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EXHIBIT
10.1
Revised Execution
Version
[*]-INDICATES MATERIAL THAT WAS OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH
OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE
24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
AMENDED AND
RESTATED
COLLABORATION
AGREEMENT
BY AND
BETWEEN
PSIVIDA, INC. (f/k/a
CONTROL DELIVERY SYSTEMS, INC.)
AND
ALIMERA SCIENCES,
INC.
DATED AS OF MARCH 14,
2008
TABLE OF
CONTENTS
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Page |
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ARTICLE 1
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DEFINITIONS |
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1 |
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ARTICLE 2
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Intentionally omitted |
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17 |
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ARTICLE 3
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DEVELOPMENT ACTIVITIES |
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17 |
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3.1
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General |
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17 |
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3.2
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Regulatory Approvals. |
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18 |
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3.3
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Performance. |
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19 |
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3.4
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Primary
Contact Persons |
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20 |
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3.5
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Availability of Employees |
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20 |
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3.6
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Visit of
Facilities |
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20 |
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3.7
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Subcontracts |
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20 |
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3.8
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Information Sharing |
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20 |
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3.9
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Records |
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21 |
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3.10
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Manufacturing for Clinical Supply Requirements |
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21 |
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3.11
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Technology Transfer by CDS |
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21 |
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ARTICLE 4
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COMMERCIALIZATION |
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22 |
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4.1
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Commercialization of Product(s) in the Collaboration
Field |
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22 |
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4.2
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Commercialization Budget |
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22 |
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4.3
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Diligence |
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23 |
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4.4
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Costs of
Commercialization |
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25 |
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4.5
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Manufacturing for Commercial Supply Requirements |
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26 |
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4.6
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Product
Recalls |
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26 |
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ARTICLE 5
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GRANT OF
RIGHTS |
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27 |
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5.1
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Grant of
License by CDS. |
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27 |
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5.2
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Grant of
License by Alimera |
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27 |
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5.3
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Sublicenses and Subcontracts |
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28 |
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5.4
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Ownership
of and Rights to Inventions |
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29 |
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5.5
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Limitation on Use |
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29 |
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5.6
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Reservation of Rights. |
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29 |
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5.7
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No Grant
of Other Technology or Patent Rights |
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30 |
-ii-
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5.8
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Options
to Licenses in the Collaboration Field. |
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30 |
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5.9
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Clinical
IP. |
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32 |
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5.10
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Section
365(n) of the Bankruptcy Code |
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32 |
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ARTICLE 6
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COSTS
& REVENUES – PRE AND POST PROFITABILITY DATE |
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32 |
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6.1
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License
Fee |
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32 |
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6.2
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Milestone
Payments |
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33 |
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6.2A
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Payments
on Execution of Amended and Restated Agreement |
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33 |
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6.2B
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Certain
Alimera Note Payments and Events |
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33 |
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6.3
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Development Costs |
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33 |
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6.4
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Revenues
Prior to Profitability Date |
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34 |
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6.5
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Costs and
Revenues After the Profitability Date. |
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34 |
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6.6
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Revenues
from Third Party Agreements |
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37 |
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6.7
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Records;
Audits. |
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37 |
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ARTICLE 7
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INTELLECTUAL PROPERTY |
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38 |
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7.1
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CDS-Prosecuted Patent Rights. |
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38 |
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7.2
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Abandonment |
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39 |
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7.3
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Alimera-Prosecuted Patent Rights. |
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40 |
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7.4
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Information Disclosure; Cooperation |
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41 |
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7.5
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Employees
and Sublicensees Assignment of Inventions |
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41 |
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7.6
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Infringement |
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41 |
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7.7
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Marking |
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44 |
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7.8
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Trademarks |
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44 |
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7.9
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UKRF
Licenses and B&L Agreement |
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45 |
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ARTICLE 8
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CONFIDENTIALITY |
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45 |
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8.1
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Confidentiality |
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45 |
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8.2
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Disclosure |
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45 |
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8.3
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Disclosure of Agreement |
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46 |
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8.4
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Disclosure of Product Achievements |
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46 |
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ARTICLE 9
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REPRESENTATIONS AND WARRANTIES |
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46 |
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9.1
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Representations and Warranties of CDS |
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46 |
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9.2
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Representations and Warranties of Alimera |
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48 |
-iii-
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9.3
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Warranty
Disclaimer |
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48 |
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9.4
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Limited
Liability |
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48 |
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ARTICLE 10
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INDEMNITY |
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49 |
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10.1
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Cross
Indemnity |
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49 |
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10.2
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Limitation on Indemnity Obligations |
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49 |
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10.3
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Procedure |
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49 |
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10.4
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Insurance |
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50 |
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10.5
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Product
Liability Claims |
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50 |
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ARTICLE 11
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TERM AND
TERMINATION |
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51 |
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11.1
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Term |
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51 |
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11.2
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Termination for Default by Either Party |
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51 |
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11.3
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Intentionally omitted. |
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52 |
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11.4
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Intentionally omitted. |
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52 |
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11.5
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Termination for Abandonment |
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52 |
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11.6
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Effect of
Expiration or Termination of the Agreement |
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53 |
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11.7
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Survival
of Provisions Upon Expiration or Termination |
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53 |
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ARTICLE 12
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MISCELLANEOUS |
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53 |
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12.1
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Interpretation. |
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53 |
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12.2
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Assignment |
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54 |
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12.3
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Severability |
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54 |
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12.4
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Notices |
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54 |
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12.5
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Governing
Law and Venue |
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55 |
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12.6
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Compliance with Applicable Laws |
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55 |
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12.7
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Dispute
Resolution |
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56 |
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12.8
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Intentionally omitted |
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56 |
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12.9
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Entire
Agreement |
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56 |
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12.10
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Headings |
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57 |
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12.11
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Independent Contractors |
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57 |
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12.12
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Waiver |
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57 |
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12.13
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Counterparts |
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57 |
-iv-
AMENDED AND RESTATED
COLLABORATION AGREEMENT
THIS AMENDED AND RESTATED COLLABORATION
AGREEMENT (the “ Agreement ”) dated as of
March 14, 2008 (the “ Amendment Effective Date
”), is made by and between PSIVIDA, INC. (f/k/a CONTROL
DELIVERY SYSTEMS, INC.), a corporation organized and existing under
the laws of the State of Delaware having its offices at 400
Pleasant St., Watertown, Massachusetts 02472 (“ CDS
”), and ALIMERA SCIENCES, INC., a corporation organized and
existing under the laws of the State of Delaware having its offices
at 6120 Windward Parkway, Alpharetta, GA 30005 (“
Alimera ”). CDS and Alimera are sometimes referred to
herein individually as a “ Party ” and
collectively as the “ Parties .”
RECITALS
WHEREAS, CDS designs and
develops innovative ophthalmic drug delivery products;
and
WHEREAS, Alimera develops and
commercializes ophthalmic drug products; and
WHEREAS, the Parties were
interested in collaborating with one another and jointly funding
the development, and sharing Net Profits from the sale, of novel
products for treating eye diseases in humans, including a product
for the treatment of diabetic macular edema using a corticosteroid;
and
WHEREAS, CDS was willing to
grant Alimera a license to certain of its proprietary technology
and know-how relating to developing products for treating eye
diseases; and
WHEREAS, the Parties entered
into such a collaboration and licensing relationship upon the terms
and conditions set forth in the Collaboration Agreement by and
between Control Delivery Systems, Inc. and Alimera Sciences, Inc.
(the “ Original Agreement ”) dated as of
February 11, 2005 (the “ Effective Date ”),
as amended by Amendment No. 1 dated February 23, 2005 and
Amendment No. 2 dated May 11, 2005; and
WHEREAS, CDS and Alimera
desire to enter into this Agreement to amend and restate the
Original Agreement (as amended prior to the Amendment Effective
Date) as of the Amendment Effective Date as set forth
herein;
NOW THEREFORE, in
consideration of the premises and of the mutual covenants herein
contained, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the
Parties hereto agree as follows:
ARTICLE 1
DEFINITIONS
For purposes of this Agreement, the
terms defined in this Article shall have the meanings specified
below, whether used in their singular or plural form:
1.1 “Affiliate”
shall mean any corporation or other entity that controls, is
controlled by, or is under common control with a Party to this
Agreement. A corporation or other entity shall be regarded as in
control of another corporation or entity if it directly or
indirectly owns or controls more than fifty percent (50%) of
the voting stock or other ownership interest of the other
corporation or
1
entity, or if it possesses, directly or
indirectly, the power to direct or cause the direction of the
management and policies of the corporation or other entity or the
power to elect or appoint more than fifty percent (50%) of the
members of the governing body of the corporation or other
entity.
1.1A “Alimera
Development Activities” shall mean (a) for activities
conducted prior to the Amendment Effective Date, Alimera’s
development activities conducted as set forth in the Development
Plan (as defined in the Original Agreement) and (b) for
activities conducted on and after the Amendment Effective Date, all
Alimera development activities related to this
Agreement.
