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Exhibit 10.35
[ ***** ] A CONFIDENTIAL PORTION OF THE MATERIAL HAS
BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
ASSET PURCHASE
AGREEMENT
between
NABI BIOPHARMACEUTICALS
(the Seller)
and
FRESENIUS USA MANUFACTURING, INC.
(the Buyer)
Dated October 11, 2006
TABLE OF
CONTENTS
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ARTICLE I DEFINITIONS AND
CONSTRUCTION
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1
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1.1
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DEFINED TERMS
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1
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1.2
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CONSTRUCTION
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10
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ARTICLE II CONTEMPLATED
TRANSACTIONS
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11
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2.1
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PURCHASE OF ASSETS
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11
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2.2
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PURCHASED ASSETS
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11
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2.3
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EXCLUDED ASSETS
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13
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2.4
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ASSUMPTION OF LIABILITIES
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14
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2.5
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CONSENT OF THIRD PARTIES
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16
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2.6
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REGISTRATIONS AND APPLICABLE
PERMITS
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17
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ARTICLE III PURCHASE PRICE AND
CLOSING
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17
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3.1
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PURCHASE PRICE
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17
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3.2
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REPORTS; PAYMENTS
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18
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3.3
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BOOKS AND RECORDS; AUDITS
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19
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3.4
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PAYMENTS
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19
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3.5
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ALLOCATION OF CLOSING PAYMENT
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20
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3.6
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FREEDOM TO CONDUCT BUSINESS
UNIMPAIRED
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20
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ARTICLE IV CLOSING
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20
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4.1
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CLOSING
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20
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4.2
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CLOSING OBLIGATIONS. AT THE
CLOSING:
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20
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ARTICLE V REPRESENTATIONS AND WARRANTIES OF
THE SELLER
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22
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5.1
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ORGANIZATION AND GOOD STANDING
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22
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5.2
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AUTHORITY RELATIVE TO THIS
AGREEMENT
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22
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5.3
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CONSENTS AND APPROVALS; NO
VIOLATIONS
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22
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5.4
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PURCHASED ASSETS
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23
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5.5
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REAL PROPERTY. [INTENTIONALLY
BLANK]
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23
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5.6
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INTELLECTUAL PROPERTY
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23
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5.7
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SOFTWARE
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25
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5.8
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PERMITS
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25
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5.9
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CONTRACTS
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26
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5.10
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FINANCIAL STATEMENTS
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27
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5.11
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BOOKS AND RECORDS
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27
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5.12
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TAXES
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27
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5.13
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LIABILITIES
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27
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5.14
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PRODUCT LIABILITY; LITIGATION
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27
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5.15
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LITIGATION
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27
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5.16
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REGULATORY COMPLIANCE
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28
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5.17
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COMPLIANCE
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29
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5.18
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CLINICAL AND SCIENTIFIC DATA; GOOD
PRACTICES
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31
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5.19
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EXPORTS AND CUSTOMS
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32
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5.20
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WARRANTY CLAIMS
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32
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5.21
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SPECIFICATIONS
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32
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5.22
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LABOR AND EMPLOYMENT MATTERS
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32
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5.23
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EMPLOYEE BENEFIT PLANS; ERISA
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33
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5.24
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ENVIRONMENTAL MATTERS
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33
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ii
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5.25
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INSURANCE
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34
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5.26
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ABSENCE OF CHANGES OR EVENTS
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34
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5.27
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CUSTOMERS AND SUPPLIERS
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35
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5.28
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BUSINESS RELATIONSHIPS
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35
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5.29
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INVENTORY; PRICING; CERTAIN
COSTS
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35
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5.30
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OVERPAYMENT
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36
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5.31
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CERTAIN INTERESTS
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36
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5.32
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COMMISSIONS
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36
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ARTICLE VI REPRESENTATIONS AND WARRANTIES OF
THE BUYER
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36
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6.1
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ORGANIZATION AND QUALIFICATION
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36
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6.2
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AUTHORITY RELATIVE TO THIS
AGREEMENT
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36
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6.3
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CONSENTS AND APPROVALS; NO
VIOLATIONS
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36
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6.4
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LITIGATION
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37
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6.5
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COMMISSION
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37
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ARTICLE VII PRE-CLOSING
COVENANTS
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37
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7.1
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CLOSING EFFORTS; HSR ACT
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37
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7.2
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OPERATION OF BUSINESS
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39
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7.3
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ACCESS
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40
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7.4
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REPORTS
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40
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7.5
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EXCLUSIVITY
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40
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7.6
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NOTICE OF SUITS
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41
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7.7
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EMPLOYEES
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41
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7.8
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UPDATED SCHEDULES
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41
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7.9
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SALES TAX
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41
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7.10
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INVENTORY
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42
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iii
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ARTICLE VIII POST-CLOSING
COVENANTS
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42
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8.1
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POST-CLOSING PAYMENTS
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42
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8.2
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REPORTS
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42
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8.3
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TAIL INSURANCE
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42
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8.4
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INTELLECTUAL PROPERTY
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43
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8.5
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ACCESS TO INFORMATION; RECORD RETENTION;
COOPERATION; CONFIDENTIALITY
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43
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8.6
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POST-EFFECTIVE TIME RECEIPTS AND
PAYMENTS
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45
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8.7
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USE OF NAME FOR TRANSITION
PERIOD
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45
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8.8
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WHOLESALER CHARGES AND REBATE
CHARGES
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46
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8.9
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ASSISTANCE WITH PROCEEDINGS
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46
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8.10
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BUYER’S DILIGENCE
OBLIGATIONS
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46
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8.11
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NON-COMPETITION BY THE BUYER
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49
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8.12
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SELLER’S DILIGENCE
OBLIGATIONS
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50
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8.13
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CERTAIN EXCLUDED LIABILITIES
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50
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8.14
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ROXANE PROCEEDING
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50
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8.15
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[ ******* ] AGREEMENT
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50
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8.16
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EXCLUDED CONTRACTS
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51
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8.17
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PART D AND COMMERCIAL REBATE
CONTRACTS
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51
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ARTICLE IX CLOSING CONDITIONS
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51
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9.1
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MUTUAL CONDITIONS
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51
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9.2
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CLOSING CONDITIONS OF THE
SELLER
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52
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9.3
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CLOSING CONDITIONS OF THE BUYER
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53
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iv
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ARTICLE X INDEMNIFICATION
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54
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10.1
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SURVIVAL OF REPRESENTATIONS
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54
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10.2
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SELLER’S AGREEMENT TO
INDEMNIFY
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55
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10.3
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BUYER’S AGREEMENT TO
INDEMNIFY
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55
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10.4
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PROCEDURE FOR THIRD-PARTY
CLAIMS
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56
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10.5
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PROCEDURE FOR DIRECT CLAIMS
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58
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10.6
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LIMITATIONS ON INDEMNIFICATION.
