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EXHIBIT
10.1
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CONFIDENTIAL
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Execution Copy |
CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE
BEEN FILED SEPARATELY WITH THE U.S. SECURITIES AND EXCHANGE
COMMISSION
AMENDED AND RESTATED
LICENSE,
COMMERCIALIZATION AND
SUPPLY AGREEMENT
by and
between
INDEVUS PHARMACEUTICALS,
INC.
and
ESPRIT PHARMA,
INC.
dated
September 18,
2007
TABLE OF
CONTENTS
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Page |
| 1. |
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D EFINITIONS |
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1 |
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| 2. |
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G RANT OF R
IGHTS |
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14 |
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2.1 |
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Grants by
Indevus |
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14 |
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2.2 |
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Sublicenses
of Third Party Rights |
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15 |
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2.3 |
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Retained
Rights; No Implied Licenses; Limitations |
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16 |
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2.4 |
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Non-Competition |
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16 |
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2.5 |
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Proposed
Sublicense by Esprit |
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16 |
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2.6 |
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Regulatory
Filings |
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17 |
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2.7 |
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Access to
Information |
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18 |
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2.8 |
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Grant by
Esprit |
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18 |
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2.9 |
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No Further
Development by Indevus |
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18 |
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| 3. |
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G OVERNANCE |
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19 |
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3.1 |
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Development
Committee |
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19 |
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3.2 |
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Marketing
Committee |
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20 |
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3.3 |
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Supply
Committee |
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22 |
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3.4 |
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Meetings |
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24 |
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3.5 |
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Minutes of
Committee Meetings |
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24 |
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3.6 |
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Disbanding
of Committees |
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24 |
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3.7 |
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Project
Coordinators |
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25 |
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| 4. |
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D EVELOPMENT AND R
EGULATORY M ATTERS |
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25 |
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4.1 |
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Development |
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25 |
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4.2 |
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Regulatory
Matters |
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25 |
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| 5. |
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P ROMOTION OF P
RODUCTS |
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29 |
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5.1 |
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General |
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29 |
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5.2 |
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Promotion
Plan |
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30 |
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5.3 |
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Target
Prescribers; Product Advisors |
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30 |
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5.4 |
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Esprit
Promotional Activities |
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31 |
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5.5 |
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Indevus
Promotional Activities |
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31 |
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5.6 |
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Promotional
Materials and Activities |
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33 |
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5.7 |
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Samples |
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35 |
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5.8 |
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Training
Program |
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35 |
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5.9 |
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Additional
Services and Assistance by Esprit |
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37 |
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5.10 |
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Additional
Personnel and Support |
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38 |
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5.11 |
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Covenants of
the Parties |
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38 |
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P AYMENTS AND S
TATEMENTS |
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39 |
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6.1 |
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Upfront and
Milestone Payments |
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39 |
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6.2 |
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Sublicensing
Royalties, Minimum Royalties and Third Party Royalties |
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40 |
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6.3 |
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Sales Force
Reimbursement |
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44 |
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6.4 |
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Reports and
Payments |
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45 |
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6.5 |
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Audits |
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47 |
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6.6 |
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License to
Dominating Patent |
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48 |
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| 7. |
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R EPRESENTATIONS AND W
ARRANTIES |
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48 |
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7.1 |
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General
Representations |
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48 |
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7.2 |
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Additional
Representations and Warranties of Indevus |
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49 |
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7.3 |
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Additional
Representations and Warranties of Esprit |
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51 |
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7.4 |
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Disclaimer
of Additional Warranties |
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51 |
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7.5 |
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Limitation
of Liability |
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51 |
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| 8. |
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P ATENT M ATTERS |
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52 |
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8.1 |
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Ownership |
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52 |
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8.2 |
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Maintenance
and Prosecution |
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52 |
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8.3 |
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Third Party
Infringement |
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53 |
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8.4 |
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Third Party
Intellectual Property |
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54 |
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8.5 |
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Patent Term
Extensions |
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54 |
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8.6 |
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Conflict
with Certain Existing Agreements |
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55 |
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| 9. |
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T RADEMARK M ATTERS |
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55 |
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9.1 |
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General |
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55 |
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9.2 |
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Maintenance |
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55 |
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9.3 |
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Use of
Trademark |
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55 |
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9.4 |
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Enforcement |
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55 |
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9.5 |
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Avoidance of
Confusion |
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56 |
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9.6 |
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Trademark
Security Interest |
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56 |
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| 10. |
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A DVERSE E XPERIENCES |
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56 |
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| 11. |
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C ONFIDENTIALITY AND P
UBLICITY |
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57 |
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11.1 |
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Non-Disclosure and Non-Use Obligations |
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57 |
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11.2 |
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Permitted
Disclosure of Proprietary Information |
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58 |
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11.3 |
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Disclosure
of Agreement to Governmental Authority |
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58 |
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11.4 |
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Publications |
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59 |
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11.5 |
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Other Public
Statements |
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59 |
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| 12. |
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T ERM AND T
ERMINATION |
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60 |
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12.1 |
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Term and
Expiration |
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60 |
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12.2 |
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Early
Termination |
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60 |
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12.3 |
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Rights Not
Affected |
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61 |
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12.4 |
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Effect of
Expiration or Termination |
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62 |
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| 13. |
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I NDEMNIFICATION AND I
NSURANCE |
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63 |
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13.1 |
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Indemnity |
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63 |
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13.2 |
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Esprit
Indemnification |
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63 |
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13.3 |
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Indevus
Indemnification |
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63 |
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13.4 |
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Indemnification Procedure |
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64 |
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13.5 |
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Defense of
Claims |
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64 |
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13.6 |
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Settlement
of Indemnified Claims |
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65 |
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13.7 |
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Product
Liability Claims |
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65 |
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13.8 |
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Insurance |
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67 |
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| 14. |
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O RDERS AND S
UPPLY |
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67 |
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14.1 |
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Orders and
Terms of Sale |
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67 |
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14.2 |
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Misdirected
Orders |
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67 |
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14.3 |
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Product
Returns |
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67 |
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14.4 |
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Supply
Obligations |
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68 |
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14.5 |
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Forecasts
for Products |
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68 |
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14.6 |
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Purchase
Orders |
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70 |
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14.7 |
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Delivery |
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70 |
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14.8 |
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Supply Price
and Payments |
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71 |
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14.9 |
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Conformity;
Specifications; Quality Control |
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72 |
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14.10 |
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Inspection;
Non-conformance |
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73 |
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14.11 |
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Inventory
Management |
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74 |
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14.12 |
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Shortages;
Failure to Supply |
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74 |
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14.13 |
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Assumption
of Processing Activities |
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75 |
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14.14 |
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Ex-US Supply
Agreement |
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77 |
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| 15. |
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M ISCELLANEOUS |
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15.1 |
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Force
Majeure |
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77 |
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15.2 |
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Assignment |
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77 |
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15.3 |
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Severability |
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78 |
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15.4 |
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Notices |
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78 |
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15.5 |
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Specific
Performance |
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79 |
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15.6 |
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Applicable
Law and Venue |
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80 |
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15.7 |
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Entire
Agreement |
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80 |
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15.8 |
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Independent
Contractors |
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80 |
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15.9 |
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Waiver |
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80 |
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15.10 |
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Headings;
References; Interpretation |
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80 |
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15.11 |
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Release |
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81 |
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15.12 |
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Counterparts |
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81 |
THIS AMENDED AND RESTATED
LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENT (the “
Agreement ”) is made as of September 18, 2007
(the “ Execution Date ”), and, except as
otherwise specified herein, is to become effective on the Effective
Date (as defined below), by and between INDEVUS PHARMACEUTICALS,
INC. , a corporation organized and existing under the laws of
the State of Delaware and having its principal office at 99 Hayden
Avenue, Suite 200, Lexington, MA 02421, United States (“
Indevus ”), and ESPRIT PHARMA, INC. , a
corporation organized and existing under the laws of the State of
Delaware and having its principal office at 2 Tower Center
Boulevard, East Brunswick, NJ 08816, United States (“
Esprit ”).
RECITALS
WHEREAS, Odyssey
Pharmaceuticals, Inc. and Indevus entered into a certain License,
Commercialization and Supply Agreement, effective as of
April 6, 2004, as amended by Amendment No. 1 thereto,
dated as of April 30, 2005, as further amended by the
Amendment and Consent Agreement, dated as of May 14, 2005 by
and among Indevus, Odyssey Pharmaceuticals, Inc. and Esprit (f/k/a
Saturn Pharmaceuticals, Inc.) (collectively, the “
Original Agreement ”);
WHEREAS , pursuant to
a certain Asset Purchase Agreement, effective as of May 14,
2005, Odyssey Pharmaceuticals, Inc. assigned to Esprit (formerly
known as “Esprit Pharma Holding Company, Inc.” and
prior to that “Saturn Pharmaceuticals, Inc.”) the
rights of Odyssey Pharmaceuticals, Inc., and Esprit assumed the
obligations of Odyssey Pharmaceuticals, Inc., in and under the
Original Agreement;
WHEREAS ,
simultaneously with the execution of this Agreement, Esprit Pharma
Holding Company, Inc. (“ Esprit Holding ”), the
current parent company of Esprit is entering into an Agreement and
Plan of Merger by and among Allergan, Inc., a Delaware corporation
(“ Allergan ”), Andrew Einhorn, solely in his
capacity as the Escrow Participants’ Representative,
Esmerelde Acquisition, Inc., a Delaware corporation and
wholly-owned subsidiary of Allergan, and Esprit Holding (the
“ Merger Agreement ”);
WHEREAS , pursuant to
the Merger Agreement, Esmerelde Acquisition, Inc. will merge with
and into Esprit Holding, and Esprit Holding will survive the merger
as a wholly-owned subsidiary of Allergan; and
WHEREAS , Indevus and
Esprit desire to amend and restate the Original Agreement to
reflect the agreements of the Parties to be effective as of the
Effective Date or, as specifically set forth in Article 14, on the
Execution Date, all on the terms and conditions set forth
below.
NOW, THEREFORE , in
consideration of the foregoing statements and the mutual agreements
and covenants herein contained, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, Indevus and Esprit hereby agree as
follows:
Unless specifically set forth
to the contrary herein, the following terms, where used in the
singular or plural, shall have the respective meanings set forth
below:
1.1 “ Act
” means the United States Food, Drug, and Cosmetic Act of
1938, as amended, and the rules and regulations promulgated
thereunder, or any successor act, as the same shall be in effect
from time to time.
1.2 “ Adverse
Experience ” or “AE(s)” means adverse drug
experiences, as defined by 21 CFR Section 314.80.
1.3 “
Affiliate ” of a Party means (i) any corporation
or business entity of which at least fifty percent (50%) of
the securities or other ownership interests representing the
equity, the voting stock or general partnership interest are owned,
controlled or held, directly or indirectly, by a Party;
(ii) any corporation or business entity which, directly or
indirectly, owns, controls or holds at least fifty percent
(50%) (or the maximum ownership interest permitted by law) of
the securities or other ownership interests representing the
equity, voting stock or general partnership interest of a Party;
(iii) any corporation or business entity of which, directly or
indirectly, an entity described in the immediately preceding
subsection (ii) controls or holds at least fifty percent
(50%) (or the maximum ownership interest permitted by law) of
the securities or other ownership interests representing the
equity, voting stock or general partnership interest of such
corporation or entity; or (iv) any corporation or business
entity of which a Party has the right to acquire, directly or
indirectly, at least fifty percent (50%) of the securities or
other ownership interests representing the equity, voting stock or
general partnership interest thereof.
1.4 “
Agreement Term ” has the meaning set forth in
Section 12.1.
1.5 “
Allergan ” has the meaning set forth in the
Recitals.
1.6 “ Annual
Purchased Amount ” means, with respect to Finished
Product and/or Samples of Trospium Twice-Daily the sum of
(a) the amount of such Finished Product and/or Samples that is
delivered to Esprit during any one (1) year period commencing
on September 1, 2007 or an anniversary thereof plus
(b) the amount of such Finished Product and/or Samples subject
to accepted and open (non-cancelled) firm Purchase Orders submitted
by Esprit and requesting delivery during the applicable annual
period, in accordance with the terms and conditions of Article 14,
if such Finished Product and/or Samples have not been delivered on
a timely basis through no fault of Esprit.
1.7 “
Batch ” means a specific quantity of Product or
Compound that is produced in a process or series of processes
according to a single manufacturing order during the same cycle of
manufacture so that it is homogeneous within specified
limits. The batch quantities are approximately *
tablets for Trospium Twice-Daily and are estimated to be
approximately * capsules for Trospium Once-Daily.
