LICENSE AGREEMENT by and among ONO PHARMACEUTICAL CO., LTD. and PROGENICS PHARMACEUTICALS, INC. Dated as of October 16, 2008
Execution
Version
Exhibit
10.29
by and
among
ONO
PHARMACEUTICAL CO., LTD.
and
PROGENICS
PHARMACEUTICALS, INC.
Dated as
of October 16, 2008
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
Execution
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TABLE
OF CONTENTS
Page
1. DEFINITIONS.
1
2. LICENSE
GRANTS AND RELATED MATTERS. 13
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2.1.
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License
from Progenics to Ono
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13
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2.2.
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Sublicenses
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13
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2.3.
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Sen-yo
Jisshiken Tohroku/Tsujyo Jisshiken Tohroku
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14
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2.4.
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Participation
in Progenics’ Right of First Refusal
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14
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2.5.
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License
from Ono to Progenics
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15
|
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2.6.
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Non-Exclusive
License Grant.
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15
|
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2.7.
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Fully
Paid-Up, Royalty Free License
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15
|
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2.8.
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Progenics
Third Party Agreements
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16
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2.9.
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Know-How
Disclosure and Transfer
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16
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2.10. | Costs of Assistance |
16
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|
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2.11.
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No
Implied Rights
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16
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3. GOVERNANCE
OF
COLLABORATION 17
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3.1.
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Management
of the Collaboration and General Committee
Procedures.
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17
|
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3.2.
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Joint
Steering Committee (JSC).
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18
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3.3.
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Joint
Development Committee (JDC).
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19
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3.4.
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Joint
Commercialization Committee (JCC).
|
20
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3.5.
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Working
Groups
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21
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4. DEVELOPMENT 21
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4.1.
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Development
Plan
|
21
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4.2.
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Development
Responsibilities of Ono
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21
|
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4.3.
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[*]
Development Activities
|
22
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4.4.
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Records
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22
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4.5.
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Reports
on Development
|
22
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5. COMMERCIALIZATION 22
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5.1.
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Ono’s
Commercialization Responsibilities and Efforts.
|
22
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5.2.
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Supply.
|
23
|
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5.3.
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Marketing
Materials and Corporate Branding
|
23
|
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5.4.
|
Sharing
of Information
|
23
|
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5.5.
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Option
to Develop and Commercialize Additional Formulations
|
24
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5.6.
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Developmental
Research License
|
24
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5.7.
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Non-Competition
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25
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6. PAYMENTS
BY ONO TO PROGENICS. 25
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6.1.
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Upfront
License Fee Payment
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25
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6.2.
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Development
Milestone Payments
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25
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6.3.
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Commercialization
Milestone Payments
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25
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6.4.
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Royalty
Payments.
|
26
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6.5.
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Reports
and Payments.
|
27
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7. INTELLECTUAL
PROPERTY.
29
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7.1.
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Ownership
of Intellectual Property.
|
29
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7.2.
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Patent
Rights.
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30
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7.3.
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Trademarks
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38
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8. CONFIDENTIALITY. 38
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8.1.
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Confidentiality
|
38
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8.2.
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Authorized
Disclosure.
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38
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8.3.
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SEC
Filings and Other Disclosures
|
39
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8.4.
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Public
Announcements; Publications.
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39
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9. REPRESENTATIONS
AND WARRANTIES.
40
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9.1.
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Representations
and Warranties of Each Party
|
40
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9.2.
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Additional
Representations and Warranties of Progenics
|
41
|
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9.3.
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Additional
Representation and Warranty of Ono
|
42
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9.4.
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Representation
by Legal Counsel
|
43
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9.5.
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No
Inconsistent Agreements
|
43
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10. TERM AND
TERMINATION. 43
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10.1.
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Term
|
43
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10.2.
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Termination
by Progenics.
|
43
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10.3.
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Termination
by Ono.
|
43
|
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10.4.
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Effects
of Expiration or Termination.
|
44
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10.5.
|
Provision
for Insolvency.
|
48
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11. INDEMNIFICATION AND
INSURANCE.
50
11.1.
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Indemnification
by Ono
|
50
|
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11.2.
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Indemnification
by Progenics
|
50
|
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11.3.
|
Procedure
|
51
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12. REGULATORY MATTERS, PRODUCT
SAFETY ISSUES, PRODUCT
RECALLS. 51
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12.1.
|
Regulatory
Matters.
|
51
|
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12.2.
|
Medical
and Customer Inquiries
|
52
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12.3.
|
Safety
Agreement
|
52
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12.4.
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Product
Recalls.
|
52
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12.5.
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Cost
of Recalls
|
53
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13. MISCELLANEOUS. 53
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13.1.
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Scope
of License
|
53
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13.2.
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Documents
and Information
|
53
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13.3.
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Assignment
|
53
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13.4.
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Further
Actions
|
54
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13.5. | Force Majeure |
54
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13.6. | Correspondence and Notices |
54
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13.7. | Amendment |
55
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13.8. | Waiver |
55
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13.9. | Severability |
55
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13.10. | Descriptive Headings |
55
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13.11. | Entire Agreement |
55
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13.12. | Independent Contractors |
56
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13.13. | Counterparts |
56
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13.14. | Future Relationships |
56
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13.15. | Interpretation |
56
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13.16. | No Third Party Rights or Obligations |
56
|
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13.17. | Governing Law |
56
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13.18. | Alternative Dispute Resolution; Jurisdiction for Actions Related to Intellectual Property; Venue; Service of Process |
57
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13.19. | Waiver of Jury Trial |
58
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13.20. | Dispute Resolution |
58
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13.21. | Specific Performance |
59
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13.22. | Purchases of Equity Securities |
59
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13.23.
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Exclusion
|
61
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SCHEDULES
Schedule
I Chemical
Drawing of Compound
Schedule
9.2 Progenics
Disclosure Schedule
Schedule
9.2(B) Licensed
Progenics Patent Rights
Schedule
9.2(C) Progenics
Third Party Agreements
Schedule
9.2(D) Exceptions
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This
LICENSE AGREEMENT (the
“Agreement”) is made and entered into as of October 16, 2008 (the “Effective Date”), by
and between Ono Pharmaceutical Co., Ltd., a corporation existing under the laws
of Japan and having a place of business at 0-0, Xxxxxxxxxxxx 0-xxxxx,
Xxxx-xx, Xxxxx 000-0000, Xxxxx (“Ono”) 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”). Ono
and Progenics may each be referred to herein individually as a “Party” and,
collectively, as the “Parties.”
BACKGROUND
A. Ono
is in the business of discovering, developing, manufacturing and marketing human
pharmaceutical products for the Japanese market.
B. Progenics
is a biopharmaceutical company focusing on the development and commercialization
of innovative therapeutic products. Progenics has developed [*]
(“[*]”) for the treatment of opioid-induced constipation associated with
advanced illness.
C. Progenics
owns or has rights under certain patents, patent applications, other valuable
technology and know-how relating to [*].
D. Ono
and Progenics wish to collaborate regarding the development of the subcutaneous
formulation of [*] for the Japanese market, and Progenics wishes to grant to
Ono, and Ono wishes to receive from Progenics a license to Develop and
Commercialize the subcutaneous formulation of [*] in Japan.
E. Progenics
wishes to grant to Ono an option to Develop and Commercialize Additional
Formulations in Japan.
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:
1.
|
DEFINITIONS.
|
Capitalized
terms not otherwise defined herein shall have the following
meanings:
Additional
Formulations. “Additional Formulations” means the oral
formulation of the Compound, the intravenous formulation of the Compound and
each other formulation of the Compound which may be developed by Progenics or
Wyeth, as to which Progenics Controls the Development and Commercialization
rights for the Territory, but excludes the Initial Formulation.
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Affiliate(s). “Affiliate(s)”
means, as of any point in time and for so long as such relationship continues to
exist with respect to any Person, any other Person which controls, is controlled
by or is under common control with such Person. A Person shall be
regarded as in control of another Person if it owns or controls more than fifty
percent (50%) of the equity securities of the subject Person entitled to vote in
the election of directors (or, in the case of a Person that is not a
corporation, for the election of the corresponding managing authority); provided, however, that the
term “Affiliate” shall not include a Person in which any other Person owns a
majority of the ordinary voting power necessary to elect a majority of the board
of directors or other governing board, but is restricted from electing such
majority by contract or otherwise, until such time as such restrictions are no
longer in effect.
API. “API” means active
pharmaceutical ingredient.
Calendar
Quarter. “Calendar Quarter” means the respective periods of
three (3) consecutive calendar months ending on March 31, June 30, September 30
or December 31, for so long as this Agreement is in effect.
Calendar
Year. “Calendar Year” means any calendar year.
Claim. “Claim”,
when used other than in connection with the contents of a patent, means any
claim, action, cause of action, chose in action, or suit (in contract or tort or
otherwise), litigation, arbitration, investigation, opposition, hearing,
complaint, demand, notice or proceeding to, from, by or before any arbitrator,
court, administrative organization, or other governmental authority or other
Person.
Collaboration. “Collaboration”
means the Development and Commercialization activities of Ono in the Territory,
and the supporting activities of Progenics to be agreed upon by the Parties, or
as expressly set forth herein, for such Development and Commercialization under
this Agreement.
Combination
Product. “Combination Product” means any Product that contains
the Compound as an active ingredient together with one or more other active
ingredients and is sold for a single invoiced price, e.g., where the Compound is
packaged for sale together with one or more other compounds or biologic products
as an active ingredient (either as a single fixed dose or as separate
doses).
Commercialization. “Commercialization”
means all activities related to the commercial exploitation of any Product,
including the manufacture, supply, use, importation, exportation, marketing,
promotion, distribution, pre-launch, launch, sale and offering for sale of the
Product. When used as a verb, “Commercialize” or “Commercializing”
means to engage in Commercialization.
Commercially Reasonable
Efforts. “Commercially Reasonable Efforts” means efforts and
resources normally used by the Party required to use such efforts and resources
for a product, proposed product or technology owned by it or to which it has
rights, which is of similar commercial potential at a similar stage in its
development or product life, (i) taking into account issues of:
[*].
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Committee. “Committee”
means the JSC, JDC, and/or JCC as the context requires.
Compound. “Compound”
means [*], which is chemically defined as [*], and its pharmacologically
acceptable salts, together with their solvates, hydrates, hemihydrates,
metabolites, pro-drugs, esters, and, if applicable, any isomers or racemates
thereof[*]. The “Compound” does not include the Excluded
Molecules. A chemical drawing of [*] is attached as Schedule I.
Confidential
Information. “Confidential Information” means, with respect to
each Party, any non-public proprietary data, information or materials that
belongs in whole or in part to, or is controlled by, such Party or its
Affiliates and information otherwise designated by such Party as Confidential
Information of such Party hereunder.
Control or
Controlled. “Control” or “Controlled” means with respect to
any material, item of information, or intellectual property right, the
possession, whether by ownership or license, of the right to grant a license
with respect thereto.
Controlling
Affiliate. “Controlling Affiliate” means an Affiliate that
controls (as such term is used in the definition of Affiliate)
Progenics.
Development. “Development”
means all activities related to the development of any Product and obtaining
Regulatory Approval for a Product, including all activities related to research,
development, preclinical testing, stability testing, toxicology, formulation,
product line-extensions, clinical trials, regulatory affairs, statistical
analysis, report writing, manufacturing process and scale up, qualification and
validation activities, product life-cycle management, quality assurance/quality
control development and regulatory filing creation and submission related to
obtaining Regulatory Approval for the Product. When used as a verb,
“Develop” or “Developing” means to engage in Development.
