KING PHARMACEUTICALS,
INC.
ACTAVIS ELIZABETH, L.L.C.
dated as of December 17,
2008
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1
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Defined
Terms
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1
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Construction of
Certain Terms and Phrases.
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12
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Article II. Purchase and Sale of
Assets
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12
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Purchase and
Sale of Assets
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12
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Article III. Assumption of
Liabilities
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13
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Assumption of
Assumed Liabilities
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13
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Excluded
Liabilities
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13
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Article IV. Purchase Price and
Payment
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13
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Purchase
Price
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13
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Inventory
Payment
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14
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Allocation of
Purchase Price
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14
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Payment of
Sales, Use and Other Taxes
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15
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Statements and
Audit Rights
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15
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16
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Time and
Place
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16
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Deliveries at
Closing
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16
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Article VI. Representations and
Warranties of Seller
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16
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Organization,
Etc.
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17
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Authority of
Seller
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17
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Consents and
Approvals
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17
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Non-Contravention
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Solvency
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Title
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18
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Litigation
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18
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Purchased
Assets
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19
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Regulatory
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Brokers
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20
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No Other
Representations and Warranties
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20
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Article VII. Representations and
Warranties of Buyer
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20
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Corporate
Organization
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20
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Authority of
Buyer
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20
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i
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Consents and
Approvals
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21
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Non-Contravention
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21
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Solvency
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21
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Brokers
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21
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No Other
Representations and Warranties
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22
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Article VIII. Covenants of the
Parties
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22
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Reasonable Best
Efforts
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22
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Cooperation and
Transition
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22
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Public
Announcements
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22
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Bulk
Sales
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23
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Corporate
Names
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23
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Regulatory
Matters
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23
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Product
Returns
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24
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Further
Assurances
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24
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Government
Price Reporting Obligations
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25
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Kadian Patent
License
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25
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DEA
Notification
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28
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Representations
True
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28
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Confidentiality; Non-Public Purchased
Assets
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28
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Filings
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29
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Recalls.
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29
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Rebates and
Coupons
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30
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Chargeback and
Rebate Period
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30
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Chargebacks
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31
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GPO
Administration Fees and IFF Payments
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31
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Manufacturing
Agreements
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32
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Sale of
Product
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32
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Delivery of
Inventory
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32
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Assumed
Contracts
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32
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Regulatory
Actions
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32
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Article IX. Conditions to the
Obligations of Seller
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33
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Alpharma
Acquisition
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33
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No Legal
Prohibition
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33
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Article X. Conditions to the Obligations
of Buyer
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33
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No Legal
Prohibition
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33
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Alpharma
Acquisition
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Article XI. Additional Post-Closing
Covenants
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Access to
Information
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Article XII.
Indemnification
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34
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3
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Survival of
Representations and Warranties
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34
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Indemnification
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Limitations
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37
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Remedies
Exclusive
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37
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Article XIII. Termination and
Abandonment
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37
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Methods of
Termination
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37
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Procedure upon
and Effect of Termination
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38
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Article XIV.
Miscellaneous
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38
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Notices
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38
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Entire
Agreement
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39
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Waiver
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40
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Amendment
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40
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Third Party
Beneficiaries
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40
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Assignment;
Binding Effect
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40
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Headings
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40
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Severability
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40
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Governing
Law
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41
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Consent to
Jurisdiction and Forum Selection
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41
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Expenses
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41
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Counterparts
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42
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iii
This Asset
Purchase Agreement (this “ Agreement ”) is made
and entered into as of December 17, 2008 (the “
Execution Date ”), by and between Actavis Elizabeth,
L.L.C., a Delaware limited liability company (“ Buyer
”), and King Pharmaceuticals, Inc., a Tennessee corporation
(“ King ”).
