Contract
Execution Copy
BY AND
AMONG
WYETH,
ACTING
THROUGH ITS
WYETH
PHARMACEUTICALS DIVISION,
and
WYETH-WHITEHALL
PHARMACEUTICALS, INC.,
and
WYETH-AYERST
LEDERLE, INC.,
and
AHP
MANUFACTURING B.V.,
TRADING
AS
WYETH
MEDICA IRELAND,
AND
PROGENICS
PHARMACEUTICALS, INC.
and
PROGENICS
PHARMACEUTICALS NEVADA, INC.
and
EXCELSIOR
LIFE SCIENCES IRELAND LIMITED
Effective
as of October 1, 2009
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
Execution
Copy
TABLE
OF CONTENTS
Page
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1.
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DEFINITIONS
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2 |
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2.
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TERMINATION
OF THE PROGENICS-WYETH AGREEMENT
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2 |
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3.
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PAYMENTS
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3 |
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3.1.
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Payment
to Progenics
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3 |
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3.2.
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No
Other Payments
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3 |
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3.3.
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Offset
for Payments Owed by / to Progenics / Wyeth
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3 |
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4.
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SC
PRODUCT TRANSITION
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3 |
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4.1.
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SC
Product Development
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3 |
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4.2.
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SC
Product Commercialization in the United States
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6 |
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4.3.
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SC
Product Commercialization Outside of the United States
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7 |
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5.
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ADDITIONAL
TRANSITION PROCEDURES
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9 |
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5.1.
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Technology
Transfer
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9 |
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5.2.
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Regulatory
and Additional Development Matters
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10 |
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5.3.
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Supply
of SC Product
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13 |
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5.4.
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Supply
of Oral Product
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14 |
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5.5.
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Pharmacovigilance
Activities; Product Recalls
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15 |
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5.6.
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Assignment
of Third Party Contracts
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15 |
| 5.7. | Waiver of Rights Under, and Amendment of, the Chicago Agreement | 17 | |
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5.8.
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Coordination
of Transition
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17 |
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6.
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INTELLECTUAL
PROPERTY
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18 |
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6.1.
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Assignment
of Certain Trademarks and Other Intellectual Property
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18 |
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6.2.
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Limited
License to Wyeth Trademarks
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19 |
| 6.3. | Ownership of Intellectual Property Developed During the Transition | 20 | |
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6.4.
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License
to Certain Know-How, Patent Rights and Technology
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20 |
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6.5.
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Non-Assertion
of Rights
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22 |
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6.6.
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Non-exclusive
License to Wyeth
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22 |
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7.
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REPRESENTATIONS,
WARRANTIES AND COVENANTS; INDEMNITY
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23
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7.1.
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By
Wyeth
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23 |
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7.2.
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By
Progenics
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24 |
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7.3.
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Indemnity
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25 |
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8.
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RELEASE;
PUBLIC STATEMENTS
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27 |
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8.1.
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Release
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27 |
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8.2.
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Non-Disparagement
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27 |
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8.3.
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Public
Announcements
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27 |
[*]
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9.
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MISCELLANEOUS
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28 |
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9.1.
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Records
and Audits
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28 |
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9.2.
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No
Further Obligations
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28 |
| 9.3. | Surviving Sections of the Progenics-Wyeth Agreement and the Partial Termination Agreement | 28 | |
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9.4.
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Confidentiality
of the Terms of this Termination Agreement
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29 |
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9.5.
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Assignment
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29 |
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9.6.
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Further
Actions
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29 |
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9.7.
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Force
Majeure
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29 |
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9.8.
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Correspondence
and Notices
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30 |
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9.9.
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Amendment
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31 |
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9.10.
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Waiver
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31 |
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9.11.
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Severability
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31 |
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9.12.
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Descriptive
Headings
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32 |
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9.13.
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Entire
Agreement
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32 |
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9.14.
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Independent
Contractors
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32 |
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9.15.
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Counterparts
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32 |
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9.16.
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Future
Relationships
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32 |
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9.17.
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Interpretation
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32 |
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9.18.
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No
Third Party Rights or Obligations
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33 |
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9.19.
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Governing
Law
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33 |
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9.20.
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Jurisdiction;
Venue; Service of Process
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33 |
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9.21.
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Waiver
of Jury Trial
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34 |
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9.22.
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Dispute
Resolution
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34 |
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9.23.
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Limitation
of Damages
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35 |
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9.24.
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Specific
Performance
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35 |
EXHIBITS
| EXHIBIT A |
Section
4.1.1
|
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EXHIBIT
B
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Section
4.2.1
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EXHIBIT
C
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Section
4.3.1
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EXHIBIT
D
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Section
5.2.2
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EXHIBIT
E
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Section
5.3
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EXHIBIT
F
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Section
5.4
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EXHIBIT
G
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Section
5.6
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EXHIBIT
H
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Section
6.1
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EXHIBIT
I
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Section
6.1
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EXHIBIT
J
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Section
6.1
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EXHIBIT
K
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Section
6.2
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EXHIBIT
L
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Section
6.4
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EXHIBIT
M
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Section
5.2.3
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[*]
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This
Termination and Transition Agreement (this “
Termination
Agreement”) is signed this ninth day of October, 2009 (the “
Signing Date”) and
effective as of the first day of October, 2009 (the “Effective Date”), by
and among
Wyeth, acting through its
Wyeth Pharmaceuticals Division, a corporation
organized and existing under the laws of the
State of Delaware and
having a principal place of business at 000
Xxxxxx Xxxx,
Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000 (“Wyeth Parent”),
Wyeth-Whitehall Pharmaceuticals, Inc., a
corporation
having a principal place of
business at Road No. 3, Kilometer 142.1, Guayama,
Puerto Rico 00784,
Wyeth-Ayerst Lederle, Inc., a corporation
having a principal place of business at 65th
Infantry Road, Kilometer 9.7, Carolina,
Puerto Rico 00987-4904, and AHP
Manufacturing B.V., trading as Wyeth Medica Ireland, a corporation organized and
existing under the laws of the Kingdom of the Netherlands and having a principal
place of business at Xxxxxxxxx 00, 0000 XX Xxxxxxxxx, Xxx Xxxxxxxxxxx
(collectively, “
Wyeth”), and
Progenics Pharmaceuticals, Inc., a corporation organized and existing under the
laws of the State of Delaware and having a principal place of business at 000
Xxx Xxx Xxxx Xxxxx Xxxx, Xxxxxxxxx, XX 00000, Progenics Pharmaceuticals Nevada,
Inc., a corporation organized and existing under the laws of the State of Nevada
and having a principal place of business at 000 Xxx Xxx Xxxx Xxxxx Xxxx,
Xxxxxxxxx, XX 00000, and a direct, wholly-owned subsidiary of Progenics
Pharmaceuticals, Inc. (“ProNev”), and
Excelsior Life Sciences Ireland Limited, a corporation organized and existing
under the laws of the Republic of Ireland and having a principal place of
business at 00/00 Xxxxx Xxxx Xxxx, Xxxxxx 0, Xxxxxx Xx. Xxxxxx, Xxxxxxx, and a
direct, wholly-owned subsidiary of Progenics Pharmaceuticals, Inc.
(collectively, “Progenics”). Wyeth
and Progenics may each be referred to herein individually as a “Party” and,
collectively, as the “Parties.”
X.
Xxxxx
Pharmaceuticals is the pharmaceutical
division of
Wyeth and
Wyeth-Whitehall Pharmaceuticals, Inc.,
Wyeth-Ayerst Lederle, Inc., and AHP
Manufacturing B.V. are indirect subsidiaries of
Wyeth Parent.
X.
Xxxxx and
Progenics are
parties to that certain
License and
Co-Development Agreement, dated as of
December 23, 2005, as amended (the “
Progenics-Wyeth
Agreement”) pursuant to which
Progenics granted to
Wyeth an exclusive worldwide license to
Develop and
Commercialize [*] (“[*]”) for all
prophylactic or therapeutic pharmaceutical uses of the Compound for the
diagnosis, treatment or prevention of disease in
humans. Wyeth-Whitehall Pharmaceuticals, Inc. and Wyeth-Ayerst
Lederle, Inc. have assigned part of their rights and obligations under the
Progenics-Wyeth Agreement to AHP Manufacturing B.V., and Progenics has consented
to such assignment.
C. Pursuant
to the
Progenics-
Wyeth Agreement, the
Parties have developed and obtained
Regulatory Approval for a subcutaneous
formulation of [*], which is marketed and sold in a number of countries under
the brand RELISTOR®.
[*]
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D. The
Parties previously terminated the
Progenics-
Wyeth Agreement with respect to
Japan pursuant to that certain
Partial Termination and License Agreement,
dated as of the 16th day
of
October, 2008, by and among the
Parties (the “
Partial Termination
Agreement”).
E. The
Parties now wish to terminate the
Progenics-
Wyeth Agreement and the
Partial
Termination Agreement, each in its entirety,
subject to the terms
hereof and except as
specifically provided
herein, and in
connection therewith set forth covenants relating to certain ongoing activities
of
Wyeth in furtherance of the transition
of the
Development and
Commercialization programs contemplated by
the
Progenics-
Wyeth Agreement from
Wyeth to
Progenics and/or its Ex-US Regional
Partner(s) (as defined in Section 4.3.2) or U.S. licensee (collectively, each a
“Commercial
Partner”), and to provide for
Wyeth to make certain payments to
Progenics in consideration of
Progenics’ efforts in connection with such
activities in lieu of any corresponding payment obligations under the
Progenics-
Wyeth Agreement.
NOW,
THEREFORE, in consideration of the mutual promises and covenants set forth
below, and other good and valuable consideration, the receipt and sufficiency of
which is hereby acknowledged, the
Parties
hereby agree as follows:
All capitalized terms used, but not
otherwise defined, in the text
hereof
shall have the meanings ascribed to such terms in the
Progenics-
Wyeth Agreement, notwithstanding the
termination thereof as provided in Section
2
below.
The
Parties hereby acknowledge and agree that,
except as otherwise expressly provided for
herein:
(a) the
Progenics-
Wyeth Agreement shall be, and hereby is,
terminated by mutual agreement of the
Parties as of the
Effective Date;
(b) the
Partial
Termination Agreement shall be, and hereby
is, terminated by mutual agreement of the
Parties as of the
Effective Date; (c)
the Trademark Co-operation Agreement dated
as of October 16, 2008 shall terminate by mutual agreement of the Parties as of
the expiration of the International Sale Period; and (d) the provisions
hereof shall supersede the provisions of the
Progenics-
Wyeth Agreement and the
Partial
Termination Agreement. For the
avoidance of doubt, and without limiting the generality of the foregoing, the
Parties acknowledge and agree that the termination of Section 2.1 of the
Progenics-Wyeth Agreement with respect to Japan as provided in Section 2 of the
Partial Termination Agreement is included in and a part of the foregoing
terminations.
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3.1.
Payment to
Progenics. Subject to the
terms and conditions of this Termination Agreement,
Wyeth shall pay
Progenics the sum of
ten million
United States dollars
(a) $1,666,666
payable within ten (10) days of the Signing Date;
(b) $1,666,666
payable on January 30, 2010;
(c) $1,666,667
payable on April 30, 2010;
(d) $1,666,667
payable on July 30, 2010;
(e) $1,666,667
payable on October 30, 2010; and
(f) $1,666,667
payable on January 30, 2011.
3.2. No Other
Payments. The payments provided for in this
Termination Agreement are in lieu of all
payments that may have been owed under the
Progenics-
Wyeth Agreement or
Partial
Termination Agreement. The
parties recognize that Wyeth has paid Progenics in advance for work performed by
Progenics under the Progenics-Wyeth Agreement or Partial Termination Agreement
in the third calendar quarter of 2009. As of the
Effective Date,
except as explicitly stated in this
Termination Agreement, Wyeth shall not be obligated to
make any payments to Progenics under the
Progenics-
Wyeth Agreement or
Partial
Termination Agreement or to reconcile any
amounts Wyeth advanced to Progenics under such agreements with any amounts
billable by Progenics to Wyeth under such agreements.
3.3. Offset for Payments
Owed. Either Party may deduct from any amount owed by such
Party to the other pursuant to this Termination Agreement any amount then due
and payable by the other Party to such Party under this Termination
Agreement.
4.1.1.
Wyeth shall, at its
expense, complete Studies [*] as provided in the termination development plan
attached hereto as Exhibit A (the “Termination Development
Plan”), and produce [*] with respect thereto in the format provided in
the Termination Development Plan within [*] of availability of a clinical data
report, which period shall be extended by [*]. Wyeth shall, at its
expense, produce the other documents specified in the Termination Development
Plan within the time periods specified in the Termination Development
Plan. Wyeth shall not be obligated to conduct any activities other
than those specified in the Termination Development Plan.
