Exhibit 10.1
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
Execution Copy
LICENSE AND COMMERCIALIZATION AGREEMENT
by and between
JAVELIN PHARMACEUTICALS, INC.
and
THERABEL PHARMA NV
January 15, 2009
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
TABLE OF CONTENTS
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1.
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DEFINITIONS
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1
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2.
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GRANT OF LICENSES
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12
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2.1.
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License to Therabel
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12
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2.2.
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Sublicensing
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12
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2.3.
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Right of Reference
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12
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2.4.
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No Other Rights
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13
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2.5.
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Sale of Javelin Pharmaceuticals
(U.K.) Limited
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13
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2.6.
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Section 365(n)
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13
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2.7.
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Non-Competition
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14
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2.8.
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Right of First Offer to
[***]
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14
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3.
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DECISION MAKING AND DISPUTE
RESOLUTION
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14
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3.1.
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Overview
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14
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3.2.
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Joint Steering
Committee
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14
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3.3.
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Other Committees
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16
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3.4.
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Elevation and Dispute
Resolution
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16
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4.
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REGULATORY SUBMISSION ACTIVITIES,
COMMERCIALIZATION AND DEVELOPMENT
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17
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4.1.
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Regulatory Submission
Activities
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17
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4.2.
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Regulatory Matters
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18
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4.3.
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Adverse Events
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19
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4.4.
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Product Label Changes
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19
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4.5.
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Manufacture and Supply of
Licensed Products
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20
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i
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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4.6.
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Quality Agreement
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20
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4.7.
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Commercialization in the
Territory
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20
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4.8.
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Phase IV and Publication
Strategy
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22
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4.9.
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Development
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23
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5.
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CONSIDERATION
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23
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5.1.
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Upfront Payments
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23
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5.2.
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Milestones
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23
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5.3.
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Royalties
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25
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5.4.
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Matters Concerning
Payments
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27
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5.5.
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Interest
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28
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6.
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COVENANTS
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28
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6.1.
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Third Party Consents
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28
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6.2.
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Confidentiality
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29
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6.3.
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Compliance with Law
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31
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7.
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REPRESENTATIONS AND
WARRANTIES
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32
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7.1.
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Representations and Warranties of
Each Party
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32
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7.2.
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Additional Representations and
Warranties of Javelin
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33
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7.3.
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Additional Representations and
Warranties of Therabel
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34
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7.4.
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No Inconsistent
Agreements
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34
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7.5.
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Disclaimer
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34
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8.
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INTELLECTUAL PROPERTY
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34
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8.1.
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Ownership
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34
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8.2.
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Prosecution and Maintenance of
Patent Rights and other IP Rights
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35
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ii
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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8.3.
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Trademarks
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36
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8.4.
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Enforcement of Technology Rights
and Trademarks
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37
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8.5.
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Third Party Claims
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37
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8.6.
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Patent Marking
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38
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8.7.
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No Implied Licenses
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38
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8.8.
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Privileged
Communications
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38
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9.
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TERM AND TERMINATION
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39
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9.1.
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Term
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39
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9.2.
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Termination
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39
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9.3.
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Change of Control
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41
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9.4.
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Survival of Certain
Obligations
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42
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10.
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LICENSED PRODUCT LIABILITY,
INDEMNIFICATION AND INSURANCE
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42
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10.1.
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Indemnification by
Javelin
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42
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10.2.
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Indemnification by
Therabel
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42
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10.3.
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Procedure
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42
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10.4.
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Insurance
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43
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10.5.
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Liability Limitations
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43
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11.
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MISCELLANEOUS
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44
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11.1.
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Governing Law and
Arbitration
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44
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11.2.
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Force Majeure
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44
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11.3.
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Additional Approvals
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45
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11.4.
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Waiver and Non-Exclusion of
Remedies
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45
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11.5.
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Notices
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45
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iii
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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11.6.
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Entire Agreement
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47
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11.7.
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Amendment
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47
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11.8.
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Assignment
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47
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11.9.
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No Benefit to Others
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47
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11.10.
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Counterparts
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47
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11.11.
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Severability
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47
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11.12.
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Further Assurance
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48
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11.13.
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Publicity
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48
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11.14.
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Relationship of the
Parties
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48
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iv
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
LICENSE AND COMMERCIALIZATION
AGREEMENT
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This
LICENSE AND COMMERCIALIZATION AGREEMENT (the “
Agreement ”) is entered into on this 15th day of
January, 2009 (the “ Execution Date ”), by and
among Javelin Pharmaceuticals, Inc., a Delaware corporation
(“Javelin”) and Therabel Pharma N.V., a limited
liability company organized and existing under the laws of the
Netherlands, with registered seat at Takkebijsters 17, 4817BL
Breda, the Netherlands, registered with the Chamber of Commerce
under number 332475990000 (“ Therabel ”).
Javelin and Therabel may each be referred to herein individually as
a “Party” and collectively as the
“Parties.”
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BACKGROUND
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Javelin
has developed (and/or has received licenses to) certain
pharmaceutical products which have uses or potential uses in the
treatment and prevention of disease in humans.
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Therabel
is engaged in the commercialization of human pharmaceutical
products.
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Javelin
and Therabel desire to collaborate on the commercialization of
Javelin’s pharmaceutical products on the terms and conditions
set forth in this Agreement.
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AGREEMENT
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NOW
THEREFORE, in consideration of the mutual promises and covenants
set forth below and other good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged, the
Parties agree as follows:
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1.
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DEFINITIONS.
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1.1.
“Affiliate(s)” means, with respect to an Entity, any Entity
that controls, is controlled by, or is under common control with
such first Entity. For purposes of this definition only,
“control” means (a) to possess, directly or indirectly,
the power to direct the management or policies of a Entity, whether
through ownership of voting securities or by contract relating to
voting rights or corporate governance, or (b) to own, directly or
indirectly, more than fifty percent (50%) of the outstanding voting
securities or other ownership interests of such Entity.
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1.2.
“ Applicable Laws
” means all applicable statutes, ordinances, regulations,
rules, or orders of any kind whatsoever of any Regulatory Authority
or other governmental authority that may be in effect from time to
time in the Territory.
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1.3.
“ Assumed Agreements
” has the meaning set forth in Section 4.5.
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1
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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1.4.
“ Calendar Quarter
” means each of the three (3) consecutive month periods
ending on March 31, June 30, September 30, and December
31.
