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Exhibit
10.14
LICENSE AND COLLABORATION
AGREEMENT
dated as of
December 4, 2007
by and
between
ADOLOR
CORPORATION
and
PFIZER INC.
TABLE OF
CONTENTS
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Page |
| ARTICLE 1 |
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DEFINITIONS
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2 |
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| ARTICLE
2 |
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LICENSE GRANTS; EXCLUSIVITY
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21 |
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2.1
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LICENSE GRANT TO PFIZER
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21 |
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2.2
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LICENSE GRANT TO ADOLOR
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21 |
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2.3
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RESEARCH LICENSE
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21 |
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2.4
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SUBLICENSING AND
SUBCONTRACTING
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22 |
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2.4.1
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RIGHT TO SUBLICENSE
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22 |
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2.4.2
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RIGHT TO SUBCONTRACT
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23 |
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2.4.3
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LIABILITY FOR AFFILIATES, SUBLICENSEES
AND SUBCONTRACTORS
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23 |
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2.5
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PATENT CHALLENGE
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23 |
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| ARTICLE
3 |
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EXCLUSIVITY; ACQUISITION OF UNNAMED
COMPOUNDS; ADDITION AND REMOVAL OF NAMED COMPOUNDS AND NAMED
INDICATIONS
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24 |
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3.1
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EXCLUSIVITY
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24 |
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3.1.1
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NON-COMPETE
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24 |
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3.1.2
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ACQUISITION OF A COMPETING
PRODUCT
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24 |
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3.2
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ADDITIONAL NAMED COMPOUNDS
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26 |
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3.2.1
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**
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27 |
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3.2.2
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**
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27 |
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3.2.3
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**
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28 |
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3.2.4
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**
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29 |
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3.2.5
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COMMERCIALIZED ACQUIRED UNNAMED COMPOUND
INCLUSION OPTION
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30 |
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3.2.6
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IN-LICENSE TRANSACTIONS
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32 |
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3.2.7
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ADDITIONAL OPTION PERIODS
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32 |
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3.2.8
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THIRD PARTY AGREEMENT FOR UNNAMED
COMPOUNDS FOR OTHER THAN NAMED INDICATIONS
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32 |
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3.2.9
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FAILURE TO EXERCISE OPTION
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32 |
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3.2.10
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CONSEQUENCES OF EXERCISE OF NEW
COLLABORATION COMPOUND OPTIONS
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33 |
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3.3
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ADDITIONAL INDICATIONS FOR NAMED
COMPOUNDS; UNNAMED COMPOUNDS FOR NAMED INDICATIONS
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33 |
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3.3.1
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ADDITIONAL PROPOSAL
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33 |
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3.3.2
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ACCEPTANCE OF UNNAMED COMPOUND OR
PROPOSED INDICATION
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33 |
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3.3.3
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REJECTION OF PROPOSED UNNAMED COMPOUND
OR INDICATION
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33 |
i
TABLE OF
CONTENTS
(continued)
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Page |
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3.4
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REMOVAL OF NAMED COMPOUNDS AND NAMED
INDICATIONS FROM THE COLLABORATION
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34 |
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3.5
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SCREENING OPTION
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34 |
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| ARTICLE 4 |
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GOVERNANCE OF DEVELOPMENT AND
COMMERCIALIZATION OF PRODUCTS
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34 |
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4.1
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JOINT STEERING COMMITTEE
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34 |
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4.1.1
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MEMBERS; OFFICERS
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34 |
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4.1.2
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RESPONSIBILITIES
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34 |
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4.1.3
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MEETINGS
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35 |
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4.1.4
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DECISION-MAKING
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35 |
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4.2
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JOINT DEVELOPMENT COMMITTEE
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36 |
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4.2.1
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MEMBERS; OFFICERS
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36 |
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4.2.2
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RESPONSIBILITIES
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36 |
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4.2.3
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MEETINGS
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37 |
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4.2.4
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DECISION-MAKING
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38 |
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4.3
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U.S. COMMERCIALIZATION
COMMITTEE
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38 |
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4.3.1
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USCC FORMATION
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38 |
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4.3.2
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MEMBERS; OFFICERS
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38 |
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4.3.3
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RESPONSIBILITIES OF USCC UNDER NET
PROFIT/NET LOSS SHARING ARRANGEMENT
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38 |
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4.3.4
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FUNCTION OF THE USCC IN THE ABSENCE OF
NET PROFIT/NET LOSS SHARING ARRANGEMENT
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39 |
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4.3.5
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MEETINGS
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39 |
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4.3.6
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DECISION-MAKING
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39 |
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4.3.7
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ROW COMMERCIALIZATION
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39 |
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4.4
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JOINT SUPPLY CHAIN COMMITTEE
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40 |
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4.4.1
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MEMBERS; OFFICERS
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40 |
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4.4.2
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RESPONSIBILITIES
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40 |
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4.4.3
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MEETINGS
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40 |
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4.5
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WITHDRAWAL FROM COMMITTEES
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40 |
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4.6
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ALLIANCE MANAGERS
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41 |
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4.7
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COLLABORATION PRINCIPLES
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41 |
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4.8
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EXCHANGE OF INFORMATION
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41 |
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4.9
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MINUTES OF COMMITTEE MEETINGS
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42 |
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4.9.1
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DISTRIBUTION OF MINUTES
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42 |
ii
TABLE OF
CONTENTS
(continued)
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Page |
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4.9.2
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REVIEW OF MINUTES
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42 |
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4.9.3
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DISCUSSION OF COMMENTS
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42 |
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4.10
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EXPENSES
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42 |
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| ARTICLE 5 |
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DEVELOPMENT OF PRODUCTS
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42 |
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5.1
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DEVELOPMENT
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42 |
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5.2
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DEVELOPMENT AND DISCONTINUATION OF
DEVELOPMENT
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42 |
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5.2.1
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DEVELOPMENT OF LICENSED
PRODUCTS
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42 |
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5.2.2
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DISCONTINUATION OF
DEVELOPMENT
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43 |
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5.3
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DEVELOPMENT PLANS
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43 |
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5.3.1
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DEVELOPMENT PLAN FOR INITIAL NAMED
COMPOUNDS
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43 |
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5.3.2
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DEVELOPMENT PLANS FOR NEW COLLABORATION
COMPOUNDS OR ADDITIONAL INDICATIONS
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44 |
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5.3.3
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SCOPE OF DEVELOPMENT PLAN
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44 |
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5.3.4
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UPDATES TO THE DEVELOPMENT
PLAN
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44 |
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5.4
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IMPLEMENTATION OF DEVELOPMENT
PLAN
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44 |
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5.5
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DEVELOPMENT BUDGET AND
FUNDING
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44 |
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5.5.1
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DEVELOPMENT BUDGETS
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44 |
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5.5.2
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COST SHARING OPT OUTS
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45 |
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5.6
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ACCESS TO RECORDS AND
FACILITIES
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46 |
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| ARTICLE
6 |
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COMMERCIALIZATION AND CO-PROMOTE
OPTION
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46 |
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6.1
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COMMERCIALIZATION
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46 |
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6.2
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COMMERCIALIZATION PLAN
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47 |
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6.2.1
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PREPARATION AND UPDATING OF
COMMERCIALIZATION PLANS
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47 |
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6.2.2
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CONTENTS OF COMMERCIALIZATION
PLAN
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47 |
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6.2.3
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BUDGET FOR COMMERCIALIZATION
EXPENSES
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48 |
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6.3
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TRADEMARKS
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48 |
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6.4
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CO-PROMOTE OPTION
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48 |
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6.5
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COMMERCIALIZATION PLAN
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49 |
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6.6
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COOPERATION AND COORDINATION
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49 |
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6.7
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SALES REPRESENTATIVES;
TRAINING
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49 |
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6.8
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USE OF PROMOTIONAL MATERIALS IN
CO-PROMOTION
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51 |
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6.9
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SAMPLES
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51 |
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6.10
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CONTRACT SALES FORCES
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51 |
iii
TABLE OF
CONTENTS
(continued)
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Page |
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6.11
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COMPENSATION FOR ADOLOR’S
CO-PROMOTION ACTIVITIES; DETAIL REPORTS
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51 |
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6.11.1
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COMPENSATION FOR DETAILING
ACTIVITIES
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51 |
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6.11.2
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REPORTS
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51 |
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6.11.3
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RECORDS AND AUDITS PERTAINING TO
DETAILS
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52 |
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6.11.4
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DETAIL SHORTFALLS
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52 |
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6.12
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CONDUCT OF COMMERCIALIZATION
ACTIVITIES
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53 |
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6.12.1
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STATEMENTS ABOUT THE LICENSED
PRODUCTS
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53 |
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6.12.2
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MAINTENANCE OF RECORDS
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53 |
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6.12.3
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COMPLIANCE WITH LAW
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53 |
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6.12.4
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MEDICAL AND SCIENTIFIC
AFFAIRS
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54 |
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6.13
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TERMINATION OF CO-PROMOTE
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54 |
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6.14
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DISCONTINUATION OF
COMMERCIALIZATION
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54 |
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| ARTICLE 7 |
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FINANCIAL PROVISIONS
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54 |
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7.1
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UPFRONT PAYMENT
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54 |
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7.2
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REIMBURSEMENT OF PRIOR DEVELOPMENT COSTS
FOR PHASE 2A STUDIES
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54 |
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7.3
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MILESTONE PAYMENTS
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55 |
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7.4
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SALE OF LICENSED PRODUCTS IN THE UNITED
STATES
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56 |
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7.4.1
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NET PROFIT/NET LOSS SHARING OF LICENSED
PRODUCTS
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56 |
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7.4.2
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CONVERSION TO ROYALTY
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56 |
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7.5
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PAYMENT OF ROYALTIES ON NET SALES IN THE
ROW
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57 |
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7.6
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ROYALTY TERM
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57 |
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7.7
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GENERIC COMPETITION; THIRD PARTY ROYALTY
PAYMENTS
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58 |
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7.7.1
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GENERIC COMPETITION
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58 |
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7.7.2
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**
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58 |
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7.7.3
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THIRD PARTY ROYALTY
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58 |
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7.7.4
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MAXIMUM ROYALTY REDUCTION