[*]
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4.1.2.
Wyeth’s
Development work shall include preparation
of documentation (i.e.,
[*]) for US Regulatory Submissions and International Regulatory Submissions
(each as defined in Section 5.2 of this Termination Agreement) to be submitted
by
Progenics and/or its Commercial
Partner to the applicable
Regulatory
Authorities in connection with Studies [*], all as specified in the
Termination Development Plan.
Except as indicated in Section 4.1.6,
Wyeth’s Development work shall extend to and conclude with the delivery to
Progenics of the aforementioned [*].
4.1.3. Wyeth
shall be responsible for out-of-pocket expenses, not to exceed [*] United States
dollars ($[*]) in the aggregate, incurred to complete [*] related to [*]
utilizing [*] as provided in the Termination Development Plan (the
“[*]”). Such stability studies shall be conducted by Wyeth through
one or more subcontractors, including [*]. If responsibility for such
studies is assigned to Progenics as contemplated in Section 5.6.5, then Wyeth
shall reimburse Progenics for amounts it pays to [*] or other subcontractors
that are conducting such stability studies (which reimbursements, taken together
with any amounts paid by Wyeth to [*] or other subcontractors in connection with
such stability studies, shall collectively be subject to the foregoing $[*]
cap), but shall otherwise cease to be responsible for any Development of
[*]. All expenses incurred in the conduct of the Development of [*]
in excess of such cap or in addition to those activities provided in the
Termination Development Plan shall be borne by Progenics and not reimbursed by
Wyeth; provided
that Progenics shall have no obligation to reimburse Wyeth for Wyeth’s internal
costs. Progenics and Wyeth intend for Wyeth to use its Commercially
Reasonable Efforts to enter into a [*] Agreement with [*] reasonably agreeable
to Progenics for the manufacture of [*] and for Wyeth to use its Commercially
Reasonable Efforts to assign such agreement to Progenics following the
expiration of the US Sale Period. However, it is understood and
agreed by Progenics that Wyeth does not represent or warrant that it will be
able to enter into such a [*] Agreement on terms and conditions that will be
acceptable to Progenics or that such [*] Agreement will be assignable by Wyeth
to Progenics or any third party without [*]’s consent and that Wyeth shall have
no obligation to undertake any additional obligations (including, without
limitation, the payment of any money or the guarantee of any performance) or
continue any obligations Wyeth may have under such [*] Agreement beyond the
expiration of the International Sales Period in connection with entering into
the [*] Agreement or any assignment thereof as contemplated by this Termination
Agreement. Subject to Section 5.3,
Progenics shall be responsible for all payments that become due under such [*]
Agreement for services performed and/or goods delivered following expiration of
the US Sale Period. Subject to the foregoing, Wyeth shall not have
any additional obligations related to the Development of
[*]. Progenics shall be solely responsible, at its expense, for [*]
to support Progenics’ Commercialization activities. Subject to
Section 5.3, Wyeth shall be solely responsible, at
its expense, for [*] to support Wyeth’s Commercialization activities during the
International Sale Period (as defined in Section 4.3.1).
[*]
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4.1.4. Progenics
shall be solely responsible for conducting, in its sole discretion, any
Development activities related to the multi-dose pen delivery mechanism for the
SC Product (the “Multi-Dose
Pen”). Wyeth’s sole and exclusive obligation with respect to
the Development of the Multi-Dose Pen shall be to reimburse Progenics for its
out-of-pocket expenses incurred under any contract with and actually paid to [*]
or another vendor of Progenics’ choice specifically for the Development of the
Multi-Dose Pen for [*] or such other vendor’s work related to the Development of
the Multi-Dose Pen; provided that Wyeth
shall not be required to reimburse Progenics for (and Progenics shall be solely
responsible for) payments to [*] or such other vendor (a) in excess of nine
million four hundred eighty thousand United States dollars ($9,480,000) or (b)
that are incurred by Progenics after [*]. The reimbursement payable
by Wyeth under this Section 4.1.4, shall be made within [*] days of Wyeth’s
receiving from Progenics an invoice therefor, which invoice is accompanied by
reasonable supporting documentation of such reimbursable out-of-pocket
expenses. Other than reimbursing Progenics for its payments to third
parties as provided in this Section 4.1.4 and
subject to the $9,480,000 cap, Wyeth shall not have any additional obligations
related to the Development of the Multi-Dose Pen and Progenics shall be solely
responsible, at its expense, for manufacturing Multi-Dose Pens to support
Progenics’ Commercialization activities.
4.1.5.
Wyeth shall not be
obligated to pay for
Development costs or
to conduct any activities associated with [*] in [*] or any other delivery
system or vehicle. If, during the period of time in which Wyeth has
Development responsibility for a particular presentation of the SC Product as
provided in the Termination Development Plan,
Progenics requests [*] in [*] or any other
delivery system or vehicle,
Progenics
shall be responsible for all incremental costs and for conducting any additional
activities associated with the change in the formulation, though
Wyeth shall continue to be responsible for
the costs and activities explicitly provided for in the Termination Development
Plan, other than those costs, expenses and activities that arise as a result of
such a change in the formulation.
4.1.6. Wyeth
shall provide [*] to participate in no more than (a) [*] per [*] that shall not
be longer than [*] in duration and shall take place at a location in [*] (the
“Area”)
selected by [*], and (b) [*] every [*] that shall not be longer than [*] in
duration and shall take place at [*] in order to keep Progenics and/or its
Commercial Partner reasonably informed about the Development activities provided
in this Section 4.1; provided, however, that (x)
such [*] shall occur during normal business hours and in such a way as to not be
disruptive to [*], (y) [*] shall provide [*] with an agenda for each such
meeting at least [*] in advance of such meeting indicating [*] and (z) [*] may,
in its sole discretion, elect to [*]. Wyeth’s obligation to
participate in such meetings with respect to a particular clinical study shall
end on the delivery of such [*] to Progenics; provided that, prior
to [*], Wyeth shall continue to make its personnel (to the extent such personnel
are knowledgeable regarding such study and remain employed by Wyeth) available
[*] or, with respect to Study [*].
[*]
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4.2.1.
From the
Effective Date through September 30, 2010
(the “
US Sale Period”),
Wyeth shall continue to Commercialize the
SC
Product in the
United States as provided
in the commercialization plan attached hereto as
Exhibit B (the “
US Termination
Commercialization Plan”), and Wyeth shall continue to book sales and pay
quarterly royalties and submit related reports as provided in Sections
6.5 and 6.6 of the
Progenics-
Wyeth Agreement. Commencing
October 1, 2010,
Wyeth shall no longer have the right and
obligation to
Commercialize the
SC
Product in the
United States and
Wyeth shall cease these
activities. Within [*] after the expiration of the
US
Sale Period, Wyeth shall submit to
Progenics a final royalty report in the form
heretofore used under the
Progenics-
Wyeth Agreement and pay
Progenics any royalties remaining due for
sales made prior to such expiration.
4.2.2.
During the
US
Sale Period,
Wyeth shall be responsible for all ongoing
SC Product Commercialization activities
in the United States,
including
[*]. During the US Sale Period, Wyeth shall have sole decision
authority over [*] activities related to the SC Product in the United States,
including, without limitation, all decisions related to [*] for the SC Product;
provided, however, that (a)
Wyeth consults in good faith with Progenics with respect to [*] and (b)
Progenics’ prior written consent shall be required for any [*], except [*] in
which case Progenics’ consent is not required.
Except as provided in this Termination
Agreement, prior to the expiration of the US Sale Period, Progenics shall not be
involved in or undertake any [*] activities related to the SC Product in the
United States.
4.2.3.
Between [*] and the
expiration of the US Sale Period, Wyeth shall, in cooperation with Progenics
and/or its US Commercial Partner, transition SC Product Commercialization
activities in the United States to Progenics and/or its US Commercial Partner in
accordance with a transition plan that the Parties establish and agree upon
within [*] after [*] (the “Termination Transition
Plan”). During this time period, Wyeth shall involve Progenics
and/or its US Commercial Partner in planning, preparation and implementation of
the transition of all SC Product Commercialization activities in the United
States, including [*], to the extent reasonably necessary to facilitate the
effective transition of such Commercialization activities as provided in the
Termination Transition Plan by providing [*] to participate in (a) [*] per [*]
that shall not be longer than [*] in duration and shall take place at a location
in the Area selected by [*], and (b) [*] every [*] that shall not be longer than
[*] in duration and shall take place at [*]; provided, however, that (w)
such [*] shall occur during normal business hours and in such a way as to not be
disruptive to [*], (x) [*] shall provide [*] with an agenda for each such
meeting at least [*] in advance of such meeting indicating [*], (y) [*] may, in
its sole discretion, elect to [*] and (z) Wyeth’s obligation to participate in
such meetings shall end [*] the expiration of the US Sale Period.
[*]
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4.2.4. If all
necessary Regulatory Approvals required to launch the Pre-Filled Syringe
presentation in the United States (including, without limitation, Regulatory
Marketing Approvals) are received from the FDA on or before [*],
Progenics may elect to have
Wyeth be responsible for the launch and
promotion of the Pre-Filled Syringe presentation in the
United States until the expiration of the
US
Sale Period by providing written notice to
Wyeth within [*] after receiving
notification of such approval. However, if (a) such approval is not
received on or before [*], (b) Progenics does not provide such notice to Wyeth
or (c) [*], Wyeth shall not have any obligation to launch and promote the
Pre-Filled Syringe presentation in the United States.
4.3.1.
From the
Effective Date through
December 31, 2010 (the “
International Sale
Period”),
Wyeth shall continue to
Commercialize the
SC Product
outside the United States as provided in the
commercialization plan attached hereto as Exhibit C (the “Ex-US Termination
Commercialization Plan”). During the International Sale
Period, Wyeth shall continue to book sales and pay quarterly royalties and
submit related reports as provided in Sections
6.5 and 6.6 of the
Progenics-
Wyeth Agreement; provided that Wyeth
shall not pay such royalties with respect to Net Sales of Product outside the
United States sold during the fourth calendar quarter of 2010 to the extent that
after paying such royalties [*] as it relates to such calendar
quarter. Within [*] after the expiration of the International Sale
Period, Wyeth shall submit a final royalty report in the form heretofore used
under the
Progenics-
Wyeth Agreement to
Progenics and pay
Progenics any royalties remaining due for
sales made prior to such expiration. [*]
4.3.2. Notwithstanding
the foregoing, if by [*],
Progenics has
entered into [*] with one or more partner(s) in a Region (as defined below),
including licensee(s), sublicense(s) and/or
distributor(s), under which such partner(s) would either distribute, market,
promote, sell or otherwise
Commercialize
the
SC Product in one or more [*] region(s)
other than the
United States (i.e., [*] (each a “Region”) (an “Ex-US Regional
Partner”), but additional time is necessary for
[*] in a country in such Region
[*],
Wyeth
shall, upon
Progenics’ request, continue
to
Commercialize the
SC
Product in such country for the period of time requested by
Progenics until [*] (with respect to each
relevant country, the “
Extended International Sale
Period”). In any event, however, the
Extended
International Sale Period for any relevant
country shall expire no later than [*]. Except as provided in Section
5.2.5,
Wyeth
shall have no obligations with respect to the
Commercialization of any
SC
Product after the expiration of (a) the International Sale Period, in any Region
for which Progenics does not enter into [*] with an Ex-US Regional Partner, or
(b) the Extended International Sale
Period, in any country to which an Extended International Sale Period
applies.
During each
applicable
Extended
International Sale Period,
Wyeth
shall continue to book sales of
SC Product, but no royalties shall be
payable by or on behalf of
Wyeth or any
of its
Affiliates in respect of
Net Sales of the
SC
Product in the relevant country during the relevant
Extended
International Sale
Period. Furthermore, during each
Extended International Sale Period,
Wyeth
shall have no obligation to launch any
SC Product in any country.
[*]
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4.3.3. Notwithstanding
anything
herein to the contrary,
Progenics may terminate the
International Sale Period or any
applicable
Extended
International Sale Period in a country at
any time prior to the expiration of such
International Sale Period or
Extended
International Sale Period, as applicable, by
giving
Wyeth at least [*] prior written
notice. Thereafter,
Wyeth’s right and obligation to
Commercialize the
SC
Product in such country shall expire and
Wyeth shall cease these
activities.
4.3.4.