1.2 “Alimera
Improvements” shall mean any and all Improvements created,
conceived or reduced to practice by Alimera, or its Affiliates,
agents, subcontractors or sublicensees, alone or with others, or by
Third Parties acting on their behalf, that are
(a) Improvements covered by or derived from practice of the
CDS Technology, and/or (b) Improvements covered by or derived
from the practice of the Improvements set forth in clause (a);
provided, however, that Alimera Improvements shall not include any
Improvement that meets each of the following: (x) is related
specifically to an active ingredient provided by Alimera and used
in the Products, (y) can be practiced without infringing any
CDS Existing Patent Rights and any Patent Rights included within
CDS Improvements, or without utilizing any CDS Know-How, and
(z) does not fall within the definition of the CDS Core
Technology.
1.3 “Alimera
Know-How” shall mean Know-How Controlled by
Alimera.
1.3A “Alimera
Note” shall have the meaning set forth in
Section 6.2A.
1.4 “Alimera Patent
Costs” shall mean fees and costs associated with filing,
prosecution and maintenance of the Alimera-Prosecuted Patent
Rights, as defined in Section 7.3, in the
Territory.
1.4A “AMD” means
age-related macular degeneration.
1.4B “Amendment
Effective Date” shall have the meaning set forth in the
preamble.
1.5 “Approval”
shall mean the approvals from applicable regulatory authorities in
any country or region required to lawfully market a Product in such
country or region, including, but not limited to, approval of an
NDA. The term “Approved” shall mean the receipt of
Approval.
1.6 “Bankruptcy
Code” shall mean Title 11 of the United States Code, as
amended from time to time.
1.7 “B&L”
shall mean Bausch & Lomb Incorporated.
1.8 “B&L
Agreement” shall mean the Amended and Restated License
Agreement between CDS and B&L dated as of December 9, 2003
as in existence and effect on the Effective Date, a full and
complete copy of which has been provided to Alimera.
2
1.9 “Business
Day” shall mean each day of the week excluding Saturday,
Sunday and U.S. federal holidays.
1.10 “CDS Core
Technology” shall mean (a) any drug delivery device, or
component thereof, for ophthalmic use that includes a core
containing one or more drugs, and (b) any method or process
for using a device described in clause (a).
1.10A “CDS Development
Activities” shall mean (a) for activities conducted
prior to the Amendment Effective Date, CDS’ development
activities conducted as set forth in the Development Plan (as
defined in the Original Agreement) and (b) for activities
conducted on and after the Amendment Effective Date, CDS’
development activities conducted to the extent specifically set
forth in Section 3.1.2 herein.
1.11 “CDS Existing
Patent Rights” shall mean (a) the United States and
foreign patents and patent applications listed in Exhibit
1.11A , (b) any Patent Rights arising from those patents
and patent applications during the Term, and (c) any other
patents or patent applications Controlled by CDS as of the
Effective Date, a Valid Claim of which, absent the licenses granted
by CDS to Alimera under Section 5.1, would be infringed by the
making, having made, using, selling, offering to sell or importing
of a Product in the Collaboration Field by Alimera or its
subcontractors or sublicensees as permitted under this Agreement;
provided, however, that CDS Existing Patent Rights shall in no
event include the patents and patent applications listed in
Exhibit 1.11B or any Patent Rights arising from those
patents or patent applications.
1.12 “CDS
Improvements” shall mean any and all Improvements created,
conceived or reduced to practice by CDS, or its Affiliates, agents,
or sublicensees, alone or with others or by Third Parties acting on
their behalf, during the course of CDS Development Activities, that
are (a) Improvements covered by or derived from practice of
the CDS Technology, and/or (b) Improvements covered by or
derived from the practice of the Improvements set forth in clause
(a); provided, however, that CDS Improvements shall not include any
Improvement that is an Alimera Improvement.
1.13 “CDS
Know-How” shall mean Know-How Controlled by CDS that is
required for development and Commercialization of a
Product.
1.14 “CDS Net
Income” or “CDS Net Losses” shall mean, for the
first calendar quarter after the CDS Profitability Date and for any
calendar quarter thereafter, Net Sales by CDS, and/or CDS
Sublicense Revenue actually received by CDS, for a Product in that
calendar quarter minus the CDS Product Costs for such Product in
that calendar quarter; provided that in the event any portions of
the CDS Product Costs are already included in arriving at CDS
Sublicense Revenue, such portions of the CDS Product Costs shall be
excluded from the above calculation to determine the CDS Net Income
or CDS Net Losses. To the extent Net Sales and/or CDS Sublicense
Revenue actually received by CDS exceed the CDS Product Costs for
the relevant calendar quarter, such amount of difference shall be
deemed “CDS Net Income,” and to the extent CDS Product
Costs exceed Net Sales and/or CDS Sublicense Revenue actually
received by CDS for the relevant calendar quarter, the amount of
such difference shall be deemed “CDS Net Losses.” For
clarification, with respect to calculating CDS Net Income for any
unit of Product, the Manufacturing Cost incurred to manufacture
such unit shall be deemed to be incurred in that country and
quarter in which such unit is sold.
3
1.15 “CDS Patent
Costs” shall mean fees and costs associated with filing,
prosecution and maintenance of the CDS-Prosecuted Patent Rights, as
defined in Section 7.1.2, in the countries listed on
Exhibit 1.15 .
1.16 “CDS Patent
Rights” shall mean CDS Existing Patent Rights and CDS’
interest in any Patent Rights included within Alimera Improvements
and CDS Improvements.
1.17 “CDS Product
Costs” shall mean, with respect to a Product, all costs CDS
incurred for developing and Commercializing such Product,
including, without limitation, the following costs: (a) all
Direct Development Costs incurred by CDS during the Term of this
Agreement, (b) each of the following to the extent paid by CDS
to Alimera pursuant to this Agreement: all Development Payments,
Compounded Development Payments, Determined Disputed Costs and
Compounded Disputed Payments (as all defined in the Original
Agreement), (c) each of the following, if any, owed by Alimera
to CDS to the extent not already paid by Alimera: any Compounded
Development Payments and Compounded Disputed Payments (as both
defined in the Original Agreement), plus any interest on such
unpaid amount that has accrued in accordance with the terms of this
Agreement after termination of either this entire Agreement or this
Agreement with respect to a Product, as applicable, (d) each
of the following to the extent not already included in Direct
Development Costs or reimbursed by Alimera: CDS Patent Costs, UKRF
Costs and insurance premiums paid by CDS to maintain insurance
required by Section 10.4, as compounded, if applicable,
pursuant to Section 4.4, and (e) any other costs incurred
by CDS for developing and Commercializing such Product.
1.18 “CDS Profitability
Date” shall mean, with respect to a Product, the first day of
the first calendar quarter in which the aggregate of Net Sales by
CDS, and CDS Sublicense Revenue actually received by CDS, of such
Product for all preceding calendar quarters and the current
calendar quarter exceeds the CDS Product Costs during all preceding
calendar quarters and the current calendar quarter; provided that
in the event that any portions of the CDS Product Costs are already
included in arriving at the CDS Sublicense Revenue, such portions
of the costs shall be excluded from the above calculation to
determine the CDS Profitability Date. For clarification, all
preceding calendar quarters include the Term of this Agreement and
for any applicable periods thereafter.
1.19 “CDS Sublicense
Revenue” shall mean any form of consideration (excluding any
amounts paid for equity securities of CDS other than amounts that
exceed the fair market value of such securities) in connection with
a sublicense agreement that CDS enters into with a Third Party to
sell or otherwise transfer some or all of CDS’ rights to a
Product, including, but not limited to, marketing rights and/or
distribution rights, provided that (1) the fair market value
of such securities shall be determined by mutual agreement of both
Parties, and (2) in the event that the Parties fail to reach
such mutual agreement, the matter shall be resolved by arbitration
in accordance with Section 12.7.2 herein.
1.20 “CDS
Technology” shall mean CDS Patent Rights, CDS Know-How and
CDS’ interest in Alimera Improvements and CDS
Improvements.
4
1.21 “Change of
Control” shall mean, with respect to a Party, (a) a
merger or consolidation of such Party with a Third Party which
results in the voting securities of such Party outstanding
immediately prior thereto ceasing to represent at least fifty
percent (50%) of the combined voting power of the surviving
entity immediately after such merger or consolidation, or
(b) except in the case of a bona fide equity financing in
which a Party issues new shares of its capital stock, a transaction
or series of related transactions in which a Third Party, together
with its Affiliates, becomes the beneficial owner of fifty percent
(50%) or more of the combined voting power of the outstanding
securities of such Party, or (c) the sale or other transfer to
a Third Party of all or substantially all of such Party’s
assets related to the Collaboration Field.