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60
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10.7
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TREATMENT OF INDEMNIFICATION
PAYMENTS
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61
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10.8
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CONSTRUCTION
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61
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10.9
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INTEREST
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61
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10.10
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REMEDIES
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61
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ARTICLE XI TERMINATION
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61
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11.1
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TERMINATION
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61
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11.2
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PROCEDURE AND EFFECT OF
TERMINATION
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62
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ARTICLE XII MISCELLANEOUS
PROVISIONS
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62
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12.1
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JURISDICTION, VENUE AND SERVICE OF
PROCESS
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62
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12.2
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REMEDIES
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62
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12.3
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ATTORNEYS’ FEES
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63
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12.4
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PUBLICITY
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63
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12.5
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EXPENSES
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63
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12.6
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WAIVER OF COMPLIANCE; CONSENTS
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63
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12.7
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NOTICES
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64
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12.8
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BINDING AGREEMENT; ASSIGNMENT
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64
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12.9
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INTERPRETATION
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65
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v
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12.10
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GOVERNING LAW
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65
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12.11
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FURTHER ASSURANCES
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65
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12.12
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SEVERABILITY
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65
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12.13
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COUNTERPARTS; ELECTRONIC
SIGNATURES
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65
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12.14
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MERGER AND MODIFICATION;
AMENDMENT
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66
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vi
SCHEDULES
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2.2(a)
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Assigned Registrations/NDAs
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2.2(b)
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Assigned Trademark Rights
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2.2(c)
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Assigned Patent Rights
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2.2(e)
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Assigned Contracts
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2.2(g)
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Brochures
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2.2(i)
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Customer, Supplier and Vendor
Materials
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2.2(j)
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Sales Force Training Materials
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2.2(k)
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Assigned Permits
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2.2(q)
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Acquired Fixed Assets
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2.2(r)
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Acquired Telephone Numbers
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2.3(e)
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Excluded Assets, Rights and Properties
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2.3(k)
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Excluded Fixed Assets
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2.3(l)
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Excluded Telephone Numbers
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2.4(a)
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Excluded Liabilities
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3.2
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Form of New Formulation Net Sales
Statement
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3.5
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Allocation of Closing Payment
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4.2(a)(xi)
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Delivered Software
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5.3
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Consents and Approvals
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5.4(a)
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Tangible Assets
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5.4(c)
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Sufficiency
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5.6(b)
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Marks
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5.6(c)
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Patents
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5.6(d)
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Copyrights
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5.6(f)
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Agreements With Other Persons
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5.6(g)
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Infringement
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5.7
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Software
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5.8(a)
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Permits
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5.9(a)
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Contracts
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5.9(c)
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Events of Default
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5.9(e)
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Seller Third Party Consents
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5.10
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Financial Statements
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5.12
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Taxes
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5.14
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Product Liability; Litigation
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5.15
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Litigation
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5.16(c)
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Notices from Medical Product Regulatory
Authorities
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5.16(f)
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Approvals
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5.17
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Compliance
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5.18(a)
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Scientific Data
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5.20
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Warranty Claims
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5.21
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Specifications
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5.22(a)
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Employees
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5.22(b)
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Employment Agreements
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5.23
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Employee Benefit Plans; ERISA
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5.24
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Environmental Matters
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vii
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5.25(a)
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Insurance
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5.25(c)
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Accident Reports
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5.26
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Absence of Changes or Events
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5.27
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Customers and Suppliers
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5.29
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Inventory Costs
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5.30
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Adjustments
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7.1(c)
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Form of Assignment Agreement
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7.2
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Operation of Business
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7.7(a)
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Excluded Employees
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8.10
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Countries with Diligence Obligations
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9.2(f)
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Seller’s Third Party Conditions
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9.3(h)
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Buyer Third Party Consents
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EXHIBITS
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Exhibit 4.2(a)(ii)
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Noncompetition and Nonsolicitation
Agreement
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Exhibit 4.2(a)(iii)
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Seller Registration Transfer Letter
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Exhibit 4.2(a)(iv)
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Bill of Sale
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Exhibit 4.2(a)(v)
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Patent Agreement
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Exhibit 4.2(a)(vi)
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Trademark Agreement
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Exhibit 4.2(a)(vii)
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Assumption Agreement
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Exhibit 4.2(a)(viii)
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Transition Services Agreement
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Exhibit 4.2(b)(v)
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Buyer Registration Transfer Letter
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Exhibit 7.2(c)
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Braintree Assignment Agreement
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Exhibit 9.2(g)
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Opinion of Counsel for Buyer
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Exhibit 9.3(f)
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Opinion of Counsel for Seller
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Exhibit 9.3(g)
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Employee Consent
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viii
ASSET PURCHASE
AGREEMENT
THIS ASSET PURCHASE AGREEMENT (this " Agreement "), dated
October 11, 2006, is between Nabi Biopharmaceuticals ,
a Delaware corporation (the " Seller "); and Fresenius
USA Manufacturing, Inc ., a Delaware corporation (the "
Buyer ").
Background Statement
The Seller is engaged in, among other activities, the business
of distributing, marketing and selling a line of phosphate binder
calcium acetate products known as PhosLo ® products, which includes
causing such products to be manufactured, inspected, packaged,
inventoried and delivered to distributors and other purchasers
(such business together with the Seller’s activities related
to New Formulation Products is referred to herein as the "
PhosLo Business ").
The Seller desires to sell to the Buyer, and the Buyer desires
to purchase from the Seller, certain of the assets of the Seller
used in the PhosLo Business, all on the terms and conditions set
forth in this Agreement.
Statement of Agreement
In consideration of the premises and the mutual covenants herein
contained, the receipt and sufficiency of which are hereby
acknowledged, the parties hereto, for themselves, their successors
and assigns, agree as follows:
ARTICLE I
DEFINITIONS AND CONSTRUCTION
1.1 Defined Terms . Except as otherwise specifically
provided herein, the following terms shall have the meanings
indicated below:
" Affiliate " means, with respect to any Person, each of
the Persons that directly or indirectly, through one or more
intermediaries, owns or controls, or is controlled by or under
common control with, such Person. For the purpose of this
definition, "control" means the possession, directly or indirectly,
of the power to direct or cause the direction of management and
policies of such Person whether through the ownership of voting
securities, by contract or otherwise.
" Agreement " means this agreement, as amended or
supplemented in accordance with the terms hereof, together with all
Exhibits and Schedules attached hereto or incorporated herein by
reference.
" Arbitration Dispute " has the meaning set forth in
Section 10.5(a) .
" Arbitrators " has the meaning set forth in
Section 10.5(c) .
" Assigned Contracts " has the meaning set
forth in Section 2.2(e) .
" Assigned Permits " shall mean the Permits which are
listed on Schedule 2.2(k) .
" Assumed Liabilities " has the meaning set forth in
Section 2.4(a) .
" Assumption Agreement " has the meaning set forth in
Section 4.2(a)(vii) .
" Bill of Sale " has the meaning set forth in
Section 4.2(a)(iv) .
" Braintree " means Braintree Laboratories, Inc., a
Massachusetts corporation.
" Braintree Purchase Agreement " has the meaning set
forth in Section 5.9(f) .
" Business Day " means any day excluding Saturday, Sunday
and any day that shall be a legal holiday in Massachusetts.
" Buyer " has the meaning set forth in the introductory
paragraph of this Agreement.
" Buyer Certificate " has the meaning set forth in
Section 9.2(c) .
" Buyer Damages " has the meaning set forth in
Section 10.2(a) .
" Buyer Indemnified Parties " has the meaning set forth
in Section 10.2(a) .
" CARE 2 Study " means the clinical study initiated by
the Seller and designed to compare the relative rate of PhosLo and
Renegal, with the addition of Lipitor, in slowing progression of
cardiovascular calcification.
" Closing " has the meaning set forth in
Section 4.1 .
" Closing Date " has the meaning set forth in
Section 4.1 .
" Closing Payment " has the meaning set forth in
Section 3.1(a) .
" CMS " means the Centers for Medicare and Medicaid
Services, a division of the United States Department of Health and
Human Services.
" COBRA " has the meaning set forth in
Section 5.22(h) .
" Code " means the Internal Revenue Code of 1986,
together with the regulations thereunder, in each case as in effect
from time to time.
" Commercial Rebate Contract " means each Contract
designated as such on Schedule 2.2(e) .
" Commercially Reasonable Discontinuance " has the
meaning set forth in Section 8.10(d) .
2
" Competitive Product " means
[*******].
" Compliance Program " means a provider compliance
program of the type described in the compliance guidance published
by the Office of Inspector General of the Department of Health and
Human Services.
" Confidentiality Agreement " has the meaning set forth
in Section 7.3(a) .
" Contract " means any legally binding obligation or
agreement, whether oral or written, and specifically including any
note, bond, mortgage, lease of real or personal property, license
and other instrument.
" Copyright " means the legal right provided by the
Copyright Act of 1976, as amended, to the expression contained in
any work of authorship fixed in any tangible medium of expression
together with any similar rights arising in any other country as a
result of statute or treaty.
" CPR " has the meaning set forth in
Section 10.5(b) .
" Damages " has the meaning set forth in
Section 10.2(a) .
" Data Lock " means, in respect of a clinical trial in
support of a new drug application, the time at which, in accordance
with the trial protocol, no modifications will be made to the
clinical trial data base.
" Deferred Payment Period " has the meaning set forth in
Section 3.1(c) .
" Deferred Payments " has the meaning set forth in
Section 3.1(c) .
" Demand " has the meaning set forth in
Section 10.5(b) .
" Diligence Breach " has the meaning set forth in
Section 8.10(a) .
" Discounts " means amounts claimed as discounts with
respect to PhosLo Products sold (a) on or before the Closing
Date or (b) under any Excluded Contract.
" Effective Time " means 12:01 a.m. on the Closing
Date.
" Employees " means the individuals employed by the
Seller principally in the operation of the PhosLo Business.
" Employee Consent " means a consent by an Employee to
the release of such Employee’s personnel files to the Buyer,
substantially in the form of the Consent of Employee Regarding
Transfer of Personnel Records attached hereto as Exhibit
9.3(g) .
" Environmental Laws " means any Legal Requirement
relating to the protection of safety, human health or the
environment, including any requirement pertaining to the
manufacture, processing, distribution, use, treatment, storage,
disposal, transportation, handling, reporting, licensing,
permitting, investigation or remediation of materials that are or
may constitute a threat to human health
3
or the environment. Without limiting the
foregoing, each of the following is an Environmental Law: the
Comprehensive Environmental Response, Compensation, and Liability
Act (42 U.S.C. § 9601 et seq .), the Hazardous
Material Transportation Act (49 U.S.C. § 5101 et
seq .), the Resource Conservation and Recovery Act (42 U.S.C.