During the International
Sale Period and any Extended International Sale Period in a country, Wyeth shall
be responsible for all ongoing SC Product Commercialization activities in such
country, including [*]. During the International Sale Period and any
Extended International Sale Period in a country, Wyeth shall have sole decision
authority over [*] activities related to the SC Product in such country,
including, without limitation, all decisions related to [*] for the SC Product;
provided, however, that (a)
Wyeth consults in good faith with Progenics with respect to any [*] and (b)
Progenics’ prior written consent shall be required for any [*], except [*] in
which case Progenics’ consent is not required. Except as provided in
this Termination Agreement, prior to the expiration of the International Sale
Period and any Extended International Sale Period in a country, Progenics shall
not be involved in or undertake any [*] activities related to the SC Product in
such country.
4.3.5. Between
[*] and the expiration of the relevant
International Sale Period or such earlier
date as may be designated in any notice given by
Progenics pursuant to Section 4.3.3, Wyeth shall, in cooperation with
Progenics and/or its Ex-US Regional
Partner(s), transition
SC Product Commercialization activities
outside the
United States on a
country-by-country basis to
Progenics
and/or its Ex-US Regional Partner
(s) in
accordance with the Termination Transition Plan.
Starting no earlier than [*] prior to the
scheduled expiration of the
International
Sale Period (or such earlier period upon
Progenics’ request in accordance with
Section
4.3.3) in a country,
Wyeth shall involve
Progenics and/or its Ex-US Regional
Partner(s) in planning, preparation and implementation of the transition of all
Commercialization activities for the
SC
Product in such country,
including [*],
to the extent reasonably necessary to facilitate the effective transition of
such
Commercialization activities as
provided in the Termination Transition Plan by providing [*] to participate in
(a) [*] per [*] that shall not be longer than [*] in duration and shall take
place at a location, selected by [*], in the Area or the relevant Region, and
(b) [*] every [*] that shall not be longer than [*] in duration and shall take
place at [*]; provided, however, that (v) if
[*], Progenics must [*] in such transition, (w) such [*] shall occur during
normal business hours and in such a way as to not be disruptive to [*], (x) [*]
shall provide [*] with an agenda for each such meeting at least [*] in advance
of such meeting indicating [*], (y) [*] may, in its sole discretion, elect to
[*] and (z) Wyeth’s obligation to participate in such meetings shall end [*] the
expiration of the
International Sale
Period or any applicable
Extended
International Sale Period in such country.
[*]
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4.3.6. If all
necessary Regulatory Approvals required to launch the Pre-Filled Syringe
presentation in a country (including Regulatory Marketing Approvals and
Regulatory Pricing Approvals, as applicable) are received from all applicable
Regulatory Authorities in such country on or before [*], Progenics may elect to
have Wyeth be responsible for the launch and promotion of the Pre-Filled Syringe
in the relevant country until the expiration of the relevant International Sale
Period and any Extended International Sale Period by providing written notice to
Wyeth within [*] after receiving notification from Wyeth of such
approval. However, if (a) such approval is not received on or before
[*] or (b) Progenics does not provide such notice to Wyeth or (c) [*], Wyeth
shall not have any obligation to launch and promote the Pre-Filled Syringe
presentation in such country.
5.1.
Technology
Transfer.
Wyeth and
Progenics shall, within [*] after [*], establish procedures and a timeline for
the transfer to Progenics and/or its Commercial Partner(s) of all [*], including
all [*], relating to the
Development,
manufacture and/or
Commercialization of
the
Products or the
Compound (
including [*] created in the course of the
Collaboration) in Wyeth’s Control, which
procedures and timeline shall be documented in the Termination Transition
Plan. To the extent not previously provided to Progenics, Wyeth
shall, at no cost to Progenics, transfer to Progenics and/or its Commercial
Partner(s) [*] ([*], as applicable) of all such [*] (including [*])
(collectively, “Transition
Materials”) in accordance with the agreed-upon timeline set forth in the
Termination Transition Plan. With each transfer of [*] Transition
Materials set forth in the Termination Transition Plan, Wyeth shall confirm [*],
and within [*] of receiving such confirmation, Progenics shall notify Wyeth in
writing [*]. Wyeth shall not be obligated to respond to any request
by Progenics for [*] Transition Materials unless such request is received by
Wyeth in writing within such [*] period; provided that
Progenics [*]. Additionally,
Wyeth
shall, at no cost to
Progenics, provide
technology transfer assistance to the extent reasonably necessary to enable
Progenics and/or its Commercial Partner(s)
to understand and utilize the
(a)
Transition Materials transferred to
Progenics and/or its Commercial Partner(s)
pursuant to this Section
5.1 and (b) Wyeth Collaboration Know-How licensed to
Progenics pursuant to Section 6.4 of this
Termination Agreement, as may be reasonably
requested by
Progenics
by providing [*] to participate in no more
than (x) [*] per [*] that shall not be longer than [*] in duration and shall
take place at a location in the Area selected by [*], and (y) [*] every [*] that
shall not be longer than [*] in duration and shall take place at [*]; provided, however, that
(i) such [*] shall occur during normal
business hours and in such a way as to not be disruptive to [*],
(ii) [*] shall provide [*] with an agenda
for each such meeting at least [*] in advance of such meeting indicating [*],
(iii) [*] may, in its sole discretion, elect to [*] and
(iv)
Wyeth’s obligation to provide such assistance and consultation shall end on [*];
provided, however, that if
Wyeth provides additional Transition Materials after such date, then, prior to
[*], Wyeth will make its personnel (to the extent such personnel are
knowledgeable about such additional Transition Materials and remain employed by
Wyeth) available [*]. At
Progenics’ request after such transfer,
Wyeth shall destroy all copies of any such
Transition Materials that relate
exclusively to the
Products; provided, however, that
Wyeth may retain [*] of
any Transition Materials in accordance with
[*].
[*]
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5.2.1.
General.
Wyeth shall, at its expense and as provided
in this Section
5.2, transfer to
Progenics and/or its Commercial Partner(s)
ownership of all
Registrational Filings
and
Regulatory Approvals submitted or
obtained for the
Products and the
Compound, and, to the extent not previously
provided to Progenics, all [*] relating to the
Products and the
Compound, each to the extent they are owned
by or held in the name of
Wyeth or its
Affiliates.
To the extent not previously provided to
Progenics, Wyeth shall, at its expense, also provide support, documentation and
assistance to the extent reasonably necessary to provide information to
Progenics and/or its Commercial Partner(s)
necessary for the completion by
Progenics
and/or its Commercial Partner(s) of all
Registrational Filings and
Regulatory Approvals transferred to
Progenics and/or its Commercial Partner(s)
pursuant to this Section 5.2,
including
support, documentation and assistance with the [*] of all such
Registrational Filings and
Regulatory Approvals. To comply
with the foregoing, in addition to providing all necessary or appropriate [*]
(to the extent not previously provided to Progenics), Wyeth will also provide
[*] to participate in no more than (a) [*] per [*] that shall not be longer than
[*] in duration and shall take place at a location in the Area selected by [*],
and (b) [*] every [*] that shall not be longer than [*] in duration and shall
take place at [*]; provided, however, that (x)
such [*] shall occur during normal business hours and in such a way as to not be
disruptive to [*], (y) [*] shall provide [*] with an agenda for each such
meeting at least [*] in advance of such meeting indicating [*] and (z) [*] may,
in its sole discretion, elect to [*].
Wyeth’s obligation to provide such support
and consultation related to such Registrational Filings and Regulatory Approvals
shall end, on a Product-by-Product basis, upon
the earlier of (i) [*] after Wyeth transfers
to Progenics and/or its Commercial Partner(s) ownership of all Registrational
Filings and Regulatory Approvals submitted or obtained for such Product or (ii)
completion by Progenics and/or its Commercial Partner(s) of all Registrational
Filings and Regulatory Approvals for such Product transferred to Progenics
and/or its Commercial Partner(s) pursuant to this Section 5.2 or (iii) [*];
provided that
Wyeth shall continue to make its personnel available [*] until [*].
[*]
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(a)
US Regulatory
Submissions. During the US Sale Period,
Wyeth
shall, at its expense, be responsible for the activities set forth on Exhibit D
related to preparing
Registrational
Filings and
Regulatory Approval
submissions to the FDA for both the current formulation of the
SC
Product and formulations arising out of additional activities undertaken by
Wyeth in connection with the
SC Product (“
US Regulatory
Submissions”). Progenics shall be responsible for the
compilation of and submission to the FDA of US Regulatory
Submissions. Following the
US Sale Period,
Progenics and/or its US Commercial Partner
shall, subject to
Wyeth’s obligations under Sections
4.1, 5.1 and 5.2.1
hereof, be responsible for preparing and
submitting all
US Regulatory Submissions for the
SC
Product. In connection therewith,
Wyeth shall, at its expense, provide to
Progenics and/or its US Commercial Partner
all
[*], to the extent not previously
provided to Progenics, that are reasonably necessary for
Progenics and/or its US Commercial Partner
to prepare and submit such
Registrational
Filings for
the SC Product,
including [*] and other relevant
data. Throughout the
US Sale Period and thereafter,
Progenics and/or its US Commercial Partner
shall be responsible for maintaining, at its own expense, the
Orange Book listing for the
SC
Product and, in connection therewith, shall be solely responsible for making
determinations as to whether to list any particular patent in the
Orange Book.
(b)
Pediatric Studies of the
SC Product.
Progenics and/or its US Commercial Partner
may conduct such pediatric studies of
SC Product as, when and in the manner it
deems necessary, and as agreed with or required by the FDA, at Progenics’ own
expense. Notwithstanding the foregoing,
Wyeth shall reimburse Progenics and/or its
US Commercial Partner for all out-of-pocket expenses incurred prior to [*] by
Progenics and/or its US Commercial Partner in conducting up to [*] pediatric
studies of the SC Product within [*] of Wyeth’s receiving an invoice therefor
accompanied by commercially reasonable supporting documentation; provided that such
pediatric study(ies) (i) is(are) [*] and (ii) were initiated prior to
[*]. Wyeth’s obligation to reimburse Progenics and/or its US
Commercial Partner for such out-of-pocket expenses for such pediatric studies
shall not exceed [*] United States dollars ($[*]) if [*] or five million United
States dollars ($5,000,000) if [*].
[*]
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5.2.3.
SC Product
– Ex-United States. During the
International Sale Period,
Wyeth
shall, at its expense, be responsible for continuing to seek
Regulatory Approval for the
SC
Product in the countries identified on Exhibit
X.
Xxxxx, at its
expense, shall be responsible for preparing all Registrational Filings and
Regulatory Approval submissions in such jurisdictions (“
International Regulatory
Submissions”) relating to the
SC Product. During the
International Sale Period
, Wyeth shall be responsible for submitting
to the relevant
Regulatory Authorities
appropriate
International Regulatory
Submissions for the
SC Product as required by the
Ex-
US Termination Commercialization
Plan. In addition, during the
International Sale Period and any
Extended
International Sale Period (on a
country-by-country basis),
Wyeth or its
Affiliates shall
(a) be responsible for
interacting with the relevant
Regulatory
Authorities with respect to such
International Regulatory Submissions related
to the
SC Product and
(b) retain ownership of all
International Regulatory Submissions
relating to the
SC Product. Subject to Section
5.2.5,
following the expiration or termination of the relevant
International Sale Period or any
Extended
International Sale Period,
Wyeth
shall, on a country-by-country basis, promptly transfer to
Progenics and/or its Ex-US Regional Partner
ownership of all
International Regulatory
Submissions made, submitted or obtained for the
SC
Product.
(a) Registrational Filings and Regulatory
Approvals. Promptly following [*],
Wyeth
shall transfer to
Progenics and/or its
Commercial Partner(s) ownership of all
Registrational Filings and
Regulatory Approvals made, submitted or
obtained for the Oral Product,
including
the investigational new drug application for the Oral Product.
Progenics and/or its Commercial Partner(s)
shall thereafter be responsible for preparing and submitting all
Registrational Filings and
Regulatory Approval submissions relating to
the Oral Product, and for all other [*] work for the Oral Product.
To the extent not previously provided to
Progenics, Wyeth shall, at its expense, provide to
Progenics and/or its Commercial Partner(s)
such [*] that are reasonably necessary for
Progenics and/or its Commercial Partner(s)
to prepare and submit
US Regulatory
Submissions and International Regulatory Submissions for the Oral Product,
including [*] and other related
data.
Progenics and/or its US
Commercial Partner(s) shall be responsible for maintaining the
Orange Book listing for the Oral
Product. Following the
Signing Date,
Wyeth
shall make
[*] and other agreed-upon [*]
available for consultation with
Progenics
and/or its Commercial Partner(s) with respect to formulation of Oral Product, at
no cost to
Progenics, until the earlier
of
(i) [*],
(ii) [*] or
(iii) [*]; provided that (x)
such consultation shall occur during normal business hours and in such a way as
to not be disruptive to [*], (y) [*] shall provide [*] with an agenda for each
such meeting at least [*] in advance of such meeting indicating [*] and (z) [*]
may, in its sole discretion, elect to [*].