Drug Price
Approval. “Drug Price Approval” means National Health
Institute (NHI) price approval, or any comparable price approval by the Japanese
national government or the government of any prefecture in the
Territory.
Excluded
Molecules. “Excluded Molecules” means [*], chemically defined
as [*], and its
pharmacologically acceptable salts, together with their solvates, hydrates,
hemihydrates, metabolites, pro-drugs, esters, and, if applicable, any isomers or
racemates thereof[*].
FDA. “FDA” means
the United States Food and Drug Administration or any successor agency
thereto.
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Field. With respect
to any Product, “Field” means all prophylactic or therapeutic pharmaceutical
uses of such Product for the diagnosis, treatment or prevention of disease in
humans.
First Commercial
Sale. “First Commercial Sale” means, with respect to any
Product and with respect to the Territory, the first sale of such Product to a
Third Party in the Territory after such Product has been granted Regulatory
Marketing Approval by a Regulatory Authority in the Territory.
[*]
FTE Rate. “FTE Rate” means the
hourly rate of [*] per hour for certain activities that Ono requests Progenics
to perform under the Collaboration. This hourly rate shall apply to Progenics
activities during Calendar Year 2008, and will be adjusted at the beginning of
each subsequent Calendar Year from the prior year amount by the change in the
United States Department of Labor Bureau of Labor Statistics Consumer Price
Index- All Urban Consumers during the prior year.
GAAP. “GAAP” means
Japanese Accounting Standards as defined from time-to-time by the Accounting
Standards Board of Japan, Financial Accounting Standards Foundation and
generally accepted accounting principles consistently applied in
Japan.
Generic
Product. “Generic Product” means any Product sold by a Third
Party in the Territory:
(i) for which
Regulatory Marketing Approval and Drug Price Approval have been obtained in the
Territory by a Third Party;
(ii) which is
authorized to be sold for an indication for which Ono or its Affiliates (or a
permitted sublicensee hereunder) has obtained Regulatory Marketing Approval and
Drug Price Approval in the Territory; and
(iii) which is
sold after the end of the [*] Royalty Period.
Generic Product Market
Share. “Generic Product Market Share” means, for any Calendar
Quarter, with respect to any Product, [*], where:
[*]. Generic
Product sales shall be determined using independent market data published by IMS
or its successor (provided such data is generally comparable to that provided by
IMS with respect to the Territory as of the Effective Date) or another mutually
agreed provider of independent market data.
GMP. “GMP” means
the laws and regulations of the Territory where the Compound and/or any Product
is manufactured and which relate to the manufacture of the Compound and/or any
Product, including but not limited to the current Good Manufacturing Practices
as specified in any applicable laws, rules, regulations and guidelines in the
Territory and/or any other relevant jurisdiction.
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Initial
Formulation. “Initial Formulation” means the subcutaneous
formulation of the Compound.
[*] Royalty
Period. “[*] Royalty Period” means with respect to a Product,
the period of time beginning [*] and extending until the later of (i) [*], or
(ii) [*].
IND. “IND” means an
investigational new drug application, clinical study application, clinical trial
exemption, or similar application or submission for approval to conduct human
clinical investigations filed with or submitted to a Regulatory Authority in
conformity with the requirements of such Regulatory Authority.
Japanese Regulatory
Authority. “Japanese Regulatory Authority” means the
Regulatory Authority authorized to grant Regulatory Marketing Approval in the
Territory.
JCC. “JCC” means
the Joint Commercialization Committee established in accordance with Section 3.4
(Joint Commercialization Committee (JCC)).
JDC. “JDC” means
the Joint Development Committee established in accordance with Section 3.3
(Joint Development Committee (JDC)).
Joint
Know-How. “Joint Know-How” means any Know-How made or created
in the course of the Collaboration jointly by (i) employees or agents of
Progenics or any of its Affiliates, and (ii) employees or agents of Ono or any
of its Affiliates.
Joint Patent
Rights. “Joint Patent Rights” means any Patent Rights related
to any invention, development or discovery made or created in the course of the
Collaboration jointly by (i) employees or agents of Progenics or any of its
Affiliates, and (ii) employees or agents of Ono or any of its Affiliates, as
determined in accordance with Section 7.1.1 (Inventorship).
Joint
Technology. “Joint Technology” means the Joint Know-How and
the Joint Patent Rights.
JSC. “JSC” means
the Joint Steering Committee established in accordance with Section 3.2
(Joint Steering Committee (JSC)).
Know-How. “Know-How”
means any confidential unpatented or unpatentable invention, development,
discovery, technology, cell line, biological material, compound, probe,
sequence, technical information, method, biological material, or other
confidential information or material.
Licensed
Activit(y/ies). “Licensed Activit(y/ies)” means, collectively,
the Development and Commercialization of any Product in the Territory, the
practice of any Progenics Technology or Joint Technology or the exercise of any
other right granted by Progenics to Ono under this Agreement, in each case to
the extent permitted under this Agreement.
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[*]
NDA. “NDA” means a
New Drug Application that is filed with the FDA to formally propose that the FDA
approve a new drug for sale and marketing in the United States, or an equivalent
application or submission.
Net Sales. “Net
Sales” means the gross amounts invoiced (“Gross Sales”) for
sales of all Products by Ono and its Affiliates and its permitted sublicensees
(each, a “Selling
Person”) to Third Parties, less the following deductions, in each case to
the extent specifically related to a Product and taken by the Selling Person or
otherwise paid for or accrued by the Selling Person (“Permitted
Deductions”):
(i) trade,
cash, promotional and quantity discounts, and wholesaler fees;
(ii) taxes
on sales (such as excise, sales or use taxes or value added taxes) to the extent
imposed upon and paid directly with respect to the sales price (and excluding
national, sales or local taxes based on income);
(iii) freight,
insurance, packing costs and other transportation charges for the Product
[*];
(iv) amounts
repaid or credits taken by reason of damaged goods, rejections, defects, expired
dating, recalls, returns or because of retroactive price changes;
(v) charge
back payments, rebates and returns granted to (a) managed healthcare
organizations, (b) federal, state and/or provincial and/or local governments or
other agencies, (c) purchasers and reimbursers, or (d) trade customers,
including, without limitation, wholesalers and chain and pharmacy buying groups,
all only to the extent permitted by applicable law and regulations;
(vi) [*];
and
(vii) documented
customs duties actually paid by the Selling Person.
A
quantity of Product not in excess of the industry standard provided by Ono or
its Affiliates, free of charge, for administration to patients enrolled in
clinical trials or distributed at no charge to eligible patients shall not be
included in Net Sales, provided that Ono and its Affiliates receive no cash
consideration from such clinical trials or such use of Product.
It is
understood that accruals taken as a deduction against Net Sales will be
periodically reviewed by Ono in accordance with GAAP and if any accrual is
reversed by Ono a corresponding credit will be made to Net Sales in the period
in which the reversal is made.
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Bundling
Any
bundling of the Product is subject to prior JSC review and written
approval. Where a Product is “bundled” for sale together with one or
more other products or is offered as a “loss leader” to encourage the sale of
one or more other product(s), Net Sales of such Product shall be [*] by Ono or
its Affiliates (less the Permitted Deductions) [*], which [*].
Combination
Sales
If a
Product is sold as a Combination Product (a “Combination Sale”),
the Net Sales for such Combination Product shall be the portion of such
Combination Sale allocable to the Compound determined as follows:
Except as
provided below, the Net Sales amount for a Combination Sale shall equal the [*],
where:
[*].
Where the
calculation of Net Sales resulting from a Combination Sale in the Territory
cannot be determined by the foregoing method, the calculation of Net Sales for
such Combination Sale shall be [*].
EXCEPT
THAT the Net Sales of a Combination Product shall not be reduced by any fraction
if:
(i) [*];
(ii) [*];
and
(iii) [*].
The foregoing adjustments shall, in the
event there is more than one active ingredient in addition to the Compound, in
addition to a Product, included in a Combination Product, apply mutatis mutandis.
Ono Collaboration
Know-How. “Ono Collaboration Know-How” means any Know-How
relating to the Collaboration or the Compound or any Product, Controlled as of
the Effective Date or at any time during the Term by Ono or its Affiliates, that
is made or created in the course of the Collaboration solely by employees or
agents of Ono or any of its Affiliates.
Ono Collaboration Patent
Rights. “Ono Collaboration Patent Rights” means any Patent
Right Controlled by Ono or its Affiliates that claims inventions invented solely
by employees or agents of Ono or any of its Affiliates (as determined in
accordance with Section 7.1.1 (Inventorship)) arising out of the Collaboration
that, if issued, would be infringed by an unlicensed Third Party’s manufacture,
use, sale, importation, development or commercialization of the Compound or any
Product.
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Ono Collaboration
Technology. “Ono Collaboration Technology” means Ono
Collaboration Know-How and Ono Collaboration Patent Rights.
Ono Fiscal
Year. “Ono Fiscal Year” shall mean each successive period of
twelve (12) months commencing on April 1 of a Calendar Year and ending on March
31 of a Calendar Year.
Ono Independent Patent
Rights. “Ono Independent Patent Rights” means any Patent Right
Controlled by Ono or its Affiliates that, if issued, would be infringed by an
unlicensed Third Party’s manufacture, use, sale, importation, development or
commercialization of the Compound or any Product, other than the Progenics
Patent Rights, the Joint Patent Rights, the Wyeth Collaboration Patent Rights,
the Wyeth Collaboration Joint Patent Rights and the Ono Collaboration Patent
Rights.
Outside
Contractor. “Outside Contractor” means any Person contracted
by Ono to provide products or services relating to the Collaboration, including
contract manufacturing services, clinical services or regulatory services that
contribute to the performance of its responsibilities under the Development Plan
or that result in any work product or other information that Progenics or Ono
could include or might reasonably be expected to include in any document or
report, including, a Registrational Filing, submitted to a Regulatory Authority
or subject to review by a Regulatory Authority.
Partial Termination
Agreement. “Partial Termination Agreement” means that certain
Partial Termination Agreement of even date herewith by and among the parties to
the Wyeth Agreement providing for the partial termination of the Wyeth Agreement
with respect to the Territory.
Patent
Rights. “Patent Rights” means any and all (i) United States or
non-United States patents, (ii) United States or non-United States patent
applications, including, without limitation, all provisional applications,
substitutions, continuations, continuations-in-part, divisions, renewals, and
all patents granted thereon, (iii) United States or non-United States
patents-of-addition, reissues, reexaminations and extensions or restorations by
existing or future extension or restoration mechanisms, including supplementary
protection certificates or the equivalent thereof, and (iv) other forms of
government-issued rights substantially similar to any of the
foregoing.
Patent Term
Extension. “Patent Term Extension” shall mean any extension of
Patent Rights that may be granted by any patent office or regulatory office,
including supplemental protection certificates (“SPCs”).
Person. “Person”
means any individual or legal entity.
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Phase 3 Clinical
Trial. “Phase 3 Clinical Trial” means a human clinical study
in Phase III as specified in the ICH E8 Guidelines.
[*] Royalty
Period. “[*] Royalty Period” means the period of time
following the expiration of the [*] Royalty Period and extending until
[*].
Product. “Product”
means a pharmaceutical product containing the Initial Formulation, including a
Combination Product.
Progenics
Know-How. “Progenics Know-How” means Know-How Controlled by
Progenics or its Affiliates as of the Effective Date or at any time during the
Term which relates to the Initial Formulation or a Product or to the use of the
Initial Formulation or a Product. For the purposes hereof, “Progenics
Know-How” does not include Wyeth Collaboration Know-How, Wyeth Collaboration
Joint Know-How, or Know-How Controlled by a Third Party which becomes an
Affiliate of Progenics pursuant to a transaction or series of related
transactions as a result of which such Third Party is able to elect a majority
of the members of the board of directors of Progenics (or its successor company)
or any of its Controlling Affiliates (a "Controlling Third
Party") to the extent such Controlling Third Party's Know-How was
Controlled by such Controlling Third Party (and not by Progenics) prior to the
completion of such transaction or series of related transactions.