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59 |
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7.8
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NOTICES OF TERMINATION
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59 |
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7.9
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REPORTS AND PAYMENTS
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59 |
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7.9.1
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INTERCOMPANY SALES
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59 |
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7.9.2
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ADOLOR REPORT
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59 |
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7.9.3
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PFIZER REPORT FOR NET PROFIT/NET LOSS
SHARING
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60 |
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7.9.4
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FINAL PFIZER REPORT
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60 |
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7.9.5
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PFIZER PAYMENT/INVOICE FOR NET
PROFIT/NET LOSS SHARING
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60 |
iv
TABLE OF
CONTENTS
(continued)
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Page |
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7.9.6
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PFIZER REPORT UNDER ROYALTY PAYMENT
ARRANGEMENT
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60 |
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7.9.7
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ROYALTY PAYMENT
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61 |
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7.9.8
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DELIVERY OF REPORTS AND
PAYMENTS
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61 |
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7.10
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GAAP
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61 |
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7.11
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CURRENCIES
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61 |
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7.12
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MANNER OF PAYMENTS
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61 |
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7.13
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INTEREST ON LATE PAYMENTS
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61 |
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7.14
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TAX WITHHOLDING; VALUE ADDED
TAX
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62 |
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7.14.1
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WITHHOLDING
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62 |
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7.14.2
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VALUE-ADDED TAX
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62 |
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7.15
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FINANCIAL RECORDS; AUDITS
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63 |
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7.16
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RIGHT OF OFFSET
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63 |
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| ARTICLE 8 |
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REGULATORY MATTERS
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64 |
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8.1
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GENERAL
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64 |
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8.2
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TRANSFER OF INDS FOR THE INITIAL NAMED
COMPOUNDS
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64 |
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8.3
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COMMUNICATIONS WITH REGULATORY
AUTHORITIES
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64 |
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8.4
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DRUG SAFETY
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65 |
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8.5
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REGULATORY INFORMATION
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65 |
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8.6
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RECALLS OR OTHER CORRECTIVE
ACTION
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65 |
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| ARTICLE
9 |
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MANUFACTURING AND
DISTRIBUTION
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65 |
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9.1
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DISTRIBUTION
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65 |
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9.2
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MANUFACTURING TRANSFER
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65 |
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9.3
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SUPPLY OF NAMED COMPOUNDS AND LICENSED
PRODUCTS
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66 |
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9.4
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MANUFACTURING COST
IMPROVEMENT
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66 |
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9.5
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MANUFACTURING PARTICIPATION
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66 |
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| ARTICLE 10 |
|
CONFIDENTIAL INFORMATION; PUBLICATIONS
AND PUBLICITY
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67 |
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10.1
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CONFIDENTIAL INFORMATION
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67 |
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10.2
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PUBLICATIONS
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68 |
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10.3
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REGISTRATION AND FILING OF THIS
AGREEMENT
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68 |
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10.4
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|
PUBLICITY
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|
69 |
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| ARTICLE
11 |
|
REPRESENTATIONS AND WARRANTIES;
COVENANTS
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69 |
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11.1
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MUTUAL REPRESENTATIONS AND
WARRANTIES
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69 |
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11.2
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ADDITIONAL PFIZER REPRESENTATIONS AND
WARRANTIES
|
|
70 |
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11.3
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ADDITIONAL ADOLOR REPRESENTATIONS AND
WARRANTIES
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|
71 |
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11.4
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|
COVENANTS
|
|
72 |
v
TABLE OF
CONTENTS
(continued)
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Page |
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11.5
|
|
ADDITIONAL COVENANTS OF
ADOLOR
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|
73 |
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11.6
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|
DISCLAIMER OF WARRANTY
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|
73 |
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ARTICLE 12
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|
INDEMNIFICATION
|
|
73 |
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12.1
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INDEMNIFICATION BY PFIZER
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73 |
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12.2
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INDEMNIFICATION BY ADOLOR
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|
74 |
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12.3
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LIABILITY CONTRIBUTION
|
|
74 |
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12.3.1
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INDEMNIFICATION PROCEDURES
|
|
74 |
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12.3.2
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|
U.S. PRODUCT LIABILITY
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|
74 |
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12.4
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|
PROCEDURE FOR INDEMNIFICATION
|
|
75 |
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12.4.1
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|
NOTICE
|
|
75 |
|
12.4.2
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|
DEFENSE OF CLAIM
|
|
75 |
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12.5
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|
ASSUMPTION OF DEFENSE
|
|
76 |
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12.6
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|
INSURANCE
|
|
76 |
|
12.7
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|
LIMITATION OF LIABILITY
|
|
76 |
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|
|
ARTICLE 13
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|
INTELLECTUAL PROPERTY
|
|
77 |
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13.1
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|
INTELLECTUAL PROPERTY
|
|
77 |
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13.1.1
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|
PFIZER TECHNOLOGY
|
|
77 |
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13.1.2
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|
ADOLOR TECHNOLOGY
|
|
77 |
|
13.1.3
|
|
JOINT OWNERSHIP
|
|
77 |
|
13.1.4
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INVENTORSHIP
|
|
77 |
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13.2
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PROSECUTION AND MAINTENANCE OF
PATENTS
|
|
77 |
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13.2.1
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|
PROSECUTION AND MAINTENANCE OF ADOLOR
PATENT RIGHTS
|
|
77 |
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13.2.2
|
|
RIGHT TO COMMENT
|
|
77 |
|
13.2.3
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|
PFIZER STEP-IN RIGHTS
|
|
78 |
|
13.2.4
|
|
EXECUTION OF DOCUMENTS BY
AGENTS
|
|
78 |
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13.3
|
|
PATENT INFRINGEMENT
|
|
78 |
|
|
|
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13.3.1
|
|
THIRD PARTY PATENT INVALIDITY
CLAIMS
|
|
78 |
|
13.3.2
|
|
INFRINGEMENT OF ADOLOR PATENT
RIGHTS
|
|
79 |
|
|
|
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13.4
|
|
PARAGRAPH IV NOTICES
|
|
79 |
|
13.5
|
|
PATENT TERM EXTENSION
|
|
79 |
|
13.6
|
|
REGISTRATION OF LICENSE
|
|
80 |
vi
TABLE OF
CONTENTS
(continued)
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| |
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Page |
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ARTICLE 14
|
|
TERM AND TERMINATION
|
|
80 |
|
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14.1
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|
TERM
|
|
80 |
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14.1.1
|
|
EXPIRATION
|
|
80 |
|
14.1.2
|
|
PARTIAL TERMINATIONS
|
|
80 |
|
|
|
|
14.2
|
|
TERMINATION FOR CAUSE
|
|
80 |
|
|
|
|
14.2.1
|
|
TERMINATION FOR MATERIAL
DEFAULT
|
|
80 |
|
14.2.2
|
|
TERMINATION AS A RESULT OF
INSOLVENCY
|
|
81 |
|
14.2.3
|
|
TERMINATION BASED ON CLINICAL STUDY
RESULTS
|
|
81 |
|
|
|
|
14.3
|
|
PFIZER’S RIGHT TO TERMINATE FOR
CONVENIENCE
|
|
82 |
|
14.4
|
|
CHANGE OF CONTROL
|
|
82 |
|
|
|
|
ARTICLE 15
|
|
EFFECTS OF TERMINATION
|
|
82 |
|
|
|
|
15.1
|
|
EFFECT OF TERMINATION BY ADOLOR FOR
CAUSE OR BY PFIZER VOLUNTARILY
|
|
82 |
|
15.2
|
|
EFFECT OF TERMINATION BY PFIZER FOR
CAUSE
|
|
83 |
|
15.3
|
|
TERMINATION ASSISTANCE AND TECHNOLOGY
TRANSFER
|
|
83 |
|
|
|
|
15.3.1
|
|
TECHNOLOGY TRANSFER
|
|
83 |
|
15.3.2
|
|
DELIVERY OF COLLATERAL
MATERIALS
|
|
84 |
|
15.3.3
|
|
ASSIGNMENT OF RIGHTS AND GRANT OF
LICENSES
|
|
85 |
|
15.3.4
|
|
INVENTORY
|
|
86 |
|
15.3.5
|
|
TERMINATION DUE TO SERIOUS SAFETY
ISSUE
|
|
86 |
|
|
|
|
15.4
|
|
SURVIVAL
|
|
86 |
|
|
|
|
ARTICLE 16
|
|
LIMITATIONS ON PURCHASES OF EQUITY
SECURITIES
|
|
86 |
|
|
|
|
16.1
|
|
PURCHASES OF EQUITY
SECURITIES
|
|
86 |
|
16.2
|
|
EXCEPTIONS FOR PURCHASING SECURITIES OF
ADOLOR
|
|
87 |
|
|
|
|
ARTICLE 17
|
|
MISCELLANEOUS
|
|
89 |
|
|
|
|
17.1
|
|
RELATIONSHIP OF THE PARTIES
|
|
89 |
|
17.2
|
|
FURTHER ASSURANCES
|
|
89 |
|
17.3
|
|
FORCE MAJEURE
|
|
89 |
|
17.4
|
|
GOVERNING LAW
|
|
89 |
|
17.5
|
|
EXPERT DETERMINATION OF CERTAIN
DISPUTES
|
|
90 |
|
17.6
|
|
JURISDICTION
|
|
90 |
|
17.7
|
|
ASSIGNMENT
|
|
91 |
|
17.8
|
|
NOTICES
|
|
91 |
vii
TABLE OF
CONTENTS
(continued)
|
|
|
|
|
| |
|
|
|
Page |
|
17.9
|
|
SEVERABILITY
|
|
92 |
|
17.10
|
|
HEADINGS
|
|
92 |
|
17.11
|
|
WAIVER
|
|
92 |
|
17.12
|
|
ENTIRE AGREEMENT
|
|
92 |
|
17.13
|
|
NO LICENSE
|
|
93 |
|
17.14
|
|
THIRD PARTY BENEFICIARY
|
|
93 |
|
17.15
|
|
COUNTERPARTS
|
|
93 |
viii
CONFIDENTIAL
EXECUTION COPY
LICENSE AND COLLABORATION
AGREEMENT
THIS LICENSE AND
COLLABORATION AGREEMENT (the “ Agreement ”),
dated as of December 4, 2007 (the “ Effective
Date ”), is made by and between Adolor Corporation, a
corporation organized and existing under the laws of the State of
Delaware and having its principal office at 700 Pennsylvania Drive,
Exton, Pennsylvania 19341 (“ Adolor ”), and
Pfizer Inc., a corporation organized and existing under the laws of
the State of Delaware and having its principal office at 235 East
42nd Street, New York, New York 10017-5755 (“ Pfizer
”). Adolor and Pfizer are sometimes referred to herein
individually as a “ Party ” and collectively as
the “ Parties .”
INTRODUCTION
WHEREAS, Pfizer has extensive
experience and expertise in the development and commercialization
of pharmaceutical products;
WHEREAS, Adolor has an
ongoing research program in the field of Delta Compounds and has
developed certain intellectual property in this field;
WHEREAS, Adolor desires to
collaborate with Pfizer on the development and commercialization of
the Licensed Products; and
WHEREAS, Pfizer desires to
collaborate with Adolor on the development and commercialization of
the Licensed Products, and to obtain licenses in the Territory to
the Adolor Technology.
NOW, THEREFORE, in
consideration of the foregoing premises and the representations,
covenants and agreements contained herein, Adolor and Pfizer,
intending to be legally bound, agree as follows:
ARTICLE 1
DEFINITIONS
For purposes of this
Agreement, the following initially capitalized terms, whether used
in the singular or plural, shall have the following
meanings:
1.1 “ ADL
5747 ” means ** .
1.2 “ ADL
5859 ” means ** .
1.3 “ Adolor
Confidential Information ” means Confidential Information
for which Adolor is the Disclosing Party.
1.4 “ Adolor
Delta Compound ” means a Delta Compound contributed by
Adolor to the Collaboration, including ADL 5859 and ADL
5747.
2
1.5 “ Adolor
Improvements ” means any Improvements that are invented
during the Term solely by Adolor, or its Affiliates, agents, or
sublicensees or by Third Parties acting on its behalf.
1.6 “ Adolor
Know-How ” means Know-How that is either Controlled by
Adolor on the Effective Date or comes within Adolor’s Control
during the Term (other than Pfizer Know-How pursuant to the
licenses granted hereunder) and is necessary or useful for the
Development, manufacture, use or Commercialization of any Licensed
Product or Named Compound, including unpatented Adolor
Improvements.
1.7 “ Adolor
Patent Costs ” means all Patent Costs incurred in filing,
prosecuting and maintaining Adolor Patent Rights.
1.8 “ Adolor
Patent Rights ” means any Patent Rights containing one or
more claims that cover the composition of matter of a Named
Compound or Licensed Product, or the manufacture or formulation of
the foregoing, or use of a Named Compound or Licensed Product for a
Named Indication, or any Patent Rights otherwise necessary or
useful for the Development, manufacture, use or Commercialization
of any Licensed Product for a Named Indication, which are
Controlled by Adolor as of the Effective Date or come within
Adolor’s Control during the Term (other than Pfizer Patent
Rights pursuant to the licenses granted hereunder), including any
Patent Rights claiming Adolor Improvements or Joint Improvements.
For purposes of this Agreement, Adolor Patent Rights shall not
include the ** unless Adolor grants Pfizer a sublicense to
the ** pursuant to a separate agreement or an amendment to
this Agreement. A list of Adolor Patent Rights as of the Effective
Date, which list may be updated from time-to-time, is set forth on
Schedule 1.8 .
1.9 “ Adolor
Technology ” means Adolor Patent Rights and Adolor
Know-How.
1.10 “
Affiliate ” of a Party means any Person, whether de
jure or de facto, which directly or indirectly controls, is
controlled by, or is under common control with such Party for so
long as such control exists. For purposes of this definition,
“control” of a Person means (including, with
correlative meanings, “controlled by,”
“controlling” and “under common control
with”) the possession of (a) the power to direct or
cause the direction of the management and policies of such Person,
or (b) ownership of at least fifty percent (50%) of the
securities or comparable equity interest (or such lesser percentage
which is the maximum allowed to be owned by a foreign corporation
in a particular jurisdiction) having the power to vote on or direct
the affairs of the Person.
1.11 “
Business Combination Transaction ” means, with respect
to a Party, the acquisition by such Party or any of its Affiliates
of, or merger or consolidation of such Party with, or the
acquisition of a Party by, a Third Party or any business unit of a
Third Party.
1.12 “
Business Day ” means any day that is not a Saturday,
Sunday or day on which banking institutions in New York, New York
or Philadelphia, Pennsylvania, are authorized by Law to remain
closed.
3
1.13 “
Calendar Quarter ” means for each Calendar Year, each
of the three (3) month periods ending
March 31, June 30, September 30 and
December 31; provided, however, that the first Calendar
Quarter for the first Calendar Year shall extend from the Effective
Date to the end of the first complete calendar quarter
thereafter.
1.14 “
Calendar Year ” means, for the first calendar year,
the period commencing on the Effective Date and ending on
December 31 of the calendar year during which the Effective
Date occurs, and each successive period beginning on January 1
and ending twelve (12) consecutive calendar months later on
December 31.
1.15 “
Call ” means a personal, face-to-face visit by a Sales
Representative to a member of the Target Audience who is legally
permitted to prescribe prescription drugs in the United States
during which such Sales Representative Details a Licensed Product.
The Parties may, by mutual agreement, designate additional types of
Calls.
1.16 “ Change
of Control ” means with respect to a Party:
1.16.1 the acquisition
by any individual, entity or group (within the meaning of
Section 13(d)(3) or 14(d)(2) of the Securities Exchange Act of
1934, as amended) (a “ Specified Person ”) of
beneficial ownership (within the meaning of Rule 13d-3 promulgated
under the Securities Exchange Act of 1934, as amended; it being
understood that “beneficial ownership” shall also
include any securities which any Person or any of such
Person’s Affiliates has the right to acquire (whether such
right is exercisable immediately or only after the passage of time,
pursuant to any agreement, arrangement, understanding, or upon the
exercise of conversion right, exchange rights, warrants or options,
or otherwise) of fifty percent (50%) or more of either
(a) the then outstanding common stock of such Party or
(b) the combined voting power of the then outstanding voting
securities of such Party;
1.16.2 the
consummation by a Party of any Business Combination Transaction,
unless immediately following such Business Combination Transaction,
the individuals and entities who were the beneficial owners,
respectively, of the outstanding common stock and outstanding
voting securities of such Party immediately prior to such Business
Combination Transaction beneficially own, directly or indirectly
(including, without limitation, through one or more holding
companies or subsidiaries), fifty percent (50%) or more of,
respectively, the outstanding common stock and the combined voting
power of the outstanding voting securities, as the case may be, of
the corporation or other entity resulting from such Business
Combination Transaction (including a corporation or other entity
which as a result of such transaction owns the then outstanding
securities of such Party or all or substantially all of such
Party’s assets either directly or through one or more
subsidiaries);
1.16.3 a Party or any
of its Affiliates sells or transfers to any Specified Person(s)
(other than the other Party or its Affiliates) in one or more
related transactions properties or assets representing all or
substantially all of such Party’s business to which this
Agreement relates at the time of such sale or transfer;
or
4
1.16.4 the individuals
who, as of the Effective Date, constitute the board of directors of
such Party (the “ Incumbent Board ”) ceasing for
any reason to constitute fifty percent (50%) or more of the
board of directors of such Party; provided, that any individual
becoming a director subsequent to the Effective Date whose
election, or nomination for election by such Party’s
stockholders, was approved by a vote of at least a majority of the
directors then comprising the Incumbent Board shall be considered
as though such individual were a member of the Incumbent Board, but
excluding, for this purpose, any such individual whose initial
assumption of office occurs as a result of an actual or threatened
election contest with respect to the election or removal of
directors or other actual or threatened solicitation of proxies or
consents by or on behalf of a Specified Person other than the board
of directors of such Party.
1.17 “
Claims ” means all charges, complaints, actions,
suits, proceedings, hearings, investigations, claims and
demands.
1.18 “
Clinical Studies ” means Phase 1 Studies, Phase 2
Studies or Phase 3 Studies.
1.19 “
Collaboration ” means the joint efforts of Adolor and
Pfizer to Develop and Commercialize Named Compounds for Named
Indications pursuant to this Agreement.
