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E XHIBIT
10.1
FOIA CONFIDENTIAL
TREATMENT REQUESTED
E XECUTION
C OPY
NEKTAR
THERAPEUTICS,
AEROGEN,
INC.,
AND
BAYER HEALTHCARE
LLC
CO-DEVELOPMENT, LICENSE
AND CO-PROMOTION AGREEMENT
AUGUST 1,
2007
[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
TABLE OF
CONTENTS
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Page |
| 1. |
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D EFINITIONS |
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2 |
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| 2. |
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L ICENSE G RANTS |
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13 |
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2.1 |
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License
Grants to Bayer |
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13 |
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2.2 |
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Certain
Covenants |
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14 |
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2.3 |
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Sublicense Rights |
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14 |
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2.4 |
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No
Implied Rights or Licenses |
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14 |
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2.5 |
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Exclusivity |
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15 |
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2.6 |
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Covenant
Not to Sue |
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15 |
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2.7 |
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Reserved
Rights |
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15 |
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| 3. |
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G OVERNANCE |
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15 |
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3.1 |
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General |
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15 |
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3.2 |
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Joint
Steering Committee |
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16 |
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3.3 |
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Joint
Finance Committee |
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17 |
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3.4 |
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Global
Project Team |
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18 |
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3.5 |
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Global
Brand Team |
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18 |
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3.6 |
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U.S.
Regional Business Unit |
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19 |
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3.7 |
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Nektar
Participation in Committees and Teams |
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20 |
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3.8 |
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Disbanding of Committees and Withdrawal from Teams or
Units |
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20 |
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3.9 |
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Decision
Making After Withdrawal from or Disbanding of
Committees |
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21 |
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| 4. |
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D EVELOPMENT P ROGRAM |
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21 |
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4.1 |
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Project |
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21 |
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4.2 |
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Development Plan and Development Budget |
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21 |
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4.3 |
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Standard
of Performance |
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22 |
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4.4 |
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Subcontracting Permitted |
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23 |
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| 5. |
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R EGULATORY M ATTERS |
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23 |
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5.1 |
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Pharmacovigilance Agreement |
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23 |
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5.2 |
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Preparation of Regulatory Filings |
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23 |
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5.3 |
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Notice of
Communication with Regulatory Authorities |
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24 |
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5.4 |
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Regulatory Compliance. |
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25 |
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5.5 |
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Regulatory Documentation |
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26 |
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5.6 |
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Transfer
of IND |
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26 |
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5.7 |
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Product
Recall |
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26 |
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5.8 |
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Conformité Europeen Mark |
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26 |
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5.9 |
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Cooperation |
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26 |
- i -
[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
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P AGE |
| 6. |
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D ILIGENCE |
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26 |
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| 7. |
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C OMMERCIALIZATION |
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27 |
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7.1 |
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Commercialization Plan and Commercialization Budget in the
Shared Territory |
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27 |
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7.2 |
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Launch
Plan and Launch Budget for the Shared Territory |
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28 |
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7.3 |
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[***] |
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28 |
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7.4 |
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[***] |
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29 |
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7.5 |
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Sales
Representative Compliance |
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29 |
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7.6 |
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Commitment in the Shared Territory |
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29 |
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7.7 |
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Packaging; Bayer and Nektar Marks |
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29 |
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7.8 |
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Promotion
in [***] |
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30 |
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| 8. |
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P AYMENT O BLIGATIONS |
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30 |
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8.1 |
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Research
and Development Funding |
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30 |
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8.2 |
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Shared
Territory Pre-Launch Costs; Profit-Sharing |
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31 |
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8.3 |
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Milestone
Payments |
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33 |
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8.4 |
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Royalties
in the Royalty Territory |
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34 |
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8.5 |
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Payments |
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36 |
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8.6 |
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Currency
of Payment |
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36 |
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8.7 |
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Single
Royalty |
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36 |
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8.8 |
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Sublicensing |
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36 |
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8.9 |
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Accounting. |
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36 |
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8.10 |
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Withholding Tax |
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37 |
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| 9. |
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M ANUFACTURE AND S
UPPLY OF A MIKACIN
AND THE D
EVICE |
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37 |
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9.1 |
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Manufacturing and Supply Agreement |
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37 |
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9.2 |
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Clinical
Manufacturing and Supply |
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38 |
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9.3 |
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Manufacturing Expenditures |
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38 |
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| 10. |
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R ECORD K EEPING , R
ECORD R ETENTION AND A
UDITS |
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38 |
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10.1 |
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Record
Keeping |
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38 |
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10.2 |
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Record
Retention |
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38 |
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10.3 |
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Audit
Request |
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39 |
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10.4 |
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Survival |
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39 |
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| 11. |
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I NVENTIONS , K NOW -H
OW AND P
ATENTS |
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39 |
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11.1 |
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Existing
Intellectual Property |
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39 |
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11.2 |
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Ownership
of Inventions |
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40 |
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11.3 |
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Patent
Prosecution and Maintenance |
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41 |
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11.4 |
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Third
Party Licenses |
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42 |
- ii -
[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
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P AGE |
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11.5 |
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Infringement by Third Parties |
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43 |
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11.6 |
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Infringement Outside the Field |
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44 |
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11.7 |
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Further
Actions |
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44 |
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| 12. |
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R EPRESENTATIONS AND W
ARRANTIES |
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44 |
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12.1 |
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The
Parties’ Representations and Warranties |
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44 |
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12.2 |
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Additional Representations and Warranties of Bayer |
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45 |
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12.3 |
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Additional Representations and Warranties of Nektar and
Aerogen |
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45 |
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| 13. |
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N ON -S OLICITATION
OF E MPLOYEES |
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47 |
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13.1 |
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Non-Solicitation |
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47 |
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| 14. |
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M UTUAL I NDEMNIFICATION
AND I NSURANCE |
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47 |
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14.1 |
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Nektar’s Right to Indemnification |
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47 |
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14.2 |
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Bayer’s Right to Indemnification |
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47 |
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14.3 |
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Process
for Indemnification |
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48 |
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14.4 |
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Insurance. |
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49 |
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| 15. |
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C ONFIDENTIALITY |
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49 |
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15.1 |
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Confidentiality; Exceptions |
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49 |
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15.2 |
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Degree of
Care; Permitted Use |
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50 |
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15.3 |
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Permitted
Disclosures |
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50 |
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15.4 |
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Irreparable Injury |
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51 |
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15.5 |
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Return of
Confidential Information |
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51 |
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| 16. |
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P UBLICITY |
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51 |
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16.1 |
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Public
Disclosure |
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51 |
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| 17. |
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T RADEMARKS |
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52 |
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17.1 |
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Product
Trademark; Use of Nektar Trademark |
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52 |
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17.2 |
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Trademark
Prosecution and Maintenance |
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52 |
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| 18. |
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T ERM AND T
ERMINATION |
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52 |
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18.1 |
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Term |
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52 |
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18.2 |
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Termination by Bayer. |
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53 |
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18.3 |
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Termination by Nektar |
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53 |
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18.4 |
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Termination for Material Breach |
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54 |
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18.5 |
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Termination upon Insolvency |
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54 |
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18.6 |
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Termination by Bayer Pursuant to Section 18.2 or by Nektar
Pursuant to Section 18.3 or 18.4 |
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54 |
- iii -
[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
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Page |
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18.7 |
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Termination by Bayer for Material Breach by Nektar |
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57 |
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18.8 |
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General
Surviving Obligations |
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59 |
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18.9 |
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Challenge |
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59 |
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18.10 |
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Accrued
Rights, Surviving Obligations |
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60 |
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18.11 |
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Rights in
Bankruptcy |
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60 |
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| 19. |
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LIMITATION OF LIABILITY AND EXCLUSION OF DAMAGES; DISCLAIMER OF
WARRANTY |
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60 |
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| 20. |
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M ISCELLANEOUS |
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61 |
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20.1 |
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Agency |
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61 |
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20.2 |
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Assignment; Change of Control. |
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61 |
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20.3 |
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Further
Actions |
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62 |
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20.4 |
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Force
Majeure |
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62 |
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20.5 |
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Notices |
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62 |
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20.6 |
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Amendment |
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64 |
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20.7 |
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Waiver |
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64 |
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20.8 |
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Counterparts |
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64 |
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20.9 |
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Construction |
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64 |
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20.10 |
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Governing
Law |
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64 |
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20.11 |
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Severability |
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64 |
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20.12 |
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Compliance with Applicable Law |
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65 |
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20.13 |
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Entire
Agreement of the Parties |
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65 |
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20.14 |
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Performance by Affiliates. |
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65 |
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20.15 |
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Certain
Additional Obligations |
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65 |
- iv -
[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
CO-DEVELOPMENT, LICENSE
AND CO-PROMOTION AGREEMENT
T HIS C
O -D EVELOPMENT , L
ICENSE AND C O -P
ROMOTION A GREEMENT (the
“Agreement” ) is made and entered into as of the
1 st
day of August, 2007 (the
“Effective Date” ) among NEKTAR
THERAPEUTICS , a Delaware corporation with a principal place of
business at 150 Industrial Road, San Carlos, California 94070
U.S.A. ( “Nektar” ), AEROGEN, INC. , a
Delaware corporation with a principal place of business at 150
Industrial Road, San Carlos, California 94070 U.S.A. (
“Aerogen” ), a wholly-owned subsidiary of
Nektar, and BAYER HEALTHCARE LLC, a Delaware corporation
with a principal place of business at 555 White Plains Road,
Tarrytown, New York 01591 U.S.A. ( “Bayer” ).
Nektar and Bayer are sometimes referred to herein individually as a
“Party” and collectively as the “Parties”
(which terms shall not include Aerogen). Except as otherwise
provided in Section 20.14 hereof, references to
“Nektar,” “Aerogen,” and
“Bayer” shall not include their respective
Affiliates.
