
20-Dec-2002
|
|
|
6,723,341 |
|
|
20-Apr-2004 |
|
|
|
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|
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|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 21 |
|
|
|
Case Number:
|
|
10/440,675 |
Title:
|
|
ANTIBIOTIC COMPOSITION |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
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|
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Sub |
|
Client |
|
Case |
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|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America
|
|
|
|
|
206200.083 |
|
|
CIP
|
|
Granted
|
|
10/440,675
|
|
19-May-2003
|
|
|
6,991,807 |
|
|
31-Jan-2006 |
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
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|
|
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|
|
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|
|
App.Title: |
|
ANTIBIOTIC COMPOSITION |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 22 |
|
|
|
Case Number:
|
|
10/611,076 |
Title:
|
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
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Sub |
|
Client |
|
Case |
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|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America
|
|
|
02 |
|
|
|
206200.084 |
|
|
RCE
|
|
Published
|
|
10/611,076
|
|
01-Jul-2003 |
|
|
|
|
|
|
|
|
|
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|
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|
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|
|
|
|
|
|
|
|
Owner: |
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 23 |
|
|
|
Case Number:
|
|
11/633,315 |
Title:
|
|
MODIFIED RELEASE AMOXICILLIN PRODUCTS |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
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Sub |
|
Client |
|
Case |
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|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of America
|
|
|
|
|
206200.214 |
|
|
ORD
|
|
Published
|
|
11/633,315
|
|
04-Dec-2006 |
|
|
|
|
|
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|
|
App.Title: |
|
MODIFIED RELEASE AMOXICILLIN PRODUCTS |
|
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|
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|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 24 |
|
|
|
Case Number:
|
|
11/634,633 |
Title:
|
|
MODIFIED RELEASE DOSAGE FORMS OF AMOXICILLIN |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
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Sub |
|
Client |
|
Case |
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Application |
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Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
Australia
|
|
|
|
|
206200.240 |
|
|
ORD
|
|
Pending
|
|
|
2006351475 |
|
|
08-Dec-2006 |
|
|
|
|
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|
Owner: |
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
|
|
App.Title: |
|
MODIFIED RELEASE DOSAGE FORMS OF AMOXICILLIN |
|
|
|
Canada
|
|
|
|
|
206200.242 |
|
|
ORD
|
|
Pending
|
|
|
2635606 |
|
|
08-Dec-2006 |
|
|
|
|
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|
Owner: |
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
|
|
App.Title: |
|
MODIFIED RELEASE DOSAGE FORMS OF AMOXICILLIN |
|
|
|
China (People’s Republic)
|
|
|
|
|
206200.237 |
|
|
ORD
|
|
Published
|
|
|
2006800522414 |
|
|
08-Dec-2006 |
|
|
|
|
|
|
|
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|
|
Owner: |
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
|
|
App.Title: |
|
MODIFIED RELEASE DOSAGE FORMS OF AMOXICILLIN |
|
|
|
European Patent Convention
|
|
|
|
|
206200.241 |
|
|
ORD
|
|
Published
|
|
|
068475425 |
|
|
08-Dec-2006 |
|
|
|
|
|
|
|
|
|
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|
|
|
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|
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|
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|
|
Owner: |
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
|
|
App.Title: |
|
MODIFIED RELEASE DOSAGE FORMS OF AMOXICILLIN |
|
|
Hong Kong
|
|
|
|
|
206200.241 |
|
|
ORD
|
|
Published
|
|
|
081130913 |
|
|
01-Dec-2008 |
|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
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|
|
Owner: |
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
|
|
App.Title: |
|
MODIFIED RELEASE DOSAGE FORMS OF AMOXICILLIN |
|
|
|
India
|
|
|
|
|
206200.238 |
|
|
ORD
|
|
Pending
|
|
|
59342008 |
|
|
08-Dec-2006
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
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|
|
|
|
Owner: |
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
|
|
App.Title: |
|
MODIFIED RELEASE DOSAGE FORMS OF AMOXICILLIN |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
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|
Page: 25 |
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Sub |
|
Client |
|
Case |
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|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
Japan
|
|
|
|
206200.239 |
|
|
|
ORD
|
|
Published
|
|
|
2009539226 |
|
|
08-Dec-2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Owner: |
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
App.Title: |
|
MODIFIED RELEASE DOSAGE FORMS OF AMOXICILLIN |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States of America
|
|
|
|
206200.187 |
|
|
|
ORD
|
|
Published
|
|
|
11/634,633 |
|
|
06-Dec-2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
MODIFIED RELEASE DOSAGE FORMS OF AMOXICILLIN |
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 26 |
|
|
|
|
|
Case Number:
|
|
206200.071 |
|
Title:
|
|
ANTIBIOTIC COMPOSITION
|
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC.
|
Disclosure Status:
|
|
Filed
|
Disclosure Date: |
|
|
|
|
Attorney(s):
|
|
EMO RES
|
|
|
|
|
|
|
|
|
|
|
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|
Sub |
|
Client |
|
Case |
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|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
Australia
|
|
|
|
|
206200.129 |
|
|
PCT
|
|
Granted
|
|
|
2003218024 |
|
|
07-Mar-2003
|
|
|
2003218024 |
|
|
05-Feb-2009
|
|
07-Mar-2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC COMPOSITION |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 27 |
|
|
|
Case Number:
|
|
60/184,545 |
Title:
|
|
ANTIBIOTIC COMPOSITION |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Country |
|
Sub Case |
|
Client Matter # |
|
Case Type |
|
Status |
|
Application Number |
|
Filing Date |
|
Patent Number |
|
Issue Date |
|
Expiration Date |
Australia |
|
|
|
206200.051 |
|
PCT |
|
Granted |
|
2001239841 |
|
23-Feb-2001 |
|
2001239841 |
|
10-Aug-2006 |
|
23-Feb-2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC COMPOSITION |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States of America |
|
01 |
|
206200.018 |
|
ORD |
|
Granted |
|
09/791,983 |
|
23-Feb-2001 |
|
6,623,757 |
|
23-Sep-2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC COMPOSITION |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 28 |
|
|
|
Case Number:
|
|
60/184,546 |
Title:
|
|
THERAPEUTIC PRODUCT, USE AND FORMULATION THEREOF
|
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Country |
|
Sub Case |
|
Client Matter # |
|
Case Type |
|
Status |
|
Application Number |
|
Filing Date |
|
Patent Number |
|
Issue Date |
|
Expiration Date |
Australia |
|
01 |
|
206200.050 |
|
DIV |
|
Granted |
|
2006201923 |
|
09-May-2006 |
|
2006201923 |
|
11-Sep-2008 |
|
22-Feb-2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
THERAPEUTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canada |
|
|
|
206200.048 |
|
PCT |
|
Granted |
|
2400784 |
|
22-Feb-2001 |
|
2400784 |
|
19-May-2009 |
|
22-Feb-2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
THERAPEUTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
European Patent Convention |
|
|
|
206200.047 |
|
PCT |
|
Published |
|
019144492 |
|
22-Feb-2001 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
THERAPEUTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Japan |
|
|
|
206200.049 |
|
PCT |
|
Published |
|
2001561296 |
|
22-Feb-2001 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
THERAPEUTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 29 |
|
|
|
Case Number:
|
|
60/184,582 |
Title:
|
|
ANTIBIOTIC COMPOSITION WITH INHIBITOR
|
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Country |
|
Sub Case |
|
Client Matter # |
|
Case Type |
|
Status |
|
Application Number |
|
Filing Date |
|
Patent Number |
|
Issue Date |
|
Expiration Date |
Australia |
|
|
|
206200.055 |
|
PCT |
|
Granted |
|
2001239869 |
|
23-Feb-2001 |
|
2001239869 |
|
30-Mar-2006 |
|
23-Feb-2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC COMPOSITION WITH INHIBITOR |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canada |
|
|
|
206200.057 |
|
PCT |
|
Granted |
|
2399856 |
|
23-Feb-2001 |
|
2399856 |
|
27-Jan-2009 |
|
23-Feb-2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC COMPOSITION WITH INHIBITOR |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States of America |
|
01 |
|
206200.015 |
|
ORD |
|
Granted |
|
09/791,536 |
|
23-Feb-2001 |
|
6,565,882 |
|
20-May-2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC COMPOSITION WITH INHIBITOR |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States of America |
|
02 |
|
206200.081 |
|
CON |
|
Granted |
|
10/419,357 |
|
21-Apr-2003 |
|
7,122,204 |
|
17-Oct-2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC COMPOSITION WITH INHIBITOR |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 30 |
|
|
|
Case Number:
|
|
60/488,754 |
Title:
|
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION
|
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Country |
|
Sub Case |
|
Client Matter # |
|
Case Type |
|
Status |
|
Application Number |
|
Filing Date |
|
Patent Number |
|
Issue Date |
|
Expiration Date |
Australia |
|
|
|
206200.180 |
|
PCT |
|
Pending |
|
2004258944 |
|
20-Jul-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canada |
|
|
|
206200.181 |
|
PCT |
|
Pending |
|
2533358 |
|
20-Jul-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
European Patent Convention |
|
|
|
206200.182 |
|
PCT |
|
Published |
|
047786314 |
|
20-Jul-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States of America |
|
01 |
|
206200.109 |
|
ORD |
|
Published |
|
10/894,787 |
|
20-Jul-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 31 |
|
|
|
Case Number:
|
|
60/488,889 |
Title:
|
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION
|
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Country |
|
Sub Case |
|
Client Matter # |
|
Case Type |
|
Status |
|
Application Number |
|
Filing Date |
|
Patent Number |
|
Issue Date |
|
Expiration Date |
Australia |
|
|
|
206200.176 |
|
PCT |
|
Pending |
|
2004258953 |
|
20-Jul-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canada |
|
|
|
206200.177 |
|
PCT |
|
Pending |
|
2533292 |
|
20-Jul-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
European Patent Convention |
|
|
|
206200.178 |
|
PCT |
|
Published |
|
047787056 |
|
20-Jul-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States of America |
|
10 |
|
206200.107 |
|
RCE |
|
Published |
|
10/894,786 |
|
20-Jul-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 32 |
|
|
|
Case Number:
|
|
60/488,901 |
Title:
|
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION
|
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Country |
|
Sub Case |
|
Client Matter # |
|
Case Type |
|
Status |
|
Application Number |
|
Filing Date |
|
Patent Number |
|
Issue Date |
|
Expiration Date |
Australia |
|
|
|
206200.172 |
|
PCT |
|
Pending |
|
2004258949 |
|
20-Jul-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canada |
|
|
|
206200.173 |
|
PCT |
|
Pending |
|
2533178 |
|
20-Jul-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
European Patent Convention |
|
|
|
206200.174 |
|
PCT |
|
Published |
|
047571559 |
|
20-Jul-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States of America |
|
01 |
|
206200.105 |
|
RCE |
|
Published |
|
10/894,994 |
|
20-Jul-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 33 |
|
|
|
Case Number:
|
|
60/494,155 |
Title:
|
|
ROBUST PELLET
|
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Country |
|
Sub Case |
|
Client Matter # |
|
Case Type |
|
Status |
|
Application Number |
|
Filing Date |
|
Patent Number |
|
Issue Date |
|
Expiration Date |
Japan |
|
|
|
206200.198 |
|
PCT |
|
Published |
|
2006523385 |
|
11-Aug-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ROBUST PELLET |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States of America |
|
01 |
|
206200.119 |
|
ORD |
|
Published |
|
10/915,912 |
|
11-Aug-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ROBUST PELLET |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 34 |
|
|
|
Case Number:
|
|
60/494,454 |
Title:
|
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION
|
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Country |
|
Sub Case |
|
Client Matter # |
|
Case Type |
|
Status |
|
Application Number |
|
Filing Date |
|
Patent Number |
|
Issue Date |
|
Expiration Date |
Australia |
|
|
|
206200.191 |
|
PCT |
|
Pending |
|
2004264356 |
|
12-Aug-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canada |
|
|
|
206200.189 |
|
PCT |
|
Pending |
|
2535398 |
|
12-Aug-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
European Patent Convention |
|
|
|
206200.188 |
|
PCT |
|
Published |
|
047809371 |
|
12-Aug-2004 |
|
|
|
|
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|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
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|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States of America |
|
01 |
|
206200.125 |
|
RCE |
|
Published |
|
10/917,059 |
|
12-Aug-2004 |
|
|
|
|
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|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
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|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 35 |
|
|
|
Case Number:
|
|
60/498,829 |
Title:
|
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
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|
|
Country |
|
Sub Case |
|
Client Matter # |
|
Case Type |
|
Status |
|
Application Number |
|
Filing Date |
|
Patent Number |
|
Issue Date |
|
Expiration Date |
Australia |
|
|
|
206200.195 |
|
PCT |
|
Pending |
|
2004270170 |
|
20-Aug-2004 |
|
|
|
|
|
|
|
|
|
|
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|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
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|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