Progenics Patent
Rights. “Progenics Patent Rights” means any Patent Right in
the Territory Controlled by Progenics or its Affiliates as of the Effective Date
or at any time during the Term that relates to, claims, or if issued, would be
infringed by an unlicensed Third Party’s manufacture, use, sale, importation,
development or commercialization of the Initial Formulation or any
Product. For the purposes hereof, “Progenics Patent Rights” does not
include Wyeth Collaboration Patent Rights, Wyeth Collaboration Joint Patent
Rights or Patent Rights Controlled by a Controlling Third Party to the extent
such Controlling Third Party's Patent Rights were Controlled by such Controlling
Third Party (and not by Progenics) prior to the completion of such transaction
or series of related transactions. Progenics Patent Rights in the
Territory as of the Effective Date are identified on Schedule 9.2(A) and
(B).
Progenics
Technology. “Progenics Technology” means the Progenics
Know-How and the Progenics Patent Rights.
Progenics Third Party
Agreement. “Progenics Third Party Agreement” means any
agreement in effect as of the Effective Date under which Progenics or any of its
Affiliates is granted any license or otherwise has any rights or interests under
any Progenics Technology or which relates to the supply or clinical study of the
Initial Formulation or any Product in the Territory, including the agreements
listed in Schedule
9.2(C) under the heading “Progenics Third Party Agreements.”
ProNev. “ProNev” means
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, XXX and a direct,
wholly-owned subsidiary of Progenics.
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Recall. “Recall”
means, with respect to any pharmaceutical product, a “recall” or a “product
withdrawal” or a “stock recovery” or any similar term as utilized by any
Regulatory Authority under such Regulatory Authority’s procedures regarding the
recall of pharmaceutical products, as the same may be amended from time to time,
and shall include any post-sale warning or mailing of information regarding such
product, including any warnings or mailings described in the Regulatory
Authority’s product recall procedures.
Registrational
Filing. “Registrational Filing” means an application submitted
to the Regulatory Authority in the Territory seeking a Regulatory Marketing
Approval.
Regulatory
Approval. “Regulatory Approval” means the technical, medical
and scientific licenses, registrations, authorizations and approvals of any
Regulatory Authority necessary for the development, clinical testing, commercial
manufacture, distribution, marketing, promotion, offer for sale, use, import,
export or sale of a drug product in a regulatory jurisdiction, including INDs,
Registrational Filings, supplements and amendments, pre- and post- approvals,
Drug Price Approval, labeling approvals, and drug master files.
Regulatory
Authority. “Regulatory Authority” means any national,
regional, state or local regulatory agency, department, bureau, commission,
council or other governmental entity involved in the granting of a Regulatory
Approval, including the Japanese Regulatory Authority.
Regulatory Marketing
Approval. “Regulatory Marketing Approval” means a Regulatory
Approval authorizing the marketing of a Product in the Territory for any
indication. For the sake of clarity, Regulatory Marketing Approval
shall be deemed to have occurred when the Regulatory Authority sends a
notification of such Regulatory Marketing Approval to the applicant seeking
Regulatory Marketing Approval.
Sublicense. “Sublicense”
means, directly or indirectly, to sublicense, grant any other right with respect
to, or agree not to assert, any right licensed to Ono under this Agreement. When
used as a noun, “Sublicense” means any agreement to Sublicense.
Territory. “Territory”
means the country of Japan (Nihon/Nippon Koku).
Third Party. “Third
Party” means any Person other than Ono, Progenics or their respective Affiliates
or permitted sublicensees.
Title 11. “Title
11” shall have the meaning set forth in Section 10.5.2 (Effect on
Licenses).
Valid Claim. “Valid
Claim” means a claim of a patent application or an issued and unexpired patent
that has not been held unpatentable, revoked, unenforceable or invalid by a
decision of a court or other governmental agency of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal, and that has not
been admitted to be invalid or unenforceable through reissue, disclaimer or
otherwise. If a claim of a pending patent application has not issued as a claim
of an issued patent within [*] years after the earliest priority date for such
claim, such claim shall cease to be a Valid Claim unless and until such claim
becomes an issued claim of an issued patent.
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Wyeth. “Wyeth”
means Wyeth, a Delaware corporation.
Wyeth
Agreement. “Wyeth Agreement” means the License and
Co-Development Agreement by and among Wyeth, Wyeth Whitehall Pharmaceuticals,
Inc., Wyeth Ayerst Lederle, Inc., Progenics and ProNev, dated as of December 23,
2005, providing for a collaboration of the parties thereto (the “Wyeth
Collaboration”).
Wyeth Collaboration
Know-How. “Wyeth Collaboration Know-How” means the “Wyeth
Collaboration Know-How” as such term is defined in the Wyeth Agreement, as and
to the extent such rights subsist in the Territory and as and to the extent
Controlled by Progenics or its Affiliates as of the Effective Date or at any
time during the Term, which relates to the Initial Formulation or a Product or
to the use of the Initial Formulation or a Product.
Wyeth Collaboration Patent
Rights. “Wyeth Collaboration Patent Rights” means the “Wyeth
Collaboration Patent Rights” as such term is defined in the Wyeth Agreement, as
and to the extent such rights subsist in the Territory and as and to the extent
Controlled by Progenics or its Affiliates as of the Effective Date or at any
time during the Term, which relates to the Initial Formulation or a Product or
to the use of the Initial Formulation or a Product.
Wyeth Collaboration Joint
Know-How. “Wyeth Collaboration Joint Know-How” means the
“Joint Know-How” as such term is defined in the Wyeth Agreement, as and to the
extent such rights subsist in the Territory and as and to the extent Controlled
by Progenics or its Affiliates as of the Effective Date or at any time during
the Term, which relates to the Initial Formulation or a Product or to the use of
the Initial Formulation or a Product.
Wyeth Collaboration Joint Patent
Rights. “Wyeth Collaboration Joint Patent Rights” means the
“Joint Patent Rights” as such term is defined in the Wyeth Agreement, as and to
the extent such rights subsist in the Territory and as and to the extent
Controlled by Progenics or its Affiliates as of the Effective Date or at any
time during the Term, which relates to the Initial Formulation or a Product or
to the use of the Initial Formulation or a Product.
Additional
Definitions. Definitions for each of the following defined
terms are set forth in the section of this Agreement indicated
below:
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Definition
|
Section / Definition
|
1Q
|
6.5.2(a)
|
1Q
Royalty
|
6.5.2(a)
|
2Q
|
6.5.2(b)
|
2001
Agreement
|
2.4
|
3Q
|
6.5.2(c)
|
4Q
|
6.5.2(d)
|
Action
Party
|
7.2.7(c)
|
Additional
Formulation Option
|
5.5.1
|
Agreement
|
Introduction
|
Controlling
Third Party
|
Progenics
Kow-How
|
Combination
Sale
|
Net
Sales
|
Commercialization
Payments
|
6.3
|
Commercialization
Plan
|
3.4.3
|
Debtor
Party
|
10.5.1
|
December
31 YTD Royalties
|
6.5.2(c)
|
Development
Milestone
|
6.2
|
Development
Milestone Payments
|
6.2
|
Development
Plan
|
4.1
|
Disclosing
Party
|
8.1
|
Effective
Date
|
Introduction
|
Exchange
Act
|
13.22.1(a)
|
[*]
|
3.1.3
|
Full
Ono Fiscal Year Royalties
|
6.5.2(d)
|
Gross
Sales
|
Net
Sales
|
Indemnified
Party
|
11.3
|
Indemnifying
Party
|
11.3
|
Inventions
|
2.4
|
Liability
|
11.1
|
Licensed
Progenics Patent Rights
|
9.2(a)
|
Negotiation
Period
|
5.5.2
|
Net
Combination Sale Amount
|
Net
Sales
|
Non-Debtor
Party
|
10.5.1
|
Ono
|
Introduction
|
Ono
Indemnified Party
|
11.2
|
Option
Period
|
5.5.1
|
Owned
Progenics Patent Rights
|
9.2(a)
|
Party
|
Introduction
|
Parties
|
Introduction
|
Party
Vote
|
3.1.3
|
Permitted
Deductions
|
Net
Sales
|
Progenics
|
Introduction
|
Progenics
Indemnified Party
|
11.1
|
Receiving
Party
|
8.1
|
Responsible
Executive
|
13.20
|
[*]
|
Background
|
SEC
|
13.22.1(b)
|
Selling
Person
|
Net
Sales
|
September
30 YTD Royalties
|
6.5.2(b)
|
SPC
|
Patent
Term Extension
|
Sued
Party
|
7.2.8(c)
|
Term
|
10.1
|
Third
Party IP Rights
|
7.2.8(b)
|
Third
Party License
|
6.4.3
|
Title
11
|
10.5.2
|
University
|
2.4
|
Working
Group
|
3.5
|
Wyeth
Collaboration
|
Wyeth
Agreement
|
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2.
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LICENSE
GRANTS AND RELATED MATTERS.
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2.1. License from Progenics to
Ono. Subject to the terms and conditions of this Agreement,
Progenics hereby grants to Ono in the Field (i) an exclusive license, even as to
Progenics, under the Progenics Technology and Progenics’ interest in the Joint
Technology and the Wyeth Collaboration Joint Patent Rights and Wyeth
Collaboration Joint Know-How, and (ii) a nonexclusive license under the Wyeth
Collaboration Patent Rights, Wyeth Collaboration Know-How and Wyeth’s interest
in the Wyeth Collaboration Joint Patent Rights and Wyeth Collaboration Joint
Know-How, in each case with the right to Sublicense the foregoing rights solely
as set forth in Section 2.2 (Sublicenses), to make, have made, use, Develop,
sell, offer to sell, have sold, import, and otherwise exploit and Commercialize
Products in the Territory, provided that the foregoing grant shall consist
solely of Know-How and Patent Rights subsisting in the Territory. Ono
shall also have the right, subject to the written approval of Progenics on a
country-by-country, manufacturer-by-manufacturer basis, which approval shall not
be unreasonably withheld, to have the API or finished goods for any Product made
for Ono by one or more Third Party manufacturers outside the Territory, solely
for the purpose of selling Products in the Territory. Ono
acknowledges that with respect to those Progenics Patent Rights that are
Controlled by Progenics pursuant to Progenics Third Party Agreements, the
license granted in this Section is subject to the rights of the Progenics Third
Party licensors under such Progenics Third Party Agreements. Ono will
not sell the Compound or any Product (a) outside of the Territory; or (b) to any
Third Party that Ono knows or should know, with the exercise of reasonable
diligence and prudence, intends to sell the Compound or any Product outside of
the Territory.
2.2. Sublicenses. Ono shall have
the right to grant Sublicenses of any and all rights granted to Ono under this
Agreement to its Affiliates in the Territory, with the prior approval by
Progenics, which shall not be unreasonably withheld or delayed, subject to the
execution and delivery of any such Affiliate of a Sublicense agreement
consistent with the terms and conditions of this Agreement and reasonably
satisfactory to Progenics. Except as otherwise set forth in this
Section 2.2 (Sublicenses), Ono shall not have the right to grant Sublicenses of
any rights granted to Ono to any Third Parties without the prior written
approval of Progenics, which approval may be withheld for any reason or no
reason.
