ASSET PURCHASE AGREEMENT by and between FOREST LABORATORIES, INC. and CARACO PHARMACEUTICAL LABORATORIES, LTD. Dated July 10, 2009
EXHIBIT
2.01
EXECUTION
COPY
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
by and
between
FOREST
LABORATORIES, INC.
and
CARACO
PHARMACEUTICAL LABORATORIES, LTD.
Dated July 10,
2009
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
TABLE OF
CONTENTS
Page
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LIST
OF EXHIBITS AND SCHEDULES
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i
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1.
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DEFINITIONS
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1
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1.01.
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Definitions.
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1
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1.02.
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Other
Definitional and Interpretative Provisions
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12
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2.
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PURCHASE
AND SALE
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12
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2.01.
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Purchased
Assets
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12
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2.02.
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Customer
Agreements
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13
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2.03.
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Retained
Assets
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14
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2.04.
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Retained
Liabilities
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14
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2.05.
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Assumed
Liabilities
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15
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2.06.
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Closing
Date Inventory
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15
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2.07.
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Closing
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16
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2.08.
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Post-Closing
Adjustments
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18
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2.09.
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Post-Closing
Royalty Payments
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18
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3.
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REPRESENTATIONS
AND WARRANTIES OF FOREST
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20
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3.01.
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Corporate
Existence and Power
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20
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3.02.
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Corporate
Authorization
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20
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3.03.
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Governmental
Authorization
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21
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3.04.
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Noncontravention;
Licenses and Permits
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21
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3.05.
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Required
Consents
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21
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3.06.
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Title
to Purchased Assets; Encumbrances
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21
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3.07.
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Claims;
Litigation
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22
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3.08.
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Product
Intellectual Property
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22
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3.09.
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Contracts.
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23
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3.10.
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Specifications.
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24
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3.11.
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FDA
Matters
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24
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3.12.
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Taxes
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25
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3.13.
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Product
Records
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26
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3.14.
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Closing
Date Inventory
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26
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3.15.
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Finders
Fees
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26
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3.16.
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Completeness
of Certain Schedules
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26
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3.17.
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Financial
Data
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26
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3.18.
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Customers
and Suppliers
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26
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i
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3.19.
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Full Disclosure
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27
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4.
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REPRESENTATIONS AND WARRANTIES OF
CARACO
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27
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4.01.
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Corporate Existence and
Power
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27
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4.02.
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Corporate Authorization
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27
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4.03.
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Governmental Authorization
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27
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4.04.
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Noncontravention; Licenses and
Permits
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28
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4.05.
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Claims; Litigation
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28
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4.06.
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Financing
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28
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4.07.
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Finders Fees
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28
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4.08.
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XXX Xxx
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00
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0.
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COVENANTS OF FOREST
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28
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5.01.
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Third Party Notices and Consents; Biovail
Consent.
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28
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5.02.
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Stability Programs
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28
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5.03.
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Manufacturing Transition
Services
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29
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5.04.
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Supply of Product
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29
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5.05.
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Notices of Certain Events
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31
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5.06.
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Conduct of the Business
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31
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6.
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COVENANTS OF CARACO
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32
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6.01.
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Access; Royalty Verification; Forest
Confidentiality
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32
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6.02.
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Notices of Certain Events
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33
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6.03.
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Product Manufacture
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33
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6.04.
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Commercialization Diligence
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33
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6.05.
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Exclusivity.
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34
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6.06.
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Transfers and Assignments of Purchased
Assets.
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35
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7.
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COVENANTS OF FOREST AND CARACO; OTHER
AGREEMENTS
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35
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7.01.
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Confidentiality.
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35
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7.02.
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Further Assurances
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36
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7.03.
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Chargebacks and Credits
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36
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7.04.
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Closing Date Inventory
Receivables
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37
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7.05.
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Medicaid Rebates for
Products
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37
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7.06.
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Federal Government Pricing
Programs
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38
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7.07.
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Recalls; Complaints
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38
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7.08.
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Product Returns
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39
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7.09.
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Cooperation with Respect to Chargebacks, Rebates
& Returns; Working Group
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39
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7.10.
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Safety Data
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39
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7.11.
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Regulatory Matters
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39
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7.12.
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Reporting Information
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41
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7.13.
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Certain Filings
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41
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7.14.
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Public Announcements
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41
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ii
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
7.15.
|
WARN Act
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42
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8.
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CONDITIONS TO CLOSING
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42
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8.01.
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Conditions to Obligations of Caraco and
Forest.
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42
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8.02.
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Conditions to Obligation of
Caraco
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43
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8.03.
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Conditions to Obligation of
Forest.
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43
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9.
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SURVIVAL; INDEMNIFICATION
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43
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9.01.
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Survival.
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43
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9.02.
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Indemnification
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44
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9.03.
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Indemnification Procedures
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45
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9.04.
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Assignment of Claims
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46
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10.
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TERMINATION
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46
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10.01.
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Grounds for Termination
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46
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10.02.
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Effect of Termination
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47
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11.
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MISCELLANEOUS
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47
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11.01.
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Notices
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47
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11.02.
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Amendments and Waivers.
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48
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11.03.
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Expenses.
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49
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11.04.
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Transfer Taxes
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49
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11.05.
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Successors and Assigns;
Assignment
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49
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11.06.
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Relationship Between the
Parties
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49
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11.07.
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Governing Law
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49
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11.08.
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Dispute Resolution;
Arbitration
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50
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11.09.
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Specific Performance
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51
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11.10.
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LIMITATION OF LIABILITY
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51
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11.11.
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WAIVER OF JURY TRIAL
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51
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11.12.
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Counterparts; Effectiveness; Third Party
Beneficiaries
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52
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11.13.
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Representation by Legal
Counsel
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52
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11.14.
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Entire Agreement
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52
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11.15.
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Severability
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52
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11.16.
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Disclosure Schedules
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53
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iii
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
LIST
OF EXHIBITS AND SCHEDULES
Exhibit
A
|
Closing
Date Inventory Cost of Goods
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Exhibit
B
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Form
of Assignment and Assumption Agreement
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|
Exhibit
C
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Biovail
Consent
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|
Exhibit
D
|
Form
of Xxxx of Sale
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Schedule 1.01(gg)
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Customer
Agreements
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Schedule 1.01(aaa)
|
Manufacture
and Supply Agreements
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Schedule 1.01(ooo)
|
Product
Rights Agreements
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Schedule 1.01(lll)
|
Products
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Schedule
1.01(gggg)
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Trade
Channel Inventory
|
|
Schedule 1.01(hhhh)
|
Trademarks
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|
Schedule
2.01(h)
|
NDAs
and ANDAs
|
|
Schedule
3.03
|
Governmental
Authorizations – Forest
|
|
Schedule
3.05
|
Required
Consents
|
|
Schedule
3.07
|
Claims;
Litigation
|
|
Schedule
3.08(a)
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Product
Intellectual Property – General
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Schedule
3.08(c)
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Product
Intellectual Property – Assigned / Licensed
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Schedule
3.09
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Contracts
|
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Schedule
3.11(a)
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Registrations
|
|
Schedule
3.17
|
Financial
Data
|
|
Schedule
3.18
|
Customers
and Suppliers
|
|
Schedule 4.03
|
Governmental
Authorizations – Caraco
|
|
Schedule
5.04(a)
|
Initial
Cost of Goods under Supply Agreement
|
|
Schedule
5.04(b)
|
Sales
and Net Profit Projections
|
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASSET PURCHASE AGREEMENT
(“Agreement”)
dated this 10th day of July, 2009 by and between FOREST LABORATORIES, INC., a
Delaware corporation having its principal offices at 000 Xxxxx Xxxxxx, Xxx Xxxx,
XX 00000 (on behalf of itself and its Affiliates which have an interest in the
Purchased Assets, “Forest”) and CARACO PHARMACEUTICAL LABORATORIES,
LTD, a Michigan corporation having its principal offices at 0000 Xxxxxx
XxXxx Xxxxx, Xxxxxxx, XX 00000 (“Caraco”). Each of
Forest and Caraco shall individually be referred to as a “Party” and collectively as the
“Parties”.
W
I T N E S S E T H:
A.
Pursuant to a Settlement Agreement (the “Settlement Agreement”) of even
date herewith by and among Forest, Forest Laboratories Holdings Limited, X.
Xxxxxxxx A/S (“Lundbeck”), Sun Pharmaceutical
Industries Ltd. (“Sun”)
and Caraco, the parties
thereto settled certain patent infringement litigation therein described which
related to Caraco’s filing of Abbreviated New Drug Application No. 78-219 with
the FDA seeking approval of a generic version of a branded product which Forest
commercializes under license from Lundbeck.
B.
In accordance with the Settlement Agreement,
Forest has agreed to sell certain assets relating to its “Inwood” line of
generic products, including the Products (as defined herein) and related assets,
and Caraco has agreed to purchase such assets from Forest, all in accordance
with, and subject to, the terms and conditions hereinafter set
forth.
NOW, THEREFORE, in
consideration of the foregoing and of the terms and conditions hereinafter set
forth, and good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, the Parties hereto agree as follows:
1.
DEFINITIONS
1.01. Definitions. As
used herein, the following terms have the following meanings:
(a) the
“Act” shall mean the
Federal Food, Drug and Cosmetic Act, as amended.
(b) “Advance Royalty Amount” shall
have the meaning set forth in Section 2.07(a)(i).
(c) “Affiliate” shall mean any
Person controlling, controlled by or under common control with the Party with
respect to which such status is at issue and shall include, without limitation,
any corporation 50% or more of the voting power of which (or other comparable
ownership interest for an entity other than a corporation) is owned, directly or
indirectly, by a Party hereto or any Person that owns 50% or more of such voting
power of a Party hereto.
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(d) “Agreement” shall have the
meaning set forth in the Preamble.
(e) “Agreed Rate,” shall be
adjusted every ninety days and shall mean (A) the rate of interest per annum
(rounded upward, if necessary, to the nearest 1/8 of 1%) at which U.S. dollar
deposits that (i) are in an amount approximately equal to the
aggregate amount of such outstanding payments, and (ii) mature in ninety days,
are offered in the London Interbank currency market on the last day of each
ninety day period as such rate is published in the “Money Rates” column of The
Wall Street Journal (and if The Wall Street Journal publishes more than one such
rate, the higher or highest of such rates and if The Wall Street Journal
subsequently publishes a correction of any such previously published rate, the
corrected rate as so published), plus (B) 200 basis points.
(f)
“ANDA” shall mean an
Abbreviated New Drug Application, including amendments and supplements thereto,
approved by the FDA in respect of the marketing of one or more of the Products
in the United States.
(g) “Applicable Law” shall mean,
with respect to any Person, any federal, state or local law (statutory, common
or otherwise), constitution, treaty, convention, ordinance, code, rule,
regulation, order, injunction, judgment, decree, ruling or other similar
requirement enacted, adopted, promulgated or applied by a Governmental Authority
that is binding upon or applicable to such Person, as amended unless expressly
specified otherwise, including the Act and other national, state, provincial and
local laws.
(h) “Arbitrators” shall have the
meaning set forth in Section 11.08.
(i)
“Assigned Customer Agreements”
shall have the meaning set forth in
1.01(gg).
(j)
“Assigned Contracts” shall
mean, collectively, the Product Rights Agreements, the Manufacture and Supply
Agreements and the Assigned Customer Agreements.
(k) “Assignment and Assumption
Agreement” shall have the meaning set forth in Section
2.07(a).
(l)
“Assumed Liabilities” shall
have the meaning set forth in Section 2.05.
(m) “Xxxx of Sale” shall have the
meaning set forth in Section 2.07(b).
2
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(n) “Biovail Agreements” shall mean
the Manufacture and Supply Agreements and the Product Rights
Agreements.
(o) “Biovail Consent” shall mean a
consent to the assignment of the Biovail Agreements substantially in the form of
that attached hereto as Exhibit C or in such
other form as the Parties may agree.
(p) “Business Day” shall mean a
day, other than Saturday, Sunday or other day on which commercial banks in New
York, New York are authorized or required by Applicable Law to
close.
(q) “Caraco” shall have the meaning
set forth in the Preamble.
(r)
“Chargebacks” shall mean
discounts or rebates provided in the form of chargeback and similar payments to
wholesalers or other distributors in connection with the Products.
(s) “Claim” shall have the meaning
set forth in Section 9.03.
(t)
“Closing” shall have the
meaning set forth in Section 2.07.
(u) “Closing Date” shall have the
meaning set forth in Section 2.07.
(v) “Closing Date Inventory” shall
have the meaning set forth in Section 2.06.
(w) “Closing Date Inventory Purchase
Price” shall mean, for each item of Inventory included in the Closing
Date Inventory, the amount equal to the per unit Cost of Goods of each such
item. Exhibit A attached
hereto sets forth a schedule of the per unit Cost of Goods for each item of
Inventory.
(x)
“Closing Inventory Notice”
shall have the meaning set forth in Section 2.06.
(y)
“Commercially Reasonable
Efforts” shall mean, with respect to either Party, the efforts,
consistent with the practice of comparable pharmaceutical companies with respect
to pharmaceutical products of comparable market potential to the Products, that
a reasonable Person in the position of such Party would use with respect to a
particular activity and, with respect to marketing a Product, the efforts a
reasonable Person would use to maximize Net Sales, and shall be determined
without regard to the particular circumstances of a Party, including other
business opportunities available to such Party.
3
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(z)
“Competing Product” shall mean
a product which is a generic equivalent to the same Orange Book reference
product as a Product.
(aa)
“Contract Year” shall mean the
twelve (12) month period beginning on the first day of the first full Quarter
following the Closing Date and each consecutive twelve (12) month period, or
portion thereof thereafter. The first Contract Year shall also
include the period from the Closing Date to the first day of the first Quarter
of such Contract Year.
(bb) “Contracts” shall mean those
contracts, agreements, arrangements or understandings set forth on Schedule 3.09 of the Forest Disclosure
Schedule.
(cc) “Copyrights” shall mean all
United States and foreign copyrights, whether or not registered, and all
applications for registration of all copyrights owned by Forest or its
Affiliates which have been used in connection with development, marketing,
commercialization or sale of the Purchased Assets as of the Closing Date or
within the two (2) year period prior to the Closing Date, including, but not
limited to: (i) the right to xxx or otherwise recover for any and all past,
present and future infringements and misappropriations thereof; (ii) all income,
royalties, damages and other payments now and hereafter due and/or payable with
respect thereto; and (iii) any and all other rights corresponding thereto and
all modifications, adaptations, translations, enhancements and derivative works,
renewals thereof, and all other rights of any kind whatsoever of Forest accruing
thereunder or pertaining thereto.
(dd) “Cost of Goods” shall mean
Forest’s direct costs of materials and labor incurred in acquiring (including
any acquisition costs paid to Third Parties), manufacturing, packaging and
labeling each Product, as the case may be, including quality assurance and
quality control activities necessary to release Product, together with directly
allocable manufacturing overheads (but excluding corporate, general or
administrative overheads). Cost of Goods shall be determined in
accordance with Forest’s standard cost accounting policies, respectively, in
each case as consistently applied to the manufacture of pharmaceutical products
and accrued and reflected in accordance with GAAP. From time to time
Forest will provide Caraco with information as Caraco may reasonably request
with respect to such standard cost accounting policies to assure compliance with
the standards set forth in the preceding sentence.
(ee) “Credits” shall mean credits,
utilization based rebates (other than Medicaid rebates), reimbursements, and
similar payments to buying groups, managed care organizations and benefit
managers, insurers and other institutions in connection with the
Products.
(ff) “Customer” shall mean insurers,
Third-Party payors, group purchasing organizations, wholesalers, managed care
organizations; chain drug stores and drug stores, and any other Persons that
purchase one or more of the Products from Forest or reimburse patients or health
care providers for their use of one or more of the Products.
4
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(gg) “Customer Agreements” shall
mean those agreements set forth on Schedule 1.01(gg)
pursuant to which Forest or any of its Affiliates sells one or more of the
Products to a Customer or provides rebates or discounts to a Customer determined
by utilization of a Product. Customer Agreements which exclusively
cover the Products (i.e. do not relate to a
bundle of products including products other than the Products) are indicated on
Schedule
1.01(gg) under the subheading “Assigned Customer Agreements” and are
referred to herein as “Assigned Customer Agreements.” For the sake of
clarity, the Parties acknowledge that “Customer Agreements” shall not include
wholesaler inventory management agreements, which shall be terminated by Forest
with respect to the Products effective as of the Closing Date, and which Caraco
may enter into after the Closing Date in its sole discretion and for its own
account.
(hh) “Damages” shall have the
meaning set forth in Section 9.02.
(ii) “Diltiazem Products” means the
generic AB-rated to Tiazac(R) and branded pharmaceutical products containing
diltiazem purchased and sold under the terms of the Biovail
Agreements.
(jj) “Dispute” shall have the
meaning set forth in Section 11.08
(kk)
“Dollars” or “$” shall mean United States
dollars.
(ll) “Encumbrance” shall mean any
mortgage, pledge, security interest, deed of trust, lease, lien, adverse claim
(including any claim of adverse ownership or any pending legal proceeding
affecting title), levy, charge, easement, right of way, covenant, restriction,
or other encumbrance, third-party right or retained right of any kind
whatsoever, or any conditional sale or title retention agreement or other
agreement to give any of the foregoing in the future.
(mm) “FDA” shall mean the United
States Food and Drug Administration or any successor agency having a similar
jurisdiction.
(nn) “Federal Programs” shall have
the meaning set forth in Section 7.06.
(oo) “Forest” shall have the meaning
set forth in Section Preamble.
(pp) “Forest Disclosure Schedule”
shall have the meaning set forth in Article 3.
(qq) “GAAP” shall mean generally accepted
accounting principles in the United States, as in effect from time to
time.