1.8 “
Business Day ” means any day that is not a Saturday or
a Sunday or a day on which the New York Stock Exchange is
closed.
1.9 “
Calendar Quarter ” means for each Calendar Year, each
of the three (3) month periods ending
March 31, June 30, September 30 and
December 31; provided , however , that
(a) the first Calendar Quarter of any particular period shall
extend from the commencement of such period to the end of the first
complete Calendar Quarter thereafter; and (b) the last
Calendar Quarter shall end upon the expiration or termination of
this Agreement.
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CONFIDENTIAL TREATMENT REQUESTED |
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1.10 “
Calendar Year ” means (a) for the first Calendar
Year of the Agreement Term, the period beginning on the Effective
Date and ending on (i) December 31, 2007 if the Effective
Date occurs prior to December 31, 2007 or
(ii) December 31, 2008 if the Effective Date occurs after
December 31, 2007 and prior to December 31, 2008,
(b) for each Calendar Year of the Agreement Term thereafter,
each successive period beginning on January 1 and ending
twelve (12) consecutive calendar months later on
December 31, and (c) for the last Calendar Year of the
Agreement Term, the period beginning on January 1 of the
Calendar Year in which the Agreement terminates or expires and
ending on the effective date of expiration or termination of this
Agreement.
1.11 “
Catalent Agreements ” means the (a) Manufacturing
and Supply Agreement by and between Catalent Pharma Solutions LLC
(“ Catalent ”) and Indevus, entered into as of
September 17, 2007 and (b) Quality Agreement by and
between Catalent and Indevus, entered into as of September 13,
2007; in each case, as in effect as of the Execution
Date.
1.12 “
CFR ” means the United States Code of Federal
Regulations.
1.13 “
cGMP ” means current Good Manufacturing Practice as
defined in Parts 210 and 211 of Title 21 of the CFR, as may be
amended from time to time, or any successor thereto.
1.14 “
Claims ” has the meaning set forth in
Section 13.2.
1.15 “
Collateral ” has the meaning set forth in
Section 2.6(b)(i).
1.16 “
Commercially Reasonable Efforts ” means that degree of
skill, effort, expertise, and resources normally used (including
the promptness in which such efforts and resources would be
applied) consistent with standards generally accepted in the
pharmaceutical industry, with respect to the diligent development,
manufacture and commercialization of pharmaceutical products of
similar market and profit potential at a similar stage in
development or product life as a Product in the Field.
1.17 “
Competing Product ” means any product in the Field
that contains Compound as one of its active ingredients
*
1.18 “
Compound ” means the chemical compound known as
Trospium Chloride whose specific chemical name is
3-alpha-benziloyloxynortropane-8-spiro-1’-pyrrolidinium
chloride, also known as
spiro[8-azoniabicyclo[3,2,1]octane-8,1’-pyrrolidinium]-3-[(hydroxydiphenyl-acetyl)-oxy]chloride((1
µ
, 3ß, 5
µ
))-(9Cl) and any related
analogues, homologues, derivative and other pharmaceutically active
salts.
1.19 “
Control ” means possession of the ability to grant a
license or sublicense as provided for herein without violating the
terms of any agreement with any Third Party.
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CONFIDENTIAL TREATMENT REQUESTED |
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1.20 “
Copromotion Period ” means the period commencing on
the Effective Date and expiring on (a) September 30,
2008, or (b) if extended by Indevus in accordance with
Section 5.5(b)(ii), on December 31, 2008 or
March 31, 2009, as applicable, or (c) the last day of any
applicable Cure Period in which Indevus completes its Detail
Obligations in accordance with Section 5.5(b)(ii) after the
dates set forth in subsections (a) and
(b) above.
1.21 “ Cure
Period ” means any two (2) consecutive Calendar
Quarters immediately following a Deficient Quarter.
1.22 “
Data ” means any and all research data, pharmacology
data, preclinical data, clinical data and/or all other
documentation submitted, or required to be submitted, to the FDA in
association with an IND or NDA for a Product (excluding any Drug
Master Files (DMFs), Chemistry, Manufacturing and Control (CMC)
data, or similar documentation).
1.23 “
Deficient Quarter ” means any Calendar Quarter in
which the Indevus Sales Force fails to deliver * of the Quarterly
Indevus Details applicable to such Calendar Quarter.
1.24 “
Deploy ” means the act of designating a particular
employee of Esprit or Indevus as a member of the Esprit Sales Force
or Indevus Sales Force, as applicable, and the inception by such
member of services to Detail the Products; provided ,
however , that no such member shall be Deployed without
first satisfying the requirements set forth in
Section 5.8.
1.25 “
Detail ” means a face-to-face contact by a
Representative with a Target Prescriber in an individual or group
practice setting (not including dinner meetings, medical
conventions, medical education meetings, Sample drops or incidental
contacts that do not otherwise constitute a Detail as defined
herein), and during which the FDA-approved indicated uses, safety,
effectiveness, contraindications, side effects, warnings, and other
relevant characteristics of a Product are described by the
Representative in a fair and balanced manner consistent with the
requirements of the Act and with FDA-approved Product information
sheets, and using, as necessary or desirable, the Product Labeling
and/or the Promotional Materials. When used as a verb, “
Detail ” shall mean to engage in a Detail.
1.26 “
Development Committee ” has the meaning set forth in
Section 3.1(a).
1.27 “
Effective Date ” means the Effective Time (as such
term is defined in the Merger Agreement).
1.28 “ Esprit
Sales Force ” has the meaning set forth in
Section 5.4(a).
1.29 “ Ex-US
Supply Agreement ” means, if Indevus exercises the Ex-US
Supply Option, the agreement to be effective as of the Processing
Assumption Date between Indevus and Esprit pursuant to which Esprit
shall supply Indevus or its designees with bulk capsules of
Trospium Once-Daily prior to being in their finished, labeled and
packaged form solely for use outside the Territory.
1.30 “ Ex-US
Supply Option ” has the meaning set forth in
Section 14.14.
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CONFIDENTIAL TREATMENT REQUESTED |
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1.31 “
FDA ” means the United States Food and Drug
Administration and any successor agency having substantially the
same functions.
1.32 “ FDA
Approval ” means with respect to a Product in the Field,
all authorizations by the FDA that are required for the marketing
of such Product in the United States.
1.33 “
Field ” means *
1.34 “
Finished Product ” means Trospium Twice-Daily or
Trospium Once-Daily, as applicable, in its finished, labeled and
packaged form, ready for distribution in the Field in the
Territory.
1.35 “ Firm
Commitment ” has the meaning set forth in
Section 14.5(b)(ii).
1.36 “ Force
Majeure ” means, with respect to a Party, any fire,
flood, earthquake, explosion, storm, blockage, embargo, war, acts
of war (whether war be declared or not), terrorism, insurrection,
riot, civil commotion, strike, lockout or other labor disturbance,
failure of public utilities or common carriers, act of God or act,
omission or delay in acting by any governmental authority or the
other Party.
1.37 “
Forecasted Supply Price ” has the meaning set forth in
Section 14.8(b)(ii).
1.38 “
GAAP ” means generally accepted accounting principles
in the United States, consistently applied.
1.39 “
Generic Competition ” shall be deemed to exist as of
any date if Generic Products have a market share in the United
States of * or greater of the total unit volume of Trospium
Once-Daily in the United States (as so shown by the average of the
monthly IMS (or IMS-equivalent) data) for the most recent Calendar
Quarter ended prior to such date.
1.40 “
Generic Product ” means any product containing
Compound that is an AB rated equivalent to Trospium Once-Daily as
defined in the 23rd edition of Approved Drug Products with
Therapeutic Equivalence Evaluations issued by the United States
Department of Health and Human Services, for which FDA Approval in
the United States has been obtained *
1.41 “
Helsinn Agreements ” means the (a) API Supply
Agreement dated as of November 22, 2006 by and between Indevus
and Helsinn Chemicals SA and Helsinn Advanced Synthesis SA
(collectively, “ Helsinn ”) and (b) Quality
Technical Agreement dated as of August 21, 2007 by and between
Helsinn and Indevus; in case, as in effect as of the Execution Date
and as amended from time to time during the Agreement
Term.
1.42 “
Improvements ” means all inventions and know-how,
patentable or otherwise, made, created, developed, conceived or
reduced to practice by or on behalf of a Party and/or any of its
Affiliates during the Agreement Term, that have application or
relate to Compound or Products for use in the Field, including
developments in the manufacture, formulation, ingredients,
preparation, presentation, means of delivery or administration,
dosage,
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CONFIDENTIAL TREATMENT REQUESTED |
5
indication, methods of use or
packaging and/or sale of Products in the Field, including a process
for manufacturing a Product, an intermediate used in such process,
a formulation of a Product in the Field, or a use or indication of
a Product in the Field.
1.43 “
IND ” means an Investigational New Drug application,
as described in 21 CFR Section 312.23, obtained for purposes
of conducting clinical trials in accordance with the requirements
of the Act and the regulations promulgated thereunder, including
all supplements and amendments thereto, relating to the use of
Compound or a Product in the Field.
1.44 “
Indevus Intellectual Property ” means Indevus Patent
Rights and Indevus Know-How.
1.45 “
Indevus Invention ” has the meaning set forth in
Section 8.1.
1.46 “
Indevus Know-How ” means all unpatented information
and Data that are as of the Effective Date or become during the
Agreement Term owned or otherwise Controlled by Indevus, including
discoveries, Improvements, processes, formulas, inventions,
know-how and trade secrets, to the extent necessary or useful for
the development, manufacture, and/or commercialization of a
Compound or Product in the Field. Indevus Know-How does not include
any Patent Rights. Indevus Know-How also includes, other than
marketing rights and marketing approvals transferred to Esprit on
the NDA Transfer Date, all marketing authorizations and marketing
approvals granted by the FDA (e.g., approved NDAs, INDs, and
related applications and other forms of marketing authorization) to
Indevus for the marketing of Products in the Field in the
Territory. Such marketing authorizations and marketing approvals
shall be deemed embodiments of Data and Indevus
Know-How.
1.47 “
Indevus Logo ” has the meaning set forth on Schedule
1.47.
1.48 “
Indevus Patent Rights ” means all Patent Rights in the
Territory that are as of the Effective Date or become during the
Agreement Term owned or otherwise Controlled by Indevus and that
generically or specifically claim, or are otherwise related to, the
making, having made, use, offer for sale, sale or importation of
Products in the Field or claim any Improvements in the Field made
by Indevus, including Indevus’ interest in any Patent Rights
in Joint Inventions.
1.49 “
Indevus Sales Force ” means those Representatives
Deployed by Indevus on a full-time basis and the field sales
management supervising such Representatives.
1.50 “
Indevus Target Prescribers ” means those Target
Prescribers with whom, pursuant to the terms of this Agreement, the
Indevus Sales Force conducts Primary Position Details and/or
Secondary Position Details; provided that such Target
Prescribers shall be determined from a list of Target Prescribers
agreed to in writing between the Parties prior to the Effective
Date, as such list may be amended from time to time with the prior
written approval of both Parties.
1.51 “
Initial Indication ” means the use of a Product in the
treatment of overactive bladder and/or urinary
incontinence.
6
1.52 “
Initial Purchase Order ” has the meaning set forth in
Section 14.6.
1.53 “ Joint
Invention ” has the meaning set forth in
Section 8.1.
1.54 “ Launch
Period ” means the period commencing on the date of
launch of Trospium Once-Daily in the United States and expiring on
the last day of the (a) fourth (4th) complete Calendar
Quarter commencing after such launch date if such launch date is on
or after the forty-fifth (45th) day of a Calendar Quarter or
(b) third (3rd) complete Calendar Quarter commencing
after such launch date if such launch date is prior to the
forty-fifth (45th) day of a Calendar Quarter.
1.55 “
Law(s) ” means all laws, statutes, rules, regulations,
ordinances and other pronouncements having the binding effect of
law of any governmental authority.
1.56 “
Losses ” means any and all damages (including all
incidental, consequential, statutory and treble damages), awards,
deficiencies, settlement amounts, defaults, assessments, fines,
dues, penalties (including penalties imposed by any governmental
authority), costs, fees, liabilities, obligations, taxes, liens,
losses, lost profits and expenses (including court costs, interest
and reasonable fees of attorneys, accountants and other experts)
awarded or otherwise paid or payable to Third Parties.
1.57 “
Madaus ” means Madaus GmbH, a successor to Madaus AG,
a company with limited liability organized under the laws of
Germany and having its principal office at Colonia-Allee 15, 51067
Cologne, Germany, and any successor thereto.