Canada |
|
|
|
206200.193 |
|
PCT |
|
Pending |
|
2535780 |
|
20-Aug-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
European Patent Convention |
|
|
|
206200.192 |
|
PCT |
|
Published |
|
047819578 |
|
20-Aug-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Japan |
|
|
|
206200.194 |
|
PCT |
|
Published |
|
2006524777 |
|
20-Aug-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States of America |
|
01 |
|
206200.123 |
|
RCE |
|
Published |
|
10/922,412 |
|
20-Aug-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION THEREOF |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 36 |
|
|
|
Case Number:
|
|
60/503,041 |
Title:
|
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
Australia |
|
|
|
206200.201 |
|
PCT |
|
Pending |
|
2004273830 |
|
14-Sep-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT, USE AND FORMULATION
THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canada |
|
|
|
206200.202 |
|
PCT |
|
Pending |
|
2538064 |
|
14-Sep-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT,
USE AND FORMULATION
THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
European Patent
Convention |
|
|
|
206200.200 |
|
PCT |
|
Published |
|
047838859 |
|
14-Sep-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT,
USE AND FORMULATION
THEREOF |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States of
America |
|
01 |
|
206200.121 |
|
RCE |
|
Published |
|
10/940,265 |
|
14-Sep-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ANTIBIOTIC PRODUCT,
USE AND FORMULATION
THEREOF |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 37 |
|
|
|
Case Number:
|
|
60/532,772 |
Title:
|
|
ENHANCED ABSORPTION OF MODIFIED RELEASE DOSAGE
FORMS |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
Australia |
|
|
|
206200.210 |
|
PCT |
|
Pending |
|
2004308419 |
|
23-Dec-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ENHANCED ABSORPTION
OF MODIFIED RELEASE
DOSAGE FORMS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canada |
|
|
|
206200.208 |
|
PCT |
|
Pending |
|
2550983 |
|
23-Dec-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ENHANCED ABSORPTION
OF MODIFIED RELEASE
DOSAGE FORMS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
European Patent
Convention |
|
|
|
206200.207 |
|
PCT |
|
Published |
|
048152607 |
|
23-Dec-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ENHANCED ABSORPTION
OF MODIFIED RELEASE
DOSAGE FORMS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Japan |
|
|
|
206200.209 |
|
PCT |
|
Published |
|
2006547321 |
|
23-Dec-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ENHANCED ABSORPTION
OF MODIFIED RELEASE
DOSAGE FORMS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States of
America |
|
01 |
|
206200.133 |
|
ORD |
|
Published |
|
11/021,309 |
|
23-Dec-2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
ENHANCED ABSORPTION
OF MODIFIED RELEASE
DOSAGE FORMS |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 38 |
|
|
|
Case Number:
|
|
60/585,202 |
Title:
|
|
TABLET FOR PULSED DELIVERY |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of
America |
|
01 |
|
206200.157 |
|
RCE |
|
Published |
|
11/173,929 |
|
01-Jul-2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
TABLET
FOR PULSED
DELIVERY |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 39 |
|
|
|
Case Number:
|
|
60/748,660 |
Title:
|
|
COMPOSITIONS AND METHODS FOR IMPROVED EFFICACY
OF PENICILLIN-TYPE ANTIBIOTICS |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
Australia |
|
|
|
206200.246 |
|
ORD |
|
Pending |
|
2006321782 |
|
08-Dec-2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Owner: |
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
|
|
App.Title: |
|
COMPOSITIONS AND
METHODS FOR
IMPROVED EFFICACY
OF PENICILLIN-TYPE
ANTIBIOTICS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Canada |
|
|
|
206200.244 |
|
ORD |
|
Pending |
|
2635378 |
|
08-Dec-2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Owner: |
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
|
|
App.Title: |
|
COMPOSITIONS AND
METHODS FOR
IMPROVED EFFICACY
OF PENICILLIN-TYPE
ANTIBIOTICS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
European Patent
Convention |
|
|
|
206200.245 |
|
ORD |
|
Published |
|
068451160 |
|
08-Dec-2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Owner: |
|
MIDDLEBROOK
PHARMACEUTICALS,
INC. |
|
|
App.Title: |
|
COMPOSITIONS AND
METHODS FOR
IMPROVED EFFICACY
OF PENICILLIN-TYPE
ANTIBIOTICS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States of
America |
|
01 |
|
206200.221 |
|
RCE |
|
Published |
|
11/636,291 |
|
08-Dec-2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Owner: |
|
MIDDLEBROOK
PHARMACEUTICALS,
INC. |
|
|
App.Title: |
|
COMPOSITIONS AND
METHODS FOR
IMPROVED EFFICACY
OF PENICILLIN-TYPE
ANTIBIOTICS |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 40 |
|
|
|
Case Number:
|
|
60/755,043 |
Title:
|
|
GASTRIC RELEASE PULSE SYSTEM FOR DRUG DELIVERY |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of
America |
|
01 |
|
206200.229 |
|
ORD |
|
Published |
|
11/644,707 |
|
22-Dec-2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Owner: |
|
MIDDLEBROOK
PHARMACEUTICALS,
INC. |
|
|
App.Title: |
|
GASTRIC RELEASE
PULSE SYSTEM FOR
DRUG DELIVERY |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 41 |
|
|
|
Case Number:
|
|
60/798,109 |
Title:
|
|
PHARMACEUTICAL COMPOSITIONS AND METHODS FOR
IMPROVED BACTERIAL ERADICATION |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
Type |
|
Status |
|
Number |
|
Date |
|
Number |
|
Date |
|
Date |
United States of
America |
|
01 |
|
206200.231 |
|
ORD |
|
Published |
|
11/800,574 |
|
07-May-2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
App.Title: |
|
PHARMACEUTICAL
COMPOSITIONS AND
METHODS FOR
IMPROVED BACTERIAL
ERADICATION |
|
|
|
|
|
|
|
Thursday, April 29, 2010
|
|
Master List
|
|
Page: 42 |
|
|
|
Case Number:
|
|
60/836,026 |
Title:
|
|
ONCE-A-DAY RNA-POLYMERASE INHIBITING
DIHYDROPTEROATE SYNTHASE INHIBITING-
DIHDROFOLATE REDUCTASE INHIBITING ANTIBIOTIC
PHARMACEUTICAL PRODUCT, FORMULATION THEREOF,
AND USE THEREOF IN TREATING INFECTION CAUSED BY
METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS |
Client:
|
|
MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
|
|
Filed |
Disclosure Date: |
|
|
Attorney(s):
|
|
EMO RES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub |
|
Client |
|
Case |
|
|
|
Application |
|
Filing |
|
Patent |
|
Issue |
|
Expiration |
Country |
|
Case |
|
Matter # |
|
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Number |
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United States of
America |
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01 |
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206200.234 |
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ORD |
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Published |
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11/890,747 |
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07-Aug-2007 |
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Owner: |
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MIDDLEBROOK
PHARMACEUTICALS, INC. |
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App.Title: |
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ONCE-A-DAY
RNA-POLYMERASE
INHIBITING
DIHYDROPTEROATE
SYNTHASE
INHIBITING-DIHDROFOLATE
REDUCTASE INHIBITING
ANTIBIOTIC
PHARMACEUTICAL PRODUCT,
FORMULATION THEREOF,
AND USE THEREOF IN
TREATING INFECTION
CAUSED BY
METHICILLIN-RESISTANT
STAPHYLOCOCCUS AUREUS |
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Thursday, April 29, 2010
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Master List
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Page: 43 |
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Case Number:
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61/134,207 |
Title:
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ONCE-A-DAY RNA POLYMERASE INHIBITING AND
ELONGATION FACTOR G (EF-G) INHIBITING ANTIBIOTIC. |
Client:
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MIDDLEBROOK PHARMACEUTICALS, INC. |
Disclosure Status:
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Filed |
Disclosure Date: |
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Attorney(s):
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EMO RES |
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Patent Cooperation
Treaty |
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206200.254 |
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PCT |
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Published |
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US2009/03915 |
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01-Jul-2009 |
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App.Title: |
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ONCE-A-DAY RNA
POLYMERASE
INHIBITING AND
ELONGATION FACTOR G
(EF-G) INHIBITING
ANTIBIOTIC |
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United States of
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01 |
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206200.253 |
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ORD |
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Pending |
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12/459,415 |
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01-Jul-2009 |
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App.Title: |
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ONCE-A-DAY RNA
POLYMERASE
INHIBITING AND
ELONGATION FACTOR G
(EF-G) INHIBITING
ANTIBIOTIC |
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Report Selection
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Thursday, April 29, 2010 RecordCount: 88 |
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by Case Number |
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by Client
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Disclosure |
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206200 |
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MIDDLEBROOK PHARMACEUTICALS,
INC. |
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All |
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Schedule A.1(k)
Product Trade Dress
Moxatag 30 Ct Bottle
Moxatag 1ct Sample Container
Moxatag Sample Container (5ct)
Moxatag Product PI
Moxatag Sample Box
Moxatag Pharmacy Objection Handler
Macrolides Resistance Sales Aid
Augmentin Comparison Flash Card
Moxatag Mechanism of Action Sales Aid
Voucher Card Sell Sheet
Moxatag Website Flier
Moxatag Detail Pieces
Moxatag PAK Package (10ct Blister Card and In Box Of Three)
Moxatag Lunch & Learn Board and Canvas Carrying Case
Moxatag Brochures
Moxatag Standup Ad
Moxatag Tradeshow Booth
Doctordirectory Email Communications and Direct Mail
Moxatag Glossy Introduction Pieces
Moxatag Website
Moxatag Banner Ads
Moxatag Formulary Kit
Moxatag Letters to Healthcare Practitioners
Moxatag Letters to Pharmacists
Moxatag Pharmacy Reminder Pieces
Moxatag Healthcare Practitioner Magazine Advertisements
Moxatag Pharmacists Treatment Guide-Strep Throat
Moxatag Co-Pay Assistance Vouchers/Checks
Moxatag Stickers (Available At Wal-Mart®)
Moxatag Stickers (Pay No More Than $20)
Moxatag Stickers (Covered By Medicaid And Medicaid Approved)
Moxatag Stickers (Covered By Tri-Care)
Moxatag “Covered By Medicaid” pads
Moxatag Sticker For Lunch & Learn Items
Moxatag Sticker
Moxatag Roll-Up Panel
Moxatag Sponsored Community Newspaper Ads
Moxatag Plates and Napkins
Moxatag Tote Bags
Moxatag Tablet Comparison Chart
Moxatag Pharmacy Pens
Moxatag Mints and Hand Sanitizer
Moxatag Sample Bins
Moxatag Slim Jims
Moxatag Patient Education Guides (English/Spanish)
Moxatag Patient Education Guide Holders
Moxatag Retail Chain Sell Sheets
Moxatag Physician Satisfaction Survey
Moxatag Patient Satisfaction Survey
Moxatag IDSA 2007 Study
Moxatag KOL Slide Deck
Moxatag CD- Summarizing The Product Action
Moxatag Managed Care Letter
Moxatag Retail Clinician Sell Sheets
Moxatag Pharmakinnex Communications
Moxatag Sample Request Forms
Keflex 250mg Bottles
Keflex 500mg Bottles
Keflex 750mg Bottles
Keflex 750mg 1ct Sample Container
Keflex Product PI
Keflex “Covered By Medicaid” pads
Keflex Pens
Keflex Detail Pieces
Keflex Brochures
Keflex Slim Jim
Keflex E-Mail Sheets
Keflex Co-Pay Check Voucher
Keflex Sample Pack
Keflex Website
Keflex Banner Ads
Keflex Letters to Healthcare Practitioners
Keflex Letters to Pharmacists
Keflex Healthcare Practitioner Magazine Advertisements
Keflex Co-Pay Assistance Checks
Keflex Communications from Pharmakinnex
Pharmakinnex Detailing Pieces and Scripts
Keflex Tradeshow Booth
Schedule A.1(l)
Promotional Materials
See Schedule A.1(k).
Toll Free Number: 1(877) 363-8080
Territory Manager Survival Guide
LEK 2008 Portfolio Survey
LEK Co-Pay Study
Adelphi Pricing Demand Study 2007
Attitude and Usage Study- Willow Group 2008
PHARMA CODE Standard Operating Procedures
PDMA Standard Operating Procedures
Moxatag Learning System (Rep Version)
Moxatag Learning System (Trainer Version)
Moxatag Competitive Training Aid
Moxatag Upper Respiratory Training Aid
Territory Manager Field Compliance Manual
Sales and Marketing Code of Conduct
Moxatag/Keflex Training Module (Participant)
Moxatag/Keflex Training Module (Trainer)
Moxatag Launch Workshop
Moxatag Patient Web Survey
Promoting Keflex SSSI
Keflex Training Materials (Revised 2009)
Keflex Training Materials (Innovex Reps)
Achieve Global Training Materials (Facilitator/Participant)
CATS Training Manual
MiddleBrook Training Cards (Keflex/ Moxatag)
Treating Streptococcal Pharyngitis: Influencing Factors and New Therapy Options
Selling Skills Assessment Rubric
Pharmakinnex Training Presentation on Keflex and Moxatag
Schedule A.1(m)
Purchased Assets
All pre-clinical and clinical data pertaining to the Products
All open IND’s (Investigational New Drugs) and all clinical development plans, pre-clinical and
clinical data, correspondence with FDA and other third parties, consultants’ reports, books and
records related thereto
All government rebate/price filing data for the past two (2) years
All financial and accounting books and records pertaining to sales, all discounts and allowances to
sales, cost of goods sold and royalties paid to third parties (e.g., Lilly)
All product safety information and records, including all adverse event reports pertaining to the
Products
All sales Product training materials and formulary kits (to be delivered in hard copy and
electronic form)
Full prescriber lists for both products that include the name, field/specialty, address, telephone
number and monthly prescription volume since January 2009 for Moxatag and each Keflex SKU.