5
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(rr) “Governmental Authority” shall
mean any transnational, domestic or foreign federal, state or local,
governmental authority, department, court, agency or official, including any
political subdivision thereof, including any governmental regulatory authority
involved in the granting of approvals for the manufacture, sale, marketing,
reimbursement or pricing of the Products (including the FDA).
(ss) “HSR Act” shall mean the
Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended.
(tt) “Indemnified Party” shall have
the meaning set forth in Section 9.03.
(uu) “Indemnifying Party” shall have
the meaning set forth in Section 9.03.
(vv) “Intellectual Property” shall
mean (i) Copyrights; (ii) Patents; (iii) Trademarks; and (iv)
Know-How.
(ww) “Inventory” shall mean all
saleable inventory of Product (other than theophylline tablets) as of the
Closing in finished form (and whether in bulk tablet or final packaged form) and
inventory of finished samples, if any, of each Product which comply with the
applicable NDA or ANDA on hand at Forest as of the Closing.
(xx) “Know-How” shall mean all
methods, processes, techniques, compositions, technology, information, data,
results of tests, studies, statistical and other analyses and expertise, to the
extent related to each Product, to the extent related to the synthesis or
manufacture of each Product or any component thereof, or to the extent
exclusively related to the marketing, selling, offering for sale, distributing
or using each Product, now in possession of Forest or an Affiliate of Forest,
which are at the time of the Closing used in development, formulation,
manufacture, sale or distribution of the Product. Know-How shall
include, without limitation, pharmacology, toxicology, drug stability,
manufacturing and formulation methodologies and techniques, clinical and non
clinical safety and efficacy studies, marketing studies and absorption,
excretion, metabolism studies, quality control and quality assurance, and all
tangible manifestations thereof, subject to Forest’s rights to retain a copy of
documents set forth herein.
(yy) “Knowledge,” “to the Knowledge of” or words
of like import shall mean, with respect to either Party, the knowledge of such
Party’s and its Affiliates’ senior executive officers after having made due
investigation and reasonable inquiry of the officers and management employees of
such Party and its Affiliates and other employees or individuals having
responsibility for such matter(s) or having access to the relevant
information. “Know” shall have a correlative
meaning.
(zz) “Lundbeck” shall have the
meaning set forth in Recital A.
6
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(aaa) “Manufacture and Supply
Agreements” shall mean those agreements (including purchase
orders outstanding and not fulfilled as of the Closing Date) set forth on Schedule 1.01(aaa)
pursuant to which Forest or any of its Affiliates acquires one or more of the
Products in finished form from a Third-Party or engages a Third-Party to process
or manufacture one or more of the Products or active pharmaceutical ingredients
included in such Products or perform any step in the manufacture process, which,
on or as of the Closing Date, shall be assigned to Caraco or its
designee.
(bbb) “Marketing Authorization” shall
mean the approval by a Governmental Authority permitting the marketing, sale and
distribution (and, if applicable, pricing and reimbursement) of each Product,
including, without limitation, the NDAs and the ANDAs, as
applicable.
(ccc) “Marketing Materials and Data”
shall mean all physician lists, customer lists, marketing studies, market
research materials, advertising and promotional materials, other similar
information and data, promotional booths and displays, and all other materials
used in connection with the sale or promotion of the Products whether or not
located at Forest’s offices, to the extent used exclusively in the marketing or
distribution of the Products within the two (2) year period prior to the date
hereof.
(ddd) “Material Adverse Effect” shall
mean any change, event, development, circumstance or effect that has a material
adverse effect on the Purchased Assets, the Assumed Liabilities or the ability
of Caraco and its Affiliates to commercially exploit the Products or any
Product; provided,
however, that none of
the following shall be deemed to constitute, and none of the following shall be
taken into account in determining whether there has been, a Material Adverse
Effect: any change, event, development, circumstance or effect to the extent
arising from or relating to (i) general business or economic conditions, (ii)
national or international political or social conditions, (iii) financial,
banking or securities markets generally, (iv) changes in Applicable Law, (v) any
“act of God,” including, but not limited to, weather, natural disasters and
earthquakes, (vi) a change in the competitive market for the Products or any
Product, (vii) compliance by the Parties or any Affiliate of the Parties with
the terms of this Agreement or any other Transaction Document or (viii) the
announcement of this Agreement or the Settlement Agreement or the transactions
contemplated hereby and thereby, except, in the case of any matter referred to
in any of clauses (i) through (vi), to the extent any of the same affect the
Purchased Assets, the Assumed Liabilities or the ability of Caraco and its
Affiliates to commercialize the Products or any Product in a disproportionate
manner relative to other participants in the pharmaceutical industry in the
relevant jurisdiction or jurisdictions. The Parties agree that the
breach of any representation or warranty contained herein by Forest or any
failure by Forest to perform its obligations hereunder shall not be deemed to be
a Material Adverse Effect to the extent that the breach or failure directly
causes Forest's inability or failure to supply a Product in accordance
with its obligations of Section 5.04(a) (including by reason of
issues of legal compliance, material safety or compliance with best industry
practices) to Caraco, and the offset and payment mechanisms in Section 5.04(b)
and 5.04(c) would cure the economic consequences of such breach or
failure.
7
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(eee) “NDA” shall mean a New Drug
Application, including amendments and supplements thereto, approved by the FDA
in respect of the marketing of a Product in the United States.
(fff)
“Net
Sales” of each Product for a period following the Closing shall mean the
gross proceeds from sales of such Product by Caraco, its Affiliates or permitted
licensees to Third Parties, less (i) allowances for actual returns, discounts,
customary discounts, Credits, adjustments and allowances given to customers,
including discounts made by means of rebates, refunds, Chargebacks or contract
administration fees with customers that are directly related to sales of such
Product (and including rebates or other payments required to be paid to
Governmental Authorities in connection with sales of Product in pursuant to the
Omnibus Budget Reconciliation Act of 1990 and similar or other U.S. Federal or
state legislation or programs); (ii) bad debt actually written off attributable
to sales of such Product; (iii) any taxes or duties included in gross invoice
amounts; and (iv) any other allowances, credits or payments which actually
reduce the selling price of such Product, to the extent consistent with standard
industry practices and as applied by Caraco on a consistent basis with respect
to its generic products generally. Net Sales shall be determined
without regard to deductions, credits, allowances or payments made or applied on
account of or in connection with Caraco’s other products or businesses (for
example, discounts applicable to bundled products). Net Sales shall
be determined in accordance with GAAP.
(ggg) “Offset Amount” shall have
the meaning set forth in Section 5.04(b).
(hhh) “Party; Parties” shall have the
meaning set forth in the Preamble.
(iii) “Patents” shall mean all United
States and foreign patent applications, and letters patent, including, but not
limited to: (i) any and all inventions and improvements described and claimed
therein, and patentable inventions and all patents issuing therefrom or
otherwise corresponding thereto; (ii) the right to xxx or otherwise recover for
any and all past, present and future infringements and misappropriations
thereof; (iii) all income, royalties, damages and other payments now and
hereafter due and/or payable with respect thereto; and (iv) any and all other
rights corresponding thereto and all reissues, divisions, continuations,
continuations-in-part, substitutes, renewals, and extensions thereof, all
improvements thereon, and all other rights of any kind whatsoever accruing
thereunder or pertaining thereto.
(jjj) “Person” shall mean any
individual, firm, corporation, partnership, trust, association, joint venture,
limited liability company, limited liability partnership, Governmental Authority
or other entity of any kind, and shall include any successor (by merger or
otherwise) of such entity.
8
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(kkk)
“Potential Contributor” shall
have the meaning set forth in 9.04.
(lll) “Products” shall mean those
pharmaceutical products approved for marketing in the United States pursuant to
the following NDAs and ANDAs in each case including the specified active
pharmaceutical ingredient as the sole active pharmaceutical ingredient and in
the dosage strength(s), formulation(s) and packaging designated in the
respective NDA and ANDA as approved on the date hereof and as set forth on Schedule
1.01(lll): (i) diltiazem approved pursuant to NDA 20-401
(including Product sold under the Tiazac(R) trademark), (ii) rimantadine
approved in tablet form pursuant to NDA 19-649 (including Product sold under the
Flumadine(R) trademark), (iii) theophylline approved in elixir form pursuant to
ANDA 85-186 (including Product sold under the Elixophyllin(R) trademark), (iv)
theophylline approved in a tablet form pursuant to ANDAs 87-400, 88-320 and
88-321 (including Product sold under the Theochron(R) trademark) and (v)
isosorbide dinitrate approved for marketing pursuant to ANDA 40-009 (including
Product sold under the Isochron(R) trademark).
(mmm) “Product Intellectual Property”
shall mean any and all Intellectual Property now owned or controlled (including,
without limitation, by means of in-license) by Forest or any of its Affiliates
to the extent used in connection with (i) the Products, Marketing Materials and
Data; (ii) the development, manufacture, sale, use, marketing and distribution
of one or more Products; and/or (iii) the synthesis or manufacture of one or
more Products or any component anywhere in the world, in each case to the extent
exclusively related to the marketing, sale, offer to sell, distribution or use
of any such Product in the U.S. or in obtaining Marketing
Authorizations.
(nnn)
“Product
Records” shall mean all books and records that relate primarily or
exclusively to the Products or the Purchased Assets, but only to the extent
relating to events occurring during the two (2) year period prior to the date
hereof, including copies of all material supplier lists, consultant reports,
invention disclosures, laboratory notebooks and records and material
correspondence (excluding invoices) related to the Product or the Purchased
Assets, to the extent maintained by or in the possession of Forest or its
Affiliates or their agents (to the extent owned by Forest or its Affiliates) at
the Closing Date, and all complaint files and adverse event files with respect
to the Product.
(ooo)
“Product Rights Agreements”
shall mean those agreements set forth on Schedule 1.01(ooo)
pursuant to which Forest or any of its Affiliates in-license the ability to
produce, market or sell one or more of the Products from a Third-Party which, on
or as of the Closing Date, shall be assigned to Caraco or its
designee.
(ppp)
“Projections” shall have the
meaning set forth in Section 5.04(b).
9
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(qqq)
“Purchased Assets” shall have
the meaning set forth in Section 2.01.
(rrr)
“Quarter” shall mean the
calendar quarterly periods ending March 31, June 30, September 30 and December
31. The first Quarter following the Closing Date shall include the
period from the Closing Date to the first day of the first full calendar quarter
after the Closing Date.
(sss) “Registrations” shall mean the
regulatory approvals, franchises, authorizations, licenses, certificates,
applications, agreements, permits, exemptions, and other permissions (including
the NDAs and ANDAs) issued by Governmental Authorities.
(ttt) “Representatives” shall have
the meaning set forth in Section 7.01.
(uuu) “Required Consents” shall have
the meaning set forth in Section 3.05.
(vvv)
“Retained Assets” shall mean
all assets of Forest of any type, nature, status or description whatsoever,
other than the Purchased Assets. For purposes of clarity and not of
limitation, “Retained Assets” shall include (i) any Forest intellectual property
other than Product Intellectual Property to be delivered to Caraco pursuant to
this Agreement and (ii) plant, equipment and fixed assets of Forest other than
as expressly included in the Purchased Assets.
(www) “Retained Liabilities” shall
have the meaning set forth in Section 2.04.
(xxx)
“Royalties”
shall have the meaning set forth in Section 2.09.
(yyy) “Safety Data” shall have the
meaning set forth in Section 7.10.
(zzz)
“Settlement Agreement” shall
have the meaning set forth in Recital A.
(aaaa)
“Specifications” shall have the
meaning set forth in Section 3.10.
(bbbb) “Sun” shall have the meaning
set forth in Recital A.
(cccc) “Supply Agreement” shall have
the meaning set forth in Section 5.04(a).
(dddd) “Tax” shall mean (i) any tax,
governmental fee or other like assessment or charge of any kind whatsoever
(including withholding on amounts paid to or by any Person), together with any
interest, penalty, addition to tax or additional amount imposed by any
Governmental Authority responsible for the imposition of any such tax, or (ii)
liability for the payment of any amounts of the type described in (i) as a
result of being party to any agreement or any express or implied obligation to
indemnify any other Person.
10
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(eeee)
“Third
Party” shall
mean a party other than Forest or Caraco or any of their respective
Affiliates.
(ffff) “Trade Channel Days” shall mean
the number of days of consumer utilization maintained by wholesalers and
retailers as of the Closing Date, which the Parties have mutually agreed based
on a good faith estimate to be 21 days (or such other number as the Parties may
agree upon prior to the Closing if information received from wholesalers prior
to the Closing suggests a substantially different number is more
accurate).
(gggg) “Trade Channel Inventory” shall
mean, on a Product-by-Product basis, the amount of Product sold by Forest and
maintained by wholesalers and retailers as of the Closing Date based on a
mutually agreed good faith estimate as set forth on Schedule
1.01(gggg).
(hhhh)
“Trademarks” shall mean the
trademarks owned by Forest or its Affiliates and set forth on Schedule
1.01(hhhh) of the Forest Disclosure
Schedule, including (i) all goodwill associated therewith; (ii) the right to xxx
or otherwise recover for any and all past, present and future infringements and
misappropriations thereof; (iii) all income, royalties, damages and other
payments now and hereafter due and/or payable with respect thereto; and (iv) any
and all other rights corresponding thereto and all other rights of any kind
whatsoever accruing thereunder or pertaining thereto, together in each case with
the goodwill of the business connected with the use of, and symbolized by, each
such trademark.
(iiii) “Transaction Documents” shall
mean, collectively, this Agreement, the Xxxx of Sale, the Assignment and
Assumption Agreement and any other documents, certificates, amendments,
schedules and agreements executed in connection with, or required to be
delivered by, any of the foregoing, but not including the Settlement Agreement
or the Patent Assignment Agreement (as such term is defined in the Settlement
Agreement).
(jjjj) “True-Up Payment” shall have
the meaning set forth in Section 5.04(c).
(kkkk) “Unidentified Claims” shall
have the meaning set forth in Section 7.03.
(llll) “United States” or “U.S.” shall mean the United
States of America, and its territories and possessions, including Puerto Rico
irrespective of its political status.
(mmmm) “WARN Act” shall mean the
Worker Adjustment Retraining and Notification Act of 1988, 29 U.S.C. section
2101, et seq., as amended.
11
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(nnnn) “Warranty Breach” shall have
the meaning set forth in Section 9.02.
(oooo) “Written Statement” shall have
the meaning set forth in Section 2.08.
1.02. Other Definitional
and Interpretative Provisions. Captions are
included for convenience of reference only and shall be ignored in the
construction or interpretation of this Agreement. All Exhibits and
Schedules annexed hereto or referred to herein are incorporated in and made a
part of this Agreement as if set forth in full herein. Any
capitalized terms used in any Exhibit or Schedule but not otherwise defined
therein, shall have the meaning as defined in this Agreement. Any
singular term in this Agreement shall be deemed to include the plural, and any
plural term the singular. Whenever the words “include”, “includes” or
“including” are used in this Agreement, they shall be deemed to be followed by
the words “without limitation”, whether or not they are in fact followed by
those words or words of like import. References to any agreement or
contract are to that agreement or contract as amended, modified or supplemented
from time to time in accordance with the terms hereof and thereof; provided that with respect
to any agreement or contract listed on any schedules hereto, all such
amendments, modifications or supplements must also be listed in the appropriate
schedule. References to any Person include the successors and
permitted assigns of that Person. References from or through any date
mean, unless otherwise specified, from and including or through and including,
respectively. References to “law”, “laws” or to a particular statute
or law shall be deemed also to include any and all Applicable Law.
2.
PURCHASE AND
SALE
2.01. Purchased
Assets. Except as otherwise provided below and upon the terms
and subject to the conditions of this Agreement, Caraco agrees to purchase from
Forest (or any applicable Affiliate of Forest), and Forest agrees to sell,
convey, transfer, assign and deliver, or cause to be sold, conveyed,
transferred, assigned and delivered, to Caraco at the Closing, free and clear of
all Encumbrances, subject to Section 5.01, all of Forest’s and its Affiliates’
right, title and interest in, to and under the assets referenced in clauses (a)
through (j) below (collectively, the “Purchased Assets”), to the
extent related to one or more Products:
(a) the
Product Intellectual Property;
(b) the
Closing Date Inventory;
(c) the
Product Rights Agreements;
(d) the
Manufacture and Supply Agreements;
(e) the
Assigned Customer Agreements;
12
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(f)
the Marketing Materials and Data;
(g) all
rights or claims of Forest or any of its Affiliates in respect to any of the
foregoing against any third party including, without limitation, any prior owner
of Product Intellectual Property but excluding any right of Forest to receive
payment for Product shipped prior to Closing;
(h) the
Registrations, including the NDAs and the ANDAs identified on Schedule
2.01(h);
(i)
the Product Records or true and correct copies of the Product
Records (but only to the extent reasonably capable of being delivered at
Closing, it being understood that Caraco will continue to have access to any
Product Records not delivered at Closing as provided in Section 7.02
below);
(j)
all goodwill relating to any of the
above.
To the
extent any Product Intellectual Property has applicability to products other
than to the Products or to the synthesis or manufacture of the Products, the
assignment of Product Intellectual Property hereunder shall be limited to the
grant, at Closing, of an irrevocable, worldwide, perpetual license to reproduce,
use, modify, adapt, create improvements to and/or create derivative works of
such Product Intellectual Property solely to the extent related to the relevant
Product.
Forest
may retain a copy of all documents or materials included in the Purchased Assets
for archival purposes, for purposes of fulfilling its obligations under this
Agreement and under Applicable Law and to the extent such documents or materials
include or relate to Retained Assets or Retained Liabilities.