1.22 “Clinical
IP” shall mean (a) all preclinical and clinical
protocols, studies, data, results, study-related forms, materials
and reports (e.g., investigator brochures, informed consent forms,
data safety monitoring board related documents, patient recruitment
related materials, biocompatibility studies, animal studies, safety
studies, and chemistry, manufacturing and control data) resulting
from any preclinical or clinical study or trial of any Product in
the Collaboration Field that is conducted by or under the direction
of Alimera or CDS, or their Permitted Subcontractors or
sublicensees, pursuant to this Agreement, and any audit of any such
preclinical or clinical study or trial, and (b) all INDs,
NDAs, any unfiled applications, components or materials normally
associated with an IND or NDA, regulatory filings or applications
comparable to INDs or NDAs in any foreign jurisdictions, and other
regulatory applications and Approvals regarding any Product in the
Collaboration Field that are prepared or submitted by or under the
direction of Alimera or CDS, or their Permitted Subcontractors or
sublicensees, pursuant to this Agreement; provided, however, that
Clinical IP shall not include any Pre-Existing Clinical
IP.
1.23 “Clinical Supply
Requirements” shall mean, with respect to each Product, the
quantities of such Product that are required for the conduct of
preclinical studies and clinical trials required to procure data
necessary for the acceptance of filing of an NDA for the Product,
pursuant to the Development Activities. For the avoidance of doubt,
supplies for Non-NDA Trials are excluded from the definition of
Clinical Supply Requirements.
1.24
“CODRUG™” shall mean a compound or a
pharmaceutically acceptable salt thereof comprising one constituent
moiety covalently or ionically associated with at least one other
constituent moiety, wherein each moiety, in its separate form
(i.e., in the absence of the association), is a therapeutically or
pharmacologically active agent or a prodrug or pharmaceutically
acceptable salt of such an agent. The covalent association
between said moieties can be either direct or indirect through a
linker. Examples of covalent association include without
limitation ester, amide, carbamate, carbonate, cyclic ketal,
thioester, thioamide, thiocarbamate, thiocarbonate, xanthate, and
phosphate ester bonds. Each constituent moiety of a
CODRUG™ compound can be the same as or different from the
other constituent moiety. Upon cleavage of the covalent or
ionic association, the individual constituent moieties are
reconstituted as the therapeutically or pharmacologically active
forms of the same moieties prior to conjugation.
5
1.25 “Collaboration
Field” shall mean the treatment and prevention of eye
diseases in humans; provided, however, that the treatment and
prevention of [*] is excluded from the Collaboration
Field.
1.26 “Commercial Supply
Requirements” shall mean, with respect to each Product,
quantities of such Product that are required to fulfill
requirements for commercial sales, Product sampling, and Non-NDA
Trials, in the Collaboration Field in the Territory.
1.27
“Commercialize” or “Commercialization”
shall mean any and all activities directed to marketing, promoting,
Detailing, distributing, importing, offering for sale, having sold
and/or selling a product, including, but not limited to, sampling,
and conducting Non-NDA Trials.
1.28 “Commercialization
Budget” shall have the meaning set forth in Section 4.2
hereof.
1.29 “Commercially
Reasonable Efforts” shall mean efforts and resources that
parties in the pharmaceutical industry would consider normal to use
for a compound or product owned by a party in that industry or to
which that party has rights, which is of similar market potential
at a similar stage in its development or product life, taking into
account the competitiveness of the marketplace, the proprietary
position of the compound or product, the regulatory structure
involved, the profitability of the applicable products, and other
relevant factors. In determining Commercially Reasonable Efforts
with respect to a particular Product, a Party may not consider any
other product(s) owned or licensed by it.
1.30 Intentionally
omitted.
1.31 “Confidential
Information” shall have the meaning set forth in
Section 8.1 hereof.
1.32 “Control” or
“Controlled by” shall mean, in the context of a license
to or ownership of intellectual property, possession of the ability
on the part of a Party to grant access to or a license or
sublicense as provided for herein without violating the terms of
any agreement or other arrangement with any Third Party existing at
the time such Party would be required hereunder to grant the other
Party such access or license or sublicense.
1.33 “Detail”
shall mean a face-to-face meeting (including a live video
presentation) with one or more healthcare professionals with
prescribing authority during which scientific and/or medical
information about the Product is discussed. Detailing does not
include merely a reminder or a promotional sample drop. When used
as a verb, the term “Detailing” shall mean to engage in
the activity of a Detail.
1.33A “Development
Activities” shall mean the Alimera Development Activities and
CDS Development Activities.
[*]-INDICATES MATERIAL THAT WAS OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH
OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE
24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
6
1.34 Intentionally
omitted.
1.35 Intentionally
omitted.
1.36 “Direct
Commercialization Costs” shall mean only the following costs
incurred, on a cash basis, by Alimera for Commercializing a Product
in accordance with this Agreement and pursuant to the
Commercialization Budget:
(a) Direct Costs of marketing
activities for the Product, including pre-launch, launch,
advertising, packaging, activities necessary for seeking and
maintaining pricing and reimbursement approvals from Third Party
payors, literature, lectures, training (including wet labs for
training healthcare professionals) and sales promotion;
(b) [*]
(c) Direct Costs associated
with maintaining Approvals for the Product;
(d) Direct Costs of package
development and package maintenance for the Product;
(e) Selling Expenses for the
Product;
(f) Manufacturing Costs to
satisfy Commercial Supply Requirements for the Product;
(g) Direct Costs of
distribution of the Product other than the costs specified in
Section 1.60(d);
(h) Royalties, milestones and
other fees paid by Alimera under Third Party license(s) [*] that
are at arms’ length to the extent they relate to the Product,
to the extent such licenses are necessary for Alimera to make, have
made, use, offer to sell, sell, and import the Product without
infringing patents of such Third Parties, including without
limitation as provided for in Section 7.6.4;
(i) Direct Costs of
selection, filing, prosecution and maintenance of trademarks used
solely for the Product (or an appropriate allocation in the case of
any trademarks used for the Product and other products);
(j) Direct Costs of Medical
Advisory Services for the Product;
(k) Recall expenses that are
Direct Commercialization Costs as set forth in
Section 4.6;
[*]-INDICATES MATERIAL THAT WAS OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH
OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE
24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
7
(l) Product Liability Losses
that are Direct Commercialization Costs as set forth in
Section 10.5;
(m) Insurance premiums paid
by Alimera for the insurance required by Section 10.4 to the
extent such insurance relates to Commercialization of the Product
(i.e., if insurance covers risks other than risks related to
Commercialization of the Product, then only an appropriate portion
of such premiums shall be included); and
(n) Taxes, duties, tariffs
and other governmental charges (excluding taxes on income)
associated with manufacture and distribution of the Product, to the
extent not deducted from Net Sales pursuant to
Section 1.60(c).
Notwithstanding any other provisions in
this Agreement, Direct Commercialization Costs shall include only
the costs of labor for those individuals who spent greater than
fifty percent (50%) of their time on activities within the
Commercialization Budget during any calendar month (the
“Majority Time Individuals”), and such costs shall be
determined according to the amount of the Majority Time
Individuals’ time actually spent on such Commercialization
activities, provided that, if the Commercialization activity is
Detailing, then such costs for the Majority Time Individuals shall
be determined in accordance with Section 1.81. In the event
there is more than one Product on the market at any given time,
Direct Commercialization Costs attributable to more than one
Product shall be allocated to each Product as appropriate;
provided, however, that in no event shall any Direct
Commercialization Costs be accounted for more than once.
Notwithstanding the foregoing, in the event that a person devotes
time to both activities under the Commercialization Budget and
Development Activities, the time spent shall be aggregated in
determining whether such person meets the fifty percent
(50%) threshold set forth in this definition and in the
definition of Direct Development Costs, and the person’s time
shall be allocated accordingly between development and
Commercialization. Notwithstanding anything else herein, no Direct
Development Costs may be categorized as Direct Commercialization
Costs.
1.37 “Direct
Costs” shall mean, on a cash basis, the costs of labor
(including only salaries, wages and current period employee
benefits (but specifically excluding expenses associated with stock
options or other equity-based or deferred compensation)), raw
materials, supplies, services, fees, and other resources, directly
and exclusively consumed or used in the conduct of the applicable
activity; provided, however, that the following costs shall not be
deemed Direct Costs: (i) corporate overhead expenses,
including, but not limited to, general administration, business
development, travel, entertainment, executive management,
facilities, finance, information system and data management
services, investor relations, human resources, legal, payroll,
purchasing, and corporate supervisory services;
(ii) amortization and depreciation expenses, interest
expenses, taxes, extraordinary or nonrecurring losses customarily
deducted by a Party in calculating and reporting consolidated net
income, capital expenditures (including, but not limited to,
purchases of facilities, property or equipment), and inventory
write-offs (to the extent not attributable to a Product);
(iii) consulting (including legal) fees unless specifically
set forth in a mutually approved budget; and (iv) payments
made to any related party or Affiliates in excess of an arm’s
length charge for the relevant product or service.