R
ECITALS
W
HEREAS , Nektar is a biotechnology company
engaged in the research, development, and commercialization of
pharmaceutical compounds and devices for delivering such
compounds;
W
HEREAS , Bayer is a pharmaceutical company
engaged in the research, development and commercialization of
products useful in the amelioration, treatment and/or prevention of
human diseases and conditions;
W
HEREAS , Nektar has developed and is conducting
clinical trials of a pharmaceutical product consisting of a liquid
formulation of the antibiotic known as Amikacin delivered using a
nebulizer device based on Nektar’s proprietary pulmonary drug
delivery system;
W
HEREAS , Bayer and Nektar desire to collaborate
in certain activities to develop such product in both “
[***] ” and “ [***] ”
configurations for the treatment of [***] infections;
W
HEREAS , Bayer and Nektar desire to collaborate
in the promotion and commercialization of such product to expand
the availability of, and access by patients to, such product
worldwide; and
W
HEREAS , Bayer desires to obtain, and Nektar and
Aerogen are willing to grant to Bayer, a license under
Nektar’s and Aerogen’s proprietary technology to
import, develop, commercialize, make, promote, market, use, offer
for sale and sell a product based upon such pulmonary delivery of
liquid Amikacin, on the terms and conditions provided in this
Agreement.
A
GREEMENT
N OW , T
HEREFORE , in consideration of the foregoing and
the covenants and promises contained in this Agreement and
intending to be legally bound, the Parties agree as
follows:
1. D
EFINITIONS . As used herein, the following terms
shall have the following meanings:
1.1
“[***]” has the meaning set forth in the
[***] .
- 1 -
[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
1.2
“[***]” has the meaning set forth in the
[***] .
1.3 “ACCME
Standards” means the standards set forth by the
Accreditation Council for Continuing Medical Education relating to
educating the medical community in the United States.
1.4
“Aerogen” has the meaning set forth in the
Preamble.
1.5
“Affiliate” means a corporation, partnership, trust
or other entity that directly, or indirectly through one or more
intermediates, controls, is controlled by or is under common
control with a specified Party. For such purposes,
“control,” “controlled by” and “under
common control with” shall mean the possession of the power
to direct or cause the direction of the management and policies of
an entity, whether through the ownership of voting equity, voting
member or partnership interests, control of a majority of the board
of directors or other similar body, by contract or otherwise. In
the case of a corporation, the direct or indirect ownership of more
than fifty percent (50%) of its outstanding voting shares or
the ability otherwise to elect a majority of the board of directors
or other managing authority of the entity shall in any event be
presumptively deemed to confer control, it being understood that
the direct or indirect ownership of a lesser percentage of such
shares shall not necessarily preclude the existence of
control.
1.6
“Agent” means any Third Party that is hired by,
licensed by, sublicensed by or otherwise contractually associated
with a Party during the term of this Agreement to the extent useful
or necessary for the Party to fulfill its obligations under this
Agreement.
1.7
“Agreement” means this Co-Development, License and
Co-Promotion Agreement, all amendments and supplements to this
Co-Development, License and Co-Promotion Agreement and all
schedules and exhibits to this Co-Development, License and
Co-Promotion Agreement.
1.8 “Allowable
Expenses” means those expenses incurred in connection
with Commercialization of Product in the Shared Territory
(excluding Pre-Launch Costs) that are consistent with the approved
Commercialization Plan and Commercialization Budget for the Shared
Territory and are specifically attributable to Product in the
Shared Territory, and shall consist of (a) Cost of Goods Sold,
(b) Marketing Expenses, (c) Distribution Expenses,
(d) Post-Launch Product R&D Expenses, and
(e) Regulatory Expenses (as such terms are defined in Exhibit
1.8). Allowable Expenses also includes all GSM Expenses (as defined
in Exhibit 1.8), whether incurred with respect to the Shared
Territory or the Royalty Territory, as more fully described in
Exhibit 1.8.
1.9
“Amikacin” means the [***] .
- 2 -
[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
1.10 “Applicable
Law” means all applicable laws, rules, and regulations,
including, without limitation, any rules, regulations, guidelines
or other requirements of the Regulatory Authorities or other
governmental authorities, that may be in effect from time to time
in any relevant legal jurisdiction in the Territory.
1.11
“Bayer” has the meaning set forth in the
Preamble.
1.12 “Change of
Control” means that a Third Party shall have become the
beneficial owner of securities representing fifty-one percent
(51%) or more of the aggregate voting power of the
then-outstanding voting securities of a Party, or any sale by a
Party of all or substantially all of its business or assets
pertaining to the Product.
1.13 “CIA”
means the Corporate Integrity Agreement between the Office of
Inspector General of the Department of Health and Human Services
and Bayer Corporation dated January 23, 2001.
1.14 “Clinical
Trials” means Phase I Clinical Trials, Phase II Clinical
Trials, Phase III Clinical Trials, Phase IV Clinical Trials, and/or
variations of such trials (e.g., Phase II/III) as those terms are
defined by the FDA.
1.15 “CMC
Data” means any and all Information contained in, as well
as data supporting, the Chemistry, Manufacturing and Control
sections (or sections corresponding thereto) of an NDA, or other
equivalent regulatory filing, relating to the Product.
1.16
“Commencement” or “Commence” means,
when used with respect to Clinical Trials (or the local
equivalent), the date of enrollment of the first patient or subject
in such Clinical Trials (or the local equivalent).
1.17
“Commercialization” means all activities undertaken
relating to the manufacture for commercial use, marketing, and/or
sale of the Product, including without limitation Pre-Launch
Activities, advertising, education, planning, marketing, promotion,
distribution, market and product support, and shall include
post-launch medical activities such as Phase IV Clinical
Trials anywhere in the world but shall exclude Development
activities. “Commercialize” shall have a
corresponding meaning.
1.18
“Commercialization Budget” has the meaning set
forth in Section 7.1(b).
1.19
“Commercialization FTE” means the equivalent of an
employee working [***] labor hours per year on
Commercialization of Product.
1.20
“Commercialization FTE Rate” means the overall
rate, as determined by the JFC pursuant to Section 3.3(b), to
be applied to each Commercialization FTE employed by Bayer or
Nektar providing support for or involved in Commercialization of
Product in the Shared Territory, including without limitation
[***] and [***] , in each year.
1.21
“Commercialization Plan” has the meaning set forth
in Section 7.1(b).
- 3 -
[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
1.22 “Commercial
Launch” means the first arm’s length commercial
sale of the Product by Bayer, an Affiliate of Bayer or a
Sublicensee of Bayer to a Third Party (including without limitation
any final sale to a distributor or wholesaler under any
non-conditional sale arrangement) in a country where Regulatory
Approval of such Product has been obtained by or on behalf of
Bayer; provided, however, that in no event shall any sale or
distribution of the Product for Pre-Launch Activities or use in a
Clinical Trial be deemed a Commercial Launch.
1.23 “Commercially
Reasonable Efforts” means, with respect to the
Exploitation of the Product, the level of efforts and resources
(including without limitation the promptness with which such
efforts and resources would be applied) commonly used in the
pharmaceutical industry with respect to a product of similar
commercial potential at a similar stage in its development or
product life, taking into consideration its safety and efficacy,
its cost to develop, manufacture and bring to market, the
prevalence of the indication, the competitiveness of alternative
products of Third Parties, the Patent and other proprietary
position of such product, the likelihood of Regulatory Approval,
its profitability and all other relevant factors. Commercially
Reasonable Efforts shall be determined on a market-by-market basis
for the Product.
1.24 “Competitive
Product” means a product containing an [***] that
is labeled for amelioration, treatment or prevention of
[***] and that includes technology that, [***]
.
1.25
“Completion” means, when used with respect to a
Clinical Trial (or the local equivalent), the date on which the
Party conducting the Clinical Trial completes the final report for
such Clinical Trial (or the local equivalent).
1.26 “Confidential
Information” has the meaning set forth in
Section 15.1.
1.27
“Control” means, with respect to any item of
Information, Patent, Patent Application, know-how or other
intellectual property right, the right to grant a license or
sublicense with respect thereto as provided for in this Agreement,
without violating the terms of any agreement or other arrangement
with, or any legal rights of, or without requiring the consent of,
any Third Party.
1.28
“Damages” has the meaning set forth in
Section 14.1.
1.29 “Develop”
or “Development” means all activities relating to
obtaining Regulatory Approval of the Product and all manufacturing
activities undertaken prior to Commercialization (including without
limitation those activities reasonably required for the scale up of
Manufacturing processes or equipment in preparation for commercial
supply of Product). This includes, for example,
(a) preclinical testing, toxicology, formulation, clinical
studies, including without limitation Clinical Trials, and
regulatory affairs and (b) manufacturing process development
for bulk and finished forms of the Device or the Product, as
applicable, production of clinical supply of Product, and
manufacturing and quality assurance technical support activities
prior to the commencement of Pre-Launch Activities, but excludes
Manufacturing for Commercialization purposes.
1.30 “Development
Budget” has the meaning set forth in
Section 4.2(a).
- 4 -
[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
1.31 “Development
Costs” means the expenses incurred by a Party or for its
account after the Effective Date that are consistent with the
approved Development Plan and are specifically attributable to the
Development of the Product.
1.32 “Development
Plan” has the meaning set forth in
Section 4.2(a).
1.33
“Device” means a nebulizer device comprising at
least an [***] . The current embodiment of the Device is set
forth in Exhibit 1.33.
1.34 “Device
Budget” has the meaning set forth in
Section 4.2(a).
1.35 “DMF”
means, as the case may be, either a drug master file or a device
master file maintained with the FDA and the equivalent thereof, if
any, in jurisdictions outside the Shared Territory.