2.02. Customer
Agreements. With respect to each Customer Agreement that
relates to a bundle of products which includes other Forest products in addition
to one or more of the Products, Forest shall continue to administer such
agreements (including the payment of all Chargebacks, Credits, rebates and
returns and the resolution of any disputes concerning the same) to the extent
related to the Products for the benefit of and the account (including costs) of
Caraco from and after the Closing Date until the expiration of the current term
of such Customer Agreement, but shall have no obligation to renew or extend the
term of such agreement with respect to such Product or
Products. Forest shall deal exclusively with such Customers with
respect to such Customer Agreements; provided, however, that any orders for
Products made pursuant to such Customer Agreements shall be referred to Caraco
and shall be filled by Caraco. For the sake of clarity, with respect
to Customer Agreements which contain evergreen renewal provisions, Forest shall
have the right to terminate such agreements prior to the next
renewal. In order to give effect to the foregoing, Forest will
collaborate with Caraco with respect to the Customer Contracts being
administered by Forest on Caraco’s behalf pursuant to this Section to enable
Caraco to smoothly transition the Products from such Customer Agreements to
agreements to which Caraco is a party, including by providing advance notice of
any contract expiration or termination. During the period in which
Forest is administering a Customer Agreement on Caraco’s behalf, Forest shall
consider any requests by Caraco to participate in interactions with the Customer
or requests for authorization to correspond directly with the Customer in
connection with such agreement, in each case to the extent related to the
Products, provided however, such decision shall be made in Forest’s sole
discretion.
13
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2.03. Retained
Assets. Notwithstanding anything contained in this Agreement
to the contrary, from and after the Closing, Forest and its Affiliates, as
applicable, shall retain all of their right, title and interest in and to the
Retained Assets.
2.04. Retained
Liabilities. Upon the terms and subject to the conditions of
this Agreement, Forest and its applicable Affiliates shall retain the following
obligations and liabilities (whether known or unknown, accrued, absolute,
contingent or otherwise) relating to or arising out of the Purchased Assets, but
only to the extent any such obligation or liability is not an Assumed Liability
(the “Retained
Liabilities”):
(a) any
and all liabilities and obligations arising under or related to the WARN Act,
and any applicable state or local notification law with respect to a layoff or
plant closing relating to the sale of the Purchased Assets as contemplated
herein that occurred on, before or after the Closing Date;
(b) all
product liability and similar claims, whether made before or after the Closing
Date, for injury to person (including death) or property (real or personal) in
connection with the manufacture, storage, handling, shipment or sale by Forest
or any Affiliate of Forest of the Products prior to the Closing Date,
and after the Closing Date to the extent arising from Forest’s or its Third
Party Designee’s failure to comply with: (a) Applicable Law (including current
Good Manufacturing Practices (as set forth in C.F.R. 21 Parts 210 and 211, or
any successor law or regulation thereto); (b) the specifications for the
Products or the facilities; or (c) any other quality or legal standards
applicable under the Supply Agreement, in each case with respect to the
manufacturing and supply of Products to be supplied by Forest to Caraco pursuant
to Section 5.04(a) hereof, except to the extent such claim arises out of an act
(other than the sale of a Product in the ordinary course of business) or
omission of Caraco or its Affiliates on or after the Closing Date;
(c) all
liabilities and obligations in respect of returns, recalls, rebates, retrofits
and warranty claims, whether arising before or after the Closing, for Products
sold to Customers by Forest or any of its Affiliates prior to the Closing Date,
and except for rebates for Products sold to Customers by Caraco or any of its
Affiliates, after the Closing Date to the extent returns, recalls, retrofits and
warranty claims arise from Forest’s failure to comply with: (a) Applicable Law
(including current Good Manufacturing Practices (as set forth in C.F.R. 21 Parts
210 and 211, or any successor law or regulation thereto); (b) the specifications
for the Products or the facilities; or (c) any other quality or legal standards
applicable under the Supply Agreement, in each case with respect to the
manufacturing and supply of Products to be supplied by Forest to Caraco pursuant
to Section 5.04(a) hereof; and
14
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(d) all
other liabilities and obligations of Forest and its Affiliates, other than
Assumed Liabilities, based upon or arising out of any act or omission of Forest
or its Affiliates occurring prior to the Closing Date, including any liability
relating to Product design or infringement arising out of any act or omission of
Forest or its Affiliates occurring prior to the Closing Date, or any matters or
events occurring prior to the Closing Date, including without limitation, any
such liabilities or obligations disclosed on any Schedule attached hereto, and
all other liabilities and obligations of Forest and its Affiliates (other than
the Assumed Liabilities) arising on or after the Closing Date to the extent
caused by Forest’s failure to comply with: (a) Applicable Law (including current
Good Manufacturing Practices (as set forth in C.F.R. 21 Parts 210 and 211, or
any successor law or regulation thereto); (b) the specifications for the
Products or the facilities; or (c) any other quality or legal standards
applicable under the Supply Agreement, in each case with respect to the
manufacturing and supply of Products to be supplied by Forest to Caraco pursuant
to Section 5.04(a) hereof.
2.05. Assumed
Liabilities. Upon the terms and subject to the conditions of
this Agreement, Caraco agrees, effective at the time of the Closing, to assume
the following obligations and liabilities of Forest and its Affiliates (the
“Assumed
Liabilities”):
(a) all
liabilities and obligations of Forest or any of its Affiliates arising under the
Product Rights Agreements, Manufacture and Supply Agreements and the Assigned
Customer Agreements, but only to the extent any such obligation or liability
arises from and after the Closing Date; and
(b) any
ongoing fees, costs or expenses related to the Products, including maintenance
fees, payable with respect to the Registrations, to the extent such fees become
due and payable after the Closing Date.
Caraco
shall not be liable or obligated for any of the Retained Liabilities and nothing
in this Agreement shall be construed in any manner to constitute an assumption
by Caraco or any of its Affiliates of any Retained Liability. Forest
and its Affiliates shall retain and pay and perform when due all of the Retained
Liabilities.
2.06. Closing Date
Inventory. Prior to the Closing Date, the Parties shall
cooperate in good faith to provide information to Caraco as to Inventory
(including number of units, lot numbers, dosage strengths and dating) which
Forest reasonably expects to have available as of the Closing Date and as to
Caraco’s anticipated requirements for Products following the Closing
Date. In connection with any Inventory that has less than 18 months
of remaining shelf-life, such Inventory shall not automatically be included in
the Closing Date Inventory (as defined below); provided that the Parties
will cooperate to try to use such Inventory, and such Inventory may be included
in the Closing Date Inventory if it can be reasonably anticipated that Caraco
will be able to sell such Inventory in the ordinary course following the Closing
Date, recognizing that Caraco shall have the final decision making authority in
that regard. At least two (2) Business Days prior to the Closing
Date, Forest shall provide Caraco with a written notice (the “Closing Inventory Notice”)
setting forth the number of units of each item included in Inventory to be
transferred to Caraco at the Closing pursuant to Section 2.01. The
Inventory actually delivered to Caraco pursuant to Section 2.07(b)(iii) is
hereinafter referred to as the “Closing Date
Inventory”.
15
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2.07. Closing. Unless
this Agreement shall have been terminated in accordance with Section 8, the
closing (the “Closing”)
of the purchase and sale of the Purchased Assets hereunder shall take place at
the offices of Dornbush Xxxxxxxxx Xxxxxxxx & Xxxxxxxx, LLP, 000 Xxxxx
Xxxxxx, Xxx Xxxx, Xxx Xxxx 00000, as soon as possible, but in no event later
than ten (10) Business Days after satisfaction of the conditions set forth in
Section 8, or at such other time or place as Forest and Caraco may agree in
writing (the “Closing
Date”). Notwithstanding the immediately preceding sentence, it
is understood and agreed that, to facilitate closing logistics, various
Purchased Assets may be delivered at one or more mutually acceptable locations
and that, if the Parties so agree, a “physical closing” may not be
necessary. The following shall be delivered in connection with the
Closing at the times specified below:
(a) At
the Closing, Caraco shall deliver or cause to be delivered to
Forest:
(i) [* * *] as a non-refundable
advance against the Royalties payable pursuant to Section 2.09(a) (the “Advance Royalty Amount”) in
immediately available funds by wire transfer to an account designated by Forest,
by notice to Caraco not later than two (2) Business Days prior to the Closing
Date (or if not so designated, then by certified or official bank check payable
in immediately available funds to the order of Forest in such
amount);
(ii) a
certificate, dated as of the Closing Date and signed by a duly authorized
officer of Caraco, to the effect that all corporate proceedings required to be
taken by Caraco in connection with the transactions contemplated hereby have
been taken and the representations and warranties of Caraco made herein are true
and correct as of the Closing Date except to the extent that inaccuracies
thereto when taken in the aggregate would not have a Material Adverse
Effect;
16
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(iii) duly
executed counterparts of the assignment and assumption agreement with respect to
the Product Rights Agreements, the Manufacture and Supply Agreements and the
Assigned Customer Agreements in substantially the
form attached hereto as Exhibit
B or as otherwise revised pursuant to Section 5.01 (the “Assignment and Assumption
Agreement”);
(iv) duly
executed counterpart of the Supply Agreement; and
(v) duly
executed counterpart of a Trademark assignment agreement in form mutually agreed
by the Parties.
(b) At
the Closing, Forest shall deliver or cause to be delivered to
Caraco:
(i)
physical possession (or the implementation
of arrangements reasonably satisfactory to the Parties for the transfer and
delivery of physical possession) of all tangible personal property (or copies
thereof) included in the Purchased Assets, including all tangible personal
property included in the Product Intellectual Property, the Know-How and the
Marketing Materials and Data and appropriate documents of transfer related
thereto in form and substance reasonably acceptable to Caraco and
Forest;
(ii)
a Xxxx of Sale for the Purchased Assets and assignments
of the Product Intellectual Property duly executed on behalf of Forest or its
Affiliates, as the case may be, in substantially the form attached hereto as
Exhibit C (the “Xxxx of Sale”);
(iii) the
Closing Date Inventory (or the implementation of arrangements reasonably
satisfactory to the Parties for the transfer and delivery of the Closing Date
Inventory);
(iv) a
certificate, dated as of the Closing Date and signed by a duly authorized
officer of Forest, to the effect that (a) all liabilities or obligations of
Forest under the Biovail Agreements have been satisfied, including, without
limitation, the payment of all royalties due and owing to Biovail Laboratories,
Incorporated through the Closing Date, and (b) all corporate proceedings
required to be taken by Forest in connection with the transactions contemplated
hereby have been taken and specifying in reasonable detail the extent, if any,
that the representations and warranties of Forest made herein are not true and
correct as of the Closing Date;
(v) duly
executed counterparts of the Assignment and Assumption Agreement
(vi) duly
executed counterpart of the Supply Agreement;
17
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(vii) duly
executed counterpart of a Trademark assignment agreement in form mutually agreed
by the Parties;
(viii) Except
as otherwise provided in Section 5.01, the duly executed Required
Consents;
(ix) duly
executed notices to the relevant Third Party manufacturers under the Manufacture
and Supply Agreements advising such manufacturers of the Closing of the
transaction and providing instructions for delivery of Product to Caraco
following the Closing Date; and
(x) copies
of notifications to Governmental Authorities effecting the transfer of the NDAs
and ANDAs and any other Marketing Authorization to Caraco, in customary
form.
(c) Following
the Closing, within 5 Business Days following delivery of the Closing Date
Inventory, Caraco shall deliver to Forest an aggregate amount equal to the
product of (i) the number of units of each item of Inventory included in the
Closing Date Inventory and (ii) the Closing Date Inventory Purchase Price of
each such item. Caraco shall deliver such amount in immediately
available funds by wire transfer to an account designated by Forest by notice to
Caraco (or if not so designated, then by certified or official bank check
payable in immediately available funds to the order of Forest in such
amount).
2.08. Post-Closing
Adjustments. Caraco shall be responsible for remitting all
payments arising under the Product Rights Agreements from and after the Closing
Date. Notwithstanding the foregoing, royalties payable pursuant to
the Product Rights Agreements after the Closing Date with respect to sales of
Products shipped by Forest or its Affiliates prior to the Closing Date shall be
for Forest’s account. Within fifteen (15) days after the last day of
the royalty period under the applicable Product Rights Agreement in which the
Closing Date occurs, each Party shall provide the other Party with a written
statement (the “Written
Statement”) setting forth its net sales for such period (as determined in
accordance with the terms of the applicable Product Rights Agreement) with
respect to the relevant Product(s) covered by such agreement, which statement
shall be accompanied by reasonable supporting documentation. Caraco and Forest shall
collaborate to calculate each Party’s share of applicable royalty
obligations. Forest shall remit any amounts due Caraco pursuant to
this Section to Caraco within fifteen (15) days following the Parties completion
of the allocation of applicable royalty obligations for such
period. Each Party may, from time to time upon reasonable notice and
request to the other Party, audit net sales information reported to it by the
other Party in the Written Statement, and shall reasonably cooperate with any
such audit or inquiry by the other Party with respect to the amount or validity
of its reported net sales information, subject to reasonable confidentiality
obligations.
2.09. Post-Closing
Royalty Payments.
18
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(a) As
additional consideration for the Purchased Assets, Caraco agrees to pay Forest
commencing after the Closing Date and for so long as it or any of its Affiliates
or any of their respective successors or assigns is selling a Product, on a
Quarterly basis in arrears running royalties payable on Net Sales in accordance
with the following (such Quarterly payments, the “Royalties”):
Product
|
Royalty
(%
of Net Sales)
|
Diltiazem
(including sales under the Tiazac(R) trademark)
|
[*
* *]
|
Rimantadine
(including sales under the Flumadine(R) trademark)
|
[*
* *]
|
Isosorbide
Dinitrate (including Product sold under the Isochron(R)
trademark)
|
[*
* *]
|
Theophylline
(including Product sold under the Theochron(R) trademark)
|
[*
* *]
|
Theophylline
in elixir form sold under the Elixophyllin(R) trademark
|
[*
* *]
|
(b) The
Royalties shall be payable Quarterly in Dollars within fifteen (15) Business
Days of the end of the Quarter to which each payment relates and shall be
reconciled on an annual basis together with the payment applicable to the fourth
Quarter of each Contract Year. Each payment of Royalties shall be
accompanied by a statement setting forth the amount of gross sales and Net Sales
for the Quarter in sufficient detail to confirm the accuracy of the payment made
(expressed in the currency of sale and units sold), the calculation of Royalties
due and the exchange rate used to convert Net Sales recorded in currencies other
than Dollars to Dollars. Net Sales recorded in
currencies other than Dollars shall be converted into Dollars for purposes of
calculating Royalties based upon the thirty (30) day average (as of the date
such Net Sales are recorded by Caraco) of the applicable currency exchange rate
published by the New York edition of The Wall Street Journal or if the New York
edition of The Wall Street Journal is not then published on a regular basis,
then such other financial periodical of general circulation in the United States
as may be widely recognized by persons active in the financial services and
banking industries. Notwithstanding the foregoing, no payments in
respect of Royalties shall be made to Forest pursuant to this Section 2.09 until
the aggregate amount of Royalties exceeds the Advance Royalty Amount, and then
only to the extent of such excess.
19
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(c) All
Royalty payments hereunder shall be made free and clear of any Taxes or
Encumbrances, except for withholding Taxes, if applicable. If any
Taxes are required to be withheld, Caraco shall (i) send proof of the payment of
such withholdings Taxes to Forest and certify its receipt by the relevant
Governmental Authority within 30 days following such payment and (ii) cooperate
in good faith with Forest in obtaining a refund of, or credit with respect to,
any such payments.
(d) If
any payment due under this Section 2 is not made when due, the payment shall
accrue interest at a rate per annum equal to the Agreed Rate.
3.
REPRESENTATIONS AND WARRANTIES
OF FOREST
Except as
set forth in Schedule
3 attached hereto (the “Forest Disclosure Schedule”),
Forest represents and warrants to Caraco, as of the date hereof (except to the
extent expressly made as of another date, in which case, solely as of such
date), as follows:
3.01. Corporate Existence
and Power. Forest and each Affiliate of Forest that is a party
to any Transaction Document is duly incorporated or organized, validly existing
and in good standing under the laws of its jurisdiction of organization and has
all organizational powers and all material governmental licenses,
authorizations, permits, consents and approvals required to carry on its
business as now conducted. Forest and each such Affiliate of Forest
is duly qualified to do business and is in good standing in each jurisdiction
where such qualification is necessary.
3.02. Corporate
Authorization. The execution, delivery and performance by
Forest of this Agreement and by Forest and each Affiliate of Forest of each
other Transaction Document to which it is a party and the consummation of the
transactions contemplated hereby and thereby are within Forest’s (and each
relevant Affiliate’s) corporate, partnership, limited liability company or other
entity powers and have been duly authorized by all necessary corporate,
partnership, limited liability company or other entity action on the part of
Forest and any relevant Affiliates of Forest. This Agreement and each
other Transaction Document to which it is a party constitutes a legal, valid and
binding obligation of, and is enforceable against, Forest and each relevant
Affiliate of Forest except as may be limited by bankruptcy, insolvency,
reorganization, moratorium and other similar laws and equitable principles
related to or limiting creditors’ rights generally and by general principles of
equity and further.
20
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3.03. Governmental
Authorization. Other than as set forth on Schedule 3.03 of the
Forest Disclosure Schedule, the execution, delivery and performance by Forest of
this Agreement, and by Forest and each Affiliate of Forest that is a party to
any Transaction Document, of each of the other Transaction Documents to which it
is a party and the consummation of the transactions contemplated hereby and
thereby require no action by or in respect of, or filing with, any Governmental
Authority. Schedule 3.03 of the
Forest Disclosure Schedule lists all material correspondence between Forest and
the FDA or other applicable Governmental Authority sent or received from and
after January 1, 2008 through the date hereof which relate exclusively to (i)
the manufacturing and testing of the Product, (ii) regulatory warning letters
with respect to the Products, (iii) the withdrawal of any Products from the
marketplace or (iv) the safety and efficacy of the Products.