8
1.38 “Direct
Development Costs” shall mean the following costs incurred,
on a cash basis, by either Party for developing a
Product:
(a) Direct Costs for
Development Activities for the Product, incurred, on a cash basis,
by a Party or paid by a Party to Permitted Subcontractors,
including, but not limited to, research, formulation development
and testing, clinical development activities, data management,
toxicology, and planning and execution of clinical trials required
to procure data necessary for the acceptance of filing of an
NDA;
(b) Manufacturing Costs to
satisfy Clinical Supply Requirements;
(c) Direct Costs for
regulatory filings pursuant to the Development Activities
(specifically excluding any filing related to Non-NDA Trials) for
the Product;
(d) Insurance premiums paid
by either Party for commercial insurance to the extent such
insurance relates to Development Activities in accordance with
Section 10.4 hereof (i.e., if insurance covers risks other
than risks related to development of the Product, then only an
appropriate portion of such premiums shall be included);
(e) CDS Patent Costs paid
from the Effective Date up to the first Product Profitability Date
that are not otherwise reimbursed by a Third Party; provided,
however, that CDS Patent Costs in excess of [*] in any calendar
year shall not be included as Direct Development Costs;
(f) Direct Costs of the
activities conducted under Section 3.11, including, but not
limited to, technology transfer assistance from CDS to Alimera to
enable Alimera to manufacture the Product for
Commercialization;
(g) Direct Costs for capital
expenditures to the extent attributable to the Product and part of
Development Activities; and
(h) Other Direct Costs as
mutually agreed upon by the Parties.
Notwithstanding any other provisions in
this Agreement, Direct Development Costs shall (1) with the
exception of (e) and (f) above, include only Direct Costs
incurred, on a cash basis, in connection with activities conducted
to procure data necessary for the acceptance of filing of an NDA
for the Product; and (2) include only the costs of labor for
those individuals who spent greater than fifty percent
(50%) of their time on Development Activities during any
calendar month, and such costs shall be determined according to the
percentage of the individuals’ time actually spent on such
development activities; and (3) not include any
Commercialization costs. Notwithstanding the foregoing, in the
event that a person devotes time to both activities under the
Commercialization Budget and Development Activities, the time spent
shall be aggregated in determining whether such person meets the
fifty percent (50%)
[*]-INDICATES MATERIAL THAT WAS OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH
OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE
24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
9
threshold set forth in this definition
and in the definition of Direct Commercialization Costs, and the
person’s time shall be allocated accordingly between
development and Commercialization.
1.39 “DME” shall
mean diabetic macular edema.
1.40 “Effective
Date” shall have the meaning set forth in the
recitals.
1.41 “Earnest Money
Loan” shall mean the aggregate of the loan under the Secured
Promissory Notes from CDS to Alimera dated October 19,
2004, November 18, 2004 and December 22,
2004.
1.42 “Excluded
Product” shall mean a [*] that generally conforms to the
drawings and specifications (and any prior iterations thereof in
whole or in part) shown in Exhibit 1.42 .
1.43 “FDA” shall
mean the United States Food and Drug Administration or any
successor agency with responsibilities comparable to those of the
United States Food and Drug Administration.
1.43A “Fifty/Fifty
Amendments” shall mean both of the following
amendments:
(1) In the first sentence of
Section 6.5.1, the words “Alimera and CDS shall be
entitled to eighty percent (80%) and twenty percent (20%),
respectively,” shall be deleted and the words “each
Party shall be entitled to fifty percent (50%)” shall be
substituted in their place.
(2) In Section 6.6, the
words “twenty percent (20%)” shall be deleted and the
words “fifty percent (50%)” shall be substituted in
their place, and the words “thirty-three percent (33%)”
shall be deleted and the words “fifty percent (50%)”
shall be substituted in their place.
1.44 “First Commercial
Sale” shall mean, with respect to each Product, the first
sale for use or consumption by the general public of such Product
in a country after required Approval has been granted by the
applicable regulatory authority of such country.
1.45 “First
Product” shall have the meaning set forth in
Section 1.77 hereof.
1.46 “GAAP” shall
mean the current United States generally accepted accounting
principles, consistently applied.
1.47 “Gross
Sales” shall mean, for any period, on a cash basis
(a) for any arm’s length transaction in which Products
are sold separately by Alimera or its Affiliates to a Third Party,
the gross invoice price for Products in such transactions, and
(b) for all other transactions (i.e., other than those
described in subsection (a)) in which Products are sold, used or
otherwise disposed of by Alimera
[*]-INDICATES MATERIAL THAT WAS OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH
OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE
24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
10
or its Affiliates (including in barter
or similar transactions, or transactions that are not at
arm’s length to a Third Party, or transactions in which
Products are not sold separately, but not including the provision
of Products intended for use solely as samples), the total imputed
sales price for Products in such transactions, using as the imputed
sales price the weighted average gross invoice price for Products
under subsection (a) during the preceding calendar quarter or,
if there have been no Gross Sales under subsection (a) in the
preceding quarter, using a reasonable imputed price to be
determined at the time by the parties. For purposes of this
Section 1.47, “sold separately” shall mean sold,
solely for monetary consideration, on a stand-alone basis (i.e.,
with a selling price independent of any other product) for not less
than arm’s length value.
1.48
“Improvements” shall mean any and all Inventions,
enhancements, derivatives, new uses, developments, techniques,
materials, compounds, products, designs, processes or other
technology or intellectual property, whether or not patentable and
all Patent Rights and other intellectual property rights in any of
the foregoing.
1.49 “IND” shall
mean the Investigational New Drug Application filed with FDA or a
similar application filed with an applicable regulatory authority
outside of the United States.
1.50 “Invention”
shall mean ideas, information, Know-How, data, research results,
writings, inventions, discoveries, modifications, improvements and
other technology (including, but not limited to, any proprietary
biological or other materials, compounds or reagents and computer
software), whether or not patentable or copyrightable.
1.51 Intentionally
omitted.
1.52 “Know-How”
shall mean unpatented information, whether or not patentable,
including, but not limited to, technical information, processes,
formulae, trade secrets, materials, designs, drawings and
data.
1.53 “Majority Time
Individuals” shall have the meaning set forth in
Section 1.36.
1.54 “
Manufacturing Costs ” shall mean:
(A) with respect to Product
manufactured by a Third Party, a Party’s cost of procuring
such Product on an arms’ length basis; or
(B) with respect to Product
manufactured by a Party or one of its Affiliates, (1) Direct
Costs incurred, on a cash basis, by such Party or one of its
Affiliates to manufacture such Product, including Direct Costs of
purchasing, inspection, quality assurance, quality control,
storage, scrap and training, and (2) a portion of
depreciation, amortization, interest expense, utilities, rent,
maintenance and repairs, insurance and other manufacturing overhead
(the “Manufacturing Overhead”) allocable to Product as
determined by the following formula: the Manufacturing Overhead
multiplied by a fraction, the numerator of which is the number of
direct labor hours of individuals who spent time on the production
of Product at a plant at which Product is manufactured, and the
denominator of which is the number of direct labor hours devoted to
the production of all products at such plant when the plant is
operating at full capacity, provided that Manufacturing Costs shall
exclude costs associated with excess capacity, selling costs
(including, without limitation,
11
marketing, advertising, salaries and
commissions), corporate overhead, costs that are otherwise
attributed as Direct Development Costs or Direct Commercialization
Costs under this Agreement, royalties (earned or paid up) and other
amounts payable to Third Parties under any license taken by a Party
in connection with the manufacture of the Product, and all amounts
spent on research and development;
provided, however, that any amount
determined pursuant to clause (B) shall not exceed the amount
that a qualified Third Party manufacturer would charge for
supplying comparable quantities of the relevant Product in a timely
manner on reasonable and customary terms and conditions.
1.55 “Medical Advisory
Services” shall mean those health care professionals employed
or engaged by a Party with sufficient medical or other pertinent
health care experience to engage in in-depth dialogues with
physicians regarding medical issues associated with a
Product.
1.55A “Medidur
FA” shall mean the product being developed as of the
Amendment Effective Date under IND #72056.
1.56 “Milestone
Payments” shall have the meaning set forth in
Section 6.2 hereof.
1.57 “NDA” shall
mean a new drug application or product license application or its
equivalent filed with and accepted by the FDA after completion of
human clinical trials to obtain marketing approval for a Product,
or any comparable application filed with and accepted by the
regulatory authorities of a country other than the United States,
including, where applicable, any applications for governmental
pricing and marketing approval.