1.36
“Dollar” means a U.S. dollar, and
“$” shall be interpreted accordingly.
1.37 “Drug
Budget” has the meaning set forth in
Section 4.2(a).
1.38
“EMEA” means the European Medicines Agency, or any
successor thereto, which coordinates the scientific review of human
pharmaceutical products under the centralized licensing procedure
in the European Union.
1.39 “European
Union” means the countries that are members of the
European Union as of the Effective Date of this Agreement or that
become members of the European Union thereafter.
1.40
“Exploitation” means the making, having made,
using, having used, selling, having sold, offering for sale and/or
otherwise disposing of, the Product, including, without limitation,
all discovery, research, development (including without limitation
the conduct of Clinical Trials), registration, modification,
enhancement, improvement, manufacturing, labeling, storage,
formulation, exportation, importation, optimization,
transportation, distribution, promotion and marketing activities
related thereto.
1.41 “FDA”
means the United States Food and Drug Administration, or any
successor thereto, having the administrative authority to regulate
the marketing of human pharmaceutical products or biological
therapeutic products, delivery systems and devices in the United
States.
1.42
“Field” means the amelioration, treatment and/or
prevention in humans of [***] .
1.43 “Force Majeure
Event” has the meaning set forth in
Section 20.4.
1.44 “Formulated
Amikacin” means Amikacin in a liquid formulation existing
as of the Effective Date or developed pursuant to this Agreement
for use in Pulmonary Delivery by means of the Device.
- 5 -
[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
1.45 “Fully Burdened
Manufacturing Costs” means, as applicable to Device,
Formulated Amikacin, or Product manufactured by Nektar or its Third
Party supplier, Nektar’s or its Affiliate’s cost of
manufacturing such Device, Formulated Amikacin, or Product for
Development or Commercial purposes, which is equal to the sum of
(a) for the Device, Formulated Amikacin or Product (or
components thereof) made by Nektar, the costs of all direct
material, direct labor, and allocable manufacturing overhead
consumed, provided or procured by Nektar, in each case for the
manufacture of the Device, Formulated Amikacin, or Product, and
(b) for Device, Formulated Amikacin, or Product (or components
thereof) made by Nektar’s Third Party supplier, the
out-of-pocket costs paid to such Third Party supplier by Nektar, to
the extent such costs in (a) and (b) are incurred by
Nektar or its Affiliates and to the extent they are reasonably
allocable to the manufacture of such Device, Formulated Amikacin,
or Product. For clarity, Fully Burdened Manufacturing Cost shall
not include any costs of scaling up Manufacturing for the Device or
Formulated Amikacin, Development Costs, or capital expenses (but
shall include depreciation on capital expenses incurred for the
Manufacture of Device, Formulated Amikacin, or Product). Fully
Burdened Manufacturing Cost shall be calculated in a manner
consistent with GAAP, consistently applied.
1.46
“GAAP” means United States generally accepted
accounting principles consistently applied.
1.47 “Global Brand
Team” or “GBT” has the meaning set forth in
Section 3.1.
1.48 “Global Phase
IV Costs” means the expenses incurred in the conduct of
Global Phase IV Trials.
1.49 “Global Phase
IV Trial” means any Phase IV Clinical Trial that is
conducted in order to benefit the Product in multiple countries,
which countries include, but are not limited to, the Shared
Territory, regardless of the country in which it is
conducted.
1.50 “Global Project
Team” or “GPT” has the meaning set forth in
Section 3.1.
1.51 “Global
Strategic Marketing Team” or “GSM” means the
internal Bayer marketing group that will oversee the global
marketing, strategy and planning for the Product, in which
[***] will participate with respect to Product-related
matters.
1.52 “Good Clinical
Practices” or “GCP” means the standards,
practices and procedures set forth in the guidelines entitled in
“Good Clinical Practice: Consolidated Guideline,”
including related regulatory requirements imposed by the FDA and
(as applicable) any equivalent or similar standards in
jurisdictions outside the Shared Territory.
1.53 “Good
Laboratory Practices” or “GLP” means the
regulations set forth in 21 C.F.R. Part 58 and the requirements
expressed or implied thereunder imposed by the FDA and (as
applicable) any equivalent or similar standards in jurisdictions
outside the Shared Territory.
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[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
1.54 “Good
Manufacturing Practices” or “GMP” means the
regulations set forth in 21 C.F.R. Parts 210–211, 820 and 21
C.F.R. Subchapter C (Drugs), Quality System Regulations and the
requirements thereunder imposed by the FDA, and, as applicable, any
similar or equivalent regulations and requirements in jurisdictions
outside the Shared Territory.
1.55 “IAS”
means International Accounting Standards consistently
applied.
1.56
“IFRS” means International Financial Reporting
Standards consistently applied.
1.57 “IND”
means an Investigational New Drug application for the Product,
which must be approved by the FDA (or foreign equivalent) before
shipment of such Product intended for administration to
humans.
1.58 “Indemnified
Party” has the meaning set forth in
Section 14.3(a).
1.59 “Indemnifying
Party” has the meaning set forth in
Section 14.3(a).
1.60
“Information” means ideas, inventions, discoveries,
concepts, formulas, practices, procedures, processes, methods,
knowledge, know-how, trade secrets, technology, designs, drawings,
computer programs, skill, experience, documents, apparatus,
results, clinical and regulatory strategies, test data, including
without limitation pharmacological, toxicological and clinical
data, analytical and quality control data, manufacturing data and
descriptions, Patent and legal data, market data, financial data or
descriptions, devices, assays, chemical formulations,
specifications, compositions of matter, product samples and other
samples, physical, chemical and biological materials and compounds,
and the like, in written, electronic or other form, now known or
hereafter developed, whether or not patentable.
1.61 “Initial Public
Disclosure” has the meaning set forth in
Section 16.1.
1.62
“Inventions” has the meaning set forth in
Section 11.2(a).
1.63 “Joint Finance
Committee” or “JFC” has the meaning set forth
in Section 3.1.
1.64 “Joint
Inventions” has the meaning set forth in
Section 11.2(a).
1.65 “Joint Patent
Rights” has the meaning set forth in
Section 11.3(a)(iii).
1.66 “Joint Steering
Committee” or “JSC” has the meaning set forth
in Section 3.1.
1.67 “Launch
Budget” has the meaning set forth in
Section 7.2(a).
1.68 “Launch
Plan” has the meaning set forth in
Section 7.2(a).
1.69 “Local Phase IV
Costs” means the expenses incurred in the conduct of
Local Phase IV Trials.
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[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
1.70 “Local Phase IV
Trial” means any Phase IV Clinical Trial that is
conducted in order to benefit the Product only in the country in
which it is conducted.
1.71 “MAA”
means a marketing authorization application filed with the EMEA for
Regulatory Approval to import, market and sell the Product in the
European Union.
1.72
“Manufacture” or “Manufacturing”
means the activities to be performed by Nektar and Bayer in
connection with the manufacture, testing (including without
limitation quality control, quality assurance and lot release
testing), bulk packaging and/or storage of Formulated Amikacin, the
Device, and/or the Product, as applicable.
1.73 “Manufacturing
and Supply Agreement” has the meaning set forth in
Section 9.1(a).
1.74 “Milestone
Payments” has the meaning set forth in
Section 8.3.
1.75 “Minimum
Acceptable Commercialization Profile” or
“MACP” means the characteristics of Product that
must be satisfied in order to enable Commercialization of the
Product, as set forth in Exhibit 1.75.
1.76
“[***]” has the meaning set forth in
Section 7.4.
1.77
“Nektar” has the meaning set forth in the
Preamble.
1.78 “Nektar
Know-How” means all Information that is
(a) Controlled by Nektar or Aerogen as of the Effective Date
or at any time during the term of this Agreement that is not
publicly known, even though parts thereof may be known, and
(b) useful or necessary to develop, make, use, sell, offer for
sale, import or export Product for use in the Field. Nektar
Know-How includes without limitation the [***] . Nektar
Know-How includes Nektar’s or Aerogen’s interest in
unpublished Inventions and unpublished Joint Inventions. Nektar
Know-How does not include Nektar Patent Rights.
1.79 “Nektar Patent
Rights” means (a) the Patents listed in Exhibit
1.79, (b) any Patents that issue from the Patent Applications
listed in Exhibit 1.79, (c) any Patents and/or Patent
Applications that claim priority to a Patent or Patent Application
listed in Exhibit 1.79, including without limitation any
continuation, continued prosecution application, divisional,
reissue or re-examination, (d) any other Patent and/or Patent
Application Controlled by Nektar or Aerogen as of the Effective
Date or at any time during the term of this Agreement that claims a
product, method, apparatus, material, manufacturing process or
other technology necessary to develop, make, use, sell, offer for
sale, import or export Formulated Amikacin, the Device, or Product,
and (e) any foreign equivalents of 1.79(a), (b), (c) or
(d). Nektar Patent Rights include, without limitation, the Patents
and Patent Applications [***] . Nektar Patent Rights
includes Nektar’s or Aerogen’s interest in Joint Patent
Rights. Nektar Patent Rights do not include Nektar
Know-How.
1.80 “Nektar
Trademarks” means the trademarks set forth in Exhibit
1.80 and any Trademarks of Nektar or Aerogen that are developed
during the term of this Agreement for use with the
Product.