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2.3. Sen-yo Jisshiken Tohroku/Tsujyo
Jisshiken Tohroku. Upon Ono’s request, Progenics shall make
Commercially Reasonable Efforts to cause Wyeth and/or Progenics Third Party
licensors of Progenics Third Party Agreements including the University of
Chicago and/or Wyeth to register “Sen-yo Jisshiken Tohroku” for Progenics to the
extent Progenics is granting exclusive rights to Ono hereunder and/or “Tsujyo
Jisshiken Tohroku” for Progenics to the extent Progenics is granting a
non-exclusive rights to Ono hereunder. In the event such Sen-yo
Jisshiken Tohroku and/or Tsujyo Jisshiken Tohroku for Progenics is registered by
Wyeth and/or Progenics Third Party licensors, then Progenics shall transfer or
assign such registration to Ono, in order to make Ono enjoy a position of an
exclusive licensee, to the extent Progenics is granting exclusive rights to Ono
hereunder, and/or a non-exclusive licensee, to the extent Progenics is granting
non-exclusive rights to Ono hereunder, subject to this Agreement, with respect
to Wyeth Collaboration Patent Rights and Wyeth Collaboration Joint Patent Rights
and/or such Progenics Third Party licensor’s patents and patent applications
which are represented as Progenics Patent Rights in accordance with the patent
law of Japan; provided,
however, that Ono shall promptly ask Wyeth and/or Progenics Third Party
licensors, through Progenics, to cancel such registration of Sen-yo Jisshiken
Tohroku and/or Tsujyo Jisshiken Tohroku in cooperation with Ono in the event of
early termination for any reason pursuant to Section 10 of this Agreement
(except to the extent that Ono continues to have the license granted by
Progenics in spite of the early termination or in accordance with the provision
of Section 2.7 (Fully Paid-Up, Royalty Free License)) or in the event that Ono
ceases to sell Product during the Term for any reason. In the event
that Wyeth and/or a Progenics Third Party licensor decides to register Sen-yo
Jisshiken Tohroku and/or Tsujyo Jisshiken for Progenics, Ono shall, subject to
this Agreement, carry out, at Ono’s sole expense and in cooperation with
Progenics and Wyeth and/or Progenics Third Party licensor, actual proceedings
with regard to such registration and transfer of Sen-yo Jisshiken Tohroku and/or
Tsujyo Jisshiken for Progenics. Any representative, confirmatory or
redacted agreement, executed for the administrative purpose of registering Ono's
license rights hereunder, shall not be construed to have been executed for any
purpose other than to effect registration, and shall not in any way affect the
Parties’ respective rights and obligations under this Agreement.
2.4. Participation in Progenics’ Right of
First Refusal. The Parties hereby acknowledge that Progenics
has been granted, pursuant to that certain letter agreement (the “2001 Agreement”)
dated as of September 20, 2001 by and among the University of Chicago, on behalf
of itself and its affiliate ARCH Development Corporation (the “University”), and
Progenics, a right of first refusal to negotiate a license with respect to
certain inventions Controlled by the University (collectively, “Inventions”). Progenics
shall (i) promptly give Ono written notice of any Inventions that are subject to
Progenics’ right of first refusal under the 2001 Agreement of which Progenics
becomes aware and (ii) if Progenics determines to enter into a license with the
University to license any such Inventions, offer Ono an opportunity to
participate, on terms reasonably satisfactory to Progenics and Ono, in such
license.
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2.5. License from Ono to
Progenics. Ono hereby grants to Progenics a non-exclusive
license under the Ono Collaboration Patent Rights and the Ono Collaboration
Know-How, and a non-exclusive license under Ono’s interest in the Joint Patent
Rights and Ono’s interest in the Joint Know-How, in each case with a right to
sublicense, to research, make, have made, manufacture, have manufactured, use,
develop, sell, offer to sell or use, have sold, market, promote, import, export,
and otherwise exploit and commercialize the Compound and/or any products
containing the Compound outside the Territory, without any compensation or
royalty relating thereto during the Term. Progenics shall timely
notify Ono of any sublicenses. An agreement with any sublicensee
shall provide that such sublicense is consistent with and subject to the
material terms and conditions of this Agreement, including without limitation
the material obligations of Progenics hereunder.
2.6. Non-Exclusive
License Grant.
2.6.1. Non-Exclusive License from Progenics
to Ono. In the event that the exercise by Ono or its
Affiliates of the rights granted by Progenics in Section 2.1 (License from
Progenics to Ono) above would infringe any Patent Rights Controlled by Progenics
or its Affiliates, and which Patent Rights are not covered by the grants in
Section 2.1 (License from Progenics to Ono), Progenics hereby grants to Ono and
its Affiliates during the Term, to the extent Progenics is legally able to do
so, a non-exclusive, royalty-free license in the Territory under such Patent
Rights solely to the extent necessary for Ono and its Affiliates to exploit the
rights granted to Ono and its Affiliates under Section 2.1 (License from
Progenics to Ono) of this Agreement, and subject to the same reservations of
rights of Progenics.
2.6.2. Non-Exclusive License from Ono to
Progenics. In the event that the exercise by Progenics, its
Affiliates, licensees, including Wyeth, or sublicensees of the rights granted by
Ono in Section 2.5 (License from Ono to Progenics) would infringe any Patent
Rights Controlled by Ono or its Affiliates, and which Patent Rights are not
covered by the grant in Section 2.5 (License from Ono to Progenics), Ono hereby
grants to Progenics, its Affiliates, licensees and sublicensees to the extent
Ono is legally able to do so, a non-exclusive, sublicensable, royalty-free
license outside the Territory under such Patent Rights solely to the extent
necessary for Progenics, its Affiliates, licensee and sublicensees to exploit
the rights granted to Progenics and its Affiliates under Section 2.5 (License
from Ono to Progenics) of this Agreement and subject to the same reservations of
rights of Ono.
2.6.3. Non-Assertion by
Ono. Ono shall not assert any Ono Independent Patent Rights
against Progenics, its Affiliates or its licensees or sublicensees relating to
the Development, Commercialization or other exploitation of the Compound or any
product containing the Compound outside the Territory.
2.7. Fully Paid-Up, Royalty Free
License. After expiration of the Term for any Product the
license granted to Ono under Section 2.1 (License from Progenics to Ono) and
Section 2.6.1 (Non-Exclusive License from Progenics to Ono) with respect to such
Product shall be a fully paid-up, perpetual, non-exclusive, irrevocable,
royalty-free license. After expiration of the Term for any Product
the license granted to Progenics under Section 2.5 (License from Ono to
Progenics) shall become a fully paid-up, perpetual, non-exclusive, irrevocable,
sublicenseable, royalty-free license; provided, however, in the
event Progenics desires to obtain an exclusive license under Ono Collaboration
Patent Rights and/or Joint Patent Rights, the Parties shall negotiate in good
faith the terms and conditions of such licenses.
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2.8. Progenics Third Party
Agreements. Progenics shall exercise its rights under the
Progenics Third Party Agreements in a manner that is as consistent as possible
with the terms of this Agreement in consultation with and as reasonably
requested by Ono.
2.9. Know-How Disclosure and
Transfer. Commencing promptly after the Effective Date,
Progenics shall disclose the then existing Progenics Know-How and then existing
Know-How included in the Wyeth Collaboration Know-How and the Wyeth
Collaboration Joint Know-How to Ono necessary for the
Collaboration. During the Term, Progenics shall promptly disclose to
Ono all Progenics Know-How, Know-How included in the Wyeth Collaboration
Know-How and Wyeth Collaboration Joint Know-How and Joint Know-How that is
developed by Progenics or otherwise comes into Progenics’ Control necessary for
the Collaboration, except for Know-How related exclusively to the Excluded
Molecules. Furthermore, during the Term, Ono shall promptly disclose
to Progenics any Joint Know-How and Ono Collaboration
Know-How. Disclosure of Know-How by Progenics as provided in this
Section 2.9 (Know-How Disclosure and Transfer) shall be accomplished through:
(i) [*]; and (ii) [*]. [*].
2.10. Costs of
Assistance. Progenics shall perform the activities it is
required to perform under Section 2.9 (Know-How Disclosure and Transfer),
Article 3 (Governance of Collaboration), Section 5.2.2 (Transfer of
Manufacturing Know-How) and Article 7 (Intellectual Property), except as
otherwise specifically provided therein, at no charge to Ono. If Ono
shall request that Progenics perform any other activities in connection with the
Collaboration or the Commercialization and Development of the Initial
Formulation or any Product, then Ono shall reimburse Progenics for any and all
costs Progenics incurs, including out-of-pocket costs (including travel) and
personnel costs at the FTE Rate. Ono shall reimburse Progenics for such costs
within thirty (30) days of Ono’s receipt of an invoice therefor accompanied by
reasonable documentation. Without limiting the generality of the
foregoing, Progenics, upon Ono's request, shall use Commercially Reasonable
Efforts to prepare reports, analyze data, produce materials not covered by
Section 2.9 (Know-How Disclosure and Transfer) and review Ono documents only in
case such review is specifically requested by Ono, subject to payment of costs
as provided in this Section 2.10 (Cost of Assistance).
2.11. No Implied
Rights. Except as expressly provided in this Agreement,
neither Party shall be deemed to have granted the other Party any license or
other right with respect to any intellectual property of such
Party.
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3.
|
GOVERNANCE
OF COLLABORATION
|
3.1. Management
of the Collaboration and General Committee Procedures.
3.1.1. Overview. A Joint
Steering Committee as defined in Section 3.2 (Joint Steering Committee), a Joint
Development Committee as defined in Section 3.3 (Joint Development Committee)
and a Joint Commercialization Committee as defined in Section 3.4 (Joint
Commercialization Committee) shall be established. Each Committee
shall have the responsibilities and authority allocated to it in this Section 3
(Governance of Collaboration) and elsewhere in this Agreement. The
following procedures shall apply to the Committees under this
Agreement.
3.1.2. Meetings. Each
Committee shall hold meetings at such times as it elects to do so, but in any
event the JSC shall meet no less than twice per year until Japanese Regulatory
Marketing Approval, and once per year thereafter, with additional meetings to be
called by either co-chairperson of the JSC on an ad-hoc basis and held
face-to-face, by telephone, by video or Webex, as they reasonably agree. At
least one meeting of the JSC each year shall be held
face-to-face. The JDC shall meet no less than twice annually,
face-to-face, by telephone, by video or Webex, with additional meetings to be
called by either co-chairperson of the JDC on an ad-hoc basis. The
JCC shall meet, commencing upon formation under Section 3.4.1 (Formation of
JCC), no less than twice annually, with additional meetings to be called by
either co-chairperson of the JCC or, as necessary, Progenics on an ad hoc
basis. JCC meetings may be held face-to-face, by teleconference,
video or Webex, as determined by the Committee chairpersons. Venue of
the meetings of each Committee shall alternate between the premises of the
Parties, if not held by telephone, video or Webex, unless the Parties agree
otherwise. Other employees of each Party involved in the Development,
Commercialization or intellectual property protection of the Product may attend
meetings of such Committee as non-voting participants with the permission of the
co-chairpersons. [*]
3.1.3. Decision
Making. Each Party’s designees on the JSC, JDC and JCC shall,
collectively, have one (1) vote (the “Party Vote”) on all
matters brought before the respective Committee. Except as expressly
provided in this Section 3.1.3 (Decision Making), each of the JSC, JDC and JCC
shall decide as to all matters within its jurisdiction by unanimous Party Vote;
provided, however, that
no such Committees shall have the authority to amend or modify, or waive
compliance with, this Agreement, and, provided further, that the
Party Vote of each Party shall be subject to the approval of such Party’s
management. In the event that a Party’s management does not concur
with the Party Vote of such Party, such Party shall notify the other Party in
writing (which may be by email) of such disapproval within [*] days after the
Party Vote, but as promptly as possible. In the event that a Party
does not give notice of its disapproval of any Committee decision as provided
for herein, such Party shall be deemed to have ratified any such Committee
decision. In the event of a tie Party Vote of the designees of Ono
and Progenics on the JDC or JCC as to matters within the jurisdiction of such
Committees, or in the event a Party’s management does not approve of the vote
cast, the co-chairpersons of the JDC or JCC shall refer the matter to the JSC
for resolution. In the event that such a matter cannot be resolved by
the JSC within [*] days of it being referred to the JSC, or in the event of a
tie Party Vote of the designees of Ono and Progenics on the JSC with respect to
any other matter within the JSC’s jurisdiction, the co-chairpersons of the JSC
shall refer the matter to [*]. In the event that such matters cannot
be resolved by these executives after good faith negotiations within [*] days,
then the matter shall be referred to the [*]. If after good faith
discussions by [*], agreement cannot be reached within [*] days, then [*] shall
decide upon a mechanism to resolve the matter.