1.20 “
Collaboration Inclusion Date ” means, with respect to
a given Unnamed Compound, (a) in the case of the exercise of
the ** , the date on which ** with respect to such
Unnamed Compound, (b) in the case of the exercise of the
** , the date on which the first ** commences with
respect to such Unnamed Compound, (c) in the case of the
exercise of the ** , the date on which the first **
commences with respect to such Unnamed Compound, or (d) in the
case of the exercise of the ** , the date of completion of
the ** that triggered the exercise of such ** . A
Clinical Study is deemed to “commence” upon enrolment
of the first patient in such Clinical Study.
1.21 “
Collateral Materials ” means, with respect to a Named
Compound or Licensed Product, information, data, or images reduced
to a tangible form (which, for the avoidance of doubt, shall
include electronic form) to the extent relating exclusively to such
Named Compound or Licensed Product. By way of example and not
limitation, Development Plans, NDAs, Regulatory Materials,
Commercialization Plans, Licensed Product Training Materials and
Promotional Materials are all considered “Collateral
Materials.”
1.22 “
Combination Product ” means a Licensed Product
containing a Named Compound and one or more other therapeutically
active ingredients.
1.23 “
Commercialization ” means any and all activities
directed to marketing, promoting, distributing, offering for sale
and selling a Licensed Product, importing a Licensed Product (to
the extent applicable) and conducting Phase 4 Studies, including,
without limitation, Co-Promoting. When used as a verb, “
Commercialize ” means to engage in
Commercialization.
1.24 “
Commercially Reasonable Efforts ” means, with respect
to a Party, the efforts and resources which would be used
(including without limitation the promptness with which such
efforts and resources would be applied) by that Party in
Developing, manufacturing,
5
promoting or Commercializing its own
pharmaceutical products that are of comparable market potential to
the Licensed Product, taking into account all relevant factors
including product labeling or anticipated labeling, present and
future market potential, past performance of the Licensed Product
and such Party’s own pharmaceutical products that are of
similar market potential, financial return, medical and clinical
considerations, present and future regulatory environment and
competitive market conditions, and the nature and extent of market
exclusivity (including patent coverage and regulatory exclusivity),
all as measured by the facts and circumstances at the time such
efforts are due. Commercially Reasonable Efforts require that a
Party, at a minimum, assign responsibility for such obligations to
qualified employees, set annual goals and objectives for carrying
out such obligations, and allocate appropriate resources designed
to meet such goals and objectives. ** .
1.25 “
Committee ” means the JSC, JDC, USCC or JSCC as the
case may be.
1.26 “
Confidential Information ” means all secret,
confidential or proprietary information or data, whether provided
in written, oral, graphic, video, electronic or other form,
provided by one Party (the “ Disclosing Party ”)
to the other Party (the “ Receiving Party ”)
pursuant to the letter agreements between Adolor and Pfizer dated
June 19, 2007 and September 18, 2007, this Agreement or
generated pursuant to this Agreement, including, but not limited
to, information relating to the Disclosing Party’s existing
or proposed research, development efforts, patent applications,
business or products, the terms of this Agreement and any other
materials, all of which are non-public. Notwithstanding the
foregoing sentence, Confidential Information shall not include any
information or materials that:
1.26.1 were already
known to the Receiving Party or its Affiliate (other than under an
obligation of confidentiality to the Disclosing Party) at the time
of disclosure by the Disclosing Party to the extent such Receiving
Party has documentary evidence to that effect;
1.26.2 were generally
available to the public or otherwise part of the public domain at
the time of its disclosure to the Receiving Party;
1.26.3 became
generally available to the public or otherwise part of the public
domain after its disclosure or development, as the case may be, and
other than through any act or omission of the Receiving Party in
breach of the Receiving Party’s confidentiality obligations
under this Agreement;
1.26.4 were disclosed
to the Receiving Party or its Affiliate, other than under an
obligation of confidentiality, by a Third Party who had no
obligation to the Disclosing Party not to disclose such information
to others; or
1.26.5 were
independently discovered or developed by or on behalf of the
Receiving Party or its Affiliate without the use of the
Confidential Information belonging to the Disclosing Party, as
demonstrated by the Receiving Party through documentary
evidence.
1.27 “
Control ” or “ Controlled ” means,
with respect to any: (a) material, item of information,
method, data or other Know-How, or (b) intellectual property
right, the possession
6
(whether by ownership or license, other
than a license pursuant to this Agreement) by a Party or its
Affiliates of the ability to grant to the other Party access and/or
a license as provided herein under such item or right without
violating the terms of any agreement or other arrangement with any
Third Party existing at the applicable time.
1.28 “
Co-Promotion ” means those Detailing and other
activities undertaken by a pharmaceutical company’s sales
force in concert with at least one other pharmaceutical
company’s sales force to implement the Commercialization
Plans and strategies with respect to a particular prescription
pharmaceutical product under a single trademark. When used as a
verb, “Co-Promote” shall mean to engage in such
activities.
1.29 “ Cost
of Goods ” means Manufacturing Costs, calculated annually
as a “standard cost,” plus, as applicable,
(a) Manufacturing Cost variances between the standard cost
components of Manufacturing Costs and the actual costs incurred,
(b) Out-of-Pocket Costs and Expenses directly related to
shipping of finished Licensed Product to the final warehouse prior
to sale of such Licensed Product to an unaffiliated Third Party in
the United States; and (c) other non-standard direct and
identifiable costs such as process improvements, obsolete
inventory, inventory revaluation, and expense portions of capital
projects. Cost of Goods shall be calculated in accordance with GAAP
and Pfizer’s policies and procedures that it uses for its
other products, in each case as consistently applied.
1.30 “
Country ” means any generally recognized sovereign
entity.
1.31 “ Delta
Compound ” means any compound or molecule that binds with
at least nanomolar affinity and which has greater than **
selectivity for the delta opioid receptor versus the kappa opioid
receptor, mu opioid receptor or any other pharmacologically
relevant receptor. For clarity, “Delta Compound” refers
to agonists, not antagonists or inverse agonists and should have no
significant pharmacological efficacy in functional assays for mu or
kappa receptor agonist activity at concentrations ** in a delta
functional assay.
1.32 “
Detail ” or “ Detailing ” means,
with respect to a Licensed Product, the activity undertaken by a
Sales Representative during a Call to a member of the Target
Audience at such member’s professional offices or in
hospitals (including at hospital displays), describing the
FDA-approved uses, safety, effectiveness, contraindications, side
effects, warnings and other relevant characteristics of such
Licensed Product. With respect to certain group or institution
Licensed Product presentations, Exhibit A sets forth how
such presentations will be counted for determination of the number
of Details. A Detail does not include (a) a reminder
presentation or (b) a sample drop. Details shall be measured
by each Party’s internal recording of such activity;
provided, that such measurement shall be on the same basis as the
recording Party’s measurement for its Sales
Representatives’ detailing of such recording Party’s
other products, if any, consistently applied throughout the Term.
If a Party has no other marketed products, it will establish a
basis of internal recording of Details that is reasonable as a
basis of recording Details.
1.33 “ Detail
Cost ” means ** per Detail in the U.S. commencing
with the Effective Date. Throughout the Term, the Detail Cost for
the previous Calendar Year shall be amended on the first Business
Day of each Calendar Year with effect for the then-current Calendar
Year, by a
7
factor equal to the rate of change for
the previous Calendar Year in the Producer Price Index as published
by the Bureau of Labor Statistics of the U.S. Department of
Labor.
1.34 “
Development ” or “ Develop ” means
preclinical and clinical drug development activities, including,
among other things, test method development and stability testing,
toxicology, formulation, process development, manufacturing
scale-up, manufacturing for Clinical Studies, preclinical studies,
Clinical Studies, regulatory filing submission and approval, and
regulatory affairs related to the foregoing. When used as a verb,
“Develop” means to engage in Development. For clarity,
Development does not include Phase 4 Studies.
1.35 “
Development Costs ” of a Licensed Product means all
Out-of-Pocket Costs and Expenses for work required for Development
of such Licensed Product, other than amounts related solely to
Development of such Licensed Product in the ROW (including
preclinical, clinical, regulatory and manufacturing activities), in
each case only to the extent provided for in an approved
Development Plan or otherwise approved in advance by the Joint
Development Committee or Joint Steering Committee. Development
Costs shall consist of:
1.35.1 Out-of-Pocket
Costs and Expenses incurred (a) to a Third Party, in
connection with all Development activities performed in accordance
with the Development Plan; (b) in connection with regulatory
submissions; or (c) for process development of the
manufacturing process for the Licensed Product;
1.35.2 the
Out-of-Pocket Costs and Expenses of clinical supplies for such
Clinical Studies or activities as agreed in the Development Plan,
which costs shall consist of: (a) the Out-of-Pocket Costs and
Expenses incurred in purchasing clinical and pre-clinical supplies,
including the Named Compound, utilized in Development,
(b) Out-of-Pocket Costs and Expenses incurred in purchasing
comparator drug(s) and in packaging comparator drug(s) and/or the
Named Products, and (c) shipping clinical supplies to centers
or disposal of clinical supplies; and
1.35.3 such other
Out-of-Pocket Costs and Expenses as the Parties may agree upon in
writing from time to time.
1.36 “
Development Plan ” for a Licensed Product means:
(a) the written comprehensive plan for the Development of such
Licensed Product through filing for Marketing Authorization,
including activities designed to generate the preclinical, process
development/manufacturing scale-up, clinical and regulatory
information required for filing Marketing Authorization
Applications and managing any contracted Third Party resources
engaged to carry out any of the foregoing activities, and
(b) a budget for Development Costs through filing for
Marketing Authorization. The initial Development Plans for Licensed
Products containing ADL 5859 and ADL 5747 are attached hereto as
Schedule 1.36 , as they may be amended and updated in
accordance with Section 5.3 of this Agreement.
1.37 “
Distribution Expenses ” means ** of Net Sales
of a Licensed Product in the U.S. for warehousing and distribution
of commercial supplies of the Licensed Product to Third Party
customers, including: (a) distributor customer services,
(b) order entry, (c) billing,
(d) insurance,
8
freight and transportation for delivery
of the Licensed Product to the end user, and (e) credit and
collection services.
1.38 “
EMEA ” means the European Medicines Agency and any
successor agency having substantially the same
functions.
1.39 “
Expert ” means a mutually acceptable, disinterested,
conflict-of-interest-free individual not affiliated with either
Party or its Affiliates who, with respect to a dispute referred to
such Expert in accordance with this Agreement, possesses the
appropriate expertise in the pharmaceutical industry to resolve
such dispute. The Expert shall not be or have been at any time an
Affiliate, employee, consultant (during the previous five
(5) years), officer or director of either Party or any of its
Affiliates.
1.40 “ Expert
Matter ” means any dispute referred to an Expert pursuant
to Section 4.1.4(b) or otherwise referred to an Expert by
mutual agreement of the Parties.
1.41 “
FDA ” means the U.S. Food and Drug Administration and
any successor agency thereto.
1.42 “
FD&C Act ” means the U.S. Federal Food, Drug, and
Cosmetic Act, as amended from time to time (21 U.S.C. §§
301 et seq.), together with any rules and regulations promulgated
thereunder.
1.43 “
Field ” means all therapeutic, prognostic and
diagnostic applications for all Named Indications for human and
non-human purposes for Named Indications.
1.44 “ First
Commercial Sale ” of a Licensed Product means the first
shipment of such Licensed Product in quantities customarily
required for a pharmaceutical product launch sold to a Third Party
by Pfizer, Pfizer’s Affiliates, or Pfizer’s
sublicensees in any Country after receipt of Marketing
Authorization (and, where applicable, Price Approval) for such
Licensed Product in such Country.
1.45 “
Generic Competition ” means, with respect to a
Licensed Product and on a Country-by-Country basis, a decrease of
Net Sales in a Pfizer Quarter resulting from sales of a Generic
Product from the level of Net Sales of the Pfizer Quarter prior to
the first entry of such Generic Product for such Licensed Product
in such Country by more than ** . For clarity, there shall
be deemed no Generic Competition in any Pfizer Quarter if the
decrease of quarterly Net Sales, if any, compared to the Pfizer
Quarter prior to the first entry of such Generic Product is less
than ** .
1.46 “
Generic Product ” means, on a Country-by-Country basis
and Licensed Product-by-Licensed Product basis, a drug product
independently developed by a Third Party that: (a) contains
the same active pharmaceutical ingredient(s) as the Licensed
Product, (b) can reasonably be or is reasonably used for the
same indication or indications for which such Licensed Product is
approved, and (c) (i) for purposes of the United States,
is approved in reliance on the prior approval of a Licensed Product
as determined by the FDA, or (ii) for
9
purposes of a country outside the United
States, is approved in reliance on the prior approval of a Licensed
Product as determined by the applicable Regulatory
Authority.
1.47 “
GCPs ” means the then-current standards, practices and
procedures promulgated or endorsed by the FDA for the design,
conduct, performance, monitoring, auditing, recording, analyses,
and reporting of clinical trials as set forth in the guidelines
titled “Guidance for Industry E6 Good Clinical Practice:
Consolidated Guidance,” including related regulatory
requirements imposed by the FDA and comparable regulatory
standards, practices and procedures in jurisdictions outside the
U.S., as they may be updated from time to time, that provide
assurance that the data and reported results are credible and
accurate, and that the rights, integrity, and confidentiality of
trial subjects are protected.
1.48 “
GLPs ” means the then-current good laboratory practice
standards promulgated or endorsed by the FDA as defined in 21
C.F.R. Part 58, and comparable regulatory standards in
jurisdictions outside the U.S., as they may be updated from time to
time.
1.49 “
GMPs ” means the then-current good manufacturing
practices required by the FDA, as defined in 21 C.F.R. Parts 210
and 211 and the regulations promulgated thereunder, for the
manufacture and testing of pharmaceutical materials, and comparable
laws or regulations applicable to the manufacture and testing of
pharmaceutical materials in jurisdictions outside the U.S., as they
may be updated from time to time. GMPs shall include applicable
quality guidelines promulgated under the International Conference
on Harmonization.
1.50 “
Governmental Authority ” means any court, agency,
department, authority or other instrumentality of any national,
state, county, city or other political subdivision.
1.51 “
Improvement ” means any invention, discovery, or
improvement (whether patentable or not) invented by or on behalf of
a Party during the Term to the extent covering a Named Compound or
Licensed Product.