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[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
1.81 “Net
Sales” means the gross amount billed by Bayer, its
Affiliates or Sublicensees to Third Parties throughout the
Territory for sales of the Product, less (a) sales returns and
allowances, including trade, quantity and cash discounts and any
other adjustments, including those granted on account of price
adjustments, billing errors, rejected goods, damaged goods,
returns, rebates, chargeback rebates, fees, reimbursements or
similar payments granted or given to wholesalers or other
distributors, buying groups, healthcare insurance carriers or other
institutions, (b) accrued allowances for normal and customary
trade, quantity and cash discounts, (c) an aggregate flat
percentage of [***] (regardless of actual cost) for all of
the following actually invoiced to the Third Party: freight,
transportation, insurance, handling, packing and distribution
charges, (d) the lower of [***] or the actual loss
experience of the global Bayer-Schering Pharmaceuticals group in
respect of bad debts written off, provided, however, that such
amount shall not exceed [***] on an annual basis,
(e) customs or excise taxes including import duties and other
duties relating to sales, (f) any payment in respect to sales
to any governmental authority in respect of any government
subsidized program, including without limitation Medicare and
Medicaid rebates and (g) any item substantially similar in
character and/or substance to the above, all as determined in
accordance with IFRS or IAS on a basis consistent with
Bayer’s annual audited financial statements. In addition, Net
Sales by Bayer hereunder are subject to the following:
(1) Any transfer, sale or
other disposal of the Product by Bayer to an Affiliate of Bayer
will not be included in Net Sales; in such case, Net Sales shall be
calculated as above on the value charged or invoiced on the first
arm’s length sale to a Third Party;
(2) If Bayer or its
Affiliates or Sublicensees make a sale or other disposition of the
Product to a customer in a particular country (i) other than
on normal commercial terms or (ii) as part of a package of
products and services, the Net Sales of the Product shall be deemed
to be “the fair market value” of such Product (i.e.,
the value that would have been derived had said Product been sold
as a separate product to a similar customer in the country
concerned on normal commercial terms); and
(3) Use of the Product in
clinical or pre-clinical trials or other research or development
activities or disposal of the Product for non-profit purposes of a
commercially reasonable program shall not give rise to any deemed
sale for purposes of this definition.
For clarity, Net Sales excludes Net
Sublicense Revenues.
1.82 “Net Sublicense
Revenues” means all revenues or other consideration
received by a Party from Third Parties as consideration for the
grant of a sublicense or license under this Agreement in the Shared
Territory, other than royalties received from such Third Parties on
Net Sales.
1.83 “New Drug
Application” or “NDA” means (a) the
single application or set of applications for the Product and/or
pre-market approval to make and sell commercially the Product,
filed by Bayer with the FDA, and (b) any related registrations
with or notifications to the FDA.
1.84 “Non-Publishing
Party” has the meaning set forth in
Section 16.1.
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[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
1.85 “OIG”
means the Office of the Inspector General.
1.86 “Party”
or “Parties” has the meaning set forth in the
Preamble.
1.87
“Patent” means (a) letters patent (or other
equivalent legal instrument), including without limitation utility
and design patents, and including without limitation any extension,
substitution, registration, confirmation, reissue, re-examination
or renewal thereof and (b) all foreign or international
equivalents of any of the foregoing in any country in the
Territory.
1.88 “Patent
Application” means (a) an application for letters
patent, including without limitation a reissue application, a
re-examination application, a continuation application, a continued
prosecution application, a continuation-in-part application, a
divisional application or any equivalent thereof that is pending at
any time during the term of this Agreement before a government
Patent agency and (b) all foreign or international equivalents
of any of the foregoing in any country in the Territory.
1.89 “PDDS Platform
Technology” means any technology, article of manufacture,
component, system, discovery, or invention that relates to the
[***] and methods of making or using the [***] . For
the avoidance of doubt, [***] .
1.90 “Phase I
Clinical Trial” means any clinical study conducted on
sufficient numbers of human subjects to establish that the Product
is reasonably safe for continued testing and to support its
continued testing in Phase II Clinical Trials. “Phase I
Clinical Trial” shall include without limitation any clinical
trial that would satisfy requirements of 21 C.F.R.
§ 312.21(a).
1.91 “Phase II
Clinical Trial” means any clinical study conducted on
sufficient numbers of human subjects that have the targeted disease
or condition of interest to investigate the safety and efficacy of
the Product for its intended use and to define warnings,
precautions, and adverse reactions that may be associated with such
pharmaceutical product in the dosage range to be prescribed.
“Phase II Clinical Trial” shall include without
limitation any clinical trial that would satisfy requirements of 21
C.F.R. § 312.21(b).
1.92 “Phase III
Clinical Trial” means any clinical study intended as a
pivotal study for purposes of seeking Regulatory Approval that is
conducted on sufficient numbers of human subjects to establish that
the Product is safe and efficacious for its intended use, to define
warnings, precautions, and adverse reactions that are associated
with the Product in the dosage range to be prescribed, and to
support Regulatory Approval of the Product or label expansion of
such pharmaceutical product. “Phase III Clinical Trial”
shall include without limitation any clinical trial that would or
does satisfy requirements of 21 C.F.R. § 312.21(c), whether or
not it is designated a Phase III Clinical Trial.
1.93 “Phase IV
Clinical Trial” means clinical study of the Product on
human subjects commenced after receipt of Regulatory Approval of
the Product for the purpose of satisfying a condition imposed by a
Regulatory Authority to obtain Regulatory Approval, or to support
the marketing of such pharmaceutical product, and not for the
purpose of obtaining initial Regulatory Approval of the
Product.
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[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
1.94 “PhRMA
Code” means the Pharmaceutical Research and Manufacturers
of America Code on Interactions with Healthcare Professionals, as
hereafter amended from time to time.
1.95
“Plan” means Development Plan, Commercialization
Plan, or Launch Plan, as applicable.
1.96 “Pre-Launch
Activities” means all Commercialization activities
undertaken with respect to the Product in the Shared Territory
prior to Commercial Launch and in preparation for the launch of the
Product in the Shared Territory. Pre-Launch Activities shall
include without limitation advertising, education, product-related
public relations, health care economic studies, governmental
affairs activities for reimbursement and formulary acceptance,
sales force training, and other activities included within the
Launch Plan or the Commercialization Plan that are to be conducted
in the Shared Territory prior to the Commercial Launch of the
Product and shall exclude all Development activities and the
[***] .
1.97 “Pre-Launch
Costs” means the costs, excluding Development Costs,
specifically attributable to the Pre-Launch Activities in the
Shared Territory that are generally consistent with the approved
Launch Plan and the Commercialization Plan.
1.98
“Product” means the combination of
(a) Formulated Amikacin and (b) the Device for use in the
Pulmonary Delivery of Formulated Amikacin, which Product is
developed in accordance with and pursuant to this Agreement.
Product shall not include any products including nebulizer devices
based upon the PDDS Platform Technology for use or sale with any
active ingredients other than Amikacin, or any products including
devices that are not based upon the PDDS Platform
Technology.
1.99 “Product Profit
and Loss” means the revenues and expenses resulting from
the Commercialization activities (other than Pre-Launch Costs) for
Product in the Shared Territory, and shall be equal to (a) Net
Sales less Allowable Expenses plus (b) Net Sublicense
Revenues.
1.100
“Project” means the collaborative Development and
Commercialization of the Product to be conducted by or on behalf of
Nektar and Bayer under this Agreement.
1.101 “Pulmonary
Delivery” means the [***] .
1.102 “Regional
Business Unit” or “RBU” has the meaning set
forth in Section 3.1.
1.103 “Regulatory
Approval” means (a) in the Shared Territory,
approval by the FDA of an NDA or other applicable filing and
satisfaction of related applicable FDA registration and
notification requirements, if any, and (b) in any country
other than the Shared Territory, approval by Regulatory Authorities
having jurisdiction in such country of a single application or set
of applications comparable to an NDA or other applicable filing and
satisfaction of related applicable regulatory and notification
requirements, if any, together with any other approval necessary to
make and sell the Product commercially in such country, including
without limitation any pricing approvals.
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[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
1.104 “Regulatory
Authority” means any applicable supra-national, federal,
national, regional, state, provincial or local regulatory agencies,
departments, bureaus, commissions, councils or other government
entities, including, without limitation, the FDA and the EMEA,
regulating or otherwise exercising authority with respect to the
Exploitation of the Product in the Territory.
1.105
“[***]” means the [***] .
1.106 “Royalty
Territory” means the world, excluding the Shared
Territory.
1.107 “Shared
Territory” means the United States, its territories and
possessions.
1.108
“Sublicensee” means any person or entity, including
without limitation Affiliates of a Party, to which either
(a) Bayer grants a sublicense to the extent useful or
necessary as set forth under this Agreement (other than Nektar or
its Affiliates), or (b) Nektar grants a sublicense to the
extent useful or necessary for Nektar to fulfill its obligations
under this Agreement (other than Bayer or its
Affiliates).
1.109
“[***]” means that [***] .
1.110
“Territory” means the Royalty Territory and the
Shared Territory.
1.111 “Third
Party” means any person or entity other than Bayer,
Nektar, or an Affiliate of either of them.
1.112
“Trademark” means any word, name, symbol, color,
designation or device or any combination thereof, whether
registered or unregistered, including, without limitation, any
trademark, trade dress, service mark, service name, brand mark,
trade name, brand name, logo or business symbol.
1.113
“[***]” has the meaning set forth in
Section 7.3.
1.114 “Valid
Claim” means, for a country, a claim of an unexpired
issued Patent or a pending Patent Application filed and kept
pending in good faith, where either or both (a) such Patent or
Patent Application is included in either the Patents or Patent
Applications licensed to Bayer under this Agreement, or
(b) such claim directed to an Invention made solely or jointly
by Nektar (whether or not assigned to Bayer pursuant to Article 11)
that in the absence of ownership thereof or a license thereto,
would be infringed by the Exploitation of the Product and that has
not been (i) cancelled with prejudice, (ii) withdrawn
from consideration without the ability to submit or refile,
(iii) finally determined to be unallowable by the applicable
governmental authority (and from which no appeal is or can be
taken), (iv) finally determined to be invalid or unenforceable
by a court of competent jurisdiction, (v) disclaimed, or
(vi) abandoned. For purposes hereof, a claim in a Patent
Application that has not been granted before the later to occur of
(A) the date that is [***] , or (B) the date of
[***] , shall not be considered to be a Valid Claim unless
and until it is granted.