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1.5.
“ Calendar Year ”
means each twelve (12) month period ending December
31st.
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1.6.
“ Change of Control
” means any of the following: (a) the sale or disposition of
all or substantially all of the assets of a Party to a Third Party,
(b) the acquisition by a Third Party, other than an employee
benefit plan (or related trust) sponsored or maintained by a Party
or any of its Affiliates, of more than fifty percent (50%) of such
Party’s outstanding shares of voting capital stock, (c) the
appointment or election to the Board of Directors of a Party of
members constituting a majority of such Board who were not
appointed, approved or recommended for election by the Board of
Directors as constituted immediately prior to the appointment or
election of such majority, or (d) the merger or consolidation of a
Party with or into another corporation, other than, in the case of
(b) or (c) of this Section, an acquisition or a merger or
consolidation of a Party in which holders of shares of such
Party’s voting capital stock immediately prior to the
acquisition, merger or consolidation have at least a majority of
the ownership of voting capital stock of the acquiring Third Party
or the surviving corporation in such merger or consolidation, as
the case may be, immediately after the merger or consolidation.
Notwithstanding the foregoing, a Change of Control shall not be
deemed to occur on account of an initial public offering, the
acquisition of securities of a Party by an institutional investor,
or Affiliate thereof, that acquires a Party’s securities in a
transaction or series of related transactions as a passive
investment which does not affect the management of such Party, or a
sale of assets, merger or other transaction effected exclusively
for the purpose of changing the corporate domicile of a
Party.
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1.7.
“ COGS ” means
the direct Manufacturing costs with respect to the Licensed
Products as well as all costs with respect to the transportation of
the Licensed Product to (and the delivery of the Licensed Product
at) Therabel’s warehouse (or the warehouse of
Therabel’s designee), determined in accordance with GAAP,
consistently applied. For the avoidance of doubt,
“COGS” shall not include the costs or charges
associated with the distribution of the Licensed
Product.
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1.8.
“ Commercialization
” means any and all activities of importing (with the
exception, however, of the importation of the Existing Inventory),
marketing, promoting, distributing, offering for sale and selling a
Licensed Product in the Field in the Territory, including for
example pre-commercial launch market development activities
conducted in anticipation of Regulatory Approval, such as preparing
advertising and promotional materials, sales force training and all
activities, interactions and correspondence with a Regulatory
Authority regarding Phase IV clinical trials. For the avoidance of
doubt, Commercialization includes pharmacovigilance activities and
Promotion, but does not
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2
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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include Development, Regulatory
Submission Activities or Manufacturing. When used as a verb,
“Commercialize” means to engage in
Commercialization.
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1.9.
“ Commercialization
Plan ” has the meaning set forth in Section
4.7.1.
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1.10.
“ Commercially Reasonable
Efforts ” means for each Party, the carrying out of
obligations in a diligent and sustained manner using such efforts
and resources normally used by a company in the same business with
similar resources as a Party for a product owned by it or to which
it has rights of the type it has hereunder, which is of similar
market potential at a similar stage in its development or product
life, taking into account, without limitation, issues of safety and
efficacy, product profile, the proprietary position of the product,
the regulatory environment and status of the product, and other
relevant scientific factors, market conditions then prevailing,
including the competitive environment (but without regard to other
products being developed or commercialized by such Party outside of
this Agreement), profitability, profitability expectations, the
extent of market exclusivity, the cost and any other burden to have
the product approved by any relevant Regulatory Authority or any
other authority or to obtain reimbursement approvals, health
economic claims, and other similar factors reasonably determined by
the Party to be relevant. “Commercially Reasonable” as
used herein shall be interpreted in a corresponding
manner.
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1.11.
“ Compound ”
means diclofenac sodium having the chemical name [***].
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1.12.
“ Confidential
Information ” means, with respect to a Party, all
information (and all tangible and intangible embodiments thereof),
which is controlled by such Party or otherwise related to such
Party, and is disclosed by such Party to the other Party pursuant
to this Agreement in writing, orally, electronically, visually or
by other means, and is designated as confidential by the disclosing
Party whether by means reasonably calculated to inform the other
Party of the confidential nature of such information, prior to or
at the time any such information is disclosed by the disclosing
Party to the other Party. In addition, any technical information
disclosed at a meeting of the JSC or any other committee
established pursuant to this Agreement shall constitute
Confidential Information unless otherwise specified.
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1.13.
“ Contraindication Label
Change ” shall mean [***].
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1.14.
“ Control ” or
“ Controlled ” means, with respect to any
intellectual property right of a Party, that the Party or its
Affiliate owns or has a license to such intellectual property
right, other than pursuant to this Agreement, and has the ability
to grant access, a license, or a sublicense to such intellectual
property right to the other Party as provided in this Agreement
without violating an agreement with or other rights of any Third
Party.
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3
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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1.15.
“ Development ”
means, to the extent applicable, the development of new forms of
the Licensed Product (i.e. any forms, including low dose forms,
that are different from the form of the Licensed Product as
currently Commercialized in the United Kingdom) for
Commercialization in the Territory. When used as a verb,
“Develop” means to engage in Development.
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1.16.
“ Development Plan
” means, to the extent applicable, the comprehensive plan for
Development.
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1.17.
“ Dispute Resolution
Panel ” shall mean the panel of experts to be appointed
on a issue by issue basis and consisting of either (i) the
Independent Financial Expert the Independent Regulatory and
Reimbursement Expert and a third qualified independent expert
(having a related background and/or knowledge relevant to the
dispute) selected jointly by the Independent Financial Expert and
the Independent Regulatory Expert and who shall act as chair of the
panel or (ii) if expressly agreed to by the parties in writing such
other expert(s) as jointly nominated by the Parties on a issue by
issue basis.
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1.18.
“ Dyloject Trademark
” means Dyloject ® .
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1.19.
“ Effective Date
” means the date on which Javelin shall have received (i) all
consents required by Section 6.1(i) hereof and (ii) all consents
necessary to assign to Therabel (or Therabel’s designated
Affiliate) the Assumed Agreements under Section 4.5 hereof on the
terms, in all material respects, that the Assumed Agreements exist
on the Execution Date.
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1.20.