1.52 “
IND ” means an Investigational New Drug Application,
as defined in the FD&C Act, that is required to be filed with
the FDA, or similar application or submission that is required to
be filed with any foreign Regulatory Authority before beginning
clinical testing of a Licensed Product in human
subjects.
1.53 “ Joint
Improvement ” means an Improvement that is invented
jointly by employees and/or agents of both Adolor and Pfizer or
their Affiliates.
1.54 “
Know-How ” means any unpatented technology, technical
information, know-how and materials, including without limitation
all biological, chemical, pharmacological, toxicological, clinical,
assay and other information, data, discoveries, inventions,
improvements, processes, formulae and trade secrets, patentable or
otherwise.
1.55 “
Laws ” means laws, rules and regulations (including
any rules, regulations, guidelines or other requirements of the
Regulatory Authorities applicable to the Development,
10
manufacturing or Commercialization of
Named Compounds or Licensed Products) that may be in effect from
time to time.
1.56 “
Licensed Product ” means any pharmaceutical product
containing a Named Compound, alone or in combination with one or
more therapeutically active ingredients. Two
(2) pharmaceutical products that contain the identical active
ingredient(s) shall be deemed to be the same Licensed Product where
the change to the initial Licensed Product does not require the
filing and approval of a new MAA, but rather requires the filing
and approval of a supplement to a then-existing MAA for the
Licensed Product.
1.57 “
Losses ” means any and all damages (including all
incidental, consequential, statutory and treble damages), awards,
deficiencies, settlement amounts, defaults, assessments, fines,
dues, penalties, costs, fees, liabilities, obligations, taxes,
liens, losses, lost profits and expenses (including without
limitation court costs, interest and reasonable fees of attorneys,
accountants and other experts) incurred by or awarded to Third
Parties and required to be paid to Third Parties with respect to a
Claim by reason of any judgment, order, decree, stipulation or
injunction, or any settlement entered into in accordance with the
provisions of this Agreement, together with all documented
Out-of-Pocket Costs and Expenses incurred in complying with any
judgments, orders, decrees, stipulations and injunctions that arise
from or relate to a Claim of a Third Party.
1.58 “ Major
EU Countries ” means France, Germany, Italy, Spain and
the United Kingdom.
1.59 “ Major
Market Countries ” means the United States, Japan, and
Major EU Countries.
1.60 “
Manufacturing Costs ” means costs to supply Licensed
Product (a) supplied by an unaffiliated Third Party or
(b) manufactured directly by a Party or an Affiliate of a
Party. In the case of (a), Manufacturing Costs shall be a
“standard cost” per unit (calculated for each calendar
year of the Term), which standard cost shall include (i) the
amount paid to such Third Party, plus (ii) direct and
identifiable personnel compensation and benefits and direct and
identifiable Out-of-Pocket Costs incurred by the manufacturing
Party (i.e., the Party responsible for overseeing the manufacturing
of the Third Party) in connection with quality assurance, supply
chain management and similar activities comprising the
manufacturing Party’s oversight of the manufacturing process
of the Third Party. In the case of (bi), Manufacturing Costs shall
be a “standard cost” per unit (calculated annually and
at a time to align with the Parties’ internal budget
processes), which standard cost shall include the cost of raw
materials, direct and identifiable labor, and other direct and
identifiable variable costs and appropriate direct and identifiable
costs (or appropriate allocation thereof) for equipment pools,
plant operations and plant support services. The costs for plant
operations and support services would include utilities,
maintenance, engineering, safety, human resources, finance, plant
management and other similar activities. Standard costs shall be
calculated in accordance with GAAP and Pfizer’s policies and
procedures for its other products, in each case consistently
applied. The plant operations and support services costs shall be
allocated consistent with GAAP and the other Pfizer products in
that facility. Costs which cannot be linked to a specific activity
supporting
11
Product manufacturing, such as charges
for corporate overhead which are not controllable by the
manufacturing plant, shall not be included in standard
cost.
1.61 “
Marketing Authorization Application ” or “
MAA ” means, with respect to a Country, the regulatory
authorization required to market and sell a Licensed Product in
such Country as granted by the relevant Regulatory Authority,
including any NDA filed with the FDA or any marketing authorization
application filed with the EMEA.
1.62 “
Marketing Authorization ” means approval by a
Regulatory Authority for sale of a Licensed Product.
1.63 “
Marketing Expenses ” of a Licensed Product means all
Out-of-Pocket Costs and Expenses, whether incurred by Adolor or its
Affiliates, or Pfizer or its Affiliates, to the extent provided for
in an approved Commercialization Plan or otherwise approved in
advance by the Joint Steering Committee, and solely to the extent
related to marketing such Licensed Product in the United States,
consisting of:
1.63.1 Marketing,
promotion and advertising (including agency fees) through any means
(including consumer-directed advertising, physician-directed
advertising, journal, newspaper, radio, internet or place-based
advertisements, promotional literature, patient education, field
and headquarters’ grants, exhibits, direct mail, advisory
boards, symposia, congress activities and dinner
programs);
1.63.2 Sampling and
promoting such Licensed Product, speakers’ programs and
symposia, but excluding all costs and expenses incurred in
retaining contract sales forces for such Licensed Product unless
otherwise mutually agreed by the Parties;
1.63.3 Conducting
Phase 4 Studies;
1.63.4 Conducting
primary and secondary market research;
1.63.5 Preparing and
producing Promotional Materials for distribution and materials and
programs used for ongoing training of Sales Representatives and of
sales trainers;
1.63.6 Conducting
recalls of Licensed Product to the extent provided in
Section 8.6;
1.63.7 Manufacturing
Costs of Samples, and costs relating to the destruction of unused
Samples; and
1.63.8 Such other
Out-of-Pocket Costs and Expenses as the Parties may agree upon in
writing from time to time.
1.64 “
Material Default ” means:
12
1.64.1 any default by
any Party hereto of its representations, warranties, covenants,
agreements or other performance obligations under this Agreement
(other than a payment obligation) that is (a) material to this
Agreement, taken as a whole, and (b) shall have continued for
** after notice thereof was provided to the alleged
defaulting Party by the non-defaulting Party (or, if such default
cannot be cured within such ** period, if the alleged
defaulting Party does not promptly commence and diligently continue
all reasonable actions to cure such defaults during such **
period, or does not materially cure such default within **
after notice thereof was provided to the alleged defaulting Party);
or
1.64.2 any default by
any Party hereto of its payment obligations hereunder that shall
have continued for ** after notice thereof was provided to
the alleged defaulting Party by the non-defaulting Party; provided
that, in the event of a good faith payment dispute, such **
cure period shall be extended for an additional ** to
resolve such dispute if the alleged defaulting Party has paid all
undisputed amounts when due and provided the non-defaulting Party
with a reasonably detailed written explanation of the alleged
defaulting Party’s basis for disputing the payment obligation
within the ** period following the notice of the default by
the non-defaulting Party. The alleged defaulting Party shall pay
interest on the final adjudicated amount due pursuant to
Section 7.13 from the date that such payment was originally
due.
1.64.3 Notwithstanding
anything to the contrary contained herein, for purposes of
determining the existence of any “Material Default,” no
Party shall be deemed to be in material breach or material default
if its actions or omissions resulted from (a) mutual agreement
in writing by the Parties or (b) required compliance with any
applicable Law.
1.65 “ Named
Compounds ” means any Delta Compounds set forth on
Schedule 1.65 , as amended from time to time pursuant to the
terms of this Agreement. As of the Effective Date the Named
Compounds shall be ADL 5859 and ADL 5747.
1.66 “ Named
Indications ” means indications set forth on Schedule
1.66 , as amended from time to time pursuant to the terms of
this Agreement. As of the Effective Date the Named Indications
shall be pain.
1.67 “
NDA ” means a new drug application or supplemental new
drug application or any amendments thereto submitted to the FDA in
the United States.
1.68 “ NDA
Acceptance ” means the written notification by the FDA
that the NDA has met all the criteria for filing acceptance
pursuant to 21 C.F.R. § 314.101.
1.69 “ Net
Profit/Net Loss ” means, as determined in accordance with
GAAP, with respect to a Licensed Product in the United States, Net
Sales of such Licensed Product less the following: (a) Cost of
Goods, (b) Royalties, if any, paid by Adolor or Pfizer to
Third Parties in accordance with Section 7.7.2 or 7.7.3,
(c) Sales Expenses, (d) Distribution Expenses,
(e) Marketing Expenses, (f) Patent Costs relating to each
of Adolor Patent Rights in the U.S. and Pfizer Patent Rights in the
U.S., and (g) Development Costs. For the avoidance of doubt,
no individual cost or expense shall be counted more than once in
calculating Net Profit/Net Loss.
13
1.70 “ Net
Sales ” of a Licensed Product means, as determined in
accordance with GAAP, the aggregate gross amount invoiced on
account of sales of such Licensed Product by Pfizer or any of its
Affiliates or their sublicensees to a Third Party less the
following relating to such sale to the extent actually paid,
granted or accrued:
1.70.1 credits or
allowances as a result of billing errors, rejected goods, damaged
or defective goods, recalls, retroactive price adjustments, or
returns;
1.70.2 trade, quantity
and cash discounts or rebates;
1.70.3 credits, volume
rebates, charge-back and prime vendor rebates;
1.70.4 actual bad
debts;
1.70.5 discounts,
rebates, reimbursements or similar payments to wholesalers and
other distributors, buying groups, health care insurance carriers,
pharmacy benefit management companies, health maintenance
organizations, Governmental Authorities, or other institutions or
health care organizations or arising in connection with any Pfizer
Discount or Savings Program (as defined below); and
1.70.6 any tax,
tariff, customs duty, excise or other duty or other governmental
charge (other than a tax on income) levied on the sale,
transportation or delivery of a Licensed Product and borne by the
seller thereof.
Net Sales shall be determined from books
and records maintained by Pfizer in accordance with GAAP, as
consistently applied with respect to sales of all its prescription
pharmaceutical products.
For purposes of this definition of
“Net Sales” only, “ Pfizer Discount or Savings
Program ” means any discount, rebate or reimbursement
program applicable to a Licensed Product under which Pfizer or its
Affiliates provides to low income, uninsured or other patients the
opportunity to purchase Pfizer pharmaceutical products at
discounted prices.
In the case of any sale for value, such
as barter or counter-trade, of a Licensed Product, or part thereof,
other than in an arm’s-length transaction exclusively for
cash, Net Sales shall be deemed to be the Net Sales at which
substantially similar quantities of such Licensed Product are sold
for cash in an arm’s-length transaction.
Notwithstanding the foregoing, Net Sales
shall not be reduced by customs or excise taxes, import duties,
sales taxes and other taxes or duties related to the active
ingredient in a Licensed Product or sales of a Licensed Product
other than in finished form, all of which shall be deemed expenses
incurred in connection with the manufacture of a Licensed
Product.
Pfizer shall have the sole right to
price, including discounting, the Licensed Products and Pfizer
shall not be prohibited from offering the Licensed Products in a
discounting program that includes a portfolio of other Pfizer
products (“ Portfolio Discounting ”); provided
that: ** .
14
In the event a Licensed Product is sold
as a Combination Product, Net Sales shall be calculated by
multiplying the Net Sales of the Combination Product by the
fraction A/(A+B), where A is the weighted (by sales volume) average
sale price in a particular Country of the Named Compound in such
Combination Product when sold separately in finished form and B is
the weighted (by sales volume) average sale price in that Country
of the other product(s) sold separately in finished form. In the
event no such separate sales are made by Pfizer or its Affiliates
or sublicensees, Net Sales of the Combination Product shall be
calculated in a manner to be negotiated and agreed upon by the
Parties, reasonably and in good faith, prior to any sale of such
Combination Product, which shall be based upon the relative value
contributed to the Combination Product of each of the active
components of such Combination Product.
1.71 “ Opt
Out ” means the ** .
1.72 “
Out-of-Pocket Costs and Expenses ” means costs and
expenses paid to Third Parties (or payable to Third Parties and
accrued in accordance with GAAP), other than Affiliates or
employees, by either Party.
1.73 “ Patent
Costs ” means all Out-of-Pocket Costs and Expenses
incurred in filing, prosecuting and maintaining Patent
Rights.
1.74 “ Patent
Rights ” means all patents and patent applications,
including any continuations, continuations-in-part, divisions,
provisionals or any substitute applications, any patent issued with
respect to any such patent applications, any reissue,
reexamination, renewal or extension (including any supplemental
protection certificate) of any such patent, and any confirmation
patent, registration patent or patent of addition based on any such
patent, and all foreign counterparts of any of the foregoing, or,
as applicable, portions thereof or individual claims
therein.
1.75 “ Patent
Term Extension ” means any term extensions, supplementary
protection certificates, and equivalents thereof, offering patent
protection beyond the initial term with respect to any issued
Patent Rights. For clarity, pediatric exclusivity under
Section 505(A) of the FDA Modernization Act of 1997 shall not
be deemed Patent Term Extension.
1.76 “
Person ” means any natural person, corporation,
general partnership, limited partnership, joint venture,
proprietorship or other business organization.
1.77 “ Pfizer
Confidential Information ” means Confidential Information
for which Pfizer is the Disclosing Party.
1.78 “ Pfizer
Delta Compound ” means a Delta Compound contributed by
Pfizer to the Collaboration.
1.79 “ Pfizer
Improvements ” means any Improvements that are invented
during the Term solely by Pfizer, or its Affiliates, agents, or
sublicensees or by Third Parties acting on its behalf.
15
1.80 “ Pfizer
Know-How ” means Know-How that is either Controlled by
Pfizer on the Effective Date or comes within Pfizer’s Control
during the Term (other than Adolor Know-How pursuant to the
licenses granted hereunder) and is necessary or useful for the
Development, manufacture, use or Commercialization of any Licensed
Product or Named Compound, including unpatented Pfizer
Improvements.
1.81 “ Pfizer
Patent Costs ” means Patent Costs incurred in connection
with filing, prosecuting and maintaining Pfizer Patent
Rights.