WHEREAS, King is
party to an Agreement and Plan of Merger, dated as of
November 23, 2008, by and among King, Albert Acquisition Corp.
and Alpharma Inc. (the “ Merger Agreement ”)
pursuant to which, subject to the terms and conditions set forth
therein, King has agreed to acquire Alpharma Inc. (“
Alpharma ”);
WHEREAS, Alpharma
is engaged in the business of selling in the Territory the Product
that contains morphine sulfate as its sole active ingredient that
is approved for distribution as of the Closing Date in the
Territory under the Regulatory Approval (the “
Business ”);
WHEREAS, effective
upon the acquisition by King of Alpharma pursuant to the Merger
Agreement, King desires to sell to Buyer the Product and certain
related assets, and Buyer desires to purchase the Product and such
assets from Seller and to assume certain related obligations;
and
WHEREAS, this
Agreement and the consummation of the transactions contemplated
hereby are not in consideration of, or intended to induce or
encourage, the settlement or other resolution of the litigation
captioned King Pharmaceuticals, Inc., King Pharmaceuticals Research
and Development, Inc., Elan Corporation plc and Elan Pharma
International Ltd. v. Actavis, Inc. and Actavis Elizabeth LLC,
Civil Action No. 07-CV-5041 (JMA, SDW) (DNJ).
NOW, THEREFORE, in
consideration of the premises and the mutual covenants and promises
contained herein, and for other good and valuable consideration,
the receipt and sufficiency of which hereby are acknowledged, the
Parties agree as follows:
Section 1.01 Defined Terms
As used in this
Agreement, the following defined terms have the meanings described
below:
(a) “
Affiliate ” means, with respect to any Person, any
other Person that, directly or indirectly, through one or more
intermediaries controls, is controlled by, or is under common
control with, such Person. For purposes of this definition,
“control” means the
possession,
direct or indirect, of the power to direct or cause the direction
of the management and policies of a Person, whether through
ownership of voting securities or general partnership or managing
member interests, by contract or otherwise. Without limiting the
generality of the foregoing, a Person shall be deemed to control
any other Person in which it owns, directly or indirectly, a
majority of the ownership interests.
(b) “
AG Distributor ” shall mean a third party
pharmaceutical company that is taking on the role of distributing
Authorized Generic Versions to trade customers (e.g. wholesalers,
retail chains, managed care organizations, government agencies,
pharmacy benefit managers, etc.), which third party pharmaceutical
company shall exclude ordinary trade customers such as
wholesalers.
(c) “
Aggregate Inventory Amount ” has the meaning set forth
in Section 4.02(b).
(d) “
Aggregate Wholesaler Amount ” has the meaning set
forth in Section 8.17(a).
(e) “
Aggregate Wholesale/Retail Amount ” has the meaning
set forth in Section 8.17(b).
(f) “
Agreement ” has the meaning set forth in the Preamble
to this Agreement.
(g) “
Alpharma ” has the meaning set forth in the Recitals
to this Agreement.
(h) “
Alpharma Subsidiary ” means each subsidiary of
Alpharma owning or controlling assets or having liabilities
relating to the Business.
(i) “
API ” means active pharmaceutical
ingredient.
(j) “
Assets and Properties ” of any Person means all assets
and properties of any kind, nature, character and description
(whether real, personal or mixed, whether tangible or intangible,
whether absolute, accrued, contingent, fixed or otherwise and
wherever situated), including the goodwill related thereto,
operated, owned or leased by such Person, including cash, cash
equivalents, accounts and notes receivable, chattel paper,
documents, instruments, general intangibles, real estate,
equipment, inventory, goods and intellectual property.
(k) “
Assumed Contract ” means (i) each Contract
relating to the Product, as in effect on the Closing Date that is
set forth in Section 1.01(k) of the Seller’s Disclosure
Schedule, and (ii) each Contract (or any portion thereof) that
is assumed by the Buyer after the Closing Date pursuant to
Section 8.23, excluding any Excluded Rights under any such
Contract (or portion thereof).