1.58 “ Madaus
Agreements ” means the Madaus Amendment, Madaus Compound
Supply Agreement, Madaus License, Madaus License and Supply
Agreement, and the Madaus Supply Agreement, as any of such
agreements may be amended from time to time during the Agreement
Term.
1.59 “ Madaus
Amendment ” means the Amendment and Agreement by and
between Indevus and Madaus, made as of November 3, 2006, as in
effect as of the Execution Date.
1.60 “ Madaus
Compound Supply Agreement ” means the Compound Supply
Agreement by and between Indevus and Madaus, made as of
November 3, 2006, as in effect as of the Execution
Date.
1.61 “ Madaus
License ” means the License Agreement by and between
Madaus and Indevus effective as of November 26, 1999, as in
effect as of the Execution Date and as amended by the Madaus
Amendment.
1.62 “ Madaus
License and Supply Agreement ” means the License and
Supply Agreement by and between Indevus and Madaus, made as of
November 3, 2006, as in effect as of the Execution
Date.
7
1.63 “ Madaus
Supply Agreement ” means the Supply Agreement by and
between Indevus and Madaus, made as of December 16, 2002, as
in effect as of the Execution Date.
1.64 “
Marketing Committee ” has the meaning set forth in
Section 3.2(a).
1.65 “ Merger
Agreement ” has the meaning set forth in the
Recitals.
1.66 “
Minimum Requirement ” has the meaning set forth in
Section 14.5(b)(iii).
1.67 “
Minimum Royalties ” means the minimum royalties
payable to Indevus by Esprit in the applicable Calendar Year
determined in accordance with the table set forth in
Section 6.2(b)(i).
1.68 “
Minimum Royalty Shortfall ” has the meaning set forth
in Section 6.2(b)(i).
1.69 “
NDA ” means a New Drug Application as defined in the
Act that is submitted under Section 505 (b) of the Act to
apply for FDA Approval.
1.70 “ NDA
Transfer Date ” means the earlier of
(a) September 30, 2012 and (b) at Esprit’s
sole election, the date, if any, that Indevus assigns its rights or
obligations under this Agreement to another person or entity in
connection with the transfer or sale of Indevus’ business or
all or substantially all of its assets or in the event of a merger,
consolidation, change in control or similar corporate
transaction.
1.71 “ Net
Sales ” means the gross amount invoiced for all
commercial sales of Finished Products to Third Parties in the Field
in the Territory by Esprit and its Affiliates, less the following
deductions actually allowed or taken in accordance with
GAAP:
(a) credits or
allowances actually granted for damaged or spoiled Finished
Product, returns, recalls or rejections of such Finished Product,
and retroactive price adjustments;
(b) normal and
customary trade, cash and quantity discounts, allowances and
credits actually allowed for such Finished Product;
(c) sales, value
added, excise or similar taxes paid or allowed, or other
governmental charges imposed upon the importation, use or sale of
such Finished Product in the Territory;
(d) fees paid to Third
Party distributors and legally allowed chargebacks, rebates or
similar payments actually granted to customers with respect to such
Finished Product, including managed health care organizations,
wholesalers, distributors, buying groups, retailers, health care
insurance carriers, pharmacy benefit management companies, health
maintenance organizations or other institutions or health care
organizations or to federal, state/provincial, local and other
governments, their agencies and purchasers and
reimbursers;
8
(e) freight, postage,
shipping and insurance charges related to delivery of such Finished
Product; and
(f) any other items
that reduce gross sales amounts as required by GAAP.
Sales or other transfers between Esprit
and its Affiliates shall be excluded from the computation of Net
Sales and no payments will be payable on such sales or transfers
except where such Affiliates are end users, but Net Sales shall
include the subsequent sales to Third Parties by such
Affiliates.
1.72 “
Original Agreement ” has the meaning set forth in the
Recitals.
1.73 “
Party ” means Indevus or Esprit.
1.74 “ Patent
Rights ” means any patents, patent applications,
certificates of invention, or applications for certificates of
invention and any supplemental protection certificates, together
with any extensions, registrations, confirmations, reissues,
substitutions, divisions, continuations or continuations-in-part,
reexaminations or renewals thereof.
1.75 “
PDMA ” means the United States Prescription Drug
Marketing Act of 1987, as amended, or any successor act thereto,
and the regulations promulgated thereunder from time to
time.
1.76 “ Phase
IV Clinical Trials ” means a human clinical trial for a
Product in the Field commenced after receipt of FDA Approval in the
United States and that is conducted within the parameters of the
FDA Approval for such Product. Phase IV Clinical Trials may include
epidemiological studies, modeling and pharmacoeconomic studies,
investigator sponsored clinical trials of such Product and
post-marketing surveillance studies.
1.77 “
Primary Position Detail ” means a Detail of a Product
in the Field in which (a) such Product is the first product
Detailed during a Detail to a Target Prescriber, (b) at least
* of the total time of the Detail is spent on the presentation of
such Product, and (c) the Representative delivers a message to
the Target Prescriber in which key attributes of such Product are
verbally promoted.
1.78 “
Primary Training ” has the meaning set forth in
Section 5.8(a).
1.79 “ Prime
Rate ” has the meaning set forth in
Section 6.4(d).
1.80 “
Processing Activities ” means the activities required
to be undertaken by (a) Indevus or its Third Party
Manufacturers in order to manufacture and supply Esprit with
Trospium Once-Daily Finished Product and/or Samples prior to the
Processing Assumption Date, and (b) in the event the Ex-US
Supply Agreement is executed between the Parties, Esprit or its
Third Party Manufacturers in order to manufacture and supply
Indevus and/or its designees after the Processing Assumption Date
with Trospium Once-Daily solely for use outside the Territory
either in (i) bulk capsule form prior to being in its
finished, labeled and packaged form or (ii) finished, labeled
and packaged form.
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1.81 “
Processing Assumption Date ” means the effective date
of Esprit’s assumption of the Processing Activities of
Indevus in accordance with the terms of Section 14.13, which
date shall be agreed to by the Parties in writing, but in any event
shall not be earlier than the Effective Date nor later than
June 30, 2008.
1.82 “
Product ” means any pharmaceutical preparation in
final form (or, where the context so indicates, the form under
development) containing Compound as a primary active therapeutic
ingredient that, except for Samples thereof, requires a
prescription from a physician or other health care professional,
for use in the Territory.
1.83 “
Product Adverse Event ” means the occurrence of any of
the following: (a) Generic Competition; (b) any
materially adverse change to a Trospium Once-Daily Product label
such as an FDA-mandated addition of a “Black Box”
warning on the Product Labeling of Trospium Once-Daily that is
unique to such product among the class of anti-cholinergic drugs
for the treatment of overactive bladder; (c) any recall or
withdrawal of Trospium Once-Daily mandated by the FDA or reasonably
initiated by a Party (other than actions arising out of or
resulting from the manufacturing of Trospium Once-Daily on or after
the Processing Assumption Date); (d) a determination by a
court of competent jurisdiction that a patent owned by a Third
Party is infringed by the manufacture, use, sale, offer for sale or
importation of Trospium Once-Daily in the Territory; or
(e) failure to deliver at least (i) * of Trospium
Once-Daily Finished Product and Samples for receipt by Esprit or
its designee by * ( provided that Esprit provides any
modifications requested by Esprit to the trade dress for such
Finished Product and Samples on or before *, and the FDA does not
reject any such modifications to the trade dress, provided
that, if Esprit does not provide such modifications or if the FDA
rejects any such modifications to the trade dress, such delivery
date shall be extended by a period of time equal to the period
between * and the date upon which Esprit provides such
modifications or the FDA approves such trade dress, as applicable),
(ii) * (not including the * to be delivered by *, as described
in subsection (i) above) of Trospium Once-Daily Finished
Product and Samples by *, and/or (iii) * (not including the *
to be delivered by *, as applicable, as described in subsections
(i) and (ii) above) of Trospium Once-Daily Finished
Product and Samples by *.
1.84 “
Product Label(ing) ” has the same meaning as defined
in the Act and as interpreted by the FDA.
1.85 “
Product Liability Claims ” means any and all claims by
purchasers or users of Products in the Field, or their family
members, insurers, health care providers, subrogees or assignees,
seeking damages for personal injury, death, expense, economic loss
(including loss of value of such Products), or any other relief or
remedy, arising out of or related to any alleged defect in the
design, labeling, packaging or marketing of such Products,
including a failure to warn.
1.86 “
Product NDAs ” means the NDAs owned by Indevus as of
the Effective Date relating to Trospium Twice-Daily (No. 21-595)
and Trospium Once-Daily (No. 22-103), together with all amendments,
supplements and updates thereto, as well as the corresponding INDs
(with respect to Trospium Twice-Daily, IND 61,381, and with respect
to Trospium Once-Daily, IND 71,305).
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1.87 “
Product Procurement Costs ” means the costs associated
with the manufacturing, purchasing, procurement and warehousing of
Trospium Twice-Daily, Trospium Once-Daily and Compound, as
applicable, and with any other Processing Activities, that are
actually incurred by Indevus ( provided that in all cases
such amounts are not included in, and do not form the basis of, any
payments payable by Esprit to Indevus pursuant to
Section 6.2(c)), including (a) costs associated with
procuring active pharmaceutical ingredients and other materials
used to manufacture Finished Products and/or Samples, (b) the
cost of transportation, testing, inspections, shrinkage and scrap,
related taxes (but in all cases excluding taxes based upon income
or receipts), (c) the cost of storage, insurance and any
subcontracted costs, and amounts payable to Third Party
Manufacturers in connection with the manufacture and supply of
Finished Products and/or Samples, including any fees related to
minimum purchase requirements, (d) direct labor and, to the
extent not in excess of (i)* for Trospium Once-Daily and Trospium
Twice-Daily through the Processing Assumption Date, provided the
aggregate production Batches do not exceed * through the Processing
Assumption Date, and (ii) * annually thereafter for Trospium
Twice-Daily provided aggregate annual production Batches do not
exceed* (plus, solely with respect to this
Section 1.87(d)(ii), the increase on * and each anniversary of
such date in the Producer Price Index, Pharmaceutical Preparations
(Series ID 325412325412) (as published by the U.S. Bureau of Labor
and Statistics (http://www.bls.gov/ppi)) multiplied by such price
) , overhead costs, including an allocation for
Indevus’ internal costs and expenses for supply chain
management, including supply chain production planning, the
formulation and placement of orders with Third Party Manufacturers,
the management of inventories throughout the supply chain process,
quality control/quality assurance, regulatory and Third Party
Manufacturer oversight and cost accounting and including, with
respect to Trospium Once-Daily Finished Product, and (e) an
amount equal to the amounts payable by Indevus to Madaus pursuant
to Section 3.7(b)(2) of the Madaus License ( provided
that such amounts are not included in any payments payable by
Esprit to Indevus pursuant to Section 6.2(c)).
1.88 “
Promotion ” means those activities normally undertaken
by a pharmaceutical company to implement promotion plans and
strategies aimed at encouraging the appropriate use of a particular
prescription pharmaceutical product under a common trademark, up to
the point of offering a product for sale. When used as a verb,
“ Promote ” shall mean to engage in such
activities.
1.89 “
Promotional Materials ” means all written, printed or
graphic material, other than Product Labeling, packaging, or trade
dress, intended for use by Representatives during Details of
Trospium Twice-Daily or Trospium Once-Daily under this Agreement,
including visual aids, file cards, premium items, clinical studies,
reprints, business cards, identification tags and any other
promotional support items or advertisements provided in accordance
with the terms of the relevant Promotion Plan and
Section 5.6.
1.90 “
Promotion Plan ” means the then-current plan relating
to the Promotion of a Product, as contemplated by and in accordance
with the requirements of Section 5.2.
1.91 “
Proprietary Information ” means any and all
scientific, clinical, regulatory, marketing, financial and
commercial information or data, whether communicated in writing,
orally or by any other means, that is owned and under the
protection of one Party and is provided by that Party to the other
Party in connection with this Agreement.
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1.92 “ Pro
Rated Minimum Royalty ” has the meaning set forth in
Section 6.2(b)(i).
1.93 “
Purchase Order ” has the meaning set forth in
Section 14.6.
1.94 “
Quarterly Indevus Details ” means the aggregate number
of Details to be performed by the Indevus Sales Force to the
Indevus Target Prescribers during each Calendar Quarter period of
the Copromotion Period, as set forth in
Section 5.5(b).