§ 6901 et seq .), the Federal Water Pollution
Control Act (33 U.S.C. § 1251 et seq .), the Clean
Air Act (42 U.S.C. § 7401 et seq .), the Toxic
Substances Control Act (15 U.S.C. § 2601 et seq
.), the Safe Drinking Water Act (42 U.S.C. § 300f et
seq .), the Occupational Safety and Health Act (29 U.S.C.
§ 651 et seq .), and the Atomic Energy Act (42
U.S.C. § 2011 et seq .), and each similar Legal
Requirement promulgated under such federal, state and local
laws.
" EPICK Study " means the clinical study initiated by the
Seller and designed to evaluate PhosLo’s ability to safely
and effectively control serum phosphorus levels, parathyroid
levels, serum calcium levels and calcium phosphorus product in
chronic kidney disease, stage 4, patients.
" ERISA " means the Employee Retirement Income Security
Act of 1974 (29 U.S.C. § 1001, et seq .).
" Excluded Assets " has the meaning set forth in
Section 2.3 .
" Excluded Contracts " has the meaning set forth in
Section 2.3(d) .
" Excluded Liabilities " has the meaning set forth in
Section 2.4(b) .
" Family Member " means any of (i) a Person’s
spouse, (ii) the natural or adoptive grandparents, parents,
siblings, children or grandchildren of a Person or such
Person’s spouse, (iii) the stepparents, stepchildren,
stepbrothers or stepsisters of a Person or such Person’s
spouse, (iv) the nieces, nephews, first cousins, aunts or
uncles of a Person or such Person’s spouse, or (v) the
spouse of any Person described in the foregoing clauses
(i) through (iv).
" FDA " means the United States Food and Drug
Administration.
" FDA Approval " means the approval, clearance or
authorization of the FDA that allows the Buyer to make, sell,
promote, market and distribute a pharmaceutical product for
therapeutic use in humans on a lawful and commercial basis in the
United States.
" FD&C Act " means the Food, Drug and Cosmetic Act,
21 U.S.C. 321, et seq., as amended, and the rules and regulations
promulgated thereunder.
" Finished Goods Inventory " has the meaning set forth in
Section 2.2(l) .
" Fixed Assets " means all equipment (including computer
hardware and data processing and telecommunications equipment),
machinery, furniture and furnishings, fixtures, tools, vehicles and
other tangible personal property of every type, in each case that
are used principally in the PhosLo Business, whether owned or
leased, all contract rights with respect thereto, and all
maintenance records and other documents relating thereto.
4
" Foreign Marketing Authorization " means
the equivalent of an FDA Approval in each country of the Territory
other than the United States.
" GAAP " means generally accepted accounting principles
as recognized by the American Institute of Certified Public
Accountants, as in effect from time to time, consistently applied
and maintained on a consistent basis for the applicable Person (or
Persons on a consolidated basis, as the case may be) throughout the
period indicated and consistent with such Person’s prior
financial practices.
" Good Practices " means compliance with the applicable
requirements contained in "Good Laboratory Practices,"
"Investigational New Drug" and/or "current Good Manufacturing
Practices" regulations as promulgated by the FDA.
" Governmental Authority " means any nation or
government, any state or other political subdivision thereof, any
municipal, local, city or county government, or any Person
exercising executive, legislative, judicial, regulatory or
administrative functions of or pertaining to government.
" Governmental Filings " has the meaning set forth in
Section 7.1(a) .
" GPOs " has the meaning set forth in the definition of
"Wholesaler Charges."
" Hazardous Material " means any substance or material
meeting any one or more of the following criteria: (i) it is
or contains a substance designated as a hazardous waste, hazardous
substance, hazardous material, pollutant, contaminant or toxic
substance under any Environmental Law; (ii) it is toxic,
explosive, corrosive, reactive, ignitable, infectious, radioactive,
mutagenic, dangerous or otherwise hazardous; (iii) its
presence at some quantity requires investigation, notification or
remediation under any Environmental Law or common law; (iv) it
constitutes a danger, a nuisance, a trespass or a health or safety
hazard to persons or property; or (v) it is or contains,
without limiting the foregoing clauses (i)-(iv), asbestos,
polychlorinated biphenyls, petroleum hydrocarbons, petroleum
derived substances or waste, crude oil or any fraction thereof,
nuclear fuel or waste, natural gas or synthetic gas.
" Healthcare Governmental Authority " means any
Governmental Authority, whether created under any federal, state or
local statute or regulation, which governs or has oversight over
the delivery or reimbursement of healthcare services, including CMS
and fiscal intermediaries and other agents acting on behalf of CMS,
and the health department or health licensing department of any
federal, state or local Governmental Authority.
" HSR Act " has the meaning set forth in
Section 5.3(a) .
" Indemnified Party " has the meaning set forth in
Section 10.4(a) .
" Indemnifying Party " has the meaning set forth in
Section 10.4(a) .
" Information " has the meaning set forth in
Section 8.5(a) .
5
" Inventory " means all inventories of
pharmaceuticals, goods, materials and supplies used principally in
the PhosLo Business.
" Know-How " means ideas, designs, concepts, compilations
of information, methods, techniques, procedures and processes,
inventions and discoveries, whether or not patentable.
" Knowledge of the Seller ," " Seller’s
Knowledge " and similar phrases means the actual knowledge of
any of the following Persons and the information available in the
books, records and files of the Seller: [*******].
" Legal Requirement " means any statute, law, treaty,
rule, regulation of any Governmental Authority or any Order
applicable or binding upon the subject Person (including its
business or the ownership or use of any of its assets), property or
other asset.
" Liabilities " means all liabilities or obligations of
any nature whatsoever, whether absolute or contingent, due or to
become due, accrued or unaccrued, known or unknown, direct or
consequential or otherwise.
" Lien " means any lien, charge, claim, pledge, security
interest, conditional sale agreement or other title retention
agreement, lease, mortgage, security agreement, right of first
refusal, option, restriction, license, covenant or other
encumbrance (including the filing of, or agreement to file any
financing statement under the Uniform Commercial Code or statute or
law of any jurisdiction).
"[*******] Agreement " has the meaning set forth in
Section 2.2(p) .
" Mark " means any word, name, symbol or device used by a
Person to identify its goods or services, whether or not
registered, and any right that may exist to obtain a registration
with respect thereto from any Governmental Authority and any rights
arising under any such application. As used in this Agreement, the
term "Mark" includes trademarks and service marks.
" Master Formulations " has the meaning set forth in
Section 2.2(d) .
" Material Adverse Effect " means any change, including
any damage, destruction or other casualty loss, that is or would
reasonably be expected to be materially adverse to the Purchased
Assets or the PhosLo Business including its financial condition or
results of operations; provided however, (i) a "Material
Adverse Effect" does not include any change caused by a change in
any circumstance, political, economic or business conditions
affecting the United States economy as a whole or the
pharmaceutical sector of the United States economy specifically and
(ii) in determining whether there has been a Material Adverse
Effect, any change shall be considered both individually and
together with all other changes.
" Medicaid " means that means tested entitlement program
under Title XIX of the Social Security Act that provides federal
grants to states for medical assistance based on specific
eligibility criteria. (Social Security Act of 1965, Title XIX, P.L.
89 87; 42 U.S.C. 1396 et seq .).
6
" Medical Product Regulatory Authority "
means any Governmental Authority that is concerned with the safety,
efficacy, reliability, manufacture, investigation, sale or
marketing of pharmaceuticals, medical products, biologics or
biopharmaceuticals, including the FDA.
" Medicare " means that government sponsored entitlement
program under Title XVIII of the Social Security Act that provides
for a health insurance system for eligible elderly and disabled
individuals. (Social Security Act of 1965, Title XVIII, P.L. 89-87
as amended, 42 U.S.C. 1395 et seq .).
" Milestone Payments " means the payments payable from
the Buyer to the Seller pursuant to Sections 3.1(a)(i)-(vi)
upon the achievement of certain milestones.
" NDA Filing Date " has the meaning set forth in
Section 5.16(a) .
" NDAs " has the meaning set forth in
Section 2.2(a) .
" Net Sales Deductions " means all: [*******].
" New Formulation Net Sales " means the excess of
(a) the gross amount invoiced by the Buyer or its subsidiaries
or Affiliates or its or their licensees, successors and assignees
from or on account of sales or other dispositions of any New
Formulation Products to unaffiliated third parties who are not
licensees or sublicensees over (b) any Net Sales Deductions.