(l) “
Assumed Liabilities ” means (i) all Liabilities
and obligations that Buyer has expressly assumed or agreed to
assume or perform under this Agreement, (ii) all Liabilities
and obligations under or pursuant to the Assumed Contracts arising
after the Closing, other than the Liabilities and obligations
listed in items (ii)-(iv) of the Excluded Liabilities,
(iii)
2
any obligations
of Seller under an Assumed Contract to deliver Product following
the Closing under purchase orders of Persons entered into prior to
the Closing in the ordinary course of business for delivery of
Product within thirty (30) days of the Closing Date and for
which Buyer shall receive payment, (iv) all Liabilities and
obligations to pay Rebates attributable to Product bearing any of
Buyer’s NDC numbers, (v) all Liabilities and obligations
to pay GPO Administration Fees and IFF payments attributable to
Product bearing any of Buyer’s NDC numbers, (vi) all
Liabilities and obligations to pay Chargebacks that are submitted
to Buyer, Seller, or their respective Affiliates, with respect to
Product bearing any of Buyer’s NDC numbers, (vii) all
Liabilities and obligations relating to recalls or product
liability claims or threatened claims or injuries caused by Product
sold by Buyer after the Closing, except to the extent that such
Product was included in Inventory and was defective when delivered
by Seller to Buyer hereunder, (viii) Seller’s
obligations under the Federal Supply Schedule to supply the Product
at the prices set forth in the Federal Supply Schedule after the
Closing for the period required by applicable Law,
(ix) Seller’s obligations under Section 340B of the
Public Health Services Act to sell Product at the prices required
by applicable Law with respect to Product sold after the Closing
Date, and (x) all other Liabilities and obligations that
(A) arise out of or are related to the Purchased Assets
(including the Regulatory Approval), the Product or the ownership,
operation or conduct of the Business by or on behalf of Buyer, its
Affiliates or (sub)licensees, or their respective successors or
assigns, (B) arise after the Closing, and (C) are not
otherwise expressly excluded under this definition.
(m) “
Authorized Generic Version ” means any Product that is
distributed under no trademark or under a trademark other than
Kadian ®
.
(n) “
Books and Records ” means all files, documents,
instruments, papers, books and records (scientific, developmental,
distribution, marketing, financial or other) owned by Seller and
relating to the Product or the Business in the Territory, including
any pricing lists, customer lists, vendor lists, financial data
(including sales histories, sales force call activities and market
studies), Regulatory Documentation, clinical data, safety data,
research and testing data and pharmacology and toxicology data,
validation documents and data, quality control histories,
litigation, adverse claims or demands, investigation information or
files, trademark registration certificates, trademark renewal
certificates, and other documentation relating to the Purchased
Assets, the Product or the Regulatory Approval, but excluding any
such items (i) to the extent that any applicable Law prohibits
their transfer, (ii) that were specifically prepared by Seller
for the negotiation of this Agreement, and (iii) to the extent
such items are included in the definition of “Marketing
Materials”. The Parties acknowledge and agree that to the
extent that any such Books and Records contain information that
relates to any product other than the Product or to any business or
operations of Seller other than the Business, such Books and
Records may be copies and in any event shall be redacted to delete
such information.
(o) “
Business ” has the meaning set forth in the Recitals
to this Agreement.
(p) “
Business Day ” means a calendar day other than
Saturday, Sunday or any other calendar day on which banks located
in New York are authorized or obligated to close.
(q) “
Buyer ” has the meaning set forth in the Preamble to
this Agreement.
3
(r) “
Calendar Quarter ” means each successive period of
three consecutive calendar months commencing on January 1,
April 1, July 1 and October 1.
(s) “
Chargeback ” means a credit, chargeback,
reimbursement, purchase discount or other payment to any
pharmaceutical wholesaler or distributor in connection with the
sale of a Product in the United States by such wholesaler or
distributor to a customer at a discount price pursuant to a
Contract between such customer and Seller or Buyer or pursuant to
the Federal Supply Schedule or Section 340B of the Public
Health Service Act, 42 U.S.C. Section 201 et. seq.
.
(t) “
Chargeback Period ” has the meaning set forth in
Section 8.17(a).
(u) “
Closing ” has the meaning set forth in
Section 5.01.
(v) “
Closing Date ” means the date that the Closing
actually occurs as provided in Section 5.01.
(w) “
Consultant ” has the meaning set forth in
Section 8.17(a).
(x) “
Contract ” means any and all legally binding
commitments, contracts, purchase orders, leases, licenses, security
agreements or other agreements, whether written or oral, including
any amendments, supplements or modifications thereto.
(y) “
Corporate Names ” has the meaning set forth in
Section 8.05(a).