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[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
2. L ICENSE
G RANTS
2.1 License Grants to
Bayer.
(a) Royalty Territory
License. Subject to the terms and conditions of this Agreement,
Nektar and Aerogen hereby grant to Bayer:
(i) an exclusive (even
as to Nektar, Aerogen and their Affiliates), royalty-bearing
license, with the right to grant sublicenses in accordance with
Section 2.3, under the Nektar Know-How and Nektar Patent
Rights, to make, have made, use, have used, promote, develop, offer
to sell, sell, have sold, import, have imported, export, have
exported, and market Formulated Amikacin and Product in the Field
throughout the Royalty Territory solely in connection with
Exploitation of the Product in the Field throughout the Royalty
Territory, provided that the foregoing license is subject to
Nektar’s right to Manufacture as set forth in Article
9;
(ii) a non-exclusive,
royalty-free license, under the Nektar Trademarks, with the right
to grant sublicenses in accordance with Section 2.3,
throughout the Royalty Territory, to use and display the Nektar
Trademarks in connection with the Commercialization of the Product
in the Field throughout the Royalty Territory, as provided under
and in accordance with Section 7.7 and Article 17;
and
(iii) a non-exclusive,
royalty-bearing license, under the Nektar Know-How and Nektar
Patent Rights, with the right to grant sublicenses in accordance
with Section 2.3, in the Field throughout the Royalty
Territory, to use, have used, promote, offer to sell, sell, have
sold, import, have imported, export, have exported, and market the
Device solely in connection with Exploitation of the Product in the
Field throughout the Royalty Territory.
(b) Shared Territory
License. Subject to the terms and conditions of this Agreement,
Nektar and Aerogen hereby grant to Bayer:
(i) a co-exclusive
(with Nektar and its Affiliates), license, subject to the payment
of a share of profits as provided in this Agreement, with the right
to grant sublicenses in accordance with Section 2.3, under the
Nektar Know-How and Nektar Patent Rights, to make, have made, use,
have used, promote, offer to sell, sell, have sold, import, have
imported, export, have exported, and market Formulated Amikacin and
the Product in the Field throughout the Shared Territory solely in
connection with Exploitation of the Product in the Field throughout
the Shared Territory, provided that the foregoing license is
subject to Nektar’s right to Manufacture as set forth in
Article 9;
(ii) a non-exclusive,
royalty-free license, under the Nektar Trademarks, with the right
to grant sublicenses in accordance with Section 2.3,
throughout the Shared Territory, to use and display the Nektar
Trademarks in connection with the Commercialization of the Product
in the Field throughout the Shared Territory, as provided under and
in accordance with Section 7.7 and Article 17; and
(iii) a non-exclusive
license, under the Nektar Know-How and Nektar Patent Rights,
subject to the payment of a share of profits as provided in this
Agreement,
- 13 -
[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
with the right to grant sublicenses in
accordance with Section 2.3, in the Field throughout the
Shared Territory, to use, have used, promote, offer to sell, sell,
have sold, import, have imported, export, have exported, and market
the Device solely in connection with Exploitation of the Product in
the Field throughout the Shared Territory.
(c) The exclusive and
co-exclusive licenses granted in Section 2.1(a)(i) and
Section 2.1(b)(i), respectively, are subject to any
pre-existing rights granted to a Third Party by Aerogen under the
agreement attached in Exhibit 1.24.
2.2 Certain Covenants.
Each Party covenants and agrees that (a) it shall not, and it
shall cause its Affiliates and Sublicensees not to, use or practice
the intellectual property rights licensed under this Agreement
except as expressly permitted by this Agreement and (b) any
use or practice of the intellectual property rights licensed under
this Agreement except as expressly permitted by this Agreement that
results in material harm to the other Party shall constitute a
material breach of a material obligation of this
Agreement.
2.3 Sublicense Rights.
Bayer’s right to grant sublicenses under the licenses granted
to it under Section 2.1, and Nektar’s right to grant
sublicenses under the licenses granted to it under
Section 11.2(a)(ii) shall be subject to the following:
(a) each Sublicensee shall agree to be bound by all of the
applicable terms and conditions of this Agreement; (b) the
terms of each sublicense granted by a Party shall provide that the
Sublicensee shall be subject to the terms and conditions of this
Agreement; (c) a Party’s grant of any sublicense shall
not relieve the Party from any of its obligations under this
Agreement; (d) the granting Party shall remain jointly and
severally liable for any breach of a sublicense by a Sublicensee to
the extent that such breach would constitute a breach of this
Agreement, and any breach of the sublicense by the Sublicensee
shall be deemed a breach of this Agreement by the Party to the
extent that such breach would constitute a breach of this
Agreement; (e) each Party will notify the other Party of the
identity of any Sublicensee, and the territory in which it has
granted such sublicense, promptly after entering into any
sublicense; (f) Bayer will not have the right to grant
sublicenses, under any rights granted to Bayer by Nektar in
Sections 2.1(a)(i), to a Third Party during the term of this
Agreement for the promotion or marketing of Product in [***]
without Nektar’s prior written consent, which consent shall
not be unreasonably withheld or delayed; (g) Bayer will not
have the right to grant sublicenses under any rights granted to
Bayer by Nektar in Section 2.1(b) to a Third Party during the
term of this Agreement for the promotion or marketing of the
Product in the Shared Territory without Nektar’s prior
written consent, which consent shall not be unreasonably withheld
or delayed; provided, however, that Bayer may grant sublicenses
under any rights granted to Bayer by Nektar in Section 2.1(b)
without Nektar’s prior written consent in the event that
Nektar opts out pursuant to Section 8.2(b)(ii), this Agreement
is terminated by Bayer pursuant to Section 18.4 for breach of
this Agreement by Nektar, or Bayer elects a Royalty Conversion in
accordance with Section 20.2(b); and (h) Nektar will not
have the right to grant sublicenses, under any rights granted to
Nektar by Bayer in Section 11.2(a)(ii), to a Third Party
during the term of this Agreement for the promotion or marketing of
Product in the Field in the Territory without Bayer’s prior
written consent, which consent shall not be unreasonably withheld
or delayed.
2.4 No Implied Rights or
Licenses. Neither Party grants to the other Party any rights or
licenses in or to any Patent or other intellectual property right,
whether by implication, estoppel or otherwise, except to the extent
expressly provided for under this Agreement.
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information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
2.5 Exclusivity.
Notwithstanding any other provision of this Agreement, during the
term of this Agreement, neither Party shall develop (including
without limitation conducting or sponsoring Clinical Trials),
market, sell, manufacture, or commercialize, directly or
indirectly, any product containing any [***] amelioration,
treatment or prevention of [***] , other than the Product
under this Agreement. For clarity, the foregoing shall not limit
either Party’s ability to develop, market, sell, manufacture
or commercialize, directly or indirectly, any product containing an
[***] amelioration, treatment or prevention of [***]
.
2.6 Covenant Not to
Sue. During the term of this Agreement, Bayer agrees that
neither it nor its Sublicensees will, and Bayer shall cause its
Affiliates not to, assert against Nektar, its subsidiaries,
Affiliates or Sublicensees, any claim, or institute any action or
proceeding, whether at law or equity, under any intellectual
property rights, including without limitation Patents or Patent
Applications, based on Nektar’s, its Affiliates’ or
Sublicensees’ development, manufacture, use, practice,
importation or sale of the Device, Formulated Amikacin or the
Product in the Field and in the Territory pursuant to this
Agreement. This covenant shall be binding upon, and inure to the
benefit of, the Parties, their successors, and assigns.
2.7 Reserved Rights.
This Agreement is subject to the rights reserved by [***] or
by the U.S. government under Title 35 of the United States Code
Sections 200 through 204.
3. G
OVERNANCE
3.1 General. Promptly
after the Effective Date, the Parties shall establish a joint
steering committee (the “Joint Steering Committee”
or “JSC” ) in accordance with Section 3.2(a)
to oversee the Parties’ performance under this Agreement, and
a joint finance committee (the “Joint Finance
Committee” or “JFC” ) in accordance with
Section 3.3(a) to oversee financial and budgetary aspects of
the Parties’ activities under this Agreement. Additionally,
Nektar shall have the right to appoint [***] to
Bayer’s internal Global Project Team for the Product (the
“Global Project Team” or “GPT” ) in
accordance with Section 3.4(a), which will oversee the
clinical Development of the Product pursuant to this Agreement,
[***] to Bayer’s internal Global Brand Team for the
Product (the “Global Brand Team” or
“GBT” ) in accordance with Section 3.5(a),
which will oversee the Commercialization of the Product pursuant to
this Agreement, and [***] to Bayer’s internal U.S.
Regional Business Unit for the Product (the “Regional
Business Unit” or “RBU” ) in accordance with
Section 3.6(a), which will implement strategies for Commercial
Launch of the Product in the Shared Territory, and oversee such
launch activities, subject to oversight of the GBT. Each of these
committees and teams shall have the responsibilities and authority
allocated to it in this Article 3 and elsewhere in this Agreement.
Each of these committees and teams shall make decisions consistent
with the goal of implementing the Plans and conducting other
activities under this Agreement in a manner consistent with the
optimization of Product Development and Commercialization. The
representatives of each Party on any committee shall be responsible
for ensuring that their decisions and actions are consistent with
the views of, and have been approved by, the Party that appointed
them. The following procedures shall apply to each of the
committees established under this Agreement and to the GPT, RBU and
GBT, as applicable.
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[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
3.2 Joint Steering
Committee.