Rights in any third party intellectual property required to operate the Businesses
Schedule A.1(n)
Regulatory Filings and Approvals
See Schedule A.1(b).
See attached list of Regulatory Filings and Approvals.
|
|
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|
|
|
|
Compound |
|
Internal Project Code |
|
IND Number |
|
IND Status |
Amoxicillin Pulsatile Formulation
|
|
APC-111
|
|
IND 62,576
|
|
Active |
|
|
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|
|
|
|
Clarithromycin Pulsatile Formulation
|
|
APC-101
|
|
IND 62,239
|
|
Active |
|
|
|
|
|
|
|
Metronidazole Pulsatile Formulation
|
|
APC-121
|
|
IND 62,425
|
|
Active |
|
|
|
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|
Amoxicillin Pulsatile Sprinkle Formulation
|
|
APC-231
|
|
IND 70,876
|
|
Active |
|
|
|
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|
|
|
APC-103 (cephalexin)
|
|
APC-103
|
|
IND 73,767
|
|
Active |
Clarithromycin Pulsatile Formulation (APC-101); IND 62,239
Submissions to IND with corresponding Serial No. and date of submission
|
|
|
|
|
0
|
|
3/27/2001
|
|
IND Application |
1
|
|
3/29/2001
|
|
Response to FDA Request for Information |
2
|
|
4/24/2001
|
|
Response to FDA Request for Information |
3
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7/24/2001
|
|
Information Amendment |
4
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9/14/2001
|
|
General Correspondence |
5
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11/19/2001
|
|
General Correspondence |
6
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2/6/2002
|
|
Information Amendment |
7
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2/6/2002
|
|
General Correspondence |
8
|
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4/29/2002
|
|
IND Annual Report |
9
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|
5/3/2002
|
|
Information Amendment |
10
|
|
5/9/2002
|
|
New Investigator |
11
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|
6/6/2003
|
|
General Correspondence |
12
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|
6/11/2003
|
|
IND Annual Report |
13
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|
6/13/2003
|
|
Information Amendment |
14
|
|
4/16/2004
|
|
Information Amendment |
15
|
|
5/7/2004
|
|
IND Annual Report |
16
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|
5/7/2004
|
|
General Correspondence |
17
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|
6/22/2006
|
|
IND Annual Report |
18
|
|
7/18/2006
|
|
Addendum to the IND Annual Report |
19
|
|
4/30/2007
|
|
IND Annual Report |
20
|
|
6/29/2007
|
|
General Correspondence |
21
|
|
4/29/2008
|
|
IND Annual Report |
22
|
|
4/3/2009
|
|
IND Annual Report |
23
|
|
1/19/2010
|
|
General Correspondence |
Amoxicillin Pulsys (APC-111); IND 62,576
Submissions to IND with corresponding Serial No. and date of submission
|
|
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|
000
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4/30/2001
|
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IND Application |
1
|
|
5/8/2001
|
|
Response to FDA Request for Information |
2
|
|
9/14/2001
|
|
General Correspondence |
3
|
|
10/22/2001
|
|
Information Amendment |
4
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|
7/3/2002
|
|
Annual Report |
5
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10/9/2002
|
|
Information Amendment |
6
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10/10/2002
|
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Protocol Amendment |
7
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6/6/2003
|
|
General Correspondence |
8
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6/11/2003
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Annual Report |
9
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6/12/2003
|
|
Information Amendment |
10
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8/28/2003
|
|
Information Amendment |
11
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10/27/2003
|
|
Information Amendment |
12
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2/27/2004
|
|
Information Amendment |
13
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3/5/2004
|
|
Information Amendment |
14
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3/16/2004
|
|
Information Amendment |
15
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3/25/2004
|
|
Information Amendment |
16
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4/6/2004
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|
Information Amendment |
17
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6/23/2004
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General Correspondence |
18
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7/9/2004
|
|
Information Amendment |
19
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7/16/2004
|
|
Other: Pre-Phase III Briefing Document |
20
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|
7/29/2004
|
|
General Correspondence: |
21
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8/4/2004
|
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Other: Type B Meeting Request |
22
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|
8/20/2004
|
|
Other: Pre-Phase III Briefing Document |
23
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9/9/2004
|
|
Annual Report |
24
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9/21/2004
|
|
Information Amendment |
25
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|
9/24/2004
|
|
Information Amendment |
26
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|
9/24/2004
|
|
Other: Type B Meeting Request |
26
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9/30/2004
|
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Other: Type B Meeting Request |
27
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|
10/7/2004
|
|
Protocol Amendment |
28
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|
10/12/2004
|
|
General Correspondence |
29
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10/14/2004
|
|
Information Amendment |
30
|
|
10/14/2004
|
|
Protocol Amendment |
31
|
|
10/18/2004
|
|
Other: CMC Briefing Document |
32
|
|
10/25/2004
|
|
Information Amendment |
33
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|
10/28/2004
|
|
Information Amendment |
34
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|
10/28/2004
|
|
Information Amendment |
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|
35
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|
11/1/2004
|
|
Response to FDA Request for Information |
36
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|
11/2/2004
|
|
Protocol Amendment |
37
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12/1/2004
|
|
Information Amendment |
38
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|
12/3/2004
|
|
Protocol Amendment |
39
|
|
12/21/2004
|
|
Protocol Amendment |
40
|
|
1/11/2005
|
|
Information Amendment |
41
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|
1/25/2005
|
|
Protocol Amendment |
42
|
|
2/18/2005
|
|
Protocol Amendment |
43
|
|
2/25/2005
|
|
Information Amendment: CMC |
44
|
|
5/13/2005
|
|
Other: Pre-NDA Meeting Request |
45
|
|
6/10/2005
|
|
IND Safety Report |
46
|
|
6/14/2005
|
|
General Correspondence |
47
|
|
7/28/2005
|
|
Annual Report |
48
|
|
8/31/2005
|
|
General Correspondence |
49
|
|
9/12/2005
|
|
Protocol Amendment |
50
|
|
10/7/2005
|
|
Information Amendment |
51
|
|
11/4/2005
|
|
Protocol Amendment |
52
|
|
11/16/2005
|
|
Protocol Amendment |
53
|
|
12/15/2005
|
|
Information Amendment |
54
|
|
12/20/2005
|
|
Protocol Amendment |
55
|
|
1/27/2006
|
|
Protocol Amendment |
56
|
|
2/7/2006
|
|
General Correspondence |
57
|
|
2/7/2006
|
|
Protocol Amendment |
58
|
|
2/9/2006
|
|
General Correspondence |
59
|
|
2/17/2006
|
|
Protocol Amendment |
60
|
|
4/25/2006
|
|
General Correspondence |
61
|
|
5/24/2006
|
|
Information Amendment |
62
|
|
6/14/2006
|
|
Pre-NDA Meeting Request Letter |
63
|
|
7/25/2006
|
|
IND Annual Report |
64
|
|
7/27/2006
|
|
Information Amendment — Clinical |
65
|
|
8/16/2006
|
|
Pre-NDA Briefing Package |
66
|
|
9/6/2006
|
|
Information Amendment — Clinical |
67
|
|
12/15/2006
|
|
Information Amendment — Clinical |
68
|
|
6/29/2007
|
|
General Correspondence |
69
|
|
7/31/2007
|
|
IND Annual Report |
70
|
|
7/23/2008
|
|
IND Annual Report |
71
|
|
1/19/2010
|
|
General Correspondence — |
72
|
|
1/22/2010
|
|
IND Annual Report |
Metronidazole Pulsatile Formulation (APC-121); IND 62,425
Submissions to IND with corresponding Serial No. and date of submission
|
|
|
|
|
0
|
|
9/4/2001
|
|
General Correspondence |
1
|
|
9/17/2001
|
|
General Correspondence |
2
|
|
9/18/2001
|
|
General Correspondence |
3
|
|
11/8/2001
|
|
General Correspondence |
4
|
|
11/14/2001
|
|
General Correspondence |
5
|
|
12/19/2001
|
|
Original IND Application |
6
|
|
2/7/2002
|
|
General Correspondence |
7
|
|
8/16/2002
|
|
Information Amendment |
8
|
|
12/20/2002
|
|
IND Annual Report |
9
|
|
6/6/2003
|
|
General Correspondence |
10
|
|
1/21/2004
|
|
IND Annual Report |
11
|
|
1/10/2005
|
|
IND Annual Report |
12
|
|
3/23/2006
|
|
IND Annual Report |
13
|
|
1/19/2007
|
|
IND Annual Report |
14
|
|
6/29/2007
|
|
General Correspondence |
15
|
|
3/18/2008
|
|
IND Annual Report |
16
|
|
4/3/2009
|
|
IND Annual Report |
17
|
|
1/19/2010
|
|
General Correspondence — |
Amoxicillin Pulsatile Sprinkle Formulation (APC-231); IND 70,876
Submissions to IND with corresponding Serial No. and date of submission
|
|
|
|
|
0
|
|
10/7/2004
|
|
IND Application |
1
|
|
10/8/2004
|
|
Response to FDA Request for Information |
2
|
|
10/27/2004
|
|
Information Amendment |
3
|
|
11/3/2004
|
|
Response to FDA Request for Information |
4
|
|
11/8/2004
|
|
Response to FDA Request for Information |
5
|
|
11/8/2004
|
|
General Correspondence |
6
|
|
11/15/2004
|
|
Other: Pre-Phase III Clinical Briefing Document |
7
|
|
12/2/2004
|
|
Information Amendment |
8
|
|
12/6/2004
|
|
Information Amendment |
9
|
|
12/16/2004
|
|