(z) “
Costs of Goods Sold ” means, with respect to any
period, Buyer’s actual direct costs to manufacture, or
purchase from a third party, the Product sold in the Territory
during such period, excluding the Purchase Price.
(aa) “
Coupons ” means any coupons, vouchers, co-pay cards or
similar promotional incentives distributed by Alpharma or any
subsidiary of Alpharma prior to the Closing Date pursuant to which
Alpharma or such subsidiary of Alpharma is obligated to reimburse
or pay a portion of the purchase price of the Product directly or
indirectly to an eligible patient.
(bb) “
Daily Sales Amount ” has the meaning set forth in
Section 8.17(a).
(cc) “
Daily Utilization Amount ” has the meaning set forth
in Section 8.17(b).
(dd) “
Damages ” has the meaning set forth in
Section 12.02(a).
(ee) “
DEA ” means the United States Drug Enforcement
Administration, and any successor agency thereto.
(ff) “
Detail ” means a face-to-face contact in which a Buyer
sales representative makes a presentation, including selling
message and features and benefits of the Product, to a medical
professional with prescribing authority.
4
(gg) “
Direct Cost ” means the cost of direct labor and
direct materials used to provide the relevant assistance or
service.
(hh) “
Embeda NDA ” means New Drug Application 22-321 filed
pursuant to the Federal Food, Drug, and Cosmetic Act and applicable
FDA rules and regulations for marketing authorization of the
pharmaceutical product containing morphine sulfate as an active
ingredient, known as Embeda, within the United States (including
all additions, amendments, supplements, extensions and
modifications thereto and the official regulatory files relating
thereto).
(ii) “
Encumbrance ” means any lien, pledge, hypothecation,
charge, mortgage, security interest, encumbrance, claim, option,
right of first refusal, preemptive right, community property
interest or restriction of any nature (including any restriction on
any other asset and any restriction on the possession or exercise
of any attribute or ownership of any asset).
(jj) “
Excluded Assets ” means all Assets and Properties of
Seller, including the Licensed Intellectual Property, except the
Purchased Assets.
(kk) “
Excluded Liabilities ” means all Liabilities of Seller
except the Assumed Liabilities, including (i) all Liabilities
and obligations under any Contract other than the Assumed
Contracts, (ii) all Liabilities and obligations of Seller to
pay Rebates and Coupons pursuant to Section 8.16,
(iii) all Liabilities and obligations of Seller to pay GPO
Administration Fees and IFF payments pursuant to Section 8.19,
(iv) all Liabilities and obligations of Seller to pay
Chargebacks pursuant to Section 8.18, (v) all Liabilities
of Seller for Taxes with respect to any taxable period, and all
Liabilities for Taxes relating or attributable to the Product, the
Business, the Purchased Assets or the sale, operating or use of any
of the foregoing with respect to any taxable period or portion
thereof ending on or prior to the Closing Date, with any property,
ad valorem or similar Taxes allocated to any period that includes
but does not end on the Closing Date on a per diem basis and
(vi) any and all Liabilities of Seller accruing or arising
prior to the Closing, including Liabilities with respect to any
claim or action asserted after the Closing to the extent the
conduct giving rise to such claim or action occurred prior to the
Closing.
(ll) “
Excluded Rights ” means, with respect to any Assumed
Contract, any rights of any Seller Indemnified Party to seek and
obtain defense and indemnification thereunder from any indemnifying
party pursuant to the terms and conditions of the applicable
Assumed Contract based on any Damages incurred by any Seller
Indemnified Party, whether prior to, on or after the Closing Date,
to the extent that such Damages (i) are attributable to
occurrences and circumstances arising prior to the Closing, and
(ii) are otherwise subject, prior to the Closing, to an
obligation of defense or indemnity by any indemnifying
party.
(mm) “
Execution Date ” has the meaning set forth in the
Preamble to this Agreement.
(nn) “
FDA ” means the United States Food and Drug
Administration and any successor agency thereto.
5
(oo) “
GAAP ” means generally accepted accounting principles,
consistently applied, as applied in the United States.
(pp) “
Generic Product ” means a drug product containing
morphine sulfate as its sole active ingredient that refers to the
Licensed Product as the reference-listed drug in an Abbreviated New
Drug Application or pursuant to an application under 21 U.S.C.