The Buyer and any such sublicensees, Affiliates, licensees,
successors and assignees shall allocate Net Sales Deductions to the
New Formulation Products in a manner consistent with the manner in
which it allocates similar deductions to products in the balance of
its business. For the avoidance of doubt, New Formulation Net Sales
shall not result from any transfer between or among the Buyer and
any of its subsidiaries or Affiliates or its or their licensees,
successors and assignees for resale, but shall result from the sale
or resale by any such subsidiary, Affiliate, licensee, successor or
assignee.
" New Formulation Net Sales Statement " has the meaning
set forth in Section 3.2(b) .
" New Formulation Products " means each and every
[*******].
" New Formulation Rights " has the meaning set forth in
Section 2.2(p) .
" Noncompetition and Nonsolicitation Agreement " has the
meaning set forth in Section 4.2(a)(ii) .
" Order " means any award, decision, injunction,
judgment, order, writ, decree, ruling, subpoena or verdict entered,
issued, made or rendered by any Governmental Authority or
arbitrator.
"Part D Rebate Contract " means each Contract designated
as such on Schedule 2.2(e) .
" Patent " means any patent granted by the United States
Patent and Trademark Office or by the comparable agency of any
other country, and any renewal thereof, and any rights arising
under any patent application filed with the United States Patent
and Trademark Office or the comparable agency of any other country
and any rights that may exist to file any such application,
together with any divisionals, continuations or continuations in
part with respect to any such patent applications, any
re-examinations of any such patent, any reissues of any such patent
and any amendments thereto as a result of reexamination.
7
" Patent Agreement " has the meaning set
forth in Section 4.2(a)(v) .
" Permits " means all licenses, permits, authorizations,
registrations, certifications, certificates of occupancy,
franchises and approvals of any nature issued by any Governmental
Authority and used in the operation of the PhosLo Business,
including regulatory approvals and worldwide registrations.
" Person " means an individual, partnership, corporation,
limited liability company, trust, decedent’s estate, joint
venture, joint stock company, association, unincorporated
organization, Governmental Authority or other entity.
" PhosLo Business " has the meaning set forth in the
Background Statement to this Agreement.
" PhosLo GelCap " means the size 0 capsule dose of PhosLo
(667 mg) or the size 2 (333.5 mg) capsule dose of PhosLo as
approved in NDA 21-160.
" PhosLo Products " means the following products: PhosLo
GelCap and PhosLo Tablets.
" PhosLo Tablets " means the round tablet dose of PhosLo
(667 mg) as approved by NDA 19-976.
" Plan " means any employee pension, retirement,
profit-sharing, stock bonus, incentive, deferred compensation,
stock option, employee stock ownership, hospitalization, medical,
dental, vacation, insurance, sick pay, disability, severance or
other plan, fund, program, policy, contract or arrangement, whether
arrived at through collective bargaining or otherwise, providing
employee benefits, including any "employee benefit plan" as that
term is defined in Section 3(3) of ERISA, currently
maintained by, sponsored in whole or in part by, or contributed to
by the Seller, for the benefit of employees, retirees, dependents,
spouses, directors, independent contractors or other beneficiaries,
whether created in writing, through an employee manual or similar
document, or orally.
" Proceeding " means any action, arbitration, audit,
hearing, investigation, litigation or suit (whether civil,
criminal, administrative, investigative or informal) commenced,
brought, conducted or heard by or before, or otherwise involving,
any Governmental Authority or arbitrator.
" Proprietary Rights " means, cumulatively, Copyrights,
Know-how, Marks, domain names, Patents, Trade Secrets and other
intellectual property rights.
" Proprietary Software " has the meaning set forth in the
definition of "Software."
" Purchased Assets " has the meaning set forth in
Section 2.2 of this Agreement.
8
" Purchased Proprietary Rights " has the
meaning set forth in Section 5.6(a) .
" Purchase Price " has the meaning set forth in
Section 3.1 .
" Qualified Beneficiaries " has the meaning set forth in
Section 5.22(h) .
" Rebate Charges " means amounts claimed by or under, and
actually paid to or in respect of, Medicaid, state rebate programs,
pharmaceutical benefit management organizations, managed care
organizations, and other Persons as rebates under Contracts between
such parties and the Seller or the Buyer, as the context
requires.
" Registrations " has the meaning set forth in
Section 2.2(a) .
" Restricted Period " has the meaning set forth in
Section 8.11(a) .
" Retained Marks " has the meaning set forth in
Section 8.7(a) .
" Roxane Proceeding " has the meaning set forth in
Section 2.4(a)(iii) .
" Scientific Data " has the meaning set forth in
Section 5.18(a) .
" Seller " has the meaning set forth in the introductory
sentence of this Agreement.
" Seller Certificate " has the meaning set forth in
Section 9.3(c) .
" Seller Damages " has the meaning set forth in
Section 10.3(a) .
" Seller Disclosure Schedule " has the meaning set forth
in Section 5 .
" Seller Indemnified Parties " has the meaning set forth
in Section 10.3(a) .
" Software " means:
-
(a) every computer software program or portion thereof
(including operating systems, application programs, software tools,
firmware and software imbedded within any telecommunications,
dialysis or other equipment, including both object code and source
code versions thereof), including computer software programs
purchased or licensed from third parties;
(b) every computer software program that the Seller (including
its employees and independent contractors) has designed or created
and all electronic or written materials that explain any such
computer software program or that were used in the development of
any such computer software program or represent an interim step in
the development of any such computer software program, including
logic diagrams, flowcharts, procedural diagrams and algorithms, and
all electronic or written materials used by the Seller or provided
to any patient or physician in connection with the installation,
customization or use of any of the computer software programs
described above.
9
" Specifications " has the meaning set forth in
Section 5.21 .
" Taxes " means all taxes, and all charges, fees, levies
or other assessments imposed in respect thereof, imposed by a
Governmental Authority (whether federal, state, local or foreign),
including income, gross receipts, excise, property, estate, sales,
use, stamp, value added, transfer, license, payroll, franchise, ad
valorem, withholding, social security and unemployment taxes; and
such term shall include any interest, penalties and additions to
such taxes, charges, fees, levies or other assessments.
" Tax Return " means, with respect to any Person, any
report, return or schedule attached to a return (or any combination
thereof) required to be supplied by such Person to any Governmental
Authority in connection with Taxes.
" Territory " shall mean each country in the world.
" Third-Party Consents " has the meaning set forth in
Section 7.1(a) .
" Third-Party Software " has the meaning set forth in the
definition of the term "Software."
" Trade Secrets " means business or technical information
of any Person including, but not limited to, customer lists and
Know-How, that is not generally known to other Persons who are not
subject to an obligation of nondisclosure and that derives actual
or potential commercial value from not being generally known to
other Persons.
" Trademark Agreement " has the meaning set forth in
Section 4.2(a)(vi) .
" Transaction Agreements " has the meaning set forth in
Section 4.2(c) .
" Transition Services Agreement " has the meaning set
forth in Section 4.2(a)(viii) .
" Wholesaler Charges " means amounts claimed by
wholesalers of the PhosLo Products as chargebacks or returns to the
wholesaler under contracts between group purchasing organizations,
FSS and PHS (collectively, " GPOs ") and the Seller and
amounts claimed by GPOs as administrative or marketing fees under
contracts between GPOs and the Seller.
1.2 Construction .
(a) The article and section headings contained in this Agreement
are solely for the purpose of reference and convenience, are not
part of the agreement of the parties, and shall not in any way
limit, modify or otherwise affect the meaning or interpretation of
this Agreement.
(b) References to "Sections" or "Articles" refer to
corresponding Sections or Articles of this Agreement unless
otherwise specified.
10
(c) Unless the context requires otherwise,
(i) the words "include," "including" and variations thereof
mean without limitation; (ii) the words "hereof," "hereby,"
"herein," "hereunder" and similar terms refer to this Agreement as
a whole and not any particular section or article in which such
words appear; (iii) words in the singular include the plural,
words in the plural include the singular, and words importing any
gender shall be applicable to all genders; (iv) a term defined
as one part of speech (such as a noun) shall have a corresponding
meaning when used as another part of speech (such as a verb); and
(v) currency amounts referenced herein are in U.S.
Dollars.
(d) Any reference herein to a Legal Requirement shall include
any amendment thereof, any successor thereto and any rules,
regulations and published interpretations promulgated thereunder by
Governmental Authorities.
(e) References to a number of days refer to calendar days unless
Business Days are specified. Except as otherwise specified,
whenever any action must be taken on or by a day that is not a
Business Day, then such action may be validly taken on or by the
next day that is a Business Day.
(f) All accounting terms used herein and not expressly defined
herein shall have the meanings given to them under GAAP.
ARTICLE II
CONTEMPLATED TRANSACTIONS
2.1 Purchase of Assets . On the terms and subject to the
conditions of this Agreement, on the Closing Date, effective as of
the Effective Time, the Seller shall sell, convey, assign, and
transfer to the Buyer (or one or more of its assignees), all of the
Seller’s right, title and interest in and to the Purchased
Assets, and the Buyer (or one or more of its assignees) shall
purchase, acquire and accept the Seller’s right, title and
interest in and to the Purchased Assets, free and clear of any Lien
of any nature except for Liens for Taxes not yet due and
payable.