“ EMEA ” means
the Regulatory Agency known as either the European Medicines Agency
or the European Agency for the Evaluation of Medicinal Products, or
a successor agency with responsibilities comparable to those of the
European Medicines Agency or the European Agency for the Evaluation
of Medicinal Products.
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1.21.
“ Entity ” means
any natural person, corporation, firm, general partnership, limited
partnership, limited liability company or partnership,
proprietorship, other business organization or entity, trust,
union, association or governmental or regulatory
authority.
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1.22.
“ European Economic
Area ” means [***].
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1.23.
“ Existing Inventory
” means Javelin’s remaining inventory of the Licensed
Product for sale in the Territory in its possession or under its
control which was produced prior to the Effective Date and has a
shelf life as of the Effective Date of at least [***] months. The
estimated quantities of such inventory are set forth in Schedule
4.5(C).
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[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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1.24.
“ FD&C Act ”
means the United States Federal Food, Drug, and Cosmetic Act, as
amended, and the regulations promulgated thereunder.
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1.25.
“ FDA ” means the
United States Food and Drug Administration or any successor agency
thereto.
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1.26.
“ Field ” means
the treatment, prevention, modulation or diagnosis of any disease,
disorder or condition in humans.
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1.27.
“ First Commercial Sale
” means, with respect to the Licensed Product and any country
of the Territory, the first sale of such Licensed Product under
this Agreement for use in the Field to a Third Party in such
country, after such Licensed Product has been granted Regulatory
Approval for use in the Field by the competent Regulatory
Authorities in such country.
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1.28.
“ First Subsequent
Regulatory Submission Plan ” means the comprehensive
country-by-country plan for the Regulatory Submission of the
Licensed Product for the purposes of obtaining Regulatory Approval
in [***] except for those countries described in the Initial
Regulatory Submission Plan, detailing Therabel’s specific
strategies and timelines for seeking marketing authorization,
including the identification of countries in which Therabel desires
not to commercialize the Licensed Products.
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1.29.
“ Force Majeure ”
has the meaning set forth in Section 11.2.
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1.30.
“ GAAP ” means
generally accepted accounting principles using the International
Financial Reporting Standards (IFRS), as in effect from time to
time in the Territory.
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1.31.
“ Improvements ”
means (i) all Know-How necessary or useful to manufacture, develop
or commercialize any injectable form of the Compound combined with
a solubilizing excipient, including without limitation any method
of making such combination, any composition or formulations of such
combination, or any method of using or administering such
combination and (ii) all Patent Rights that cover or recite any
injectable form of the Compound combined with a solubilizing
excipient, any method of making such combination, any composition
or formulations of such combination, or the method of using or
administering such combination.
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1.32.
“ Indemnified Party
” has the meaning set forth in Section 10.3.
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1.33.
“ Indemnifying Party
” has the meaning set forth in Section 10.3.
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1.34.
“ Independent Financial
Expert ” shall mean a senior partner of an independent
international accounting firm having relevant expertise with
respect to the
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[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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country in respect of which the
dispute has arisen and having a related background and/or knowledge
relevant to the dispute, as jointly appointed by the Parties or if
the Parties fail to agree on the identity of the expert, as
appointed by the arbitrational tribunal in accordance with Section
11.1.
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1.35.
“ Independent Regulatory
and Reimbursement Expert ” shall mean a reputed expert in
the field of regulatory and reimbursement matters, having relevant
expertise with respect to the country in respect of which the
dispute has arisen and having related background and/or knowledge
relevant to the dispute, as jointly appointed by the Parties on a
issue by issue basis, or if the Parties fail to agree on the
identity of the expert, as appointed by the arbitrational tribunal
in accordance with Section 11.1.
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1.36.
“ Infringement ”
has them caning set forth in Section 8.4.1.
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1.37.
“ Initial Regulatory
Submission Plan ” means the comprehensive plan for the
Regulatory Submission of the Licensed Product for the purpose of
obtaining Regulatory Approval in [***], and other countries of the
Territory as agreed by the JSC in accordance with Section 4.1,
which will then be considered, together with [***] as the
“first wave countries”, detailing Therabel’s
specific strategies and timelines for seeking marketing
authorization.
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1.38.
“ IP Owners ”
means any and all Third Parties having proprietary interest in the
Javelin Technology, including but not limited to Janssen
Pharmaceutica NV, Shimoda Biotech (Proprietary) Ltd., Farmarc
Netherlands N.V. and Farmarc Netherlands Antilles.
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1.39.
“ Javelin House Marks
” has the meaning set forth in Section 8.3.3.
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1.40.
“ Javelin Improvements
” means Improvements that Javelin Controls as of the
Effective Date or that comes into the Control of Javelin during the
Term.
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1.41.
“ Javelin Know-How
” means Know-How that Javelin Controls as of the Effective
Date or that comes into the Control of Javelin during the Term, in,
each case, to the extent necessary or useful in the Territory to
Manufacture, Commercialize a Licensed Product or conduct the
Regulatory Submission Activities, including without limitation any
method of making a Licensed Product, any composition or
formulations of a Licensed Product, or any method of using or
administering a Licensed Product.
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1.42.
“ Javelin Patent Rights
” means any Patent Right that Javelin Controls (including
without limitation the patent rights listed in Schedule 1.42) as of
the Effective Date or that comes into the Control of Javelin during
the Term of this Agreement, in each case, to the extent such rights
cover or recite a Licensed Product, any method of making
a
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6
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
Licensed
Product, any composition or formulations of a Licensed Product, or
the method of using or administering a Licensed Product.
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1.43.
“ Javelin Technology
” means (i) the Javelin Know-How, (ii) the Javelin Patent
Rights and (iii) the Javelin Improvements.
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1.44.
“ JSC ” has the
meaning set forth in Section 3.2.
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1.45.
“ Know-How ”
means all inventions, discoveries, data, information (including
scientific, technical or regulatory information), processes,
methods, techniques, materials, technology, results, analyses,
laboratory, pre-clinical and clinical data, or other know-how,
whether or not patentable, including without limitation
pharmacology, toxicology, drug stability, manufacturing and
formulation methodologies and techniques, clinical and non-clinical
safety and efficacy studies, marketing studies, absorption,
distribution, metabolism and excretion studies.
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1.46.
“ Licensed Formulation
” means any combination of the Compound and [***] that is
covered by any claim in the Javelin Patent Rights that exist on the
Effective Date.
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1.47.