(a) Composition. Each
Party shall appoint [***] to serve on the JSC. Bayer’s
initial JSC representatives shall be [***] . Nektar’s
initial JSC representatives shall be [***] . The initial JSC
chairperson shall be [***] , who shall serve in such
capacity for a period of twelve (12) months. Thereafter, the
member of the JSC who shall serve as the JSC chairperson shall be
designated alternately by each Party, with each chairperson serving
for a period of twelve (12) months. Each Party may replace its
JSC representatives by written notice to the other
Party.
(b) Responsibilities.
The JSC shall oversee and monitor the direction and course of the
activities to be conducted hereunder. Without limiting the
generality of the foregoing, the JSC shall: (i) review,
provide comment on, and approve Plans and related budgets;
(ii) review the activities and obligations of the Parties and
the JFC under this Agreement; (iii) resolve any disputes or
disagreements submitted to it by the JFC, the GPT, or the GBT, and,
if applicable, submit disputes or disagreements that it does not
resolve within the time provided in Section 3.2(c) to
designated Executives of the Parties, as further described in
Section 3.2(d); (iv) review all material data arising in
the course of activities conducted pursuant to this Agreement by
either Party; (i) appoint subcommittees as it deems
appropriate for carrying out the Project; and (vi) perform
such other functions as appropriate to further the purposes of this
Agreement as determined by the Parties, including without
limitation the periodic evaluation of performance against
goals.
(c) Meetings and
Voting. The JSC shall meet at least once a calendar quarter at
times mutually agreed upon by the Parties. At least two
(2) such meetings per calendar year must be held in person,
and all other such meetings may be held by teleconference or
videoconference. The location of the meetings of the JSC to be held
in person shall alternate between sites designated by each Party,
with the first such meeting to be held in San Carlos, California,
U.S.A., and the second such meeting to be held in Berlin, Germany.
Each Party shall bear all the expenses of its representatives on
the JSC, and such expenses shall not be included in Allowable
Expenses. The JSC chairperson shall issue an agenda reasonably in
advance of each meeting and shall appoint one (1) member to
keep accurate minutes of each meeting, which appointment shall be
effective upon approval of the other Party, such approval not to be
unreasonably withheld or delayed. Each of Bayer and Nektar shall
have one (1) collective vote on the JSC regardless of how many
representatives such Party has on the JSC, and any matter voted on
shall require the unanimous vote of both Parties. If a disagreement
among members of the JSC remains unresolved for more than thirty
(30) days after the JSC first addresses such matter (or such
longer period as the Parties may mutually agree upon), such
disagreement shall be resolved in accordance with
Section 3.2(d). The JSC shall have no power to amend or waive
compliance with this Agreement.
(d) Dispute
Resolution. If the JSC is unable to resolve any dispute,
controversy, or claim arising under this Agreement within thirty
(30) days after it first addresses such matter (or such longer
period as the Parties may mutually agree upon), then the
dispute
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information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
shall be referred to senior executive
officers of each Party having authority to make decisions in such
matters ( “Executives” ) of each Party. In the
event the Executives of each Party are unable to resolve the
dispute within thirty (30) days after receiving notice of the
dispute (or such longer period as the Parties may mutually agree
upon), then the following shall apply: Matters submitted to the JSC
and the Executives pursuant to this Section 3.2(d) that remain
unresolved by the JSC or the Executives (i) that relate to
matters set forth in Exhibit 3.2 in the column titled “Bayer
Lead” shall be finally decided by Bayer, (ii) that
relate to matters set forth in Exhibit 3.2 in the column titled
“Nektar Lead” shall be finally decided by Nektar,
(iii) that relate to matters set forth in Exhibit 3.2 in the
column titled “Co-Lead” shall continue to be discussed
by the Executives until such Executives agree upon a resolution of
such matter, and (iv) that relate to matters not set forth in
Exhibit 3.2 shall be submitted upon the initiative of either Party
after expiration of the thirty (30) day Executive discussion
period for resolution by a court of competent jurisdiction as set
forth in Section 20.10. For clarity, matters relating to a
Party’s alleged breach of its obligations under this
Agreement shall not be finally decided by either Party but may be
submitted for resolution by either Party after such matter has been
discussed by the Executives for the foregoing thirty (30) day
period to a court of competent jurisdiction as set forth in
Section 20.10.
3.3 Joint Finance
Committee.
(a) Composition. Each
Party shall appoint [***] to serve on the JFC prior to the
first meeting of the JFC. The initial JFC chairperson shall be
appointed by Bayer and shall serve in such capacity for a period of
twelve (12) months. Thereafter, the member of the JFC who
shall serve as the JFC chairperson shall be designated alternately
by each Party, with each chairperson serving for a period of twelve
(12) months. Each Party may replace its JFC representatives by
written notice to the other Party.
(b) Responsibilities.
The JFC shall oversee the preparation and implementation of all
Development Budgets, Launch Budgets, and Commercialization Budgets,
establish a policy (no more than ninety (90) days after the
Effective Date) for the appropriate level of detail to be reported
in calculating Allowable Expenses and Product Profit and Loss,
designate policies for the Parties’ reporting and recording
of Allowable Expenses and calculation of Product Profit and Loss
and other financial terms set forth in this Agreement, approve all
variances from the applicable budgets, establish the
Commercialization FTE Rate at least six (6) months prior to
commencement of Commercialization activities in the Shared
Territory (including without limitation Pre-Launch Activities), as
well as determine appropriate annual adjustments to the
Commercialization FTE Rate to reflect relevant price indices, and,
as directed by the JSC, perform other activities as appropriate to
effect the intent of this Agreement.
(c) Meetings and
Voting. The JFC shall meet at least once per month, unless
otherwise specified by the JSC, at times mutually agreed upon by
the Parties. At least four (4) such meetings per calendar year
must be held in person, and all other such meetings may be held by
teleconference or videoconference. Each Party shall bear all the
expenses of its representatives on the JFC. Such expenses shall not
be included in Allowable Expenses. The location of the JFC meetings
shall alternate between sites designated by each Party, with the
first
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information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
such meeting of the JFC to be held in
person to be in Berlin, Germany, and the second such meeting to be
held in San Carlos, California, U.S.A. The JFC chairperson shall
issue an agenda reasonably in advance of each meeting and shall
appoint one (1) member to keep accurate minutes of each
meeting, which appointment shall be effective upon approval of the
other Party, such approval not to be unreasonably withheld or
delayed. Each of Bayer and Nektar shall have one
(1) collective vote on the JFC regardless of how many
representatives such Party has on the JFC, and any matter voted on
shall require the unanimous vote of both Parties. If a disagreement
among members of the JFC remains unresolved for more than thirty
(30) days after the JFC first addresses such matter (or such
longer period as the Parties may mutually agree upon), such
disagreement shall be submitted to the JSC for resolution. The JFC
shall have no power to amend or waive compliance with this
Agreement.
(d) All committees and
teams identified in this Agreement shall prepare the budgets and
plans for which they are responsible as provided for herein within
ninety (90) days after the Effective Date.
3.4 Global Project
Team.
(a) Composition.
Nektar shall appoint [***] to serve on the GPT prior to the first
meeting of the GPT. Bayer may appoint to the GPT [***]. The GPT
chairperson shall be appointed by Bayer. Each Party may replace GPT
representatives by written notice to the other Party.
(b) Responsibilities.
Within ninety (90) days after the Effective Date, the GPT may
propose updates to the Development Plan and Development Budget for
approval by the GBT and then by the JSC, coordinate the supply of
the Product for use in non-clinical and clinical trials of the
Product, oversee the Parties’ implementation of the
Development Plan and Development Budget as directed by the JSC, and
perform other activities as appropriate to effect the intent of
this Agreement.
(c) Meetings. The GPT
shall meet at least once per calendar quarter. At least two
(2) such meetings per calendar year must be held in person,
and all other such meetings may be held by teleconference or
videoconference. Each Party shall bear all the expenses of its
representatives on the GPT. Such expenses shall not be included in
Allowable Expenses. The location of the meetings of the GPT to be
held in person shall be determined by Bayer. The GPT chairperson
shall issue an agenda reasonably in advance of each meeting and
shall appoint one (1) member to keep accurate minutes of each
meeting, which appointment shall be effective upon approval of the
other Party, such approval not to be unreasonably withheld or
delayed. The GPT shall have no power to amend or waive compliance
with this Agreement.
3.5 Global Brand
Team.
(a) Composition. Prior
to the first meeting of the GBT, Nektar shall appoint [***] to
serve both on the GSM and [***] on the GBT. Bayer may appoint to
the GBT [***], at least one of whom shall be a representative from
the GSM. The GBT chairperson shall be such GSM representative. Each
Party may replace GBT representatives by written notice to the
other Party.
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[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
(b) Responsibilities.
The GBT shall be responsible for preparation of launch,
Commercialization and life cycle management strategies in the form
of Launch Plans, Launch Budgets, Commercialization Plans and
Commercialization Budgets for approval by the JSC, and shall
oversee the Commercial supply of Formulated Amikacin, the Device
and the Product, prepare materials for supporting Commercialization
of the Product, plan training activities for [***] and sales
representatives, determine if any Global Phase IV Trials are to be
conducted, and perform other activities as appropriate to effect
the intent of this Agreement. At least one (1) of each
Party’s representatives shall also present to and gain
approval from the representative’s own Party for the Launch
Plans, Launch Budgets, Commercialization Plans and
Commercialization Budgets, and any subsequent revisions thereto,
before the GBT proposes such Launch Plans, Launch Budgets,
Commercialization Plans, and Commercialization Budgets to the
JSC.