1.58 “Net
Profits” or “Net Losses” shall mean, for a
particular calendar quarter, the Net Sales for a Product in a
country minus the Direct Commercialization Costs for such Product
in that country. For the avoidance of doubt, Net Profits shall be
calculated on a Product-by-Product and calendar quarter-by-quarter
basis. To the extent Net Sales exceed Direct Commercialization
Costs for the relevant calendar quarter, such amount of difference
shall be deemed “Net Profits,” and to the extent Direct
Commercialization Costs exceed Net Sales for the relevant calendar
quarter, such amount of difference shall be deemed “Net
Losses.” For clarification, with respect to calculating Net
Profits or Net Losses for any unit of Product, the Manufacturing
Cost incurred to manufacture such unit shall be deemed to be
incurred in the country and quarter in which such unit is
sold.
1.59 “Net Profits
Payment” shall have the meaning set forth in
Section 6.5.1(b) hereof.
1.60 “Net Sales”
shall mean, with regard to a Product, on a cash basis, for any
period, Gross Sales less the following reasonable and customary
deductions:
(a) normal and customary
trade, cash and other discounts, allowances and credits allowed and
actually taken directly with respect to sales of the
Product;
(b) credits or allowances
actually granted for damaged goods or returns or rejections of the
Product;
12
(c) taxes or other
governmental charges imposed directly on the sales of Products,
including value added taxes or other similar governmental charges,
but not including any tax levied with respect to income;
(d) freight, postage,
shipping, and insurance charges; and
(e) charge back payments and
government rebates allowed and taken.
1.61 “Non-NDA
Trial” shall mean any clinical trial, or part of a clinical
trial, of a Product that is not designed or required to procure
data necessary for the acceptance of filing of an NDA. Non-NDA
Trials may be conducted before or after the filing of an NDA,
before Approval or at any time after Approval. Non-NDA Trials shall
specifically not include (that is, costs associated with such
trials may be deemed Direct Development Costs) any
(i) clinical trials designed to obtain favorable labeling at
the time of initial Approval, (ii) post-Approval or
post-marketing trials required by the FDA or other regulatory
authority in granting a conditional Approval, or (iii) trials
required to obtain Approval for pediatric use of a Product, whether
such trials are prior or subsequent to the filing of an NDA or
Approval.
1.62 Intentionally
omitted.
1.63 “Option
Compound” shall mean a compound, other than a compound that
is a corticosteroid, that (i) Alimera has a right to use and
(ii) is selected by Alimera under an Alimera Compound Option
set forth in Section 5.8; provided, however, that Option
Compound shall not include any compound that is included in a
license or option by CDS to a Third Party, or is included in a term
sheet with a Third Party, as of the date on which Alimera notifies
CDS under Section 5.8 that Alimera wishes to exercise an
Alimera Compound Option with regard to such compound. For the
avoidance of doubt, a “compound,” as used herein, shall
be a specific compound and shall not be a category or class of
compounds.
1.64 “Option
Product” shall mean (i) a product that meets the
definition of “Product” in Section 1.77, except
that the term “Option Compound” shall be substituted in
place of “corticosteroid,” and (ii) clause (B)(2)
and the third sentence of Section 1.77 shall be
omitted.
1.65 “Option
Term” shall mean the period commencing on the Effective Date
and expiring on the earliest of (i) [*] months after the
Effective Date; (ii) the date on which [*]; and
(iii) Alimera’s exercise of all [*] Alimera Compound
Options under Section 5.8.
1.65A “Original
Agreement” shall have the meaning set forth in the
recitals.
1.66 Intentionally
omitted.
1.67 “Party”
shall mean CDS or Alimera.
[*]-INDICATES MATERIAL THAT WAS OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH
OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE
24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
13
1.68 “Patent
Rights” shall mean any United States or foreign patent or
patent applications, any patents issuing from such patent
applications, and any continuations, continuations-in-part to the
extent specifically directed to subject matter specifically
described in such patent applications, divisionals, renewals,
reexaminations, reissues, extensions or provisional applications of
any of the foregoing and any corresponding patent, patent
application, utility model, inventor certificate, registration or
the like in any country of the world with respect to the
foregoing.
1.69 “Permitted
Subcontractor” shall mean a Third Party or an Affiliate that
has been awarded a subcontract with one Party in accordance with
Section 3.7 hereof.
1.70 “Phase I Clinical
Trial” shall mean a clinical trial as defined in 21 C.F.R.
312.21(a), as may be amended from time to time, or any foreign
equivalent thereto.
1.71 Intentionally
omitted.
1.72 “Phase II Clinical
Trial” shall mean a clinical trial as defined in 21 C.F.R.
312.21(b), as may be amended from time to time, or any foreign
equivalent thereto.
1.73 “Phase III
Clinical Trial” shall mean a clinical trial as defined in 21
C.F.R. 312.21(c), as may be amended from time to time, or any
foreign equivalent thereto.
1.74 “Pre-Existing
Clinical IP” shall mean [*].
1.75 “Primary Contact
Person” shall have the meaning set forth in
Section 3.4.
1.76 “Prime”
shall have the meaning set forth in
Section 6.5.1(b).
1.77 “Product”
shall mean a drug delivery device that meets all of the following
criteria: (A) it has a core within a polymer layer that
contains a drug in a form other than a CODRUG™ and no other
active ingredient, where the core does not include a CODRUG™,
(B) it is Approved or designed to be Approved (1) to
deliver a corticosteroid and no other active ingredient by
implantation, injection, or other direct delivery method to the
posterior portion of the eye, or (2) to treat DME by
delivering a compound or formulation by implantation, injection, or
other direct delivery method other than through an incision smaller
than that required for a 25 gauge needle, (C) it does not fall
under the definition of Excluded Product, and (D) it is
Approved or designed to be Approved for a particular indication in
a particular country. For clarification, eye drops or other topical
administration and tablets or other oral administration shall not
be deemed to be direct delivery to the posterior portion of the
eye. For example, “Product” shall specifically include
a drug delivery device that meets all of the following criteria
(such product sometimes referred to as the “First
Product”): (1) consists of [*]; (2) is Approved or
designed to be Approved to be administered [*]; (3) is
Approved or designed to be
[*]-INDICATES MATERIAL THAT WAS OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH
OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE
24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
14
Approved [*]; and (4) is Approved
or designed to be Approved for a particular indication in a
particular country. For clarification, with regard to the same drug
delivery device described above, each indication in each country
shall be a separate Product. By way of non-limiting examples, with
regard to a particular drug delivery device X, (i) X for DME
and X for age-related macular degeneration shall be two different
Products, and (ii) X for DME in the United States and X for
DME in Japan shall be two different Products. The Parties
acknowledge that Medidur FA is a First Product.
1.78 “Profitability
Date” shall mean, with respect to each Product, the first day
of the first calendar quarter in which Net Profits are realized for
such Product.
1.79 “Recall”
shall mean any recall of a product or any related actions (e.g.,
market withdrawal and stock recovery). For avoidance of doubt,
Recall includes recall of product packaging.
1.80 “Right of Access
to Clinical IP” shall mean the right to reference,
cross-reference, review, have access to, incorporate and use
Clinical IP in any regulatory applications or filings, any patent
filings, or for any research or development purpose.
1.81 “Selling
Expenses” shall mean Direct Costs incurred, on a cash basis,
by Alimera for the sales force who are employees of Alimera or its
Affiliates, all only pursuant to the Commercialization Budget;
provided, however, that if a portion of time of Alimera Majority
Time Individuals involved in Detailing Products is devoted to
Detailing products other than Products, then only the following
percentages of the Alimera Majority Time Individuals’ time
spent in Detailing shall be Direct Commercialization
Costs:
(a) [*] if the Product is
carried in the sole Detail position, in which the Product is the
only product presented during a Detail and the key Product
attributes are verbally presented in a presentation delivered
during the Detail by Alimera’s or its Affiliates’ sales
representative;
(b) [*] if the Product is
carried in the primary Detail position, in which key Product
attributes are verbally presented in the first position during a
Detail, where the Product is given primary emphasis (i.e., an
emphasis that is more important than the emphasis given to any
other product presented), and where no more than three products are
presented during such Detail;
(c) [*] if the Product is
carried in the secondary Detail position, in which key Product
attributes are presented in the second position during a Detail,
where the Product is given significant but not primary emphasis,
and where no more than three products are presented during such
Detail;
[*]-INDICATES MATERIAL THAT WAS OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH
OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE
24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
15
(d) [*] if the Product is
carried in the tertiary Detail position, in which key Product
attributes are presented in the third position during a Detail,
where the Product is given some emphasis, and where three products
are presented during such Detail;
provided that (1) if
more than one Product is the subject of a Detail, the foregoing
percentages shall be cumulative, not to exceed 100% (e.g., if one
Product is carried in the primary Detail position and another
Product is carried in the secondary Detail position, then [*] of
the sales force time shall be a Direct Commercialization Cost with
respect to the first Product and [*] shall be a Direct
Commercialization Cost with respect to the second Product), and
(2) if there are more than three products presented in a
Detail, the percentages specified in (b)-(d) above shall be
multiplied by a fraction, the numerator of which is three and the
denominator of which is the number of products presented in that
Detail (e.g., if a Product is carried in the secondary Detail
position and there are four products presented during such Detail,
then [*] is multiplied by 3
/ 4 and [*] of the sales force time shall be
a Direct Commercialization Cost with respect to that Product). For
clarification, the costs of Majority Time Individuals shall be
determined according to the amount of Majority Time
Individuals’ time actually spent on Detailing multiplied by
the applicable percentage as specified in this Section 1.81
above. For example, if a Majority Time Individual spends
twenty-five (25) hours on Detailing, in which Products are
carried in the primary Detail positions, then Direct
Commercialization Costs attributable to such Detailing shall be the
Direct Costs of 25 hours multiplied by [*] (as may be further
adjusted as specified above). For further clarification, Selling
Expenses relating to a Product may be incurred prior to First
Commercial Sale of such Product (e.g., for sales force training);
in such event, the percentages referred to in this
Section 1.81 initially shall be based on the Detail position
for the relevant Product contemplated in the Commercialization
Budget. For example, if the Product is projected in the
Commercialization Budget to be the sole product Detailed by the
sales force, then initially [*] of the Direct Costs associated with
the sales force shall be allocated as Selling Expenses. In the
event that the actual Detail position for a Product differs from
that projected in the Commercialization Budget, then the amount of
the Direct Costs that are included as Direct Commercialization
Costs shall be adjusted subsequently to reflect the actual Detail
position.