Information Amendment |
10
|
|
12/16/2004
|
|
Information Amendment |
11
|
|
1/11/2005
|
|
Protocol Amendment |
12
|
|
1/11/2005
|
|
Protocol Amendment |
13
|
|
2/11/2005
|
|
Protocol Amendment |
14
|
|
2/15/2005
|
|
Protocol Amendment |
15
|
|
3/3/2005
|
|
IND Safety Report |
16
|
|
3/8/2005
|
|
Information Amendment |
17
|
|
3/15/2005
|
|
General Correspondence |
18
|
|
3/29/2005
|
|
Follow-up IND Safety Report |
19
|
|
4/20/2005
|
|
Protocol Amendment |
20
|
|
6/14/2005
|
|
IND Safety Report |
21
|
|
6/15/2005
|
|
IND Safety Report |
22
|
|
7/12/2006
|
|
Information Amendment |
23
|
|
9/29/2006
|
|
Information Amendment |
24
|
|
10/18/2006
|
|
Information Amendment |
25
|
|
12/15/2006
|
|
IND Annual Report |
26
|
|
4/4/2007
|
|
Information Amendment |
27
|
|
6/29/2007
|
|
General Correspondence — Company Name Change |
28
|
|
2/28/2008
|
|
IND Annual Report |
29
|
|
12/15/2008
|
|
IND Annual Report |
30
|
|
1/19/2010
|
|
General Correspondence — Company Address Change |
31
|
|
3/4/2010
|
|
IND Annual Report |
APC-103 (cephalexin) (APC-103); IND 73,767
Submissions to IND with corresponding Serial No. and date of submission
|
|
|
|
|
0
|
|
10/19/2005
|
|
IND Application |
1
|
|
11/7/2005
|
|
Response to FDA Request for Information |
2
|
|
11/28/2005
|
|
Response to FDA Request for Information |
3
|
|
1/27/2006
|
|
Protocol Amendment |
4
|
|
2/2/2006
|
|
Protocol Amendment |
5
|
|
5/4/2006
|
|
Protocol Amendment |
6
|
|
8/25/2006
|
|
Information Amendment |
7
|
|
10/9/2006
|
|
Information Amendment |
8
|
|
11/2/2006
|
|
Information Amendment |
9
|
|
12/11/2006
|
|
IND Annual Report |
10
|
|
4/20/2007
|
|
Type B Meeting Request |
11
|
|
5/16/2007
|
|
Pre-Phase III Clinical Briefing Document |
12
|
|
6/29/2007
|
|
Company Name Change |
13
|
|
2/22/2008
|
|
IND Annual Report |
14
|
|
12/16/2008
|
|
IND Annual Report |
15
|
|
4/2/2009
|
|
Pre-Phase III Type B Meeting Request — Clinical |
16
|
|
6/15/2009
|
|
Special Protocol Assessment — Clinical |
17
|
|
1/19/2010
|
|
General Correspondence — Address Change Notification |
18
|
|
1/21/2010
|
|
IND Annual Report |
|
|
|
|
|
|
|
Compound |
|
Internal Project Code |
|
NDA Number |
|
NDA Status |
Keflex Powder for
Oral Suspension
|
|
APC-903
|
|
NDA 050-406
|
|
NDA Withdrawn |
Keflex Capsules
|
|
APC-102
|
|
NDA 050-405
|
|
Active |
Moxatag
|
|
Moxatag
|
|
NDA 050-813
|
|
Active |
NDA 50-405 KEFLEX CAPUSLES REGULATORY SUBMISSIONS
|
|
|
|
|
Submission Date |
|
Submission Type |
|
Notes |
7/1/2004
|
|
Correspondence-Change of Sponsor
|
|
Letters, 356h forms |
10/25/2004
|
|
FPL for Approved Supplement
|
|
Letter, 356h, labeling |
2/8/2005
|
|
General Correspondence
|
|
Letter, 356h |
2/11/2005
|
|
Meeting Request
|
|
Letter, 356h |
2/23/2005
|
|
Meeting Request
|
|
Letter, 356h |
4/6/2005
|
|
FPL for Approved Supplement
|
|
Letter, 356h, label |
4/6/2005
|
|
Type C Meeting Briefing Packet
|
|
Letter, 356h, Type C briefing packet |
5/13/2005
|
|
2005 Annual Report
|
|
Letter, 2252, Annual Report |
7/1/2005
|
|
Puerto Rico Field Office
|
|
Meeting Request w/CD |
10/25/2005
|
|
Request to Revoke PSUR Waiver
|
|
Revoke PSUR and submit 314.81 regs |
11/18/2005
|
|
Changes Being Effected — 30 Days
|
|
Manufacturing Site Transfer from Lilly Italy to Ceph Intl. PR |
12/20/2005
|
|
Prior Approval Supplement
|
|
Additional Keflex Strengths (333 and 750) |
3/3/2006
|
|
Annual Periodic Report
|
|
Annual Report included 050-406 information |
3/3/2006
|
|
Annual Adverse Drug Experience Report
|
|
Contains 050-406 information |
6/27/2006
|
|
FPL for Approved Supplement
|
|
Letter, 356h, label |
7/26/2006
|
|
Drug Product Listing
|
|
Drug Product Listing for Keflex 333 mg and 750 mg with labeling and PI |
9/26/2006
|
|
Documentation to Support Type A
Meeting
|
|
Emailed submission to Valerie Jimenez and sent
HCs on 9/28/06 |
1/26/2007
|
|
CBE-30 New Process API
|
|
Change in API process |
1/26/2007
|
|
Changes Being Effected w/in 30 Days
|
|
CBE-30 Keflex Capsules (Cephalexin) |
3/12/2007
|
|
Special Supplement — CBE Keflex PI
|
|
Requested Changes by FDA on Safety |
4/24/2007
|
|
NDA Annual Report
|
|
NDA 2007 Annual Report |
6/28/2007
|
|
CBE-30 PAC-ATLS Special Supplement
|
|
Post Approval Change New Analytical Testing Lab |
6/28/2007
|
|
Special Supplement PAC-ATLS
|
|
Addition/transfer of stability testing facility |
6/29/2007
|
|
General Correspondence
|
|
Name Change |
6/29/2007
|
|
Company Name Change
|
|
Change from Advancis to Middlebrook |
11/9/2007
|
|
Change of Ownership
|
|
Change of Ownership from Middlebrook to Lex Pharmaceuticals |
3/20/2008
|
|
Supplement — CBE -0
|
|
Change to 500 mg 20 and 100 count labels at the request of FDA. |
4/9/2008
|
|
NDA Annual Report
|
|
NDA 2008 Annual Report |
5/21/2008
|
|
Change of Ownership Correspondence
|
|
Responses to DOHHS letter re: change of ownership |
8/1/2008
|
|
Supplement — CBE-0
|
|
250 mg stability update report per S-098 commitment |
|
|
|
|
|
Submission Date |
|
Submission Type |
|
Notes |
10/21/2008
|
|
Supplement — Waiver Request
|
|
Waiver request under 21 CFR 314.90 for postmarking safety reporting req. |
1/4/2009
|
|
2009 Annual Adverse Drug Experience
Report
|
|
Combined with 50-406 (Periodic Annual Report
for Keflex Capsules) |
3/25/2009
|
|
General Correspondence NDA Applicant
Notification
|
|
Keflex Capsules (Cephalexin) |
3/27/2009
|
|
Special Supplement: PAC-ALTS
|
|
CBE-30 Keflex Capsules (Cephalexin) |
4/1/2009
|
|
NDA Annual Report
|
|
Keflex Capsules and Keflex Powder for Oral Suspension |
5/12/2009
|
|
Chemistry Amendment to Supplement
S-102
|
|
Keflex Capsules (Cephalexin) |
6/12/2009
|
|
Prior Approval Supplement — Chemistry
|
|
Prior Approval Supplement — Chemistry |
10/5/2009
|
|
Amendment to PAS |
|
|
11/24/2009
|
|
Change of Ownership
|
|
From LEX to MiddleBrook |
1/19/2010
|
|
Address Change Notification
|
|
Germantown MD to Westlake TX |
3/3/2010
|
|
SAE Annual Report
|
|
Safety Reports for Keflex Capsules and Keflex Powder for Oral Suspension |
3/31/2010
|
|
NDA Annual Report
|
|
NDA Annual Report for Keflex Capsules and Keflex Powder for Oral Suspension |
NDA 50-406 KEFLEX POWDER FOR ORAL SUSPENSION REGULATORY SUBMISSIONS
|
|
|
|
|
Submission Date |
|
Submission Type |
|
Notes |
7/1/2004
|
|
Correspondence — Change of Sponsor
|
|
Letters and 356h forms |
8/12/2004
|
|
Correspondence
|
|
Reconsideration Letter & 356h |
2/22/2005
|
|
General Correspondence: Transfer
of Name
|
|
Letter, 356h |
3/3/2006
|
|
Annual Adverse DrugExperience
Report
|
|
Combined with 50-405 |
3/3/2006
|
|
2006 Annual Periodic Report
|
|
Combined with 50-405 |
11/9/2007
|
|
Change of Ownership
|
|
Change NDA ownership from MiddleBrook to Lex Pharmaceuticals |
4/24/2007
|
|
NDA Annual Report
|
|
NDA Annual Report |
6/29/2007
|
|
Change of Name
|
|
Name change notification from Advancis to MiddleBrook |
4/9/2008
|
|
NDA Annual Report
|
|
NDA Annual Report |
5/21/2008
|
|
Response to change of ownership
request
|
|
Letter re: Lex and labeling Keflex powder |
10/21/2008
|
|
Waiver Request Supplement
|
|
Waiver request for postmarketing safety reporting req. |
10/31/2008
|
|
Supplement: Changes Being Effected
|
|
Notice to rescind orig. notification re:Keflex powder |
4/1/2009
|
|
NDA Annual Report
|
|
Keflex Powder for Oral Suspension (Cephalexin) |
5/18/2009
|
|
Voluntary Withdrawal of NDA
|
|
Keflex Powder for Oral Suspension (Cephalexin) |
NDA 50-813: MOXATAG® TABLETS REGULATORY SUBMISSIONS
|
|
|
|
|
Submission Date |
|
Submission Type |
|
Notes |
12/14/2006
|
|
Original NDA
|
|
First NDA submission |
2/13/2007
|
|
Request for Meeting
|
|
RTF meeting request |
3/23/2007
|
|
Re-submission of NDA
|
|
Second NDA submission |
6/29/2007
|
|
General Correspondence
|
|
Company Name Change |
7/12/2007
|
|
Response to FDA Request for
Information
|
|
Response to Day 74 filing letter with
request for information on CMC. |
7/24/2007
|
|
General Correspondence
|
|
Correct registration # for MiddleBrook’s analytical facility is 3004214243 |
8/21/2007
|
|
4 Month Update Report
|
|
4 Month Update Report |
9/18/2007
|
|
Request for Information
|
|
11 CRFs |
10/5/2007
|
|
General Correspondence — Product
Names
|
|
Submission of Product Names for APC-111 MP
Tablet, 775 mg for Evaluation |
10/12/2007
|
|
Response to FDA Request for
Information
|
|
Responded to list of 26 CMC questions
received on August 30, 2007 |
11/7/2007
|
|
AMENDMENT: Withdrawal of
Secondary Quality Control
|
|
Withdrawal of MiddleBrook in Germantown MD, as the secondary Quality Control Lab
from NDA |
11/14/2007
|
|
Notification of Amendment
|
|
District Office |
11/16/2007
|
|
Response to FDA Request for
Information
|
|
Responded to list of 6 questions received
on November 5, 2007 |
11/16/2007
|
|
General Correspondence — Draft
Mock-up Labeling
|
|
Provided draft mock-ups of labeling
(package insert excluded) for APC-111. |
11/29/2007
|
|
E-mail Correspondence
|
|
Provided dissolution information (COAs) for 111.302 overencapsulated PEN VK. |
12/17/2007
|
|
Response to FDA Request for
Information
|
|
Provided response to CMC questions
received on 12/6/07 during review of NDA |
1/11/2008
|
|
Response to FDA Request for
Information
|
|
Provided response to CMC questions
received on 1/11/08 during review of NDA |
1/23/2008
|
|
Post-Marketing Study Commitment
|
|
Commitment to provide final CSR for Phase 3 pediatric study by March 2013. |
2/5/2008
|
|
SPL for Approved NDA 50-813
|
|
Prescribing Information in SPL Format |
5/12/2008
|
|
Periodic Report for Moxatag
|
|
Quarterly Adverse Drug Experience Report 23 January 2008 to 22 April 2008 |
8/19/2008
|
|
Periodic Report for Moxatag
|
|
Quarterly Adverse Drug Experience Report 23 April 2008 to 22 July 2008 |
8/19/2008
|
|
Periodic Report for Moxatag
|
|
Quarterly Adverse Drug Experience Report April 23 2008 to July 22 2008 |
8/28/2008
|
|
Chemistry Supplement #001
|
|
Changes being effected in 30 days |
|
|
|
|
|
Submission Date |
|
Submission Type |
|
Notes |
10/24/2008
|
|
Patent information for Moxatag,
775mg
|
|
Patent information for Patent No.