1.95 “
Regulatory Documents ” means filings, applications,
modifications, amendments, supplements, revisions, reports,
submissions, authorizations and approvals, including any IND or
NDA, and any reports or amendments necessary to maintain FDA
Approvals.
1.96 “
Representative ” means a sales representative employed
(or in the case of Esprit, otherwise engaged) on a full-time basis
by a Party to conduct Details pursuant to this
Agreement.
1.97 “
Rolling Forecast ” has the meaning set forth in
Section 14.5(b)(i).
1.98 “ Sales
Force(s) ” means the Esprit Sales Force and/or the
Indevus Sales Force, as applicable.
1.99 “ Sales
Force Reimbursement ” has the meaning set forth in
Section 6.3.
1.100 “
Samples ” means units of the Product described in the
Specifications distributed or provided to health care professionals
in the Territory for dispensing, in turn, to patients for
“trial use” at no cost to the patient pursuant to
Law.
1.101 “
Secondary Position Detail ” means a promotional
message involving a Product delivered by a Representative during a
face-to face contact with a Target Prescriber in which key product
attributes are verbally presented after presenting a detail for
another product, consistent with the terms of this Agreement, and
where such Product is given an important but not primary emphasis,
and shall be at least * of the total time of such face-to face
contact. A Secondary Position Detail shall meet all of the
requirements for a Detail, except as specified in this
Section 1.101 and Section 5.5(b)(ii).
1.102 “
Sublicensing Royalties ” has the meaning set forth in
Section 6.2(a)(i).
1.103 “
Specifications ” means the respective specifications
for Trospium Twice-Daily and Trospium Once-Daily Finished Product
as set forth in the applicable Product NDAs, as such may be
modified from time to time in such Product NDAs and pursuant to
Section 4.2(x).
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1.104 “
Supernus ” means Supernus Pharmaceuticals, Inc. (f/k/a
Shire Laboratories, Inc.), a Delaware corporation with a principal
place of business at 1550 East Gude Drive, Rockville, Maryland
20850.
1.105 “
Supernus Agreement ” means the Development and License
Agreement by and between Supernus and Indevus, effective as of
March 11, 2003, as in effect as of the Execution Date, and as
such agreement may be amended from time to time.
1.106 “
Supply Committee ” has the meaning set forth in
Section 3.3(a).
1.107 “
Supply Price ” has the meaning set forth in
Section 14.8(b).
1.108 “
Supply Term ” has the meaning set forth in
Section 14.4.
1.109 “
Target Prescribers ” means those physicians determined
to be high potential prescribers of urologic products to treat
overactive bladder and set forth in a list specified in the
Promotion Plan by the Marketing Committee.
1.110 “
Technology Transfer ” means the transfer of technology
to Esprit in connection with Esprit’s assumption of
Processing Activities, as set forth in Section 14.13 and as
may be further agreed to by the Parties.
1.111 “
Territory ” means the United States of America,
including the District of Columbia, and its territories and
possessions, such as Puerto Rico.
1.112 “ Third
Party(ies) ” means a person or entity who or which is
neither a Party nor an Affiliate of a Party.
1.113 “ Third
Party Manufacturer(s) ” means Third Parties that have
been, or may during the Agreement Term be, engaged by a Party to
perform services or supply facilities or goods (including Finished
Product and/or Samples) in connection with any part of the
manufacture, testing and/or packaging of Finished Product and/or
Samples.
1.114 “ Third
Party Royalties ” means the amount payable by Indevus
(a) to Madaus pursuant to Section 5.2.1(d)(ii) of the
Madaus License as a result of payments made by Esprit to Indevus
pursuant to Section 6.2(a) and (b); provided that the
amounts payable by Esprit to Indevus pursuant to
Section 6.2(c) shall not give effect to the credit due to
Indevus from Madaus as provided for in Section 5.1(a) of the
Madaus License; and/or (b) to Supernus pursuant to
Section 5.6.1 of the Supernus Agreement.
1.115 “
Trademark(s) ” means the SANCTURA trademarks, owned by
Esprit, and all related domain names and other trademark related
rights, and/or any other trademark that either Party may apply to
register in the Territory if such alternate trademark is selected
for use in the Promotion of a Product in the Field by the Parties
under this Agreement.
1.116 “
Training Program(s) ” means the training program(s)
described in Section 5.8.
13
1.117 “
Trospium Once-Daily ” means a controlled or
extended-release oral formulation of Product that is indicated for
administration once per day for the Initial Indication.
1.118 “
Trospium Twice-Daily ” means a twenty milligram (20
mg) dosage oral formulation of Product that is indicated for
administration twice per day for the Initial Indication and that is
marketed by Esprit in the Territory as of the Execution Date as
SANCTURA ® .
2.1 Grants by Indevus
. In consideration of the commitments and undertakings of
Esprit under this Agreement, and subject to the terms and
conditions of this Agreement, Indevus hereby grants to Esprit
during the Agreement Term:
(a) an exclusive (even
as to Indevus, subject to Section 2.8) right and license in
the Field (with the right to grant sublicenses, subject to the
provisions of Section 2.5), under the Indevus Intellectual
Property, to use, import, offer for sale, and Promote Products in
the Territory;
(b) an exclusive (even
as to Indevus) right and license in the Field (with the right to
grant sublicenses, subject to the provisions of Section 2.5),
under the Indevus Intellectual Property, to sell and distribute
Products in the Territory;
(c) effective on the
Processing Assumption Date, an exclusive right and license under
the Indevus Intellectual Property, to make and have made Trospium
Once-Daily for use in the Field in the Territory; and
(d) during the
Copromotion Period and any period of time thereafter that Esprit
has Promotional Materials that were printed prior to the end of the
Copromotion Period and that contain the Indevus Logo, an exclusive
(even as to Indevus, subject to Section 2.8) right and license
in the Field in the Territory (with the right to grant sublicenses,
subject to the provisions of Section 2.5) to use the Indevus
Logo on the Promotional Materials solely in accordance with this
subsection (d). All representations of the Indevus Logo that Esprit
intends to use, if not previously approved by Indevus, will first
be submitted to Indevus for approval, such approval not to be
unreasonably withheld. Indevus will have thirty (30) days to
review the representation of the Indevus Logo. If Indevus does not
provide written notice of its approval or disapproval (together
with its reasons for such disapproval) within such thirty
(30) day period, Indevus will be deemed to have approved such
representation.
Notwithstanding the rights and licenses
granted under Sections 2.1(a), (b) and (c), Esprit does not
expect or anticipate receiving any further Indevus Intellectual
Property subsequent to the NDA Transfer Date, and through the
Agreement Term, as Indevus has represented to Esprit that it
believes that it is remote that after the NDA Transfer Date that
Indevus will be performing any research or development activities
which would generate any future Indevus Intellectual Property
related to the licenses granted hereunder with respect to Product
in the Field. Indevus shall not refund any consideration
received from Esprit or pay any penalties if Indevus terminates any
or all development activities which may result in additional
Indevus Intellectual Property on or prior to NDA Transfer
Date.
14
2.2 Sublicenses of Third
Party Rights .
(a) The licenses
granted to Esprit under Section 2.1 include exclusive
sublicenses by Indevus in the Field of Indevus’ rights under
the Madaus License and the Supernus Agreement to use, import, offer
for sale, and sell Products in and, effective as of the Processing
Assumption Date, make Trospium Once-Daily for use in, the
Territory. Esprit acknowledges that it is a sublicensee under the
Madaus License and the Supernus Agreement to the extent stated in
the foregoing sentence and agrees not to act inconsistently with
the terms of such agreements to the extent applicable to the
sublicenses granted to Esprit hereunder.
(b) Provided that
Esprit is in compliance with its obligations to pay the applicable
Third Party Royalties in accordance with this Agreement, the
payments required by Section 14.13(e)(iv) and the portion of
Product Procurement Costs described in Section 1.87(e), and is
otherwise in material compliance with its obligations hereunder,
Indevus shall pay all amounts that Indevus shall owe to Madaus or
Supernus under the Madaus Agreements or the Supernus Agreement,
respectively, by virtue of this Agreement and shall perform in all
material respects its obligations under the Madaus Agreements or
the Supernus Agreement, as applicable, that are required to enable
Esprit to perform its obligations or exercise the rights granted to
Esprit under this Agreement. In the event that Indevus fails to
make any such payment when due, Esprit, in its sole discretion, may
elect to directly pay Madaus or Supernus, as applicable, any such
payment and to offset against any payments due from Esprit to
Indevus under this Agreement an amount equal to such payments made
by Esprit to Madaus or Supernus. Indevus shall use good faith
efforts to obtain the right, including by amendment of the Madaus
Agreements and the Supernus Agreement, for Esprit to make such
payments to Madaus and Supernus, as applicable, as described in and
in accordance with this Section 2.2(b). Without limiting the
generality of the foregoing, (i) as between the Parties,
Indevus shall be responsible for any required milestone payments to
Madaus pursuant to the Madaus Agreements and to Supernus pursuant
to the Supernus Agreement, and (ii) Esprit shall, to the
extent required by and in accordance with the terms of
Section 6.2(c), reimburse Indevus for any Third Party
Royalties payable pursuant to such agreements.
(c) In the event that
Indevus receives notice from Madaus or Supernus that Indevus has
breached the Madaus Agreements (other than the Madaus License and
Supply Agreement) or the Supernus Agreement, respectively, which
breach gives rise to a right (whether upon further notice, or with
or without the passage of time) by Madaus or Supernus, as
applicable, to terminate the respective agreement in a way that
would terminate or materially adversely affect Esprit’s
ability to perform its obligations or exercise the rights granted
to Esprit under this Agreement, Indevus shall notify Esprit of such
situation as soon as practicable, and in any event within sixty
(60) hours after receipt of such notice, and use commercially
reasonable efforts to promptly cure such breach. Provided that
Esprit is in compliance with its obligations to pay the applicable
Third Party Royalties in accordance with this Agreement, the
payments required by Section 14.13(e)(iv) and the portion of
Product Procurement Costs described in Section 1.87(e), and is
otherwise in material compliance with its obligations hereunder, if
Indevus is unable to cure such breach, and Esprit has not
materially breached its obligations under this Agreement, Indevus
shall, to the extent possible, permit Esprit to cure such breach
(and any costs or expenses of Esprit incurred in curing such breach
shall, at Esprit’s election, either be reimbursed by Indevus
to Esprit or offset by Esprit against any amounts owed to Indevus
under this
15
Agreement). As soon as
reasonably practicable after the Effective Date, Indevus shall also
use commercially reasonable efforts to obtain the agreements of
each of Madaus and Supernus, as applicable, to grant, in the event
that the Madaus Agreements (other than the Madaus License and
Supply Agreement) or Supernus Agreement, as applicable, are
terminated for any reason and Esprit is in compliance with its
obligations to pay the applicable Third Party Royalties in
accordance with this Agreement, the payments required by
Section 14.13(e)(iv) and the portion of Product Procurement
Costs described in Section 1.87(e), and is otherwise in
material compliance with its obligations hereunder, substantially
equivalent rights on substantially equivalent terms as those
granted to Indevus pursuant to the Madaus Agreements (other than
the Madaus License and Supply Agreement) or Supernus Agreement, as
applicable, as are necessary for Esprit to exercise its rights and
perform its obligations under this Agreement.
(d) Notwithstanding
anything to the contrary in this Agreement, except with respect to
the payment obligation in Section 6.2(c)(i),
Section 14.13(e)(iv), and the portion of Product Procurement
Costs described in Section 1.87(e), in no event shall Esprit
be responsible for or liable with respect to, or have any
obligation to reimburse Indevus in respect of, any payments,
claims, demands, actions, causes of action, damages, costs,
expenses, attorneys’ fees, obligations and liabilities of
whatever kind or nature, in law or equity, arising under the Madaus
Agreements or the Supernus Agreement, and, as between the Parties,
Indevus shall be solely responsible and liable with respect to any
such payments, claims, demands, actions, causes of action, damages,
costs, expenses, attorneys’ fees, obligations and
liabilities, and shall bear all costs associated
therewith.
2.3 Retained Rights; No
Implied Licenses; Limitations . All rights not
specifically granted by a Party in this Agreement are reserved and
retained by such Party. Nothing in this Agreement shall be deemed
to constitute the grant of any license or other right to either
Party, to or in respect of any product, patent, trademark,
Proprietary Information, trade secret or other data or any other
intellectual property of the other Party, except as expressly set
forth herein. Except as otherwise set forth in this Agreement,
neither Party shall grant any license to, or permit or authorize,
any Third Party to Promote Products in the Field in the Territory
without the prior written consent of the other Party.