“ Licensed Product
” means any [***] that contains the Licensed Formulation
either alone or in combination with one or more other active
ingredients. For the avoidance of doubt and unless otherwise
mutually agreed by the Parties, each in its sole discretion,
“Licensed Product” excludes [***].
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1.48.
“ Manufacturing ”
means, as applicable, all activities associated with the
production, manufacture, processing, filling, finishing, packaging,
labeling, shipping, and storage of the Compound or Licensed
Product, including process validation, stability testing,
manufacturing scale-up, pre-clinical, clinical and commercial
manufacture and analytical development, product characterization,
quality assurance and quality control, whether such activities are
conducted by a Party, its Affiliates or a Third Party contractor of
such Party. When used as a verb, “Manufacture” means to
engage in Manufacturing.
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1.49.
“ Net Sales ”
shall mean the aggregate amount invoiced for sales of the Licensed
Product by or on behalf of Therabel, its Affiliates, and/or any of
its Sublicensees, in each case on an arms-length basis to a Third
Party (other than a Third Party who is a Sublicensee or a Third
Party that sells the Licensed Product on behalf of Therabel), less
only the sum of the following:
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(a)
Customary trade, quantity, or cash discounts and non-affiliated
brokers’ or agents’ commission actually allowed and
taken which are not already reflected in the amount
invoiced;
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7
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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(b)
Rebates, including but not limited to government mandated rebates,
actually allowed;
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(c)
Amounts actually repaid or credited by reason of rejections or
return or recalls;
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(d)
Any freight or other transportation costs, and insurance charges to
the extent included in the invoice price and separately identified
on the invoice or other documentation maintained in the ordinary
course of business;
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(e)
Duties, tariffs, and all sales, pharmaceutical, excise and other
taxes based directly on sales or turnover or delivery of Licensed
Products under this Agreement (including VAT) to the extent
included in the invoice price and to the extent such taxes are
remitted to the applicable taxing authority;
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(f)
Invoiced amounts actually written off during the period covered by
the relevant royalty report (even if they relate to sales made
during prior periods); and/or
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(g)
A reasonable reserve for pharmaceutical taxes or other taxes or
charges on sales or turnover or delivery of Licensed Products under
this Agreement that are not included in the invoice price for the
Licensed Product (but excluding corporate income tax) consistent
with past practices, having the de facto effect of reducing
the effective price received by Therabel (or its Affiliates or
sublicensees) for such Licensed Products;
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provided that, the deductions in
clauses (a) through (d) above shall be consistent with
corresponding deductions taken by Therabel with respect to other
products sold by Therabel. In the event that Javelin disputes
Therabel’s Net Sales calculations, Javelin may invoke its
audit right pursuant to Section 5.4.1
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Net Sales will be determined in
accordance with GAAP, but only to the extent that the provisions of
this Section 1.50 does not expressly deviate from the GAAP
provisions. Without limiting the generality of the foregoing, sales
at cost, transfers or dispositions of Licensed Product for
charitable, promotional (including samples), pre-clinical,
clinical, or regulatory purposes will be excluded from Net Sales,
as will sales or transfers of Licensed Product among a Party and
its Affiliates or Sublicensees.
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1.50.
“ Net Sales Price
” means the net sales price per unit of Licensed Product,
calculated in accordance with the provisions set forth in Section
1.50.
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1.51.
“ New Drug Application
” or “ NDA ” means any application
corresponding to a New Drug Application filed with the FDA as
described in 21 CFR §
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8
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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314 for Regulatory Approval (not
including pricing and reimbursement approval) in any country or
regulatory jurisdiction.
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1.52.
“ Patent Right ”
means any and all (a) patent applications in the Territory,
including, without limitation, all provisional applications,
substitutions, continuations, continuations-in-part, divisions,
renewals, and all patents granted thereon, (b) patents in the
Territory, reissues, reexaminations and extensions or restorations
by existing or future extension or restoration mechanisms,
including, without limitation, supplementary protection
certificates or the equivalent thereof, and (c) any other form: of
government-issued right substantially similar to any of the
foregoing.
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1.53.
“ Pharmacovigilence
Agreement ” has the meaning set forth in Section
4.3.
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1.54.
“ Phase IV ” in
reference to a clinical trial means a trial conducted for purposes
of further characterizing and supporting the Licensed Product for
marketing but not for purposes of seeking Regulatory Approval or
otherwise fulfilling a requirement of a Regulatory
Authority.
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1.55.
“ Promotion ”
means those activities normally undertaken by a pharmaceutical
company’s sales force to implement marketing plans and
strategies aimed at encouraging the appropriate use of a particular
prescription or other pharmaceutical product.
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1.56.
“ Recipients ”
has the meaning set forth in Section 6.2.1.
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1.57.
“ Regulatory Approval
” means the approval and authorization of a Regulatory
Authority in a country necessary to manufacture, distribute, sell
or market a Licensed Product in that country, including, where
required and in accordance with the Commercialization Plan, pricing
and reimbursement approval.
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1.58.
“ Regulatory Authority
” means any applicable national, regional, state or local
regulatory agency, department, bureau, commission, council, or
other governmental entity involved in the granting of Regulatory
Approval for a Licensed Product in the Territory, including the
EMEA.
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1.59.
“ Regulatory
Submissions ” means applications for Regulatory Approval,
notification and other submissions made to or with a Regulatory
Authority that are necessary or reasonably desirable to Manufacture
or Commercialize the Licensed Product in the Field in a particular
country, whether obtained before or after a Regulatory Approval in
the country. Regulatory Submissions include, without limitation,
investigational new drug applications, Mutual Recognition Process
applications, post approval submissions required to maintain
Regulatory Approvals, and amendments and
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9
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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supplements to any of the
foregoing and their foreign counterparts, applications for pricing
and reimbursement approvals, and all proposed labels, labeling,
package inserts, monographs and packaging for the Licensed Product
in the Territory.
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1.60.
“ Regulatory Submission
Activities ” means all activities performed by Therabel
in the performance of any Regulatory Submission Plan for the
Licensed Product in the Field in the Territory. Regulatory
Submission Activities shall include, without limitation, all
activities conducted for the purpose of filing for and obtaining
Regulatory Approval in the Field in the Territory and, to the
extent such is required for obtaining said Regulatory Approval,
preclinical testing, test method development and stability testing,
toxicology, formulation, process development, manufacturing
scale-up, quality assurance/quality control, clinical studies,
seeking Regulatory Approval and otherwise handling regulatory
affairs, statistical analysis and report writing, all of the above
performed pursuant to (and to the extent required under) the
Regulatory Submission Plans with respect to the Licensed Product.