3.04. Noncontravention;
Licenses and Permits. The execution, delivery and performance
by Forest of this Agreement, and by Forest and each Affiliate of Forest that is
a party to any Transaction Document, of each of the other Transaction Documents
to which it is a party and the consummation of the transactions contemplated
hereby and thereby do not and will not (i) violate the organizational documents
of Forest or any relevant Affiliate of Forest, (ii) assuming compliance with the
matters referred to in Section 3.03, violate any Applicable Law, (iii) assuming
the obtaining of all Required Consents, violate or result in the breach of,
constitute a default under, or accelerate the performance required by, (A) any
term of any covenant, agreement or understanding to which Forest or any of its
Affiliates is a party which is materially related to the Purchased Assets or
Forest’s or any of its Affiliates’ ability to consummate the transactions
contemplated by each Transaction Document to which they are a party, or (B) any
judgment, order, decree, law, rule or regulation to which Forest or any of its
Affiliates is subject or (iv) result in the creation or imposition of any
Encumbrances on any Purchased Asset.
3.05. Required
Consents. Schedule 3.05 of the
Forest Disclosure Schedule sets forth each agreement or other instrument binding
upon Forest or any of its Affiliates requiring a consent or other action by any
Third Party (including any Governmental Authority) as a result of the execution,
delivery and performance of this Agreement, including, without limitation, the
assignment to Caraco or its Affiliates of the Product Rights Agreements, the
Manufacture and Supply Agreements and the Assigned Customer Agreements (the
“Required
Consents”).
3.06. Title to Purchased
Assets; Encumbrances. Forest or one or more of its Affiliates
have, and on the Closing Date will have, good title to the Purchased Assets
which are owned by Forest or such Affiliate, free and clear of all Encumbrances
whatsoever. Subject only to the securing of the Required Consents,
Forest or one or more of its Affiliates has the valid and exclusive right to
possess, use and transfer the Purchased Assets; in each case, which right shall
be fully transferred to Caraco at the Closing pursuant to the terms and
conditions of this Agreement. The Purchased Assets constitute all of
Forest’s and its Affiliates’ assets of the type and
nature of assets constituting the Purchased Assets as enumerated in Section 2.01
relating primarily or exclusively to the Products.
21
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3.07. Claims;
Litigation. Other than as set forth on Schedule 3.07 of the
Forest Disclosure Schedule, (i) there is no action, suit, investigation or
proceeding pending against, or to the Knowledge of Forest, threatened against or
affecting, the Purchased Assets (including, without limitation, claims in the
nature of product liability or patent or other Intellectual Property
infringement) before any arbitrator or any Governmental Authority or which in
any manner challenges or seeks to prevent, enjoin, alter or materially delay the
transactions contemplated by this Agreement or the other Transaction Documents;
(ii) no officer, director, manager, employee, consultant or agent of Forest or
any of its Affiliates is asserting or has asserted any claim or right in any
Product or Purchased Asset and (iii) Forest and its Affiliates have not received
any written notice from any Governmental Authority or any Person in the two (2)
year period prior to the date hereof alleging any violation of or liability with
respect to any Product or Purchased Asset which could result in a lien or claim
against the Purchased Assets or could reasonably be anticipated to interfere
with the commercialization of a Product by Caraco in substantially the same
manner as such Product has been commercialized by Forest as of the Closing Date,
and do not Know of any reasonable basis for any such actions, suits,
investigations, proceeding, claims, rights or allegations.
3.08. Product
Intellectual Property.
(a) Forest
or one or more of its Affiliates own all right, title and interest in and to all
of the Forest or Affiliate owned Product Intellectual Property, and the full
right and interest in and to the in-licensed Product Intellectual Property, for
use in the United States and, assuming compliance with the matters referred to
in Section 3.03 and the receipt of the Required Consents, is legally entitled to
transfer to Caraco all of the Product Intellectual Property, free and clear of
all Encumbrances and free of license or royalty obligations to any third party
whatsoever (other than those designated as in-licensed). Schedule 3.08(a) of
the Forest Disclosure Schedule describes all such owned Product Intellectual
Property and in-licensed Product Intellectual Property. Except with
respect to the in-licensed Product Intellectual Property, no Third Party
(including, for this purpose, directors, officers, employees or other
consultants to or agents for Forest or any of its Affiliates) has any legal or
beneficial interest in the Product Intellectual Property.
(b) No
claim of ownership, infringement or invalidity adverse to the ownership or use
by Forest or any of its Affiliates of any of the Product Intellectual Property
(including without limitation, any such claim by any shareholder, officer,
director, manager, employee, consultant or agent of Forest or any of its
Affiliate) has been asserted. Forest does not Know of any reasonable
basis for anyone to assert that the development, modification, manufacture,
importation, sale, marketing, promotion or use of the Products as performed by
Forest or its Affiliates prior to the Closing Date infringes or misappropriates
the intellectual property rights of any Third Party.
22
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(c) Set
forth on Schedule
3.08(c) of the Forest Disclosure Schedule is a true, correct and complete
list of the Product Intellectual Property owned by Forest to be assigned to
Caraco and licensed to Caraco under this Agreement.
(d) Forest
has no Knowledge of any prior use, infringement, piracy or counterfeiting of any
Trademarks, any superior rights by any third party in any Trademarks, or any
adverse claims pertaining to any Trademarks, and does not Know of a reasonable
basis for any such claim.
(e) With
respect to all registered Patents and Trademarks, Forest and/or its Affiliates
have properly executed and recorded all documents necessary to perfect their
respective title in the United States to the Patents and Trademarks, and Forest
has filed all documents and paid all taxes, fees, and other financial
obligations required to renew and maintain in force and effect all such Product
Intellectual Property until Closing. Forest and its Affiliates have
not taken any action (or failed to take any actions) that has resulted in the
loss, lapse, abandonment, invalidity or unenforceability of any Product
Intellectual Property.
(f) The
execution, delivery and performance of this Agreement by Forest and each
Affiliate of Forest that is party to any Transaction Document will not (i)
result in Forest (including its Affiliates and predecessors in interest)
granting to any Person, other than Caraco, any rights or licenses to any Product
Intellectual Property, (ii) impair the right, title or interest of Caraco in or
to any of the Product Intellectual Property or (iii) result in any modification
of rights and obligations under any contract to which Forest or any of its
Affiliates is a party, such that Caraco’s use of the Purchased Assets is subject
to restrictions, impairments or payments that did not apply to Forest’s use of
such Purchased Assets in such manner prior to the Closing Date.
(g) Forest
(including its Affiliates and predecessors in interest) has taken all reasonable
steps to protect the Know-How, including requiring each current and former
employee and independent contractor of Forest (including its Affiliates and
predecessors in interest) that contributed to the Product Intellectual Property
to enter into agreements with Forest (including its Affiliates and predecessors
in interest) pursuant to which he, she or it agrees to protect the confidential
information of Forest (including its Affiliates and predecessors in interest)
and assign (and has assigned) to Forest all intellectual property related to the
Product created in the course of his, her or its employment or other
relationship with Forest (including its Affiliates and predecessors in interest)
to the extent permitted by Applicable Law.
3.09. Contracts. Set
forth on Schedule
3.09 of the Forest Disclosure Schedule is a true, correct and complete
list of the Product Rights Agreements, the Manufacture and Supply Agreements
and the Customer Agreements. Other than the agreements set forth on
Schedule 3.09
of the Forest Disclosure Schedule, there are no material contracts relating to
or affecting the Product or the Purchased Assets. The Product Rights
Agreements, the Manufacture and Supply Agreements and the Customer Agreements
are in full force and effect, without revocation or change, and neither Forest
nor, to the best of Forest’s Knowledge, any other party to any of the Product
Rights Agreements, the Manufacture and Supply Agreements or the Customer
Agreements is in material default of its respective obligations thereunder, nor
does any condition exist which, with notice or lapse of time or both, would
constitute a material breach by any such party of its respective obligations
under any of the Product Rights Agreements, the Manufacture and Supply
Agreements or the Customer Agreements. Forest is not aware of any
dispute with respect to the performance of any material term or condition of any
of the Product Rights Agreements, the Manufacture and Supply Agreements or the
Customer Agreements.
23
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3.10. Specifications. The
Products, as manufactured, sold and delivered by Forest or its Affiliates on or
prior to the date hereof were (i) manufactured, packaged, labeled, stored, sold
and shipped in compliance with the applicable NDA or ANDA, and with the quality
control procedures, formulae and specifications (collectively, “Specifications”) in compliance
with all applicable FDA, and federal, state and local laws and regulations,
including, without limitation, applicable current Good Manufacturing Practice
regulations promulgated by the FDA and all rules and regulations promulgated
thereunder; and (ii) free from all defects in manufacture, storage, packaging
and the printing and affixing of labels. The Closing Date Inventory
is labeled in compliance with all applicable FDA and state and local
regulations. The Specifications comply with all applicable FDA and
corresponding state and local regulations, including, without limitation,
applicable current Good Manufacturing Practice regulations promulgated by the
FDA. The NDAs and the ANDAs remain in effect and Forest or its
relevant Affiliate has submitted, or, to the best of Forest’s Knowledge, the
relevant Third-Party licensor of the Product has submitted, all reports to the
FDA with respect to the NDAs and ANDAs required to have been submitted prior to
the date hereof. Forest has paid or has caused to be paid all fees
applicable to its ownership of the NDAs and ANDAs for all periods prior to the
Closing.
3.11. FDA
Matters.
(a) All
Registrations held by Forest are set forth in Schedule 3.11(a) of
the Forest Disclosure Schedule. Other than as set forth on Schedule 3.11(a) of
the Forest Disclosure Schedule: (i) the approved NDAs and ANDAs provide Forest
with the legal right to market the Products in the United States in accordance
with such NDAs and ANDAs, including all of its approved supplements; (ii) Forest
has all Registrations from the FDA required for it to develop and manufacture
the Products and such Registration are in full force and effect, subject only to
certain supplements which may be necessary as a result of changes in the
location of the manufacture of one or more Products; (iii) to the Knowledge of
Forest, there are no facts that would prevent the satisfaction of, or compliance
with, any additional FDA requirements for marketing or distributing the Products
in the United States. Forest has not received any notice that the FDA
is, or may consider limiting, suspending, or revoking such Registrations; (iv)
to Forest’s Knowledge, there is no false or misleading information or
significant omission in an application, submission, or any other communication
to the FDA regarding the Products; (v) subject only to certain supplements which
may be necessary as a result of changes in the location of the manufacture of
one or more Products, Forest has fulfilled and performed its obligations under
each Registration in all respects, and no event has occurred or condition or
state of facts exists which would constitute a breach or default that would
cause revocation or termination of any such Registration; and, (vi) to the
Knowledge of Forest, each Third Party supplier or manufacturer that is a party
to a Product Rights Agreement or Manufacture and Supply Agreement complies with
all applicable requirements of the FDA (including any drug establishment
registration, drug listing, and good manufacturing requirements) to supply the
Product to, or manufacture the Product for, Forest.
24
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(b) Subject
only to certain supplements which may be necessary as a result of changes in the
location of the manufacture of one or more Products and the information set
forth on Schedule
3.11(a) of the Forest Disclosure Schedule, Forest is in compliance with
the Act and all applicable statutes, rules, regulations, standards, guidelines,
registrations, policies and orders administered or issued by the FDA with
respect to the Products and the Purchased Assets, including new drug approval,
investigational new drugs, annual reporting, good manufacturing practices,
record-keeping, adverse event reporting and labeling.
(c) Other
than as set forth on Schedule 3.11(a) of
the Forest Disclosure Schedule: (i) Forest is not subject to any
obligation arising under any FDA administrative or regulatory action or from any
FDA inspection, FDA warning letter, FDA notice of violation letter, recall
notice, or any other notice from the FDA to Forest or its Affiliates alleging a
violation of any Applicable Law or required Registration, or any response or
other commitment made to or with the FDA regarding the Product or the Inventory,
other than obligations arising from ownership of the Registrations that are
required by the FDA and set forth in the Act or in the approval letters for the
NDAs or ANDAs and set forth in the FDA regulations, and (ii) Forest has not
received any written or other notice from the FDA within the period beginning
two (2) years prior to the date hereof alleging that the Products or the
Inventory is the subject of any pending or threatened investigation in the
United States and, to the Knowledge of Forest, there are no facts or
circumstances that would reasonably be expected to give rise to any such
notice.
3.12. Taxes. There
are no liens for Taxes (other than liens for current Taxes not yet due and
payable) on the Purchased Assets. There is no action in respect of
Taxes pending, or, to Forest’s Knowledge, threatened, that would result in such
a lien. To the extent a breach of the following would result in a
liability of Caraco for Taxes to any Person, whether as a result of applicable
law, contract or otherwise, (a) Forest has timely paid all Taxes that have
become due or payable and has timely filed all Tax returns it is required to
have filed, and (b) all such Tax returns were correct and complete in all
material respects.
25
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3.13. Product
Records. Since the date which is two (2) years prior to the
date hereof, all of the Product Records have been maintained in accordance, in
all material respects with Applicable Law and generally accepted business
practices.
3.14. Closing Date
Inventory. As of the Closing Date,
all Closing Date Inventory is in good and marketable condition and is in
substantial compliance with all Applicable Law applicable to its manufacture,
labeling and storage.
3.15. Finders
Fees. There is no investment banker, broker, finder or other
intermediary which has been retained by or is authorized to act on behalf of
Forest who might be entitled to any fee or commission in connection with the
transactions contemplated by this Agreement or the other Transaction Documents
which would be payable by Caraco in whole or in part.
3.16. Completeness of
Certain Schedules. Schedule 1.01(ooo)
lists all those agreements pursuant to which Forest or any of its Affiliates
in-license the ability to produce, market or sell one or more of the Products
from a Third-Party. Schedule 1.01(aaa)
lists all agreements (including purchase orders outstanding and not fulfilled as
of the Closing Date) pursuant to which Forest or any of its Affiliates acquires
one or more of the Products in finished form from a Third-Party or engages a
Third-Party to process or manufacture one or more of the Products or active
pharmaceutical ingredients included in such Products or perform any step in the
manufacture process, which, on or as of the Closing Date, shall be assigned to
Caraco or its designee. Schedule 1.01(gg)
lists all agreements pursuant to which Forest or any of its Affiliates sells one
or more of the Products to a Customer or provides rebates or discounts to a
Customer determined by utilization of a Product. Schedule 1.01(gg),
under the heading “Customer Agreements,” lists all agreements pursuant to which
Forest or any of its Affiliates sells one or more of the Products to a Customer
or provides rebates or discounts to a Customer determined by utilization of a
Product which exclusively cover the Products (i.e. do not relate to a bundle of
products including products other than the Products).
3.17. Financial
Data. Forest has provided Caraco with the financial data
referenced in Schedule
3.17 of the Forest Disclosure Schedule. All such information
is derived from the books and records maintained by Forest in the ordinary
course of its business, and is complete and accurate for the periods
indicated. Forest makes no representation or warranty as to any Cost
of Goods information with respect to theophylline tablets which may be included
in Schedule
3.17 with respect to the first year only, however, Forest agrees that
this in no way affects the accuracy or reliability of the amounts set forth on
Schedule
5.04(b) and Forest will not claim otherwise.
3.18. Customers and
Suppliers. Schedule 3.18 of the
Forest Disclosure Schedule lists the Customers of the Products for each of the
two (2) most recent fiscal years and sets forth opposite the name of each such
Customer the dollar amount of net sales to such Customer on a Product-by-Product
basis, taking into account chargebacks, rebates, credits and other discounts
attributable to such Customer, but not reflecting adjustments for unapplied
chargebacks, rebates credits or discounts generally attributable to such
Products. No supplier of Forest or its Affiliates have indicated to
Forest or its Affiliates that it will stop, or materially decrease the rate of,
supplying materials, products or services and no Customer of the Products has
indicated to Forest or its Affiliates that it will stop, or materially decrease
the rate of, purchasing materials, products or services.
26
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3.19. Full
Disclosure. No representation or warranty of Forest contained
in this Agreement or in any schedule hereto or in any Transaction Document
delivered to Caraco pursuant hereto or in connection herewith and none of the
written data or information furnished or made available to Caraco by Forest
(including, without limitation, any financial statements) contains an untrue
statement of a material fact or omits to state a material fact required to be
stated therein or necessary to make the statements made, in the context in which
made, not false or misleading.
4.
REPRESENTATIONS AND WARRANTIES OF CARACO
Caraco
represents and warrants to Forest as of the date hereof that:
4.01. Corporate Existence
and Power. Caraco is duly incorporated or organized, validly
existing and in good standing under the laws of its jurisdiction of organization
and has all organizational powers and all material governmental licenses,
authorizations, permits, consents and approvals required to carry on its
business as now conducted. Caraco is duly qualified to do business
and is in good standing in each jurisdiction where such qualification is
necessary.
4.02. Corporate
Authorization. The execution, delivery and performance by
Caraco of this Agreement and each other Transaction Document to which it is a
party and the consummation of the transactions contemplated hereby and thereby
are within Caraco’s corporate powers and have been duly authorized by all
necessary corporate action on the part of Caraco. This Agreement and
each other Transaction Document to which it is a party constitutes a legal,
valid and binding obligation of, and is enforceable against, Caraco, except as
may be limited by bankruptcy, insolvency, reorganization, moratorium and other
similar laws and equitable principles related to or limiting creditors’ rights
generally and by general principles of equity and further.
4.03. Governmental
Authorization. Except as set forth on Schedule 4.03, the
execution, delivery and performance by Caraco of this Agreement the other
Transaction Documents to which it is a party and the consummation of the
transactions contemplated hereby and thereby require no action by or in respect
of, or filing with, any Governmental Authority.