2.4 Non-Competition
. During the Agreement Term, neither Party will Promote, or
permit its Affiliates to Promote, market or sell any Competing
Product in the Territory, or acquire, or permit its Affiliates to
acquire, directly or indirectly any rights or interest in or to a
Competing Product that is being detailed, Promoted, marketed or
sold in the Territory; provided , however , that, in
the event that *
2.5 Proposed Sublicense by
Esprit . Esprit shall have the right to grant
sublicenses to an Affiliate under any of the rights or licenses
granted to it by Indevus under this Agreement as set forth in this
Section 2.5. Esprit shall advise Indevus in advance of any
proposed sublicense and give due consideration to Indevus’
comments with respect thereto. Any sublicense shall be subject to
the terms and conditions of this Agreement, including the
provisions relating to payments set forth in Article 6, and Esprit
shall be responsible to Indevus for any non-performance by any
sublicensee of Esprit’s obligations under this Agreement that
are assumed by the sublicensee. In the event Esprit grants a
sublicense to an Affiliate, any payment due to Indevus under this
Agreement must be received in its full amount by Indevus in the
United States without any tax withholding or tax deduction
therefrom.
| * |
CONFIDENTIAL TREATMENT REQUESTED |
16
2.6 Regulatory Filings
.
(a) Transfer of Product
NDAs. Indevus hereby assigns to Esprit all right, title and
interest in the Product NDAs, effective as of the NDA Transfer
Date. On the NDA Transfer Date, Indevus shall submit to the FDA a
letter authorizing the transfer of ownership from Indevus to Esprit
of the Product NDAs. As soon as practicable after the submission of
such letter and the receipt by Esprit of the FDA’s
acknowledgment letter, Esprit shall execute and submit to the FDA a
letter, accompanied by the Product NDA transfer letter referred to
in the preceding sentence, acknowledging Esprit’s commitment
to assume ownership of the Product NDAs.
(b) Security
Interest.
(i) Grant of Security
Interest. The Parties acknowledge and agree that pursuant to
the Original Agreement, as security for Indevus’ performance
of its material covenants and obligations thereunder, Indevus
granted to Esprit a security interest in Indevus’ right,
title and interest in and to Indevus’ FDA marketing
authorizations or marketing approvals related to a Product in the
Field in the Territory (including the Product NDAs), subject to the
Madaus Agreements (other than the Madaus License and Supply
Agreement) and the Supernus Agreement and to Laws. Indevus hereby
reaffirms the grant of such security interest, and hereby grants
Esprit, as security for Indevus’ performance of its material
covenants and obligations hereunder, a security interest in
Indevus’ right, title and interest in and to any
Indevus’ FDA marketing authorizations or marketing approvals
related to a Product in the Field in the Territory that were not in
existence as of the date of the Original Agreement (together with
the subject matter described in the first sentence of this
Section 2.6(a), the “ Collateral ”). The
security interest is granted as security only and, except for the
security interest granted, shall not transfer or in any way
otherwise affect or modify any rights of Indevus with respect to
the Collateral. The security interest shall be released on the
earlier of (A) the NDA Transfer Date or (B) termination
of this Agreement by Indevus pursuant to
Section 12.2(a).
(ii) Further Assurances
and Attorney in Fact.
(A) Indevus agrees that from
time to time, at Esprit’s expense, Indevus shall promptly
execute and deliver all further instruments and documents, and take
all further action, that Esprit may reasonably request in order to
perfect, protect or more fully evidence any security interest
granted or purported to be granted hereby or to enable Esprit to
exercise or enforce its rights and remedies hereunder with respect
to the Collateral.
(B) To the extent permitted
by Law, Indevus hereby authorizes Esprit, to file at Esprit’s
expense, one or more financing or continuation statements, and
amendments thereto and assignments thereof, relating to all or any
part of the Collateral now existing or hereafter arising without
the signature of Indevus, and Esprit shall promptly upon the filing
thereof by it deliver to Indevus a copy of each such financing or
continuation statement or amendment or assignment. To the extent
permitted by Law, a carbon, photographic or other reproduction of
this Agreement or any financing statement covering the Collateral
or any part thereof shall be sufficient as a financing
statement.
17
(C) Indevus hereby
irrevocably appoints Esprit as Indevus’ attorney in fact,
with full authority in the place and stead of Indevus and in the
name of Indevus or otherwise, from time to time in Esprit’s
reasonable discretion upon the occurrence and during the
continuance of a material default by Indevus of its covenants and
obligations hereunder, to take any action and to execute any
instrument that Indevus may reasonably deem necessary or advisable
to accomplish the purposes of the security interests in the
Collateral granted by Indevus hereunder.
2.7 Access to
Information . Subject to the terms and conditions of
this Agreement, Indevus shall promptly provide to Esprit all Data
obtained by Indevus or any of its licensees related to the Products
and data and information with respect to pharmacovigilance related
to the Products, and Indevus shall cooperate in good faith to
provide Esprit access to and reasonable assistance with all Indevus
Intellectual Property and other Proprietary Information as may be
required for Esprit to exercise the rights and licenses explicitly
granted and to perform its obligations hereunder. After the
disbanding of any committee pursuant to Section 3.6, Esprit
shall have the right to continue to receive the information it
would otherwise be entitled to receive under this
Agreement.
2.8 Grant by Esprit
. In consideration of the commitments and undertakings of
Indevus under this Agreement, and subject to the terms and
conditions of this Agreement, Esprit hereby grants to Indevus,
during the Copromotion Period:
(a) an exclusive
(except as to Esprit), nontransferable right and license in the
Field in the Territory to Promote Products solely for the purpose
of co-Promoting Products with Esprit in accordance with and subject
to the terms of Article 5; and
(b) an exclusive
(except as to Esprit), nontransferable right and license in the
Field in the Territory to use the trademarks owned or otherwise
controlled by Esprit that are included in Promotional Materials
provided by Esprit pursuant to this Agreement in connection with
the use of such Promotional Materials in connection with the
Promotion of Products; provided that Indevus shall not have
the right to use any representations of such trademark except as
set forth in Section 5.6(e).
2.9 No Further Development
by Indevus . The Parties acknowledge and agree that
Indevus has no obligation under this Agreement to develop or
continue to develop any Indevus Intellectual Property and that
after the NDA Transfer Date Indevus shall not be permitted to
develop or continue to develop any inventions or intellectual
property in the Field in the Territory relating to
Products.
18
3.1 Development
Committee.
(a) Members. Pursuant
to the Original Agreement, the Parties established a joint
development committee with certain obligations and powers.
Effective as of the Effective Date, the Parties shall establish a
new joint development committee (the “ Development
Committee ”) composed of four (4) individuals, two
(2) of whom shall be appointed by Indevus and two (2) of
whom shall be appointed by Esprit and all of whom shall be
qualified to appropriately represent their respective Party at the
Development Committee level. The members of the Development
Committee as of the Effective Date shall be as set forth on
Schedule 3.1. Membership shall include representation from each
Party’s scientific, clinical development, and regulatory
affairs and/or such other departments as the Development Committee
may deem appropriate. Either Party may replace any or all of its
representatives on the Development Committee at any time upon
written notice to the other Party. A Party may designate a
substitute to temporarily attend and perform the functions of such
Party’s designated representative at any meeting of the
Development Committee. The Development Committee shall be chaired
by a representative of Esprit. The chairperson shall appoint a
secretary of the Development Committee, who shall be a
representative of Indevus.
(b) Role and
Responsibilities. The Development Committee shall have as its
overall purpose, subject to Section 4.2 and Section 5.6,
the oversight of development, including review of clinical
protocols and timetables for development, oversight of development
and selection of entities or individuals, including Indevus or
Esprit, to perform tasks required in connection with development of
Products in the Field in the Territory. In particular, the
Development Committee shall perform the following
functions:
(i) Review development
activities conducted under this Agreement with respect to Compound
and Products in the Field in the Territory, including any Phase IV
Clinical Trials;
(ii) Monitor
regulatory strategy and communications with FDA;
(iii) In concert with
the Marketing Committee, assist in the coordination and monitoring
of regulatory strategy and activities for Phase IV Clinical Trials
in the Field in the Territory;
(iv) Review and
approve in advance any Promotional Materials or educational
materials and literature related to Trospium Twice-Daily or
Trospium Once-Daily, including Product advertising;
(v) Oversee any
changes to the Specifications proposed by the Parties and propose
whether any such changes require any supplements to a Product NDA,
as further described in Section 4.2(a)(x); and
(vi) Have such other
responsibilities as may be assigned to the Development Committee
pursuant to this Agreement or as may be mutually agreed upon by the
Parties from time to time.
(c) Primary Contact.
Indevus and Esprit each shall appoint a person (a “
Development Primary Contact ”) to be the primary
contact between the Parties with respect to development and to
coordinate related correspondence between the Parties. The
Development Primary Contact of each Party as of the Effective Date
is set forth on Schedule 3.1. Each Party shall notify the other in
writing as soon as practicable upon changing its Development
Primary Contact. The Development Primary Contact of each Party will
be one of its representatives on the Development
Committee.
19
(d) Oversight. The
Development Committee may make decisions with respect to any
subject matter that is subject to the Development Committee’s
decision-making authority and responsibilities as set forth in
Section 3.1(b). The Development Committee shall use its good
faith efforts to resolve by consensus any issue relevant to
development of Products. The Development Committee shall give
consideration to the views, position and recommendations of each
Party on any issue that has been brought before the Development
Committee. If the Development Committee shall arrive at a consensus
on any issue relating to the development of a Product, such
consensus shall be binding upon the Parties. All decisions of the
Development Committee shall be made by unanimous vote or written
consent, as indicated by all members signing the written minutes
thereof, with Esprit representatives collectively having one
(1) vote and Indevus representatives collectively having one
(1) vote in all decisions. If the Development Committee cannot
reach consensus on a matter brought to its attention, Esprit shall
be entitled to make the final decision with respect to such matter,
subject to Section 3.1(e) and Section 5.6(a).
(e) The Development
Committee shall have only the powers assigned to it in this
Section 3.1. All activities conducted by the Development
Committee shall be consistent with and subject to the provisions of
this Agreement, and the Development Committee shall not have any
power to take any action that conflicts with the terms of this
Agreement or to amend, modify or waive compliance with this
Agreement.
3.2 Marketing
Committee .
(a) Members. Pursuant
to the Original Agreement, the Parties established a joint
marketing committee with certain obligations and powers. Effective
as of the Effective Date, the Parties shall establish a new joint
marketing committee (the “ Marketing Committee
”) composed of four (4) individuals, two (2) of
whom shall be appointed by Indevus and two (2) of whom shall
be appointed by Esprit and all of whom shall be qualified to
appropriately represent such Party at the Marketing Committee
level. The members of the Marketing Committee as of the Effective
Date shall be as set forth on Schedule 3.2. Either Party may
replace any or all of its respective representatives on the
Marketing Committee at any time upon written notice to the other
Party. Either Party may designate a substitute to temporarily
attend and perform the functions of such Party’s designated
representative at any meeting of the Marketing Committee. The
Marketing Committee shall be chaired by a representative of Esprit.
The chairperson shall appoint a secretary of the Marketing
Committee, who shall be a representative of Indevus.
(b) Role and
Responsibilities. The Marketing Committee will be used as the
forum for the Parties to discuss the Promotion strategy for
Products and, subject to the terms and conditions of this
Agreement, will review the pre-launch, launch, post-launch and
ongoing Promotional activities for Products in the Territory. In
particular, the Marketing Committee shall perform the following
functions:
(i) Review and provide
recommendations regarding the Promotion Plan and any material
amendments or modifications to the Promotion Plan;
20
(ii) Discuss the
actual results of the Promotion of Trospium Twice-Daily and
Trospium Once-Daily in the Territory as compared to the Promotion
Plan;
(iii) In concert with
the Development Committee, assist in the coordination and
monitoring of regulatory strategy and activities for Phase IV
Clinical Trials in the Field in the Territory;
(iv) Propose the
launch date for Trospium Once-Daily in the Territory, subject to
the provisions of Section 5.1;
(v) Discuss the state
of the markets for Trospium Twice-Daily and Trospium Once-Daily in
the Territory and opportunities and issues concerning the Promotion
of such Products in the Territory, including consideration of
marketing and promotional strategy, marketing research plans,
labeling, Product positioning and Product profile issues, to
determine the kind of marketing and selling efforts that are
appropriate, in accordance with the Promotion Plan and
Law;
(vi) Review Training
Program(s) and promotional activities to be performed by the
Parties in the Promotion of Trospium Twice-Daily and Trospium
Once-Daily in the Territory;
(vii) Review the
overall performance and effectiveness of the Sales
Forces;
(viii) Review and
propose physicians to be high potential prescribers of urologic
products to treat overactive bladder and propose a list of such
physicians for inclusion in the Promotion Plan;
(ix) Review in advance
any Promotional Materials or educational materials and literature
related to Trospium Twice-Daily or Trospium Once-Daily, including
Product advertising; and
(x) Have such other
responsibilities and address any other matters delegated to the
Marketing Committee under this Agreement or as may be mutually
agreed upon in writing by the Parties from time to time, as well as
any other matters pertaining to each Party’s performance of
its Promotion obligations under this Agreement.