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3.1.4. Meeting
Agendas. Each Party will have an equal right to place items on
the JSC, JDC and JCC agendas through the co-chairperson of the JSC, JDC or JCC
designated by such Party. Each Party will disclose to the other Party
its proposed agenda items along with appropriate information at least [*] days
in advance of each Committee meeting; provided, however, that under
exigent circumstances requiring JSC, JDC or JCC input, a Party may provide its
agenda items for a JSC, JDC or JCC meeting to the other Party within a lesser
period of time in advance of the meeting, or may propose that there not be a
specific agenda for a particular JSC, JDC or JCC meeting, so long as the other
Party consents to such later addition of such agenda items or the absence of a
specific agenda for such JSC, JDC or JCC meeting.
3.2. Joint
Steering Committee (JSC).
3.2.1. Formation and
Purpose. Within fifteen (15) days after the Effective Date,
Ono and Progenics shall nominate the members of the JSC, which shall coordinate
the Parties’ key activities under this Agreement and have the additional
responsibilities provided for in this Agreement. The first JSC
meeting will be held at Ono’s facilities on a mutually agreeable date within [*]
days after the Effective Date. The JSC will dissolve upon the
expiration of the Term.
3.2.2. Membership and
Chairpersons. Each Party shall designate [*] with appropriate
expertise to serve as members of the JSC. Each Party may replace any
of its JSC representatives at any time upon written notice to the other
Party. The JSC shall have two co-chairpersons, one designated by each
of Ono and Progenics. The co-chairpersons shall be responsible for
calling meetings, preparing and circulating an agenda in advance of each meeting
of the JSC, and preparing and issuing minutes of each meeting within [*] days
thereafter. Such minutes will not be finalized until each Party
reviews and confirms the accuracy of such minutes in writing or by unanimous
Party Vote at a subsequent Committee meeting.
3.2.3. Specific Responsibilities of the
JSC. The JSC shall have responsibility for the overall
strategic and operational direction of the Parties’ collaboration under this
Agreement, including:
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(a) [*];
(b) [*];
(c) [*];
(d) [*];
(e) [*];
(f) [*];
(g) [*];
(h) [*];
(i) [*];
and
(j) [*].
3.3. Joint
Development Committee (JDC).
3.3.1. Formation and
Purpose. Within fifteen (15) days after the Effective Date,
the Parties shall nominate the members of the JDC, which shall oversee,
coordinate and expedite the Development of, and the making of regulatory
submissions for, the Product in order to obtain Regulatory
Approvals. The first JDC meeting will be held at Ono’s facilities on
a mutually agreeable date within [*] days after the Effective Date following
preparation by Ono of the Development Plan for the purpose of review and
approval of the Development Plan. At any time that any Product is
being Developed under this Agreement, the JDC shall exist and receive and
comment upon periodic reports concerning the status of Product Development and
the Development Plan. The JDC shall also facilitate the flow of
information with respect to Development activities being conducted and will
oversee all clinical trials for any Product.
3.3.2. Membership and
Chairpersons. Each Party shall designate [*] representatives
with appropriate expertise to serve as members of the JDC. Each Party
may replace its JDC representative at any time upon written notice to the other
Party. The JDC shall have two co-chairpersons, one designated by each
of Progenics and Ono. The chairpersons shall be responsible for
calling meetings, preparing and circulating an agenda in advance of each meeting
of the JDC, and preparing and issuing minutes of each meeting within [*] days
thereafter. Such minutes will not be finalized until each Party
reviews and confirms the accuracy of such minutes in writing or by unanimous
Party Vote at a subsequent meeting of the JDC.
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3.3.3. Specific Responsibilities of the
JDC. The JDC shall have responsibility for overseeing,
coordinating and expediting the Development of the Initial Formulation and the
Product for Commercialization in the Territory, including, without
limitation:
(a) [*];
(b) [*];
(c) [*];
(d) [*];
(e) [*];
(f) [*];
(g) [*];
(h) [*];
(i) [*];
and
(j) [*].
3.4. Joint
Commercialization Committee (JCC).
3.4.1. Formation of
JCC. The Parties shall nominate the members of, and establish,
the JCC, which shall facilitate the exchange of information between the Parties
regarding the Commercialization of the Product in the Territory,
[*].
3.4.2. Membership. The JCC
shall be composed of at least [*] representatives designated by each Party in
number and function according to the responsibilities of each
Party. The JCC shall have two co-chairpersons, one designated by each
of Progenics and Ono. The chairpersons shall be responsible for
calling meetings, preparing and circulating an agenda in advance of each meeting
of the JCC, and preparing and issuing minutes of each meeting within [*] days
thereafter. Such minutes will not be finalized until each Party
reviews and confirms the accuracy of such minutes in writing or by unanimous
Party Vote at a subsequent meeting of the Committee.
3.4.3. Responsibilities of the
JCC. The JCC shall have responsibility for overseeing,
coordinating and expediting the Commercialization of the Product in the
Territory, including:
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(a) [*];
(b) [*];
(c) [*];
(d) [*];
(e) [*];
(f) [*];
and
(g) [*].
3.5. Working
Groups. From time to time Progenics and Ono may establish and
delegate duties to other committees, subcommittees, or directed teams (each, a
“Working
Group”) on an “as needed” basis to oversee particular projects or
activities, including intellectual property, manufacturing, CMC, Development and
Commercialization, and similar matters. Each such Working Group shall
be constituted and shall operate as the applicable Committee delegates its
responsibilities. Each Working Group and its activities shall be
subject to the oversight, review and approval of, and shall report to, the
applicable Committee. In no event shall the authority of any Working
Group exceed that specified for the applicable Committee.
4.
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DEVELOPMENT
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4.1. Development
Plan. The Development of the Product will be conducted by or
on behalf of Ono pursuant to a mutually agreed development plan that will govern
all aspects of Development of the Product in the Territory (as such plan is in
effect from time to time, the “Development
Plan”). The initial Development Plan will be prepared by Ono
within [*] days of the Effective Date and shall become a part of this Agreement
as Appendix I. The JDC shall be responsible for reviewing and
endorsing the Development Plan. The Development Plan shall be updated subject to
approval by both Parties, on an as-needed basis, but in no event less than once
annually.
4.2. Development Responsibilities of
Ono. Ono shall pay one hundred percent (100%) of the
Development costs to Develop the Products in the Territory; and Ono shall be
solely responsible for, and shall use Commercially Reasonable Efforts
to:
4.2.1. Develop
the Product(s) in the Territory in accordance with the Development Plan,
including (i) preparing and submitting and/or revising and amending
Registrational Filings, (ii) conducting and managing all clinical trials
included in the Development Plan, and (iii) obtaining and maintaining Regulatory
Approvals for the Product;
4.2.2. perform
the work under the Development Plan in accordance with the estimated timelines
set forth therein;
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4.2.3. obtain
Regulatory Approval from Regulatory Authorities for the Product(s) in the
Territory;
4.2.4. make all
required correspondence and any official communications (except where Progenics
may be required by applicable law or Regulatory Authority to communicate)
regarding the Product(s) with Regulatory Authority in the
Territory;
4.2.5. perform
any other work necessary and appropriate as determined by the JDC;
4.2.6. disclose
to Progenics all data, information and other Ono Collaboration Know-How and
Joint Know-How; and
4.2.7. if the
JSC decides to Develop any Combination Product, Develop such Combination Product
in the Territory in accordance with the Development Plan, including, without
limitation, (i) preparing and submitting and/or revising and amending
Registrational Filings for such Combination Product, (ii) conducting and
managing all clinical trials included in the Development Plan for such
Combination Product, and (iii) obtaining and maintaining Regulatory
Approvals for such Combination Product.
4.3. [*] Development
Activities. Ono shall Develop the Product in accordance with
the Development Plan, as the Development Plan may be revised with the review and
approval of the JDC from time to time. [*].
4.4. Records. Ono shall
maintain, and shall use Commercially Reasonable Efforts to cause its Outside
Contractors to maintain, accurate and complete records of all activities related
to the Development of the Product, as consistent with the responsibilities of
Ono under this Agreement, and all results of any trials, studies and other
investigations conducted under this Agreement by or on behalf of Ono, and its
Affiliates and Outside Contractors, as applicable.
4.5. Reports on
Development. For so long as Ono continues to Develop a Product
under this Agreement, it shall provide the JDC with periodic reports containing
relevant information regarding data and results, activities, and timelines,
related to Regulatory Filings and clinical trials of such Product conducted or
overseen by Ono. In addition, through its representatives on the JDC,
each Party shall make periodic oral reports to the JDC, updating the JDC as to
the status and results of such Party’s Development efforts with respect to any
Product, for so long as the JDC continues in existence.
5.
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COMMERCIALIZATION
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5.1. Ono’s
Commercialization Responsibilities and Efforts.
5.1.1. Responsibilities. Subject
to the supervision of the JSC and the JCC, Ono shall be responsible for the
Commercialization of the Product in the Territory and shall pay one hundred
percent (100%) of the costs of Commercialization of the Product; and Ono shall
be solely responsible for distribution and pricing of the Product and shall book
all sales of the Product in the Territory.
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5.1.2. Efforts. Ono shall
use Commercially Reasonable Efforts to pre-launch, launch, promote, market,
distribute, sell in finished pharmaceutical form, and otherwise Commercialize
Products in the Territory. Ono’s Commercially Reasonable Efforts in
Commercialization of the Product shall include the following:
(a) [*];
(b) [*];
and
(c) [*].
5.2. Supply.
5.2.1. Supply. Ono shall
be solely responsible at its expense for the manufacture, and/or acquisition,
and supply of one hundred percent (100%) of the Initial Formulation and finished
Product, including packaging and labeling, for Commercialization both as bulk
API and as finished and packaged Products, it being understood that all Compound
and/or Product supplied by Ono for clinical use shall be manufactured under GMP
conditions.
5.2.2. Transfer of Manufacturing
Know-How. Progenics will disclose to Ono, Ono’s Affiliates,
and/or Ono’s Third Party contract manufacturer all relevant Progenics Know-How
and Know-How included in the Wyeth Collaboration Know-How and Wyeth
Collaboration Joint Know-How relating to the manufacture of the Initial
Formulation and/or Products. Progenics shall use its Commercially
Reasonable Efforts to cause Wyeth to provide Ono with that cooperation,
inventory, technology, know-how and documentation set forth in Section 10.4.1(d)
of the Wyeth Agreement. Such Know-How disclosure shall include the transfer of
data and information stored on the computer systems of Progenics for the
NDA.