(c) Meetings. The GBT
shall meet at least once per calendar quarter. At least two
(2) such meetings per calendar year must be held in person,
and all other such meetings may be held by teleconference or
videoconference. Each Party shall bear all the expenses of its
representatives on the GBT. Such expenses shall not be included in
Allowable Expenses, except that expenses of GBT members who are
also members of the GSM shall be included in Allowable Expenses.
The location of the meetings of the GBT to be held in person shall
be determined by Bayer. The GBT chairperson shall issue an agenda
reasonably in advance of each meeting and shall appoint one
(1) member to keep accurate minutes of each meeting, which
appointment shall be effective upon approval of the other Party,
such approval not to be unreasonably withheld or delayed. The GBT
shall have no power to amend or waive compliance with this
Agreement.
3.6 U.S. Regional Business
Unit.
(a) Composition.
Nektar shall appoint [***] to serve on the RBU for the Shared
Territory prior to the first meeting of the RBU for the Product.
Bayer may appoint to the RBU for the Product [***]. The RBU
chairperson shall be appointed by Bayer. Each Party may replace RBU
representatives by written notice to the other Party.
(b) Responsibilities.
The RBU shall oversee the implementation of the Launch Plan and the
Commercialization Plan approved by the JSC for Commercial Launch in
the Shared Territory and oversee the conduct of Local Phase IV
Trials in the Shared Territory, subject to the oversight of the
GBT.
(c) Meetings. The RBU
shall meet at least once per calendar quarter. At least two
(2) such meetings per calendar year must be held in person,
and all other such meetings may be held by teleconference or
videoconference. The location of the meetings of the RBU to be held
in person shall be determined by Bayer. The expenses of RBU members
shall be included in Allowable Expenses. The RBU chairperson shall
issue an agenda reasonably in advance of each meeting and shall
appoint one (1) member to keep accurate minutes of each
meeting, which appointment shall be effective upon approval of the
other Party, such approval not to be unreasonably withheld or
delayed. The RBU shall have no power to amend or waive compliance
with this Agreement.
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[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
3.7 Nektar Participation
in Committees and Teams. Nektar’s membership in each of
the JSC and JFC, and participation in each of Bayer’s
internal GPT, GBT and RBU, shall be at its sole discretion, as a
matter of right and not obligation, for the sole purpose of
participation in governance, decision making and information
exchange with respect to activities within the jurisdiction of such
committee, team, or unit. At any time prior to the disbanding of,
or withdrawing Nektar’s membership or participation in, such
committee or internal team or unit pursuant to Section 3.8,
Nektar shall have the right to withdraw from membership or
participation in any or all of the committees, teams, or units upon
thirty (30) days’ prior written notice to Bayer, which
notice shall be effective as to the relevant committee, team, or
unit specified in such notice upon the expiration of such thirty
(30) day period ( “Withdrawal Notice” ).
Following the issuance of a Withdrawal Notice for a given
committee, team, or unit, (a) the applicable committee, team,
or unit shall be disbanded or, if it is an internal Bayer team or
unit, Nektar’s participation therein shall be withdrawn and
Bayer may elect to continue such internal team or unit in its
discretion, subject to this Section 3.7, (b) the
decisions formerly made by the team or unit from which Nektar has
elected to withdraw shall be made as set forth in Section 3.9,
and (c) Nektar shall have the right to continue to receive the
information it would otherwise be entitled to receive under the
Agreement.
3.8 Disbanding of
Committees and Withdrawal from Teams or Units. The Parties
shall have the right to disband either or both of the JSC or JFC,
and/or withdraw Nektar’s participation in each of
Bayer’s internal GPT, GBT and RBU, upon mutual agreement.
Additionally, to the extent the applicable committee is not
disbanded or Nektar’s participation in the applicable team or
unit is not withdrawn pursuant to Section 3.7, such
committees, teams, or units shall be automatically disbanded or
Nektar’s participation therein shall be withdrawn, as
applicable, as set forth below:
(a) The JSC shall be
automatically disbanded upon the later of (i) expiration or
termination of the obligation to pay royalties in the Royalty
Territory, or (ii) discontinuation of Commercialization
activities in the Shared Territory.
(b) The JFC shall be
automatically disbanded upon the later of (i) expiration or
termination of the obligation to pay royalties in the Royalty
Territory, or (ii) discontinuation of Commercialization
activities in the Shared Territory.
(c) Nektar’s
participation in the GPT shall be automatically withdrawn [***]
years after the last to occur Regulatory Approval of the Product in
the United States, Japan or Europe.
(d) Nektar’s
participation in the GBT shall be automatically withdrawn upon the
later of (i) expiration or termination of the obligation to
pay royalties in the Royalty Territory, or
(ii) discontinuation of Commercialization activities in the
Shared Territory.
(e) Nektar’s
participation in the RBU shall be automatically withdrawn upon the
later of (i) expiration or termination of the obligation to
pay royalties in the Royalty Territory, or
(ii) discontinuation of Commercialization activities in the
Shared Territory.
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[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
3.9 Decision Making After
Withdrawal from or Disbanding of Committees. If Nektar elects
to withdraw from the JSC and/or the JFC under Section 3.7, or
if either such committee is disbanded pursuant to Section 3.8,
then after such withdrawal or disbanding, the following shall apply
to decisions formerly within the jurisdiction of the committee(s)
from which Nektar has withdrawn or that has been
disbanded:
(a) Decisions formerly
within the jurisdiction of the JSC shall be submitted for
resolution by senior officers of each Party, subject to the
decision making processes and principles set forth in Sections
3.2(c) and 3.2(d) as if Sections 3.2(c) and 3.2(d) applied to
decisions to be made by such senior officers rather than to
decisions to be made by the JSC.
(b) Decisions formerly
within the jurisdiction of the JFC shall be submitted for
resolution by the JSC, if it then exists, or otherwise by senior
officers appointed by each Party as described in Section
3.9(a).
4. D
EVELOPMENT P ROGRAM
4.1 Project. Bayer and
Nektar shall collaborate to Develop the Product. Nektar shall use
Commercially Reasonable Efforts, and shall have primary control and
direction in the Project for developing and Manufacturing
Formulated Amikacin through the completion of Phase III Clinical
Trials, developing and Manufacturing the Device, the conduct of the
[***] , and the completion of Phase II Clinical Trials that
are ongoing as of the Effective Date. Bayer shall use Commercially
Reasonable Efforts, and shall have primary control and direction in
the Project, for the clinical Development of the Product except for
such [***] and Phase II Clinical Trials, the preparation and
submission of regulatory filings for the Product, on a worldwide
basis, and further CMC development of Formulated Amikacin and the
final packaging of the Product, obtaining and maintaining all
Regulatory Approvals for the Product in the Shared Territory and in
the Royalty Territory, and generally for the Commercialization of
the Product.
4.2 Development Plan and
Development Budget.
(a) The Development of
the Product shall be governed by a global Development plan (
“Development Plan” ), and the costs and expenses
relating to the Development of the Product shall be governed by a
Development budget ( “Development Budget” ), the
initial forms of which are attached as Exhibits 4.2(a)(i) and
4.2(a)(ii), respectively. Updates thereto made pursuant to
Section 4.2(b) shall be prepared by the GPT, for approval by
the JSC. Each Development Plan shall include without limitation
details of all Clinical Trials to be conducted by the Parties to
support Regulatory Approval in the Territory, and related time
lines, as well as other material activities necessary for
Development of the Product in the Territory, and shall describe the
proposed overall program of Development for the Product in each
applicable country, including without limitation all preclinical
studies, toxicology, pharmacology studies, formulation, process
development, clinical studies, and regulatory plans and other
elements of obtaining Regulatory Approval in each applicable
country. The Development Plan and the Development Budget shall be
updated at least once (1) per year and shall cover the
following three (3) year period. The Parties have prepared a
portion of the initial Development Plan specifically relating to
the Device and a portion of the initial Development
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information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
Budget relating to the Device (
“Device Budget” ) as well as a portion of the
initial Development Plan specifically relating to Formulated
Amikacin and a portion of the initial Development Budget relating
to Formulated Amikacin ( “Drug Budget” ),
respectively, as of the Effective Date, which initial budgets are
attached as Exhibits 4.2(a)(iii) and 4.2(a)(iv),
respectively.
(b) The GPT shall, on
an annual basis, propose updates to the Development Plans and
Development Budgets (including, for clarity, the Device Budget and
the Drug Budget) for the following calendar year. The GPT shall
submit such updated Development Plans and Development Budgets to
the JSC (with such Development Budgets first being submitted to the
JFC for review and endorsement), for review and approval by
September 30 of each calendar year for the following calendar
year. The JSC shall provide comments on each such updated
Development Plan or Development Budget, as applicable, within
fifteen (15) days following their submission. Within thirty
(30) days following such original submission, the JSC shall
either approve the Development Plan and Development Budget or
approve a modified Development Plan and Development Budget prepared
by the GPT and endorsed by the JFC, consistent with the objectives
for the Product and the aims of the Project.
(c) If the actual
costs incurred by Bayer under the Drug Budget in meeting
Bayer’s obligations as set forth on Exhibit 4.2(a)(iv) exceed
the approved amount set forth in the Drug Budget, Bayer may spend
such additional amounts without reimbursement from Nektar; provided
that, if aggregate actual costs incurred by Bayer exceed
[***] of the aggregate approved amount set forth in the Drug
Budget, the Parties agree to discuss whether the economic terms
between the Parties should be restructured to reflect the
investment of the additional funds. If the actual costs incurred by
Nektar under the Device Budget in meeting Nektar’s
obligations as set forth on Exhibit 4.2(a)(iii) exceed the approved
amount set forth in the Device Budget, Nektar may spend such
additional amounts without reimbursement from Bayer; provided that,
if aggregate actual costs incurred by Nektar exceed [***] of
the aggregate approved amount set forth in the Device Budget, the
Parties agree to discuss whether the economic terms between the
Parties should be restructured to reflect the investment of the
additional funds.