[*]
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5.2.5.
Delays in Transferring International
Regulatory Submissions. In the event that, despite
Progenics’ good faith, diligent efforts, any
International Regulatory Submissions
cannot be transferred to
Progenics and/or
its Ex-US Regional Partner in the manner provided in this Section
5.2 upon the
expiration or termination of the
International Sale Period and any
Extended International Sale Period due to
any inability to secure, or any delay in securing, any necessary regulatory
approvals, at
Progenics’ written request
delivered no later than [*] the expiration of the
International Sale Period or
any Extended International Sale Period,
Wyeth shall
(a) retain ownership of any such
International Regulatory Submissions and
(b) continue to be responsible for
submitting to the relevant
Regulatory
Authority, and interacting with the relevant
Regulatory Authorities, with respect to such
International Regulatory Submissions as
provided for in this Section
5.2 for the benefit of
Progenics until such time as the necessary
regulatory approvals have been obtained and then
Wyeth shall promptly transfer to
Progenics and/or its Ex-US Regional Partner
such
International Regulatory
Submissions; provided, however,
that Wyeth shall have no obligation to
perform any acts or services (other than forwarding notices and other
ministerial acts) in respect of such delayed
International Regulatory
Submissions.
Progenics shall
reimburse
Wyeth for all of Wyeth’s
reasonable out-of-pocket costs and expenses incurred at the request of Progenics
or a Regulatory Authority associated with
Wyeth’s retaining ownership of any
International Regulatory Submissions and
associated activities contemplated by this Section
5.2.5. Notwithstanding the foregoing,
Wyeth shall not be required to retain
ownership of any
International Regulatory
Submissions pursuant to this Section
5.2.5 beyond [*], after which time
Wyeth shall have no obligations with respect
to such
International Regulatory
Submissions and Wyeth may abandon or retain such International Regulatory
Submissions if
Wyeth so chooses in its
sole discretion.
5.3. Supply of
SC Product. Wyeth
shall be responsible for manufacturing sufficient supplies of the current vial
presentation and, to the extent Commercialized by Wyeth at Progenics’ request as
provided in Section 4.2.4 and 4.3.6, the Pre-Filled Syringe, to satisfy demand
for such presentation(s) of the SC Product in each country in which Wyeth is
Commercializing such presentation(s) of the SC Product pursuant to Sections 4.2
or 4.3 of this Termination Agreement through [*] for the US and [*] for the
ex-US Regions. Not later than [*], Wyeth and Progenics shall assess
the state of the US and ex-US inventory for each such presentation of the SC
Product that is available for such Commercialization in the US and in the ex-US
Regions. If, in Progenics’ reasonable business judgment, there is not
a sufficient quantity of either presentation to fulfill [*] through [*] for the
US and [*] for the ex-US Regions, Progenics may give Wyeth [*] for Wyeth to
manufacture such quantities of each presentation of the SC Product according to
the manufacturing and supply terms attached hereto as Exhibit E (the “Manufacturing and Supply
Terms”) and subject to the limitations of any contracts related to the
manufacturing or supply of such presentations of the SC Product between Wyeth
and any Third Party: [*]. Subject to the Manufacturing and Supply
Terms, Wyeth shall have such presentations of the SC Product manufactured using
[*] of each presentation of the SC Product and the requirements of any contracts
related to the manufacturing or supply of such presentations of the SC Product
between Wyeth and any Third Party. Subject to the Manufacturing and
Supply Terms, Wyeth shall transfer [*] finished SC Product (including any
inventory of the Pre-Filled Syringe in Wyeth’s possession, whether manufactured
for Development or Commercial use and any SC Product ordered by Progenics
pursuant to this Section 5.3 to fulfill [*] through [*] for the US or [*] for
the ex-US Regions) to Progenics and/or its Commercial Partner(s) as
follows:
[*]
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(a) commencing
[*], Wyeth shall transfer [*] inventory [*];
(b) within
[*] of [*], Wyeth shall transfer [*] inventory [*];
(c) commencing
[*], Wyeth shall transfer [*] inventory [*];
(d) within
[*] of [*], Wyeth shall transfer [*] inventory [*];
(e) within
[*] of [*], Wyeth shall transfer [*] inventory [*].
In each
case, Progenics shall purchase such inventory of finished SC Product at
[*]. In no event shall Progenics be required to purchase inventory
that [*] or that [*]. After
Wyeth has discontinued manufacturing of the
SC
Product,
Wyeth shall transfer to
Progenics [*] API, excipients and packaging
components purchased or produced by
Wyeth
specifically for the manufacture of the
SC
Product, other than those necessary for
Wyeth to fulfill its obligations pursuant to
this Section
5.3, and Progenics shall reimburse Wyeth for its costs
associated with purchasing or producing such material. All
SC
Product, API, excipients, and package components delivered by
Wyeth
to
Progenics shall be delivered
[*]. On delivery,
Wyeth
will provide
Progenics with an invoice for costs of such
SC
Product, API, excipients, and package components delivered.
Progenics shall pay
Wyeth within [*] of receiving such
invoice.
5.4.
Supply of Oral
Product.
To the extent
not previously provided to Progenics, Wyeth shall promptly transfer to
Progenics and/or its Commercial Partner all
technology [*] for the manufacture of each form of the Oral Product developed by
Wyeth set forth on Exhibit F, including
[*] the Oral Product
. Wyeth
shall
transfer to Progenics or its
Commercial Partner
[*] oral [*] and [*]
manufactured [*], at no cost to
Progenics, which transfer shall occur in two
or more stages: [*] an initial quantity of [*] oral [*] will be made on or
before [*] and [*] the remaining quantity of [*] oral [*] will be made
[*]. All such deliveries shall be [*].
All Oral Product delivered by
Wyeth
to
Progenics shall be delivered
[*]. Except as provided for
herein,
Progenics shall be responsible for all costs
and activities related to the
Development
and
Commercialization of the Oral
Product.
[*]
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5.5.
Pharmacovigilance Activities; Product
Recalls.
Wyeth shall
continue to perform its pharmacovigilance activities pursuant to the existing
Wyeth/Progenics Pre-Approval
Pharmacovigilance Agreement and Post-Approval Pharmacovigilance Agreement in
(a) the
United States during the
US
Sale Period and
(b) each country where
Wyeth is
Commercializing the
SC
Product so long as
Wyeth holds the
Regulatory Approval for the
SC
Product in such country in accordance with this
Termination Agreement. If
Wyeth is required or voluntarily decides to
initiate a
Recall with respect to any
Product,
Wyeth
shall promptly notify
Progenics of such
requirement or decision. In the event of any
Recall, in the
United States during the
US
Sale Period and/or any country where
Wyeth holds the
Regulatory Approval for the
SC
Product in accordance with this
Termination Agreement,
Wyeth shall be solely responsible for
(x) all contact with applicable
Regulatory Authorities and
(y) implementing, directing and
administering any
Recall of any
Product required or recommended by any
Regulatory Authority, court or other
governmental authority of competent jurisdiction, or determined by
Wyeth, in consultation with
Progenics, to be necessary or
advisable. Notwithstanding any other provision of this Termination
Agreement, to facilitate the transition of Development and Commercialization
activities provided for herein, the Quality Agreements between the Parties
entered into pursuant to the Progenics-Wyeth Agreement shall remain in effect
until completion of the US Sale Period in the United States and the
International Sale Period or Extended International Sale Period (as applicable)
in other countries (on a country-by-country basis).
5.6.1. Wyeth has
delivered or shall deliver promptly after [*] to Progenics copies of all
agreements related to the Development, manufacture and/or Commercialization of
the Compound and/or the Products (“Third Party
Contracts”), subject to provisions in any such Contracts regarding the
confidentiality thereof, and has, to the extent consistent with such provisions,
fully informed or will inform Progenics as to the subject matter
thereof. A list of Third Party Contracts is set forth on Exhibit
G1.
5.6.2. Wyeth
shall use its reasonable efforts to assign and delegate to
Progenics and/or its Commercial Partner(s)
all of
Wyeth’s rights and obligations under those
Third Party Contracts
identified as being
a
Selected Third
Party Contract on
Exhibit
G2 (the “
Selected Third Party
Contracts”). Each
Selected Third
Party Contract shall be assigned to
Progenics and/or its Commercial Partner(s)
on or about the assignment effective date set forth on
Exhibit
G2 with respect to
such contract, subject to obtaining, if necessary, the consent of the
Third
Party to such assignment.
Wyeth and
Progenics shall use their respective
reasonable efforts to obtain the consent of such
Third
Party(ies) to the assignment of any such
Selected Third
Party Contracts. In connection
with obtaining such consents, Progenics will cooperate with Wyeth in
[*]. The
Parties shall
commence, if necessary, discussions with all counterparties to the
Selected Third
Party Contracts promptly following
[*] in order to effectuate terms of this
Section
5.6
as promptly as practicable. The
Parties shall each cooperate with one
another to, as promptly as practicable, prepare all necessary documentation to
obtain all necessary consents for such
Selected Third
Party Contracts necessary to consummate the
transactions contemplated by this
Termination Agreement or otherwise
reasonably required in connection therewith.
Wyeth shall [*] the assignment of any
Selected Third
Party Contract.
[*]
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5.6.3. To the
extent that any
Selected Third
Party Contract is not assignable without the
consent of the counterparty to such
Selected Third
Party Contract
and [*], the performance obligations of
Wyeth thereunder shall, unless not permitted
by such
Selected Third
Party Contract, be deemed to be
subcontracted to
Progenics and/or its
Commercial Partner(s) until such
Selected Third
Party Contract has been effectively assigned
[*]. If any such consent to assignment
[*] cannot be timely obtained,
(a)
Wyeth shall waive any exclusivity provision
contained in such
Selected Third
Party Contract to the extent necessary to
allow
Progenics and/or its Commercial
Partner(s) to enter into its/their own agreement with such
Third
Party, and
(b)
Wyeth and
Progenics shall cooperate in any reasonable
arrangement designed to provide for
Progenics and/or its Commercial Partner(s)
the benefits and obligations intended to be assigned or delegated to and assumed
by
Progenics and/or its Commercial
Partner(s) under the relevant
Selected Third
Party Contract,
including enforcement for the account of
Progenics and/or its Commercial Partner(s)
(and at
the expense of Progenics and/or
its Commercial Partner(s)) of any and all rights of
Wyeth against the other party(ies) thereto
arising out of the breach or cancellation thereof by such other party(ies) or
otherwise. In furtherance of the foregoing, Wyeth agrees that in the
event any Selected Third Party Contract is not assignable to Progenics or its
Commercial Partner(s), and in the event that Progenics or its Commercial
Partner(s) and the relevant counterparty wish to enter into a new contract with
such Third Party, Wyeth shall, and hereby does, consent to the use by any such
Third Party for the benefit of Progenics of any confidential information,
technology and/or Know-How of such Third Party developed in connection with the
Third Party’s work for Wyeth, subject to applicable restrictions of
confidentiality and limitations on use.
5.6.4. Pursuant
to Section 5.6.2, Wyeth shall use its reasonable
efforts to assign to Progenics all of its right, title and interest in, to and
under the Non-Disclosure Agreement between Wyeth and [*]. As of the
Signing Date, no other agreement is in place between Wyeth and [*] with respect
to the Development of the Multi-Dose Pen. Progenics and Wyeth intend
for Progenics to negotiate directly with [*] or any other vendor of Progenics’
choosing and enter into its own agreement with [*] or such other vendor related
to the Development of the Multi-Dose Pen and for Wyeth to reimburse Progenics
for its out-of-pocket expenses paid pursuant to such agreement(s) as provided in
Section 4.1.4 and subject to the monetary
limitations contained therein.
[*]
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5.6.5. Similarly,
pursuant to Section 5.6.2, Wyeth shall use its
reasonable efforts to assign to Progenics all its right, title and interest in,
to and under the [*] Agreement and the [*] Agreement, as amended, between Wyeth
and [*]; provided that Wyeth
shall not assign such agreements to Progenics until Wyeth reasonably determines
that such agreements are no longer necessary for Wyeth to satisfy its
Development obligations under this Termination Agreement. As of the
Signing Date, no other agreement is in place between Wyeth and [*] with respect
to the Development of [*]. Wyeth shall be responsible for expenses
incurred in completing the activities contemplated in these agreements with [*]
as provided in Section [*] and subject to the monetary limitations contained
therein. Progenics and Wyeth intend for Wyeth to enter into a [*]
Agreement with [*] related to the manufacture of [*]. Once executed,
such [*] Agreement shall be considered a Selected Third Party Contract for the
purposes of this Termination Agreement and shall be subject to the provisions of
Section 5.6.2, with an anticipated assignment
effective date corresponding to expiration of the US Sale
Period.