(c) Primary Contact.
Indevus and Esprit each shall appoint a person (a “
Marketing Primary Contact ”) to be the primary contact
between the Parties with respect to the Promotion Plan and to
coordinate related correspondence between the Parties. The
Marketing Primary Contact is set forth on Schedule 3.2. Each Party
shall notify the other in writing as soon as practicable upon
changing its Marketing Primary Contact appointment. The Marketing
Primary Contact of each Party will be one of its two
representatives on the Marketing Committee.
21
(d) Oversight. The
Marketing Committee may make decisions with respect to any subject
matter that is subject to the Marketing Committee’s
decision-making authority and responsibilities as set forth in
Section 3.2(b). The Marketing Committee shall use its good
faith efforts to resolve by consensus any issue relevant to the
commercialization of Products. Each Party shall provide input with
respect to the Promotion Plan, and the Marketing Committee shall
give substantial consideration to the views, position and
recommendations of each Party on any issue that has been brought
before the Marketing Committee. If the Marketing Committee shall
arrive at a consensus on any issue relating to the
commercialization of Products, such consensus shall be binding upon
the Parties. All decisions of the Marketing Committee shall be made
by unanimous vote or written consent, as indicated by all members
signing the written minutes thereof, with Esprit representatives
collectively having one (1) vote and Indevus representatives
collectively having one (1) vote in all decisions. If the
Marketing Committee cannot reach consensus on a matter brought to
its attention, Esprit shall be entitled to make the final decision
with respect to such matter, subject to
Section 3.2(e).
(e) The Marketing
Committee shall have only the powers assigned to it in this
Section 3.2. All activities conducted by the Marketing
Committee shall be consistent with and subject to the provisions of
this Agreement, and the Marketing Committee shall not have any
power to take any action that conflicts with the terms of this
Agreement or to amend, modify or waive compliance with this
Agreement.
3.3 Supply Committee
.
(a) Members. Effective
as of the Effective Date, the Parties shall establish a joint
supply committee (the “ Supply Committee ”)
composed of four (4) individuals, two (2) of whom shall
be appointed by Indevus and two (2) of whom shall be appointed
by Esprit and all of whom shall be qualified to appropriately
represent their respective Party at the Supply Committee level. The
members of the Supply Committee as of the Effective Date are set
forth on Schedule 3.3. Membership shall include representation from
each Party’s manufacturing department and/or such other
departments as the Supply Committee may deem appropriate. Either
Party may replace any or all of its respective representatives on
the Supply Committee at any time upon written notice to the other
Party. A Party may designate a substitute to temporarily attend and
perform the functions of such Party’s designated
representative at any meeting of the Supply Committee. The Supply
Committee shall be chaired by a representative of Esprit. The
chairperson shall appoint a secretary of the Supply Committee, who
shall be a representative of Indevus.
(b) Role and
Responsibilities. The Supply Committee shall oversee all
aspects of supply of Trospium Twice-Daily and Trospium Once-Daily
under this Agreement and shall have as its overall purpose the
management of the supply to Esprit of Finished Products and/or
Samples prior to the Processing Assumption Date, the transition of
Processing Activities from Indevus to Esprit pursuant to the terms
of this Agreement and, if Indevus exercises the Ex-US Supply
Option, the management of the supply of Trospium Once-Daily solely
for use outside the Territory either in (i) bulk capsule form
prior to being in its finished, labeled and packaged form or
(ii) finished, labeled and packaged form. In particular, the
Supply Committee shall perform the following functions:
(i) Oversee all
aspects of the supply of Trospium Twice-Daily prior to the NDA
Transfer Date and Trospium Once-Daily prior to the Processing
Assumption Date;
22
(ii) Prepare a supply
plan coordinating the entire supply chain to support all needs for
Products in the Field within and outside the Territory;
(iii) Oversee all
Processing Activities;
(iv) Identify and
propose actions to prevent potential interruptions of
supply;
(v) Oversee audits of
Third Party Manufacturers;
(vi) Propose new Third
Party Manufacturers, subject to the terms and conditions of
Indevus’ agreements with Third Party
Manufacturers;
(vii) Oversee quality
control and assurance, implementation process improvements, cost
reduction initiatives, and logistics initiatives;
(viii) Coordinate the
supply of Compound in sufficient quantities for Indevus to satisfy
its obligations under Section 14.6(b);
(ix) Coordinate
assumption by Esprit of Processing Activities, including the
Technology Transfer, and recommend a timeline and procedures for
the Technology Transfer in its first meeting; and
(x) Have such other
responsibilities and address any other matters delegated to the
Supply Committee under this Agreement or as may be mutually agreed
upon in writing by the Parties from time to time, as well as any
other matters pertaining to each Party’s performance of its
supply obligations under this Agreement.
(c) Oversight. The
Supply Committee may make decisions with respect to any subject
matter that is subject to the Supply Committee’s
decision-making authority and responsibilities as set forth in
Section 3.3(b). The Supply Committee shall use its good faith
efforts to resolve by consensus any issue relevant to the supply of
Finished Products and/or Samples. Each Party shall provide input
with respect to the supply of Finished Products and/or Samples, and
the Supply Committee shall give substantial consideration to the
views, position and recommendations of each Party on any issue that
has been brought before the Supply Committee. If the Supply
Committee shall arrive at a consensus on any issue relating to the
supply of Finished Products and/or Samples, such consensus shall be
binding upon the Parties. All decisions of the Supply Committee
shall be made by unanimous vote or written consent, as indicated by
all members signing the written minutes thereof, with Esprit
representatives collectively having one (1) vote and Indevus
representatives collectively having one (1) vote in all
decisions. If the Supply Committee cannot reach consensus on a
matter brought to its attention, Esprit shall be entitled to make
the final decision with respect to such matter, subject to
Section 3.3(d).
23
(d) The Supply
Committee shall have only the powers assigned to it in this
Section 3.3. All activities conducted by the Supply Committee
shall be consistent with and subject to the provisions of this
Agreement and, if applicable, the Ex-US Supply Agreement, and the
Supply Committee shall not have any power to take any action that
conflicts with the terms of this Agreement or to amend, modify or
waive compliance with this Agreement.
3.4 Meetings .
The chairpersons of the Development Committee, Marketing Committee,
and Supply Committee shall call meetings as reasonably requested by
one of the Parties; provided , however ,
that:
(a) the Marketing
Committee shall meet at least three (3) times per year (with a
meeting to be held not later than thirty (30) days after the
Effective Date at Esprit’s offices) through the end of the
Copromotion Period, unless the Parties agree otherwise;
(b) the Development
Committee shall meet at least three (3) times per year (with a
meeting to be held not later than thirty (30) days after the
Effective Date at Indevus’ offices) through the NDA Transfer
Date, unless the Parties agree otherwise; and
(c) the Supply
Committee shall meet on at least a Calendar Quarterly basis (with a
meeting to be held not later than thirty (30) days after the
Effective Date at Indevus’ offices) through the Processing
Assumption Date, unless the Parties agree otherwise, and, after the
Processing Assumption Date through the NDA Transfer Date, the
Supply Committee shall meet at least three (3) times per
year.
Meetings may be held in person, by
telephone, or by video conference call, and, except as set forth
above, the location of each meeting shall alternate between the
Parties’ headquarters or such other location as may be
mutually agreed upon by the Parties. On advance written notice to
the other Party, additional participants may be invited by any
representative to attend meetings where appropriate. Each Party
shall be responsible for all travel and related costs and expenses
of its members and other representatives to participate or attend
committee meetings. The Parties shall cause their respective
representatives on the committees to use good faith efforts to
resolve all matters presented to them. Any Proprietary Information
disclosed in any meeting of the Development Committee, Marketing
Committee, or Supply Committee by a Party shall remain Proprietary
Information of the disclosing Party.
3.5 Minutes of Committee
Meetings . Minutes of the each committee meeting shall
be transcribed and issued by the secretary within thirty
(30) days after each meeting (or, if shorter, at least ten
(10) Business Days prior to the date of the next scheduled
meeting of such committee) and shall be approved as the first order
of business at the immediately succeeding meeting of such
committee. Such minutes shall include only key discussion points
and decisions made and provide a list of any identified issues yet
to be resolved, either within such committee or through the
relevant resolution process, if any.
3.6 Disbanding of
Committees.
(a) The Parties shall
have the right to disband any or all of the Development Committee,
Marketing Committee, and Supply Committee, upon mutual agreement.
Additionally, to the extent the applicable committee is not
disbanded pursuant to the
24
preceding sentence, the
Development Committee shall be automatically disbanded effective on
the NDA Transfer Date, the Marketing Committee shall be
automatically disbanded effective on the expiration of the
Copromotion Period, and the Supply Committee shall be automatically
disbanded effective on the NDA Transfer Date.
(b) After the
disbanding of a committee, Esprit shall be entitled to make the
final decision with respect to any and all matters or actions for
which it had the right to make such decisions prior to the
disbanding of any such committee subject to any provisions
applicable to such decision.
3.7 Project
Coordinators . Promptly following the Effective Date,
each Party shall designate an appropriate expert to facilitate
communication and coordination of the Parties’ activities
under this Agreement relating to Products and to provide support
and guidance to the Development Committee, Marketing Committee, and
Supply Committee (each, a “ Project Coordinator
”). Each Project Coordinator shall be experienced in project
management and may also serve as one of the representatives of its
respective Party on any of the Development Committee, Marketing
Committee, and Supply Committee. From time to time each Party may
replace its Project Coordinator by written notice to the other
Party specifying such replacement.
| |
4. |
D EVELOPMENT AND R
EGULATORY M ATTERS |
4.1
Development.
(a) General. After the
Effective Date, Development of Products in the Field in the
Territory shall be conducted, administered and funded solely by
Esprit or its designees, and Indevus shall not conduct any
development activities with respect to Products in the Field in the
Territory.
(b) Phase IV Clinical
Trials. After the Effective Date, all Phase IV Clinical Trials
or other pre-clinical or clinical trials that are required by the
FDA as a condition to or in connection with an FDA Approval in the
United States shall be conducted, administered and funded solely by
Esprit or its designees. Indevus shall have the right, but not the
obligation, to provide appropriate personnel to support and assist
in the conduct of such Phase IV Clinical Trials, as mutually agreed
to between the Parties, subject to reimbursement of Indevus’
costs and expenses associated therewith.
4.2 Regulatory
Matters.
(a) Prior to the NDA
Transfer Date. The Parties acknowledge that Indevus has
obtained FDA Approval for Trospium Twice-Daily and Trospium
Once-Daily and is the owner of the Product NDAs as of the Execution
Date and is expected to be the owner of the Product NDAs as of the
Effective Date. Prior to the NDA Transfer Date:
(i) Indevus shall own
and control all Regulatory Documents relating to a Product in the
Field in the Territory.
(ii) Indevus shall
have sole authority and responsibility for the timely preparation,
filing, prosecution, and maintenance of all Regulatory Documents
relating to a Product in the Field in the Territory, including
Product NDAs and any reports or amendments necessary to maintain
FDA Approvals, and for seeking any revisions of the conditions of
each FDA Approval.
25
(iii) Indevus shall
have sole authority and responsibility to seek and/or obtain any
necessary FDA approvals of any Product Label(ing), packaging,
advertising or other promotional or informational materials used in
connection with Product and Promotional Materials and for
determining whether the same requires FDA approval, and Indevus
shall submit Promotional Materials to the FDA after approval of
both Parties, in accordance with the procedures set forth in
Section 5.6.
(iv) Indevus shall
remain the primary contact with the FDA and shall be solely
responsible for all communications with the FDA that relate to any
IND or NDA relating to a Product in the Field in the Territory
prior to and after any FDA Approval.