4.3 Standard of
Performance. Each Party, in performing its activities in
connection with the Project, shall comply with all Applicable Laws,
including without limitation where applicable, then-current GCP,
GLP, and GMP.
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[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
4.4 Subcontracting
Permitted.
(a) Bayer acknowledges
and agrees that portions of the work to be performed by Nektar
under the Project (including, without limitation, manufacture of
the Device) may be performed on behalf of Nektar by Third Parties,
provided that (i) Nektar shall first have obtained written
confidentiality agreements with any such subcontractors and written
assignments of, or equivalent rights under, all Patent rights and
know-how that such subcontractors may develop by reason of work
performed under this Agreement, (ii) Nektar may not
subcontract obligations to co-promote in the Shared Territory
without Bayer’s prior written consent (which consent may not
be unreasonably withheld or delayed), unless the GBT has previously
approved such subcontracting, and (iii) Nektar shall be and
remain responsible to Bayer for the performance of its
subcontractors.
(b) Nektar
acknowledges and agrees that portions of the work to be performed
by Bayer under the Project (including, without limitation,
manufacture of Formulated Amikacin for commercial use) may be
performed on behalf of Bayer by Third Parties, provided that
(i) Bayer shall first have obtained written confidentiality
agreements with any such subcontractors and written assignments of,
or equivalent rights under, all Patent rights and know-how that
such subcontractors may develop by reason of work performed under
this Agreement, (ii) Bayer may not subcontract obligations to
co-promote in the Shared Territory, without Nektar’s prior
written consent (which consent may not be unreasonably withheld or
delayed), and (iii) Bayer shall be and remain responsible to
Nektar for the performance of its subcontractors.
5. R
EGULATORY M ATTERS
5.1 Pharmacovigilance
Agreement. The Parties shall, within sixty (60) days after
written request by the JSC, convene a meeting to negotiate in good
faith the terms and conditions of a pharmacovigilance agreement (
“Pharmacovigilance Agreement” ), which shall
establish all material economic, regulatory, business and technical
terms under which the Parties shall collect, monitor, research,
assess and evaluate information from healthcare providers and
patients on the adverse effects, if any, of Formulated Amikacin,
the Device and the Product, with a view to identifying new
information about hazards associated with Formulated Amikacin, the
Device and the Product and preventing harm to patients. Within
ninety (90) days after the commencement of those negotiations,
the Parties shall exercise Commercially Reasonable Efforts to
execute a mutually satisfactory Pharmacovigilance
Agreement.
5.2 Preparation of
Regulatory Filings. Each Party, at such Party’s sole cost
and expense unless otherwise provided for herein, shall be
responsible for preparing, filing, and maintaining, and shall own,
the regulatory filings relating to the Product as set forth
below:
(a) At its expense,
Nektar shall use Commercially Reasonable Efforts to prepare and
maintain DMFs covering the Device, and Nektar shall own any such
DMFs. Nektar shall also use Commercially Reasonable Efforts to
prepare and maintain DMFs covering Formulated Amikacin and the
Product; provided, however, that the Party conducting Manufacturing
for Commercialization of the Formulated Amikacin and Product shall
own and maintain any such DMFs, it being understood and agreed that
during the term hereof, such
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[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
Manufacture of Formulated Amikacin and
Product may be conducted by Bayer. During the term of this
Agreement, Nektar grants to Bayer and its Sublicensees a right of
reference to the DMFs for the Device owned by Nektar to the extent
necessary for, and for the purposes of, preparing, filing or
maintaining INDs, NDAs, MAAs and other regulatory filings relating
to the Product in the Shared Territory or the Royalty Territory,
including without limitation CMC Data. Nektar shall share with
Bayer relevant CMC Data (redacted, if deemed necessary in
Nektar’s reasonable opinion) portions of such DMFs, with the
right to inspect, upon Bayer’s request. The Party that owns a
DMF shall be responsible for all interactions with Regulatory
Authorities relating to such DMF. The foregoing notwithstanding,
all Information required by Bayer for regulatory filings will be
provided to Bayer by Nektar for all countries where such filings
are required.
(b) At its expense,
Bayer, its Affiliates and its Sublicensees shall use Commercially
Reasonable Efforts to prepare, obtain and maintain all regulatory
dossiers and Regulatory Approvals covering the Product in the
Territory, and shall provide Nektar, [***] , with a copy of
all documents included in such regulatory dossiers and Regulatory
Approvals. Except as provided in Section 5.2(a), Bayer or its
designee shall be the owner of all such filings and shall be
responsible for all interactions with Regulatory Authorities
relating thereto; provided, however, that at all times during the
term hereof, Nektar shall have the opportunity to participate in
all meetings and other communications with Regulatory Authorities
relating to the Product, [***] . In addition to
Bayer’s other obligations under this Section 5.2(b),
Bayer shall keep Nektar informed, on a regular basis (but no less
frequently than quarterly) of regulatory filings related to the
Product.
(c) During the term of
this Agreement, Bayer grants to Nektar a right of reference
(including, without limitation, the right to inspect) to the CMC
Data pertaining to the Product or for Nektar’s use in
applications within the Field that do not conflict with
Nektar’s covenants set forth in Section 2.5.
5.3 Notice of
Communication with Regulatory Authorities. Bayer shall be
responsible for reporting all adverse events and handling all
complaints and communications (including without limitation with
Regulatory Authorities) relating to the Product, except in those
countries where the CE Mark owner for the Device is required to
communicate Device pharmacovigilance directly to Regulatory
Authorities (in which case Nektar shall report all adverse events
and handle all complaints and communications, including without
limitation with Regulatory Authorities, relating to the Device).
Except as otherwise provided for in this Section 5.3, each
Party shall provide quarterly summaries to the other Party of any
oral or written communications to or from Regulatory Authorities on
matters related to the Product or which may reasonably be deemed to
impact Product Development, manufacture, Commercialization or
Regulatory Approval. Notwithstanding the foregoing, if Nektar
Manufactures Device or Formulated Amikacin at any time during the
term of this Agreement, then Bayer shall notify Nektar of any oral
communications, and provide Nektar with copies of any written
communications, to or from Regulatory Authorities on matters
related to the Device or Formulated Amikacin, as applicable, or
which may reasonably be deemed to impact Device or Formulated
Amikacin, as applicable, within three (3) business days of
receipt of such communication, or such earlier date as required by
Applicable Law or Regulatory Authority. Moreover, in each such
case, Bayer shall give Nektar reasonable opportunity to review and
comment on any proposed response to any such oral or written
communications to or from Regulatory Authorities prior to
submitting any response thereto, and provide Nektar with a copy of
the final response as specified herein.
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[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
5.4 Regulatory
Compliance.
(a) Each of Nektar and
Bayer shall reasonably cooperate with the other Party in its
efforts toward ensuring that all government price and gift
reporting, sales, marketing and promotional practices with respect
to the Product meet the standards required by Applicable Laws,
including without limitation state and federal laws and
regulations, as well as applicable guidelines concerning the
advertising of prescription drug products, the OIG Compliance
Guidance Program, the American Medical Association (the
“AMA” ) Guidelines on Gifts to Physicians, the
PhRMA Code, and the ACCME Standards.
(b) Each of Nektar and
Bayer shall provide its employees and its contract sales force, if
any, involved in sales, marketing, promotion, or price or gift
reporting for the Product appropriate training on proper marketing
and sales techniques. Such training will include, among other
topics, FDA requirements and other state and federal regulations
and guidelines concerning the advertising of prescription drug
products, the OIG Compliance Guidance Program, the AMA Guidelines
on Gifts to Physicians, the PhRMA Code, and the ACCME Standards. If
requested by the other Party, each of Nektar and Bayer shall
provide a written description of the training to the other Party no
less frequently than on an annual basis.
(c) Nektar shall
provide to Bayer upon request copies of all Nektar documents that
are related to the pricing issues addressed in the CIA and other
price reporting obligations of Bayer under Applicable Laws. This
will include, but is not necessarily limited to, a list of all
research and continuing medical education grants, the date of the
grant, the amount of the grant, and, if requested by Bayer, the
rationale for the grant.
(d) Each of Nektar and
Bayer shall reasonably cooperate with the other Party to provide
the other Party access to any and all information, data and reports
required by the other Party in order to comply with the relevant
provisions of the Medicare Modernization Act and any other
Applicable Laws, including without limitation reporting
requirements, in a timely and appropriate manner. Bayer shall
ensure that its reporting to the Centers for Medicare and Medicaid
Services and other federal and state healthcare programs related to
the Product is true, complete and correct in all respects;
provided, however, that Bayer shall not be held responsible for
submitting erroneous reports if such deficiencies result from
information provided by Nektar which itself was not true, complete
and correct.
(e) Nektar shall
endeavor to prepare and provide to Bayer any data or other
information covered by this Section 5.4 in accordance with
methodologies specified by Bayer, and shall advise Bayer if there
is any respect in which it has been unable to do so. If Nektar has
a question about whether a specific transaction or other event
needs to be reported to Bayer pursuant to this Section 5.4,
Nektar’s obligation shall be satisfied by delivery of a true,
complete and correct report of such transaction or other event,
without a determination as to the proper reporting or legal
characterization of such matter.
- 25 -
[***] indicates that certain
information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted
portions.
(f) Bayer shall notify
Nektar in advance of submission of any material information
provided by Nektar pursuant to this Section 5.4 that Bayer
proposes to submit to any governmental entity. Bayer further agrees
to seek confidential treatment of any such information relating to
Nektar that it submits to any governmental entity to the extent
permitted under the CIA and any Applicable Laws.
(g) Nektar and Bayer
shall confer with each other on a regular basis to discuss and
compare their respective procedures and methodologies relating to
each Party
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