Regulatory Submission Activities shall not include Manufacturing or
Commercialization.
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1.61.
“ Regulatory Submission
Plans ” means the Initial Regulatory Submission Plan and
the First and Second Subsequent Regulatory Submission Plans for the
Regulatory Submission of the Licensed Product as approved by the
JSC and as amended or updated, from time to time, but in no event
less frequently than- once a year, in accordance with this
Agreement.
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1.62.
“ Relevant Laws ”
has the meaning set forth in Section 9.2.4.
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1.63.
“ Right of Reference
” has the meaning set forth in Section 2.3.
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1.64.
“ Senior Management
” of a Party includes, at a minimum, each of the Chief
Executive Officer, Chief Financial Officer, Head of Research and
Development, Head of Marketing, Head of Business Development,
General Counsel and President or Chief Operating Officer of the
pharmaceutical business or division or, if a Party does not employ
any of such persons under such titles, such employees having
similar responsibilities or, if none such employees exist, any
other senior executives of the relevant Party.
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1.65.
“ Sublicense Income
” means all payments that Therabel or an Affiliate receives
from a Third Party Sublicensee in connection with any grant of
rights that includes the rights granted to Therabel under Section
2.1, including without limitation license fees, milestone payments,
license maintenance fees and other payments in connection with said
grant of rights, but specifically excluding royalties, the purchase
price for Licensed Product, reimbursement of costs for patent
prosecution and defense, and sale of equity at fair market
value.
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10
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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1.66.
“ Sublicensee ”
means an Affiliate or Third Party that is granted a license,
sublicense, covenant not to sue or other grant of rights under this
Agreement pursuant to Section 2.2 of this Agreement.
“Sublicense means an agreement or arrangement pursuant to
which a sublicense or distribution right has been
granted.
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1.67.
“Second Subsequent
Regulatory Submission Plan” means the comprehensive
country-by-country plan for the Regulatory Submission of the
Licensed Product for the purposes of obtaining Regulatory Approval
in [***], detailing Therabel’s specific strategies and
timelines for seeking marketing authorization, including the
identification of countries in which Therabel desires not to
Commercialize the Licensed Products.
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1.68.
“Sued Party” has the meaning set forth in Section
8.5.2.
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1.69.
“Technology” means Know-How and Patent Rights.
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1.70.
“Term” is
defined in Section 9.1.
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1.71.
“Territory” means [***].
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1.72.
“Therabel Improvements” means all Improvements (if any) that are
invented, conceived or developed solely by Therabel or its
Sublicensees or jointly be the Parties, their Affiliates,
Sublicensees or Third Parties acting on their behalf or by Therabel
and any of its Affiliates or Sublicensees during the Term of this
Agreement or, as applicable, during the term of any sublicense
agreement hereunder.
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1.73.
“Therabel Know-How” means all Know-How (if any) that is invented,
conceived or developed solely by Therabel or jointly by the
Parties, their Affiliates or Third Parties acting on their behalf
in each case in the course of such Party’s performance under
this Agreement.
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1.74.
“Therabel Patent Right” means any Patent Right (if any) that claims
Therabel Know-How.
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1.75.
“Therabel Technology” means Therabel’s interest in the (i)
Therabel Know-How, (ii) the Therabel Patent Rights and (iii)
Therabel Improvements, if any.
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1.76.
“Third Part(y/ies)” means any person(s) or entit(y/ies) other than
Javelin and its Affiliates and Therabel and its
Affiliates.
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1.77.
“Trademark” means any trademark under which the Licensed
Product is sold, other than the Parties’ trade names and
trademarks used by the Parties to identify their companies
generally, including without limitation, the Dyloject
Trademark.
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11
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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1.78. “United States” or “U.S.”
means the United States of America, its territories and possessions
(including Puerto Rico, irrespective of political
status).
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1.79. “Valid Claim” means a claim of a Patent
Right in the Territory, which claim has not been revoked or held
unenforceable, unpatentable or invalid by a decision of a court or
other governmental agency of competent jurisdiction, which is not
appealable or has not been appealed within the time allowed for
appeal, and which has not been abandoned, disclaimed, denied or
admitted to be invalid or unenforceable through reissue,
re-examination or disclaimer or otherwise.
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1.80. “Violating Party” has the meaning set
forth in Section 9.2.4.
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2.
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GRANT OF
LICENSES.
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2.1. License to Therabel. Subject to the terns and
conditions of the Agreement, Javelin hereby grants to Therabel,
effective on the Effective Date of the Agreement, an exclusive
license, with the right to sublicense to its Affiliates or as
expressly provided in Section 2.2, under the Javelin Technology to
develop, have developed, import, make, have made, use; offer to
sell, sell, commercialize and distribute the Licensed Product in
the Field in the Territory for the purpose of Manufacturing,
seeking Regulatory Approval for and/or Commercializing Licensed
Products in accordance with the terms of this Agreement. The
exclusivity granted hereunder shall be absolute, meaning that
Javelin shall not only refrain from granting further licenses (or
appoint further sales intermediaries) with respect to the Licensed
Product in the Territory, but also from selling, commercializing
and distributing the Licensed Product in the Territory itself.
Notwithstanding the foregoing, Javelin reserves the right under the
Javelin Technology to develop and manufacture the Licensed Product
in the Territory solely for commercialization outside the
Territory.
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2.2. Sublicensing. Therabel will have no right, except upon
prior written consent of Javelin, which consent may not be
unreasonably withheld, to grant sublicenses to Third Parties under
the rights granted to Therabel under this Agreement. Any
sublicenses granted by Therabel hereunder shall be consistent with
the terms of this Agreement. In addition Therabel shall require any
Sublicensee to transfer or convey to Javelin all Improvements and
all Technology necessary or useful to make, use or sell a Licensed
Product which such Sublicensee may develop or acquire, if any, so
that any of such Technology will be Controlled by
Javelin.