(v) Esprit shall have
the right, but not the obligation, to assist and consult with
Indevus with respect to all regulatory submissions, including
applications for FDA Approvals, prior to making any such
submissions. At least thirty (30) days prior to the filing of
any documents with the FDA relating to Products in the Field,
Indevus shall provide Esprit with copies of all such filings,
submissions, authorizations and FDA Approvals, including any
correspondence related to manufacturing of Products in the Field;
provided that, if Indevus believes it is required by Law to
make such submission sooner, Indevus shall provide Esprit with
final copies of such submissions for Esprit’s review at least
two (2) Business Days prior to filing them with the FDA.
Indevus shall consider in good faith any comments of Esprit with
respect to the foregoing.
(vi) Indevus shall
provide Esprit with a copy of all safety data received by Indevus
regarding Products in the Field worldwide.
(vii) Indevus shall
provide advance notice to Esprit of any planned meetings,
discussions, or other communications with the FDA relating to
Products in the Field. Esprit shall have the right, but not the
obligation, to participate with respect to such meetings,
discussions, or other communications; provided that, in
providing any such assistance, Esprit shall not contact the FDA
without the prior approval of Indevus and, if contacted by the FDA
with respect to Product, shall refer such contact to
Indevus.
(viii) If contacted by
the FDA with respect to a Product in the Field, Indevus shall
notify Esprit within two (2) Business Days of such contact,
and provide Esprit with any related official correspondence
received from the FDA, including as applicable minutes of any
meetings or telephone conferences and/or discussions between
Indevus and the FDA. Esprit shall have a right to participate in
and provide comments with respect to any subsequent meetings,
discussions, or other communications with respect to such
contact.
(ix) To the extent
Esprit reasonably believes that a filing or submission relating to
Products in the Territory is required by Law, Esprit shall notify
Indevus. If Indevus decides not to prepare such filing or
submission, Indevus shall promptly notify Esprit, but in no event
later than thirty (30) days, unless notified by Esprit that a
shorter period of review
26
is mandated by FDA or Law,
after such notice by Esprit of such decision, and Esprit shall be
entitled to prepare such filing or submission, to be filed or
submitted by Indevus; provided that Esprit shall use good
faith efforts to include any comments of Indevus in such filing or
submission.
(x) Prior to the
Processing Assumption Date, changes to the Specifications shall be
made only by mutual prior agreement of the Parties, except as
required by Law. The Parties shall determine whether any such
changes require any supplements to a Product NDA, and each Party
shall provide the other Party with notice of any such changes as
soon as practicable. After the Processing Assumption Date, but
prior to the NDA Transfer Date, changes to the Specifications shall
be made only after prior notification to Indevus of any such
changes as soon as practicable, and the Parties shall determine
whether any such changes require any supplements to a Product NDA,
except as required by Law.
(xi) Notwithstanding
anything herein to the contrary, Indevus shall not file with the
FDA any regulatory submissions that are intended to change or
modify the Product label or FDA-approved prescribing information
for, or the indications of, Trospium Twice-Daily or Trospium
Once-Daily in the Territory without providing to Esprit a draft of
such submission at least ten (10) days prior to planned
submission to the FDA and giving prompt and reasonable
consideration to any comments Esprit may have; provided
that, if and to the extent required by Law Indevus is required to
file any such submission in less than ten (10) days after
notice from the FDA, Indevus will notify Esprit of any such
requirement promptly and in no event later than two
(2) Business Days after such notice.
(xii) Notwithstanding
Section 14.13(f), during the period beginning on the
Processing Assumption Date and ending on the NDA Transfer Date, in
connection with Indevus’ responsibilities as holder of the
Product NDAs, Indevus and Esprit shall cooperate in good faith, in
coordination with the Supply Committee, for Indevus to subcontract
or assign the performance and management of quality assurance
responsibilities to Esprit, while retaining the authority for
Indevus to monitor Esprit’s performance, as subcontractor to
Indevus with respect to such activities, consistent with
Indevus’ quality obligations under the Product NDA for
Trospium Once-Daily.
(b) After the NDA Transfer
Date. After the NDA Transfer Date:
(i) Esprit shall own
and control all Regulatory Documents relating to a Product in the
Field in the Territory. Indevus hereby assigns to Esprit all right,
title and interest in such Regulatory Documents, effective as of
the NDA Transfer Date.
(ii) Esprit will be
solely responsible for the timely preparation, filing, prosecution,
and maintenance of all Regulatory Documents relating to a Product
in the Field in the Territory, including Product INDs and NDAs and
any reports or amendments necessary to maintain FDA Approvals, and
for seeking any revisions of the conditions of each FDA
Approval.
27
(iii) Esprit shall
have sole authority and responsibility to develop, modify, seek
and/or obtain any necessary FDA approvals of any Product
Label(ing), packaging, advertising or other promotional or
informational materials used in connection with Product in the
Field in the Territory, and Promotional Materials and for
determining whether the same requires FDA approval.
(iv) Esprit will be
the primary contact with the FDA and shall be solely responsible
for all communications with the FDA that relate to any IND or NDA
relating to a Product in the Field in the Territory prior to and
after any FDA Approval.
(v) Esprit may, in its
sole discretion, file any submissions that are intended to change
or modify the Product label or FDA-approved prescribing information
for, or the indications of, Trospium Twice-Daily or Trospium
Once-Daily in the Territory provided that, except as
required by Laws, it provides to Indevus a draft of such submission
at least ten (10) days prior to planned submission to the FDA
and gives prompt and reasonable consideration to any comments
Indevus may have.
(vi) To the extent
Indevus reasonably believes that a filing or submission relating to
Products in the Field in the Territory is required by Law, Indevus
shall notify Esprit. If Esprit decides not to prepare such filing
or submission, it shall promptly notify Indevus, but in no event
later than thirty (30) days, unless notified by Indevus that a
shorter period of review is mandated by FDA or Law, after such
notice by Indevus of such decision, and Indevus shall be entitled
to prepare such filing or submission, to be filed or submitted by
Esprit; provided that Indevus shall use good faith efforts
to include any comments of Esprit in such filing or
submission.
(vii) Indevus may, but
is not required to, assist Esprit, at Esprit’s election, in
Esprit’s efforts to seek and obtain FDA Approvals, subject to
reimbursement of Indevus’ related costs and
expenses.
(c) Regulatory
Cooperation. Each Party shall inform the Development Committee
or, if the Development Committee has been disbanded, the other
Party, within twenty four (24) hours, of its receipt of any
information that: (i) raises any concern regarding the safety
of Compound or Product; (ii) concerns suspected or actual
tampering, counterfeiting (excluding diversion, which is subject to
Section 5.7(c)) or contamination or other similar problems
with respect to Compound or Product; (iii) is reasonably
likely to lead to a recall or market withdrawal of a Product; or
(iv) concerns any ongoing or potential FDA investigation,
inspection, detention, seizure or injunction involving a Compound
or Product.
(d) Adverse
Experiences. The reporting of Adverse Experiences shall be
governed by Article 10.
(e) Recalls and Other
Corrective Action. The Development Committee shall make all
final decisions with respect to any recall, market withdrawal or
any other corrective action related to a Product in the Field in
the Territory, and neither Party shall initiate any such action
without the approval of the Development Committee; provided
, however , that nothing herein shall prohibit Indevus,
prior to the NDA Transfer Date, from initiating or conducting any
recall or other corrective action mandated by the FDA or Law. At a
Party’s request, the other Party shall provide reasonable
assistance in conducting such recall, market
28
withdrawal or other
corrective action, including providing all pertinent records that
such Party may reasonably request to assist in effecting such
action, subject to reimbursement of such other Party’s
reasonable costs and expenses associated with providing such
cooperation. Any documented, direct, out-of-pocket costs incurred
(paid or accrued) with respect to such recall, market withdrawal or
other corrective action prior to the Processing Assumption Date
shall be borne by Indevus; provided , however , that,
in the event that the recall or other corrective action is
attributable solely to Promotional activities under Article 5,
Esprit shall bear such expenses. Any documented, direct,
out-of-pocket costs incurred (paid or accrued) with respect to a
recall, market withdrawal or other corrective action with respect
to Products in the Field in the Territory after the Processing
Assumption Date shall be borne by Esprit. Neither Party shall have
any obligation to reimburse or otherwise compensate the other Party
or its Affiliates for any consequential damages, lost profits or
income that may arise in connection with any recall, market
withdrawal or corrective action with respect to
Products.
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5. |
P ROMOTION OF P
RODUCTS |
5.1
General.
(a) Subject to the
terms and conditions of this Agreement, Esprit shall during the
Agreement Term, and Indevus shall during the Copromotion Period,
use Commercially Reasonable Efforts to Promote Products in the
Field in the Territory and to perform their respective obligations
under this Agreement. All activity conducted by a Party under this
Agreement shall occur at such Party’s sole expense except as
otherwise expressly provided in this Agreement.
(b) Without limiting
the generality of the foregoing, Esprit shall use Commercially
Reasonable Efforts to launch Trospium Once-Daily in the United
States by *, subject to the following:
(i) If Indevus has
complied in all material respects with its obligations under this
Agreement and there has not been an event of Force Majeure, Esprit
shall launch Trospium Once-Daily in the United States by the later
of (a) * or (b) * in the event that Esprit pays Indevus,
on or before *, if necessary, * or such other amount, if any,
agreed to by *, or (c) such other date to which the Parties
may mutually agree.
(ii) If, because of a
Force Majeure event, Esprit is unable to launch Trospium Once-Daily
in the United States on or before *, Esprit shall launch Trospium
Once-Daily in the United States on the date that is the number of
days beyond * equal to the number of days of Force Majeure, and
Indevus, on or before *, shall be required to obtain an extension
of the launch requirement * if required to prevent a breach of
*.
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CONFIDENTIAL TREATMENT REQUESTED |
29
(iii) If, because
Indevus has not complied with its obligations under this Agreement,
Esprit is unable to launch Trospium Once-Daily in the United States
on or before *, Indevus, on or before *, shall be required to
obtain an extension of the launch date requirement, which extended
launch date requirement shall not be before *, including *, if
necessary, * (in which case the extended launch date requirement
shall be *) or such other lesser amount, if any, agreed to *; and
Indevus shall not have the right to terminate this Agreement for
Esprit’s failure to launch Trospium Once-Daily on or before *
provided that Esprit launches Trospium Once-Daily by such extended
launch date requirement.
(c) Notwithstanding
anything herein to the contrary, if Esprit determines, in
consultation with the Development Committee prior to the NDA
Transfer Date, in its sole discretion, that market acceptance of
Trospium Once-Daily relative to Trospium Twice-Daily justifies the
discontinuation of Trospium Twice-Daily, it shall have the right to
discontinue Promotion of Trospium Twice-Daily and to require
Indevus to provide notice of discontinuation of Trospium
Twice-Daily to the FDA by providing written notice to Indevus and
citing this Section 5.1(c). For the avoidance of doubt,
the exercise of the rights provided in this Section 5.1(c) by
Esprit and the related obligation by Indevus shall not be deemed a
Product Adverse Event.
5.2 Promotion Plan.
Esprit will prepare a Promotion Plan and budget, which will be
provided to the Marketing Committee by not later than * before the
commencement of the Launch Period, covering the Copromotion Period;
provided that any and all Promotion Plans shall terminate
and shall have no effect upon termination of the Copromotion
Period. Subject to the other terms and conditions of this
Agreement, the Promotion Plan shall focus on the Promotion of
Products in the Field in the Territory, and shall include matters
such as:
(a) The determination
and review of the content, quantity, method of distribution of, and
guidelines for the use of Promotional Materials related to,
Trospium Twice-Daily and Trospium Once-Daily, including any claims
made about such Products, including any seminars, conferences or
medical education materials, which shall be consistent with the
provisions of Section 5.6.
(b) The quantity and
timing of distribution of Samples of Trospium Twice-Daily and
Trospium Once-Daily.
(c) The level of
marketing and other support for Trospium Twice-Daily and Trospium
Once-Daily to be provided by either Party; provided ,
however , that no additional obligations or costs may be
imposed upon either Party without the prior written consent of such
Party.
5.3 Target Prescribers;
Product Advisors.
(a) For each Calendar
Year, Esprit shall review with the Marketing Committee by
October 1 of the immediately preceding Calendar Year (or, for
the Calendar Year ending December 31, 2008, thirty
(30) days after the Effective Date) the specific Target
Prescribers for Trospium Twice-Daily and Trospium Once-Daily and
the planned copromotion
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CONFIDENTIAL TREATMENT REQUESTED |
30
coverage by Esprit and
Indevus; provided , however , that (a) the
Target Prescribers for the Indevus Sales Force shall be the Indevus
Target Prescribers; and (b) Esprit may also conduct Details to
the Indevus Target Prescribers.