1.82 “ Pfizer
Patent Rights ” means any Patent Rights containing one or
more claims that cover the composition of matter of a Named
Compound or Licensed Product or the manufacture or formulation of
the foregoing, or use of a Named Compound or Licensed Product for a
Named Indication, or any Patent Rights otherwise necessary or
useful for the Development, manufacture, use or Commercialization
of any Licensed Product for a Named Indication, which are
Controlled by Pfizer as of the Effective Date or come within
Pfizer’s Control during the Term (other than Adolor Patent
Rights pursuant to the licenses granted hereunder), including any
Patent Rights claiming Pfizer Improvements or Joint
Improvements.
1.83 “ Pfizer
Quarter ” means each of the four (4) thirteen
(13) week periods (i) with respect to the United States,
commencing on January 1 of any calendar year, and
(ii) with respect to any Country in the Territory other than
the United States, commencing on December 1 of any calendar
year.
1.84 “ Pfizer
Year ” means the twelve (12) month period
(i) with respect to the United States, commencing on
January 1 of any calendar year, and (ii) with respect to
any Country in the Territory other than the United States,
commencing on December 1 of any calendar year.
1.85 “ Pfizer
Technology ” means Pfizer Patent Rights and Pfizer
Know-How.
1.86 “ Phase
1 Study ” means, with respect to a Licensed Product, a
clinical study identified as a Phase 1 Study in the Development
Plan and conducted in humans on a pharmaceutical product with the
primary purpose of determining safety, metabolism and
pharmacokinetic properties, and clinical pharmacology of such
pharmaceutical product, and that is consistent with 21 C.F.R.
§ 312.21(a).
1.87 “ Phase
2 Study ” means, with respect to a Licensed Product, a
clinical study identified as a Phase 2 Study in the Development
Plan and conducted in human patients designed to evaluate clinical
efficacy and safety for such product for one or more indications,
as well as to obtain an understanding of the dosage regimen before
embarking on Phase 3 Studies, and that is consistent with 21 C.F.R.
§ 312.21(b).
1.87.1 “
Phase 2a Study ” means a Phase 2 Study identified as a
Phase 2a Study in the applicable Development Plan.
1.87.2 “
Phase 2b Study ” means a Phase 2 Study identified as a
Phase 2b Study in the applicable Development Plan.
16
1.88 “ Phase
3 Study ” means, with respect to a Licensed Product, a
clinical study identified as a Phase 3 Study in the Development
Plan and conducted as a pivotal trial for purposes of filing a
Marketing Approval Application for a Licensed Product that provides
for the clinical study of such Licensed Product on sufficient
numbers of patients to confirm with statistical significance the
efficacy, and confirm the safety of such Licensed Product
sufficient to support such Marketing Approval Application for such
Licensed Product, and is consistent with 21 C.F.R. §
312.21(c).
1.89 “ Phase
4 Study ” means a study for a Licensed Product that is
initiated in a Country after receipt of a Marketing Authorization
for such Licensed Product in such Country and is principally
intended to support the marketing and Commercialization of such
Licensed Product, including without limitation investigator
initiated trials, clinical experience trials and studies conducted
to fulfill local commitments made as a condition of any Marketing
Authorization. For clarity, no Phase 3 Studies are included in this
definition of Phase 4 Studies.
1.90 “ Price
Approval ” means, in any Country where a Governmental
Authority authorizes reimbursement for, or approves or determines
pricing for, pharmaceutical products, receipt (or, if required to
make such authorization, approval or determination effective,
publication) of such reimbursement authorization or pricing
approval or determination (as the case may be).
1.91 “
Promotional Materials ” means all written, printed,
video or graphic advertising, promotional, educational and
communication materials (other than the Licensed Product package
insert), including all written, graphic, electronic, audio and
video pieces and including journal advertisements, direct mail,
direct-to-consumer advertising, internet postings, broadcast
advertisements and sales aids, relating to the Licensed Products in
the United States.
1.92 “
Regulatory Approvals ” means all approvals (including,
without limitation, INDs, Marketing Authorizations and supplements
and amendments thereto), licenses, registrations or authorizations
of any national, supra-national, regional, state or local
regulatory agency, department, bureau, commission, council or other
governmental entity necessary for the Development or
Commercialization of the Licensed Product, including clinical
testing, importation, manufacture, distribution, use or sale of the
Licensed Product in a given regulatory jurisdiction.
1.93 “
Regulatory Authority ” means any applicable
Governmental Authority responsible for the granting of Marketing
Authorizations for a Licensed Product in a regulatory jurisdiction
within the Territory, including, without limitation, the FDA and
the EMEA.
1.94 “
Regulatory Exclusivity ” means any exclusive marketing
rights or data exclusivity rights conferred by any Regulatory
Authority with respect to a Licensed Product other than a Patent
Right, including, without limitation, rights conferred in the U.S.
under the Hatch-Waxman Act or the FDA Modernization Act of 1997
(including pediatric exclusivity), or rights similar thereto
outside the U.S.
17
1.95 “
Regulatory Materials ” means any regulatory
submissions, notifications, registrations, approvals and/or other
filings and correspondence made to or with a Regulatory Authority,
and any other records required to be maintained for possible audit
by a Regulatory Authority, that are necessary or reasonably
desirable to Develop, manufacture, promote, market, sell or
otherwise Commercialize Licensed Products in the
Territory.
1.96 “
ROW ” means all the Countries of the world other than
the United States.
1.97 “
Royalty Term ” means on a Country-by-Country and
Licensed Product-by-Licensed Product basis, the period beginning on
the date of the First Commercial Sale of a Licensed Product and
ending on the last day on which royalty payments are payable by
Pfizer to Adolor pursuant to Section 7.6.
1.98 “ Sales
Expenses ” of a Party means the Detail Cost multiplied by
the number of Details conducted by such Party in Detailing the
applicable Licensed Product during the applicable period of
time.
1.99 “ Sales
Representative ” means an employee of Adolor or Pfizer
who engages in Detailing and other promotional efforts with respect
to the Licensed Product and who has been trained by Adolor or
Pfizer in accordance with this Agreement.
1.100 “
Samples ” means Licensed Product packaged as samples
and distributed to members of the Target Audience on a
complimentary basis for use with patients in the United States and
in accordance with all Laws.
1.101 “
Target Audience ” means the target prescribers
established by the USCC for the Sales Representatives to Detail, as
included in the Commercialization Plan.
1.102 “
Territory ” means ROW and the United
States.
1.103 “ Third
Party ” means a Person who is not a Party or an Affiliate
of a Party.
1.104 “**”
means **.
1.105 “**”
means **.
1.106 “
Unnamed Compound ” means any Delta Compound that is
not a Named Compound.
1.107 “
United States ” or “ U.S. ” means
the United States of America, and its territories and
possessions.
1.108 “ Valid
Claim ” means any claim of (a) an issued and
unexpired patent included within the Adolor Patent Rights that has
not been revoked or held unenforceable or invalid by a decision of
a court or other Governmental Authority of competent jurisdiction,
and which has not been disclaimed, denied or admitted by Adolor to
be invalid or unenforceable through reissue or disclaimer or
otherwise, or (b) a pending patent application within the
Adolor Patent Rights that
18
has not been cancelled, withdrawn,
abandoned, or pending for more than ** after the earliest
filing date to which such pending application claims priority;
provided, however, when such patent issues based on such patent
application, any claim contained therein shall be deemed a Valid
Claim. If, in any Country, there should be two (2) or more
such decisions conflicting with respect to the validity of the same
claim, the decision of the higher or highest tribunal shall
thereafter control; however, should the tribunals be of equal rank,
then the decision or decisions upholding the claim shall prevail
when the conflicting decisions are equal in number, and the
majority of decisions shall prevail when the conflicting decisions
are unequal in number.
1.109
Construction . Except where expressly stated otherwise in
this Agreement, the following rules of interpretation apply to this
Agreement: (a) “include,” “includes”
and “including” are not limiting and mean include,
includes and including, without limitation; (b) definitions
contained in this Agreement are applicable to the singular as well
as the plural forms of such terms; (c) references to an
agreement, statute, Law or instrument defined or referred to herein
mean such agreement, statute, Law or instrument as from time to
time amended, modified or supplemented, including (in the case of
agreements and instruments) by waiver or consent and (in the case
of statutes and Laws) by succession of comparable successor
statutes or Laws and all attachments thereto and instruments
incorporated therein; (d) references to a person are also to
its permitted successors and assigns; (e) references to an
“Article,” “Section,” “Exhibit”
or “Schedule” refer to an Article or Section of, or any
Exhibit or Schedule to, this Agreement unless otherwise indicated;
(f) the word “will” shall be construed to have the
same meaning and effect as the word “shall”; and
(g) the word “any” shall mean “any and
all” unless otherwise indicated by context.
Other Defined Terms
|
|
|
| Abandoned
Adolor Patent Rights |
|
13.2.3 |
| Acquired
Competing Product |
|
3.1.2(a) |
| Acquiring
Party |
|
3.1.2(a) |
| Acquisition |
|
16.2.2 |
| Additional Proposal |
|
3.3.1 |
| Adolor |
|
Preamble |
| Adolor
Expenses |
|
7.9.2 |
| Adolor
Indemnitees |
|
12.1 |
| Adolor
Report |
|
7.9.2 |
| Adolor
Sales Force |
|
6.7.1 |
| Adolor
Sales Force Trainers |
|
6.7.1 |
| Adolor
Sales Representatives |
|
6.7.1 |
| Adolor
Targets |
|
6.4 |
| Agreement |
|
Preamble |
| Alliance
Manager |
|
4.6 |
| Annual
Cost Sharing Opt Out |
|
5.5.2(c) |
| Auditing
Party |
|
7.15 |
| Collaboration Principles |
|
4.7 |
| Commercialization Plan |
|
6.2.1 |
| Commercialized Acquired Unnamed Compound |
|
3.2.5 |
| Commercialized Acquired Unnamed Compound Inclusion
Option |
|
3.2.5 |
| Competing
Product |
|
3.1.1 |
| Competing
Products |
|
3.1.1 |
| Co-Promote Option |
|
6.4 |
| Courts |
|
17.6 |
| Detail
Reporting Party |
|
6.11.3 |
| Detail
Requirements |
|
6.2.2(h) |
| Detail
Shortfall Period |
|
6.11.4(b) |
| Developing Party |
|
3.2 |
| Development Milestone |
|
7.3.1 |
| Disclosing Party |
|
1.26 |
| Due
Date |
|
7.13 |
| Effective
Date |
|
Preamble |
| Estimated
Pfizer Report |
|
7.9.3 |
| Exchange
Act |
|
16.1.1 |
| Executives |
|
4.1.4(a) |
19
|
|
|
| Force
Majeure Event |
|
17.3 |
| GAAP |
|
7.10 |
| HSR
Act |
|
11.2.3 |
| Incumbent
Board |
|
1.16.4 |
|
**
|
|
3.2.1 |
| Indemnified Party |
|
12.4.1 |
| Indemnifying Party |
|
12.4.1 |
| Indication of Interest |
|
3.2.5(b) |
| Initial
Commercialization Plan |
|
6.2.1 |
| Initial
Cost Sharing Opt Out |
|
5.5.2(a) |
| Internal
Detailing Report |
|
6.11.2 |
| JDC |
|
4.2.1 |
| Joint
Development Committee |
|
4.2.1 |
| Joint
Steering Committee |
|
4.1.1 |
| Joint
Supply Chain Committee |
|
4.4.1 |
| JSC |
|
4.1.1 |
| JSCC |
|
4.4.1 |
| Manufacturing Transfer |
|
9.2 |
| Marketed
Unnamed Compound |
|
3.2.9 |
| Medical
Information Requests |
|
6.12.4 |
| New
Collaboration Compound |
|
3.2 |
| New
Collaboration Compound Options |
|
3.2 |
| Notification of Non Interest |
|
3.1.2(b) |
| Offered
Compound |
|
3.2 |
| Offeree
Party |
|
3.2 |
| Opt Out
Notice |
|
5.5.2(c) |
| Option
Costs |
|
3.2.1(a) |
| Paragraph
IV Notice |
|
13.4 |
| Parties |
|
Preamble |
| Party |
|
Preamble |
| Patent
Challenge |
|
2.5 |
| PDMA |
|
6.12.3 |
| Pfizer |
|
Preamble |
| Pfizer
Discount or Savings Program |
|
1.70.6 |
| Pfizer
Expenses |
|
7.9.3 |
| Pfizer
Indemnitees |
|
12.2 |
| Pfizer
Report |
|
7.9.4 |
| ** |
|
3.2.2 |
| ** |
|
3.2.3 |
| Portfolio
Discounting |
|
1.70.6 |
| ** |
|
3.2.4 |
| Product
Marks |
|
6.3 |
| Receiving
Party |
|
1.26 |
| Recording
Party |
|
7.15 |
| Redacted
Agreement |
|
10.3 |
| Responsible Party |
|
7.14.2 |
| Safe
Harbor Regulations |
|
6.12.3 |
| Screening
Option |
|
3.5 |
| SEC |
|
16.1.2 |
| Second
Cost Sharing Opt Out |
|
5.5.2(b) |
| Shortfall
Party |
|
6.11.4(a) |
| Specified
Person |
|
1.16.1 |
| Standstill Provisions |
|
16.2.1 |
| Term |
|
14.1.1 |
| Third
Party Agreement |
|
3.2.8 |
| Third
Party Claim |
|
12.4.1 |
| Thirty
Day LIBOR Rate |
|
7.13 |
| Training
Program |
|
6.7.2 |
| Trigger
Event |
|
16.2.2 |
| U.S.
Commercialization Committee |
|
4.3.1 |
| U.S. IP
Liability |
|
12.3.3 |
| U.S.
Product Liability |
|
12.3.2 |
| ** |
|
7.7.2 |
| USCC |
|
4.3.1 |
| ** |
|
3.1.2(b)(i) |
| ** |
|
3.1.2(b)(i) |
| VAT |
|
7.14.2 |
| Voting
Securities |
|
16.1.1 |
| Withdrawal Notice |
|
4.5 |
| Withholding Party |
|
7.14.1 |
20
ARTICLE 2 LICENSE GRANTS;
EXCLUSIVITY
2.1 License Grant
to Pfizer .
2.1.1 Subject to the
terms and conditions of this Agreement, Adolor hereby grants Pfizer
an exclusive license (even as to Adolor), with the right to
sublicense as provided in Section 2.4 under Adolor Technology,
to make, have made, sell, offer to sell, import and use the Named
Compounds and Licensed Products in the Field in the
Territory.