6,544,555/6,669,948/6,723,341 |
11/19/2008
|
|
Periodic Adverse Drug Experience
Report
|
|
Quarterly Adverse Drug Experience Report
July 23 2008 to October 22 2008 |
12/5/2008
|
|
Final Printed Labeling
|
|
Package insert, red-lined insert, sample carton, sample blister foil, labels, SPL |
12/10/2008
|
|
Chemistry Supplement CBE-30
|
|
Documentation for addition of new packaging facility, Almac Pharma Services. |
12/10/2008
|
|
Request for Waiver
|
|
Request for waiver of requirement 314.80(c)(ii)(b) to submit case safety reports of non-serious, labeled SADRs |
12/17/2008
|
|
NDA 50-813 Introductory Material
for Moxatag
|
|
Form FDA-2253 and introductory ads and
promotional labeling for Moxatag |
4/22/2009
|
|
NDA 50-813 DRAFT Qrtrly Rpt -
Adverse Drug Exp Rpt
|
|
Periodic Report for Moxatag (amoxicillin extended-release) Tablets 23 Jan 2009
through 22 April 2009 |
4/22/2009
|
|
NDA 50-813 Periodic Safety Report
|
|
Periodic Adverse Drug Experience Report for Moxatag (amoxicillin extended-release) tablet 23 Jan 2009 through 22 Apr 2009 |
4/30/2009
|
|
NDA 50-813 NDA Annual Report for
Moxatag
|
|
NDA Annual Rport for Moxatag |
5/19/2009
|
|
NDA Periodic Report
|
|
Quarterly Report |
8/19/2009
|
|
Periodic Safety Report
|
|
Quarterly Report |
11/18/2009
|
|
Periodic Safety Report
|
|
Quarterly Report |
1/19/2010
|
|
General Correspondence
|
|
Address change Germantown MD to Westlake TX |
2/19/2010
|
|
Periodic Safety Report
|
|
Quarterly Report |
4/30/2010
|
|
NDA Annual Report
|
|
NDA Annual Rport for Moxatag |
|
|
|
|
|
|
|
Report |
|
NDA |
|
|
|
Date of |
Number |
|
Number |
|
Date Submitted |
|
Report |
2005AD000001
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/17/2005 |
2005AD000002
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/17/2005 |
2005AD000004
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/20/2005 |
2005AD000006
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/20/2005 |
2005AD000007
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/20/2005 |
2005AD000008
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/8/2005 |
2005AD000009
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/11/2005 |
2005AD000010
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/11/2005 |
2005AD000011
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/11/2005 |
2005AD000012
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/14/2005 |
2005AD000013
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
2/14/2005 |
2005AD000014
|
|
050-405
|
|
02/14/2005
|
|
2/14/2005 |
2005AD000014
|
|
050-405
|
|
03/15/2005
|
|
3/14/2005 |
2005AD000015
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/24/2005 |
2005AD000016
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/4/2005 |
2005AD000017
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/4/2005 |
2005AD000018
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
3/31/2005 |
2005AD000019
|
|
050-405
|
|
03/31/2005
|
|
3/30/2005 |
2005AD000020
|
|
050-405
|
|
04/11/2005
|
|
4/7/2005 |
2005AD000021
|
|
050-405
|
|
04/08/2005
|
|
4/5/2005 |
2005AD000021
|
|
050-405
|
|
04/18/2005
|
|
4/14/2005 |
2005AD000021
|
|
050-405
|
|
04/29/2005
|
|
4/27/2005 |
2005AD000022
|
|
050-405
|
|
04/11/2005
|
|
4/8/2005 |
2005AD000023
|
|
050-406
|
|
04/13/2005
|
|
4/11/2005 |
2005AD000024
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/21/2005 |
2005AD000025
|
|
050-405
|
|
04/15/2005
|
|
4/13/2005 |
2005AD000026
|
|
050-406
|
|
04/18/2005
|
|
4/14/2005 |
2005AD000027
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/21/2005 |
2005AD000028
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/2/2005 |
2005AD000029
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/2/2005 |
2005AD000030
|
|
050-405
|
|
04/27/2005
|
|
4/25/2005 |
2005AD000031
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/3/2005 |
2005AD000032
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/2/2005 |
2005AD000033
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/2/2005 |
2005AD000034
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/9/2005 |
2005AD000035
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/12/2005 |
2005AD000035
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
6/23/2005 |
2005AD000036
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/23/2005 |
|
|
|
|
|
|
|
Report |
|
NDA |
|
|
|
Date of |
Number |
|
Number |
|
Date Submitted |
|
Report |
2005AD000037
|
|
050-405
|
|
05/26/2005
|
|
5/25/2005 |
2005AD000037
|
|
050-405
|
|
05/16/2005
|
|
5/12/2005 |
2005AD000038
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/22/2005 |
2005AD000038
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/18/2005 |
2005AD000039
|
|
050-406
|
|
05/19/2005
|
|
5/18/2005 |
2005AD000040
|
|
050-405
|
|
05/24/2005
|
|
5/19/2005 |
2005AD000042
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/1/2005 |
2005AD000043
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/1/2005 |
2005AD000044
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/14/2005 |
2005AD000045
|
|
050-405
|
|
06/09/2005
|
|
6/7/2005 |
2005AD000046
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/14/2005 |
2005AD000047
|
|
050-405
|
|
06/09/2005
|
|
6/7/2005 |
2005AD000048
|
|
050-405
|
|
06/09/2005
|
|
6/8/2005 |
2005AD000048
|
|
050-405
|
|
06/23/2005
|
|
6/23/2005 |
2005AD000049
|
|
050-405
|
|
08/17/2005
|
|
8/17/2005 |
2005AD000049
|
|
050-405
|
|
06/13/2005
|
|
6/10/2005 |
2005AD000050
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/15/2005 |
2005AD000051
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/15/2005 |
2005AD000052
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/15/2005 |
2005AD000053
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
6/15/2005 |
2005AD000057
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/23/2005 |
2005AD000065
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/28/2005 |
2005AD000065
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/24/2006 |
2005AD000073
|
|
050-405
|
|
08/12/2005
|
|
8/12/2005 |
2005AD000073
|
|
050-405
|
|
07/07/2005
|
|
7/5/2005 |
2005AD000074
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/8/2005 |
2005AD000075
|
|
050-405
|
|
07/14/2005
|
|
7/13/2005 |
2005AD000076
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/19/2005 |
2005AD000077
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
7/19/2005 |
2005AD000078
|
|
050-405
|
|
07/25/2005
|
|
7/22/2005 |
2005AD000079
|
|
050-405
|
|
07/21/2005
|
|
7/19/2005 |
2005AD000081
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/26/2005 |
2005AD000082
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/26/2005 |
2005AD000083
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
7/26/2005 |
2005AD000084
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/10/2005 |
2005AD000085
|
|
050-405
|
|
08/05/2005
|
|
8/4/2005 |
2005AD000086
|
|
050-405
|
|
08/05/2005
|
|
8/4/2005 |
2005AD000087
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/23/2005 |
2005AD000088
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/22/2005 |
2005AD000089
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/23/2005 |
2005AD000090
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
8/23/2005 |
|
|
|
|
|
|
|
Report |
|
NDA |
|
|
|
Date of |
Number |
|
Number |
|
Date Submitted |
|
Report |
2005AD000091
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/23/2005 |
2005AD000092
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/23/2005 |
2005AD000093
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/1/2005 |
2005AD000094
|
|
050-405
|
|
09/01/2005
|
|
9/1/2005 |
2005AD000094
|
|
050-405
|
|
09/14/2005
|
|
9/13/2005 |
2005AD000095
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
9/1/2005 |
2005AD000096
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/27/2005 |
2005AD000096
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/6/2005 |
2005AD000097
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
9/6/2005 |
2005AD000098
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/16/2005 |
2005AD000099
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
9/16/2005 |
2005AD000100
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/23/2005 |
2005AD000101
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/23/2005 |
2005AD000102
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/27/2005 |
2005AD000103
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
10/7/2005 |
2005AD000104
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
10/6/2005 |
2005AD000105
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
10/14/2005 |
2005AD000106
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/1/2005 |
2005AD000107
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/1/2005 |
2005AD000108
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/1/2005 |
2005AD000109
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/1/2005 |
2005AD000110
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/3/2005 |
2005AD000111
|
|
050-405
|
|
11/14/2005
|
|
11/10/2005 |
2005AD000112
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/18/2005 |
2005AD000113
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/18/2005 |
2005AD000115
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/18/2005 |
2005AD000116
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/18/2005 |
2005AD000117
|
|
050-405
|
|
11/22/2005
|
|
11/22/2005 |
2005AD000118
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/23/2005 |
2005AD000119
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/7/2005 |
2005AD000120
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/7/2005 |
2005AD000121
|
|
050-405
|
|
12/20/2005
|
|
12/19/2005 |
2005AD000122
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/28/2005 |
2005AD000123
|
|
050-405
|
|
12/20/2005
|
|
12/19/2005 |
2005AD000124
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/28/2005 |
2005AD000124
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/23/2006 |
2005AD000125
|
|
050-405
|
|
12/20/2005
|
|
12/20/2005 |
2005AD000126
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/28/2005 |
2006AD000001
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/12/2006 |
2006AD000002
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/19/2006 |
2006AD000003
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/19/2006 |
|
|
|
|
|
|
|
Report |
|
NDA |
|
|
|
Date of |
Number |
|
Number |
|
Date Submitted |
|
Report |
2006AD000004
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
1/19/2006 |
2006AD000005
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/19/2006 |
2006AD000006
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/19/2006 |
2006AD000007
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/6/2006 |
2006AD000008
|
|
050-405
|
|
01/30/2006
|
|
1/27/2006 |
2006AD000008
|
|
050-405
|
|
08/21/2006
|
|
8/16/2006 |
2006AD000009
|
|
050-405
|
|
01/31/2006
|
|
1/30/2006 |
2006AD000010
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/27/2006 |
2006AD000011
|
|
050-405
|
|
03/13/2006
|
|
3/3/2006 |
2006AD000012
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
3/3/2006 |
2006AD000013
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/2/2006 |
2006AD000014
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
3/23/2006 |
2006AD000015
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/13/2006 |
2006AD000015
|
|
050-405
|
|
06/06/2006
|
|
5/31/2006 |
2006AD000017
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/22/2006 |
2006AD000018
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/30/2006 |
2006AD000019
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/4/2006 |
2006AD000020
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/30/2006 |
2006AD000021
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/4/2006 |
2006AD000022
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/11/2006 |
2006AD000023
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/11/2006 |
2006AD000024
|
|
050-405
|
|
04/13/2006
|
|
4/11/2006 |
2006AD000026
|
|
050-405
|
|
04/13/2006
|
|
4/11/2006 |
2006AD000027
|
|
050-405
|
|
04/28/2006
|
|
4/25/2006 |
2006AD000028
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/15/2006 |
2006AD000029
|
|
050-405
|
|
05/09/2006
|
|
5/4/2006 |
2006AD000030
|
|
050-405
|
|
12/01/2006
|
|
11/22/2006 |
2006AD000030
|
|
050-405
|
|
06/15/2007
|
|
6/8/2007 |
2006AD000030
|
|
050-405
|
|
05/17/2006
|
|
5/15/2006 |
2006AD000030
|
|
050-405
|
|
06/09/2006
|
|
6/1/2006 |
2006AD000030
|
|
050-405
|
|
08/16/2006
|
|
8/10/2006 |
2006AD000031
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/17/2006 |
2006AD000032
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/17/2006 |
2006AD000033
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/17/2006 |
2006AD000034
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/17/2006 |
2006AD000036
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/30/2006 |
2006AD000037
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/30/2006 |
2006AD000038
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/6/2006 |
2006AD000039
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
6/6/2006 |
2006AD000040
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/28/2006 |
2006AD000041
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/28/2006 |
|
|
|
|
|
|
|
Report |
|
NDA |
|
|
|
Date of |
Number |
|
Number |
|
Date Submitted |
|
Report |
2006AD000042
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/19/2006 |
2006AD000043
|
|
050-405
|