27
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
4.04. Noncontravention;
Licenses and Permits. The execution, delivery and performance
by Caraco of this Agreement and the other Transaction Documents to which it is a
party and the consummation of the transactions contemplated hereby and thereby
do not and will not (i) violate the organizational documents of Caraco, (ii)
assuming compliance with the matters referred to in Section 4.03, violate any
Applicable Law or (iii) constitute a default under, or accelerate the
performance required by, any term of any covenant, agreement or understanding to
which Caraco or any of its Affiliates is a party, or any judgment, order,
decree, law, rule or regulation to which Caraco or any of its Affiliates is
subject.
4.05. Claims;
Litigation. There is no action, suit, investigation or
proceeding pending against, or to the best of Caraco’s Knowledge threatened
against or affecting, Caraco or any of its Affiliates before any arbitrator or
any Governmental Authority which in any manner challenges or seeks to prevent,
enjoin, alter or materially delay the transactions contemplated by this
Agreement or the other Transaction Documents.
4.06. Financing. Caraco
has, or will have prior to the Closing, sufficient cash, available lines of
credit or other sources of immediately available funds to enable it to make
payment of the payments due at Closing.
4.07. Finders
Fees. There is no investment banker, broker, finder or other
intermediary which has been retained by or is authorized to act on behalf of
Caraco who might be entitled to any fee or commission in connection with the
transactions contemplated by this Agreement or the other Transaction Documents
which would be payable by Forest in whole or in part.
4.08. HSR
Act. Caraco has determined that the monetary value of the
transactions contemplated by this Agreement is less than the
“Size-of-Transaction Test” applicable to transactions of the type contemplated
by this Agreement pursuant to the HSR Act.
5.
COVENANTS OF
FOREST
5.01. Third Party Notices and Consents;
Biovail Consent. Forest shall, and shall cause its Affiliates
to, use their respective reasonable efforts to obtain the Required Consents, and
to give notice to all Third Parties to whom such notice is required, to ensure
the transfer of the Purchased Assets to Caraco. In the event that (i)
Forest is nonetheless unable to obtain the Biovail Consent, and (ii)
all other conditions to Closing hereunder shall have been satisfied or duly
waived, then and in such event: (A) this Asset Purchase Agreement (including all
definitions contained herein and all schedules and exhibits attached hereto)
shall automatically be deemed to be amended, without the necessity or
requirement of any further action by the Parties, to eliminate (except for the
purposes of the interpretation of this Section 5.01) any reference to the
Diltiazem Products or the Biovail Agreements, it being understood that in such
event no rights in respect of the Diltiazem Products or the Biovail Agreements
shall be assigned to or acquired by Caraco hereunder, (B) the Closing shall
proceed subject to the conditions to Closing set forth in Article 8, and (C) at
the Closing, Forest shall pay to Caraco, by wire transfer of immediately
available funds, a sum equal to [* * *],
as and for liquidated damages, and not as a penalty, for Forest’s inability to
deliver the assets related to the Diltiazem Products, and the Parties agree that
the determination of actual damages to Caraco from Forest’s inability to obtain
the Biovail Consent are difficult to measure and that the amount of such
liquidated damages payment is reasonable in light of the anticipated loss to
Caraco, representing, among other things, the present value of Caraco’s
estimated lost profits from the sale of the Diltiazem Products net of Forest’s
incremental costs in connection with its continued distribution of such
Products. Forest agrees that it will not directly or indirectly
challenge the reasonableness of such amount.
28
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
5.02. Stability
Programs. To the extent related to the Closing Date Inventory,
Forest shall continue all stability testing required by Applicable Laws to be
conducted which Forest is, as of the date hereof, conducting or causing to be
conducted through its completion. Forest shall report the results of such tests
to Caraco as soon as practicable, but in no event later than thirty (30) days
after each stability testing station.
5.03. Manufacturing
Transition Services. In connection with Caraco’s undertaking
to take over the manufacturing of the Products promptly following the Closing
Date in accordance with Section 6.03, Forest shall cooperate with Caraco, at
Caraco’s reasonable request, in connection with the transfer of manufacturing
technology included in the Purchased Assets as reasonably necessary to
effectively enable Caraco to manufacture the Products. Caraco shall
reimburse Forest for the directly allocable costs (including internal costs but
excluding, corporate, general or administrative overheads) incurred by Forest in
providing such services, as determined in accordance with Forest’s standard cost
accounting policies consistently applied to the manufacture of pharmaceutical
products.
5.04. Supply of
Product.
(a) Promptly
after the date hereof, the Parties shall form a working group of appropriately
qualified personnel to negotiate definitive supply and quality agreements to be
effective at Closing pursuant to which Forest will manufacture and supply the
Products to Caraco (together, the “Supply Agreement”), which
Supply Agreement shall include, without limitation, the obligation of Forest to
do all that is necessary to be able to supply Caraco with each Product, directly
or through a qualified Third Party service provider, including but not limited
to securing all applicable FDA approvals, and conducting, at its sole cost and
expense, all required tests and studies, including bioequivalency
studies. The Supply Agreement shall also include customary ordering
and forecasting mechanisms, quality control and quality assurance procedures and
shall provide for (i) maintenance of satisfactory product and other liability
insurance, (ii) the supply of the Products at Forest’s Cost of Goods for first
Contract Year, and (iii) if, despite Caraco’s Commercially Reasonable Efforts to
assume the commercial manufacture of the Products in accordance with Section
6.03, Caraco, after the end of the first Contract Year, continues to be unable
to take over manufacturing of a Product or Products, the continued supply of
such Products at Forest’s Cost of Goods plus a [* * *] xxxx-up for a period
of up to ten (10) years following the Closing Date, which ten (10) year period
may be extended upon the mutual agreement of the Parties. The Parties
agree that the Cost of Goods applicable under the Supply Agreement for the first
Contract Year shall be the amounts set forth on Schedule
5.04(a). For purposes of this Section 5.04, the term
“Products” shall not include diltiazem or Products sold under the Tiazac(R)
trademark.
29
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(b) Notwithstanding
the foregoing, if and to the extent Forest does not or is unable to supply a
Product to Caraco for any reason (including an inability to supply because a
Product does not meet applicable quality requirements) in accordance with the
Supply Agreement or through a Third Party, Caraco shall be entitled
to the offset provided pursuant to this Section for its Lost Profit with respect
to such Product and the True-Up Payment, if any, with respect to such Product
pursuant to Section 5.04(c) as its sole and exclusive remedy for such failure to
supply, as set forth below and in subsection (c) as follows:
(i) Caraco
may offset against future Royalty payments due to Forest hereunder an amount
equal to Caraco’s Lost Profit caused by such failure to supply (the actual
amount of such offset against Royalties referred to herein as the “Offset Amount”) during the
period in which Forest is required to supply Caraco with Products hereunder
(i.e., up to ten (10)
years from the Closing Date).
(ii) For
purposes of this Section, “Lost
Profit” shall be calculated Quarterly in arrears by subtracting from
[* * *]
(iii) For
purposes of this Section 5.04(b), “Caraco Net Profit” with respect to a Product
shall have the meaning set forth in the annual sales and net profit projections
(the “Projections”) for
the relevant period as reasonably agreed to by the Parties and consistent with
the sales forecasts delivered by Caraco under the Supply Agreement, but without
taking into account any projected or actual failure or inability of Forest to
supply Product to Caraco.
(iv) To
illustrate the calculation contemplated by clause (ii) above: [* * * ]
(v) The
Projections for the first Contract Year are attached as Schedule 5.04(b) which has
been agreed to by the Parties. Notwithstanding Section 5.04(b)(iii),
the Projections for any Product (other than rimantadine) which has not been
supplied or has been supplied in a de minimis amount during a
Contract Year will remain the same for any subsequent year (but reduced in the
second Contract year, pro rata, by the interim period included in the first
Contract Year). The estimated offsets provided pursuant to this
Section will be trued-up annually as follows: if the cumulative
Royalties withheld by Caraco pursuant to this Section 5.04(b) in respect of any
Contract Year as an offset against Royalties due Forest with respect to such
Contract Year exceed Caraco’s Lost Profit for such year, Caraco shall pay to
Forest the amount of such excess within 45 days following the end of such
Contract Year. Notwithstanding the above, the first true-up will occur at the
end of the second Contract Year. For purposes of the true-up provided in the
foregoing sentences, Lost Profits shall be calculated
Quarterly.
30
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(c) At
the end of the second Contract Year (and at the end of each Contract Year
thereafter), the Parties shall determine the aggregate amount, if any, that the
Lost Profit calculated pursuant to Section 5.04(b) in respect of the first two
Contract Years (or such subsequent Contract Year, as the case may be), exceeded
the Offset Amount in respect of the relevant period. In the event
Lost Profit exceeded the Offset Amount (the “Shortfall”), Forest will make
a cash payment in an amount equal to such Shortfall (the “True-Up Payment”) to Caraco
within 45 days following the end of the relevant period. In the event
a True-Up Payment is payable with respect to the first two Contract Years,
Forest shall, together with such True-Up Payment, pay interest on the Shortfall
(determined with respect to the first Contract Year) in respect of the first
Contract Year, if any, from the date which is 45 days after the end of the first
Contract Year to the date of payment at the Agreed Rate in effect from time to
time.
5.05. Notices of Certain
Events. Forest shall promptly notify Caraco of:
(a) any
notice or other communication from any Person alleging that the consent of such
Person is or may be required in connection with the transactions contemplated by
this Agreement or any other Transaction Document;
(b) any
notice or other communication from any Governmental Authority in connection with
the transactions contemplated by this Agreement or any other Transaction
Document; and
(c) any
actions, suits, claims, investigations or proceedings commenced relating to
Forest or the Purchased Assets that, if pending on the date of this Agreement,
would have been required to have been disclosed pursuant to Section
3.07.
5.06. Conduct of the
Business. From the date hereof until the Closing Date, Forest
shall, and shall cause its Affiliates to, continue to maintain and use the
Purchased Assets and market and sell the Products in the ordinary course
consistent with past practice. Without limiting the foregoing, between the date
hereof and the Closing Date, without the consent of Caraco Forest shall
not:
(a) Fail
to exercise any rights of renewal with respect to any Assigned Contract or
Registration that by its terms would otherwise expire; or
31
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(b) Settle
or compromise any claim or take or fail to take any action if any such
settlement, compromise, act or failure to act could reasonably be anticipated to
have a Material Adverse Effect.
6.
COVENANTS OF CARACO
6.01. Access; Royalty
Verification; Forest Confidentiality.
(a) On
and after the Closing Date but no more than once in any twelve (12) month
period, Caraco will promptly afford to Forest and its agents reasonable access
on reasonable prior notice during business hours to its properties, books,
records, employees and auditors to the extent necessary to permit Forest to
determine any matter relating to the Purchased Assets which arose prior to the
Closing Date; provided
that any such access by Forest shall not unreasonably interfere with the conduct
of the business of Caraco.
(b) Without
limiting the generality of the foregoing, Caraco shall maintain, and shall
require its Affiliates, distributors and licensees to maintain, books and
records which accurately reflect Net Sales, any Offset Amount or Shortfall and
the underlying information used to calculate figures, including number of units
sold, for a period of at least five (5) years after the end of the period to
which they relate. Forest shall have the right, at its own expense,
by an accountant or other authorized representative to which Caraco shall have
no reasonable objection (the “Initial Auditor”), to
inspect, audit and copy such books and records no more than once in any twelve
(12) month period upon reasonable notice solely for purposes of verifying the
Royalties payable to Forest hereunder, the Offset Amount and Shortfall, if
any. Such inspection shall be at Forest’s sole expense; provided, however, that in the event
the inspection determines that Royalties have been underpaid, Caraco shall
promptly make the appropriate payments or refunds to correct such underpayment
and if an underpayment was by [* * *] or more of the amount
of the relevant Royalty as calculated by Caraco, Caraco will be responsible for
the costs of the Initial Auditor. In the event Caraco disputes a
finding by the Initial Auditor of an underpayment, Caraco’s
obligation to pay the costs of the Initial Auditor shall be suspended and the
Parties shall retain a reputable accounting firm selected by the mutual
agreement of the Parties in good faith (the “Review Auditor”), which firm
shall review the Initial Auditor’s findings to determine if such auditor’s
determination was accurate. The fees and expenses payable to the
Review Auditor shall be paid by Caraco, provided that if the Review Auditor
determines that Royalties have not been underpaid, Forest will be responsible
for the costs of such review inspection or audit in addition to the costs of the
Initial Auditor.
(c) Forest
will hold, and will use its best efforts to cause its Representatives to hold,
in confidence, unless compelled to disclose by judicial or administrative
process or by other requirements of Applicable Law, all confidential documents
and information concerning Caraco which may be disclosed to it in the course of
the exercise of its rights pursuant to this Section.
32
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
6.02. Notices of Certain
Events. Caraco shall promptly notify Forest of:
(a) any
notice or other communication from any Person alleging that the consent of such
Person is or may be required in connection with the transactions contemplated by
this Agreement or any other Transaction Document;
(b) any
notice or other communication from any Governmental Authority in connection with
the transactions contemplated by this Agreement or any other Transaction
Document; and
(c) any
actions, suits, claims, investigations or proceedings commenced relating to
Forest or the Purchased Assets that, if pending on the date of this Agreement,
would have been required to have been disclosed pursuant to Section
4.05.
6.03. Product
Manufacture. With respect to each Product other than diltiazem
AB-rated to Tiazac(R) or Products sold under the Tiazac(R) trademark,
Caraco shall use Commercially Reasonable Efforts to assume diligently the
commercial manufacture of the Products following the Closing
Date. For the sake of clarity, Caraco’s inability despite its use of
Commercially Reasonable Efforts to commence manufacturing due to failure to
obtain FDA approval for any Product or for its facility(ies) shall not be deemed
to be a breach of its obligations under this Section. The parties
agree that Caraco is not precluded from using a Third Party to commercially
manufacture the Products.
6.04. Commercialization
Diligence. From and after the Closing Date, Caraco shall, and
shall cause its Affiliates which are participating in the commercialization of
the Products under this Agreement to, use Commercially Reasonable Efforts to
market and sell the Products. Caraco shall have the right to cease
the production, marketing or sale of any Product directly or indirectly by it if
Caraco has determined in its sole discretion that, based on its level of
profitability, selling the Products is no longer commercially reasonable
provided that (i) Caraco has provided Forest with reasonable written evidence of
such level of profitability, and (ii) Caraco has previously conferred in good
faith with Forest regarding possible alternatives to the cessation of the
production, marketing and sale of such Product, including, for example,
negotiating a revised royalty rate or a sale of the Products to a third party in
accordance with Section 6.06 or Section 11.05. Upon the cessation of
the production, marketing or sale of any Product by Caraco, Caraco shall, upon
Forest’s request, assign, transfer and deliver to Forest [* * *] the Product
Intellectual Property relating to any such discontinued Product and Forest shall
thereafter be free to commercially exploit such Product Intellectual Property;
provided that (a) in
the event Forest would like to acquire any improvements to the Product
Intellectual Property developed by Caraco following the Closing, Caraco and
Forest shall negotiate in good faith appropriate compensation to Caraco for such
improvements, and (b) in connection with such assignment and transfer Forest
shall indemnify Caraco and its Affiliates with respect to such Product in the
same manner and to the same extent Caraco is required to indemnify Forest
hereunder with respect to such Product pursuant to Section 9.02. For the avoidance of doubt, it is understood that each
Party shall retain all responsibility and liability for any claims related to
Product design or infringement of the Product Intellectual Property arising from
acts or omissions occurring only during any period in which such Party held the
right to commercialize the Products hereunder and not for any period prior or
subsequent to such Party’s right to commercialize the
Products.
33
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
6.05. Exclusivity. With respect to each
Product other than diltiazem AB-rated to Tiazac(R) or Products
sold under the Tiazac(R) trademark, Caraco agrees that for a period of [* * *] years following the
Closing Date, without the prior written consent of Forest, neither Caraco nor
any of its Affiliates shall engage either directly or indirectly, as a principal
or for its own account or solely or jointly with any Third Party, or as a
stockholder, member, equity owner, consultant or in any other capacity in any
corporation or joint stock association or in any other entity, in the clinical
development, commercialization or marketing in the United States (including its
territories and possessions) of a Competing Product, provided that in lieu of
complying with the foregoing requirement, Caraco may elect to clinically
develop, commercialize or market a Competing Product, Royalties payable
hereunder shall be payable to Forest with respect to net sales of such Competing
Product (calculated in the same manner as Net Sales of a Product) for the [* * *] year period following
the Closing Date based on the royalty rates applicable to the corresponding
Product as set forth in Section 2.09. In the event Caraco elects to
so commercialize or market a Competing Product, Caraco shall provide Forest with
prior written notice reasonably in advance of its introduction of such new
product, and provided Caraco is using Commercially Reasonable Efforts to sell
the Competing Product during the [* * *] year period following
the Closing Date, Section 6.04 will be inapplicable with respect to the related
Product and Caraco may cease to commercialize the related Product without any
obligation to negotiate with Forest for the return of the same.
If any of
the terms contained in this Section shall for any reason be held invalid,
illegal or unenforceable in any respect, such invalidity, illegality or
unenforceability shall not affect any other terms in this Section, but this
Section shall be construed as if such invalid, illegal or unenforceable
provision had never been contained herein. It is the intention of the
Parties that if any of the restrictions or covenants contained herein is held to
cover a geographic area or to be for a length of time which is not permitted by
Applicable Law, or in any way construed to be too broad or to any extent
invalid, such provision shall not be construed to be null, void and of no
effect, but to the extent such provision would be valid or enforceable under
Applicable Law, a court of competent jurisdiction shall construe and interpret
or reform this Section to provide for a covenant having the maximum enforceable
geographic area, time period and other provisions (not greater than those
contained herein) as shall be valid and enforceable under such Applicable
Law.