5.7.
Waiver of Rights Under, and Amendment
of, the
Chicago Agreement.
Wyeth hereby waives any and all rights and
licenses under that certain
Agreement
Related to Progenics’ MNTX In-License dated as of the 22nd day
of
December, 2005 by and among the
University of Chicago, acting on behalf of
itself and its affiliate
ARCH
Development Corporation (the “University”),
Progenics,
ProNev and
Wyeth (the “
Chicago Agreement”).
Wyeth shall, and shall cause its
Affiliates to, cooperate with
Progenics in connection with
Progenics’ efforts to amend and restate the
Chicago Agreement. The
University is hereby named as an express third party beneficiary of the waiver
referred to above with the right to enforce such waiver as if it were a party to
this Termination Agreement.
5.8. Coordination of
Transition. [*] following [*], the Parties shall each
designate at least [*] representatives, with appropriate expertise, who shall be
solely responsible for coordinating the activities and communication between the
Parties contemplated by this Termination Agreement and shall constitute a
Transition Committee for the purposes of this Termination
Agreement. Each Party shall determine, in its sole discretion, each
representative’s role in coordinating such activities and communications and the
applicable expertise required of such representative. [*] following
[*], each Party will provide written notice to the other Party identifying its
designated representatives and describing how they may be contacted by the other
Party, and by like notice, each Party may replace any of its designated
representatives or otherwise change the constitution of its group of designated
representatives. Each Party shall direct all communications to the
other Party to the appropriate representative(s) designated to receive and
coordinate communications related to the particular subject matter of the
communication. The Transition Committee shall meet [*] for [*] during
each [*] at a location in the Area selected by [*], during normal business hours
and in such a way as to not be disruptive to [*]. The Transition
Committee shall meet until all Development and Commercialization activities of
Wyeth have been transferred to Progenics and/or its Commercial Partner(s) as
provided for herein. [*] shall provide [*] with an agenda for each
such meeting at least [*] in advance of such meeting indicating [*], and [*]
may, in its sole discretion, elect to [*].
[*]
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6.1.1.
Assignment of
US Trademarks and Other
US Intellectual
Property. Effective as of the expiration of the applicable
US
Sale Period,
Wyeth shall, and hereby does, assign to
Progenics all United States trademarks,
trade dress, Internet domain names and all copyright rights in and to any
content (including website content), advertising, promotional and marketing
materials and other copyrightable materials owned by Wyeth and its Affiliates
identified on
Exhibit H1 (“
Assigned US
IP”). In furtherance of the assignment of
(a) trademarks identified on
Exhibit H1, the
Parties have executed and delivered to one
another the
Trademark and Domain Name
Assignment Agreement attached hereto as
Exhibit I and
(b) the other
Assigned US IP, the
Parties have executed and delivered to one
another the
Assignment of Copyrights
attached hereto as
Exhibit
J. Progenics
shall be responsible for the costs of recording such assignments, when necessary
or, in the opinion of Progenics, advisable, and all such assignments shall be
executed and delivered to Progenics no later than [*] after the expiration of
the US Sale Period.
6.1.2.
Assignment of Ex-
US
Trademarks and Other Ex-
US Intellectual
Property. Effective as of the expiration of the International
Sale Period, Wyeth
shall, and hereby does, assign to Progenics all Ex-United States trademarks,
trade dress, Internet domain names and all copyright rights in and to any
content (including website content), advertising, promotional and marketing
materials and other copyrightable materials owned by Wyeth and its Affiliates
identified on Exhibit
H2 (“Assigned
Ex-US IP” and, together with the Assigned US IP, the “Assigned
IP”). If there is an Extended International Sale Period in any
particular country in the Territory, then the foregoing assignment shall be
effective as of the expiration of the Extended International Sale Period in such
country with respect to any trademark registration or other Assigned Ex-US IP in
such country. In furtherance of the assignment of (a) trademarks
identified on Exhibit
H2, the
Parties have executed and
delivered to one another the
Trademark
and Domain Name Assignment Agreement attached hereto as
Exhibit I and
(b) the other
Assigned Ex-US IP, the
Parties have executed and delivered to one
another the
Assignment of Copyrights
attached hereto as
Exhibit J. Progenics
shall be responsible for the costs of recording such assignments, where
necessary or, in the opinion of Progenics, advisable, and all such assignments
shall be executed and delivered to Progenics no later than [*] after the
expiration of the International Sale Period or any Extended International Sale
Period (if applicable). In the event that the Trademark and Domain
Name Assignment Agreement cannot be recorded in any country due to the form
thereof, Progenics shall prepare a reasonable country-specific assignment
agreement (which in substance is not inconsistent with this Termination
Agreement and/or the Trademark and Domain Name Assignment Agreement attached
hereto as Exhibit
I) to assign to Progenics the trademarks in such country that are
included in the Assigned IP, and Wyeth shall execute and deliver to Progenics
any such assignment agreement within [*] after Progenics delivers such
assignment agreement to Wyeth.
[*]
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6.1.3. Accuracy of Exhibits H1 and
H2. The Assigned IP constitute all trademarks, Internet domain
names, trade dress and copyrights owned by Wyeth that relate exclusively to the
Products.
6.2.1. License
Grant. Effective as of the expiration of the
US
Sale Period or
International Sale Period
and any applicable
Extended
International Sale Period (as applicable),
Wyeth shall, and hereby does, grant to
Progenics a limited, royalty-free,
non-exclusive, non-transferable license, without the right to sublicense (other
than to Progenics’ Commercial Partners), to use the trademarks listed on
Exhibit
K (the “
Wyeth Trademarks”) in
the Territory in which they apply, as follows:
(a) on
[*]
until [*]; provided that such
Trademarks are used in the identical manner
as supplied by
Wyeth; provided, however, that
Progenics must maintain the quality of the
Products supplied by
Wyeth in accordance with
Wyeth’s past practice and with all
applicable legal requirements; and
(b) on [*]
for no longer than [*] following the end of the
US
Sale Period or
International Sale Period
and any
Extended
International Sale Period (as applicable);
provided, however, that
Progenics shall remove the
Wyeth Trademarks from any Internet web site
operated by
Progenics and/or its
Commercial Partner(s) no later than [*] following the end of the
US
Sale Period (for
US-directed web sites)
or
International Sale Period or any
Extended
International Sale Period (as applicable
for ex-
US directed Internet web
sites).
In
any event, however
, Progenics shall use
Commercially Reasonable Efforts to cease all use of the
Wyeth Trademarks as soon as
practicable.
6.2.2. No License to Third Party
Marks. No rights are granted by Wyeth under this Termination
Agreement with respect to any Third Party trademark. Progenics
acknowledges that trademarks owned by [*] appear on [*] certain SC Product [*]
and have been included in certain marketing materials relating to the Product
with the approval of [*]. Progenics acknowledges that Wyeth is not
granting any rights to Progenics with respect to any [*]
trademark. Progenics will be solely responsible for obtaining
authorization from [*] to use any such trademark after expiration of the US Sale
Period and International Sale Period, as applicable.
[*]
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6.3.
Ownership of Intellectual Property
Developed During the Transition. Inventorship of any invention
that arises during the performance of the
Termination Development Plan,
US Termination Commercialization Plan,
Ex-
US Termination Commercialization Plan
, transfer of technology or any other activities contemplated by this
Termination Agreement, and any
Patent Right claiming such invention, shall
be determined in accordance with rules and guidelines regarding inventorship as
established under United States patent law,
including case law and regulations
associated therewith. Authorship of any work subject to copyright
protection shall be determined in accordance with
United States copyright law, including case
law and regulations associated therewith. For the purposes of this
Termination Agreement, any such invention or work shall be included within the
definitions of
Wyeth Collaboration Know-How,
Wyeth Collaboration Patent Rights,
Progenics Know-How,
Progenics Patent Rights,
Joint Know-How, and
Joint Patent Rights to the extent
consistent with the definitions of those terms in the
Progenics-
Wyeth Agreement as if such invention or
work was made or created during the Term in the course of the
Collaboration.
6.4.1.
License. Subject to
the terms and conditions of this
Termination Agreement,
Wyeth shall, and hereby does, grant to
Progenics a fully paid-up, perpetual,
irrevocable, royalty-free, worldwide, transferable (to the extent provided in
Section 9.5), exclusive (except as to Wyeth and its
Affiliates) license (with the right to grant sublicenses) in the
Field to all
Wyeth Collaboration Patent Rights,
Wyeth Collaboration Know-How and
Wyeth’s interest in the
Joint Patent Rights and the Joint Know-How,
to make, have made, use,
Develop, sell,
offer to sell, have sold, import, export and otherwise exploit or
Commercialize the
Compound and the
Products in the
Territory (including Japan). To
the extent not included in the preceding license, subject to the terms and
conditions of this
Termination
Agreement,
Wyeth shall, and hereby does,
also grant to
Progenics a fully paid-up,
perpetual, irrevocable, royalty-free, worldwide, transferable, non-exclusive
license (with the right to grant sublicenses) in the
Field to all manufacturing technology
Controlled by
Wyeth and that has been used or, as of the
Effective Date, is in development specifically for use by or on behalf of Wyeth
in the manufacture of the
Compound and
Products to make, have made, use,
Develop, sell, offer to sell, have sold,
import, export and otherwise exploit or
Commercialize the
Compound and the
Products in the
Territory (including Japan). A
list of all
Wyeth Collaboration Patent Rights and
Joint Patent Rights existing as of the
Effective Date,
including the title,
application number and filing date is set forth on
Exhibit L1 for Wyeth
Collaboration Patent Rights and Exhibit L2 for Joint
Patent Rights hereto. Progenics shall be permitted to transfer
Progenics’ ownership interests in the Joint Technology, including the Joint
Patent Rights, on a country-by-country basis, through sublicense, sale or
otherwise, without prior consent from Wyeth.
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6.4.2. Enforcement. Progenics shall
have the sole right but not the obligation, at its own expense, to take action
to obtain a discontinuance of any infringement of, bring suit against a Third
Party infringer or alleged Third Party infringer of, or defend against any
action commenced by a Third Party (including any declaratory judgment action)
with respect to any Wyeth Collaboration Patent Rights and Joint Patent Rights
licensed to Progenics hereunder, without prior notice to or consent of
Wyeth. Progenics shall have the right to control any such action or
suit using counsel of its own choice, and shall have the right to enter into any
settlement with respect to such any action or suit, without the prior notice to
or consent of Wyeth, including any settlement which grants a Third Party
sublicense as permitted by Section 6.4.1, or would enjoin or grant other
equitable relief against Progenics or Wyeth. For the purpose of
exercising and enforcing its rights under Section
6.4.1 and this
Section 6.4.2,
Progenics may join
Wyeth as a party to any such action or suit
brought, or defended,
by Progenics;
provided
, however, that
Progenics shall bear all the expenses of
such action or suit,
including those
incurred by
Wyeth as a participant
(including Wyeth’s own independent counsel). Wyeth shall cooperate
(including by executing any documents required to enable Progenics to initiate
or defend such litigation) with Progenics in any suit for infringement of any
Wyeth Collaboration Patent Rights or Joint Patent Rights licensed to Progenics
hereunder brought by Progenics against a Third Party or in the defense of any
Claim commenced by a Third Party in accordance with this Section 6.4.2, at
Progenics’ expense, and shall have the right to consult with Progenics and to
participate in and be represented by independent counsel in such litigation at
Progenics’ expense. Progenics shall not incur any liability to Wyeth
as a consequence of such litigation or any unfavorable decision resulting
therefrom, including any decision holding any Patent Right invalid or
unenforceable. However, Progenics shall indemnify and hold Wyeth
harmless from any liability to a Third Party as a consequence of such litigation
or defense or any unfavorable decision resulting therefrom arising out of the
use by Progenics of any Patent Rights licensed by Progenics hereunder, except
for any liability (a) in respect of which Wyeth has an indemnification
obligation to Progenics or (b) that may arise from actions of Wyeth in violation
of any law or regulation not related to the Product or Compound. Any
recovery obtained by Progenics as a result of any such proceeding against a
Third Party infringer shall be retained by Progenics.
6.4.3.