5.3. Marketing Materials and Corporate
Branding. Subject to Section 7.3 (Trademarks), Ono shall be
solely responsible at its expense for all pre-marketing and marketing efforts
and for creating all packaging and promotional materials for the
Product. Subject to Progenics’ reasonable approval of the form and
presentation thereof, the corporate name and logo of Progenics shall appear on
all Product packaging, package inserts and promotional materials in the
Territory, subject, in each case, to compliance with applicable law and
regulatory requirements.
5.4. Sharing of
Information. Without limiting the provisions regarding the JCC
under Section 3.4.3 (Responsibilities of the JCC), Ono shall provide the JCC
with a copy of Ono’s Commercialization Plan for any Product and any updates
thereof, including, without limitation, information regarding strategies for
Commercialization and detailing of the Product, market research and strategy,
promotional activities, and sales plans and forecasts, and Ono shall report to
the JCC on the progress of its implementation of the Commercialization
Plan. All such commercial information shall be Ono’s Confidential
Information for the purposes of Section 8.1 (Confidentiality).
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5.5. Option
to Develop and Commercialize Additional Formulations
5.5.1. Provided
Ono is in compliance with all material terms of this Agreement, including
performing its obligations under the Development Plan, during the [*] commencing
on [*] of a product using an Additional Formulation (the “Option Period”), Ono
shall, provided that the Additional Formulation does not infringe the Patent
Rights of any Third Party in the Territory, have the option to obtain the right
to Develop and Commercialize in the Territory the Additional Formulation (the
“Additional
Formulation Option”). Ono shall be entitled to an Additional Formulation
Option for each different Additional Formulation, but the Option shall arise
only upon [*] for the first product using that Additional Formulation, and no
further option shall arise if other products using that Additional Formulation
subsequently receive [*].
5.5.2. If Ono
exercises the Additional Formulation Option in a timely manner, then Ono and
Progenics will promptly enter into good faith negotiations for a period of [*]
(the “Negotiation
Period”) [*], the Parties will enter into an agreement pursuant to which
Ono will develop and commercialize the Additional Formulation on terms
substantially similar to those contained herein. Notwithstanding the
foregoing, and in consideration for [*], Ono shall not be required to pay [*] to
Progenics for any Additional Formulation that Ono elects to develop and
commercialize in the Territory, but shall pay [*] as shall be commercially
reasonable.
5.5.3. If Ono
does not timely elect to exercise its Additional Formulation Option hereunder,
or if is not entitled to exercise the Additional Formulation Option because it
is not in compliance with all material terms of this Agreement as provided in
Section 5.5.1, or if Ono and Progenics are unable to reach agreement on [*]
during the Negotiation Period, Progenics may, at its discretion, provided it has
bargained in good faith, license the development and commercialization of the
Additional Formulation to a Third Party, or develop and commercialize the
Additional Formulation on its own, in the Territory at any time thereafter, so
long as [*] entered into with, if applicable, any Third Party are, on the whole,
at least as favorable to Progenics as [*] in the negotiations following the
exercise of the Additional Formulations Option (ignoring for the purposes of
this comparison the amount [*] fee payable by the Third Party).
5.6. Developmental Research
License. At any time during the Term Ono may submit a written
request to Progenics requesting the right to engage in research activities in
the Territory with respect to any Additional Formulation. Progenics
may grant or decline to grant any such request in its sole
discretion. Any eventual license pertaining to any such research
request shall be on terms mutually agreeable to Progenics and Ono.
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5.7. Non-Competition. Subject
to [*], except for the Development and Commercialization of any Product in the
Territory, or for other purposes related to this Agreement, Ono shall not, and
shall ensure that its Affiliates do not, either alone or in conjunction with a
Third Party, directly or indirectly (i) [*], or (ii) [*]. In the
event that Ono intends to [*], either alone or with any Third Parties, with
respect to [*], Ono shall, prior to [*].
6.
|
PAYMENTS
BY ONO TO PROGENICS.
|
6.1. Upfront License Fee
Payment. Ono shall pay to Progenics upon the execution of this
Agreement fifteen million United States dollars ($15,000,000) as a
one-time nonrefundable and noncreditable license fee in partial consideration
for the licenses granted under Section 2 (License Grants and Related Matters)
hereof. Such amount shall be paid within twenty (20) business days
after receipt by Ono of an invoice from Progenics. If Progenics does
not provide to Ono prior to the time that payment is required all necessary
Japanese taxation documents, Ono shall nevertheless make the payment required
hereunder subject to Section 6.5.3 (Taxes and Withholding).
6.2. Development Milestone
Payments. In partial consideration for the licenses granted to
Ono under Section 2 (License Grants and Related Matters) hereof, Ono shall pay
to Progenics the following one-time, nonrefundable, noncreditable research and
development payments (“Development Milestone
Payments”) in United States dollars within twenty (20) business days of
receipt by Ono of an invoice and all taxation documents necessary for the
payment of each Development Milestone Payment (each a “Development
Milestone”), provided that if Progenics does not provide all such
taxation documents, Ono shall nevertheless make the payment required hereunder
subject to Section 6.5.3 (Taxes and Withholding). [*]
Condition
|
Payment
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[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
[*]
|
6.3. Commercialization Milestone
Payments. In partial consideration for the licenses granted to
Ono under Section 2 (License Grants and Related Matters) hereof, Ono shall pay
to Progenics the following one-time, nonrefundable, noncreditable
Commercialization milestone payments (“Commercialization
Payments”) in United States dollars within twenty (20) business days of
receipt by Ono of an invoice. If Progenics does not provide to Ono prior to the
time that payment is required all necessary Japanese taxation documents, Ono
shall nevertheless make the payment required hereunder subject to Section 6.5.3
(Taxes and Withholding). [*]
Condition
|
Payment
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· [*]
|
[*]
|
· [*]
|
[*]
|
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6.4. Royalty
Payments.
6.4.1. [*] Royalty Period [*]. In partial
consideration for the licenses granted and which may be granted to Ono under
Section 2 (License Grants and Related Matters) and Section 7.3 (Trademarks)
hereof, during the [*] Royalty Period, Ono shall pay to Progenics royalties in
the amount of [*] of the Net Sales made during the [*] Royalty
Period.
6.4.2. [*] Royalty
Period. Following the expiration of the [*] Royalty Period and
during the [*] Royalty Period, Ono shall pay to Progenics, in consideration of
the continuing license to Ono [*], royalties in the following
amounts:
(a) [*] of
Net Sales made during each Calendar Quarter during the [*] Royalty Period during
which the Generic Product Market Share does not exceed [*]; and
(b) [*] of
Net Sales made during each Calendar Quarter during the [*] Royalty Period during
which the Generic Product Market Share exceeds [*] but does not exceed
[*].
There
shall be no royalty payable for any Calendar Quarter during the [*] Royalty
Period during which the Generic Product Market Share exceeds [*].
6.4.3. Third Party
Agreements. Except as otherwise provided for herein, Progenics
shall, as between the Parties, be solely responsible for all obligations under
the Progenics Third Party Agreements. Ono shall be responsible for
all obligations under its agreements with Third Parties that are (i) in
effect as of the Effective Date or (ii) entered into by Ono during the Term,
and, in each case, no adjustment to the royalties payable by Ono under Section
6.4.1 ([*] Royalty Period) and 6.4.2 ([*] Royalty Period) shall be made on
account of any such obligations. In the event that the JSC determines
to Develop a Product that would require the payment of a royalty under [*], Ono
shall also pay all royalty payments under [*]. Notwithstanding the
foregoing, if during the Term, Ono enters into an agreement with a Third Party
to license Patent Rights in the Territory that would, but for such license, in
the written reasoned opinion of Ono’s outside patent counsel (which written
opinion shall be reasonably acceptable to Progenics), be infringed by the
Development, manufacture, use, sale, offering for sale, importation, exportation
or other Commercialization or exploitation of any Product in the Territory
(“Third Party
License”), then with respect to such Product, Ono and its Affiliates may
deduct up to [*] of the royalties payable pursuant to such Third Party License
actually paid by Ono to such Third Parties with respect to such Product from the
royalties otherwise due to Progenics with respect to the Net Sales of such
Product in the Territory under Section 6.4.1 ([*] Royalty Period), and 6.4.2
([*] Royalty Period) provided that such withholding shall not in any Calendar
Quarter reduce the royalties otherwise due to Progenics with respect to the Net
Sales of such Product in the Territory under Section 6.4.1 ([*] Royalty Period)
and Section 6.4.2 ([*] Royalty Period) by more than [*] percentage
points. For clarity and by way of example, if the royalty rate
otherwise payable to Progenics for the Product is [*], the royalty rate after
such withholding shall in no event be less than [*].
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6.5. Reports
and Payments.
6.5.1. Cumulative
Royalties. The obligation to pay royalties under this
Agreement shall be imposed only once with respect to any sale of any Product,
regardless of the number of patents that may cover the Product.
6.5.2. Royalty Statements and
Payments. Within [*] days of the end of each Calendar Quarter,
Ono shall deliver to Progenics a report, setting forth in reasonable detail for
such Calendar Quarter, the following information, on a Product-by-Product basis:
(a) Net Sales of the Product, (b) the amounts and types of Permitted Deductions
taken, (c) the amount and types of the Product provided at no charge, and
(d) the royalty due under this Agreement for the sale of the
Product. The royalty shall be calculated and paid quarterly as
follows:
(a) Ono shall
calculate the royalty due to Progenics based upon the Net Sales of all Products
by Ono during the first quarter of each Ono Fiscal Year (ending June 30) (“1Q”) (“1Q Royalty”) and Ono
shall make such payment to Progenics.
(b) Ono shall
calculate the royalty due to Progenics based upon the Net Sales of all Products
by Ono for 1Q and the second quarter of each Ono Fiscal Year (“2Q”) and this shall
be “September 30 YTD
Royalties”. Ono shall deduct 1Q Royalty from September 30 YTD
Royalties to arrive at the amount which is due to Progenics for 2Q and Ono shall
make such payment to Progenics.
(c) Ono shall
calculate the royalty due to Progenics based upon the Net Sales of all Products
by Ono for 1Q, 2Q and the third quarter of each Ono Fiscal Year (“3Q”) and this shall
be “December 31 YTD
Royalties”. Ono shall deduct September 30 YTD Royalties from
December 31 YTD Royalties to arrive at the amount which is due to Progenics for
3Q and Ono shall make such payment to Progenics.
(d) Ono shall
calculate the royalty due to Progenics based upon the aggregated Net Sales of
all Products by Ono for 1Q, 2Q, 3Q and the final quarter of an Ono Fiscal Year
(“4Q”) (“Full Ono Fiscal Year
Royalties”). Ono shall deduct December 31 YTD Royalties from
Full Ono Fiscal Year Royalties to arrive at the amount which is due to Progenics
for 4Q and Ono shall make such payment to Progenics.
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(e) The
royalties payable hereunder for the period commencing with the First Commercial
Sale of any Product shall be paid at the end of the first Ono Fiscal Year
quarter in which such First Commercial Sale occurs and, thereafter, shall be
paid as provided for above.
No such
reports shall be due for the Product before the First Commercial Sale of such
Product. All royalty payments due hereunder shall be due and payable
within twenty (20) business days following the distribution of each royalty
statement specified in this Section 6.5.2 (Royalty Statements and
Payments).