34
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
6.06. Transfers and Assignments of
Purchased Assets. Neither Caraco nor its Affiliates may
transfer or assign any of the Purchased Assets to a Third Party without (a)
Forest’s prior written consent, which may not be unreasonably withheld (it being
agreed that it would be unreasonable for Forest to withhold its consent in
connection with a transfer of the Purchased Assets by Caraco to the extent such
transfer is required by a Governmental Authority), and (b) the prior agreement
of the transferee or assignee to perform all of the obligations of Caraco and
its Affiliates set forth herein with respect to such transferred or assigned
Purchased Assets (e.g., if any Product is the subject of such transfer or
assignment, the agreement to pay all Royalties with respect to such
Product). No transfer or assignment pursuant to this Section 6.06
shall relieve, release or discharge Caraco’s duties, obligations and liabilities
hereunder with respect to such transferred or assigned Purchased
Assets.
7.
COVENANTS OF FOREST AND CARACO; OTHER
AGREEMENTS
7.01. Confidentiality.
(a) From
and after the date hereof, Caraco and its Affiliates will hold, and will use
their best efforts to cause their respective officers, directors, employees,
accountants, counsel, consultants, advisors and agents (collectively, “Representatives”) to hold, in
confidence, unless compelled to disclose by judicial or administrative process
or by other requirements of Applicable Law, all confidential documents and
information which Forest has furnished to Caraco, its Affiliates or its
Representatives in connection with the transactions contemplated by this
Agreement, except to the extent that such documents or information (a) can be
shown to have been (i) previously known on a nonconfidential basis by Caraco,
(ii) in the public domain through no fault of Caraco or (iii) later lawfully
acquired by Caraco from sources other than Forest or (b) are included in the
Purchased Assets and have been purchased by Caraco pursuant to Section 2.01;
provided that Caraco
may disclose such information to its Representatives in connection with the
transactions contemplated by this Agreement so long as such Persons are informed
by Caraco of the confidential nature of such information and are directed by
Caraco to treat such information confidentially. Caraco shall be
responsible for any failure to treat such information confidentially by such
Persons. If this Agreement is terminated, Caraco and its Affiliates
will, and will use their best efforts to cause their respective Representatives
to, destroy or deliver to Forest, at Caraco’s sole expense, all documents and
other materials, and all copies thereof, obtained by Caraco or its Affiliates or
on their behalf from Forest in connection with this Agreement that are subject
to such confidence.
(b) From
and after the date hereof, Forest and its Affiliates will hold, and will use
their best efforts to cause their respective Representatives to hold, in
confidence, unless compelled to disclose by judicial or administrative process
or by other requirements of Applicable Law, all confidential documents and
information which Forest has furnished to Caraco, its Affiliates or its
Representatives in connection with the transactions contemplated by this
Agreement, except to the extent that such documents or information are (i) known
on a nonconfidential basis by Forest following the Closing Date, (ii) in the
public domain through no fault of Forest or (iii) later lawfully acquired by
Forest from sources other than Caraco; provided that Forest may
disclose such information to its Representatives in connection with the
transactions contemplated by this Agreement so long as such Persons are informed
by Forest of the confidential nature of such information and are directed by
Forest to treat such information confidentially. After the Closing,
Forest and its Affiliates will, and will use their best efforts to cause their
respective Representatives to, destroy or deliver to Caraco, upon Caraco’s
request and at Forest’s sole expense, all such information that is subject to
such confidence, provided however, Forest may retain a copy of all documents or
materials included in the Purchased Assets for archival purposes, for purposes
of fulfilling its obligations under this Agreement and under Applicable Law and
to the extent such documents or materials include or relate to Retained Assets
or Retained Liabilities.
35
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
7.02. Further
Assurances. Subject to the terms and conditions of this
Agreement, Caraco and Forest will use their Commercially Reasonable Efforts to
take, or cause to be taken, all actions and to do, or cause to be done, all
things necessary or desirable under Applicable Law to consummate the
transactions contemplated by this Agreement and the other Transaction
Documents. Forest and Caraco agree to execute and deliver such other
documents, certificates, agreements and other writings and to take such other
actions as may be necessary or desirable in order to consummate or implement
expeditiously the transactions contemplated by this Agreement and the other
Transaction Documents and to vest in Caraco good title to the Purchased
Assets. In the event that after the Closing Caraco requests
additional information, data or documentation to transfer technology related to
the Products, Forest shall cooperate with such transfer. Caraco shall
reimburse Forest for the directly allocable costs (including internal costs but
excluding, corporate, general or administrative overheads) incurred by Forest in
providing such services, as determined in accordance with Forest’s standard cost
accounting policies consistently applied.
7.03. Chargebacks and
Credits. All Chargebacks or Credits with respect to sales of
the Products which were recognized prior to the Closing pursuant to a Customer
Agreement or with respect to sales of the Products for which Forest or any of
its Affiliates received the purchase price thereof shall be for the account of
Forest or its Affiliates and all Chargebacks or Credits with respect to sales of
the Products, including sales made pursuant to Section 2.02, which are
recognized after the Closing pursuant to a Customer Agreement or with respect to
which the Products were sold by or on behalf of Caraco shall be for the account
of Caraco. For the avoidance of doubt, the Parties agree that the
Party that ultimately receives the benefit of the underlying sale of the
applicable Product shall be responsible for handling and paying any related
Chargeback or Credit.
36
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Notwithstanding
the preceding, in light of the difficulties of determining which Party may have
sold Product which is the subject of a wholesaler Chargeback or Credit as to
which lot numbers are not included in the relevant Chargeback invoice, the
Parties agree to assign responsibility for such Chargebacks and Credits (“Unidentified Claims”) as
follows: all such Unidentified Claims with respect to wholesaler invoices to the
trade dated on or before the date which is the Closing Date plus the Trade
Channel Days shall be for the account of Forest or its Affiliates and all such
Unidentified Claims with respect to wholesaler invoices to the trade dated after
such date shall be for the account of Caraco. In addition, the
responsibility for the allocation of wholesaler corrections and customer
re-bills, irrespective of when received by Forest or Caraco, shall be allocated
in accordance with the preceding provisions based upon the date for the
wholesaler invoice which originally reflected the sales to which such correction
or re-xxxx is made. The Parties will cooperate in good faith and
share all relevant wholesaler data so as to be able to allocate the
responsibility for Chargebacks and Credits in accordance with the foregoing and
to verify such allocations.
7.04. Closing Date
Inventory Receivables. From and after
the Closing Date, to the extent that Caraco does not relabel, at it sole cost
and expense, any Closing Date Inventory with its or its Affiliate’s National
Drug Code number and such Closing Date Inventory is delivered to a Customer for
sale by or on behalf of Caraco, Forest shall promptly remit to Caraco any
payment amounts received by it or any of its Affiliates from any such Customer
with respect to such Closing Date Inventory. Forest may invoice
Caraco for the direct cost of processing such remittances.
7.05. Medicaid Rebates
for Products.
(a) Forest
shall be responsible for Medicaid rebates associated with the first units of
Product sold following the Closing Date, up to the aggregate number of units
included in the Trade Channel Inventory as set forth on Schedule
1.01(gggg). All other Medicaid rebates, including, without
limitation, Medicaid rebates attributable to the Closing Date Inventory, shall
be for Caraco’s account. Subject to compliance with Applicable Law,
Caraco shall have the right, but not the obligation, to relabel the Closing Date
Inventory with its National Drug Code number at its sole cost and
expense. Forest shall be responsible for the processing and payment
of all Medicaid rebates for Trade Channel Inventory and Closing Date Inventory
bearing its or its Affiliate’s National Drug Code number; provided, however, Forest shall invoice
Caraco for any such rebates representing units in excess of the number of units
contained in the Trade Channel Inventory plus the direct cost of processing any
such rebates. Any and all payments due and owing to Forest under this
Section shall be paid no later than thirty (30) days following Caraco’s receipt
of Forest’s invoice therefor, which invoice shall include reasonable supporting
documentation and shall specify: (i) each rebate program to which the rebate is
paid, (ii) the period covered by the payment, (iii) the specific amount of the
rebate paid to any such programs; and (iv) a reasonable description of the
direct cost to Forest of processing such claim. The parties will
cooperate as contemplated in Section 7.09 to ensure a smooth and accurate
processing of the Medicaid rebates in accordance with this
Section. Subject only to the foregoing, each Party shall at all times
have the exclusive responsibility for the processing and payment of any and all
rebates arising from or with respect to Product bearing its National Drug Code
numbers.
37
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(b) The
Parties agree that, with respect to Medicaid rebates applicable to Closing Date
Inventory sold by Caraco which bears a National Drug Code number of Forest or
any of its Affiliates, the “best price” (as defined under the Social Security
Act, 42 U.S.C. Sec.1396r-8(c)(1)(C)) and the “average manufacturer price” (as
defined under the Social Security Act, 42 U.S.C. Sec.1396r-8(k)(1)) shall be
calculated on a Product by Product basis by adding (i) the per unit Cost of
Goods of each such Product and (ii) the per unit Royalty due upon the sale of
such Product pursuant to the terms hereof. In furtherance of the
foregoing, Caraco will deliver to Forest, within fifteen (15) days after the end
of each calendar quarter, the number of units sold and the expiration date of
each such Product, each identified by National Drug Code
number. Caraco agrees to provide to Forest any additional data or
other information regarding sales or pricing of the Product by Caraco which
Forest requests as necessary for the calculation of the “best price,” the
“average manufacturer price” and the rebates contemplated in this Section
7.05. Caraco agrees that Forest may use all information described in
this Section 7.05(b) in Forest’s reporting to the Center for Medicaid
Services.
7.06. Federal Government
Pricing Programs. Promptly after the Closing Date, Forest
shall notify the Center for Medicaid Services and the Veteran’s Affairs National
Acquisition Center (the foregoing being hereinafter collectively referred to as
the “Federal Programs”)
of Caraco’s distribution rights with respect to the Product, and that as of the
Closing Date that Forest will no longer support or sell the Product under any
contracts in place with said Federal Programs. Caraco shall establish
its own contractual relationships with the Federal Programs as soon as
commercially reasonable, and Forest shall use its reasonable efforts to
cooperate with Caraco to assure the smooth transition of federal contracting to
Caraco.
7.07. Recalls;
Complaints. Except as otherwise provided in the Supply
Agreement, if any Governmental Authority with applicable jurisdiction shall
order, or it shall otherwise become necessary to perform, any corrective action
or market action with respect to Products sold by Caraco following the Closing
(including, without limitation, any recall, field correction, market withdrawal,
stock recovery, customer notice or restriction), while Caraco shall have the
exclusive responsibility to appropriately manage such action and shall be
responsible for the costs of management of such action, this will not alter the
liability of the Party responsible for the recall under this Agreement
(including, but not limited to, as set forth in Section
2.04(c)). Caraco shall also be exclusively responsible for handling
all customer complaints, inquiries and similar communications, and, with respect
to Product manufactured by Forest, Forest shall cooperate with Caraco, including
the completion of an investigation and the preparation and submission of a
complaint report to Caraco or its designees. The preceding shall not
be in lieu or limitation of any obligation of indemnity of a Party pursuant to
Section 9.02.
38
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
7.08. Product
Returns. Returns of the Products shall be the responsibility
of the Party who delivered, or caused to be delivered, to the customer the lot
with respect to which a return has occurred. From and after the
Closing, each Party shall be responsible for, and shall reimburse the other
Party for, the invoiced value of the returns of the Product from batches from
which any sale has been made by it prior to the Closing Date. Following the Closing
Date, Caraco shall be responsible for any price adjustments to Trade Channel
Inventory (e.g., shelf stocking adjustments) that are related to any pricing,
rebate allowance, promotional or marketing program or activities, special
returns policy or special restocking program offered by Caraco.
7.09. Cooperation with
Respect to Chargebacks, Rebates & Returns; Working
Group. The Parties shall cooperate following the Closing
(including, without limitation, through tracking and exchange of lot number
information and pro-ration of amounts due pursuant to Customer Agreements) from
time to time and for such period as may reasonably be required to implement the
intended allocation of economic responsibilities set forth in Sections 7.03
through 7.08. To facilitate such cooperation, the Parties shall
establish a working group with appropriate members from each party’s finance
departments to facilitate the exchange of commercial information required to
allocate responsibility for Chargebacks, Credits, rebates, returns or any other
payments or credits required to be made pursuant to pursuant to Sections 7.03
through 7.08.
7.10. Safety
Data. Each of the Parties hereto shall disclose to the other
Party all safety reports and other information (collectively “Safety Data”) which they may
from time to time receive or obtain with respect to any adverse drug experiences
with respect to the Products, in accordance with a reporting protocol to be
mutually agreed by the Parties as promptly as possible following the Closing
Date. From and after the Closing, Caraco shall be responsible for the
reporting of Safety Data to regulatory authorities.
7.11. Regulatory
Matters.
(a) Responsibility for
the
Product. From and after the Closing Date, Caraco shall have
all post-Closing regulatory responsibilities under applicable laws and
regulations, reporting and otherwise, in connection with the Products, except
that Forest shall have the authority and responsibility with respect to
regulatory matters and compliance with Applicable Law relating to Forest’s
manufacture and supply obligations pursuant to Section 5.04(a) and the Supply
Agreement referenced therein, including, securing necessary FDA approvals and
site transfer approvals.
(b) Transfer of NDAs and ANDAs;
Regulatory Responsibility Transfer.
(i) On
the Closing Date, the Parties shall file with the FDA all of the documents and
information required by the FDA to effect the transfer of the Product
Intellectual Property, including the NDAs and ANDAs from Forest or any Affiliate
of Forest to Caraco or an Affiliate of Caraco designated by
Caraco. Forest shall file and shall cause its Affiliates to file all
of the documents and the information required of a former owner, including but
not limited to a letter acknowledging the transfer of ownership of the Product
Intellectual Property, including the NDAs and ANDAs, and Caraco shall file the
information required of a new owner. Each of Caraco and Forest shall
take any and all other actions required by the FDA or other relevant
Governmental Authorities, if any, to effect the transfer of the Product
Intellectual Property, including the NDAs and ANDAs from Forest or its Affiliate
to Caraco or its designated Affiliate as soon as reasonably
practicable. Forest may retain an archival copy of the Product
Intellectual property, including the NDAs and ANDAs, including supplements and
records that are required to be kept under 21 C.F.R. Sec.314.81. In
addition to the foregoing, the Parties shall file with the FDA any documentation
and information required to transfer to Caraco any agency status Forest may have
with respect to any in-licensed Products.
39
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(ii) From
and after the Closing Date, Caraco shall assume from Forest or its Affiliate all
responsibility for any and all post-Closing fee obligations for holders or
owners of approved NDAs and ANDAs relating to the Products, including, but not
limited to, those defined under the Prescription Drug User Fee Act of 1992, as
the same may be amended from time to time.
(iii) From
and after the Closing Date, Caraco shall assume all regulatory responsibility
with respect to the Products including those related to (A) the marketing and
promotion of the Product; (B) Adverse Drug Reaction reporting relating to the
Products; and (C) the filing of NDAs and ANDAs and/or supplements to NDAs and
ANDAs for product line extensions, extensions of the expiry date and additional
product claims or additions to the labeling of the Products.
(c) Communications with
Regulatory Agencies. From and after the Closing Date, Caraco
shall have responsibility for all communication with the FDA with respect to the
matters relating to the Products. Notwithstanding the foregoing,
during any period in which Forest is responsible for manufacturing a Product or
Forest has any liability under Section 5.04(a), Caraco will invite Forest to
participate in all interactions between Caraco and the FDA with respect to
manufacturing issues, and Forest shall have final decision making authority and
responsibility with respect to all regulatory issues relating to manufacturing
and supply activities being performed by Forest or its Third Party designee or
for which Forest or its Third Party designee is responsible in connection with
the supply of Products to Caraco pursuant to Section 5.04(a) or the Supply
Agreement referenced therein. From and after the Closing Date, Forest
shall make available to Caraco, copies of all correspondence to or from the FDA
or other applicable Governmental Authority relating exclusively to the
manufacturing and testing of the Products. From and after the Closing
Date, Forest shall make available to Caraco copies of all regulatory
correspondence regarding regulatory warning letters, withdrawal of any Products,
and correspondence bearing on the safety and efficacy of the Products and
reports of inspection related exclusively to the Products. To the
extent such regulatory correspondence is material and applies to the facility
where the Products are manufactured generally or to Forest products in addition
to the Products, to the extent practicable Forest shall provide Caraco with
redacted copies of such correspondence and in any event, will promptly advise
Caraco of its receipt of any such correspondence and will provide a summary of
any issues affecting the Products raised by such
correspondence.
40
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(d) Additional
Information. From and after the Closing Date, Forest shall
provide to Caraco in a timely manner, but in no event less than sixty (60) days
prior to the due date of Caraco’s annual report to the FDA with respect to the
Products, all information (in written form) which Caraco reasonably requests
regarding the manufacture of the Products which may be needed for Caraco to
comply with applicable annual reporting requirements of the FDA and Applicable
Laws.
7.12. Reporting
Information. From time to time after the Closing, the Parties
hereto shall deliver to each other such information and data concerning the
transactions contemplated hereby as either Party may reasonably request which is
required to enable such Party to complete and file all national, state and local
forms, filings or other required reports required to be filed or made by it
pursuant to Applicable Law and to complete all customary tax and accounting
procedures and otherwise to enable such Party to satisfy its internal
accounting, tax and other requirements.