§ 355(b)(2).
(qq) “
Governmental or Regulatory Authority ” means any
court, tribunal, arbitrator, authority, agency, commission,
official or other instrumentality of the United States or other
country, or any supra-national organization, state, county, city or
other political subdivision.
(rr) “
GPO Administration Fee ” means any administration,
service or similar fee paid to a group purchasing organization,
buying group or similar organization pursuant to a Contract between
Seller or Buyer and such group purchasing organization, buying
group or similar organization relating to the sale of Product to
members of or participants in such group purchasing organization,
buying group or similar organization.
(ss) “
Gross Profit ” means, with respect to any period,
(i) Net Sales for such period, less (ii) Cost of Goods
Sold for such period, less (iii) an amount equal to five
percent (5%) of Net Sales for such period (as an allowance for
handling and distribution costs).
(tt) “
IFF ” means the industrial funding fee payable to the
United States Department of Veterans Affairs in connection with the
sale of the Product to the United States Department of Veterans
Affairs under the Federal Supply Schedule, as in effect from time
to time.
(uu) “
Indemnification Claim Notice ” has the meaning set
forth in Section 12.02(c).
(vv) “
Indemnified Party ” has the meaning set forth in
Section 12.02(c).
(ww) “
Indemnifying Party ” has the meaning set forth in
Section 12.02(c).
(xx) “
Inventory ” means all inventory in whole lots of
Product owned as of the Closing by Seller in finished, packaged
form, whether held at a location or facility of Seller (or of any
other Person on behalf of Seller) in the Territory, or in transit
within the Territory to or from Seller (or any such other
Person).
(yy) “
Kadian ” means pharmaceutical product
(i) approved for distribution under the Regulatory Approval in
the Territory in any dosage or form, whether or not distributed
under the Trademark Kadian ® or (ii) otherwise marketed or sold by
Seller in the Territory under the Trademark Kadian
® as of the Closing Date.
(zz) “
Kadian Patents ” means United States patent number
5,202,128, United States patent number 5,378,474, and United States
patent number 5,330,766, and any continuations,
continuations-in-part, divisionals, reexaminations, reissues and
extensions thereof.
6
(aaa) “
Knowledge of King ” means the actual knowledge of
those employees who hold the position of vice president or are more
senior at King that were engaged in the diligence of acquisition of
Alpharma by King, including but not limited to, the following
people, without any duty to conduct an investigation: Eric Carter,
Ken Touw, Brad Knoll, Chris McClendon, James Elrod and Mary
Flipse.
(bbb) “
Law ” means any federal, state or local law, statute
or ordinance, or any rule, regulation, or published guidelines or
pronouncements promulgated by any Governmental or Regulatory
Authority.
(ccc) “
Liability ” means any debt, liability, losses,
damages, cost, expenses and obligations of every kind (whether
fixed or contingent, known or unknown, asserted or unasserted,
absolute or contingent, accrued or unaccrued, liquidated or
unliquidated, or due or to become due), including any liability for
Taxes.
(ddd) “
License Term ” means the period commencing on the
Closing Date and ending on the earlier of (i) the date of
expiration of the last to expire of the Licensed Patents and
(ii) the date on which a court enters a final decision from
which no appeal has been or can be taken holding that all claims of
the Licensed Patents that would otherwise be infringed by the
making, having made, using, selling, offering for sale or
importation of any Licensed Product or Generic Product are
unenforceable or invalid.
(eee) “
Licensed Intellectual Property ” means all Product
Patents (including the Kadian Patents), unpatented inventions,
know-how, trade secrets, technical data (including the Seller
Data), trade dress, and package designs owned or controlled by
Sellers and their Affiliates that are not exclusively related to
the Product and that would be infringed or violated by the making,
having made, using, selling, offering for sale or importation of
the Licensed Product in the Territory.
(fff) “
Licensed Patents ” means United States patent number
5,202,128 and United States patent number 5,378,474, and any
continuations, continuations-in-part, divisionals, reexaminations,
reissues and extensions thereof.
(ggg) “
Licensed Product ” means the Product in the dosage
strengths and formulations approved for distribution in the
Territory pursuant to the Regulatory Approval as of the Closing
Date and manufactured in accordance with the manufacturing process
used as of the Closing Date, including, after the Closing Date, any
Minor Changes.