6.5.3. Taxes and
Withholding. All payments under this Agreement will be made
without any deduction or withholding for or on account of any tax, duties,
levies, or other charges unless such deduction or withholding is required by
applicable laws or regulations to be assessed against Progenics. If
Ono is so required to make any deduction or withholding from payments due to
Progenics, Ono will (a) promptly notify Progenics of such requirement, (b) pay
to the relevant authorities on Progenics’ behalf the full amount required to be
deducted or withheld promptly upon the earlier of determining that such
deduction or withholding is required or receiving notice that such amount has
been assessed against Progenics, and (c) promptly forward to Progenics an
official receipt (or certified copy) or other documentation reasonably
acceptable to Progenics evidencing such payment to such
authorities. Ono shall, at the request of Progenics, use Commercially
Reasonable Efforts in cooperation with Progenics to apply and qualify for all
exemptions and other positions available to Progenics and its Affiliates under
Japanese law and Article 22 of the Income Tax Convention between Japan and the
United States with a view to achieving the maximum lawful reduction of Japanese
withholding and other taxes payable by Progenics.
6.5.4. Currency. All
payments under this Agreement shall be made in United States
dollars. All such payments shall be translated into United States
dollars at the exchange rate for conversion of Japanese Yen into United States
dollars posted by [*] on the date on which Ono is required to make the
applicable payment hereunder, provided that no deduction from any amount shall
be made in respect of bank fees or charges.
6.5.5. Record Keeping. Ono
shall keep and shall cause its Affiliates to keep books and accounts of record
in connection with the sale of the Product, in accordance with GAAP and in
sufficient detail to permit accurate determination of all figures necessary for
verification of royalties to be paid under this Agreement. Ono and
its Affiliates shall maintain such records for a period of at least [*] after
the end of the Calendar Quarter in which they were generated, provided, however, that if
any records are in dispute and Ono has received written notice from Progenics of
the records which are in dispute, Ono shall keep such records until the dispute
is resolved.
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6.5.6. Audits. Upon thirty
(30) days’ prior written notice from Progenics, Ono shall permit an independent
certified public accounting firm of nationally recognized standing
selected by Progenics and reasonably acceptable to Ono, to examine, at
Progenics’ sole expense, the relevant books and records of Ono and its
Affiliates as may be reasonably necessary to verify the amounts reported by Ono
in accordance with Section 6.5.2 (Royalty Statements and Payments) and the
payment of royalties under Section 6.4 (Royalty Payments). An
examination by Progenics under this Section 6.5.6 (Audits) shall occur not more
than once in any Calendar Year and shall be limited to the pertinent books and
records for any Calendar Year ending not more than [*] before the date of the
request. The accounting firm shall be provided access to such books
and records at Ono’s facilit(y/ies) where such books and records are normally
kept and such examination shall be conducted during Ono’s normal business
hours. Ono may require the accounting firm to sign a standard
non-disclosure agreement before providing the accounting firm access to Ono’s
facilities or records. Upon completion of the audit, the accounting
firm shall, subject to Section 6.5.8 (Confidentiality) provide both Ono and
Progenics with a written report disclosing any discrepancies in the reports
submitted by Ono or the royalties paid, and, in each case, the specific details
concerning any discrepancies.
6.5.7. Underpayments/Overpayments. If
such accounting firm concludes that additional royalties were due to Progenics,
Ono shall pay to Progenics the additional royalties within [*] days of the date
Ono receives such accountant’s written report, plus interest, which shall be
calculated at the average of the prime rate reported by JPMorgan Chase, New York
City, each month during the period from the time any royalty payment was due
until paid in full, plus [*] per annum. If such underpayment exceeds
[*] of the royalties that were to be paid to Progenics, Ono also shall reimburse
Progenics for the out-of-pocket expenses incurred in conducting the
audit. Progenics shall not reveal to such accounting firm the
conditions under which the audit expenses are to be reimbursed
hereunder. If such accounting firm concludes that Ono overpaid
royalties to Progenics, Progenics will refund such overpayments to Ono, within
[*] days of the date Progenics receives such accountant’s report. No
interest shall be due Ono on such overpayment.
6.5.8. Confidentiality. All
progress reports and financial information of Ono which are subject to review
under this Section 6 (Payments by Ono to Progenics) shall be deemed to be Ono’s
Confidential Information subject to the provisions of Section 8
(Confidentiality) hereof, and Progenics shall not disclose such Confidential
Information to any Third Party or use such Confidential Information for any
purpose other than reviewing progress made or verifying payments to be made by
Ono to Progenics under this Agreement; provided, however, that such
Confidential Information may be disclosed by Progenics to Third Parties only to
the extent necessary to enforce Progenics’ rights under this
Agreement.
7.
|
INTELLECTUAL
PROPERTY.
|
7.1. Ownership
of Intellectual Property.
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7.1.1. Inventorship. Inventorship
of any invention and any Patent Right claiming such invention shall be
determined in accordance with the rules and guidelines regarding inventorship as
established under (i) United States patent law (including case law and
regulations associated therewith) for any Progenics Patent Rights and any Joint
Patent Rights or purported Joint Patent Rights, and (ii) the patent law in
effect in the place where such invention has been made (including case law and
regulations associated therewith) for any Ono Collaboration Patent Rights and
Ono Independent Patent Rights. Authorship of any work subject to
copyright protection shall be determined in accordance with the copyright law in
effect in the place where such work was made. The foregoing shall be
determined without references to conflict of law principles. Without
limiting the foregoing, each Party shall own all right, title and interest in
and to all Patent Rights and Know-How created solely by or on behalf of such
Party.
7.1.2. Ownership of Joint Know-How and Joint
Patent Rights. The Parties shall jointly own any Joint
Know-How and any Joint Patent Rights.
7.1.3. Exploitation of Joint Patent Rights
and Joint Know-How Other Than as Provided in this
Agreement. Except as expressly provided in this Agreement,
neither Party shall exploit any Joint Patent Right or Joint Know-How without the
prior written approval of the other Party, provided, however, that (i) Progenics
shall have the right to exploit, including the right to sub-license, any Joint
Patent Right or Joint Know-How outside the Territory without the express written
consent of Ono in connection with the development and commercialization of
products that do not include the Compound, and, (ii) subject to Section 5.7
(Non-Competition) above, Ono shall have the right to exploit, including the
right to sub-license, any Joint Patent Right or Joint Know-How inside the
Territory without the express written consent of Progenics in connection with
the development and commercialization of products that do not include the
Compound.
7.2. Patent
Rights.
7.2.1. Progenics Patent Rights and Wyeth Collaboration Joint Patent
Rights. The Parties
acknowledge that the prosecution of the Progenics Patent Rights and Wyeth
Collaboration Joint Patent Rights is governed by the Wyeth Agreement and the
Partial Termination Agreement. In the event Wyeth determines that any
Progenics Patent Rights and/or Wyeth Collaboration Joint Patent Rights should
not be prepared, filed, prosecuted or maintained in the Territory, Progenics
shall, subject to Wyeth’s rights under the Wyeth Agreement and the Partial
Termination Agreement, use Commercially Reasonable Efforts to prepare, file,
prosecute and maintain the Progenics Patent Rights and the Wyeth Collaboration
Joint Patent Rights (including provoking, instituting or defending interference,
opposition, revocation, reexamination and similar proceedings related to the
Progenics Patent Rights and the Wyeth Collaboration Joint Patent Rights) in the
Territory consistent with the intellectual property strategy developed by the
JDC, and approved by the JSC, in the Territory and the intellectual property
strategy applicable to such rights outside of the Territory, all at Progenics’
expense. The Parties shall cause their respective patent counsel to
communicate regularly regarding the prosecution and maintenance of the Progenics
Patent Rights and the Wyeth Collaboration Joint Patent Rights. In the
event Progenics, in the exercise of its reasonable business judgment, elects not
to prepare, file, prosecute or maintain any Progenics Patent Rights or Wyeth
Collaboration Joint Patent Rights in the Territory, Progenics shall give Ono
notice to this effect, sufficiently in advance to permit Ono to instruct
Progenics to undertake such filing, prosecution and maintenance without a loss
of rights, and, thereafter, Progenics will use Commercially Reasonable Efforts
to prepare, file and prosecute patent applications and maintain patents included
in such Patent Rights in Progenics’ name in the Territory, all at Ono’s expense,
as provided for herein. All such Progenics Patent Rights shall remain
owned exclusively by Progenics and all such Wyeth Collaboration Joint Patent
Rights shall remain exclusively co-owned by Progenics and Wyeth.
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7.2.2. Joint Patent Rights. The
Parties shall discuss in good faith, and thereupon, implement, in accordance
with Sections 3.3 (Joint Development Committee (JDC) and 3.2 (Joint Steering
Committee (JSC)), a mutually agreeable patent strategy with respect to all Joint
Technology that may be patentable, and shall cause their respective patent
counsel to communicate regularly regarding the prosecution and maintenance of
the Joint Patent Rights in the Territory and outside the
Territory. With respect to all Joint Technology for which the Parties
agree patent prosecution should be sought, the Parties shall cooperate in the
preparation, filing and prosecution of patent applications (including provoking,
instituting or defending interference, opposition, revocation, reexamination and
similar proceedings related to the Joint Patent Rights), and shall discuss and
agree on the content and form of relevant patent applications and any other
relevant matters before such applications are made. Each Party shall
consider in good faith any comments from the other Party regarding steps to be
taken to strengthen any Joint Patent Right. With respect to Joint
Patent Rights, Ono shall serve as the lead Party in the Territory and Progenics
shall serve as the lead Party outside the Territory to prosecute and maintain
all applications covering Joint Patent Rights (including provoking, instituting
or defending interference, opposition, revocation, reexamination and similar
proceedings related to the Joint Patent Rights) the costs of which shall be
borne by Ono in the Territory and by Progenics outside the Territory, unless
otherwise agreed by the Parties. In the event that the Parties, after
good faith discussions, cannot agree with respect to any decision to be made
regarding the prosecution and maintenance of the Joint Patent Rights (including
decisions relating to interference, opposition, revocation, reexamination and
similar proceedings related to the Joint Patent Rights), Ono shall make such
decision in the Territory and Progenics shall make such decision outside the
Territory. In all cases, each Party shall provide reasonable
assistance to the other Party, at Ono’s expense with respect to Joint Patent
Rights in the Territory and at Progenics’ expense with respect to Joint Patent
Rights outside the Territory, with respect to any activities determined by a
Party to be necessary or desirable to obtain patent protection for such Joint
Technology. In the event Ono elects not to prepare, file, prosecute
or maintain any Joint Patent Rights in the Territory, it shall give Progenics
notice to this effect, sufficiently in advance to permit Progenics to undertake
such filing, prosecution and maintenance without a loss of rights, and,
thereafter, Progenics may, upon written notice to Ono, file and
prosecute patent applications and maintain patents included in such
Patent Rights in Progenics’ name, all at Progenics’ expense, provided that
Progenics shall provide to Ono, for Ono’s review and approval, copies of all
communications sent to and received from the Japanese patent office pertaining
to the Joint Patent Rights, including, but not limited to, draft patent
applications, filing receipts, office actions, responses and/or amendments, and
notices of allowance. In the event that Progenics assumes the filing,
prosecution and maintenance of any Joint Patent Rights as provided for herein,
Ono shall, and hereby does, assign to Progenics all of Ono’s right, title and
interest in and to any such Joint Patent Rights. Further, in the
event that Progenics wishes to exploit any Joint Patent Rights outside the
Territory, but Ono does not wish to do so, then Ono shall, and hereby does,
assign to Progenics all of Ono’s right, title and interest in and to any such
Joint Patent Rights. Ono hereby acknowledges that as of the Effective Date it
has no intention of exploiting any Joint Patent Rights outside of the
Territory.