|
06/30/2006
|
|
6/21/2006 |
2006AD000044
|
|
050-405
|
|
06/30/2006
|
|
6/27/2006 |
2006AD000045
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/10/2006 |
2006AD000046
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
7/11/2006 |
2006AD000047
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
7/11/2006 |
2006AD000048
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/12/2006 |
2006AD000049
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/20/2006 |
2006AD000050
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/20/2006 |
2006AD000051
|
|
050-405
|
|
07/31/2006
|
|
7/27/2006 |
2006AD000051
|
|
050-405
|
|
08/14/2006
|
|
8/9/2006 |
2006AD000052
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/28/2006 |
2006AD000053
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
7/28/2006 |
2006AD000054
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/10/2006 |
2006AD000055
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/10/2006 |
2006AD000056
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/9/2006 |
2006AD000057
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/16/2006 |
2006AD000058
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/16/2006 |
2006AD000059
|
|
050-405
|
|
08/28/2006
|
|
8/23/2006 |
2006AD000060
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/25/2006 |
2006AD000061
|
|
050-405
|
|
08/31/2006
|
|
8/30/2006 |
2006AD000061
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/23/2006 |
2006AD000062
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/24/2006 |
2006AD000063
|
|
050-405
|
|
08/30/2006
|
|
8/24/2006 |
2006AD000063
|
|
050-405
|
|
05/31/2007
|
|
5/23/2007 |
2006AD000064
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/30/2006 |
2006AD000065
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/19/2006 |
2006AD000066
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/13/2006 |
2006AD000067
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/19/2006 |
2006AD000068
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/19/2006 |
2006AD000069
|
|
050-405
|
|
09/18/2006
|
|
9/13/2006 |
2006AD000069
|
|
050-405
|
|
02/01/2007
|
|
1/25/2007 |
2006AD000070
|
|
050-405
|
|
09/26/2006
|
|
9/19/2006 |
2006AD000071
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/19/2006 |
2006AD000072
|
|
050-406
|
|
09/27/2006
|
|
9/21/2006 |
2006AD000073
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/21/2006 |
2006AD000074
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
9/29/2006 |
2006AD000075
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
10/24/2006 |
2006AD000076
|
|
050-405
|
|
10/23/2006
|
|
10/16/2006 |
2006AD000077
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
10/20/2006 |
2006AD000078
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
10/20/2006 |
|
|
|
|
|
|
|
Report |
|
NDA |
|
|
|
Date of |
Number |
|
Number |
|
Date Submitted |
|
Report |
2006AD000079
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
10/24/2006 |
2006AD000080
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
10/24/2006 |
2006AD000081
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
10/24/2006 |
2006AD000082
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/6/2006 |
2006AD000083
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/6/2006 |
2006AD000084
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/8/2006 |
2006AD000085
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/8/2006 |
2006AD000086
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/8/2006 |
2006AD000087
|
|
050-405
|
|
12/05/2006
|
|
11/22/2006 |
2006AD000088
|
|
050-405
|
|
12/05/2006
|
|
11/27/2006 |
2006AD000089
|
|
050-405
|
|
12/05/2006
|
|
11/22/2006 |
2006AD000090
|
|
050-405
|
|
12/01/2006
|
|
11/22/2006 |
2006AD000091
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/7/2006 |
2006AD000092
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/13/2006 |
2006AD000093
|
|
050-405
|
|
12/15/2006
|
|
12/7/2006 |
2006AD000094
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/13/2006 |
2006AD000095
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/13/2006 |
2006AD000096
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/13/2006 |
2006AD000098
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/13/2006 |
2006AD000099
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/19/2006 |
2006AD000100
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/13/2006 |
2006AD000101
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/19/2006 |
2006AD000102
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/28/2006 |
2006AD000103
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/28/2006 |
2006AD000104
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/28/2006 |
2006AD000105
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/28/2006 |
2006AD000106
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
1/8/2007 |
2006AD000107
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
1/8/2007 |
2006AD000108
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/31/2007 |
2006AD000108
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/31/2007 |
2007AD000001
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/11/2007 |
2007AD000002
|
|
050-406
|
|
02/01/2007
|
|
1/25/2007 |
2007AD000004
|
|
050-406
|
|
02/01/2007
|
|
1/25/2007 |
2007AD000005
|
|
050-405
|
|
02/08/2007
|
|
1/29/2007 |
2007AD000003
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/31/2007 |
2007AD000009
|
|
050-405
|
|
02/15/2007
|
|
2/5/2007 |
2007AD000007
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/5/2007 |
2007AD000006
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
2/5/2007 |
2007AD000008
|
|
050-406
|
|
02/16/2007
|
|
2/5/2007 |
2007AD000011
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/9/2007 |
2007AD000010
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/9/2007 |
|
|
|
|
|
|
|
Report |
|
NDA |
|
|
|
Date of |
Number |
|
Number |
|
Date Submitted |
|
Report |
2007AD000013
|
|
050-405
|
|
02/22/2007
|
|
2/16/2007 |
2007AD000017
|
|
050-405
|
|
02/27/2007
|
|
2/19/2007 |
2007AD000012
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
2/20/2007 |
2007AD000015
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/20/2007 |
2007AD000014
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/20/2007 |
2007AD000016
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/20/2007 |
2007AD000019
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/28/2007 |
2007AD000020
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/28/2007 |
2007AD000018
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/28/2007 |
2007AD000021
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/28/2007 |
2007AD000008
|
|
050-406
|
|
03/20/2007
|
|
3/13/2007 |
2007AD000025
|
|
050-405
|
|
03/20/2007
|
|
3/13/2007 |
2007AD000026
|
|
050-405
|
|
03/27/2007
|
|
3/19/2007 |
2007AD000023
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
3/19/2007 |
2007AD000022
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/19/2007 |
2007AD000024
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
3/20/2007 |
2007AD000028
|
|
050-405
|
|
04/03/2007
|
|
3/27/2007 |
2007AD000027
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/27/2007 |
2007AD000029
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/29/2007 |
2007AD000030
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
4/2/2007 |
2007AD000031
|
|
050-405
|
|
04/12/2007
|
|
4/4/2007 |
2007AD000035
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/10/2007 |
2007AD000036
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/10/2007 |
2007AD000037
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/11/2007 |
2007AD000038
|
|
050-405
|
|
04/25/2007
|
|
4/18/2007 |
2007AD000039
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/20/2007 |
2007AD000034
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
4/23/2007 |
2007AD000032
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/23/2007 |
2007AD000040
|
|
050-405
|
|
05/03/2007
|
|
4/25/2007 |
2007AD000042
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/26/2007 |
2007AD000043
|
|
050-405
|
|
05/04/2007
|
|
4/26/2007 |
2007AD000046
|
|
050-405
|
|
05/08/2007
|
|
4/26/2007 |
2007AD000044
|
|
050-405
|
|
05/04/2007
|
|
4/26/2007 |
2007AD000045
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/27/2007 |
2007AD000041
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/27/2007 |
2007AD000037
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/27/2007 |
2007AD000047
|
|
050-405
|
|
05/08/2007
|
|
4/30/2007 |
2007AD000048
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/2/2007 |
2007AD000033
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/4/2007 |
2007AD000049
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/22/2007 |
2007AD000052
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/22/2007 |
|
|
|
|
|
|
|
Report |
|
NDA |
|
|
|
Date of |
Number |
|
Number |
|
Date Submitted |
|
Report |
2007AD000050
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/23/2007 |
2007AD000051
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/23/2007 |
2007AD000053
|
|
050-405
|
|
06/07/2007
|
|
5/29/2007 |
2007AD000055
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/5/2007 |
2007AD000054
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
6/8/2007 |
2007AD000056
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/15/2007 |
2007AD000057
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/15/2007 |
2007AD000060
|
|
050-405
|
|
06/28/2007
|
|
6/20/2007 |
2007AD000058
|
|
050-405
|
|
06/26/2007
|
|
6/25/2007 |
2007AD000061
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/25/2007 |
2007AD000062
|
|
050-406
|
|
07/05/2007
|
|
6/27/2007 |
2007AD000059
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/29/2007 |
2007AD000063
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/3/2007 |
2007AD000064
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/17/2007 |
2007AD000065
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/23/2007 |
2007AD000067
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/23/2007 |
2007AD000068
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/27/2007 |
2007AD000069
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
7/27/2007 |
2007AD000066
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/27/2007 |
2007AD000072
|
|
050-405
|
|
08/10/2007
|
|
8/3/2007 |
2007AD000071
|
|
050-405
|
|
08/14/2007
|
|
8/6/2007 |
2007AD000074
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/10/2007 |
2007AD000075
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
8/14/2007 |
2007AD000076
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/16/2007 |
2007AD000078
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
8/24/2007 |
2007AD000080
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/24/2007 |
2007AD000079
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/30/2007 |
2007AD000082
|
|
050-405
|
|
09/07/2007
|
|
8/30/2007 |
2007AD000037
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/30/2007 |
2007AD000033
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/4/2007 |
2007AD000083
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/5/2007 |
2007AD000081
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/5/2007 |
2007AD000077
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/7/2007 |
2007AD000085
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/14/2007 |
2007AD000084
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/14/2007 |
2007AD000087
|
|
050-405
|
|
10/02/2007
|
|
9/25/2007 |
2007AD000006
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
9/25/2007 |
2007AD000086
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/25/2007 |
2007AD000088
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/26/2007 |
2007AD000089
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
10/16/2007 |
2007AD000091
|
|
050-405
|
|
10/23/2007
|
|
10/18/2007 |
|
|
|
|
|
|
|
Report |
|
NDA |
|
|
|
Date of |
Number |
|
Number |
|
Date Submitted |
|
Report |
2007AD000094
|
|
050-405
|
|
10/23/2007
|
|
10/19/2007 |
2007AD000092
|
|
050-405
|
|
10/23/2007
|
|
10/19/2007 |
2007AD000090
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
10/22/2007 |
2007AD000093
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/1/2007 |
2007AD000097
|
|
050-405
|
|
11/13/2007
|
|
11/6/2007 |
2007AD000105
|
|
050-405
|
|
11/07/2007
|
|
11/6/2007 |
2007AD000096
|
|
050-405
|
|
11/13/2007
|
|
11/6/2007 |
2007AD000095R
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/7/2007 |
2005AD000125
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/12/2007 |
2007AD000101
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/12/2007 |
2007AD000100
|
|
050-405
|
|
11/14/2007
|
|
11/12/2007 |
2007AD000099
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/12/2007 |
2007AD000104
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/12/2007 |
2007AD000098
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/12/2007 |
2006AD000023
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/12/2007 |
2007AD000095
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/14/2007 |
2005AD000001
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/15/2007 |
2006AD000018
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/15/2007 |
2007AD000103
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/19/2007 |
2007AD000107
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
11/20/2007 |
2006AD000095
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/28/2007 |