Prosecution and
Documentation. With respect to each
Wyeth Collaboration Patent Right, Joint
Patent Right, and Progenics Patent Right, as of the Effective Date, Progenics
shall be solely responsible for filing,
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prosecuting
(including the right to direct counsel and make final patent prosecution
decisions), and abandoning
such Patent
Right in the
Field at Progenics’ own
expense. In furtherance of such right,
Wyeth shall, at Progenics’ expense,
reasonably cooperate with
Progenics as
set forth in this Section 6.4.3 with respect to the
Wyeth Collaboration Patent Rights and Joint Patent Rights.
At Progenics’ request and to the extent
not previously provided to Progenics, Wyeth shall provide to Progenics [*] ([*],
as applicable) of [*] that
Wyeth may
have in its possession related to the
Wyeth Collaboration Patent Rights and
Wyeth’s interest in the
Joint Patent Rights and related to the
Development and/or Commercialization of the Compound and Products.
Progenics’ and Wyeth’s prosecution counsel
shall meet [*] after [*] to create and implement a plan for transferring
prosecution responsibility to Progenics, including [*]. Wyeth shall
promptly sign, and cause its then-current employees, as appropriate, to sign,
and require its employees to sign in the future, where appropriate, all
documents as may be reasonably requested by
Progenics, make all rightful oaths, and
take other actions reasonably necessary to assist
Progenics in prosecuting and maintaining
appropriate protection for such
Patent
Rights, all at
Progenics’ cost and
expense. Wyeth shall provide Progenics the contact information that
Wyeth has for any employee whose employment with Wyeth has ceased, to the extent
such information is available and its disclosure to Progenics would not violate
any applicable law, and cooperate with Progenics to the extent reasonably
necessary to effectuate the provisions of this Section
6.4.3
by providing [*] to participate in no more
than [*] per [*] that shall not be longer than [*] in duration; provided that
(a) such consultation shall occur during
normal business hours and in such a way as to not be disruptive to [*],
(b)
Wyeth’s obligation to participate in such
meetings shall end [*] after [*], (c) [*] shall provide [*] with an agenda for
each such meeting at least [*] in advance of such meeting indicating [*], and
(d) [*] may, in its sole discretion, elect to [*].
6.5.
Non-Assertion of
Rights. Following the Signing Date,
Wyeth, on behalf of itself and its current
and/or future Affiliates, agrees not to assert any
Wyeth Independent Patent Rights against
Progenics, its current and/or future
Affiliates, designees, licensees,
sublicensees, independent contractors, distributors, wholesalers or other Third
Parties with which or whom Progenics does business relating to the
Development,
Commercialization or other exploitation of
the
Compound and the
Products.
6.6.
Non-exclusive License to
Wyeth. Solely in order
to enable
Wyeth to fulfill its
obligations pursuant to this
Termination
Agreement and only for such time and to the extent as
Wyeth is fulfilling such obligations,
Progenics shall, and hereby does, grant to
Wyeth a fully paid-up, royalty-free,
worldwide, non-exclusive license in the
Field under the
Assigned IP
and
Progenics Technology and
Progenics’ interest in the
Joint Technology.
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7.1.
By
Wyeth.
Wyeth hereby represents, warrants and
covenants to
Progenics that as of the
Signing Date:
7.1.1.
Authorization and Enforcement of
Obligations.
Wyeth
(a) has the corporate power and authority
and the legal right to enter into this
Termination Agreement and to perform its
obligations
hereunder and
(b) has taken all necessary corporate
action on its part to authorize the execution and delivery of this
Termination Agreement and the performance
of its obligations
hereunder. This
Termination Agreement has been duly
executed and delivered on behalf of
Wyeth, and constitutes a legal, valid,
binding obligation, enforceable against
Wyeth in accordance with its
terms.
7.1.2.
Consents. To the
knowledge of Wyeth, all necessary consents, approvals and authorizations of all
governmental authorities and other
Persons required to be obtained by
Wyeth in connection with this
Termination Agreement, other than consents
to the assignment of any
Third
Party Contracts, have been
obtained.
7.1.3.
Accuracy of Exhibit
L. Exhibit L1 and Exhibit L2 contains a
complete and accurate list of the
Wyeth Collaboration Patent Rights and the
Joint Patent Rights,
respectively. No
Omission
from Exhibit L1
of any
Wyeth Collaboration Patent Right or from
Exhibit L2 of
any
Joint Patent Right shall be in
derogation of the license in Section
6.4.1
hereof,
and upon the discovery of such omission, the
Parties shall promptly update Exhibit L1 and Exhibit L2 to
include any such omitted
Wyeth Collaboration Patent Right or
Joint Patent Right. Subject to
the provisions of the
Progenics-
Wyeth Agreement and this
Termination Agreement,
Wyeth is, as of the
Signing Date, the exclusive owner of the
Wyeth Collaboration Patent Rights and
Wyeth’s interest in the
Joint Patent Rights, free and clear of all
liens and encumbrances.
7.1.4.
No Representations Related to Sales
and Forecasts. Progenics acknowledges and agrees that nothing
in this Termination Agreement (including, without limitation, any exhibits or
attachments hereto or any Third Party Contracts) or any information provided to
Progenics pursuant to this Termination Agreement shall be construed as a
representation, warranty, or covenant by Wyeth (i) that a particular Product
under Development will be successfully Developed on any particular timetable (or
at all), or (ii) with respect to demand for, anticipated sales of, or the actual
value of any Product. Without limiting the foregoing, Progenics
acknowledges and agrees that the [*] contemplated in Section 5.3 or the information provided to Progenics in any
[*] provided in Sections 4.1.1, 4.2.1 or 4.3.1 or
elsewhere in this Termination Agreement or that have otherwise been discussed by
the Parties are merely intended to assist the parties in their planning as they
transition responsibility for Development and Commercialization of the Products
to Progenics. WYETH MAKES NO REPRESENTATION, WARRANTY OR COVENANT,
EITHER EXPRESS OR IMPLIED, THAT IT WILL BE ABLE TO SUCCESSFULLY DEVELOP OR
COMMERCIALIZE ANY PRODUCT OR, IF COMMERCIALIZED, THAT ANY PRODUCT WILL ACHIEVE
ANY PARTICULAR SALES LEVEL.
[*]
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7.1.5. No Implied
Warranties. EXCEPT FOR THE EXPRESS REPRESENTATIONS AND
WARRANTIES SET FORTH IN THIS SECTION
7.1,
WYETH MAKES NO REPRESENTATION OR WARRANTY,
EXPRESS OR IMPLIED, REGARDING THE COMPOUNDS, THE PRODUCTS OR ABOUT ANY KNOW-HOW
OR PATENT RIGHTS. WITHOUT LIMITATION, WYETH EXPRESSLY DISCLAIMS ANY
IMPLIED WARRANTY OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY, OR FITNESS FOR A
PARTICULAR PURPOSE.
7.2.
By
Progenics.
Progenics hereby represents, warrants and
covenants to
Wyeth that as of the
Signing Date:
7.2.1.
Authorization and Enforcement
of Obligations.
Progenics
(a) has the corporate
power and authority and the legal right to enter into this
Termination Agreement and to perform its
obligations
hereunder and
(b) has taken all necessary corporate
action on its part to authorize the execution and delivery of this
Termination Agreement and the performance
of its obligations
hereunder. This
Termination Agreement has been duly
executed and delivered on behalf of
Progenics, and constitutes a legal, valid,
binding obligation, enforceable against
Progenics in accordance with its
terms.
7.2.2.
Consents. To the
knowledge of Progenics, all necessary consents, approvals and authorizations of
all governmental authorities and other
Persons required to be obtained by
Progenics in connection with this
Termination Agreement have been
obtained.
7.2.3.
Accuracy of Exhibit
L. Exhibit L2 contains a
complete and accurate list of the
Joint
Patent Rights. No
omission
from
Exhibit L2 of any
Joint Patent Right shall be in derogation
of the license in Section
6.4.1
hereof,
and upon the discovery of such omission, the
Parties shall promptly update
Exhibit L2 to
include any such omitted
Joint Patent Right. Subject to
the provisions of the
Progenics-
Wyeth Agreement and this
Termination Agreement,
Progenics is, as of the
Signing Date, the exclusive owner of
Progenics’ interest in the
Joint Patent Rights, free and clear of all
liens and encumbrances.
7.2.4. No Implied
Warranties. EXCEPT FOR THE EXPRESS REPRESENTATIONS AND
WARRANTIES SET FORTH IN THIS SECTION 7.2, PROGENICS MAKES NO REPRESENTATION OR
WARRANTY, EXPRESS OR IMPLIED, REGARDING THE COMPOUNDS, THE PRODUCTS OR ABOUT ANY
KNOW-HOW OR PATENT RIGHTS. WITHOUT LIMITATION, PROGENICS EXPRESSLY
DISCLAIMS ANY IMPLIED WARRANTY OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY, OR
FITNESS FOR A PARTICULAR PURPOSE.
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7.3.1.
Indemnification by
Wyeth.
Wyeth shall indemnify, defend and hold
harmless each
Progenics
Indemnified
Party from and against any and all
Liability that the
Progenics
Indemnified
Party may be required to pay one or more
Third Parties resulting from or arising out
of:
(a) any intentional
misconduct or gross negligence on the part of
Wyeth or its
Affiliates in performing any activity
contemplated by this Termination Agreement;
(b) personal injury or death of any person
as a result of use of any
Product sold
by
Wyeth, its
Affiliates or
sublicensees prior to or during the
US
Sale Period or
International Sale
Period
; (c) the material breach by
Wyeth of any of its representations,
warranties or covenants set forth in this Termination Agreement; (d) any breach
by Wyeth of any Selected Third Party Contract occurring or liability arising
prior to the assignment of such contract to Progenics; or (e) any action taken
by Wyeth or failure of Wyeth to act prior to the Effective Date with regard to
the listing of any Patent Right in the Orange Book with respect to any Product;
except, in each case, to the extent caused by the gross negligence or
intentional misconduct of
Progenics or
any
Progenics
Indemnified
Party.
7.3.2.
Indemnification by
Progenics.
Progenics shall indemnify, defend and hold
harmless each
Wyeth
Indemnified
Party from and against any and all
Liability that the
Wyeth
Indemnified
Party may be required to pay one or more
Third Parties resulting from or arising out
of:
(a)
Wyeth’s
Commercialization of the
SC
Product or retaining ownership of any
Registrational Filings and
Regulatory Approvals beyond the
International Sale Period as a result of
Progenics’ request, pursuant to Section
4.3.1 or 5.2.5;
(b) any
intentional misconduct or gross negligence on the part of
Progenics or its
Affiliates in performing any activity
contemplated by this Termination Agreement;
(c) personal injury or death of any person
as a result of use of any
Product sold
by
Wyeth, its
Affiliates or
sublicensees in accordance with this
Termination Agreement after the
US Sale Period or
International Sale Period or by
Progenics, its
Affiliates or
sublicensees, regardless of whether Wyeth’s
name appears on the label for such Product;
(d) the material breach by
Progenics of any of its representations,
warranties or covenants set forth in this Termination Agreement;
(e) any breach by Progenics of any
Selected Third
Party Contract occurring or liability
arising after the assignment of such contract to
Progenics;
(f) the Development, marketing, promotion,
manufacture, use, sale, offer for sale, or importation of any
Product after the
US
Sale Period or
International Sale
Period, as applicable; or
(g) any action
taken by Progenics or failure of Progenics to act after the Effective Date with
regard to the listing of any
Patent
Right in the
Orange Book with respect to
any
Product; except, in each case, to
the extent caused by the gross negligence or intentional misconduct of Wyeth or
any Wyeth Indemnified Party.
[*]
CONFIDENTIAL TREATMENT REQUESTED
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7.3.3.
Procedure. Each
Party
will notify the other
Party in writing in the event it becomes
aware of a
Claim for which indemnification may be
sought
hereunder. In case any
proceeding (
including any governmental
investigation) shall be instituted involving any
Party in respect of which indemnity may be
sought pursuant to this Section
7.3 (Indemnity), such
Party (the “
Indemnified Party”)
shall promptly notify the other
Party
(the “
Indemnifying Party”)
in writing and the
Indemnifying
Party and
Indemnified
Party shall meet to discuss how to respond
to any
Claims that are the subject
matter of such proceeding. The
Indemnified
Party shall cooperate fully with the
Indemnifying
Party in defense of such
matter. The
Indemnifying
Party, upon request of the
Indemnified
Party, shall retain counsel reasonably
satisfactory to the
Indemnified
Party to represent the
Indemnified
Party and shall pay the fees and expenses
of such counsel related to such proceeding. In any such
Claim, the
Indemnified
Party shall have the right to retain its
own counsel, but the fees and expenses of such counsel shall be at the expense
of the
Indemnified
Party unless
(i) the
Indemnifying
Party and the
Indemnified
Party shall have mutually agreed to the
retention of such counsel or
(ii) the
named parties to any such
Claim (
including any impleaded parties)
include both the
Indemnifying
Party and the
Indemnified
Party and representation of both
Parties by the same counsel would be
inappropriate due to actual or potential differing interests between
them. All such fees and expenses shall be reimbursed as they are
incurred. The
Indemnifying
Party shall not be liable for any
settlement of any Claim effected without its written consent, but, if settled
with such consent or if there be a final judgment for the plaintiff, the
Indemnifying
Party agrees to indemnify the
Indemnified
Party from and against any loss or
liability by reason of such settlement or judgment. The
Indemnifying
Party shall not, without the written
consent of the
Indemnified
Party, effect any settlement of any pending
or threatened
Claim in respect of which
the
Indemnified
Party is, or arising out of the same set of
facts could have been, a party and indemnity could have been sought
hereunder by the
Indemnified
Party, unless such settlement
includes an unconditional release of the
Indemnified
Party from all liability on claims that are
the subject matter of such proceeding.