7.13. Certain
Filings. Forest and Caraco shall cooperate with one another
(i) in determining whether any action by or in respect of, or filing with, any
Governmental Authority is required, including filings under the HSR Act, or any
actions, consents, approvals or waivers are required to be obtained from parties
to any material contracts, in connection with the consummation of the
transactions contemplated by this Agreement and the other Transaction Documents
and (ii) in taking such actions or making any such filings, furnishing
information required in connection therewith and seeking timely to obtain any
such actions, consents, approvals or waivers, including, the prompt filing of
the Settlement Agreement and the agreements ancillary to the Settlement
Agreement, including the Transaction Documents, to the Federal Trade Commission
and the Department of Justice pursuant to Section 1112 of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003, as amended and,
if necessary, the prompt filing or submission of any notifications or additional
information required or requested pursuant to the HSR Act.
7.14. Public
Announcements. The Parties agree to consult with each other
before issuing any press release or making any public statement with respect to
this Agreement or the transactions contemplated hereby and, except for any press
releases and public statements the making of which may be required by Applicable
Law or any listing agreement with any national securities exchange, will not
issue any such press release or make any such public statement prior to such
consultation. Nothing herein shall prevent a party from disclosing
the terms of this Agreement as required by law, including by filing a copy of
the Transaction Documents with the Securities and Exchange
Commission. In the event copies of this Agreement or any other
Transaction Documents are to be filed with the Securities and Exchange
Commission or as otherwise required by Applicable Laws, the disclosing Party
shall consult with and shall reasonably consider comments from the
non-disclosing Party with respect to proposed redactions, recognizing that the
disclosing party shall have final decision making authority with respect to the
form and content of the document to be so filed.
41
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
7.15. WARN
Act. Forest shall provide and be responsible for any notice
required, pursuant to the WARN Act and any other state or local applicable plant
closing notification law with respect to a mass layoff or plant closing relating
to the business of manufacturing, marketing or selling the Products that occurs
as a result of or after the Closing, and Forest shall indemnify and hold Caraco
and its Affiliates harmless from and against any and all liability relating to
any obligations or claims arising from a failure to comply with such notice
requirements.
8.
CONDITIONS TO CLOSING
8.01. Conditions to
Obligations of Caraco and Forest. The obligations of Caraco
and Forest to consummate the Closing are subject to the satisfaction or waiver
of the following conditions:
(a) All
conditions for the Stipulations and Orders (as such terms are defined in the
Settlement Agreement) to be filed pursuant to the Settlement Agreement (other
than the closing of the transactions under this Asset Purchase Agreement) have
been satisfied;
(b) No
provision of any Applicable Law shall prohibit the consummation of the
Closing.
(c) At
the Closing Date, there shall be no injunction, restraining order or decree of
any nature of any court or governmental agency or body of competent jurisdiction
that is in effect that restrains or prohibits the consummation of the
transactions contemplated by this Agreement or otherwise seeks to modify any of
the terms of the transactions contemplated by this Agreement or questions the
validity or legality of this Agreement or any of the transactions contemplated
by this Agreement. At the Closing Date, there shall be no action,
suit, or proceeding brought by any governmental agency or body pending before
any court or governmental agency or body wherein an unfavorable injunction,
judgment, order, decree or ruling would restrain or prohibit the consummation of
the transactions contemplated by this Agreement or otherwise seeks to modify any
of the terms of the transactions contemplated by this Agreement or questions the
validity or legality of this Agreement or any of the transactions contemplated
by this Agreement.
42
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
8.02. Conditions to
Obligation of Caraco. The obligation of Caraco to consummate
the Closing is subject to the satisfaction of the following further
conditions:
(a) (i)
Forest shall have performed in all material respects all of its obligations
hereunder required to be performed by it on or prior to the Closing Date, (ii)
the representations and warranties of Forest contained in this Agreement or in
any other Transaction Document and in any certificate or other writing delivered
by Forest pursuant hereto shall be true at and as of the Closing Date, as if
made at and as of such date, with only such exceptions as would not in the
aggregate reasonably be expected to have a Material Adverse Effect and (iii)
Caraco shall have received a certificate signed by a duly authorized officer of
Forest to the foregoing effect.
(b) Forest
shall have made the deliveries required to be made by it under Sections 2.06 and
2.07.
(c) All
material registrations, filings, applications, notices, consents, approvals,
orders, qualifications and waivers required to be made, filed, given or obtained
with, to or from any governmental authorities in connection with the
consummation of the transactions contemplated by this Agreement shall have been
made, filed, given or obtained.
(d) There
shall not have been any Material Adverse Effect.
8.03. Conditions to
Obligation of Forest. The obligation of Forest to consummate
the Closing is subject to the satisfaction of the following further
conditions:
(a) (i)
Caraco shall have performed in all material respects all of its obligations
hereunder required to be performed by it at or prior to the Closing Date, (ii)
the representations and warranties of Caraco contained in this Agreement or any
other Transaction Document and in any certificate or other writing delivered by
Caraco pursuant hereto shall be true in all material respects at and as of the
Closing Date, as if made at and as of such date, with only such exceptions as
would not in the aggregate reasonably be expected to have a Material Adverse
Effect and (iii) Forest shall have received a certificate signed by a duly
authorized officer of Caraco to the foregoing effect.
(b) Caraco
shall have made the deliveries required to be made by it under Section
2.07.
9.
SURVIVAL; INDEMNIFICATION
9.01. Survival. The
representations and warranties of the Parties hereto contained in this Agreement
shall survive the Closing until [***] from the Closing Date; provided, however, that the
representations and warranties of Forest contained in Sections 3.01, 3.02, 3.06,
3.08(a) and the first sentence 3.12 and the representations and warranties of
Caraco contained in Sections 4.01 and 4.02 shall survive the Closing
indefinitely. The covenants and agreements of the Parties hereto
contained in this Agreement or in any certificate or other writing delivered
pursuant hereto or in connection herewith, including without limitation,
Caraco’s obligations to use Commercially Reasonable Efforts to commercialize the
Products, to pay royalties hereunder, and to perform all of the assumed
liabilities and obligations, shall survive the Closing indefinitely or for the
shorter period explicitly specified therein, except that for such covenants and
agreements that survive for such shorter period, breaches thereof shall survive
indefinitely or until the latest date permitted by Applicable
Law. Notwithstanding the preceding, any breach of a covenant,
agreement, representation or warranty in respect of which indemnity may be
sought under this Agreement shall survive the time at which it would otherwise
terminate pursuant to the preceding sentences, if notice of the inaccuracy or
breach thereof giving rise to such right of indemnity shall have been given to
the Party against whom such indemnity may be sought prior to such
time.
43
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
9.02. Indemnification.
(a) Effective
at and after the Closing, Forest hereby indemnifies Caraco and its Affiliates
against and agrees to hold each of them harmless from any and all damage, loss
and expense (including reasonable expenses of investigation, experts and
reasonable attorneys’ fees and expenses in connection with any action, suit or
proceeding) (“Damages”)
actually suffered by Caraco and its Affiliates arising from Third Party Claims
arising out of or otherwise relating to:
(i)
any misrepresentation or breach of warranty (each such misrepresentation
and breach of warranty a “Warranty Breach”) or breach of
covenant or agreement made or to be performed by Forest pursuant to this
Agreement;
(ii) the
Retained Assets or Retained Liabilities (including, any Retained Liabilities
that becomes a liability of Caraco and its Affiliates under any common law
doctrine of de factor merger or successor liability or otherwise by operation of
law).
(iii) the
manufacture, marketing, sale or distribution by Forest or its Third Party
designee of the Products prior to the Closing Date, and on or after the Closing
Date to the extent arising from Forest’s or its Third Party Designee’s failure
to comply with: (a) Applicable Law (including current Good Manufacturing
Practices (as set forth in C.F.R. 21 Parts 210 and 211, or any successor law or
regulation thereto); (b) the specifications for the Products or the facilities;
or (c) any other quality or legal standards applicable under the Supply
Agreement, in each case with respect to the manufacturing and supply of Products
to be supplied by Forest to Caraco pursuant to Section 5.04(a) hereof; provided that, in no event
shall Forest be liable under Section 9.02(a) for any Damages arising from the
negligence, strict liability of, or violation of any law by, Caraco, any of its
Affiliates or any licensee of Caraco or any of its Affiliates.
44
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(b) Effective
at and after the Closing, Caraco hereby indemnifies Forest and its Affiliates
against and agrees to hold each of them harmless from any and all Damages
actually suffered by Forest or any of its Affiliates arising from Third Party
Claims arising out of or otherwise relating to:
(i)
any Warranty Breach or breach of covenant or agreement made or
to be performed by Caraco pursuant to this Agreement;
(ii) any
Assumed Liability; or
(iii) the
manufacture, marketing, sale or distribution of the Products on or after the
Closing Date by Caraco or its Third Party designee (including, without
limitation, lawsuits, regulatory or other actions or proceedings, recalls,
complaints or other Damages incurred with respect to the Product sold by or on
behalf of Caraco or any of its Affiliates after the Closing Date, but not to the
extent such claim arises from a manufacturing issue for which Forest is required
to indemnify Caraco pursuant to Section 9.02(a)(iii) above);
provided that, in no event
shall Caraco be liable under Section 9.02(b) for any Damages arising from the
negligence, strict liability of, or violation of any law by, Forest or any of
its Affiliates, including in connection with Forest’s manufacture of the
Products for Caraco.
9.03. Indemnification
Procedures.
(a) The
Party seeking indemnification under Section 9.02 (the “Indemnified Party”) agrees to
give prompt notice in writing to the Party against whom indemnity is to be
sought (the “Indemnifying
Party”) of the assertion of any claim or the commencement of any suit,
action or proceeding (a “Claim”) in respect of which
indemnity may be sought under such Section. Such notice shall set
forth in reasonable detail such Claim and the basis for indemnification (taking
into account the information then available to the Indemnified
Party). The failure to so notify the Indemnifying Party shall not
relieve the Indemnifying Party of its obligations hereunder, except to the
extent such failure shall have adversely prejudiced the Indemnifying
Party.
(b) The
Indemnifying Party shall be entitled to participate in the defense of any Claim
brought by any Third Party and, subject to the limitations set forth in Section
9.03(c), shall be entitled to control and appoint lead counsel for such defense,
in each case at its own expense. Each Party shall cooperate, and
cause their respective Affiliates to cooperate, in the defense or prosecution of
any Claim brought by any Third Party and shall furnish or cause to be furnished
such records, information and testimony, and attend such conferences, discovery
proceedings, hearings, trials or appeals, as may be reasonably requested in
connection therewith.
45
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(c) If
the Indemnifying Party shall assume the control of the defense of any Claim
brought by any Third Party in accordance with the provisions of Section 9.03(b),
(i) the Indemnifying Party shall obtain the prior written consent of the
Indemnified Party (which shall not be unreasonably withheld) before entering
into any settlement of such Claim if the settlement does not release the
Indemnified Party and its affiliates from all liabilities and obligations with
respect to such Claim or the settlement imposes injunctive or other equitable
relief against the Indemnified Party or any of its affiliates and (ii) the
Indemnified Party shall be entitled to participate in the defense of such Claim
and to employ separate counsel of its choice for such purpose. The
fees and expenses of such separate counsel shall be paid by the Indemnified
Party.
9.04. Assignment of
Claims. If the Indemnified Party receives any payment from an
Indemnifying Party in respect of any Damages pursuant to Section 9.02 and the
Indemnified Party could have recovered all or a part of such Damages from a
third party other than an insurance company (a “Potential Contributor”) based
on the underlying Claim asserted against the Indemnifying Party, the Indemnified
Party shall assign such of its rights to proceed against the Potential
Contributor as are necessary to permit the Indemnifying Party to recover from
the Potential Contributor the amount of such payment.
10. TERMINATION
10.01. Grounds for
Termination. This Agreement may be terminated at any time
prior to the Closing:
(a) By
either Party hereto if the Parties (as defined in the Settlement Agreement) have
returned to the Court (as defined in the Settlement Agreement) pursuant to
Section 6(a) of the Settlement Agreement.
(b) by
mutual written agreement of Forest and Caraco;
(c) by
either Party hereto if the other Party or any of its Affiliates is in breach of
the Settlement Agreement or any agreement ancillary to the Settlement
Agreement.
(d) by
either Forest or Caraco if consummation of the transactions contemplated hereby
would violate any nonappealable final order, decree or judgment of any
Governmental Authority having competent jurisdiction.
46
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
The Party
desiring to terminate this Agreement pursuant to clause 10.01(b) or 10.01(c)
shall give notice of such termination to the other Party.
10.02. Effect of
Termination. If this Agreement is terminated as permitted by
Section 10.01, such termination shall be without liability of either Party (or
any stockholder, director, officer, employee, agent, consultant or
representative of such party) to the other Party to this Agreement; provided that if such
termination shall result from the willful (i) failure of either Party to fulfill
a condition to the performance of the obligations of the other Party, (ii)
failure to perform a covenant of this Agreement or (iii) breach by either Party
hereto of any representation or warranty or agreement contained herein, such
party shall be fully liable for any and all Damages incurred or suffered by the
other Party as a result of such failure or breach. The provisions of
Sections 7.01 (Confidentiality), 11.02 (Amendments and Waivers), 11.05
(Successors and Assigns), 11.06 (Governing Law), 11.08 (Dispute Resolution;
Arbitration), 11.08 (Limitation of Liability) and 11.09 (Waiver of Jury Trial)
shall survive any termination hereof pursuant to Section 10.01.
11. MISCELLANEOUS
11.01. Notices. All
notices, requests and other communications to any Party hereunder shall be in
writing (including facsimile transmission) and shall be given,
|
(a)
|
if
to Forest, to:
|
Forest
Laboratories, Inc.
000 Xxxxx
Xxxxxx
Xxx Xxxx,
Xxx Xxxx 00000
Facsimile:
000-000-0000
Attention:
Chief Executive Officer
|
With
a copy to (which copy shall not constitute
notice):
|
Forest
Laboratories, Inc.
000 Xxxxx
Xxxxxx
Xxx Xxxx,
Xxx Xxxx 00000
Facsimile:
000-000-0000
Attention:
General Counsel
|
With
a copy to (which copy shall not constitute
notice):
|
Dornbush
Xxxxxxxxx Xxxxxxxx & Xxxxxxxx, LLP
000 Xxxxx
Xxxxxx
Xxx Xxxx,
Xxx Xxxx 00000
Facsimile:
000-000-0000
Attention:
Xxxxxxx X. Xxxxxx, Esq.
47
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
|
(b)
|
if
to Caraco, to:
|
Caraco
Pharmaceutical Laboratories, Ltd.
0000
Xxxxxx XxXxx Xx.
Xxxxxxx,
Xxxxxxxx 00000
Facsimile:
(000) 000-0000
Attention:
Xxxxxx X. Xxxxxx
With a
copy to (which copy shall not constitute notice):
Caraco
Pharmaceutical Laboratories, Ltd.
0000
Xxxxxx XxXxx Xx.
Xxxxxxx,
Xxxxxxxx 00000
Facsimile:
(000) 000-0000
Attention:
Xxxxxx X. Xxx
With a
copy to (which copy shall not constitute notice):
Bodman,
LLP
0000 Xx.
Xxxxxxx Xxxxxx
Xxxxxxx,
Xxxxxxxx 00000
Facsimile:
(000) 000-0000
Attention:
Xxxx X. Xxxxx
or such
other address or facsimile number as such party may hereafter specify for the
purpose by notice to the other Parties hereto. All such notices,
requests and other communications shall be deemed received on the date of
receipt by the recipient thereof if received prior to 5:00 p.m. in the place of
receipt and such day is a Business Day in the place of
receipt. Otherwise, any such notice, request or communication shall
be deemed not to have been received until the next succeeding Business Day in
the place of receipt.
11.02. Amendments and
Waivers.
(a) Any
provision of this Agreement may be amended or waived if, but only if, such
amendment or waiver is in writing and is signed, in the case of an amendment, by
each Party to this Agreement, or in the case of a waiver, by the Party against
whom the waiver is to be effective.
48
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(b) No
failure or delay by any party in exercising any right, power or privilege
hereunder shall operate as a waiver thereof nor shall any single or partial
exercise thereof preclude any other or further exercise thereof or the exercise
of any other right, power or privilege. The rights and remedies
herein provided shall be cumulative and not exclusive of any rights or remedies
provided by law.
11.03. Expenses. Except
as otherwise provided herein, all costs and expenses incurred in connection with
this Agreement shall be paid by the Party incurring such cost or
expense.
11.04. Transfer
Taxes. All excise, sales, use, value added, registration
stamp, recording, documentary, conveyancing, franchise, property, transfer,
gains and similar Taxes, levies, charges and fees incurred in connection with
the transactions contemplated by this Agreement, if any, shall be borne by
Caraco.
11.05. Successors and
Assigns; Assignment. The provisions of this Agreement shall be
binding upon and inure to the benefit of the Parties hereto and their respective
successors and assigns; provided that (i) Caraco may
not assign its rights or delegate its obligations under this Agreement, in whole
or in part, without the prior written consent of Forest, which consent shall not
be unreasonably withheld, and (ii) Forest may not assign its obligations to
manufacture and supply Products to Caraco without Caraco’s prior written
consent, which consent may not be unreasonably withheld, and (iii) Forest shall
not assign any of its rights to Royalty payments without Caraco’s prior written
consent, which consent shall not be unreasonably withheld. No
transfer or assignment pursuant to this Section shall relieve, release or
discharge a Party’s duties, obligations and liabilities
hereunder. Any attempted assignment or delegation in violation of
this Section shall be void.
11.06. Relationship
Between the Parties. The Parties’ relationship hereunder,
including pursuant to Sections 7.03 through 7.09, is solely that of independent
contractors. This Agreement does not create any partnership, joint
venture, agency or similar business relationship between the
Parties. Neither Party is a legal representative of the other Party,
and neither Party can assume or create any obligation, representation, warranty
or guarantee, express or implied, on behalf of the other Party for any purpose
whatsoever.