(hhh) “
Marketing Materials ” means all market research,
marketing plans and strategies, media plans, advertising, form
letters, sales force training materials, advertising, promotional
and marketing data and materials (including competitor information,
product data, market intelligence reports and marketing and sales
statistical programs), advertising and promotional materials and
literature, mailing lists, sales data and detailing reports,
reimbursement data, customer information (including customer sales
information, sales forecasting models, medical educational
materials, website content and advertising and display materials
and speakers lists), packaging artwork and television masters, in
each case (i) owned by Seller and used exclusively in
connection with the marketing, advertising and promotion
of
7
the Product in
the Territory that Seller, in its sole discretion, determines to
transfer to Buyer and (ii) to the extent that Seller is able
to share such materials with Buyer without violation of any third
party agreement; provided that “Marketing
Materials” shall exclude the labeling of the Product, which
shall be deemed part of the Regulatory Approval.
(iii) “
Material Adverse Effect ” means an effect, condition
or change that individually or in the aggregate is materially
adverse to the Purchased Assets taken as a whole or the business,
results of operations, or financial condition of the Business taken
as a whole, other than changes in general economic or market
conditions or changes or developments generally affecting the
pharmaceutical industry.
(jjj) “
Merger Agreement ” has the meaning set forth in the
Recitals to this Agreement.
(kkk) “
Minor Changes ” means changes to the Licensed Product
that would not cause the manufacture, use or sale of the Licensed
Product to fall within the Licensed Intellectual Property owned or
controlled by Seller or its Affiliates after the Closing Date,
other than the Kadian Patents.
(lll) “
NDC ” means the unique identifying number assigned to
a drug product, including the labeler code, product code and
package code, in connection with the drug listing requirements of
Section 510(j) of the Federal Food, Drug, and Cosmetic Act and
applicable FDA rules and regulations.
(mmm) “
Net Sales ” means, with respect to any period, the
gross sales recorded by Buyer and its Affiliates or sublicensees,
on its books and records, in accordance with GAAP, for sales of the
Product to third parties in the Territory during such period, less
(if not already deducted or reflected in the amount recorded and to
the extent actually allowed by Buyer) (i) trade and quantity
discounts, Rebates, Chargebacks paid by Buyer, GPO Administrative
Fees paid by Buyer, and IFF paid by Buyer and other ordinary course
administrative or promotional fees, (ii) repayments, credits
and allowances to customers on account of ordinary course
promotional allowances, rejection, withdrawal, recall, or return of
the Product or on account of retroactive price reductions affecting
the Product, and (iii) customary cash discounts (“
fast pay ”), which, in each case ((i), (ii), and
(iii)), for the avoidance of doubt, shall be paid in accordance
with GAAP and shall not include write-offs, bad debts or freight,
insurance and handling costs, Taxes and expenses for all activities
related to the distribution of the Product incurred by Buyer. Net
Sales with respect to sales of the Product that are not made on an
arm’s length basis or that are made for consideration other
than cash shall be calculated based on the average per-unit Net
Sales of the Product during the applicable period without regard to
such non-arm’s length or non-cash sales. If the Product is
sold with other products on a portfolio basis, any commercially
reasonable discounts or other adjustments with respect to the
Product shall be allocated pro rata across all products in such
portfolio based on the non-discounted, non-adjusted price for each
such product. In the event that one or more Authorized Generic
Versions are sold by an AG Distributor, (A) sales from Buyer
or its Affiliates to an AG Distributor shall not be included in Net
Sales and (B) such AG Distributor’s sales to third
parties shall be included in Net Sales.
8
(nnn) “
Order ” means any writ, judgment, decree, injunction,
charge, ruling or similar order of any Governmental or Regulatory
Authority (in each such case whether preliminary or
final).
(ooo) “
Party ” means either Buyer or Seller.
“Parties” means Buyer and Seller,
collectively.