2.1.2 Except for the
rights granted to Pfizer under this Agreement, all right, title and
interest in and to the Adolor Technology shall at all times remain
with and be vested in Adolor. All rights with respect to any Adolor
Technology that are not specifically granted herein shall remain
with Adolor and subject to Sections 3.1 and 3.2, Adolor shall have
the right to grant licenses to any Third Party under the Adolor
Technology to make, have made, sell, offer to sell, import and use
Unnamed Compounds and any product containing any Unnamed Compound
outside of the Field in the Territory and Adolor shall have the
right to grant such licenses to any Third Party as referred to in
the last sentences of Sections 3.2.8 and 3.2.9. For clarity, the
licenses and rights granted in this Agreement shall not be
construed to convey any licenses or rights under the Adolor Patent
Rights with respect to any active pharmaceutical ingredients other
than Named Compounds.
2.2 License Grant
to Adolor . Subject to the terms and conditions of this
Agreement, Pfizer hereby grants Adolor a non-exclusive royalty-free
license, with the right to sublicense as provided in
Section 2.4 (a) under Pfizer’s rights in Adolor
Technology, and (b) under the Pfizer Technology, in each case
solely to the extent necessary to exercise its rights and perform
its obligations pursuant to this Agreement.
2.3 Research
License .
2.3.1 Without limiting
any of the licenses granted in Section 2.1, Adolor hereby
grants to Pfizer a nonexclusive, irrevocable, worldwide,
royalty-free, perpetual license, including the right to sublicense
to Affiliates, to use for all research purposes those portions of
the Adolor Know-How (excluding any Patent Rights relating thereto)
disclosed to Pfizer during the Term to the extent retained in the
unaided memories of Pfizer’s employees and individual
consultants who have had access to such Adolor Know-How; provided
that Pfizer shall not have any right to use the Adolor Know-How for
the sale or manufacture for sale of products or
processes.
2.3.2 Without limiting
any of the licenses granted in Section 2.2, Pfizer hereby
grants to Adolor a nonexclusive, irrevocable, worldwide,
royalty-free, perpetual license, including the right to sublicense
to Affiliates, to use for all research purposes those portions of
the Pfizer Know-How (excluding any Patent Rights relating thereto)
disclosed to Adolor during the Term to the extent retained in the
unaided memories of Adolor’s employees and individual
consultants who have had access to such Pfizer Know-How; provided
that Adolor shall not have any right to use the Pfizer Know-How for
the sale or manufacture for sale of products or
processes.
21
2.3.3 The licenses
granted in Section 2.3.1 and Section 2.3.2 shall not be
construed as permitting either Party to use, disclose, publish or
disseminate: (a) the identity of the other Party as the source
of such Know-How, (b) any financial or statistical
information, or business plans of the other Party, or (c) any
drawings, designs or chemical formulae.
2.4 Sublicensing
and Subcontracting .
2.4.1 Right to
Sublicense .
(a) Adolor may not
sublicense any of the rights granted under this Agreement without
the prior written consent of Pfizer, such consent not to be
unreasonably delayed, withheld, refused or conditioned, except to
its Affiliates, which right shall automatically terminate when such
Affiliate ceases to be an Affiliate of Adolor.
(b) Pfizer may not
sublicense any of the rights granted under this Agreement without
the prior written consent of Adolor, such consent not to be
unreasonably delayed, withheld, refused or conditioned, except that
Pfizer may, without prior written consent of Adolor, grant
sublicenses to (i) its Affiliates, which right shall
automatically terminate when such Affiliate ceases to be an
Affiliate of Pfizer; and (ii) Third Parties, with respect to
rights to Develop, import, market or sell in any Country other than
a Major Market Country; subject to Adolor receiving the applicable
royalties pursuant to this Agreement for Net Sales of such
sublicensee.
(c) Each sublicense
granted by Pfizer to a permitted sublicensee pursuant to
Section 2.4.1(b) shall be subject and subordinate to the terms
and conditions of this Agreement and shall contain terms and
conditions consistent with those in this Agreement and shall not in
any way diminish, reduce or eliminate any of Pfizer’s
obligations under this Agreement. Each sublicense agreement with
permitted sublicensees shall contain the following provisions:
(i) a requirement that such sublicensee submit applicable
sales or other reports consistent with the requirements set forth
in Section 7.9.6(c), (ii) a requirement to keep books and
records, and permit Adolor to audit (either directly or through an
independent auditor) such books and records, consistent with the
requirement set forth in Section 7.15, (iii) a
requirement that such sublicensee comply with the confidentiality
and non-use provisions of ARTICLE 10 with respect to both
Parties’ Confidential Information, (iv) a requirement to
comply with all other applicable terms of this Agreement,
(v) a provision prohibiting such sublicensee from further
sublicensing except on terms consistent with this
Section 2.4.1 and (vi) if such sublicensee will be
performing Development activities for any Named Compound or
Licensed Product, a requirement that each sublicensee allow Pfizer
to inspect its facilities upon reasonable notice consistent with
the requirements set forth in Section 5.6. Pfizer shall
provide Adolor with a copy of each such sublicense agreement within
thirty (30) days after the execution thereof, provided that
Pfizer may redact confidential financial information from such
sublicense agreement. For clarity, Pfizer does not have the right
hereunder to grant any sublicensee a manufacturing license to
manufacture the Named Compounds or Licensed Products.
22
2.4.2 Right to
Subcontract . Each Party may, subject to Section 6.10,
subcontract its obligations under this Agreement to a Third Party
as it would in the normal course of its business without the prior
written consent of the other Party, except, in the Major Market
Countries:
(a) neither Party may
subcontract its obligations to create, oversee and manage the
execution of the Development Plan without the prior written consent
of the other Party;
(b) Pfizer may not
subcontract, without prior written consent of Adolor:
(i) its obligations to
create, oversee and manage the execution of the Commercialization
Plan;
(ii) its obligations
to prepare and submit regulatory filings and its dealings with
Regulatory Authorities; and
(iii) its Detail
Requirements, on a Country-by-Country basis, for a Licensed Product
for a period beginning with the ** and ending on the **.
**.
2.4.3 Liability for
Affiliates, Sublicensees and Subcontractors . Each Party shall
ensure that each of its Affiliates and permitted sublicensees or
subcontractors accepts and complies with all of the applicable
terms and conditions of this Agreement as if such Affiliates or
permitted sublicensees or subcontractors were a party to this
Agreement and each Party shall remain fully responsible for its
Affiliates’ and permitted sublicensees’ or
subcontractors’ performance under this Agreement.
2.5 Patent
Challenge . Pfizer and its Affiliates hereby covenant and agree
not to, directly or indirectly, commence or maintain any opposition
proceeding, challenge the validity or enforceability of, or,
without limiting Pfizer’s rights under Section 13.5,
oppose any extension of or the grant of a supplementary protection
certificate, with respect to any Adolor Patent Rights, or with
respect to Adolor Patent Rights contained on Schedule 1.8 as
of the Effective Date, actively participate in any interference
proceeding (each such action, a “ Patent Challenge
”). Except to the extent the following is unenforceable under
the Law of a particular Country where a patent application within
the Adolor Patent Rights is pending or a patent within the Adolor
Patent Rights is issued, Adolor shall be permitted to terminate
this Agreement by written notice effective upon receipt if Pfizer
or its Affiliates directly, or indirectly through a Third Party,
commence or maintain any Patent Challenge. Pfizer shall include
provisions in all agreements granting sublicenses of Pfizer’s
rights hereunder providing that if the sublicensee or its
Affiliates undertake a Patent Challenge with respect to any Adolor
Patent under which the sublicensee is sublicensed, Pfizer shall be
permitted to terminate such sublicense agreement in its entirety.
If a sublicensee of Pfizer (or an Affiliate of such sublicensee)
undertakes a Patent Challenge of any such Adolor Patent Right under
which such sublicensee is sublicensed, then Pfizer upon receipt of
notice from Adolor of such Patent Challenge may terminate the
applicable sublicense agreement in its entirety. If Pfizer fails to
so terminate such sublicense agreement, Adolor shall
23
terminate all licensed rights granted to
Pfizer covered by such sublicense agreement and any sublicenses
previously granted in such Country(ies) shall automatically
terminate. Pfizer shall cooperate with Adolor’s reasonable
requests to cause such terminated sublicensee to discontinue all
activities under such sublicense agreement.
ARTICLE 3 EXCLUSIVITY;
ACQUISITION OF UNNAMED COMPOUNDS;
ADDITION AND REMOVAL OF
NAMED COMPOUNDS AND NAMED INDICATIONS
3.1 Exclusivity
.
3.1.1
Non-Compete . During **, neither Party nor any of its
Affiliates shall, directly or indirectly, by itself or through any
Third Party, Develop or Commercialize any: (a) pharmaceutical
product containing any Unnamed Compound for a Named Indication, or
(b) pharmaceutical product (other than the Licensed Products
pursuant to this Agreement) containing any Named Compound for any
indication (pharmaceutical products described in (a) and (b),
are each a “ Competing Product ” and
collectively, the “ Competing Products ”).
Notwithstanding the foregoing, each Party shall have the right to
conduct research on Named Compounds for the purpose of developing
Additional Indication Proposals, provided that such research does
not include Clinical Studies or animal studies in
primates.
3.1.2 Acquisition
of a Competing Product .
(a) Notwithstanding
the restrictions set forth in Section 3.1.1, in the event that
a Party (the “ Acquiring Party ”) effects a
Business Combination Transaction with a Third Party that as of the
date of the closing of such transaction would be Developing or
Commercializing a Competing Product in any Country in the Territory
(such product, an “ Acquired Competing Product
”) or enters into any agreement with respect to any such
Business Combination Transaction, and the Acquiring Party is
informed by a Governmental Authority that it or, if applicable, its
acquiror, will be required as a condition to such Business
Combination Transaction either to (i) divest such Acquired
Competing Product or (ii) divest its interest in the
Collaboration, then not later than ** after receipt of notice of
such requirement from such Governmental Authority, the Acquiring
Party shall notify the other Party in writing of such requirement
and whether the Acquiring Party intends to (1) divest such
Acquired Competing Product or to (2) divest its interest in
the Collaboration (x) if the Licensed Product under the
Collaboration is Commercialized, by terminating this Agreement
pursuant to Section 14.3 or selling its interest in the
Collaboration pursuant to Section 3.1.2(b) below and
(y) if the Licensed Product under the Collaboration is in the
Development stage, solely with respect to Pfizer, by terminating
this Agreement pursuant to Section 14.3, which divestiture,
sale or termination may be conditioned upon the consummation of
such Business Combination Transaction. If the Acquiring Party
notifies that other Party that it intends to divest such Acquired
Competing Product, the Acquiring Party shall have ** following the
consummation of the Business Combination Transaction to divest such
Acquired Competing Product; provided, that Pfizer shall continue
its Development and/or Commercialization activities hereunder for
such ** period.
24
(b) If instead the
Acquiring Party notifies the other Party that it intends to sell
its interest in the Collaboration to the other Party, such notice
shall constitute an irrevocable offer to sell such interest to the
other Party as provided below. Unless the other Party notifies the
Acquiring Party in writing that it does not desire to purchase such
interest (a “ Notification of Non Interest ”)
not more than ** after receipt of such notice from Acquiring Party,
or the applicable Governmental Authority rejects the other Party as
a buyer, then the Parties shall negotiate in good faith to reach an
agreement within the ** period following the date of such notice
with respect to the price to be paid by the other Party for such
interest, and the sale of such interest shall be conditioned upon
the consummation of such Business Combination Transaction. If
(a) the other Party delivers a Notification of Non Interest
during such ** period or (b) the Parties are unable to agree
in writing on the price to be paid for such interest within such **
period and the other Party provides a Notification of Non Interest
to the Acquiring Party within ** following the expiration of such
** period, then the Acquiring Party may sell its interest in the
Collaboration to a Third Party without the consent or approval of
the other Party; provided that (i) such Third Party shall
expressly assume in a writing delivered to the other Party all of
the rights and obligations of the Acquiring Party hereunder and
(ii) the terms of sale shall be more favorable than those
offered by the other Party to the Acquiring Party (unless no such
offer has been made by the other Party); and the Acquiring Party
shall have ** (or, if shorter, such period of time as may be
required by the applicable Governmental Authority(ies) for such
divestiture) to sell such interest; provided, that Adolor shall
have the option to undertake Pfizer’s Development and/or
Commercialization activities under the Collaboration during such **
period at Pfizer’s expense. If the other Party does not
provide a Notification of Non Interest to the Acquiring Party
within such ** period after such ** negotiation period or within **
after determination of the value of the Acquiring Party’s
interest in the Collaboration, the other Party shall purchase the
Acquiring Party’s interest in the Collaboration; and the
price to be paid shall, **, and, subject to the consummation of the
Business Combination Transaction, and except as set forth in
Section 3.12(b)(iv) below, the Acquiring Party shall sell and
convey to the other Party, and the other Party shall purchase, the
Acquiring Party’s entire interest in the Collaboration at the
price so determined:
(i) **.
(ii) **.
(iii) **.
(iv) Such
determination shall be final and binding on both
Parties.
(v) Except as provided
in this Section 3.1.2(b), such determination shall be
conducted in accordance with the procedures set forth in
Section 17.5.
(vi) The closing of
such purchase and sale of the Acquiring Party’s interest in
the Collaboration pursuant to this Section 3.1.2(b) shall take
place at a reasonable place and time designated by the Acquiring
Party in writing on not less than ten (10) days’ prior
written notice after the determination of the value of such
interest and the price to be
25
paid, but not earlier than the
termination or expiration of any applicable waiting periods under
the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended, and the receipt of all requisite approvals from
Governmental Authorities, and, if the sale has been conditioned on
the consummation of such Business Combination Transaction, such
consummation having occurred. The Parties shall cooperate and shall
promptly make such filings with and applications to such
Governmental Authorities as may be required in connection with such
purchase and sale.