11.07. Governing
Law. This Agreement shall be governed by and construed in
accordance with the law of the State of Illinois, without regard to the
conflicts of law rules of such state.
49
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
11.08. Dispute Resolution;
Arbitration.
(a) The
Parties recognize that a bona fide dispute as to certain matters may, from time
to time, arise during that relates to a Party’s rights and/or obligations under
the Transaction Documents (a “Dispute”). In the
event of the occurrence of a Dispute, either Party may, by written notice to the
other Party, have such Dispute referred to the respective officers designated
below, or their successors, for attempted resolution by good faith negotiation
within thirty (30) days after such notice is received. Such
designated officers are as follows:
|
For
Caraco:
|
Chief
Executive Officer
|
|
For
Forest:
|
Chief
Executive Officer
|
(b) In
the event of a Dispute arising in connection with any Transaction Document which
is not resolved under Section 11.08(a), such Dispute shall be submitted to
arbitration under the then existing Commercial Arbitration Rules of the American
Arbitration Association. Unless the Parties otherwise agree in
writing, the arbitration proceedings shall be conducted and the arbitrators
shall be appointed in accordance with the Rules then in effect, subject to the
procedures described in this Section 11.08.
(c) The
arbitration proceedings shall take place in Chicago, Illinois, or such other
location as may be mutually agreed by the Parties. The arbitration
will be conducted in the English language.
(d) The
arbitration shall be held before a panel of three arbitrators (the “Arbitrators”). One
Arbitrator shall be chosen by Forest and one Arbitrator shall be chosen by
Caraco, and the third Arbitrator shall be chosen by mutual agreement of the
Arbitrators chosen by Forest and Caraco.
(e) Unless
the Parties otherwise agree in writing, during the period of time that any
arbitration proceeding is pending under this Agreement, the Parties shall
continue to comply with all those terms and provisions of this Agreement that
are not the subject of the pending arbitration proceeding.
(f) The
award or decision of a majority of the arbitrators pursuant to this Section
shall be binding and conclusive on the Parties, provided that the enforcement of
such award or decision may be obtained in any court having jurisdiction over the
Party against whom such enforcement is sought. The losing party shall
pay all reasonable attorneys fees and costs associated with such
arbitration. If there is any dispute that is not subject to
arbitration and for which the United States District Court for the Northern
District of Illinois does not have subject matter jurisdiction, the state courts
in Illinois shall have jurisdiction. In connection with any dispute
arising out of or in connection with this Agreement that is not subject to
arbitration, each Party hereby expressly consents and submits to the personal
jurisdiction of the federal and state courts in the State of
Illinois.
50
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Nothing
contained in this Agreement shall deny any Party the right to seek injunctive or
other equitable relief from a court of competent jurisdiction in the context of
a bona fide emergency or prospective irreparable harm, and such an action may be
filed and maintained notwithstanding any ongoing arbitration
proceeding.
11.09. Specific
Performance. The Parties hereto agree that irreparable damage
would occur if any provision of this Agreement were not performed in accordance
with the terms hereof and that, with respect to Disputes arising prior to the
Closing Date, following the issuance of a decision in an arbitration conducted
pursuant to Section 11.08, the Parties shall be entitled to an injunction or
injunctions to prevent breaches of this Agreement or to enforce specifically the
performance of the terms and provisions hereof in the United States District
Court for the Northern District of Illinois or any Illinois State court sitting
in Chicago, Illinois, in addition to any other remedy to which they are entitled
at law or in equity.
11.10. LIMITATION OF
LIABILITY.
(a) Each
Party’s maximum liability for all Warranty Breaches shall not exceed [* * *] and neither Party
shall be liable to the other for Warranty Breaches unless the aggregate amount
of Damages with respect to such Warrant Breaches exceeds [* * *] and then only to the
extent of such excess, provided, however, that the foregoing limitations of
liability shall not apply to the liabilities arising from either Party’s
indemnification obligations with respect to Third Party claims pursuant to
Section 9.02 or to Forest’s obligations pursuant to Section
5.04(b).
(b) IN
NO EVENT SHALL EITHER PARTY, ITS DIRECTORS, OFFICERS, EMPLOYEES, AGENTS OR
AFFILIATES BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, PUNITIVE,
SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES (INCLUDING ,WITHOUT LIMITATION, LOST
PROFITS), WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT, WARRANTY,
NEGLIGENCE, STRICT LIABILITY OR OTHER TORT, ARISING OUT OF OR RELATED TO THIS
AGREEMENT; PROVIDED, HOWEVER, THAT THE FOREGOING LIMITIATION OF LIABILITYSHALL
NOT APPLY TO THE LIABILITIES ARISING FROM EITHER PARTY’S GROSS NEGLIGENCE OR
WILLFULL MISCONDUCT OR LIMIT EITHER PARTY’S INDEMNIFICATION OBLIGATIONS WITH
RESPECT TO THIRD PARTY CLAIMS.
11.11. WAIVER OF JURY
TRIAL. EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES
ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR
RELATED TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED
HEREBY.
51
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
11.12. Counterparts;
Effectiveness; Third Party Beneficiaries. This Agreement may
be signed in any number of counterparts, each of which shall be an original,
with the same effect as if the signatures thereto and hereto were upon the same
instrument. Any counterpart may be signed and transmitted by
facsimile with the same force and effect as if such counterpart was an
ink-signed original. This Agreement shall become effective when each
Party hereto shall have received a counterpart hereof signed by the other Party
hereto. Until and unless each Party has received a counterpart hereof signed by
the other Party hereto, this Agreement shall have no effect and no Party shall
have any right or obligation hereunder (whether by virtue of any other oral or
written agreement or other communication). No provision of this
Agreement is intended to confer any rights, benefits, remedies, obligations, or
liabilities hereunder upon any Person other than the Parties hereto and their
respective successors and assigns.
11.13. Representation by
Legal Counsel. Each
Party hereto represents that it has been represented by legal counsel in
connection with this Agreement and acknowledges that it has participated in the
drafting. In interpreting and applying the terms and provisions of
this Agreement, the Parties agree that no presumption shall exist or be implied
against the Party which drafted such terms and provisions.
11.14. Entire
Agreement. This Agreement and the other Transaction Documents
constitute the entire agreement between the Parties with respect to the subject
matter of hereby and thereby and supersedes all prior agreements and
understandings, both oral and written, between the Parties with respect to the
subject matter of this Agreement and the other Transaction
Documents. Notwithstanding the foregoing, the Settlement Agreement
shall be deemed of equal dignity to this Agreement and this Agreement shall be
construed together with the Settlement Agreement in a consistent manner as
reflecting a single intent and purpose.
11.15. Severability. If
any term, provision, covenant or restriction of this Agreement is held by a
court of competent jurisdiction or other Governmental Authority to be invalid,
void or unenforceable, the remainder of the terms, provisions, covenants and
restrictions of this Agreement shall remain in full force and effect and shall
in no way be affected, impaired or invalidated so long as the economic or legal
substance of the transactions contemplated hereby is not affected in any manner
materially adverse to any Party. Upon such a determination, the
Parties shall negotiate in good faith to modify this Agreement so as to effect
the original intent of the Parties as closely as possible in an acceptable
manner in order that the transactions contemplated hereby be consummated as
originally contemplated to the fullest extent possible.
52
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
11.16. Disclosure
Schedules. Forest has set forth information on the Forest
Disclosure Schedule in a section thereof that corresponds to the section of this
Agreement to which it relates. A matter set forth in one section of
the Forest Disclose Schedule need not be set forth in any other section so long
as its relevance to such other section of the Forest Disclosure Schedule or
section of the Agreement is reasonably apparent on the face of the information
disclosed therein to the Person to which such disclosure is being
made. The parties acknowledge and agree that (i) the schedules to
this Agreement may include certain items and information solely for
informational purposes for the convenience of the Person to which such
disclosure is being made and (ii) the disclosure by Forest of any matter in the
Forest Disclosure Schedules shall not be deemed to constitute an acknowledgment
by Forest that the matter is required to be disclosed by the terms of this
Agreement or that the matter is material.
[SIGNATURE
PAGE FOLLOWS]
53
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
IN WITNESS WHEREOF, the
Parties hereto have caused this Agreement to be duly executed by their
respective authorized officers as of the day and year first above
written.
FOREST LABORATORIES, INC.
By:
/s/ Xxxxxx Xxxxxxx
|
|
Name:
Xxxxxx Xxxxxxx
Title:
Chairman and CEO
|
|
CARACO PHARMACEUTICAL
LABORATORIES, LTD.
By:
/s/ Xxxxxx X. Xxxxxx
|
|
Name:
Xxxxxx X. Xxxxxx
Title:
CEO
|
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Forest
Laboratories, Inc.
000
Xxxxx Xxxxxx
Xxx
Xxxx, XX 00000
September
8, 2009
Caraco
Pharmaceutical Laboratories, Ltd.
0000
Xxxxxx XxXxx Xxxxx
Xxxxxxx,
Xxxxxxxx 00000
|
Re:
|
That
certain Asset Purchase Agreement (the “Agreement”) dated July 10, 2009 by
and between Forest Laboratories, Inc. (“Forest”) and Caraco Pharmaceutical
Laboratories, Ltd. (“Caraco”)
|
Gentlemen,
Forest
and Caraco have agreed to amend the Agreement in accordance with the following
terms and conditions:
|
1.
|
The
first sentence of the first paragraph of Section 2.07 of the Agreement is
amended hereby to read in its entirety as
follows:
|
Unless
this Agreement shall have been terminated in accordance with Section 8, the
closing (the “Closing”)
of the purchase and sale of the Purchased Assets hereunder shall take place at
the offices of Dornbush Xxxxxxxxx Xxxxxxxx & Xxxxxxxx, LLP, 000 Xxxxx
Xxxxxx, Xxx Xxxx, Xxx Xxxx 00000, as soon as possible, but in no event later
than fifteen (15) Business Days after satisfaction of the conditions set forth
in Section 8, or at such other time or place as Forest and Caraco may agree in
writing (the “Closing
Date”).
|
2.
|
Except
to the extent amended hereby, the Agreement remains unmodified and in full
force and effect in accordance with its
terms.
|
[SIGNATURE
PAGE FOLLOWS]
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Very
truly yours,
FOREST LABORATORIES, INC. | ||
By:
|
/s/ Xxxxxx X. Xxxxxx, Xx.
|
|
Name: Xxxxxx
X. Xxxxxx, Xx.
Title:
Senior Vice President - Finance &
CFO
|
AGREED
AND ACCEPTED:
CARACO PHARMACEUTICAL
LABORATORIES, LTD.
|
||
By:
|
/s/ XX Xxxxx | |
Name:
Title:
|
XX
Xxxxx
Senior Vice President - Business
Strategies
|
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Forest
Laboratories, Inc.
000
Xxxxx Xxxxxx
Xxx
Xxxx, XX 00000
September
11, 2009
Caraco
Pharmaceutical Laboratories, Ltd.
0000
Xxxxxx XxXxx Xxxxx
Xxxxxxx,
Xxxxxxxx 00000
|
Re:
|
That
certain Asset Purchase Agreement dated July 10, 2009, as amended by that
certain letter agreement dated September 8, 2009 (as so amended, the
“Agreement”), by and between Forest Laboratories, Inc. (“Forest”) and
Caraco Pharmaceutical Laboratories, Ltd.
(“Caraco”).
|
Gentlemen,
Forest
and Caraco have agreed to amend the Agreement in accordance with the following
terms and conditions:
|
3.
|
The
first sentence of the first paragraph of Section 2.07 of the Agreement is
amended hereby to read in its entirety as
follows:
|
Unless
this Agreement shall have been terminated in accordance with Section 8, the
closing (the “Closing”)
of the purchase and sale of the Purchased Assets hereunder shall take place at
the offices of Dornbush Xxxxxxxxx Xxxxxxxx & Xxxxxxxx, LLP, 000 Xxxxx
Xxxxxx, Xxx Xxxx, Xxx Xxxx 00000, as soon as possible, but in no event later
than twenty (20) Business Days after satisfaction of the conditions set forth in
Section 8, or at such other time or place as Forest and Caraco may agree in
writing (the “Closing
Date”).
|
4.
|
Except
to the extent amended hereby, the Agreement remains unmodified and in full
force and effect in accordance with its
terms.
|
[SIGNATURE
PAGE FOLLOWS]
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Very
truly yours,
|
||
FOREST LABORATORIES,
INC.
|
||
By:
|
/s/ Xxxxxxx X. Xxxxxx, Xx. | |
Name:
Xxxxxxx X. Xxxxxx, Xx.
Title:
Senior Vice President - Finance &
CFO
|
AGREED
AND ACCEPTED:
CARACO PHARMACEUTICAL
LABORATORIES, LTD.
|
||
By:
|
/s/ XX Xxxxx | |
Name:
XX Xxxxx
Title:
Senior Vice President - Business
Strategies
|
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Forest
Laboratories, Inc.
000
Xxxxx Xxxxxx
Xxx
Xxxx, XX 00000
September
22, 2009
Caraco
Pharmaceutical Laboratories, Ltd.
0000
Xxxxxx XxXxx Xxxxx
Xxxxxxx,
Xxxxxxxx 00000
|
Re:
|
That
certain Asset Purchase Agreement dated July 10, 2009, as amended by the
letter agreements dated September 8, 2009 and September 11, 2009 (as so
amended, the “Agreement”), by and between Forest Laboratories, Inc.
(“Forest”) and Caraco Pharmaceutical Laboratories, Ltd.
(“Caraco”).
|
Gentlemen,
Forest
and Caraco have agreed to amend the Agreement in accordance with the following
terms and conditions:
|
5.
|
Section
5.01 of the Agreement is amended hereby to read in its entirety as
follows:
|
Section
5.01. Third Party Notices and
Consents; Biovail Consent. Forest shall, and shall cause its
Affiliates to, use their respective reasonable efforts to obtain the Required
Consents, and to give notice to all Third Parties to whom such notice is
required, to ensure the transfer of the Purchased Assets to
Caraco. In the event that (i) Forest is nonetheless unable to obtain
the Biovail Consent, and (ii) all other conditions to Closing hereunder shall
have been satisfied or duly waived, then and in such event:
|
(A)
|
(1)
this Agreement (including all definitions contained herein and all
schedules and exhibits attached hereto) shall automatically be deemed to
be amended, without the necessity or requirement of any further action by
the Parties, to eliminate (except for the purposes of the interpretation
of this Section 5.01) any reference to the Diltiazem Products or the
Biovail Agreements, it being understood that in such event no rights in
respect of the Diltiazem Products or the Biovail Agreements shall be
assigned to or acquired by Caraco hereunder and (2) the Closing shall
proceed subject to the conditions to Closing set forth in Article 8; provided that the
Parties shall not be required to execute and deliver the Assignment and
Assumption Agreement as contemplated by Section 2.07;
and
|
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
|
(B)
|
during
the period beginning on the Closing Date and ending six (6) Business Days
thereafter, Forest shall continue to use its respective reasonable efforts
to obtain the Biovail Consent and (1) if the Biovail Consent is received
within such six (6) Business Day period, each Party shall execute and
deliver to the other Party the Assignment and Assumption Agreement and the
deemed amendments to this Agreement made in accordance with the preceding
clause (A) shall, upon the execution and delivery of the Assignment and
Assumption Agreement, automatically be deemed to be null and void without
the necessity or requirement of any further action by the Parties and
Forest’s rights in respect of the Diltiazem Products and the Biovail
Agreements shall be assigned to or acquired by Caraco in accordance with
and subject to the terms of this Agreement as if they were assigned or
acquired at the Closing, or (2) if the Biovail Consent is not received
within such six (6) Business Day period, then, upon the expiration of such
six (6) Business Day period Forest shall pay to Caraco, by wire transfer
of immediately available funds, a sum equal to [* * *], as and for
liquidated damages, and not as a penalty, for Forest’s inability to
deliver the assets related to the Diltiazem Products, and the Parties
agree that the determination of actual damages to Caraco from Forest’s
inability to obtain the Biovail Consent are difficult to measure and that
the amount of such liquidated damages payment is reasonable in light of
the anticipated loss to Caraco, representing, among other things, the
present value of Caraco’s estimated lost profits from the sale of the
Diltiazem Products net of Forest’s incremental costs in connection with
its continued distribution of such Products. Forest agrees that
it will not directly or indirectly challenge the reasonableness of such
amount. Caraco agrees that if the Biovail Consent is not so
obtained, Forest shall retain all of its rights to and interests in the
Diltiazem Products and the Biovail Agreements and shall be relieved of any
obligation to transfer the same to Caraco. Caraco and Forest
agree that, upon the receipt of the Biovail Consent as contemplated by
clause (1) above or the payment of the [* * *] in liquidated
damages by Forest to Caraco as contemplated by clause (2) above, the
transactions contemplated hereby shall be deemed closed for the purposes
of Section 6(b) of the Settlement
Agreement.
|
|
6.
|
Except
to the extent amended hereby, the Agreement remains unmodified and in full
force and effect in accordance with its
terms.
|
[SIGNATURE
PAGE FOLLOWS]
THIS
EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Very
truly yours,
|
||
FOREST LABORATORIES,
INC.
|
||
By:
|
/s/ Xxxxx X. Xxxxxxx | |
Name:
Xxxxx X. Xxxxxxx
Title:
Corporate Vice President - Business Development and Strategic
Planning
|
AGREED
AND ACCEPTED:
CARACO PHARMACEUTICAL
LABORATORIES, LTD.
|
||
By:
|
/s/ XX Xxxxx | |
Name:
XX Xxxxx
Title:
Senior Vice President - Business
Strategies
|