7.3.4.
Insurance.
As long as Progenics, directly or
indirectly, continues to Commercialize a Product, Progenics agrees to use
Commercially Reasonable Efforts to obtain
and maintain commercial general liability insurance,
including products liability insurance,
with reputable and financially secure insurance carriers to cover its
indemnification obligations under Section
7.3.2
(Indemnification by
Progenics), in each
case with limits of not less than
[*]
United States dollars (
US$[*]) per occurrence and in the
aggregate. Insurance shall be procured with carriers having
[*].
[*]
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8.
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Release; Public
Statements
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8.1.
Release. Each
Party (each, a “
Releasing Party”)
hereby releases and forever discharges the other
Party and its past, present and future
Affiliates, directors, officers, employees,
agents, representatives and each of their respective successors and assigns
(individually, a “
Releasee” and,
collectively, “
Releasees”) from any
and all Claims whatsoever, whether known or unknown, suspected or unsuspected,
both at law and in equity which the
Releasing
Party now has, has ever had, or may
hereafter have against the respective
Releasees arising out of any matter, cause
or event occurring prior to the
Signing
Date,
including any rights to
indemnification or reimbursement, other than as preserved
herein; provided, however, that this
Release shall not release or discharge
(a) any
Claims by a
Releasing
Party against a
Releasee under this
Termination Agreement,
including as a result of a breach of any
representation, warranty or covenant, and
(b)
Wyeth’s obligation to pay royalties under
the
Progenics-
Wyeth Agreement that have accrued prior to
the
Signing Date but have not yet been
paid. Each
Releasing
Party hereby irrevocably covenants to
refrain from, directly or indirectly, asserting any claim or demand, or
commencing, instituting or causing to be commenced or instituted any proceeding
of any kind, against any
Releasee, based
upon any Claim released hereby. Furthermore, if a
Releasing
Party commences such a proceeding against a
Releasee and the judicial body before
which the proceeding is brought determines in a final judgment that such claim
or demand has been released pursuant to this Section
8.1, such
Releasing
Party shall reimburse the
Releasee for all expenses (
including reasonable costs of
investigation and defense and attorney’s fees) incurred in connection with such
proceeding.
8.2.
Non-Disparagement. Neither
Party, nor any of its
Affiliates, shall, at any time, make any
public statements that disparage the other
Party or any of its
Affiliates or their respective officers,
directors, employees, advisors, businesses or reputations relating to the
subject matter of the
Progenics-
Wyeth Agreement or this
Termination Agreement. Notwithstanding
the foregoing, this
Section 8.2 shall
not, in and of itself, preclude a
Party
from (a) marketing or promoting any products that compete with the other Party’s
products (including engaging in competitive advertising to market such product)
or (b) making truthful statements or disclosures that are required by applicable
law, regulation or legal process.
8.3.
Public
Announcements. Neither
Party hereto shall issue any press release
or other publicity materials, or make any public representation with respect to
the existence of this
Termination
Agreement or the reasons therefor or the subject matter
hereof, except for the mutually agreed upon
press release announcing the change in the relationship of the
Parties, the reasons for that change and
the Parties’ mutual appreciation for the
work invested into the
Compound and the
Product.
[*]
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9.1.
Records and
Audits. Each Party (the “Audited Party”) shall
keep and maintain, and shall cause its Affiliates and Commercial Partners (each
also an “Audited
Party”), to keep and maintain, accurate and complete books and records in
sufficient detail to permit accurate determination of all figures necessary for
the other Party (the “Auditing Party”) to
verify the amounts paid, or requested to be paid, by the Auditing Party to the
Audited Party as provided in this Termination Agreement, including, without
limitation, Sections 4.1.2, 4.2.1, 4.3.1, 5.2.2 and
5.6.4, for a period of at least [*] after the end
of the calendar quarter in which they were generated. Upon [*] prior
written notice from the Auditing Party, the Audited Party shall permit an
independent certified public accounting firm of nationally recognized standing,
selected by the Auditing Party and acceptable to the Audited Party, to examine,
at the Auditing Party’s expense, the relevant books and records of the Audited
Party as may be necessary to verify any amounts paid, or requested to be paid,
by the Auditing Party to the Audited Party. Each Party shall not be
entitled to conduct more than [*] such [*] in any calendar year. The
accounting firm shall be provided access to books and records at the Audited
Party’s facility(ies) where such books and records are normally kept and such
examination shall be conducted during the Audited Party’s normal business
hours. The Audited Party may require the accounting firm to sign a
standard non-disclosure agreement before providing access to its facilities or
records. Upon completion of the audit, the accounting firm shall
provide both Wyeth and Progenics a written report disclosing any discrepancies
in the amount paid, or requested to be paid, by the Auditing
Party. If the accounting firm concludes that the Auditing Party
overpaid the Audited Party, the Audited Party shall pay the Auditing Party the
amount of such overpayment within [*] of receiving such audit report plus
interest, which shall be calculated at the average of the prime rate reported by
[*], each month during the period from the time such overpayment was paid, plus
[*] per annum. Additionally, if the accounting firm concludes that
the Auditing Party overpaid the Audited Party by more than [*], the Audited
Party shall reimburse the Auditing Party for the out-of-pocket expenses incurred
in conducting the audit. If the accounting firm concludes that the
Auditing Party underpaid the Audited Party, the Auditing Party shall promptly
pay the amount of such underpayment to the Audited Party, without
interest.
9.2. No Further
Obligations. Except as expressly provided in this
Termination Agreement,
Wyeth shall have no obligations with
respect to the
Development and
Commercialization of the
Compound and
Product. Without limiting the
generality of the foregoing, except as expressly provided in Sections
4.1 and 5.2 and Exhibits A, D and M,
Wyeth shall have no obligation to conduct
or reimburse
Progenics for conducting
any
Development activities related to
the
Products or
Compounds.
9.3.
Surviving Sections of the
Progenics-
Wyeth Agreement and the
Partial
Termination Agreement. The
Parties hereby acknowledge, agree and
reaffirm that Section 8 (Confidentiality) of the
Progenics-
Wyeth Agreement
will not be terminated by reason of the
termination of the
Progenics-
Wyeth Agreement, but shall survive the
termination of the
Progenics-
Wyeth Agreement; provided, however, that in the
event of any conflict between the terms of this
Termination Agreement and the terms of the
Progenics-
Wyeth Agreement, the terms of this
Termination Agreement shall
control.
[*]
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9.4.
Confidentiality of the Terms of this
Termination
Agreement. The
Parties
hereby agree that the terms of this
Termination Agreement shall be treated in
the same manner as the
Parties have
agreed to treat the terms of the
Progenics-Wyeth Agreement pursuant to
Section
8 (Confidentiality) of the
Progenics-
Wyeth
Agreement.
9.5.
Assignment. Neither
this
Termination Agreement nor any
interest under this
Termination
Agreement shall be assignable by a
Party
without the prior written consent of the other
Party, except as provided in this Section
9.5. Either
Party may assign
its rights and obligations under this
Termination Agreement
, without the prior written consent of the
other Party, (a) to an Affiliate of such Party or (b) by way of the sale of such
Party itself or the sale of a
substantial portion of the business of such
Party to which this
Termination Agreement relates, through
merger, sale of assets and/or sale of stock or ownership interest; provided, however, that such
sale is not primarily for the benefit of such
Party’s creditors. In any such
case, the assignment may only be made to the
Person acquiring the
Party to this
Termination Agreement or the business of
the
Party. Further, Progenics
and ProNev may assign or sublicense any or all of their rights under this
Termination Agreement or the Progenics-Wyeth Agreement, without the prior
written consent of Wyeth, to any Third Party in connection with any financing
being provided to Progenics or ProNev; provided that
Progenics shall remain fully liable for the performance of this Termination
Agreement by any such assignee. This
Termination Agreement shall be binding upon
the successors and permitted assigns of the
Parties to this
Termination Agreement and the name of a
Party to this
Termination Agreement appearing
herein shall be deemed to
include the names of such
Party’s successors and permitted assigns to
the extent necessary to carry out the intent of this
Termination Agreement. Any
assignment not in accordance with this Section 9.5 above shall be
void. Each Party to this Termination Agreement shall promptly notify
the other Party of any assignment or transfer under the provisions of this
Section 9.5.
9.6.
Further
Actions. Each
Party to
this
Termination Agreement agrees to
execute, acknowledge and deliver such further agreements, instruments and
documents,
including confirmatory
letters to
Third Parties relating to
this
Termination Agreement and the
transactions contemplated thereby, and to do all such other commercially
reasonable acts as may be necessary in order to carry out the purposes and
intent of this
Termination Agreement and
to secure the benefits thereof to the other
Party.
9.7.
Force
Majeure. Neither
Party
shall be liable to the other for delay or failure in the performance of the
obligations on its part contained in this
Termination Agreement if and to the extent
that such failure or delay is due to circumstances beyond its control that it
could not have avoided by the exercise of reasonable diligence. It
shall notify the other
Party promptly in
the event such circumstances arise, giving an indication of the likely extent
and duration thereof, and shall use all
Commercially Reasonable Efforts to resume
performance of its obligations as soon as practicable; provided, however, that neither
Party shall be required to settle any
labor dispute or disturbance.
[*]
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9.8.1.
Ordinary
Notices. Correspondence, reports, documentation and any other
communication in writing between the
Parties in the course of ordinary
implementation of this
Termination
Agreement shall be delivered by hand, sent by facsimile transmission (receipt
verified), or by nationally recognized overnight delivery service to the
employee or representative of the other
Party who is designated by such other
Party to receive such written
communication.
9.8.2.
Extraordinary
Notices. Extraordinary notices and communications (
including notices of termination, force
majeure, material breach, change of address) shall be in writing and delivered
by hand or sent by nationally recognized overnight delivery service, prepaid
registered or certified air mail, or by facsimile confirmed by prepaid first
class, registered or certified mail letter and shall be deemed to have been
properly served to the addressee upon receipt of such written
communication.
Wyeth
Pharmaceuticals Division
AHP Manufacturing B.V.
Grange Castle International Business Park
Clondalkin, Xxxxxx 00, Xxxxxxx
Attn: Managing Director
Fax: [*]
[*]
CONFIDENTIAL TREATMENT REQUESTED
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with a
copy to:
000 Xxx Xxx Xxxx Xxxxx Xxxx
000 Xxx Xxx Xxxx Xxxxx Xxxx
9.9.
Amendment. No
amendment, modification or supplement of any provision of this
Termination Agreement shall be valid or
effective unless made in writing and signed by a duly authorized officer of each
Party.
9.10.
Waiver. No
provision of this
Termination Agreement
shall be waived by any act, omission or knowledge of a
Party or its agents or employees except by
an instrument in writing expressly waiving such provision and signed by a duly
authorized officer of the waiving
Party.
9.11.
Severability. If
any clause or portion thereof in this
Termination Agreement is for any reason
held to be invalid, illegal or unenforceable, the same shall not affect any
other portion of this
Termination
Agreement, as it is the intent of the
Parties that this
Termination Agreement shall be construed in
such fashion as to maintain its existence, validity and enforceability to the
greatest extent possible. In any such event, this
Termination Agreement shall be construed as
if such clause of portion thereof had never been contained in this
Termination Agreement, and there shall be
deemed substituted therefore such provision as
will most nearly carry out the intent of
the
Parties as expressed in this
Termination Agreement to the fullest extent
permitted by applicable law.
[*]
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9.12.
Descriptive Headings. The
descriptive headings of this
Termination
Agreement are for convenience only and shall be of no force or effect in
construing or interpreting any of the provisions of this
Termination Agreement.
9.13.