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2.3. Right of Reference. Therabel hereby grants to Javelin
(and any of Javelin’s partners and licensees) a “Right
of Reference,” as that term is defined in 21 C.F.R. §
314.3(b) in the Field in the Territory to the data included in the
Therabel Technology (if any) to the extent necessary or useful to
Manufacture, Commercialize or Develop a Licensed Product in the
Field throughout the world, subject to the terms and
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12
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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conditions of this Agreement. The
Parties agree that Javelin may make available to its collaborators,
partners and licensees with respect to Licensed Products outside
the Territory any Regulatory Submissions made in the Territory and
data and results arising from clinical trials conducted by or on
behalf of Therabel pursuant to this Agreement. The Parties agree
that Therabel may make available to its collaborators, partners and
sublicensees with respect to Licensed Products in the Territory any
Regulatory Submissions made outside the Territory and data and
results arising from clinical trials related to the Licensed
Product conducted by or on behalf of Javelin. Therabel shall, at
its own expense, take any action reasonably requested by Javelin to
affect the Right of Reference described in this Section.
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2.4. No Other Rights. No rights, other than those expressly
set forth in this Agreement are granted to either Party hereunder,
and no additional rights shall be deemed granted to either Party by
implication, estoppel or otherwise. All rights not expressly
granted by either Party to the other hereunder are
reserved.
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2.5. Sale of Javelin Pharmaceuticals (U.K.) Limited. In view
of facilitating the start-up of Therabel’s distribution and
commercialization activities hereunder in the territory of the
United Kingdom, Javelin and Therabel agree that Therabel shall take
over Javelin’s existing United Kingdom distribution business
(which consists of, among other things, the UK Marketing
Authorization, the wholesalers license, employees and certain
contracts in relation to existing marketing, sales, and
distribution of the Licensed Product in the United Kingdom), by
means of acquiring, upon the Effective Date, of 100% of the shares
of capital stock of Javelin Pharmaceuticals (U.K.) Limited
(“JPUK”). The terms and conditions of such acquisition
shall be governed by the Share Purchase Agreement substantially in
the form attached hereto as Exhibit 2.5 with such other changes as
the Parties may agree to in good faith (the “ Agreed
SPA ”). The Parties shall execute (and Javelin shall
cause its Affiliate, Innovative Drug Delivery Systems Inc, to
execute) the Agreed SPA within 15 days following the Execution Date
and in any event prior to the Effective Date. In addition, until
completion of the Agreed SPA in accordance with its terms, Javelin
undertakes to cause that (i) JPUK’s business be continued to
be operated in the ordinary course of business and in accordance
with past practice, (ii) [***] and (iii) [***].
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2.6. Section 365(n). All rights and licenses granted under
or pursuant to this Agreement by Therabel or Javelin are, and will
otherwise be deemed to be, for purposes of Section 365(n) of the
U.S. Bankruptcy Code, licenses of rights to “intellectual
property” as defined under Section 101 of the U.S. Bankruptcy
Code. The Parties agree that the Parties, as licensees of such
rights under this Agreement, will retain and may fully exercise all
of their rights and elections under the U.S. Bankruptcy Code. The
Parties further agree that, in the event of the commencement of a
bankruptcy proceeding by or against either Party under the U.S.
Bankruptcy Code, the Party hereto that is not a party to such
proceeding will be entitled free of charge to a complete duplicate
of (or
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REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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complete access to, as
appropriate) any such intellectual property and all embodiments of
such intellectual property, and same, if not already in their
possession, will be promptly delivered to them (i) upon any such
commencement of a bankruptcy proceeding upon their written request
therefor, unless the Party subject to such proceeding elects to
continue to perform all of its obligations under this Agreement, or
(ii) if not delivered under (i) above, following the rejection of
this Agreement by or on behalf of the Party subject to such
proceeding upon written request therefor by the non-subject
party.
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2.7. Non-Competition. During the Term of this Agreement,
neither Therabel nor any of its Affiliates shall, in or in relation
to the Territory, develop, have developed, import, make, have made,
use, offer to sell and/or sell any injectable non-steroidal
anti-inflammatory drug for use in the Field in the Territory,
except pursuant to the Agreement. During the Term of this
Agreement, neither Javelin nor any of its Affiliates shall, in or
in relation to the Territory, import, make, have made, use, offer
to sell and/or sell any injectable non-steroidal anti-inflammatory
drug for use in the Field in the Territory, except pursuant to the
Agreement; provided that, the restrictions set forth in this
sentence shall cease to have any effect following any Change of
Control of Javelin.
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2.8. Right of First Offer to [***]. In the event that, at
any time during the Term of this Agreement, Javelin (or any
Affiliate of Javelin) desires to license the rights [***] to [***],
Javelin shall so notify Therabel (the “First Offer
Notice”) and grant access to Therabel (on a confidential
basis) to such relevant data in respect of [***] that Javelin
intends to provide other Third Parties for such license rights.
Therabel shall have the right, but not the obligation, exercisable
within [***] days of receipt of the access to the data as mentioned
hereinabove, to make the first offer to Javelin for such right,
which offer shall be in the form of a term sheet setting forth the
key terms of the license agreement including the proposed financial
terms (the “Offer”). Javelin may accept or reject the
Offer made by Therabel, in its sole discretion. In the event that
Javelin accepts the Offer, the Parties shall, for a period of up to
[***] days, negotiate in good faith the terms of a final license
agreement. If Javelin initially accepts the Offer from Therabel,
but the Parties are not able to consummate a binding license
agreement within the [***] day period, either Party may terminate
the negotiations. If the negotiations are terminated by Javelin or
if none of the Parties formally terminate the negotiations or if
Javelin does not accept an Offer from Therabel, Javelin shall not
be entitled to accept an offer from a Third Party for the same
rights which is, in relation to [***] solely, overall less
favorable than Therabel’s Offer. If the negotiations are
terminated by Therabel, such termination shall have the effect as
Therabel declining to make an Offer, and, in such case, Javelin
shall be free to license the rights to [***] to any Third Party
without limitation. The same will be the case if Therabel declines
to make an Offer.
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3.
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DECISION MAKING AND DISPUTE
RESOLUTION.