1.82 “Term” shall
have the meaning set forth in Section 11.1.
1.83 “Territory”
shall mean all countries and territories worldwide.
1.84 “Third
Party” shall mean any person or entity other than CDS,
Alimera or their respective Affiliates.
1.85 “UKRF” shall
mean the University of Kentucky Research Foundation.
1.86 “UKRF Costs”
shall mean all royalties, milestones and other fees due to UKRF
related to a Product pursuant to the UKRF Licenses.
[*]-INDICATES MATERIAL THAT WAS OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH
OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE
24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
16
1.87 “UKRF
Licenses” shall mean the licenses set forth in Exhibit
1.87 , as may be amended from time to time consistent with
Section 7.9, full and complete copies of which agreements in
effect as of the Effective Date have been provided to
Alimera.
1.88 “Valid
Claim” shall mean a claim of an issued and unexpired patent,
or a claim of a pending patent application, which has not been
withdrawn, cancelled, abandoned, disclaimed, or held permanently
revoked, unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal.
ARTICLE 2 Intentionally
omitted
ARTICLE 3 DEVELOPMENT
ACTIVITIES
3.1 General . Subject
to Sections 3.1.1 and 3.1.2 below, (a) CDS and Alimera shall
undertake development activities for the Products in the
Collaboration Field in accordance with this Agreement and
(b) during the course of performing such activities, CDS and
Alimera shall communicate regularly and shall assume certain rights
and responsibilities for the development of the Products in the
Collaboration Field in accordance with this Agreement.
3.1.1. Limitation on CDS
Development . Notwithstanding any other provision in this
Agreement to the contrary (including any provision of Article 2 or
3) and except as the Parties mutually agree in writing, CDS will
have no obligation relating to the development of (a) Medidur
FA after December 31, 2009 or (b) any Product other than
Medidur FA at any time on or after the Amendment Effective
Date.
3.1.2. CDS Development
Responsibilities and Development Payments . Subject to
Section 3.1.1 and this Section 3.1.2, CDS shall be
responsible for the performance of only the following development
activities: (a) providing clinical supply of Medidur FA as
necessary for: (i) the FAME trial (i.e., the fluocinolone
acetonide in macular edema trial) ongoing as of the Amendment
Effective Date to the extent set forth in protocol C-01-05-001
under IND # 72056, (ii) the PK trial ongoing as of the
Amendment Effective Date to the extent set forth in protocol
C-01-06-002 under IND # 72056, (iii) an upcoming wet AMD trial
for up to thirty (30) patients, (iv) an upcoming vein
occlusion trial for up to thirty (30) patients, and
(v) one additional marketing support trial, similar to the wet
AMD and vein occlusion trials, for up to thirty (30) patients;
(b) with respect to Medidur FA, performing the support
expressly set forth on Exhibit 3.1.2A hereto for:
(i) stability studies for clinical supply of Medidur FA, and
(ii) ongoing preclinical work; and (c) performing the
technology transfer activities with respect to Medidur FA set forth
in Section 3.11. CDS will be reimbursed by Alimera for the
costs associated with CDS Development Activities pursuant to this
Section 3.1.2, and such payments shall be deemed Direct
Development Costs, provided that all such reimbursed costs
associated with the wet AMD trial, the vein occlusion trial and the
additional marketing support trial shall be deemed Direct
Commercialization Costs to the extent such trials are Non-NDA
Trials.
CDS Development Budget . Attached
hereto as Exhibit 3.1.2B as of the Amendment Effective Date
is CDS’ initial budget relating to CDS Development Activities
(the “ CDS Development Budget ”). CDS shall from
time to time provide to Alimera an updated written budget relating
to CDS Development Activities promptly after CDS becomes aware of
any discrepancy between the cost of
17
performing the CDS Development
Activities and the amount included in the current CDS Development
Budget, which updated budget will become the new “CDS
Development Budget” hereunder following good faith
discussions and agreement by the Parties in writing on the content
thereof.
CDS Reporting and Reimbursement .
During the course of the CDS Development Activities as described in
this Section 3.1.2, within fifteen (15) calendar days
after the end of each calendar month, CDS shall report in writing
to Alimera a detailed itemization (including copies of any third
party invoices) of the actual costs incurred by CDS in the
preceding calendar month. Alimera shall reimburse CDS the actual
costs on a monthly basis as follows: to the extent CDS incurred
such costs in a calendar month that are within (and do not exceed)
the costs in the applicable CDS Development Budget, CDS shall issue
an invoice to Alimera for the full amount of such costs incurred
and Alimera shall pay to CDS the amount of such invoice (the
“ Development Payment ”) within thirty
(30) calendar days after delivery of the invoice.
Non-Payment by Alimera . In the
event that (i) Alimera fails to make a timely payment of all
or a portion of any of its Development Payments and
(ii) Alimera fails to pay all such payments under this
Agreement within thirty (30) days after receiving written
notice from CDS of such outstanding payments (provided that Alimera
has a one-time right to use sixty (60) days to cure
hereunder), then, automatically and without further action by CDS
or Alimera, the Fifty/Fifty Amendments shall be deemed to have been
made, which amendments shall apply to all payments due or paid
thereafter. The foregoing states the entire liability of Alimera
with respect to its failure to make a timely payment of all or a
portion of any of its Development Payments (but will not limit
Alimera’s liability for any failure to pay CDS Net Profits
payments, which is addressed in
Section 6.5.1(c)(I)).
3.1.3. Alimera Development
Responsibilities . Alimera shall use Commercially Reasonable
Efforts to develop the First Product for at least one indication in
the Collaboration Field. Before January 31 st of each calendar year, Alimera shall
provide CDS with a written status update of its Alimera Development
Activities. Alimera shall have sole decision-making authority with
respect to the development of Products, consistent with its other
obligations under this Agreement.
3.2 Regulatory
Approvals.
3.2.1. Regulatory
Filings . Unless otherwise agreed in writing by the Parties,
Alimera shall be responsible for all U.S. and non-U.S. regulatory
matters, including filing an IND and NDA for the First Product,
provided that no regulatory filings by Alimera shall include any
Pre-Existing Clinical IP. Alimera shall be responsible for
obtaining Approvals and for subsequent maintenance of Approvals.
For all regulatory filings made in the name of Alimera, Alimera
shall have the sole authority and responsibility, for submitting
supplements, communications, annual reports, adverse event reports,
manufacturing changes, supplier designations and other related
filings to, and for communicating with, the FDA and other
regulatory authorities. Alimera shall provide CDS with copies of
all substantive submissions to (which may be in draft form), and
all correspondences from, the FDA or other regulatory authorities
which relate to Products.
18
3.2.2. Manufacture-related
Activities . Alimera shall be responsible for preparing and
submitting all documentation to regulatory authorities regarding
the manufacture of the Product for commercial sale necessary to
obtain Approvals for such Product. Alimera shall be responsible for
all activities related to pre-Approval inspections of
Alimera’s (or its subcontractor’s) manufacturing
facility. Alimera shall have the right to inspect and audit
CDS’ manufacturing facility and related records and its
operations, in each case solely to the extent related to Medidur
FA, upon reasonable notice. Any information obtained by Alimera
during such visits shall be treated as Confidential Information in
accordance with Article 8 of this Agreement.
3.2.3. Documentation .
Each Party shall maintain all records, including, but not limited
to, batch records and supporting documentation required by the FDA
and other applicable regulatory authorities with respect to each
Product for the periods of time required by such authorities.