(c) If the applicable
Governmental Authority does not require the Acquiring Party, as a
condition to such Business Combination Transaction, to divest
either (i) such Acquired Competing Product or (ii) its
interest in the Collaboration, then, if the Royalty Term is still
in effect in the United States, Japan or a Major EU Country, the
Acquiring Party shall notify the other Party in writing within **
after the consummation of such Business Combination Transaction of
the acquisition of such Acquired Competing Product and whether it
intends to (1) divest such Acquired Competing Product in the
Countries where the Royalty Term is then in effect,
(2) include the Acquired Competing Product as a Licensed
Product under this Agreement in the Countries where the Royalty
Term is then in effect; or (3) solely with respect to Pfizer,
exercise its right of termination pursuant to Section 14.3. If
the Acquiring Party notifies the other Party that it intends to
divest such Acquired Competing Product, the Acquiring Party shall
have ** following the consummation of the Business Combination
Transaction to divest such Acquired Competing Product.
(d) If the Acquiring
Party has notified the other Party in accordance with this
Section 3.1.2 that an Acquired Competing Product will be
divested, or the Acquiring Party will sell its interest in the
Collaboration pursuant to subsection (b) hereof, the
Development or commercialization of an Acquired Competing Product
by the Acquiring Party during the period from the consummation of
the applicable merger, consolidation or acquisition to the
consummation of such divestiture or sale shall not be considered a
breach by the Acquiring Party of its obligations under this
Agreement; provided, however, that the Acquiring Party shall
conduct any such Development or commercialization using personnel
(i) distinct from personnel engaged in activities under this
Agreement and (ii) who are not provided, directly or
indirectly, or permitted to, access any Confidential Information
relating to Named Compounds or Licensed Products.
3.2 Additional
Named Compounds . In the event that, at any time during the
Term, either Party or any of such Party’s Affiliates (as the
case may be, the “ Developing Party ”) proposes
to Develop an Unnamed Compound Controlled by such Party or
Affiliate for indications other than a Named Indication, the other
Party (the “ Offeree Party ”) shall have the
options described below (collectively, the “ New
Collaboration Compound Options ”) and the options
described in Section 3.2.7 to include such compound (each, an
“ Offered Compound ”) in the Collaboration, as
set forth below. Any Unnamed Compound that is included in the
Collaboration as the result of the exercise of any such option is
referred to herein as a “ New Collaboration Compound
.” Within thirty (30) days after the Offeree
Party’s exercise of any New Collaboration Compound Option,
such Party shall have the right to audit the Developing
Party’s prior Development Costs relating to the Offered
Compound, in a manner consistent with Section 7.15, provided,
however, that any such audit shall not constitute the one
(1) audit per Calendar
26
Year permitted under Section 7.15.
Neither Party shall have any obligation to Develop any Offered
Compound unless a New Collaboration Compound Option is exercised
with respect to such Offered Compound. Each New Collaboration
Compound shall be Developed in accordance with this Agreement,
including such New Collaboration Compound’s Development Plan.
If the Offered Compound that a Party proposes to Develop for other
than a Named Indication was obtained by the Developing Party by
virtue of a Business Combination Transaction, such Offered Compound
shall, upon the closing of such Business Combination Transaction,
become subject to this Section 3.2.
3.2.1 **. If the
Developing Party proposes to ** with respect to an Offered
Compound, the Offeree Party shall have the option (the
“**”), exercisable by written notice delivered to the
Developing Party, to include such Offered Compound in the
Collaboration, effective **, as provided below:
(a) Not less than **
with respect to such Offered Compound, the Developing Party shall
prepare and provide to the Offeree Party (i) **, (ii) a
statement of all of the Developing Party’s Out-of-Pocket
Costs and Expenses attributable to the development of such Offered
Compound (“ Option Costs ”), (iii) a
representation letter making to the Offeree Party substantially the
same representations and warranties concerning the Developing
Party’s intellectual property relating to the Offered
Compound as are set forth in Section 11.3 with respect to ADL
5859 and ADL 5747 (except that any reference to (x) the
Effective Date shall refer to the date such representations and
warranties are given and (y) to Adolor shall be deemed to
refer to the Developing Party), along with any exceptions to such
representations and warranties that such Party may disclose and
provide in writing at such time, (iv) a proposed Development
Plan for the Offered Compound (**), including a proposed budget
therefore and (v) such other reasonably available information
as the Offeree Party may reasonably request in connection with its
evaluation of the option with respect to the Offered Compound
provided for in this Section 3.2.1.
(b) At any time on or
before the date which is ** after receipt of all the information
specified in Section 3.2.1(a) the Offeree Party may exercise
the ** with respect to such Offered Compound, and for such **
period the Developing Party shall be prohibited from entering into
a Third Party Agreement pursuant to Section 3.2.8, by
(i) delivering to the Developing Party written notice of such
exercise and (ii) paying to the Developing Party ** the
Developing Party’s Option Costs relating to the Offered
Compound.
(c) If the Offeree
Party exercises the **, then (i) the Offered Compound shall be
a New Collaboration Compound thenceforth and shall be included in
the Collaboration, and (ii) the Parties shall bear Development
Costs, and shall share the Net Profit/Net Loss, with respect to the
Licensed Products containing such New Collaboration Compound, in
each case incurred on or after the Collaboration Inclusion Date, in
the manner otherwise provided for in this Agreement.
3.2.2 **. If the
Offeree Party does not exercise the ** with respect to an Offered
Compound and provided that no Third Party Agreement has been
entered into with respect to such Offered Compound pursuant to
Section 3.2.8, the Offeree Party shall have an
27
additional option (the “**”)
to include any such Offered Compound in the Collaboration,
commencing with the **, as provided below:
(a) Not less than **
prior to the commencement of ** with respect to the Offered
Compound, the Developing Party shall provide to the Offeree Party
(to the extent not previously provided) (i) the results of all
** with respect to such Offered Compound, (ii) a statement of
the Developing Party’s Option Costs with respect to such
Offered Compound, (iii) a representation letter making to the
Offeree Party substantially the same representations and warranties
concerning the Developing Party’s intellectual property
relating to the Offered Compound as are set forth in
Section 11.3 with respect to ADL 5859 and ADL 5747 (except
that any reference to (x) the Effective Date shall refer to
the date such representations and warranties are given; and
(y) Adolor shall be deemed to refer to the Developing Party),
along with any exceptions to such representations and warranties
that such Party may disclose and provide in writing at such time,
(iv) a Development Plan for the Offered Compound (including
the details of the proposed **), including a proposed budget
therefor, and (v) such other reasonably available information
as the Offeree Party may reasonably request in connection with its
evaluation of the option with respect to the Offered Compound
provided for in this Section 3.2.2.
(b) At any time on or
before the date which is ** after receipt of all the information
specified in Section 3.2.2(a), the Offeree Party may exercise
the ** with respect to such Offered Compound, and for such **
period the Developing Party shall be prohibited from entering into
a Third Party Agreement pursuant to Section 3.2.8, by
(i) delivering to the Developing Party written notice of such
exercise and (ii) paying to the Developing Party ** times the
Developing Party’s Option Costs up to the commencement of **
relating to the Offered Compound.
(c) If the Offeree
Party exercises the **, then (i) the Offered Compound shall be
a New Collaboration Compound thenceforth and shall be included in
the Collaboration, and (ii) the Parties shall bear Development
Costs, and shall share the Net Profit/Net Loss, with respect to the
Licensed Products containing such New Collaboration Compound, in
each case incurred on or after the Collaboration Inclusion Date, in
the manner otherwise provided for in this Agreement.
3.2.3 **. If the
Offeree Party does not exercise the ** with respect to an Offered
Compound and provided that no Third Party Agreement has been
entered into with respect to such Offered Compound pursuant to
Section 3.2.8, the Offeree Party shall have an additional
option (the “**”) to include any such Offered Compound
in the Collaboration, commencing with **, as provided
below:
(a) Not less than **
prior to the commencement of ** with respect to the Offered
Compound, the Developing Party shall provide to the Offeree Party
(to the extent not previously provided) (i) the results of all
** with respect to such Offered Compound, (ii) a statement of
the Developing Party’s Option Costs with respect to such
Offered Compound, (iii) a representation letter making to the
Offeree Party substantially the same representations and warranties
concerning the Developing Party’s intellectual property
relating to the Offered
28
Compound as are set forth in
Section 11.3 with respect to ADL 5859 and ADL 5747 (except
that any reference to (x) the Effective Date shall refer to
the date such representations and warranties are given and
(y) Adolor shall be deemed to refer to the Developing Party),
along with any exceptions to such representations and warranties
that such Party may disclose and provide in writing at such time,
(iv) a Development Plan for the Offered Compound (including
the details of the proposed **), including a proposed budget
therefor, and (v) such other reasonably available information
as the Offeree Party may reasonably request in connection with its
evaluation of the option with respect to the Offered Compound
provided for in this Section 3.2.3.
(b) At any time on or
before the date which is ** after receipt of all the information
specified in Section 3.2.3(a), the Offeree Party may exercise
the ** with respect to such Offered Compound, and for such **
period the Developing Party shall be prohibited from entering into
a Third Party Agreement pursuant to Section 3.2.8, by
(i) delivering to the Developing Party written notice of such
exercise and (ii) paying to the Developing Party ** times the
Developing Party’s Option Costs up to the commencement of **
relating to the Offered Compound.
(c) If the Offeree
Party exercises the **, (i) the Offered Compound shall be a
New Collaboration Compound thenceforth and shall be included in the
Collaboration, and (ii) the Parties shall bear Development
Costs, and shall share the Net Profit/Net Loss, with respect to the
Licensed Products containing such New Collaboration Compound, in
each case incurred on or after the Collaboration Inclusion Date, in
the manner otherwise provided for in this Agreement.
3.2.4 **. If the
Offeree Party does not exercise the ** with respect to an Offered
Compound and provided that no Third Party Agreement has been
entered into with respect to such Offered Compound pursuant to
Section 3.2.8, the Offeree Party shall have an additional
option (the “**”) to include any such Offered Compound
in the Collaboration effective upon ** with respect to such Offered
Compound as provided below:
(a) Promptly following
the completion of ** with respect to the Offered Compound and not
less than ** prior to the filing of the ** with respect to the
Offered Compound, the Developing Party shall provide to the Offeree
Party (to the extent not previously provided) (i) the results
of all ** with respect to such Offered Compound, (ii) a
statement of the Developing Party’s Option Costs with respect
to such Offered Compound, (iii) a representation letter making
to the Offeree Party substantially the same representations and
warranties concerning the Developing Party’s intellectual
property relating to the Offered Compound as are set forth in
Section 11.3 with respect to ADL 5859 and ADL 5747 (except
that any reference to (x) the Effective Date shall refer to
the date such representations and warranties are given and
(y) Adolor shall be deemed to refer to the Developing Party),
along with any exceptions to such representations and warranties
that such Party may disclose and provide in writing at such time,
(iv) a Development Plan for the Offered Compound (**),
including a proposed budget therefor and a proposed ** for the
Offered Compound, and (v) such other reasonably available
information as the Offeree Party may reasonably request
in
29
connection with its evaluation of the
option with respect to the Offered Compound provided for in this
Section 3.2.4.
(b) At any time on or
before the date which is ** after receipt of all the information
specified by Section 3.2.4(a), the Offeree Party may exercise
the ** with respect to such Offered Compound, and for such **
period the Developing Party shall be prohibited from entering into
a Third Party Agreement pursuant to Section 3.2.8, by
(i) delivering to the Developing Party written notice of such
exercise and (ii) paying to the Developing Party (x) **
of the Developing Party’s Option Costs up to ** with respect
to the Offered Compound; and (y) **.
(c) If the Offeree
Party exercises the **, then (i) the Offered Compound shall be
a New Collaboration Compound thenceforth and shall be included in
the Collaboration, and (ii) the Parties shall bear Development
Costs, and shall share the Net Profit/Net Loss, with respect to the
Licensed Products containing such New Collaboration Compound, in
each case incurred on or after the Collaboration Inclusion Date, in
the manner otherwise provided for in this Agreement.
3.2.5
Commercialized Acquired Unnamed Compound Inclusion Option .
In the event that an Acquiring Party effects a Business Combination
Transaction with a Third Party that as of the date of the closing
of such transaction would (a) have a Marketing Authorization
Application filed and pending for, or have achieved Regulatory
Approval for, a product containing an Unnamed Compound for other
than a Named Indication in any Country in the Territory, or
(b) be promoting, distributing, marketing or selling a product
containing an Unnamed Compound for other than a Named Indication in
any Country in the Territory (each such product referred to in
clauses (a) and (b) above being referred to herein as a
“ Commercialized Acquired Unnamed Compound ”),
then the Acquiring Party shall offer the Commercialized Acquired
Unnamed Compound into the Collaboration on written notice within **
after the consummation of such Business Combination Transaction of
the acquisition of such Commercialized Acquired Unnamed Compound,
and such Acquiring Party shall be considered the Developing Party
and the Commercialized Acquired Unnamed Compound shall be an
Offered Compound for purposes of this Section 3.2.5 and the
Offeree Party shall have an option (the “ Commercialized
Acquired Unnamed Compound Inclusion Option ”) to include
such Commercialized Acquired Unnamed Compound in the Collaboration
as provided below:
(a) Not later than **
after the delivery of the notice pursuant to this
Section 3.2.5, the Developing Party shall provide to the
Offeree Party (i) the results of all Clinical Studies relating
to such Commercialized Acquired Unnamed Compound, (ii) a
statement of the Developing Party’s Development costs with
respect to any Phase 2 Clinical Studies or later Clinical Studies
for the indications then being Commercialized or for which a
Marketing Authorization Application has been filed, (iii) a
representation letter making to the Offeree Party substantially the
same representations and warranties concerning the Developing
Party’s intellectual property relating to the Offered
Compound as are set forth in Section 11.3 with respect to ADL
5859 and ADL 5747 (except that any reference to the Effective Date
shall refer to the date such representations and warranties are
given), along with any exceptions to such representations and
warranties that such Party may disclose and provide in writing at
such
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time, (iv) a Commercialization Plan
for the Offered Compound, (v) a Calendar Quarter-by-Calendar
Quarter statement of Net Sales, Development Costs, Marketing
Expenses, Sales Expenses, and Net Profit/Net Loss (in each case
calculated as if the Commercialized Acquired Unnamed Compound were
a Licensed Product) of the Commercialized Acquired Unnamed
Compound, (vi) a statement showing the aggregate cost of goods
sold for such compound for each of the past four (4) Calendar
Quarters, and (vii) such other information as the Offeree
Party may reasonably request in connection with its evaluation of
the option with respect to the Offered Compound provided for in
this Section 3.2.5 above.