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3.1. Overview. During the Term, oversight for all of the
activities of the Parties related to the Regulatory Submission
Activities, the Commercialization and Development (if any) of the
Licensed Product in the Field in the Territory will be provided by
the JSC set forth below and elsewhere in this Agreement. The JSC
shall perform the functions ascribed to them hereunder;
provided , however , that the functions and
operations of the JSC may be altered from time to time during the
Term by the mutual agreement of the Parties to appropriately
address ongoing requirements with respect to the Regulatory
Submission Activities, the Commercialization and Development (if
any) of the Licensed Product. In addition to the JSC meetings, the
Parties anticipate that members of Senior Management from Therabel
and Javelin will meet periodically as necessary or appropriate
during the Term (and in any event at least [***]) in order to
review significant issues and developments with respect to the
Regulatory Submission Activities, the Commercialization and
Development (if any) of the Licensed Product in the
Territory.
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3.2. Joint Steering Committee. The Parties will establish a
joint steering committee (“ JSC ”) that will
oversee the Regulatory Submission Activities, the Commercialization
and Development (if any) of the Licensed Product in the Field in
the Territory. The JSC will oversee the Regulatory Submission
Activities of the Licensed Product in the Field in the Territory,
the selling and marketing efforts under the Commercialization Plan
and will serve as a forum for exchanging data, information
and
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[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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strategy regarding the Regulatory
Submission Activities, the Commercialization and Development (if
any) of the Licensed Product in the Field in the Territory. The JSC
will have no other tasks and responsibilities than those as
ascribed to them hereunder.
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3.2.1.
Composition . The JSC will consist of three (3) senior
representatives from each Party. Javelin and Therabel will each
designate a co-chair for the JSC. The co-chairs will be responsible
for logistical issues related to such meetings, but will not
otherwise have any greater power or authority than any other member
of the JSC. Responsibility for facilitating and calling meetings,
setting meeting agendas, and producing and distributing meeting
minutes shall alternate between the co-chairs on an annual basis.
JSC members shall have such expertise as appropriate to the
activities of the JSC from time to time and the JSC shall invite
personnel of the Parties having relevant functional expertise to
participate in discussions of the JSC from time to time as
appropriate to assist in the activities of the JSC.
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3.2.2.
Responsibilities . The JSC will be responsible for (i)
approving the Regulatory Submission Plans for the Licensed Product
in accordance with the terms of this Agreement, and any amendments
to such plans, (ii) approving (or establishing procedures to
approve) protocols for clinical studies (if any), (iii) supervising
the quarterly monitoring of progress of clinical studies (if any)
and additional studies of the Licensed Product (if any), (iv)
reviewing and commenting on Regulatory Submissions relating to the
Licensed Product prior to submission, (v) facilitating the exchange
of all data, information, material or results relating to the
development. of the Licensed Product, (vi) approving the strategy
for the Commercialization of the Licensed Product in the Field in
the Territory, in accordance with the terms of this Agreement,
(vii) approving the Commercialization Plan for the Licensed Product
in the Field in the Territory in accordance with the terms of this
Agreement, as well as any updates thereof (to reflect materially
changed circumstances), (viii) overseeing the implementation of the
Commercialization Plan, (ix) establishing usage instructions for
the Trademarks in accordance with the terms of this Agreement, (x)
reviewing Therabel’s marketing and promotional activities to
ensure that such activities are consistent with the
Commercialization Plan, (xi) approving the Development Plan (if
any) and overseeing the Development activities (if any) and (xii)
such other responsibilities as are explicitly delegated to the JSC
in this Agreement. The JSC may appoint additional committees as
desired. Under no circumstances shall the JSC have any tasks or
responsibilities other than those provided herein or as expressly
agreed upon between the Parties in writing. Javelin shall report
[***] to the JSC all progress made in respect of clinical studies
and additional studies of the Licensed Product made or prepared by
or under the control of Javelin (or its licensees or designees)
outside of the Territory, which reports shall be Confidential
Information of Javelin.
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3.2.3.
No new obligations . For the avoidance of any doubt, it is
expressly stated that the JSC, in fulfilling its tasks and
responsibilities hereunder, shall
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REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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have no authority (i) to create
any obligation incumbent on either Party hereunder that goes beyond
the scope of the obligations expressly provided for herein or (ii)
to construe any existing obligations in such a way that it exceeds
the scope of the obligations expressly provided for
herein.
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3.2.4.
Meetings . The JSC will meet at such frequency as shall be
established by the Parties (but not less frequently than [***]
times per [***]). The first meeting of the JSC shall occur within
[***] days of the Execution Date of this Agreement. Meetings of the
JSC shall alternate between the offices of the Parties, unless
otherwise agreed upon by the members of the JSC, or may be held
telephonically or by video conference. Meetings of the JSC shall be
effective only if at least [***] representatives of each Party are
in attendance or participating in the meeting. Members of the JSC
shall have the right to participate in and vote at meetings by
telephone, or in their absence, to deputize another member of such
Party’s Senior Management to vote on their behalf. If there
is no quorum at any duly convened JSC meeting (i.e. at least [***]
representatives of each Party being present), all agenda items of
such JSC meeting requiring a vote shall automatically be considered
as deadlock matters and shall be subject to Section 3.4. Each Party
shall be responsible for expenses incurred by its employees and its
members of the JSC in attending or otherwise participating in JSC
meetings.
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3.2.5.
Minutes and Agendas . The minutes of each JSC meeting shall
provide a description in reasonable detail of the discussions held
at the meeting and a list of any actions, decisions or
determinations approved by the JSC. Minutes of each JSC meeting
shall be approved or disapproved, and revised as necessary, at the
next meeting.
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3.2.6.
No Joint Venture . For the avoidance of any doubt, it is
expressly stated that the sole purpose of the JSC is to provide for
an efficient means of communication between the Parties and that
nothing ‘contained in the Agreement shall imply the JSC to
constitute a legal entity or a joint venture between the
Parties.
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3.3. Other Committees. The Parties may establish other
committees or subcommittees as the Parties deem
appropriate.