Alimera shall provide a copy of all such records to CDS within ten
(10) Business Days of reasonable request by CDS. Within ninety
(90) days after the Amendment Effective Date, CDS shall
provide a copy of all such records that relate to Medidur FA to
Alimera (to the extent such records have not previously been
provided by CDS to Alimera). In addition, within thirty
(30) days after the end of each calendar quarter following the
Amendment Effective Date, CDS shall provide to Alimera a copy of
all such records that relate to Medidur FA and were generated
during such calendar quarter. Without limiting any other provision
of this Agreement, upon at least ten (10) days prior written
notice, during regular business hours, each Party shall provide the
other Party with reasonable access to documents and other materials
Controlled by the other Party that are useful in the regulatory
filings and maintenance of Approvals for Medidur FA in the
Territory.
3.2.4. Reporting .
Each Party shall use Commercially Reasonable Efforts to immediately
provide notice to the other Party (and shall in any event provide
such notice within five (5) days) of: (a) discovery by
such Party of any event that triggers a filing requirement with FDA
or other regulatory authorities with respect to any Product; and
(b) any requirements that FDA may impose with respect to the
Approval (including, but not limited to, additional clinical
trials) and all FDA inquiries requiring a response with respect to
any Product.
3.2.5. Meetings . In
connection with Sections 3.2.1 through 3.2.4 above, Alimera shall
provide CDS with notice of all meetings, conferences, and
discussions (including, but not limited to, advisory committee
meetings and any other meeting of experts convened by FDA or other
regulatory authorities concerning any topic relevant to Medidur FA)
scheduled with FDA or such other regulatory authorities concerning
any regulatory matters relating to the Product within five
(5) days after Alimera receives notice of the scheduling of
such meetings, conferences, or discussions.
3.3 Performance
.
3.3.1. Commercially
Reasonable Efforts . Subject to Section 3.1.1 and 3.1.2,
each Party shall use Commercially Reasonable Efforts to conduct all
development activities and responsibilities assigned to it under
this Agreement.
19
3.3.2. Intentionally
omitted.
3.4 Primary Contact
Persons . As of the Amendment Effective Date, CDS has
designated [*] as CDS’ primary contact person and Alimera has
designated [*] as Alimera’s primary contact person (each, a
“ Primary Contact Person ”). The Primary Contact
Persons shall be responsible for the day-to-day interactions
between the Parties related to Development Activities and oversight
of the day-to-day operations of these activities. The Primary
Contact Persons shall attempt to resolve any disputes that arise
during the course of performing such activities. If the Primary
Contact Persons cannot resolve any such dispute within thirty
(30) days (or such longer reasonable period of time as they
may agree) after their initial discussion of such issue, the
dispute shall be resolved in accordance with Section 12.7.
Each Party may change its Primary Contact Person upon written
notice to the other Party.
3.5 Availability of
Employees . Each Party agrees to make its employees involved in
the conduct of the Development Activities related to Medidur FA
reasonably available upon reasonable advance notice and during
business hours at their respective places of employment to consult
with the other Party on issues related to Medidur FA, including,
but not limited to, regulatory, scientific, technical and clinical
testing issues, arising under Development Activities and in
connection with any request from any regulatory agency.
3.6 Visit of
Facilities . Subject to the provisions of Article 8, each Party
shall permit the other Party or the representatives of the other
Party to visit, upon reasonable notice and at reasonably acceptable
times, their respective facilities where the Development Activities
are being conducted, and to consult informally, during such visits
and by telephone, facsimile and email, with their respective
personnel performing work on the Development Activities in
connection with Medidur FA. Any information obtained by a Party
during such visits shall be treated as Confidential Information in
accordance with Article 8 of this Agreement. Each Party shall use
Commercially Reasonable Efforts to obtain comparable inspection
rights with respect to subcontractors.
3.7 Subcontracts .
Subject to the provisions of Article 8 and Section 7.3 hereof,
each Party may subcontract portions of the development activities
to be performed by it to subcontractors, provided that CDS shall
obtain the prior written consent of Alimera to subcontract its
development activities, which consent shall not be unreasonably
withheld or delayed (each such subcontractor, a “
Permitted Subcontractor ”). Any subcontract entered
into pursuant to this Section 3.7 shall be consistent with the
terms of this Agreement, including providing for intellectual
property ownership as set forth herein and all confidentiality
obligations of the Parties.
3.8 Information
Sharing . Each Party shall provide the other Party with such
information related to the providing Party’s Development
Activities as the other Party may reasonably request.
[*]-INDICATES MATERIAL THAT WAS OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH
OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE
24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
20
3.9 Records . The
Parties will make available to one another all results of the work
conducted pursuant to the Development Activities, will promptly
disclose to one another such results to the extent they are
material, and shall keep such records as described in this
Section 3.9 or elsewhere in this Agreement; provided, however,
that each Party shall maintain in confidence, and shall limit its
use of, such results and records in confidence in accordance with
Article 8 hereof and shall not use such results or records without
written consent of the other Party except to the extent provided in
Section 5.9 or other provisions of this Agreement. The Parties
shall maintain records of the results in sufficient detail and in
good scientific manner appropriate for patent purposes and FDA
filings and as will properly reflect all work done and results
achieved in the performance of the Development Activities
(including, but not limited to, all data in the form required to be
maintained under any applicable governmental regulations). Such
records shall include books, records, reports, research notes,
charts, graphs, comments, computations, analyses, recordings,
photographs, computer programs and documentation thereof, computer
information storage means, samples of materials and other graphic
or written data generated in connection with the Development
Activities. Each Party hereby grants the other Party the right to
inspect and copy such records upon reasonable advance notice by the
other Party for purposes of this Agreement.
3.10 Manufacturing for
Clinical Supply Requirements . CDS and/or its Permitted
Subcontractors shall use Commercially Reasonable Efforts to provide
an adequate and timely clinical supply, but limited to such
quantities and such type and specification as set forth in
Section 3.1.2 and all in accordance with GMP and/or ISO
standards, to the extent applicable for clinical trials in the
relevant country, and other applicable laws and regulations. The
Manufacturing Costs for such supply shall be reimbursed by Alimera
in accordance with Section 3.1.2 and shall be Direct
Development Costs (except that the Manufacturing Costs associated
with the wet AMD trial, the vein occlusion trial and the additional
marketing support trial shall be deemed Direct Commercialization
Costs to the extent such trials are Non-NDA Trials). All Clinical
Supply Requirements (beyond those listed in Section 3.1.2)
will be Alimera’s sole responsibility.
3.11 Technology Transfer
by CDS . Upon the earlier of: (i) written request by
Alimera to CDS and (ii) [*] prior to [*], CDS and/or its
Permitted Subcontractors shall be responsible for providing to
Alimera all information, support and materials that are in each
case in CDS’ Control and reasonably necessary to enable
Alimera and/or its subcontractors to manufacture and perform
quality testing on Medidur FA to satisfy Commercial Supply
Requirements, all to the extent set forth in the CDS Development
Budget and reimbursed pursuant to Section 3.1.2. CDS and/or
its Permitted Subcontractors shall be responsible for the following
activities in association therewith (to the extent set forth in the
CDS Development Budget and any costs of which will be reimbursed by
Alimera in accordance with Section 3.1.2): (a) assist
with technology transfer to commercial manufacture site,
(b) assist with manufacturing scale-up and validation
activities, and (c) transfer analytical methods to commercial
manufacture site for stability monitoring. In addition, within
ninety (90) days after the Amendment Effective Date, CDS shall
provide to Alimera a Pharmaceutical Development
[*]-INDICATES MATERIAL THAT WAS OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH
OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE
24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
21
Report, the form and content of which
should follow the ICH Guidance documents Q8 Pharmaceutical
Development (dated May 19, 2006) and draft Q8(R1)
Pharmaceutical Development Revision 1 (dated January 10,
2008). Within thirty (30) days after receipt of such report,
Alimera shall notify CDS in writing whether such report is accepted
or rejected (provided that any rejection must be reasonable). If
Alimera notifies CDS of its acceptance or fails to notify CDS of
its reasonable rejection within the thirty (30) day time
period, then such report is deemed to be accepted. If Alimera
reasonably rejects the report, then it shall notify CDS in writing
of its reasons, with reasonable specificity, for the rejection, and
CDS shall use commercially reasonable efforts to revise the report
to address such reasons within ten (10) Business Days
following receipt of such rejection notice and reasons. CDS shall
submit the revised report to Alimera for another review in
accordance with the acceptance procedures and timeline specified
above. Alimera shall have primary responsibility, with reasonable
input and assistance from CDS, for the preparation of the
Chemistry, Manufacturing and Controls (the “ CMC
”) section of Alimera’s IND and NDA filings. Technology
transfer shall be effected in accordance with GMP and ISO
guidelines, to the extent applicable for Commercialization in the
relevant country.