(b) At any time on or
before the date which is ** after receipt of all the information
specified in Section 3.2.5(a), the Offeree Party may deliver
to the Developing Party a notice indicating that the Offeree Party
is interested in including such Offered Compound in the
Collaboration (an “ Indication of Interest ”),
it being understood that such Indication of Interest does not
constitute an exercise of the Commercialized Acquired Unnamed
Compound Inclusion Option. If the Offeree Party delivers such
Indication of Interest within such **, the Parties shall promptly
commence negotiations in good faith for a period of not less than
** (or such longer period as the Parties may agree by mutual
consent) concerning the terms on which such Offered Compound would
be included in the Collaboration, which terms may include the
amount of any upfront payments, terms relating to any indications
then being Commercialized and terms relating to any indications
that may still be in Development and any other matters the Parties
deem relevant. If within such negotiation period the Parties agree
by mutual consent to the terms on which the Offered Compound will
be included in the Collaboration, such agreement shall constitute
the exercise of the Commercialized Acquired Unnamed Compound
Inclusion Option with respect to such Offered Compound. If the
Offeree Party fails to deliver an Indication of Interest within the
time period specified above or if the Parties fail to reach
agreement on the terms on which the Offered Compound will be
included in the Collaboration within the negotiation period
provided for above, then such failure shall constitute the failure
to exercise the Commercialized Acquired Unnamed Compound Inclusion
Option and such Offered Compound shall be considered an Unnamed
Compound.
(c) If the Offeree
Party exercises the Commercialized Acquired Unnamed Compound
Inclusion Option, then (i) the Offered Compound shall be a New
Collaboration Compound thenceforth, (ii) products containing
such Offered Compound shall be Licensed Products, (iii) unless
the Parties have otherwise agreed by mutual consent on the terms on
which the Offered Compound will be included in the Collaboration as
provided in Section 3.2.5(b), the Parties shall each bear
future Development Costs, if any, with respect to the Development,
and the Net Profit/Net Loss, with respect to Licensed Products
containing such New Collaboration Compound, in each case incurred
after the Collaboration Inclusion Date, in the manner otherwise
provided for, with respect to Named Compounds and Licensed Products
pursuant to this Agreement, (iv) unless the Parties have
otherwise agreed by mutual consent as provided in
Section 3.2.5(b) above, the Offeree Party shall not be
obligated to pay to the Developing Party any milestone payments
with respect to such Named Compounds and Licensed Products, and
(v) the Offeree Party shall pay to the Developing Party any
agreed upfront or other payment agreed by the Parties.
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3.2.6 In-License
Transactions . Other than pursuant to a Business Combination
Transaction, neither Party shall, and each Party shall cause its
Affiliates not to, in-license or acquire from a Third Party any
Unnamed Compound being Developed for other than a Named Indication
that is in Phase 1 Studies or later Clinical Studies if the
terms of such in-license or acquisition would prevent such Unnamed
Compound from being included in the Collaboration pursuant to this
Section 3.2 on the terms provided for in this Agreement;
provided that Section 3.1.1 shall apply to any Unnamed
Compound under Development or being Commercialized for a Named
Indication, whether or not such Unnamed Compound is acquired in a
Business Combination Transaction.
3.2.7 Additional
Option Periods . During the periods between (a) the end of
the exclusive ** exercise period and the beginning of the exclusive
** exercise period; (b) the end of the exclusive ** exercise
period and the beginning of the exclusive ** exercise period and
(c) the end of the exclusive ** exercise period and the
beginning of the exclusive ** exercise period, the Offeree Party
shall have the right with respect to an Offered Compound to include
such Offered Compound in the Collaboration; provided, that the
Developing Party has not entered into a Third Party Agreement as
provided for in Section 3.2.8, by (i) delivering to the
Developing Party written notice to include such Offered Compound
and (ii) paying to the Developing Party the greater of
(x) the option price for the immediately preceding New
Collaboration Compound Option and (y) the option price for the
next succeeding New Collaboration Compound Option, as applicable;
provided, that the option price shall be calculated with respect to
the Option Costs incurred through the date of receipt of such
notice, which amount the Developing Party shall provide to the
Offeree Party within ten (10) days after receipt of the
written notice from the Offeree Party described in this
Section 3.2.7.
3.2.8 Third Party
Agreement for Unnamed Compounds for Other Than Named
Indications . During the periods (a) between the end of
the exclusive ** exercise period and the beginning of the exclusive
** exercise period, (b) between the end of the exclusive **
exercise period and the beginning of the exclusive ** exercise
period, (c) between the end of the exclusive ** exercise
period and the beginning of the exclusive ** exercise period and
(d) from the end of the exclusive ** exercise period and
thereafter, in each case, as long as none of the New Collaboration
Compound Options has been exercised with respect to such Offered
Compound, the Developing Party shall have the right to enter into a
license, collaboration or similar agreement with a Third Party with
respect to such Offered Compound for any indication other than a
Named Indication (at the time of execution of such agreement) (a
“ Third Party Agreement ”; provided, however,
that once the Developing Party enters into a Third Party Agreement
and the Parties later add the indication that is the subject of
such Third Party Agreement to Schedule 1.66 as a Named
Indication, Section 3.1.1(a) shall not apply to activities
under such Third Party Agreement for such Unnamed Compound for such
indication provided that such indication was not a Named Indication
at the time that such Third Party Agreement was entered
into.
3.2.9 Failure to
Exercise Option . If the Offeree Party fails to exercise all of
the New Collaboration Compound Options with respect to an Offered
Compound, the Developing Party shall have the right to
Commercialize such Offered Compound solely for
32
indications other than a Named
Indication, outside the Collaboration and shall bear one hundred
percent (100%) of the cost of such Development; provided that
Section 3.1.1 shall continue to apply to the Offered Compound.
For clarity, if any Unnamed Compound that was an Offered Compound
for which the Offeree Party failed to exercise all of the New
Collaboration Compound Options and such Offered Compound is
Commercialized for an indication that is not a Named Indication at
the time the first MAA is obtained with respect to such Unnamed
Compound (a “ Marketed Unnamed Compound ”),
Commercialization of such Unnamed Compound for such indication
shall not constitute a breach of Section 3.1.1 as a result of
the Parties’ subsequent agreement to add such indication to
Schedule 1.66 as a Named Indication.
3.2.10 Consequences
of Exercise of New Collaboration Compound Options . In the
event the Offeree Party exercises a New Collaboration Compound
Option with respect to a given Offered Compound, the Development
Plan proposed by the Developing Party (or such other Development
Plan as is agreed upon by the Parties on or prior to the date of
the exercise of such option) with respect thereto pursuant to this
Section 3.2 shall be the initial Development Plan with respect
to such New Collaboration Compound and the New Collaboration
Compound shall be added to Schedule 1.65 and if the Licensed
Product is for an indication other than a Named Indication, such
indication shall be added to Schedule 1.66 .
3.3 Additional
Indications for Named Compounds; Unnamed Compounds for Named
Indications .
3.3.1 Additional
Proposal . Each Party may propose to Develop jointly as part of
the Collaboration a Named Compound for an indication other than a
Named Indication, or an Unnamed Compound for a Named Indication, by
submitting a written proposal describing the proposed indication or
Unnamed Compound, as applicable, which shall include a proposed
Development Plan for Developing a product containing such Delta
Compound for such proposed indication (an “ Additional
Proposal ”) to the Joint Development Committee at any
time during the Term. The non-proposing Party shall have sole
discretion as to whether to accept such proposed indication as a
Named Indication or such proposed Unnamed Compound as a Named
Compound.
3.3.2 Acceptance of
Unnamed Compound or Proposed Indication . If the non-proposing
Party elects to accept the proposed indication as a Named
Indication or proposed Unnamed Compound as a Named Compound, it
shall give the proposing Party a notice of acceptance in writing
within thirty (30) days after the Additional Proposal is
submitted by the proposing Party, which acceptance shall become
effective upon receipt. On and after such acceptance, such proposed
indication shall be deemed a Named Indication and Schedule
1.66 shall be revised accordingly, or, as applicable, such
proposed Unnamed Compound shall be deemed a Named Compound and
Schedule 1.65 shall be revised accordingly. The proposed
development plan shall be adopted by the Parties as the initial
Development Plan for developing a Licensed Product for the proposed
indication.
3.3.3 Rejection of
Proposed Unnamed Compound or Indication . If the non-proposing
Party fails to accept the proposed indication for a Named Compound
as a Named Indication, or the proposed Unnamed Compound for a Named
Indication as a Named
33
Compound, in either case within thirty
(30) days after the proposing Party’s submission of the
Additional Proposal, then the provisions of Section 3.1.1
shall apply and, neither Party may, directly or indirectly, itself
or through any Affiliate or Third Party, Develop or Commercialize
either of the foregoing unless changes to Schedules 1.65
and/or 1.66 allow otherwise.
3.4 Removal of
Named Compounds and Named Indications from the Collaboration .
A Named Compound shall cease to be a Named Compound and shall be
removed from the Named Compound list on Schedule 1.65 and a
Named Indication shall cease to be a Named Indication and shall be
removed from the Named Indication list on Schedule 1.66
pursuant to Section 5.2.2 or Section 6.14.
3.5 Screening
Option . Subject to the rights, if any, granted to a Third
Party to an Unnamed Compound pursuant to a Third Party Agreement
entered into pursuant to Section 3.2.8, Pfizer shall have an
option to screen additional Adolor Delta Compounds from
Adolor’s Delta Compound library (the “ Screening
Option ”). In the event that Pfizer exercises the
Screening Option, the Parties shall negotiate in good faith the
terms and conditions related to such screening. Such discovery and
research collaboration may include Adolor granting to Pfizer or a
Pfizer Affiliate a sublicense to the **.
ARTICLE 4 GOVERNANCE OF
DEVELOPMENT AND COMMERCIALIZATION OF PRODUCTS
4.1 Joint Steering
Committee .
4.1.1 Members;
Officers . Within thirty (30) days after the Effective
Date, the Parties shall establish a joint steering committee (the
“ Joint Steering Committee ” or “
JSC ”), which shall consist of six (6) members,
three (3) of whom shall be designated by each of Pfizer and
Adolor, who shall have appropriate expertise and seniority. Each of
Pfizer and Adolor may replace any or all of its representatives on
the Joint Steering Committee at any time upon written notice to the
other Party. A Party may designate a substitute to temporarily
attend and perform the functions of such Party’s designee at
any meeting of the Joint Steering Committee. Pfizer and Adolor each
may, on advance notice to the other Party, invite non-member
employees of such Party to attend meetings of the Joint Steering
Committee. The Joint Steering Committee shall be co-chaired by a
representative of each of Pfizer and Adolor. One member of the JSC
shall serve as secretary of the Joint Steering Committee at each
Committee meeting, and the secretary shall alternate from meeting
to meeting between a Pfizer Committee member and an Adolor
Committee member.
4.1.2
Responsibilities . The Joint Steering Committee shall
perform the following functions:
(a) Oversee all
aspects of Collaboration pursuant to the terms of this
Agreement;
(b) Review and approve
the Development Plans for Licensed Products and any material
amendments thereto;
34
(c) To the extent the
USCC has decision-making authority pursuant to Section 4.3.3,
review and approve the Commercialization Plans for Licensed
Products in the U.S. and any material amendments
thereto;
(d) Oversee the
integration of New Collaboration Compounds and new Named
Indications into the Collaboration;
(e) Review and update
Schedule 1.65 and Schedule 1.66 ;
(f) If, and only if,
the Parties are sharing the Net Profit/Net Loss, at each meeting of
the Joint Steering Committee, review Net Profit/Net
Loss;
(g) Review the
progress of the other Committees;
(h) Resolve disputes
and other matters referred to the Joint Steering Committee by any
other Committee; and
(i) Have such other
responsibilities as may be assigned to the Joint Steering Committee
pursuant to this Agreement or as may be mutually agreed upon by the
Parties from time to time.
4.1.3 Meetings
. The Joint Steering Committee shall meet in person at least once
every six (6) months during every Calendar Year, and more or
less frequently as Pfizer and Adolor mutually agree upon as
appropriate or as required to resolve disputes, disagreements or
deadlocks in the other Committees, or as reasonably requested by
either such Party, on such dates, and at such places and times as
the Parties shall agree; provided that the Parties shall endeavor
to have the first meeting of the Joint Steering Committee within
sixty (60) days after the Effective Date. Meetings of the
Joint Steering Committee that are held in person shall alternate
between offices of Pfizer and Adolor, or such other place as the
Parties may agree. The members of the Joint Steering Committee also
may convene or be polled or consulted from time to time by means of
telecommunications, video conferences, electronic mail or
correspondence.
4.1.4
Decision-Making . The Joint Steering Committee may make
decisions with respect to any subject matter that is subject to the
Joint Steering Committee’s decision-making authority and
functions as set forth in Section 4.1.2. All decisions of the
Joint Steering Committee shall be made by unanimous vote or written
consent, with Pfizer and Adolor each having, collectively, among
its respective members, one (1) vote in all decisions. The
Joint Steering Committee shall use commercially reasonable best
efforts to resolve the matters within its roles and functions or
otherwise referred to it. If the Joint Steering Committee cannot
reach consensus on a matter within ten (10) Business Days
after such matter has been brought to the Joint Steering
Committee’s attention, then such matter shall be handled in
the manner set forth below:
(a) Dispute
Resolution . Any dispute that cannot be resolved by the JSC
shall be first referred to the Alliance Managers. The Alliance
Managers shall use their
35
commercially reasonable best
efforts to reach mutually acceptable resolutions on all such
disputed matters. If the Alliance Managers are unable to resolve
such dispute within ten (10) Business Days after the dispute
is first referred to the Alliance Managers, the matter shall be
referred on the eleventh (11 th ) Business Day to the Chief Executive Officer of Adolor
and to Pfizer’s (i) Head of Worldwide Development for
the applicable therapeutic area for issues originally referred to
the JSC by the JDC and/or issues related to Development, or
(ii) Head of the applicable U.S. Business Unit for issues
originally referred to the JSC by the USCC and/or issues related to
Commercialization for resolution (the “ Executives
”). In the event that
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