2005AD000071
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
11/28/2007 |
2007AD000109
|
|
050-405
|
|
12/06/2007
|
|
12/3/2007 |
2007AD000114
|
|
050-405
|
|
12/06/2007
|
|
12/3/2007 |
2007AD000112
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/4/2007 |
2007AD000113
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/4/2007 |
2007AD000108
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/4/2007 |
2007AD000115
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/5/2007 |
2007AD000117
|
|
050-405
|
|
12/14/2007
|
|
12/6/2007 |
2007AD000120
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/14/2007 |
2007AD000121
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/14/2007 |
2007AD000119
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/14/2007 |
2007AD000110
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/17/2007 |
2007AD000111
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/17/2007 |
2007AD000118
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/17/2007 |
2007AD000122
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/17/2007 |
2007AD000123
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/17/2007 |
2007AD000116
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/19/2007 |
2007AD000126
|
|
050-405
|
|
12/28/2007
|
|
12/20/2007 |
2007AD000127
|
|
050-406
|
|
12/28/2007
|
|
12/20/2007 |
2007AD000125
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
12/20/2007 |
|
|
|
|
|
|
|
Report |
|
NDA |
|
|
|
Date of |
Number |
|
Number |
|
Date Submitted |
|
Report |
2007AD000124
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/20/2007 |
2007AD000128
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/26/2007 |
2007AD000129
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
12/26/2007 |
2007AD000131
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/3/2008 |
2007AD000130
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
1/4/2008 |
2008MB000002
|
|
050-405
|
|
01/21/2008
|
|
1/15/2008 |
2008MB000004
|
|
050-405
|
|
01/21/2008
|
|
1/17/2008 |
2008MB000001
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/18/2008 |
2008MB000003
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
1/18/2008 |
2008MB000006
|
|
050-406
|
|
01/25/2008
|
|
1/21/2008 |
2008MB000007
|
|
050-406
|
|
01/25/2008
|
|
1/21/2008 |
2008MB000008
|
|
050-405
|
|
02/04/2008
|
|
1/28/2008 |
2008MB000005
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/28/2008 |
2008MB000010
|
|
050-406
|
|
02/28/2008
|
|
2/19/2008 |
2008MB000011
|
|
050-405
|
|
02/28/2008
|
|
2/20/2008 |
2008MB000009
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/20/2008 |
2008MB000015
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/26/2008 |
2008MB000012
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
2/26/2008 |
2008MB000014
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/4/2008 |
2008MB000016
|
|
050-405
|
|
03/18/2008
|
|
3/6/2008 |
2008MB000013
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/6/2008 |
2008MB000019
|
|
050-405
|
|
03/20/2008
|
|
3/12/2008 |
2008MB000018
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
3/17/2008 |
2008MB000020
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/18/2008 |
2008MB000017
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/19/2008 |
2008MB000022
|
|
050-405
|
|
04/01/2008
|
|
3/24/2008 |
2008MB000023-S
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/26/2008 |
2008MB000021
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/31/2008 |
2008MB000025
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
3/31/2008 |
2008MB000027
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/2/2008 |
2008MB000024
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
4/2/2008 |
2008MB000039
|
|
050-405
|
|
04/21/2008
|
|
4/10/2008 |
2008MB000052
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
4/15/2008 |
2008MB000041
|
|
050-405
|
|
04/21/2008
|
|
4/16/2008 |
2008MB000040
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/17/2008 |
2008MB000042
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/17/2008 |
2008MB000044
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/22/2008 |
2008MB000046
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/23/2008 |
2008MB000047
|
|
050-405
|
|
05/01/2008
|
|
4/24/2008 |
2008MB000043
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
4/24/2008 |
2008MB000050
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/30/2008 |
|
|
|
|
|
|
|
Report |
|
NDA |
|
|
|
Date of |
Number |
|
Number |
|
Date Submitted |
|
Report |
2008MB000048
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/30/2008 |
2008MB000049
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
4/30/2008 |
2008MB000045
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
4/30/2008 |
2006AD000030
|
|
050-405
|
|
05/13/2008
|
|
5/9/2008 |
2008MB000056
|
|
050-405
|
|
05/14/2008
|
|
5/12/2008 |
2008MB000054
|
|
050-405
|
|
05/14/2008
|
|
5/12/2008 |
2008MB000031
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/14/2008 |
2008MB000029
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/14/2008 |
2008MB000029
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/14/2008 |
2008MB000030
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/14/2008 |
2008MB000032
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/14/2008 |
2008MB000033
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/14/2008 |
2008MB000034
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/14/2008 |
2008MB000035
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/14/2008 |
2008MB000036
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/14/2008 |
2008MB000037
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/14/2008 |
2008MB000038
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/14/2008 |
2008MB000055
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/14/2008 |
2008MB000051
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/14/2008 |
2008MB000057
|
|
050-405
|
|
05/29/2008
|
|
5/28/2008 |
2008MB000061
|
|
050-405
|
|
06/02/2008
|
|
5/30/2008 |
2008MB000058
|
|
050-405
|
|
06/02/2008
|
|
5/30/2008 |
2008MB000060
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/5/2008 |
2008MB000059
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/12/2008 |
2008MB000062
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/16/2008 |
2008MB000053
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/17/2008 |
2008MB000065
|
|
050-405
|
|
06/26/2008
|
|
6/23/2008 |
2008MB000066
|
|
050-405
|
|
06/26/2008
|
|
6/23/2008 |
2008MB000067
|
|
050-405
|
|
06/26/2008
|
|
6/23/2008 |
2008MB000068
|
|
050-405
|
|
06/26/2008
|
|
6/23/2008 |
2008MB000069
|
|
050-405
|
|
06/26/2008
|
|
6/23/2008 |
2008MB000070
|
|
050-405
|
|
06/26/2008
|
|
6/23/2008 |
2008MB000071
|
|
050-405
|
|
06/26/2008
|
|
6/23/2008 |
2008MB000072
|
|
050-405
|
|
06/26/2008
|
|
6/23/2008 |
2008MB000073
|
|
050-405
|
|
06/26/2008
|
|
6/23/2008 |
2008MB000074
|
|
050-405
|
|
06/26/2008
|
|
6/23/2008 |
2008MB000075
|
|
050-405
|
|
06/26/2008
|
|
6/23/2008 |
2008MB000064
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/23/2008 |
2008MB000075
|
|
050-405
|
|
06/26/2008
|
|
6/25/2008 |
2008MB000079
|
|
050-405
|
|
07/08/2008
|
|
7/2/2008 |
2008MB000078
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/7/2008 |
|
|
|
|
|
|
|
Report |
|
NDA |
|
|
|
Date of |
Number |
|
Number |
|
Date Submitted |
|
Report |
2008MB000080
|
|
050-405
|
|
07/14/2008
|
|
7/10/2008 |
2008MB000081
|
|
050-405
|
|
07/30/2008
|
|
7/21/2008 |
2008MB000082
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/23/2008 |
2008MB000083
|
|
050-405
|
|
7/30/2008
|
|
7/24/2008 |
2008MB000084
|
|
050-405
|
|
8/01/2008
|
|
7/30/2008 |
2008MB000086
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/1/2008 |
2008MB000026
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/4/2008 |
2008MB000085
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/21/2008 |
2008MB000087
|
|
050-405
|
|
08/22/2008
|
|
8/21/2008 |
2008MB000088
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
8/25/2008 |
2008MB000089
|
|
050-405
|
|
08/29/2008
|
|
8/28/2008 |
2008MB000092
|
|
050-405
|
|
09/02/2008
|
|
8/29/2008 |
2008MB000093
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
9/5/2008 |
2008MB000091
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/5/2008 |
2008MB000090
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/5/2008 |
2008MB000089FU
|
|
050-405
|
|
09/09/2008
|
|
9/8/2008 |
2008MB000090
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
9/17/2008 |
2008MB000095
|
|
050-405
|
|
09/29/2008
|
|
9/26/2008 |
2008MB000103
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
10/8/2008 |
2008MB000097
|
|
050-405
|
|
10/16/2008
|
|
10/9/2008 |
2008MB000098
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
10/20/2008 |
2008MB000099
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
10/20/2008 |
2008MB000100
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
10/20/2008 |
2008MB000101
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
10/20/2008 |
2008MB000105
|
|
050-405
|
|
10/23/2008
|
|
10/20/2008 |
2008MB000103
|
|
050-405
|
|
10/23/2008
|
|
10/20/2008 |
2008MB000102
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
10/21/2008 |
2008MB000106
|
|
050-405
|
|
10/30/2008
|
|
10/27/2008 |
2008MB000104
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
10/28/2008 |
2008MB000107
|
|
050-405
|
|
10/31/2008
|
|
10/29/2008 |
2008MB000108
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/2/2008 |
2008MB000109
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/7/2008 |
2008MB000110
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
11/7/2008 |
2008MB000097FU
|
|
050-405
|
|
11/13/2008
|
|
11/11/2008 |
2008MB000112
|
|
050-405
|
|
11/19/2008
|
|
11/14/2008 |
2008MB000113
|
|
050-045
|
|
12/16/2008
|
|
12/12/2008 |
2008MB000114
|
|
050-405
|
|
12/29/2008
|
|
12/23/2008 |
2008MB000115
|
|
050-405
|
|
12/29/2008
|
|
12/23/2008 |
2009MB000001
|
|
050-405
|
|
01/15/2009
|
|
1/12/2009 |
2009MB000004
|
|
050-405
|
|
02/02/2009
|
|
1/26/2009 |
2009MB000005
|
|
050-405
|
|
02/02/2009
|
|
1/26/2009 |
|
|
|
|
|
|
|
Report |
|
NDA |
|
|
|
Date of |
Number |
|
Number |
|
Date Submitted |
|
Report |
2009MB000006
|
|
050-405
|
|
02/02/2009
|
|
1/26/2009 |
2009MB000007
|
|
050-405
|
|
02/02/2009
|
|
1/26/2009 |
2009MB000008
|
|
050-405
|
|
02/02/2009
|
|
1/26/2009 |
2009MB000009
|
|
050-405
|
|
02/02/2009
|
|
1/26/2009 |
2009MB000003
|
|
050-405
|
|
02/02/2009
|
|
1/26/2009 |
2009MB000002
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
1/26/2009 |
2009MB000010
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/11/2009 |
2009MB000018
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
2/23/2009 |
2009MB000013
|
|
050-405
|
|
2/25/2009
|
|
2/23/2009 |
2009MB000014
|
|
050-405
|
|
2/24/2009
|
|
2/23/2009 |
2009MB0000016
|
|
050-813
|
|
03/3/2009
|
|
2/24/2009 |
2009MB000017
|
|
050-813
|
|
03/3/2009
|
|
2/24/2009 |
2009MB000015
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/3/2009 |
2009MB000013FU
|
|
050-405
|
|
03/05/2009
|
|
3/4/2009 |
2009MB000019
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
3/6/2009 |
2009MB000020-S
|
|
050-405
|
|
3/1/2009
|
|
3/13/2009 |
2009MB000025-S
|
|
050-405
|
|
3/04/2009
|
|
3/13/2009 |
2009MB000024
|
|
050-405
|
|
3/13/2009
|
|
3/13/2009 |
2009MB000022
|
|
050-405
|
|
3/13/2009
|
|
3/13/2009 |
2009MB000023
|
|
050-405
|
|
3/16/2009
|
|
3/16/2009 |
2009MB000026
|
|
050-405
|
|
3/20/2009
|
|
3/20/2009 |
2009MB000027
|
|
05-405
|
|
3/26/2009
|
|
3/26/2009 |
2009MB000031
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/3/2009 |
2009MB000029
|
|
050-405
|
|
4/6/2009
|
|
4/6/2009 |
2009MB000030
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/15/2009 |
2009MB000032
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
4/20/2009 |
2009MB000034
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
4/20/2009 |
2009MB000033
|
|
050-813
|
|
Reported in Annual Report -Periodic
|
|
4/21/2009 |
2009MB000036
|
|
050-405
|
|
04/27/2009
|
|
4/27/2009 |
2009MB000035
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/1/2009 |
2009MB000038
|
|
050-813
|
|
Reported in Annual Report -Periodic
|
|
5/15/2009 |
2009MB000037
|
|
050-406
|
|
Reported in Annual Report -Periodic
|
|
5/15/2009 |
2009MB000041
|
|
050-813
|
|
05/29/2009
|
|
5/27/2009 |
2009MB000039
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
5/28/2009 |
2009MB00041F/U
|
|
050-813
|
|
6/22/2009
|
|
6/16/2009 |
2009MB000043
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/25/2009 |
2009MB000042
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
6/25/2009 |
2009MB000041F/U-2
|
|
050-813
|
|
6/22/2009
|
|
6/29/2009 |
2009MB000047
|
|
050-813
|
|
Reported in Annual Report -Periodic
|
|
7/22/2009 |
2009MB000048
|
|
050-405
|
|
Reported in Annual Report -Periodic
|
|
7/30/2009 |
Keflex Capsules Reportable AEs from April 2009 through April 2010
050-405 KEFLEX CAPSULES
15-DAY REPORTABLE ADVERSE EXPERIENCE REPORTS
FOLLOW-UP REPORTS 13APR2009 — 12APR2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DATE SENT |
|
PRIMARY |
|
|
|
UN- |
|
COUNTRY OF |
|
ADVERSE REACTION |
|
SERIOUSNESS |
CASE ID |
|
TO FDA |
|
SOURCE |
|
SERIOUS |
|
EXPECTED |
|
ORIGIN |
|
TERM(S) |
|
CRITERIA |
2009MB000061 |
|
09/21/2009 |
|
LITERATURE |
|
YES |
|
YES |
|
PUERTO |
|
Methaemoglobinaemia |
|
HOS, LFT |
|
|
|
|
|
|
|
|
|
|
RICO |
|