2.2 Purchased Assets . For purposes of this
Agreement, the term " Purchased Assets " shall mean all of
the tangible and intangible assets, rights and properties used or
held for use by the Seller principally in connection with the
PhosLo Business, including the following assets, rights and
properties, but excluding the Excluded Assets:
(a) all regulatory approvals, worldwide product registrations
and associated materials (including the product dossier) relating
to the PhosLo Business or the PhosLo Products (the "
Registrations "), including the New Drug Applications (No.
19-976 and No. 21-160) issued by the FDA (together with all
amendments, supplements and updates thereto (the " NDAs ")),
and the other approvals, registrations, pending registrations and
associated materials set forth on Schedule 2.2(a)
hereto;
(b) the name "PhosLo" and any variant thereof, and the other
Marks, trade names and domain names set forth on Schedule
2.2(b) hereto;
(c) the Patents set forth on Schedule 2.2(c) hereto;
11
(d) the intangible property rights that relate
primarily to or are embodied in the PhosLo Products or the PhosLo
Business (including phosphate binders generally or any product,
device or service for the treatment of hyperphosphetemia, if any),
whether or not patentable, including but not limited to Copyrights,
Know-how, Trade Secrets, the goodwill associated with the PhosLo
Business, master formulations for the PhosLo Products (" Master
Formulations "), master processes used for manufacturing the
PhosLo Products from the Master Formulations and other confidential
business information;
(e) the Contracts related to the PhosLo Business that are listed
on Schedule 2.2(e) hereto exclusive of the rights thereunder
that relate to PhosLo Products sold prior to the Closing Date or
the operation of the PhosLo Business prior to the Closing Date (the
" Assigned Contracts ");
(f) the exclusive right to satisfy all unfilled purchase orders
relating to the PhosLo Products from and after the Closing
Date;
(g) all brochures and other promotional and printed materials,
trade show materials (including displays), videos, advertising
and/or marketing materials, including materials containing
post-marketing clinical data, in the Seller’s possession or
under its control used solely in connection with the sale of the
PhosLo Products and/or the conduct of the PhosLo Business,
including the materials listed on Schedule 2.2(g) ;
(h) all warranties and guarantees and other similar contractual
rights made by third parties in favor of the Seller with respect to
the PhosLo Products or the PhosLo Business included in the Assigned
Contracts exclusive of those to the extent relating to PhosLo
Products sold prior to the Closing Date or the operation of the
PhosLo Business prior to the Closing Date;
(i) copies of all customer and supplier lists, account lists,
call data, sales history, call notes, marketing studies, consultant
reports, physician databases, and correspondence (excluding
invoices and credit memos) principally relating to the PhosLo
Products or the PhosLo Business to the extent maintained by the
Seller, and all complaint files and adverse event files principally
relating to the PhosLo Products or the PhosLo Business to the
extent maintained by the Seller, including the materials listed on
Schedule 2.2(i) ;
(j) all PhosLo specific training materials including an outline
of training, quizzes and answers that accompany the written
training materials to the extent maintained by the Seller,
including the materials listed on Schedule 2.2(j) ;
(k) the Permits listed in Schedule 2.2(k) (the "
Assigned Permits ");
(l) all PhosLo Products held by or on behalf of the Seller in
inventory as finished goods (the " Finished Goods Inventory
"), as well as all other Inventory;
(m) the Scientific Data, including any rights of access that the
Seller has to the Scientific Data;
(n) copies of all financial records maintained by the Seller
principally in connection with the sale of PhosLo Products relating
to sales, accounts receivable, returns, chargebacks, rebates and
discounts, redacted as necessary to delete all records and data
respecting or including other products of the Seller and/or other
aspects of its business;
12
(o) all rights of the Seller and its Affiliates
to develop, make, have made, sell, distribute, promote, and use the
PhosLo Products worldwide subject, in the case of Canada, to the
rights of Genpharm Inc. pursuant to that certain Distribution
Agreement between Genpharm Inc. and the Seller dated July 12,
2005;
(p) all rights of the Seller, and its Affiliates to [*******]
(the " New Formulation Rights ") and all rights of the
Seller and its Affiliates, if any, to develop and manufacture such
products;
(q) the Fixed Assets listed on Schedule 2.2(q) ;
(r) all telephone numbers and listings in telephone directories
maintained by third parties as listed on Schedule 2.2(r)
;
(s) copies of all other files, records, books, documents, data,
plans and proposals of the Seller relating principally to the
PhosLo Business or PhosLo Products, whether in written, electronic,
visual or other form, redacted as necessary to delete all files,
records, books, documents, data, plans and proposals respecting or
including other products of the Seller and/or aspects of its
business;
(t) [intentionally blank];
(u) all claims and rights relating principally to the Purchased
Assets or the Assumed Liabilities, whether choate or inchoate,
known or unknown, contingent or noncontingent, including all claims
and rights of the Seller against third parties relating principally
to the Purchased Assets or the Assumed Liabilities and including
claims and rights under express or implied warranties but exclusive
of those relating principally to PhosLo Products sold prior to the
Closing Date or the operation of the PhosLo Business prior to the
Closing Date; and
(v) the PhosLo Business as a going concern.
2.3 Excluded Assets . Notwithstanding anything in
Section 2.2 to the contrary, the Purchased Assets shall
not include any of Seller’s right, title or interest in or to
the following assets, rights and properties (the " Excluded
Assets "), all of which shall be retained by the Seller:
(a) [ intentionally blank ] ;
(b) all cash, cash equivalents and short-term investments of
cash;
(c) all accounts receivable (billed and unbilled) in respect of
sales of PhosLo Products made prior to the Closing Date;
(d) all Contracts and rights arising under any Contracts not
specifically included in the Purchased Assets (the " Excluded
Contracts ");
(e) the assets, rights and properties, if any, set forth on
Schedule 2.3(e) ;
13
(f) any inter-company balances due to or from the
Seller and any Affiliate;
(g) all interests in any real property, whether leased or
owned;
(h) all Tax refunds and Tax deposits;
(i) any insurance policies;
(j) all Software;
(k) the Fixed Assets listed or described on Schedule
2.3(k) ;
(l) all telephone numbers and listings in telephone directories
maintained by third parties other than those listed on Schedule
2.2(r) ; and
(m) all rights to receive payment of a license fee pursuant to
Section 6.1(b) of the Distribution Agreement, dated as of
July 12, 2005, between the Seller, Genpharm, Inc. and
Prepharm, Inc.
2.4 Assumption of Liabilities .
(a) Assumed Liabilities . On the Closing Date, the Buyer
shall assume, and shall thereafter timely pay and perform, the
following Liabilities of the Seller (the " Assumed
Liabilities "):
-
(i) the Liabilities of the Seller arising after the Effective
Time under the Assigned Contracts (including in respect of all open
purchase orders for PhosLo Products placed by customers with the
Seller as of the Effective Time and all purchase orders and
committed forecasts placed by the Seller with Braintree and Verdugt
for the production or delivery of Inventory as of the Effective
Time), excluding, however, any such Liabilities that arise from
defaults or breaches under such Assigned Contracts based upon
actions, omissions, circumstances or occurrences existing or
occurring before the Closing Date (including for this purpose any
event which, with notice or time, would constitute such a breach or
default and any breach or default that occurs as a result of the
Closing);
(ii) all Liabilities under the Registrations and the Assigned
Permits, if any, to the extent to be satisfied or performed, or
arising out of acts or omissions of the Buyer, after the Closing
Date; and
(iii) any Liabilities arising from the Proceeding known as
Nabi Biopharmaceuticals v. Roxane Laboratories, Inc ., filed
in the United States District Court for the Southern District of
Ohio (the " Roxane Proceeding "), based on acts,
circumstances or omissions occurring after the Effective Time
including the fees and expenses of counsel and experts and other
third parties incurred in connection with the prosecution of the
Roxane Proceeding after the Effective Time. Any such Liabilities
based on acts, circumstances or omissions occurring prior to the
Effective Time shall remain Liabilities of the Seller.