ARTICLE 4
COMMERCIALIZATION
4.1 Commercialization of
Product(s) in the Collaboration Field . Alimera is granted a
license under this Agreement to market, distribute and/or sell any
Product in the Collaboration Field in the Territory, including, but
not limited to, the right to conduct marketing, reimbursement
(e.g., seeking and maintaining pricing and reimbursement approvals
from Third Party payors), sales and distribution activities.
Alimera may subcontract with any Affiliate or Third Party to
perform any of the foregoing activities in accordance with
Section 5.3. Alimera shall have sole decision-making authority
with respect to the Commercialization of Products, consistent with
its other obligations under this Agreement.
4.2 Commercialization
Budget . Alimera shall have sole responsibility for
implementing Commercialization based on Alimera’s
commercially reasonable expectations of the resources and expenses
required to Commercialize each Product in the Territory, taking
into account industry standards and the competitive environment in
effect from time to time with regard to each Product. Alimera shall
prepare a budget (“ Commercialization Budget ”)
that shall set forth, on a rolling two (2) year basis, the
projected sales and the projected Direct Commercialization Costs
broken down on a calendar quarter-by-quarter and Product-by-Product
basis. Alimera shall prepare semi-annual updates to the
Commercialization Budget prior to June 30 and December 31
of each year in which Alimera has a Commercialization Budget or
engages in Commercialization of any Products, and shall provide CDS
with copies of such semi-annual updates. Prior to finalizing the
initial Commercialization Budget and prior to finalizing each
subsequent updated Commercialization Budget due by
December 31, Alimera shall arrange for the Parties to have an
in-person meeting (or, at CDS’ option, a meeting by
telephone, videoconference or other means), during which an
executive from Alimera shall present in reasonable detail its
planned Commercialization activities and Commercialization Budget
for the time period covered in the subject Commercialization Budget
and CDS shall have opportunities to ask questions and to present
its comments on the applicable Commercialization Budget. It is
understood and agreed that Alimera shall have sole decision-making
authority with respect to the Commercialization Budget, consistent
with its other obligations under this Agreement. Alimera shall
provide an initial draft Commercialization Budget to CDS on the
Amendment Effective Date.
22
4.3 Diligence .
Alimera shall use Commercially Reasonable Efforts to Commercialize
the First Product for at least one indication in the Collaboration
Field in [*] (collectively, the “ Major Markets
”) and in all countries outside the Major Markets, except for
any country outside the Major Markets as to which Alimera has made
an election pursuant to Section 4.3.9. For purposes of this
Section 4.3 (including Subsections 4.3.1- 4.3.9), the term
“Alimera” shall include Alimera and any of its
Affiliates, sublicensees and subcontractors. Without limiting the
foregoing, Alimera agrees to the following specific
obligations:
4.3.1. Alimera shall effect a
First Commercial Sale in the United States of the first First
Product to receive Approval in the United States (the “
Alimera First Product ”) no later than [*] after
obtaining such Approval. Alimera’s nonperformance of an
obligation in this Section 4.3.1 shall be excused to the
extent directly attributable to a disruption in Commercial Supply
Requirements, but only to the extent that such disruption and the
impact thereof is outside the control of Alimera.
4.3.2. With respect to
Commercialization of the Alimera First Product, Alimera shall
expend not less than [*] in Direct Commercialization Costs
(excluding Manufacturing Costs) on or before [*], provided that if
Alimera is making Commercialization expenditures substantially in
accordance with a Commercialization Budget designed to provide for
such level of expenditures and the FDA provides Approval sooner
than reasonably contemplated by the Commercialization Budget, then
the failure to spend at least [*] in Direct Commercialization Costs
(excluding Manufacturing Costs) on or before [*] shall be
excused.
4.3.3. With respect to
Commercialization of the Alimera First Product, Alimera shall
expend not less than [*] in Direct Commercialization Costs
(excluding Manufacturing Costs, but including expenditures referred
to in Section 4.3.2) on or before [*].
4.3.4. With respect to
Commercialization of the Alimera First Product, Alimera shall
expend not less than [*] in Direct Commercialization Costs
(excluding Manufacturing Costs) between [*] and [*].
4.3.5. Alimera shall cause
Gross Sales of the Alimera First Products in the United States
during the [*] period referred to in Section 4.3.4 to be at
least [*] more than Gross Sales of the Alimera First Products in
the United States during the immediately preceding [*] period.
Alimera’s nonperformance of an obligation in this
Section 4.3.5 shall be excused to the extent directly
attributable to (1) one or more of the following events, but
only to the extent that such event is outside the control of
Alimera: a breach of this Agreement by CDS, a disruption in
Commercial Supply Requirements, or a Product Recall, or
(2) one or more of the following events, but only to the
extent that such event materially and adversely affects the market
for the First Product: FDA action
[*]-INDICATES MATERIAL THAT WAS OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH
OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE
24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
23
or regulatory guidance affecting
Product, a change in reimbursement rates or policies relating to
Product, or the introduction of one or more competitive products or
services that provide for superior dosing, safety or
efficacy.
4.3.6. If Alimera fails to
meet any spending obligation set forth in Sections 4.3.2, 4.3.3 or
4.3.4 and such nonperformance is not excused, Alimera may cure such
failure by paying to CDS an amount equal to [*]. Alimera’s
right to cure under this Section 4.3.6 shall terminate upon a
Change of Control of Alimera.
4.3.7. If Alimera fails to
achieve the Gross Sales obligation set forth in Section 4.3.5,
Alimera may cure such failure by paying to CDS an amount equal to
[*] (the “ Extrapolated Net Profits ”). For
purposes of this Section 4.3.7, the Extrapolated Net Profits
for the [*] period referred to in Section 4.3.4 shall be
determined by the following formula: [*].
4.3.8. Non-Performance
.
(a) In the event the
Fifty/Fifty Amendments have not previously been made in accordance
with Sections 3.1.2, 4.3.8(a), 4.4, 6.2B or 6.5.1(c)(II),if Alimera
fails to meet any of its obligations under subsections 4.3.1
– 4.3.5 and does not cure such failure in accordance with
this Agreement within thirty (30) days of receiving a written
notice from CDS requesting Alimera to cure such failure (provided
that Alimera has a one-time right to use sixty (60) days to
cure hereunder), then, automatically and without further action by
CDS or Alimera, the Fifty/Fifty Amendments shall be deemed to have
been made, which amendments shall apply to all payments due or paid
thereafter.
(b) In the event the
Fifty/Fifty Amendments have previously been made in accordance with
Sections 3.1.2, 4.3.8(a), 4.4, 6.2B or 6.5.1(c)(II), if Alimera
fails to meet any of its obligations under subsections 4.3.1
– 4.3.5 and does not cure such failure in accordance with
this Agreement within thirty (30) days of receiving a written
notice from CDS requesting Alimera to cure such failure (provided
that Alimera has a one-time right to use sixty (60) days to
cure hereunder), then CDS may choose one of the following two
options: (a) terminate this Agreement, or (b) terminate
this Agreement only with respect to the Alimera First Product. In
the event of termination pursuant to this Section 4.3.8,
Alimera shall not, for a period of [*] from the date of such
termination, Develop or Commercialize, or license or otherwise
assist an Affiliate or a Third Party to Develop or Commercialize,
any product that is Approved or designed to be Approved (1) to
[*] or (2) to deliver a [*]. For purposes of this
Section 4.3.8, the term “Develop” shall mean
performance of human clinical trials for a product. In the event of
termination of this Agreement with respect to the Alimera First
Product, CDS shall no longer be bound by Section 5.1.2(1),
(2), (3) or (4) with respect to such Product. After
termination pursuant to this Section 4.3.8 and in the event
that CDS (i) makes a First Commercial Sale of the Alimera
First Product in the United
[*]-INDICATES MATERIAL THAT WAS OMITTED
AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH
OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE
24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED.
24
States and (ii) reaches the CDS
Profitability Date for the Alimera First Product, CDS shall
thereafter pay Alimera [*] of CDS Net Income realized by CDS in the
United States with respect to such Product until such time as the
sum of all such payments plus the revenues otherwise realized by
Alimera with respect to such Product in the United States equal the
amount of Direct Development Costs and Direct Commercialization
Costs previously incurred, on a cash basis, or reimbursed by
Alimera with respect to such Product in the United States;
provided, however, that in the event that there are CDS Net Losses
in any calendar quarter after the CDS Profitability Date, any
payment to Alimera shall be offset by such CDS Net
Losses.
4.3.9. For clarification,
Alimera may elect not to engage in Commercialization in any country
outside the Major Markets. If Alimera determines not to engage in
Commercialization of any Product in any country outside the Major
Markets, Alimera shall so notify CDS. At any time after receipt of
such notice, CDS may by written notice to Alimera, effective upon
the giving of such notice, terminate Alimera’s license(s),
and rights to Commercialize, in such country. Thereafter CDS may,
in its sole discretion, directly or through an Affiliate or Third
Party, Commercialize the relevant Product(s) in such country. In
the event of such termination with respect to a country, CDS shall
no longer
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