Entire Agreement. This
Termination Agreement constitutes and
contains the complete, final and exclusive understanding and agreement of the
Parties and cancels and supersedes any and
all prior negotiations, correspondence, understandings and agreements, whether
oral or written, between the
Parties
respecting the subject matter
hereof and
thereof,
including, without limitation,
the
Progenics-
Wyeth Agreement and the
Partial
Termination Agreement, except to the extent
provided herein.
9.14.
Independent Contractors. Both
Parties are independent contractors
under this
Termination
Agreement. Nothing
herein
contained shall be deemed to create an employment, agency, joint venture or
partnership relationship between the
Parties hereto or any of their agents or
employees, or any other legal arrangement that would impose liability upon one
Party for the act or failure to act of
the other
Party. Neither
Party shall have any express or implied
power to enter into any contracts or commitments or to incur any liabilities in
the name of, or on behalf of, the other
Party, or to bind the other
Party in any respect
whatsoever. Other than the express duties and obligations set forth
in this
Termination Agreement, neither
Party shall have any implied fiduciary
duty to the other
Party.
9.15.
Counterparts. This
Termination Agreement may be executed in
any number of counterparts, each of which need not contain the signature of more
than one
Party, but all such
counterparts taken together shall constitute one and the same
agreement.
9.16.
Future Relationships. Except
as expressly stated
herein, nothing
contained in this
Termination Agreement
shall be construed, by implication or otherwise, as an obligation of any
Party hereto to enter into a further
agreement regarding the subject matter of this
Termination Agreement. Further,
other than as expressly stated
herein,
nothing
herein shall be construed to
grant either
Party hereto a license,
either express or implied, to any patent, know-how, trademark or trade name of
the other
Party.
9.17.
Interpretation. The
use of any gender
herein shall be deemed
to be or
include the other genders and
the use of the singular
herein shall be
deemed to
include the plural (and vice
versa), wherever appropriate. The words “
include,” “
includes” and “
including” shall be deemed to be followed
by the phrase “without limitation,” “but not limited to,” or their
equivalent. The word “
will”
shall be construed to have the same meaning and effect as the word
“shall.” Unless the context requires otherwise
(a) any definition of or reference to any
agreement, instrument or other document
herein shall be construed as referring to
such agreement, instrument or other document as from time to time amended,
supplemented or otherwise modified,
(b)
any reference
herein to any
Person shall be construed to
include the
Person’s successors and assigns,
(c) the words “
herein,” “
hereof” and “
hereunder,” and words of similar import,
shall be construed to refer to this
Termination Agreement in its entirety and
not to any particular provision
hereof
and
(d) all references
herein to Sections,
Exhibits or
Schedules shall be construed to refer to
Sections,
Exhibits and
Schedules of this
Termination Agreement.
[*]
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9.18.
No Third
Party Rights or
Obligations. Except as provided hereunder, no provision of
this
Termination Agreement shall be
deemed or construed in any way to result in the creation of any rights or
obligation in any
Person not a
Party to this
Termination Agreement.
9.19.
Governing Law. This
Termination Agreement, the rights of the
Parties, and all
Claims
arising in whole or in part under or in
connection herewith,
will be governed by
and construed in accordance with the substantive laws in effect in the
State of New York, without giving effect to
any choice or conflict of law provision or rule that would cause the application
of the laws of any other jurisdiction.
9.20.1.
Jurisdiction. Each
Party to this
Termination Agreement, by its execution
hereof,
(a) hereby irrevocably submits to the
exclusive jurisdiction of the state courts of the
State of New York located in
New York City or the
United States District Court for the
Southern District of New York located in
New York City for the purpose of any Claim
between the
Parties
arising in whole or in part under or in
connection with this
Termination
Agreement,
(b) hereby waives to the
extent not prohibited by applicable law, and agrees not to assert, by way of
motion, as a defense or otherwise, in any such
Claim, any claim that it is not subject
personally to the jurisdiction of the above-named courts, that its property is
exempt or immune from attachment or execution, that any such
Claim brought in one of the above-named
courts should be dismissed on grounds of forum non conveniens, should
be transferred or removed to any court other than one of the above-named courts,
or should be stayed by reason of the pendency of some other proceeding in any
other court other than one of the above-named courts, or that this
Termination Agreement or the subject matter
hereof may not be enforced in or by such
court and
(c) hereby agrees not to
commence any such
Claim other than
before one of the above-named courts. Notwithstanding the previous
sentence, a
Party may commence any Claim
in a court other than the above-named courts solely to seek pre-litigation
attachment of assets or preliminary injunction relief prior to litigation on the
merits in the above-named courts or for the purpose of enforcing an order or
judgment issued by one of the above-named courts.
9.20.2.
Venue. Each
Party agrees that for any Claim between
the
Parties
arising in whole or in part under or in
connection with this
Termination
Agreement, such
Party shall bring any
such
Claims only in the
City of New York. Each
Party further waives any Claim and
will not assert that venue should properly
lie in any other location within the selected jurisdiction.
[*]
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9.20.3.
Service of Process. Each
Party hereby
(a) consents to service of process in any
Claim between the
Parties
arising in whole or in part under or in
connection with this
Termination
Agreement in any manner permitted by
New
York law,
(b) agrees that service of
process made in accordance with clause
(a) or made by registered or certified
mail, return receipt requested, at its address specified pursuant to Section
9.8,
will constitute good and valid service of
process in any such
Claim and
(c) waives and agrees not to assert (by way
of motion, as a defense, or otherwise) in any such
Claim any Claim that service of process
made in accordance with clause
(a) or
(b) does not constitute good and valid
service of process.
9.21.
Waiver of Jury
Trial. TO THE EXTENT NOT PROHIBITED BY APPLICABLE LAW THAT
CANNOT BE WAIVED, THE PARTIES HEREBY WAIVE, AND COVENANT THAT THEY WILL NOT
ASSERT (WHETHER AS PLAINTIFF, DEFENDANT OR OTHERWISE), ANY RIGHT TO TRIAL BY
JURY IN ANY ACTION
ARISING IN WHOLE OR
IN PART UNDER OR IN CONNECTION WITH THIS
TERMINATION AGREEMENT OR ANY OF THE
CONTEMPLATED TRANSACTIONS, WHETHER NOW EXISTING OR HEREAFTER ARISING, AND
WHETHER SOUNDING IN CONTRACT, TORT OR OTHERWISE. THE PARTIES AGREE
THAT ANY OF THEM
MAY FILE A COPY OF THIS
PARAGRAPH WITH ANY COURT AS WRITTEN EVIDENCE OF THE KNOWING, VOLUNTARY AND
BARGAINED-FOR AGREEMENT AMONG THE PARTIES IRREVOCABLY TO WAIVE ITS RIGHT TO
TRIAL BY JURY IN ANY PROCEEDING WHATSOEVER BETWEEN THEM RELATING TO THIS
TERMINATION AGREEMENT OR ANY OF THE CONTEMPLATED TRANSACTIONS, WHICH WILL
INSTEAD BE TRIED IN A COURT OF COMPETENT JURISDICTION BY A JUDGE SITTING WITHOUT
A JURY.
9.22.
Dispute Resolution. If the
Parties are otherwise unable to resolve a
dispute among them informally,
Wyeth or
Progenics, by written notice to the other,
may have such dispute referred to their respective executive officers designated
for attempted resolution by good faith negotiations (each, a “
Responsible
Executive”).
Any such dispute shall be submitted to the
Responsible Executives no later than [*]
following such request by either
Wyeth or
Progenics. In the event the
Responsible Executives are not able to
resolve any such dispute within [*] after submission of the dispute to such
executive officers,
Wyeth or
Progenics, as the case may be, may pursue
whatever measures legally available to resolve such dispute. All
negotiations pursuant to this Section
9.22 shall be treated as compromise and settlement
negotiations. Nothing said or disclosed, nor any document produced,
in the course of such negotiations which is not otherwise independently
discoverable shall be offered or received as evidence or used for impeachment or
for any other purpose in any current or future arbitration or litigation between
the
Parties.
[*]
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9.23.
Limitation of
Damages. IN NO
EVENT SHALL EITHER
PARTY OR ITS AFFILIATES BE LIABLE TO THE
OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY OR
CONSEQUENTIAL DAMAGES, WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT,
WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER TORT, OR OTHERWISE, ARISING OUT
OF OR RELATING TO THE SUBJECT MATTER OF THIS
TERMINATION AGREEMENT. THE
FOREGOING LIMITATION SHALL NOT LIMIT EITHER
PARTY’S RIGHT TO RECOVER UNDER THE
INDEMNIFICATION PROVISIONS IN THIS
TERMINATION AGREEMENT OR FOR ANY BREACH OF
CONFIDENTIALITY OBLIGATIONS BY EITHER PARTY HERETO.
9.24.
Specific
Performance. The
Parties to this
Termination Agreement agree that if any of
the provisions of this
Termination
Agreement were not performed in accordance with their specific terms, or were
otherwise breached, irreparable damage may occur which would be extremely
impractical or difficult to measure and that as a result no adequate remedy of
law may exist; accordingly the non-defaulting
Party, in addition to any other available
rights or remedies, shall have the right to seek, in a court of competent
jurisdiction, specific performance of the terms of this
Termination Agreement.
[*]
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IN WITNESS WHEREOF, duly authorized
representatives of the
Parties have duly
executed this
Termination Agreement on
the Signing Date to be effective as of the
Effective Date of this
Termination Agreement.
|
Wyeth,
acting through its Wyeth Pharmaceuticals Division
|
Progenics
Pharmaceuticals, Inc.
|
|
By:/s/
Xxxxxx X. Xxxxxx
|
By:/s/
Xxxx X. Xxxxx
|
|
Name:
Xxxxxx X. Xxxxxx
Title:
Senior Vice President
|
Name:
Xxxx X. Xxxxx
Title:
President
|
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Wyeth-Whitehall
Pharmaceuticals, Inc.
|
Progenics
Pharmaceuticals Nevada, Inc.
|
|
By:/s/
Xxxxxx X. Xxxxxx
|
By:/s/
Xxxx X. Xxxxx
|
|
Name:
Xxxxxx X. Xxxxxx
Title:
Vice President
|
Name:
Xxxx X. Xxxxx
Title:
Director and Secretary
|
|
Wyeth-Ayerst
Lederle, Inc.
|
Excelsior
Life Sciences Ireland Limited
|
|
By:/s/
Xxxxxxx Xxxxxx
|
By:/s/
Xxxx X. Xxxxx
|
|
Name:
Xxxxxxx Xxxxxx
Title:
Executive Vice President
|
Name:
Xxxx X. Xxxxx
Title:
Director and Secretary
|
|
AHP
Manufacturing B.V., trading as Wyeth Medica Ireland
|
|
|
By:/s/
Xxxx X. Xxxxx
|
|
|
Name:
Xxxx X. Xxxxx
Title:
Vice President and Managing Director
|
|
|
By:/s/
Xxxxxx X. Xxxx
|
|
|
Name:
Xxxxxx X. Xxxx
Title:
Vice President and Managing Director
|
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
Execution
Copy
[*]
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
|
12221462_5.DOC
|
Execution
Copy
US Termination
Commercialization Plan
[*]
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
|
12221462_5.DOC
|
Execution
Copy
Ex-US Termination
Commercialization Plan
[*]
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
|
12221462_5.DOC
|
Execution
Copy
Wyeth Activities Related to
the US Regulatory Submissions
[*]
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
|
12221462_5.DOC
|
Execution
Copy
Exhibit E
[*]
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
|
12221462_5.DOC
|
Execution
Copy
Exhibit F
Wyeth Formulations of Oral
Products
[*]
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
|
12221462_5.DOC
|
Execution
Copy
Exhibit
G
[*]
[*]
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
|
12221462_5.DOC
|
Execution
Copy
Exhibit
H1: Assigned US IP
US
Trademarks
[*]
Exhibit H2: Assigned Ex-US
IP
Ex-US
Trademarks
[*]
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
|
12221462_5.DOC
|
|
|
Execution
Copy
Form of Trademark and Domain
Name Assignment Agreement
[*]
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
|
12221462_5.DOC
|
Form of Assignment of
Copyrights
[*]
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
|
12221462_5.DOC
|
Execution
Copy
Wyeth
Trademarks
[*]
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
|
12221462_5.DOC
|
Execution
Copy
Exhibit
L1: Licensed Wyeth Collaboration Patent Rights
[*]
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
|
12221462_5.DOC
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Execution
Copy
Exhibit
L2: Licensed Joint Patent Rights
[*]
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
|
12221462_5.DOC
|
|
|
Execution
Copy
Exhibit
M
Possible Ex-US Launch
Countries
[*]
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
|
12221462_5.DOC
|
|
|