14
(b) Liabilities Not Assumed . Except for
the Liabilities specifically assumed pursuant to
Section 2.4(a) , the Buyer shall not assume, shall not
take subject to and shall not be liable for, any Liabilities of the
PhosLo Business, the Seller or any Affiliate of the Seller (the "
Excluded Liabilities "). Without limiting the generality of
the foregoing and notwithstanding anything in
Section 2.4(a) to the contrary, the Excluded
Liabilities shall include the following:
-
(i) any Liabilities incurred or arising in connection with the
operation of the PhosLo Business, the condition of the
Seller’s assets or the ownership of the Purchased Assets
prior to the Effective Time, including any claims made by or
against the Seller or any Affiliate of the Seller, whether before
or after the Closing Date, that arise out of actions, omissions,
circumstances or occurrences existing or occurring before the
Closing Date;
(ii) any claim, lawsuit or Liability of any kind or nature
whatsoever (including any Liabilities relating to malpractice, tort
or breach of contract claims asserted by any customer, patient,
former patient, employee or any other party) that is based on
PhosLo Products sold prior to the Effective Time, the sale after
the Effective Time of Finished Goods Inventory existing as of the
Effective Time, or marketing practices or marketing materials for
PhosLo Products used prior to the Effective Time;
(iii) any Liabilities to refund or repay, and all Liability
associated with, any unreconciled payments, overpayments, duplicate
payments, refunds, discounts, rebates or adjustments due to
Medicare, Medicaid, Blue Cross Blue Shield, or any other healthcare
reimbursement or payment program or intermediary third-party payor,
any states, the Veterans Administration, other governmental
programs or any other Person in respect of PhosLo Products sold
prior to the Effective Time, including any Liabilities to repay any
amounts for failure to report correctly average manufacturing price
or best price in violation of any Contract or Permit, including the
Seller’s Medicaid Rebate Agreement, Pharmaceutical Provider
Agreement with the Veterans Administration, or 340B Agreement, in
violation of any Legal Requirement with respect to the calculation
of reported prices, or any Liabilities for rebates or discounts for
PhosLo Products bearing the Seller’s NDC number arising under
Part D Rebate Contracts and Commercial Rebate Contracts assigned to
the Buyer pursuant to Section 8.17 ;
(iv) any Liabilities relating to investigations of the Seller or
any Affiliate of the Seller by any Governmental Authority or
relating to any noncompliance by the Seller or any Affiliate of the
Seller with Legal Requirements, including applicable healthcare
laws and regulations;
(v) any Liabilities arising out of or relating to the conduct of
the CARE 2 Study or the EPICK Study prior to the Effective
Time;
(vi) any Liabilities (whether assessed or unassessed) of the
Seller or any Affiliate of the Seller for any Taxes, including any
Taxes arising by reason of the transactions contemplated
herein;
15
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(vii) all Liabilities with respect to the
Wholesaler Charges and Discounts in respect of PhosLo Products sold
prior to the Effective Time;
(viii) any product liability relating to or arising out of the
sale of PhosLo Products prior to the Effective Time or the sale
after the Effective Time of the Finished Goods Inventory existing
as of the Effective Time;
(ix) all Liabilities arising out of or relating to the recall,
replacement or return of, or any claim for breach of warranty in
respect of or for refund of the purchase price of, the PhosLo
Products sold prior to the Closing Date;
(x) all Liabilities of the Seller or its predecessors arising
under any Environmental Laws;
(xi) any Liabilities attributable to any period prior to the
Closing Date that arises out of any Contract, including Assigned
Contracts, so long as such Liabilities do not arise as a result of
the performance or non-performance of such Assumed Contract by the
Buyer after the Closing Date;
(xii) except as specifically set forth in this Agreement, any
Liabilities to former or current officers, directors, employees,
shareholders or Affiliates of the Seller or any Affiliate of the
Seller, including any Liabilities of the Seller or any Affiliate of
the Seller in connection with any Plans or collective bargaining,
labor or employment agreement or other similar arrangement, any
obligations in respect of retiree health benefits, and any accrued
employee paid time off, including for vacation and sick leave;
(xiii) any Liabilities of the Seller or any Affiliate of the
Seller incurred or arising in connection with this Agreement,
including any fees or expenses of the Seller or any Affiliate of
the Seller incurred in connection with the transactions
contemplated herein; and
(xiv) any Liabilities relating to Excluded Assets.
2.5 Consent of Third Parties . On the Closing
Date, the Seller shall assign to the Buyer, and the Buyer shall
assume, the Assigned Contracts to the extent provided in this
Agreement. To the extent that the assignment of all or any portion
of any Assigned Contract shall require the consent of the other
party thereto or any other third party, this Agreement shall not
constitute an agreement to assign any such Assigned Contract if an
attempted assignment without any such consent would constitute a
breach or violation thereof. In order, however, to seek to provide
the Buyer the full realization and value of every Assigned Contract
of the character described in the immediately preceding sentence
(i) as soon as practicable after the Closing, the Seller and
the Buyer shall cooperate, in all reasonable respects, to obtain
any necessary consents to the assignment of the Assigned Contracts,
provided that neither party shall be required to make any payments
or agree to any material undertakings in connection therewith, and
(ii) until all such consents are obtained or all such Assigned
Contracts expire or are terminated, the Seller and the Buyer shall
cooperate, in all reasonable respects, to provide to the Buyer the
benefits under the Assigned Contracts (with the Buyer entitled to
all the gains and responsible for all the losses, Taxes and
Liabilities thereunder). In connection with clause (ii) of
this Section 2.5 , the Seller shall seek to enforce
at
16
the cost of and for the benefit and risk of the
Buyer all claims or rights of the Seller arising under the Assigned
Contracts to the extent such claims or rights are included in the
Purchased Assets, and the Buyer shall perform and comply with, at
the Buyer’s cost, all of the Seller’s obligations under
the Assigned Contracts, to the extent such obligations are Assumed
Liabilities as if the Buyer was the Seller thereunder. Nothing in
this Section 2.5 shall in any way diminish the
conditions in Article IX of this Agreement.
2.6 Registrations and Applicable Permits . On the
Closing Date, the Seller shall assign or transfer to the Buyer, and
the Buyer shall assume, the Registrations and Assigned Permits to
the extent provided in this Agreement to the extent that they are
assignable, provided, however, that the Buyer will reimburse the
Seller on the Closing Date for the portion of the fees paid by the
Seller in respect of periods after the Effective Time under the
Prescription Drug User Fee Act. To the extent that the assignment
or transfer of all or any portion of any Registration or Permit
shall require the consent of the other party thereto or any other
third party, this Agreement shall not constitute any agreement to
assign or transfer any such Registration or Permit if an attempted
assignment or transfer without any such consent would constitute a
breach or violation thereof. In order, however, to seek to provide
the Buyer the full realization and value of every Registration and
Permit of the character described in the immediately preceding
sentence (i) as soon as practicable after the Closing, the
Seller and the Buyer shall cooperate, in all reasonable respects,
and use best efforts to obtain, at the earliest possible date, any
necessary consents to the assignment or transfer of the
Registrations and Permits, provided that neither party shall be
required to make any payments or agree to any material undertakings
in connection therewith, and (ii) until all such consents are
obtained or all such Registrations and Permits expire or are
terminated, the Seller and the Buyer shall cooperate, in all
reasonable respects, to provide to the Buyer the benefits under the
Registration and Permits (with the Buyer entitled to all the gains
and responsible for all the losses, Taxes and Liabilities
thereunder). In such event, the Buyer shall perform and comply
with, at the Buyer’s cost, all of the Seller’s
obligations under the Registrations and Permits to the extent such
obligations are Assumed Liabilities, as if the Buyer was the Seller
thereunder. Nothing in this Section 2.6 shall in any
way diminish the conditions in Article IX of this
Agreement.
ARTICLE III
PURCHASE PRICE AND CLOSING
3.1 Purchase Price . In consideration of the transfer to
the Buyer of the Purchased Assets and the covenants of the Seller
set forth herein, and subject to the terms and conditions of this
Agreement, the Buyer shall pay or cause to be paid to the Seller
the following amounts (together, the " Purchase Price
"):
(a) $65,000,000 in cash on the Closing Date (the " Closing
Payment ");
(b) the following amounts payable within ten (10) Business
Days of notification of the achievement of each of the following
Milestones; provided, however, that the payment due in connection
with the achievement prior to the Closing Date of the Milestone in
Section 3.1(b)(i) shall be payable on the Closing Date
or within five (5) Business Days after the Closing Date:
17
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(ii) $2,500,000 upon submission to the FDA of an
application seeking FDA Approval to market PhosLo GelCaps for use
by chronic kidney disease, stage 4 patients, which application
meets the requirements of 21 CFR Part 3.14 and other relevant FDA
guidance and has been prepared in accordance with normally accepted
industry standards for such applications, but only if such
application is submitted by December 31, 2009;
(iii) $2,500,000 upon FDA Approval to market a PhosLo Product
for use by chronic kidney disease, stage 4 patients, but only if
such FDA Approval is obtained by the tenth anniversary of the date
hereof;
(iv) $2,500,000 upon presentation of the CARE 2 Study abstract
at the American Society of Nephrology 2006 meeting or cancellation
of the meeting by ASN;
(v) $2,500,000 upon acceptance and publication of the CARE 2
Study by a mutually agreed upon third party peer reviewed medical
journal, but only if published by December 31, 2010;
(vi) $5,000,000 within ten Business Days after the first
commercial sale of a New Formulation Product by the Buyer or its
Affiliates or their licensees or assignees, but only if such first
commercial sale is made by the tenth anniversary of the date
hereof; and
(c) deferred payments (the " Deferred Payments ") equal
to [*******] of the annual New Formulation Net Sales in excess of
$32,000,000 in each such calendar year during the period (the "
Deferred Payment Period ") from the Closing Date through the
earlier to occur of (a) receipt by the Seller of Closing
Payments, Milestone Payments and Deferred Payments totaling
$150,000,000, and (b) the tenth anniversary of the Closing
Date. Notwithstanding the foregoing, the $32,000,000 threshold for
the calendar year that includes the tenth anniversary of the
Closing Date shall be prorated and reduced by multiplying
$32,000,000 by a fraction equal to the total number of days between
January 1, 2016 and the tenth anniversary of the Closing Date
(inclusive) divided by 366. In no event shall the Buyer be
obligated to pay the Seller Closing Payments, Milestone Payments
and Deferred Payments of more than $150,000,000.