(b) Notwithstanding
and in addition to any rights or requirements set forth in any
other provision of this Agreement, during the Copromotion Period,
Indevus shall, with the prior consent of Esprit, and at
Indevus’ cost, have the right to (i) have reasonable
access to all medical advisors and consultants and with medical
education, advertising and public relations agencies engaged by any
Party with respect to Trospium Twice-Daily and Trospium Once-Daily
(collectively, “ Product Advisors ”) and
(ii) participate in meetings or discussions relating to
marketing, medical education programs, advertising or any other
promotional activities relating principally to Trospium Twice-Daily
and Trospium Once-Daily between any Party or any Affiliate of any
Party and any Product Advisor.
5.4 Esprit Promotional
Activities.
(a) Esprit intends to
provide a professional fully trained sales force to support
Esprit’s obligations under this Agreement (the “
Esprit Sales Force ”). The Esprit Sales Force shall
include Representatives Promoting Products to Target Prescribers
and sales managers and sales directors who shall observe and
supervise each Esprit Representative in the field, conduct and
provide meaningful field evaluations, time supervision, territory
management and field reports and other miscellaneous paperwork on
behalf of the Esprit Sales Force. Esprit will provide the Marketing
Committee at each meeting (but not more often than each meeting)
with a report with respect to the monthly number and composition of
the Esprit Sales Force.
(b) The Esprit Sales
Force may conduct Details of products other than Products, as may
be determined by Esprit from time to time. Esprit acknowledges and
agrees that the absence of a requirement in this Agreement that
Esprit provide a specified minimum number of Representatives or
annual or quarterly Details shall not in any way minimize
Esprit’s commitment to Promote Products hereunder.
5.5 Indevus Promotional
Activities.
(a) The Indevus Sales
Force shall include Representatives Promoting Products to the
Indevus Target Prescribers and sales managers and sales directors
who shall observe and supervise each such Indevus Representative in
the field, conduct and provide meaningful field evaluations, time
supervision, territory management and field reports and other
miscellaneous paperwork on behalf of the Indevus Sales Force.
Indevus will provide the Marketing Committee at each meeting (but
not more often than each meeting) with a report with respect to the
monthly number and composition of the Indevus Sales
Force.
(b) Detail
Requirements.
(i) For the portion of
the Copromotion Period ending September 30, 2008, the number
of Quarterly Indevus Details, all of which shall be Primary
Position Details, to be delivered to the Indevus Target Prescribers
shall * during each Calendar Quarter; provided ,
however , that, if the period from the Effective Date to the
end of the first Calendar Quarter ending after the Effective Date
is less a full Calendar Quarter, the number of such Details shall
be subject to pro rata adjustment to the give effect to the reduced
number of days in such period.
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CONFIDENTIAL TREATMENT REQUESTED |
31
(ii) Indevus may
extend the Copromotion Period until December 31, 2008 by
providing written notice of such extension to Esprit by not later
than July 31, 2008. Indevus may further extend the Copromotion
Period until March 31, 2009 by providing written notice of
such extension to Esprit by not later than October 31, 2008.
In the event Indevus elects to extend the Copromotion Period, the
determination as to the number of Quarterly Indevus Details during
each extended Calendar Quarter shall be mutually agreed to by the
Parties by not later than June 30, 2008 and September 30,
2008 for the Calendar Quarter ending December 31, 2008 and
March 31, 2009, respectively; provided , however
, that the number of Quarterly Indevus Details during each such
extended Calendar Quarter shall be not less than * The foregoing
Details in each such extended Calendar Quarter may be Primary
Position Details or Secondary Position Details in such proportion
as is specified by Indevus on or prior to June 30, 2008 or
September 30, 2008, as applicable; provided that, for
the purpose of determining the number of Details completed pursuant
to this Section 5.5(b)(ii), each Primary Position Detail
conducted by Indevus during such extended Calendar Quarter shall
equal one (1) Detail, and each Secondary Position Detail
conducted by Indevus during such extended Calendar Quarter shall
equal * Detail.
(c) Detail
Adjustments. The Quarterly Indevus Details may be adjusted from
time to time based on the Marketing Committee’s determination
that the Product is promotionally sensitive as measured by
immediate sales increases through promotional efforts and such
other measurements of then-current market conditions (qualitative
or/and quantitative) as may be commercially reasonable;
provided , however , that any such adjustments shall
be subject to the prior written approval of Indevus. The Indevus
Sales Force may also conduct details of products other than
Product, as may be determined by Indevus from time to
time.
(d) Failure to Meet Detail
Requirements. If, for any Calendar Quarter during the
Copromotion Period, the Indevus Sales Force delivers less than one
hundred percent (100%) of the Quarterly Indevus Details set
forth in Section 5.5(b) for such Calendar Quarter, such
Calendar Quarter shall be deemed a Deficient Quarter, and the
following shall be applicable:
(i) If the Indevus
Sales Force delivers less than one hundred percent (100%) but
greater than * of the Quarterly Indevus Details set forth in
Section 5.5(b) for such Deficient Quarter, the Indevus Sales
Force shall cure the deficiency by delivering the deficient number
of Details during the Cure Period in addition to its required
Quarterly Indevus Details for the Cure Period.
(ii) If the Indevus
Sales Force delivers less than or equal to * but greater than * of
the Quarterly Indevus Details set forth in Section 5.5(b) for
such Deficient Quarter, (A) the Indevus Sales Force shall, at
Esprit’s election, cure the deficiency by delivering the
deficient number of Details during the Cure Period in addition to
its required Quarterly Indevus Details for the Cure Period and
(B) Esprit’s Sales Force Reimbursement payment
obligations for such Deficient Quarter pursuant to Section 6.3
shall be reduced to * of the amount that would otherwise have been
due for such Calendar Quarter pursuant to
Section 6.3.
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CONFIDENTIAL TREATMENT REQUESTED |
32
(iii) If the Indevus
Sales Force delivers less than or equal to * but greater than * of
the Quarterly Indevus Details set forth in Section 5.5(b) for
such Deficient Quarter, (A) the Indevus Sales Force shall, at
Esprit’s election, cure the deficiency by delivering the
deficient number of Details during the Cure Period in addition to
its required Quarterly Indevus Details for the Cure Period and
(B) Esprit’s Sales Force Reimbursement payment
obligations for such Deficient Quarter pursuant to Section 6.3
shall be reduced to * of the amount that would otherwise have been
due for such Calendar Quarter pursuant to
Section 6.3.
(iv) If the Indevus
Sales Force delivers less than or equal to * of the Quarterly
Indevus Details set forth in Section 5.5(b) for such Deficient
Quarter, at Esprit’s election, (A) the Copromotion
Period shall terminate and the Indevus Sales Force shall, at
Esprit’s election, cease all Details and (B) * pursuant
to Section 6.3 for such Deficient Quarter or
thereafter.
(e) The actual number
of Details made by the Indevus Sales Force to Target Prescribers
during each Calendar Quarter shall be determined and reported in
accordance with a call reporting system provided by Esprit to
Indevus under this Agreement during the Copromotion
Period.
5.6 Promotional Materials
and Activities. During the Copromotion Period, and in
compliance with Law, Esprit shall have the sole right to create and
develop the Promotional Materials with, during the Copromotion
Period, input and participation from the Marketing Committee,
subject to Section 5.6(a). During the Copromotion Period,
prior to finalizing such Promotional Materials and promotional
activities, each Party shall include the other Party in its
internal circulation of information regarding such promotional
materials and activities during the development of such Promotional
Materials and any event related materials and upon the finalization
of such materials.
(a) Neither Party
shall produce (other than as concepts for consideration by the
other Party), distribute or otherwise use any Promotional Materials
that have not been approved in advance by the Development Committee
for purposes of determining compliance with Law and agreed upon
standard operating procedures of each Party. Prior to the NDA
Transfer Date, Promotional Materials shall be submitted to
Indevus’ internal regulatory compliance personnel for timely
review pursuant to applicable internal standard operating
procedures, for an assessment of compliance with Law and shall be
subject to Indevus’ approval solely with respect to
compliance with Law. Such assessment shall be provided to both
Parties. Each Party shall limit its statements, discussions and
claims regarding Products, including those as to safety and
efficacy, to those that are consistent with the Product Labeling
and the Promotional Materials. Neither Party shall add, delete,
modify or distort claims of safety or efficacy in the Detailing of
Products, nor shall it make any changes (including underlining or
otherwise highlighting any language or adding any notes thereto) or
alter the presentation order or format in the Promotional
Materials.
(b) Esprit shall own
all right, title and interest in and to the copyrights in all
marketing, sales, advertising or Promotional Materials relating to
the Products in the Field in the Territory (“ Territory
Copyrighted Works ”). Indevus shall execute all documents
and take all actions as are reasonably requested by Esprit to vest
title to such Territory Copyrighted
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CONFIDENTIAL TREATMENT REQUESTED |
33
Works in Esprit. Esprit shall
be responsible, at its expense, for searching, clearing and filing
applications for registration of all such Territory Copyrighted
Works. To the extent such materials include or incorporate original
works of authorship created by Indevus prior to the Effective Date,
Indevus shall not use, or make any proprietary claim with regard
to, those pre-existing materials separate and apart from their use
and inclusion in Territory Copyrighted Works relating to
Products.
(c) Subject to
Section 5.6(b), Esprit and Indevus shall retain all rights,
including all copyrights and trademarks, to all of their respective
programs and materials existing as of the Effective Date in all
formats (including print, video, audio, digital, and computer
formats) regarding sales training, patient education and disease
management programs owned or licensed by each at the time such
materials are shared with the other Party, as well as any
modifications of such programs each may develop in the future that
are not specific to Products in the Field. Esprit and Indevus
shall, from time to time, each notify the other as to the identity
of such proprietary programs. In addition, all new programs that
are not specific to Products in the Field that are jointly
developed by Esprit and Indevus pursuant to this Agreement shall be
jointly owned by Esprit and Indevus, and each Party shall have the
right to use such jointly developed programs free of charge after
the expiration of the Agreement Term.
(d) Esprit shall be
the primary Party responsible for preparing all submissions with
the FDA regarding approval of all Promotional Materials that
require FDA approval; provided that prior to the NDA
Transfer Date Indevus shall be responsible for filing all such
submissions and participating with Esprit in any interactions with
the FDA regarding such matters. After the NDA Transfer Date, Esprit
shall be responsible for all submissions and interactions with the
FDA regarding approval of all Promotional Materials that require
FDA approval.
(e) Except as
otherwise prohibited by Law, during the Copromotion Period, all
Promotional Materials used by Indevus in connection with the
Promotion of Products under this Agreement shall be only those
supplied by Esprit. Indevus may display on such Promotional
Materials the Indevus Logo; provided that the trademark of
and specified by Esprit (or any person or entity to which Esprit
assigns or sublicenses rights hereunder) shall appear to the left
of and/or above the Indevus Logo. Indevus shall not use any
representations of any mark of Esprit other than those supplied by
Esprit in Promotional Materials. Solely to the extent required by
Law, all Promotional Materials used by Esprit will indicate that a
Product is sold under license from Indevus and promoted by Esprit
or any such Affiliate, as directed by Esprit. All promotional
materials used by Indevus in connection with the Promotion of
Products under this Agreement shall indicate that the Trademarks
(except for the Indevus Logo) are owned by Esprit or any such
Affiliate, as directed by Esprit. Notwithstanding anything to the
contrary in this Section 5.6(e), except to the extent required
by Law, in no event shall any packaging, trade dress, journal
advertising and sales aids, or FDA approved Product Labeling
display any mark of Indevus.
(f) Within ninety
(90) days after the expiration or termination of this
Agreement, each Party shall return (unless prohibited by Law), or
otherwise dispose of in accordance with instructions from the other
Party, all remaining Promotional Materials provided by the other
Party and will provide the other Party with a certified statement
that all remaining Promotional Materials have been returned or
otherwise properly disposed of and that the Party is no longer in
possession or control of any such Promotional Materials in any form
or fashion.
34
5.7 Samples. The
following terms shall apply to any Samples in the
Territory:
(a) Esprit shall
distribute to each Party Samples to be used by the Sales Forces.
All supply and costs of Samples shall be subject to the provisions
of Article 14.
(b) Each Party shall
receive and use such Samples in accordance with the Promotion Plan
and Laws. The quantity of Samples to be provided to each Party and
the method of distribution shall be determined by Esprit;
provided , that the number of Samples provided to a Party
shall be consiste
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