(ppp) “
Patent ” means (i) all patents, patent
applications and statutory invention registrations, (ii) any
substitutions, divisions, continuations, continuations-in-part,
reissues, renewals, registrations, confirmations, re-examinations,
extensions, supplementary protection certificates and the like, and
any provisional applications, of any such patents, patent
application or statutory invention registrations, (iii) all
inventions disclosed in the foregoing, (iv) all rights therein
provided by international treaties and conventions, and
(v) all rights to obtain and file for patents and
registrations thereto anywhere in the Territory.
(qqq) “
Permitted Encumbrance ” means (i) any Encumbrance
for Taxes not yet due or delinquent or for those Taxes being
contested in good faith by appropriate proceedings for which
adequate reserves have been established and (ii) any
Encumbrance that does not materially detract from the value of, or
interfere with the present use of, the properties or assets it
affects.
(rrr) “
Person ” means any natural person, corporation,
general partnership, limited partnership, limited liability
company, proprietorship, other business organization, trust, union,
association or Governmental or Regulatory Authority.
(sss) “
Product ” means Kadian.
(ttt) “
Product Copyrights ” means any and all copyrights
owned by Seller relating exclusively to the Product, including
copyrights in Marketing Materials for the Product.
(uuu) “
Product Domain Names ” means (i) the domain names
set forth in Section 1.01(uuu) of the Seller’s
Disclosure Schedule and (ii) any other domain name owned by
Seller as of the Closing Date the includes the word
“Kadian”.
(vvv) “
Product IND ” means Investigational New Drug
Application 35,553 filed in accordance with Section 505(i) of the
Federal Food, Drug, and Cosmetic Act, as amended, and applicable
FDA rules and regulations (including all additions, amendments,
supplements, extensions and modifications thereto and the official
regulatory files relating thereto).
(www) “
Product Intellectual Property ” means the Product
Copyrights, Product Know-How, Product Marks and Product Trade
Dress, in each case relating to the Territory, and the Product
Domain Names.
(xxx) “
Product Know-How ” means any research and development
information, validation methods and procedures, unpatented
inventions, know-how, trade secrets or technical data (including
clinical data and safety data) or information that exclusively
relate to the Product or the Business and are owned by Seller,
other than such know-how that is or becomes the subject of a
Patent.
9
(yyy) “
Product Mark(s) ” means (i) the Trademark
“Kadian ® ” and (ii) such other Trademark(s)
owned by Seller and exclusively used in connection with the
Product.
(zzz) “
Product Patent ” means all Patents in the Territory
owned or controlled by Seller that claim the Product or the
manufacture, use or sale of the Product.
(aaaa) “
Product Trade Dress ” means the trade dress, package
designs, product inserts, labels and associated artwork owned by
Seller that is used exclusively in connection with the Product, the
packaging thereof or the Business, excluding all Seller Brands used
thereon other than the Product Marks.
(bbbb) “
Public Filings ” means all of Alpharma’s
periodic reports and registration statements filed or furnished on
EDGAR with the Securities and Exchange Commission under the
Securities Exchange Act of 1934 or Securities Act of
1933.
(cccc) “
Purchase Price ” shall have the meaning set forth in
Section 4.01(a).
(dddd) “
Purchased Assets ” means: (i) the Assumed
Contracts; (ii) the Marketing Materials; (iii) the Books
and Records; (iv) the Regulatory Approval; (v) the
Inventory, (vi) the Product Intellectual Property and
(vii) the Product IND. The Purchased Assets do not include any
fixed assets, entities, the Seller Data or the Licensed
Intellectual Property.
(eeee) “
Reasonable Best Efforts ” means such prompt,
substantial and persistent efforts as a prudent Person desirous of
achieving a result would use in similar circumstances; provided,
that the Parties shall be required to expend only such resources to
achieve such results as are commercially reasonable in similar
circumstances.
(ffff) “
Rebate ” means any rebate payable pursuant to
(i) state Medicaid or other state and governmental
pharmaceutical assistance programs or (ii) Contracts between
Seller or Buyer and managed care organizations (including pharmacy
benefit management companies, health plans and insurance
companies), in each case relating to utilization of the Product in
the United States during any particular period.
(gggg) “
Rebate Period ” has the meaning set forth in
Section 8.17(b).