(d) The Buyer agrees that it shall have no right to set-off or
apply against any Milestone Payment or Deferred Payment that the
Buyer is obligated to make to the Seller under this Agreement after
the Closing any amounts owed to the Buyer or its Affiliates by the
Seller (including, without limitation, any indemnification
obligation of the Seller under Section 10.2 ) unless
and until such amount(s) shall have been reduced to an arbitration
award or judgment.
3.2 Reports; Payments .
(a) Each party shall notify the other in writing whenever it
believes that the Buyer has earned a Milestone Payment (including
the Milestone in Section 3.1(b)(i) ), together with
reasonably detailed information supporting the achievement of the
corresponding Milestone. Except with respect to the Milestone in
Section 3.1(b)(i) , the Seller shall not notify the
Buyer of the achievement of any Milestone before the Closing Date.
Except as otherwise provided in Section 3.1(b)(i) ,
within ten (10) Business Days of the notice of
18
achievement of a Milestone, the Buyer shall
either pay the Seller the Milestone Payment or, if the Buyer
disputes whether the Seller has earned the Milestone Payment,
provide the Seller with written notice of its objections to payment
of the Milestone Payment, with reasonably detailed supporting
information.
(b) The Buyer shall deliver to the Seller, within forty-five
(45) days after the last day of each calendar quarter (or
partial quarter) that ends during the Deferred Payment Period, a
statement in the form attached hereto as Schedule 3.2 (each,
a " New Formulation Net Sales Statement "), setting forth
(i) the gross amount of invoiced sales for each New
Formulation Product (including unit quantities) for the year to
date and the quarter then ended, (ii) the Net Sales Deductions
for each such period (which deductions shall be aggregated by
category), and (iii) the calculation of the related Deferred
Payment then due, if any. For the avoidance of doubt the Seller
agrees that no Deferred Payments shall be due in respect of any
quarter unless the New Formulation Net Sales Statement delivered
for such quarter establishes that the New Formulation Net Sales for
the period from January 1 of such year through the end of such
quarter exceed $32,000,000. If a New Formulation Net Sales
Statement shall establish that Deferred Payments are due, then the
Buyer shall pay such Deferred Payments to the Seller within ten
days of its receipt of such New Formulation Net Sales Statement.
The parties agree that the first Deferred Payment hereunder and the
associated statement shall be made by the Buyer with respect to the
quarter ending after the first commercial sale of a New Formulation
Product.
(c) Any disputes regarding the right to receive any of the
foregoing payments that cannot be settled amicably between the
parties shall be resolved by arbitration in accordance with the
arbitration procedures set forth in Sections 10.5(b) through
10.5(i) .
3.3 Books and Records; Audits . For a period of
not less than three years after the relevant calendar year, the
Buyer and its subsidiaries and Affiliates and its and their
licensees that sell PhosLo Products and New Formulation Products
shall keep full, true and accurate books of account sufficient to
determine the amounts payable pursuant to Section 3.1 .
The Seller shall have the right, not more than once during any
calendar year, to have the books and records of the Buyer, its
subsidiaries and Affiliates and its and their licensees audited by
a qualified independent accounting firm of the Seller’s
choosing, subject to the Buyer’s approval, which approval
shall not be unreasonably withheld or delayed, under appropriate
confidentiality provisions, to ascertain the accuracy of the
reports and payments under Section 3.2 and compliance
by the Buyer with its obligations under Section 3.1 .
Such audit shall be conducted upon at least ten days’ advance
notice during normal business hours and in a manner that does not
interfere unreasonably with the business of the audited entity.
Subject to the Buyer’s right to dispute such amounts, any
underpayment determined by such audit shall promptly be paid by the
Buyer. The Seller shall pay for the costs of such audit unless such
audit shall establish an underpayment to the Seller in any calendar
year of more than the greater of (i) 10% of the correct
Deferred Payment and (ii) $50,000, in which event the Buyer
shall reimburse the Seller for not more than $20,000 of the
Seller’s out-of-pocket costs incurred in connection with
conducting such audit.
3.4 Payments . Payments of Purchase Price shall be
made by wire transfer to an account or accounts designated by the
Seller at least two Business Days prior to the payment due
date.
19
3.5 Allocation of Closing
Payment . The parties shall allocate the Closing Payment
among the Purchased Assets and the Seller’s covenants as
indicated on Schedule 3.5 . The parties agree to report the
transactions contemplated by this Agreement for income Tax purposes
in accordance with such allocation pursuant to Section 1060 of
the Code and the regulations thereunder, and agree not to take, in
any filing with or accompanying any Tax Return reporting any part
of the transactions contemplated herein, a position inconsistent
with such allocations.
3.6 Freedom to Conduct Business Unimpaired .
Subject to the terms of this Agreement, including Sections
8.10 and 8.11 , the Seller acknowledges and agrees that
the Buyer and its Affiliates shall be free to pursue their
respective business goals and that New Formulation Net Sales may be
affected thereby. Accordingly, this Agreement shall not be deemed
to impose any express or implied obligation on the Buyer or any of
its Affiliates to maximize New Formulation Net Sales for all or any
portion of the Deferred Payment Period or to impair the freedom of
the Buyer and its Affiliates to conduct their respective businesses
as they deem appropriate.
ARTICLE IV
CLOSING
4.1 Closing . The closing of the purchase and sale of the
Purchased Assets and the consummation of the other transactions
contemplated herein (the " Closing ") shall take place on
October 18, 2006, or, if all of the conditions to the
obligations of the parties to consummate the transactions
contemplated hereby (excluding the delivery of any documents to be
delivered at the Closing by any of the parties, it being understood
that the occurrence of the Closing shall remain subject to the
delivery of such documents) have not been satisfied in full or
waived by such date, on such mutually agreeable later date as soon
as practicable (but in no event more than three Business Days)
after the first date on which the conditions to the obligations of
the parties to consummate the transactions contemplated hereby
(excluding the delivery of any documents to be delivered at the
Closing by any of the parties, it being understood that the
occurrence of the Closing shall remain subject to the delivery of
such documents) have been satisfied or waived (the " Closing
Date "), at the offices of Nutter McClennen & Fish
LLP, in Boston, Massachusetts, beginning at 10:00 a.m., local time.
The Closing shall be effective as of the Effective Time.
4.2 Closing Obligations . At the Closing:
(a) The Seller shall deliver (or cause to be delivered) to the
Buyer:
-
(i) the various certificates, instruments and documents required
to be delivered under Section 9.3 ;
(ii) a Non-solicitation and Non-competition Agreement in the
form attached hereto as Exhibit 4.2(a)(ii) (the "
Noncompetition and Nonsolicitation Agreement ")
(iii) a letter from the Seller in the form attached hereto as
Exhibit 4.2(a)(iii) , notifying the FDA of the transfer of
the rights to the Registrations to the Buyer;
20
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(iv) a Bill of Sale in the form attached hereto
as Exhibit 4.2(a)(iv) (the " Bill of Sale
");
(v) a Patent Assignment Agreement in the form attached hereto as
Exhibit 4.2(a)(v) (the " Patent Agreement ");
(vi) a Trademark Assignment Agreement in the form attached
hereto as Exhibit 4.2(a)(vi) (the " Trademark
Agreement ");
(vii) an Assignment and Assumption Agreement in the form
attached hereto as Exhibit 4.2(a)(vii) (the " Assumption
Agreement ");
(viii) a Transition Services Agreement in the form attached
hereto as Exhibit 4.2(a)(viii) (the " Transition Services
Agreement ");
(ix) such other instruments of conveyance, consent, and
acknowledgement as may be required to convey all of the Purchased
Assets to the Buyer, to permit the Buyer to record or register all
registrable Purchased Proprietary Rights and to put the Buyer in
possession and control of all of the Purchased Assets of a tangible
nature, including documents and data in electronic formats, to the
extent that such documents and data are in electronic formats;
(x) original executed versions of the Assigned Contracts except
for those that are not in the Seller’s possession, as
indicated on Schedule 2.2(e) ; and
(xi) copies of the Software listed on Schedule 4.2(a)(xi)
(the Buyer acknowledging that such copies of Software will be
provided by the Seller without any representation or warranty of
any kind including as to any title or right of the Seller or the
Buyer to use such Software).