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3.4. Elevation and Dispute Resolution. Each Party’s
representatives on the JSC will collectively have one (1) vote on
all matters. The members of the JSC will use reasonable efforts to
reach consensus on all decisions. In the event of a deadlock
regarding a particular issue on which the members of the JSC cannot
reach consensus, such issue will be resolved as follows:
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In
the event that the members of the JSC are unable to agree on a
particular issue, such issue shall be referred to the
Parties’ respective Chief Executive Officers or their
designees for resolution, and such individuals shall use good faith
efforts to resolve such
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[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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issue within [***] days of such
matter being referred to them, which period may be extended by
mutual agreement. If the Chief Executive Officers or their
designees are unable to resolve any matter referred to them within
such [***]-day period, as it may be extended, then such matter will
be resolved as follows:
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(a)
all matters relating to [***], shall be determined by Therabel, it
being understood however that the decision with respect to the
following matters shall be finally decided as follows:
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(i)
Each matter regarding the obligation of [***] shall be finally
decided by the Dispute Resolution Panel, in accordance with the
criteria as indicated in Sections 4.1.2 (a) and 4.7.2 below;
and
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(ii)
Each matter regarding [***], shall be finally decided by the
Dispute Resolution Panel, in accordance with the following
criteria: [***];
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(b)
except as set forth in Sections 3.4(a)(i) or (ii) or as set forth
below, all matters relating to [***], including, without
limitation, [***], shall be determined by Therabel. Notwithstanding
the foregoing, (i) matters relating to [***] shall be finally
decided by the Dispute Resolution Panel and (ii) Javelin shall have
the final approval of any [***].
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(c)
except as set forth in Sections 3.4(a)(i) or (ii), all matters
relating to [***] shall be determined by the Javelin in accordance
with Section 4.9; provided that Therabel shall not be bound
by any decision by Javelin in this respect and shall not be under
an obligation to proceed with [***] if [***].
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4.
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REGULATORY SUBMISSION
ACTIVITIES, COMMERCIALIZATION AND DEVELOPMENT.
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4.1. Regulatory Submission Activities
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4.1.1.
Regulatory Submission Plans . Therabel shall (i) within
[***] days of the Effective Date of this Agreement, present the
[***] to the JSC for approval and (ii) within [***] days of the
notice of the receipt of approval of the marketing authorization in
the [***] (as set forth in the [***]), present the [***] to the JSC
for approval, and (iii) within [***] of the Effective Date of the
Agreement, present the [***] to the JSC for approval. Neither the
[***] nor the [***] shall be effective until approved by the JSC.
The Parties agree that it is their intent that Therabel shall seek
Regulatory Approval for the Licensed Product throughout the
Territory as soon as Commercially Reasonable, but without prejudice
to [***] as referred to in (i), (ii) and (iii) hereinabove and
subject to the other provisions of this Agreement.
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[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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4.1.2.
In the event the JSC does not approve the [***], the [***] or the
[***] proposed by Therabel (subject to Subsection (c) below),
Therabel shall promptly provide to the JSC for its approval a
revised plan that incorporates the reasonable comments and feedback
from the JSC. The JSC will oversee the [***] of the Licensed
Product in the Field in the Territory, according to the [***]. The
following provisions shall apply with respect to the [***] of the
Licensed Product:
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(a)
The [***] for the Licensed Product will include, among other
things, [***].
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(b)
[***].
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(c)
[***].
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(d)
[***].
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4.1.3.
Reports of [***] . Therabel shall report on the [***] it has
undertaken in accordance with [***] in connection with meetings of
the JSC, including by providing a reasonably detailed summary of
all results, data and material inventions, if any, obtained from
such activities. In addition, Therabel shall, at its own expense,
make appropriate scientific and regulatory personnel available to
the JSC, either by telephone or in person as the Parties may
mutually agree, as reasonably required to keep informed of [***],
in all material respects.
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4.2. Regulatory Matters.
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4.2.1.
Responsibility for [***] . All activities and costs required
to affect the [***] shall be the responsibility of Therabel, which
may request the assistance of Javelin as required and shall keep
Javelin reasonably informed of the status and progress.
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4.2.2.
Responsibility for other Regulatory Interactions .
Regulatory strategy for the Licensed Product shall be determined by
the Regulatory Submission Plans. Therabel shall use Commercially
Reasonable Efforts to prepare and maintain all Regulatory
Submissions and any other documents required to be submitted to the
applicable Regulatory Authorities and obtain in a timely manner
Regulatory Approvals with respect to the Licensed Product, to the
extent contemplated by the Regulatory Submission Plans. The costs
incurred by Therabel in carrying out their assigned
responsibilities pursuant this Section 4.2.2 shall be the sole
responsibility of [***].
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4.2.3.
Regulatory Cooperation . Therabel shall keep Javelin
reasonably informed regarding the status and progress of regulatory
activity in the Territory in all material respects, including
without limitation, providing Javelin with a copy of all
substantive written correspondence from a Regulatory Authority
involving a Regulatory Submission, notifying Javelin of all oral
substantive correspondence from a Regulatory
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[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
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Authority involving a Regulatory
Submission, and providing the JSC with an advance draft of each
proposed Regulatory Submission sufficiently in advance of providing
the submission to the Regulatory Authority (and in any event no
less than [***] days in advance) to enable the JSC to have a
meaningful opportunity to provide comments on the content of such
submission and no such Regulatory Submission shall be submitted for
filing with the Regulatory Authority without the mutual agreement
of the Parties, such consent not to be unreasonably withheld or
delayed. In the event that Javelin does not provide written
comments within [***] days on any draft Regulatory Submission
submitted to it by Therabel for comment, Javelin shall be
considered as having approved said documents. Furthermore, the
Parties shall agree in advance on all substantive written
communications with Regulatory Authorities in the United Kingdom to
the extent related to the Licensed Product. Each Party shall bear
its own costs and expenses incurred pursuant to this Section
4.2.
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4.2.4.
Assumption of Marketing Authorization . As of the Effective
Date, Therabel shall assume and maintain Javelin’s ownership
rights and obligations for the approved marketing authorization for
the Licensed Product in the Territory. Javelin hereby represents
and warrants that, to the best of its knowledge, as of the
Execution Date of the Agreement, it has completed all necessary
development activities for the Licensed Product in the Field in
connection with obtaining Regulatory Approval in the
Territory.
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4.2.5.
Clinical Trial Data . Therabel shall, at its sole cost and
expense, maintain a database for any clinical trial data resulting
from any Phase IV clinical studies, the Regulatory Submission
Activities and Development activities hereunder.
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4.3. Adverse Events. By, or as soon as reasonably possible
following, the Effective Date, the Parties will enter into a
pharmacovigilence agreement, which upon such execution will be
attached as an exhibit hereto and hereby incorporated into this
Agreement by reference (the “ Pharmacovigilence
Agreement ”). The Parties will comply with the provisions
of such agreement, however in the event of a conflict between the
Pharmacovigilence Agreeme
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