(hhhh) “
Regulatory Approval ” means the New Drug Application
20-616 filed pursuant to Section 505(b)(1) of the Federal
Food, Drug, and Cosmetic Act and applicable FDA rules and
regulations for marketing authorization of the Product within the
United States (including all additions, amendments, supplements,
extensions and modifications thereto and the official regulatory
files relating thereto).
(iiii) “
Regulatory Documentation ” means
(i) registrations or applications for, or other filings or
submissions with respect to, the Regulatory Approval or the
Product, including regulatory compliance reports and other reports,
and other written materials filed as part of or referenced in, the
Regulatory Approval, and the risk management plan with respect to
the Product, (ii) any other filings or submissions with
respect to the Product with any Governmental or Regulatory
Authority in the Territory other than the FDA and
(iii) written communications,
10
and written
summaries and minutes of other communications, with the FDA or
other Governmental or Regulatory Authorities to the extent relating
to any of the foregoing.
(jjjj) “
Seller ” means King and, from and after the Closing,
shall also include Alpharma and any subsidiary of Alpharma owning
or controlling assets or having liabilities relating to the
Business, jointly and severally, or if the context so requires
individually.
(kkkk) “
Seller Brands ” means all Trademarks owned by,
licensed to, controlled by or used by Seller, whether or not
registered, including the name “King”, but excluding
the Product Marks and excluding any trade dress rights in the
shape, configuration, coloring or appearance of the Product or its
packaging as sold by Seller before the Closing Date.
(llll) “
Seller Data ” means the clinical data, safety data and
other information that is included or referenced in the Regulatory
Approval as of the Closing Date, but excluding the Product
Know-How.
(mmmm) “
Seller’s Disclosure Schedule ” has the meaning
set forth in Article VI.
(nnnn) “
Seller Indemnified Parties ” has the meaning set forth
in Section 12.02(b).
(oooo) “
Solvent ” means, with respect to any Person on a
particular date, that at fair valuations, the sum of such
Person’s assets is greater than all of such Person’s
debts.
(pppp) “
Tax ” means any and all taxes, customs, duties, fees
or other like assessments, charges or Liabilities imposed by any
governmental, regulatory or administrative entity or agency
responsible for the imposition of any amount, including
(i) any net income, alternative or add-on minimum tax, gross
income, gross receipts, sales, use, ad valorem, transfer,
franchise, profits, license, excise, severance, stamp, occupation,
premium, property, withholding, employment, payroll, recapture,
environmental or windfall profit tax; (ii) any Liability for
the payment of any amounts of the type described in clause
(i) above as a result of being a member of any affiliated,
consolidated, combined, unitary or other group for any Taxable
period; and (iii) any Liability for the payment of any amounts
of the type described in clause (i) or (ii) above as a
result of any express or implied obligation to indemnify any other
Person, and including any liability for taxes of a predecessor or
transferor or otherwise by operation of law.
(qqqq) “
Tax Return ” means any return, form, estimate,
information statement or report relating to Taxes, including any
attachment, appendix, addendum or amendment.
(rrrr) “
Territory ” means the United States.
(ssss) “
Third Party Claim ” has the meaning set forth in
Section 12.02(d).
(tttt) “
Toll Manufacturing Agreement ” has the meaning set
forth in Section 8.20(a).
(uuuu) “
Trademark ” means trademarks, service marks,
certification marks, trade dress, Internet domain names, trade
names, product names, company names and any other source
11
identifying
symbols, designs, slogans, logos or insignia, whether registered or
unregistered, and all common law rights, applications and
registrations therefor, and all goodwill associated
therewith.
(vvvv) “
United States ” means the United States of America,
its territories and possessions, including Washington, D.C. and
Puerto Rico.
Section 1.02 Construction of Certain Terms
and Phrases.
Unless the context
of this Agreement otherwise requires: (a) words of any gender
include each other gender; (b) words using the singular or
plural number also include the plural or singular number,
respectively; (c) the terms “hereof,”
“herein,” “hereby” and derivative or
similar words refer to this entire Agreement; (d) the terms
“Article” or “Section” refer to the
specified Article or Section of this Agreement; (e) the term
“or” has, except where otherwise indicated, the
inclusive meaning represented by the phrase “and/or”;
(f) the terms “including” and “in
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