(b) The Buyer shall deliver (or cause to be delivered) to the
Seller:
-
(i) The various certificates, instruments and documents required
to be delivered under Section 9.2 ;
(ii) The Assumption Agreement;
(iii) The Noncompetition and Nonsolicitation Agreement;
(iv) The Transition Services Agreement;
(v) A letter from the Buyer to the FDA in the form attached
hereto as Exhibit 4.2(b)(v) , notifying the FDA of the
transfer of the Registrations to the Buyer; and
(vi) The Closing Payment.
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(c) The agreements and instruments referred to in
Sections 4.2(a)(ii) through (viii) and
Section 4.2(b)(v) , together with this Agreement, are
referred to herein as the " Transaction Agreements
."
ARTICLE V
REPRESENTATIONS AND WARRANTIES OF THE SELLER
Except as disclosed on Schedule 5 hereto (the " Seller
Disclosure Schedule ") the Seller represents and warrants to
the Buyer the following:
5.1 Organization and Good Standing . The Seller is
a corporation duly organized, validly existing and in good standing
under the laws of its state of incorporation, as indicated in the
introductory paragraph of this Agreement. The Seller has full
corporate power and authority necessary to enable it to own, lease
or otherwise hold its properties and assets (including the
Purchased Assets) and to carry on the PhosLo Business as presently
conducted. The Seller is duly qualified to do business as a foreign
corporation in all the states, provinces and jurisdictions in which
such qualification is necessary because of the operation of the
PhosLo Business, the ownership or use of the Purchased Assets or
otherwise.
5.2 Authority Relative to this Agreement . The
Seller has full corporate or other power and authority to execute,
deliver and perform this Agreement and the other Transaction
Agreements and to consummate the transactions contemplated hereby
and thereby. The execution, delivery and performance by the Seller
of the Transaction Agreements and the consummation of the
transactions contemplated thereby have been duly and validly
authorized by all necessary corporate or other action on its part
and no other further authorization or consent of the Seller or its
board of directors, lenders or stockholders will be necessary. This
Agreement has been, and each other Transaction Agreement will be,
duly executed and delivered by the Seller and constitutes, and such
other Transaction Agreement will constitute, the legally valid and
binding obligation of the Seller, enforceable against the Seller in
accordance with its terms, except as such enforceability may be
limited by applicable bankruptcy, insolvency or other laws of
general applicability affecting creditors’ rights and by
general principles of equity.
5.3 Consents and Approvals; No Violations .
(a) Subject to compliance with the applicable requirements of
the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended (the " HSR Act "), there is no requirement
applicable to the Seller to make any filing with, or to obtain any
permit, authorization, consent or approval of, any Governmental
Authority as a condition to the lawful consummation of the
transactions contemplated hereby.
(b) The execution, delivery and performance of each Transaction
Agreement by the Seller and the Seller’s compliance with the
terms thereof will not: (i) conflict with any provision of the
articles of incorporation, bylaws or other governing documents of
the Seller; (ii) conflict with, result in a breach of,
constitute (with or without due notice or lapse of time or both) a
default under, result in the acceleration of obligations under,
create in any party the right to terminate or modify, result in the
loss of any rights under, or require any notice, consent or waiver
under, any Assigned Contract or any Assigned Permit;
(iii) contravene, conflict with, violate, or
22
give any Governmental Authority or other Person
the right to challenge any of the transactions contemplated hereby
or exercise any remedy (including revocation, withdrawal,
suspension or modification of any Permit) or obtain any relief
under, any Legal Requirement applicable to the Seller;
(iv) violate any Order specifically naming the Seller or any
of its properties or assets; or (v) result in the creation or
imposition of any Lien of any nature upon any of the Purchased
Assets.
5.4 Purchased Assets .
(a) Tangible Assets . Schedule 5.4(a) lists or
describes, as of the Closing Date, each item of the Purchased
Assets that is tangible personal property (other than Inventory).
The Fixed Assets listed on Schedule 2.2(q) are all of the
Fixed Assets owned or leased by the Seller that are used primarily
in connection with the PhosLo Business. All such Purchased Assets
are in good working order and condition, reasonable wear and tear
excepted.
(b) Title . The Seller has the right to sell and transfer
to the Buyer good title to the Purchased Assets, free and clear of
all Liens except for Liens for Taxes not yet due and payable. The
delivery to the Buyer of the instruments of transfer of ownership
contemplated by this Agreement will vest good title to the
Purchased Assets in the Buyer, free and clear of all Liens except
for Liens for Taxes not yet due and payable and Liens arising
solely by actions or failures to act of the Buyer.
(c) Sufficiency . Except for the Excluded Assets and for
the Seller’s assets that are used in connection with the
provision of the corporate overhead and administrative services and
the assets listed or described in Schedule 5.4(c) , the
Purchased Assets constitute all of the assets necessary for the
continued conduct of the PhosLo Business by the Buyer after the
Closing in substantially the same manner as conducted by the Seller
prior to the Closing. The telephone numbers and telephone directory
listings listed on Schedule 2.2(r) are all of the telephone
numbers and telephone directory listings that are used by the
Seller primarily in connection with the PhosLo Business.
5.5 Real Property . [Intentionally Blank]
.
5.6 Intellectual Property .
(a) Ownership and Right to Use . The Seller owns or has
the right to use on a worldwide basis all of the Proprietary Rights
included within the Purchased Assets (the " Purchased
Proprietary Rights "). The Purchased Proprietary Rights include
all of the Proprietary Rights necessary for the continued conduct
of the PhosLo Business by the Buyer after the Closing in
substantially the same manner as conducted by the Seller prior to
the Closing. None of the Purchased Proprietary Rights will lapse,
be terminable, be diminished or limited or be subject to any
additional restrictions as a result of the Closing and the
assignment of the Purchased Proprietary Rights to the Buyer. Each
Person under Seller’s control, if any, who has participated
in the creation, development, testing, modification or
documentation of any PhosLo Product or New Formulation Product has
entered into an enforceable agreement with the Seller assigning to
the Seller, or is required by Legal Requirement to assign to the
Seller, any of such Person’s rights in the Purchased
Proprietary Rights.
23
(b) Marks and Trade Names . Schedule
5.6(b) lists each Mark, trade name and domain name that has
been used by the Seller since August 4, 2003 to identify the
PhosLo Business or the PhosLo Products and lists each registration
that has been filed or obtained by the Seller with respect to any
such Marks. All such pending and registered Marks are valid. To the
Knowledge of the Seller, no other Person is using a confusingly
similar Mark to describe products that are similar to the PhosLo
Products.
(c) Patents . Schedule 5.6(c) lists each Patent
owned or licensed by the Seller and used in or in connection with
the PhosLo Business, specifies whether each such Patent is owned or
licensed by the Seller and lists each country in which each such
issued Patent has been issued. Each such issued Patent is valid and
enforceable with regard to its coverage of the applicable PhosLo
Product. Each Contract pursuant to which the Seller licenses any
Patent included within the Purchased Proprietary Rights grants the
Seller the unrestricted right to carry on any business within the
scope of the inventions covered by such Patent in the countries in
which the Patent is valid. Neither the Seller nor, to the Knowledge
of the Seller, anyone acting on its behalf in a representative
capacity, has knowledge of any material misrepresentation made to
any Governmental Authority in connection with the procurement of
any Patent included in the Purchased Proprietary Rights.
(d) Copyrights . Schedule 5.6(d) lists each
Copyright registration included within the Purchased Proprietary
Rights.
(e) Trade Secrets . The Seller has taken efforts that are
reasonable under the circumstances to prevent the unauthorized
disclosure to any other Person of such portions of the
Seller’s Trade Secrets included in the Purchased Assets as
would enable any other Person to compete with the Seller within the
scope of the PhosLo Business as now conducted and as presently
proposed to be conducted. Each current or former Employee and
independent contractor of the Seller engaged principally in the
operation of the PhosLo Business has executed a confidentiality
agreement with the Seller or is subject to an obligation of
confidentiality.
(f) Agreements with Other Persons . Schedules
5.6(c) and 5.6(f) list each Contract pursuant to which
the Seller
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