(Methemoglobinemia) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intentional overdose |
|
HOS, LFT |
|
|
|
|
|
|
|
|
|
|
|
|
(Intentional overdose) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss of consciousness |
|
HOS, LFT |
|
|
|
|
|
|
|
|
|
|
|
|
(Unconscious) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cyanosis (Cyanosis) |
|
HOS, LFT |
|
|
|
|
|
|
|
|
|
|
|
|
Tachycardia
(Tachycardia) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dyspnoea (Increased |
|
HOS, LFT |
|
|
|
|
|
|
|
|
|
|
|
|
work of breathing) |
|
|
Serious Criteria: ANO-Congenital Anomaly, DIS-Disability, DTH-Death, HOS-Hospitalization,
INT-Intervention, LFT-Life Threatening, SIG-Medically Significant, OTH-Other
050-405 KEFLEX CAPSULES
NON SERIOUS ADVERSE EXPERIENCE REPORTS MiddleBrook Pharmaceuticals, Inc.*
INITIAL REPORTS 13APR2009 — 12APR2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PRIMARY |
|
DATE |
|
|
|
ADVERSE REACTION |
|
REPORTER |
|
|
CASE ID |
|
SOURCE |
|
RECEIVED |
|
UNEXPECTED |
|
TERM(S) |
|
TYPE |
|
PAGE No. |
2009MB000058
|
|
SPONTANEOUS
|
|
08/18/2009
|
|
YES
|
|
Drug exposure via breast milk (Drug exposure via breast milk)
|
|
Consumer |
|
|
2010MB000002
|
|
SPONTANEOUS
|
|
01/07/2010
|
|
NO
|
|
Drug ineffective (Lack of drug effect)
|
|
Consumer
|
|
# |
2010MB000007
|
|
SPONTANEOUS
|
|
02/08/2010
|
|
NO
|
|
Hypersensitivity (Allergic reaction)
|
|
Consumer
|
|
# |
2010MB000008
|
|
SPONTANEOUS
|
|
02/08/2010
|
|
NO
|
|
Rash (Rash) Dizziness (Dizziness)
|
|
Consumer
|
|
# |
2010MB000010
|
|
SPONTANEOUS
|
|
02/18/2010
|
|
YES
|
|
Drug hypersensitivity (Drug allergy) Abdominal pain upper
(stomach cramps)
|
|
Consumer |
|
|
2010MB000011
|
|
SPONTANEOUS
|
|
02/25/2010
|
|
NO
|
|
Hypersensitivity (Allergic reaction) Rash (Rash) Urticaria (Hives)
|
|
Consumer
|
|
# |
2010MB000012
|
|
SPONTANEOUS
|
|
03/02/2010
|
|
NO
|
|
Drug ineffective (Lack of drug effect)
|
|
Consumer
|
|
# |
2010MB000014
|
|
SPONTANEOUS
|
|
03/10/2010
|
|
YES
|
|
Palpitations (Palpitations) Supraventricular extrasystoles
(Premature atrial contraction) Condition aggravated (Condition
aggravated)
|
|
HCP |
|
|
2010MB000017
|
|
SPONTANEOUS
|
|
03/16/2010
|
|
NO
|
|
Drug ineffective (Lack of drug effect)
|
|
HCP
|
|
# |
2010MB000020
|
|
SPONTANEOUS
|
|
03/24/2010
|
|
YES
|
|
Nausea (Nausea) Flatulence (Gas) Condition aggravated (Condition
aggravated)
|
|
Consumer |
|
|
2010MB000021
|
|
SPONTANEOUS
|
|
03/29/2010
|
|
NO
|
|
Hypersensitivity (Allergic reaction)
|
|
Consumer
|
|
# |
|
|
|
* |
|
- International |
|
# |
|
- No Medwatch printed, case is non-serious and expected
|
050-405 KEFLEX CAPSULES
NON SERIOUS ADVERSE EXPERIENCE REPORTS MiddleBrook Pharmaceuticals, Inc.*
FOLLOW UP REPORTS 13APR2009 — 12APR2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PRIMARY |
|
DATE |
|
|
|
ADVERSE REACTION |
|
REPORTER |
|
|
CASE ID |
|
SOURCE |
|
RECEIVED |
|
UNEXPECTED |
|
TERM(S) |
|
TYPE |
|
PAGE NO. |
2009MB000035
|
|
SPONTANEOUS
|
|
04/14/2009
|
|
NO
|
|
Drug intolerance (Drug intolerance)
|
|
HCP
|
|
# |
2009MB000039
|
|
SPONTANEOUS
|
|
05/08/2009
|
|
NO
|
|
Dizziness (Dizzy)
|
|
Consumer
|
|
# |
2009MB000040
|
|
SPONTANEOUS
|
|
05/18/2009
|
|
NO
|
|
Drug ineffective (Lack of drug effect)
|
|
Consumer
|
|
# |
2009MB000042
|
|
SPONTANEOUS
|
|
06/08/2009
|
|
YES
|
|
Decreased appetite (Appetite suppression Fatigue (Tiredness)
|
|
Consumer |
|
|
2009MB000043
|
|
SPONTANEOUS
|
|
06/15/2009
|
|
YES
|
|
Headache (Headache) Blood pressure increased (Blood pressure increased)
|
|
Consumer |
|
|
2009MB000045
|
|
SPONTANEOUS
|
|
06/22/2009
|
|
NO
|
|
Hypersensitivity (Allergic reaction NOS)
|
|
Consumer
|
|
# |
2009MB000046
|
|
SPONTANEOUS
|
|
06/29/2009
|
|
NO
|
|
Drug ineffective (Lack of drug effect)
|
|
HCP
|
|
# |
2009MB000048
|
|
SPONTANEOUS
|
|
07/14/2009
|
|
YES
|
|
Pyrexia (High temperature)
|
|
Consumer |
|
|
2009MB000050
|
|
SPONTANEOUS
|
|
07/23/2009
|
|
NO
|
|
Hypersensitivity (Allergic reaction)
|
|
Consumer
|
|
# |
2009MB000051
|
|
SPONTANEOUS
|
|
07/27/2009
|
|
NO
|
|
Clostridial infection (Clostridium difficile infection)
|
|
Consumer
|
|
# |
2009MB000052
|
|
SPONTANEOUS
|
|
07/30/2009
|
|
YES
|
|
Asthenia (weakness) Mobility decreased (Mobility decreased) Fall
(Fall)
|
|
Consumer |
|
|
2009MB000053
|
|
SPONTANEOUS
|
|
08/10/2009
|
|
NO
|
|
Hypersensitivity (Allergic reaction NOS)
|
|
Consumer
|
|
# |
2009MB000054
|
|
SPONTANEOUS
|
|
08/11/2009
|
|
YES
|
|
Hair disorder (Hair disorder)
|
|
HCP |
|
|
050-405 KEFLEX CAPSULES
NON SERIOUS ADVERSE EXPERIENCE REPORTS MiddleBrook Pharmaceuticals, Inc.*
FOLLOW UP REPORTS 13APR2009 — 12APR2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PRIMARY |
|
DATE |
|
|
|
ADVERSE REACTION |
|
REPORTER |
|
|
CASE ID |
|
SOURCE |
|
RECEIVED |
|
UNEXPECTED |
|
TERM(S) |
|
TYPE |
|
PAGE NO. |
|
|
|
|
|
|
|
|
Rash (Rash) |
|
|
|
|
2009MB000064
|
|
SPONTANEOUS
|
|
09/22/2009
|
|
YES
|
|
Blood glucose increased (Blood sugar increased)
|
|
Consumer |
|
|
2009MB000066
|
|
SPONTANEOUS
|
|
10/06/2009
|
|
NO
|
|
Hypersensitivity (Allergic reaction)
|
|
Consumer
|
|
# |
2009MB000068
|
|
SPONTANEOUS
|
|
10/16/2009
|
|
NO
|
|
Aspartate aminotransferase increased (AST increased)
|
|
HCP
|
|
# |
2009MB000069
|
|
SPONTANEOUS
|
|
10/26/2009
|
|
NO
|
|
Drug Hypersensitivity (Drug allergy)
|
|
Consumer
|
|
# |
2009MB000071
|
|
SPONTANEOUS
|
|
11/06/2009
|
|
NO
|
|
Drug ineffective (Lack of drug effect)
|
|
Consumer
|
|
# |
2009MB000076
|
|
SPONTANEOUS
|
|
11/30/2009
|
|
YES
|
|
Palpitations (Heart racing)
|
|
Consumer |
|
|
2010MB000001
|
|
SPONTANEOUS
|
|
01/04/2010
|
|
NO
|
|
Drug Hypersensitivity (Drug allergy)
|
|
Consumer
|
|
# |
050-405 KEFLEX CAPSULES
15-DAY REPORTABLE ADVERSE EXPERIENCE REPORTS
INITIAL REPORTS 13 APR 2009 — 12APR2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DATE SENT |
|
PRIMARY |
|
|
|
UN- |
|
COUNTRY OF |
|
ADVERSE REACTION |
|
SERIOUSNESS |
CASE ID |
|
TO FDA |
|
SOURCE |
|
SERIOUS |
|
EXPECTED |
|
ORIGIN |
|
TERM(S) |
|
CRITERIA |
2009MB000061
|
|
09/04/2009
|
|
LITERATURE
|
|
YES
|
|
YES
|
|
PUERTO RICO
|
|
Methaemoglobinaemia
(Methemoglobinemia)
|
|
LFT |
|
|
|
|
|
|
|
|
|
|
|
|
Overdose (Overdose)
|
|
LFT |
2009MB000067
|
|
* 10/23/2009
|
|
LITERATURE
|
|
YES
|
|
YES
|
|
UNITED KINGDOM
|
|
Photosensitivity reaction
(Photosensitive rash)
|
|
HOS |
2009MB000078
|
|
12/28/2009
|
|
LITERATURE
|
|
YES
|
|
YES
|
|
UNITED STATES
|
|
Liver injury (Liver injury)
|
|
SIG |
2010MB000006
|
|
02/15/2010
|
|
SPONTANEOUS
|
|
YES
|
|
YES
|
|
UNITED STATES
|
|
Haemoglobin decreased
(Hemoglobin decreased)
Rectal haemorrhage (Rectal
bleeding) Vomiting
(Vomiting)
|
|
SIG |
Serious Criteria: ANO-Congenital Anomaly, DIS-Disability, DTH-Death, HOS-Hospitalization,
INT-Intervention, LFT-Life Threatening, SIG-Medically Significant, OTH-Other
050-405 KEFLEX CAPSULES
15-DAY REPORTABLE ADVERSE EXPERIENCE REPORTS
FOLLOW-UP REPORTS 13 APR 2009 — 12APR2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DATE SENT |
|
PRIMARY |
|
|
|
UN- |
|
COUNTRY OF |
|
ADVERSE REACTION |
|
SERIOUSNESS |
CASE ID |
|
TO FDA |
|
SOURCE |
|
SERIOUS |
|
EXPECTED |
|
ORIGIN |
|
TERM(S) |
|
CRITERIA |
2009MB000061 |
|
09/21/2009 |
|
LITERATURE |
|
YES |
|
YES |
|
PUERTO |
|
Methaemoglobinaemia |
|
HOS, LFT |
|
|
|
|
|
|
|
|
|
|
RICO |
|
(Methemoglobinemia) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intentional overdose |
|
HOS, LFT |
|
|
|
|
|
|
|
|
|
|
|
|
(Intentional overdose) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss of consciousness |
|
HOS, LFT |
|
|
|
|
|
|
|
|
|
|
|
|
(Unconscious) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cyanosis (Cyanosis) |
|
HOS, LFT |
|
|
|
|
|
|
|
|
|
|
|
|
Tachycardia
(Tachycardia) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dyspnoea (Increased |
|
HOS, LFT |
|
|
|
|
|
|
|
|
|
|
|
|
work of breathing) |
|
|
Serious Criteria: ANO-Congenital Anomaly, DIS-Disability, DTH-Death, HOS-Hospitalization,
INT-Intervention, LFT-Life Threatening, SIG-Medically Significant, OTH-Other
MOXATAG ONLY — Need to add 7-2009 through Present SAEs from PPD
|
|
|
|
|
|
|
|
|
|
Start Time : 03-MAY-2010 10:08:59
|
|
|
|
Database : |
|
|
Oracle AERS
|
|
AERS45P |
User ID : SHALEEBA |
|
|
|
|
|
|
|
|
Queue ID: 11261 |
Case List Details
|
|
|
Report Parameter |
|
Value |
Report Format?
|
|
PDF |
Case List Name?
|
|
ACTIVE |
Include Case List?
|
|
Y |
Include Query Details?
|
|
N |
Report Title?
|
|
Case List Details |
|
|
|
|
|
|
|
Cases ID List |
2009MB000047
|
|
2009MB000049
|
|
2009MB000057
|
|
2009MB000059 |
2009MB000062
|
|
2009MB000065
|
|
2009MB000070
|
|
2009MB000072 |
2009MB000073
|
|
2009MB000074
|
|
2009MB000075
|
|
2009MB000077 |
2010MB000003
|
|
2010MB000005
|
|
2010MB000009
|
|
2010MB000013 |
2010MB000015
|
|
2010MB000016
|
|
2010MB000018
|
|
2010MB000019 |
2010MB000022
|
|
2010MB000023
|
|
2010MB000024
|
|
2010MB000025 |
2010MB000026
|
|
2010MB000027
|
|
2010MB000028 |
|
|
Schedule 1.2(h)
Prepaid Items and Deposits
The deposit held by Cardinal pursuant to the co-pay voucher program for the Products.
Any other prepaid items or deposits of the Company, except prepaid fees paid to the FDA and prepaid
items or deposits related to Assumed Liabilities.
Schedule 1.2(l)
Excluded Assets
Accounts receivable
Excluded Inventory
Excluded Contracts
All IT systems
Phone systems
Schedule 1.3(h)
Purchaser Cure Amounts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Date of |
|
|
Invoice |
|
|
|
|
|
|
Exchange |
|
|
|
|
Vendor |
|
|
Description |
|
Invoice |
|
|
Invoice |
|
|
Amount |
|
|
Currency |
|
|
Rate |
|
|
Amount |
|
Almac |
|
Sample Packaging Components |
|
|
S1501280 |
|
|
|
01/27/10 |
|
|
£ |
116,551.62 |
|
|
GBP |
|
$ |
1.53 |
|
|
$ |
178,543.00 |
|
Stada |
|
Moxatag Tablet batch —
Alternate API |
|
|
92007119 |
|
|
|
12/31/09 |
|
|
€ |
116,260.92 |
|
|
EUR |
|
$ |
1.37 |
|
|
$ |
158,848.00 |
|
Stada |
|
Moxatag Samples Batch —
Bulk Tablets |
|
|
PO003924 |
|
|
|
06/15/10 |
|
|
€ |
116,325.00 |
|
|
EUR |
|
$ |
1.37 |
|
|
$ |
159,365.25 |
|
Stada |
|
Moxatag Samples Batch —
Bulk MGT Fee |
|
|
PO003924 |
|
|
|
06/15/10 |
|
|
€ |
8,250.00 |
|
|
EUR |
|
$ |
1.37 |
|
|
$ |
11,272.03 |
|
Stada |
|
Moxatag Samples Batch —
Packaging |
|
|
PO003927 |
|
|
|
06/15/10 |
|
|
£ |
181,500.00 |
|
|
GBP |
|
$ |
1.53 |
|
|
$ |
277,695.00 |
|
Stada |
|
MoxaPak - 3 Batches (Pkg
Lab & Mat’ls) |
|
|
PO033110 |
|
|
|
08/01/10 |
|
|
€ |
161,280.00 |
|
|
EUR |
|
$ |
1.37 |
|
|
$ |
220,357.84 |
|
Patheon/Ceph |
|
Product Stability — Keflex |
|
|
30363 |
|
|
|
11/30/09 |
|
|
$ |
11,791.88 |
|
|
USD |
|
|
N/A |
|
|
$ |
11,791.88 |
|
Patheon/Ceph |
|
Keflex 750mg product |
|
|
60202764 |
|
|
|
01/30/09 |
|
|
$ |
155,221.96 |
|
|
USD |
|
|
N/A |
|
|
$ |
155,221.96 |
|
Patheon/Ceph |
|
Keflex 250mg product |
|
|
60202775 |
|
|
|
01/30/09 |
|
|
$ |
6,679.11 |
|
|
USD |
|
|
N/A |
|
|
$ |
6,679.11 |
|
Patheon/Ceph |
|
Keflex 750mg product |
|
|
60202776 |
|
|
|
01/30/09 |
|
|
$ |
17,122.17 |
|
|
USD |
|
|
N/A |
|
|
$ |
17,122.17 |
|
Patheon/Ceph |
|
Keflex 500mg product |
|
|
60202778 |
|
|
|
01/30/09 |
|
|
$ |
72,589.86 |
|
|
USD |
|
|
N/A |
|
|
$ |
72,589.86 |
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,269,486.10 |
|
Schedule 1.3(i)
Assumed Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Date of |
|
|
Invoice |
|
|
|
|
|
|
Exchange |
|
|
|
|
Vendor |
|
|
Description |
|
Invoice |
|
|
Invoice |
|
|
Amount |
|
|
Currency |
|
|
Rate |
|
|
Amount |
|
Sandoz |
|
Keflex Product
(250mg, 500mg, &
750mg) |
|
|
PO022610 |
|
|
|
08/01/10 |
|
|
€ |
165,692.04 |
|
|
EUR |
|
$ |
1.37 |
|
|
$ |
226,386.04 |
|
Physicians’ Desk |
|
2010 Physicians |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reference |
|
Desk Reference
Listing |
|
|
M042127 |
|
|
|
12/07/09 |
|
|
$ |
47,592.45 |
|
|
USD |
|
|
N/A |
|
|
$ |
47,592.45 |
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
273,978.49 |
|
Schedule 1.4(o)
Excluded Liabilities
All Liabilities under Excluded Contracts
All Liabilities other than Assumed Liabilities
Schedule 5.3(c)(i)(A)
Identified Persons
Sandoz GmbH or any affiliate thereof
Any party to an Assumed Contract that is terminated or expires prior to Closing
Schedule 7.5(a)(ii)
Best Price; AMP
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010-Q1 |
|
|
|
|
|
|
|
Unit of |
|
|
AMP |
|
|
Best |
|
Product |
|
|
|
|
|
Measure |
|
|
per Each |
|
|
Price |
|
Keflex 250mg 100 capsules |
|
|
0112-96 |
|
|
cap |
|
|
2.265212 |
|
|
|
2.013466 |
|
Keflex 250mg 20 capsules |
|
|
0112-97 |
|
|
cap |
|
|
2.265212 |
|
|
|
2.013466 |
|
Keflex 500mg 100 Capsules |
|
|
0113-96 |
|
|
cap |
|
|
4.391004 |
|
|
|
3.957590 |
|
Keflex 500mg 20 capsules |
|
|
0113-97 |
|
|
cap |
|
|
4.391004 |
|
|
|
3.957590 |
|
Keflex 750mg 50 capsules |
|
|
0115-40 |
|
|
cap |
|
|
2.356246 |
|
|
|
2.274636 |
|
Moxatag 775mg 30 Tablets |
|
|
0142-03 |
|
|
tab |
|
|
7.036931 |
|
|
|
6.375000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009-Q4 |
|
|
|
|
|
|
|
Unit of |
|
|
AMP |
|
|
Best |
|
Product |
|
|
|
|
|
Measure |
|
|
per Each |
|
|
Price |
|
Keflex 250mg 100 capsules |
|
|
0112-96 |
|
|
cap |
|
|
2.274584 |
|
|
|
2.013466 |
|
Keflex 250mg 20 capsules |
|
|
0112-97 |
|
|
cap |
|
|
2.274584 |
|
|
|
2.013466 |
|
Keflex 500mg 100 Capsules |
|
|
0113-96 |
|
|
cap |
|
|
4.260620 |
|
|
|
3.957590 |
|
Keflex 500mg 20 capsules |
|
|
0113-97 |
|
|
cap |
|
|
4.260620 |
|
|
|
3.957590 |
|
Keflex 750mg 50 capsules |
|
|
0115-40 |
|
|
cap |
|
|
2.349147 |
|
|
|
2.274636 |
|
Moxatag 775mg 30 Tablets |
|
|
0142-03 |
|
|
tab |
|
|
6.915244 |
|
|
|
6.232500 |
|