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7.2.3. Ono Collaboration
Technology. Ono shall be solely responsible for the
prosecution of the Ono Collaboration Patent Rights and the maintenance of any
patents included within the Ono Collaboration Patent Rights at Ono’s
expense. Ono shall provide to Progenics copies of all communications
sent to and received from patent offices pertaining to the prosecution of the
Ono Collaboration Patent Rights including, but not limited to, draft patent
applications, filing receipts, office actions, responses and/or amendments, and
notices of allowance. Ono shall use Commercially Reasonable Efforts
to provide timely English translations of all such communications, provided,
however, that if time does not permit timely complete translation of such
communications, Ono shall use Commercially Reasonable Efforts to provide
Progenics with a summary of such communications in English or to communicate
with Progenics’ patent counsel. Furthermore, the Parties shall cause
their patent counsel to communicate regularly in advance regarding the
prosecution of the Ono Collaboration Patent
Rights. Progenics shall be given at least fifteen (15)
business days prior to the earlier of the expiration of any shortened statutory
period for response or anticipated filing to review and comment upon the text of
any such communication. Ono also shall keep Progenics advised on the
maintenance of any patents included within the Ono Collaboration Patent Rights
and provide Progenics with a reasonable opportunity to comment on
maintenance. In the event that the Parties, after good faith
discussions, cannot agree with respect to any decision to be made with respect
to the preparation, filing, prosecution and maintenance of the Ono Collaboration
Patent Rights (including decisions relating to interference, opposition,
revocation, reexamination and similar proceedings related to the Ono
Collaboration Patent Rights), Ono shall make such decision. In no
event, however, shall Ono take any action that would cause a breach of any
Progenics Third Party Agreement or that would materially interfere with
Progenics’ worldwide intellectual property strategy regarding the Compound or
related formulations thereof. In the event Ono elects not to prepare,
file, prosecute or maintain any Ono Collaboration Patent Rights, it shall give
Progenics notice to this effect, sufficiently in advance to permit Progenics to
undertake such filing, prosecution and maintenance without a loss of rights,
and, thereafter, Progenics may, upon written notice to Ono, file and
prosecute patent applications and maintain patents included in such
Patent Rights in Progenics’ name, all at Progenics’ expense, provided that
Progenics shall provide to Ono, for Ono’s review and approval, copies of all
communications sent to and received from the Japanese office pertaining to the
Ono Collaboration Patent Rights, including, but not limited to, draft patent
applications, filing receipts, office actions, responses and/or amendments, and
notices of allowance. In the event that Progenics assumes the filing,
prosecution and maintenance of any Ono Collaboration Patent Rights as provided
for herein, Ono shall, and hereby does, assign to Progenics all of Ono’s right,
title and interest in and to any such Ono Collaboration Patent
Rights. Further, in the event that Progenics wishes to exploit any
Ono Collaboration Patent Rights outside the Territory, but Ono does not wish to
do so, then Ono shall, and hereby does, assign to Progenics all of Ono’s right,
title and interest in and to any such Ono Collaboration Patent Rights. Ono
hereby acknowledges that as of the Effective Date it has no intention of
exploiting any Ono Collaboration Patent Rights outside of the
Territory.
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7.2.4. Cooperation. Each
Party agrees to cooperate with the other with respect to the preparation,
filing, prosecution and maintenance of patents and patent applications pursuant
to this Section 7.2 (Patent Rights), including the execution of all such
documents and instruments and the performance of such acts (and causing its
relevant employees to execute such documents and instruments and to perform such
acts) as may be reasonably necessary in order to permit the other Party to
continue any preparation, filing, prosecution or maintenance of Patent Rights as
provided for in this Section 7.2 (Patent Rights).
7.2.5. Application for Patent Term
Extension.
The Parties shall cooperate in obtaining Patent Term Extensions. At
least [*] days prior to the expiration of any statutory or other regulatory time
period in the Territory for submitting an application for patent term extension
pertaining to any of the patent rights included in the Progenics Patent Rights,
Wyeth Collaboration Joint Patent Rights, Joint Patent Rights, Ono Collaboration
Patent Rights or Ono Independent Patent Rights, including applications for
interim extension and SPC in the Territory, Progenics shall submit to Ono a
draft application therefor for Ono’s review and comment. Progenics
shall also promptly provide to Ono copies of all correspondence received from
any patent office or regulatory office concerning such application for
extension, and Ono shall have at least [*] days to review and comment on all
correspondence sent to any patent office or regulatory office pertaining to such
application. Progenics shall consider in good faith any comments made
by Ono pursuant to this Section. In the event that the Parties, after
good faith discussions at the JSC, cannot agree with respect to any decision to
be made under this Section 7.2.5 (Application for Patent Term Extension)
including the patent to apply for extension, Progenics shall make such
decision.
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7.2.6. Patent
Markings. Ono and Progenics shall discuss whether the Product
shall be marked with the appropriate numbers of Patents owned solely or jointly
by the Parties.
7.2.7. Enforcement
of Patent Rights.
(a) Notice. If a Party
becomes aware of any infringement, anywhere in the world, of any issued patent
within the Progenics Patent Rights, Wyeth Collaboration Joint Patent Rights or
Joint Patent Rights, such Party will notify the other Party in writing to that
effect. Any such notice shall include any available evidence to
support an allegation of such infringement.
(b) Enforcement of Progenics Patent
Rights and Wyeth
Collaboration Joint Patent Rights in the Territory and Joint Patent
Rights. Except as otherwise provided in this Section 7.2.7(b)
(Enforcement of Progenics Patent Rights and Wyeth Collaboration Joint Patent
Rights in the Territory and Joint Patent Rights), Progenics shall, as between
Progenics and Ono, have the first right but not the obligation, at its own
expense, to take action (or cause or permit to be taken action) to obtain a
discontinuance of infringement or bring suit against a Third Party infringer in
the Territory of any Progenics Patent Rights, Wyeth Collaboration Joint Patent
Rights, or the Joint Patent Rights consistent with the intellectual property
strategy developed by the JSC in the Territory and Progenics’ intellectual
property strategy applicable to such rights, if any, outside of the
Territory. Such right shall remain in effect until ninety (90) days
after the date of notice given under Section 7.2.7(a)
(Notice). Progenics, at its own expense, may join Ono as a party
plaintiff to any action or suit resulting from Progenics’ exercise of such
rights. Ono may participate, and be represented by independent
counsel, in such litigation at its own expense. Progenics shall not
consent to the entry of any judgment or enter into any settlement with respect
to such an action or suit without the prior written consent of Ono (not to be
unreasonably withheld or delayed) if such judgment or settlement includes a
finding or agreement that any Progenics Patent Rights, Wyeth Collaboration Joint
Patent Rights, or Joint Patent Rights are invalid, unenforceable, or not
infringed, grants a Third Party license, or would enjoin or grant other
equitable relief against Ono. Progenics shall bear all the expenses
of any such action or suit brought by Progenics under this first right claiming
infringement of any Progenics Patent Rights, Wyeth Collaboration Joint Patent
Rights, or Joint Patent Rights. If, after the expiration of the
ninety (90) day period, Progenics has not obtained a discontinuance of the
infringement of the Progenics Patent Rights, Wyeth Collaboration Joint Patent
Rights, or the Joint Patent Rights or filed suit against any such Third Party
infringer of the Progenics Patent Rights, Wyeth Collaboration Joint Patent
Rights, or the Joint Patent Rights, or provided Ono with information and
arguments demonstrating to Ono’s reasonable satisfaction that there is
insufficient basis for the allegation of such infringement of the Progenics
Patent Rights,
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Wyeth
Collaboration Joint Patent Rights, or the Joint Patent Rights, then Ono shall
have the second right, but not the obligation, at its own expense, to instruct
Progenics to bring suit against such Third Party infringer (i) in the Territory
of the Progenics Patent Rights, Wyeth Collaboration Joint Patent Rights, or the
Joint Patent Rights or (ii) outside of the Territory of Joint Patent
Rights. Progenics may join Ono as a party plaintiff to any action or
suit resulting from Ono’s exercise of such rights. Progenics shall not consent
to the entry of any judgment or enter into any settlement with respect to such
an action or suit without the prior written consent of Ono (not to be
unreasonably withheld or delayed) if such judgment or settlement includes a
finding or agreement that any Progenics Patent Rights, Wyeth Collaboration Joint
Patent Rights, or Joint Patent Rights are invalid, unenforceable, or not
infringed, grants a Third Party license, or would enjoin or grant other
equitable relief against Ono. Ono shall bear all the expenses of any
such action or suit brought by Progenics, including the expenses of Progenics,
under this second right claiming infringement of any Progenics Patent Rights,
Wyeth Collaboration Joint Patent Rights, or Joint Patent Rights. Each Party
shall cooperate with the other Party (including by executing any documents
required to enable Progenics to initiate such litigation) in any action or suit
for infringement of any Progenics Patent Rights, Wyeth Collaboration Joint
Patent Rights, or Joint Patent Rights brought by Progenics against a Third Party
in accordance with this Section 7.2.7(b) (Enforcement of Progenics Patent Rights
and Wyeth Collaboration Joint Patent Rights in the Territory and Joint Patent
Rights) and shall have the right to consult with the other. Neither
Party shall incur any liability directly to the other Party as a consequence of
such action or suit or any unfavorable decision resulting therefrom, including
any decision holding any Patent Right invalid or
unenforceable. However, the Party exercising the right to bring an
action or suit shall indemnify and hold the other Party harmless from any
liability to a Third Party as a consequence of such action or suit or any
unfavorable decision resulting therefrom. Any recovery obtained by
either Party as a result of any such action or suit against a Third Party
infringer shall be allocated as follows:
(i) [*];
and
(ii) [*].
(c) Enforcement of Ono Collaboration
Patent Rights. Except as otherwise provided in this Section
7.2.7(c) (Enforcement of Ono Collaboration Patent Rights), Ono in the Territory
and Progenics outside the Territory (the “Action Party”) shall
have the first right but not the obligation, at its own expense, to take action
(or cause or permit to be taken action) to obtain a discontinuance of
infringement or bring suit against a Third Party infringer of any Ono
Collaboration Patent Rights. Such right shall remain in effect until
ninety (90) days after the date of notice given under Section 7.2.7(a)
(Notice).
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The
Action Party may join the other Party as a party plaintiff to any action or suit
resulting from the Action Party’s exercise of such rights. The Action
Party shall not consent to the entry of any judgment or enter into any
settlement with respect to such an action or suit without the prior written
consent of the other Party (not to be unreasonably withheld or delayed) if such
judgment or settlement includes a finding or agreement that any Ono
Collaboration Patent Rights is invalid, unenforceable, or not infringed, grants
a Third Party license, or would enjoin or grant other equitable relief against
the other Party. The Action Party shall bear all the expenses of any
such action or suit brought by the Action Party claiming infringement of any Ono
Collaboration Patent Rights. If, after the expiration of the ninety
(90) day period, the Action Party has not obtained a discontinuance of the
infringement of Ono Collaboration Patent Rights or filed suit against any such
Third Party infringer of Ono Collaboration Patent Rights, or provided the other
Party with information and arguments demonstrating to the other Party’s
reasonable satisfaction that there is insufficient basis for the allegation of
such infringement of Ono Collaboration Patent Rights, then the other Party shall
have the right, but not the obligation, to bring an action or suit against such
Third Party infringer of Ono Collaboration Patent Rights. The other
Party may join the Action Party as a party plaintiff to such action or suit
resulting from the other Party’s exercise of such rights. The other
Party shall not consent to the entry of any judgment or enter into any
settlement with respect to such an action or suit without the prior written
consent of the Action Party (which consent shall not unreasonably be withheld)
if such judgment or settlement materially impacts any of the Action Party’s
rights under this Agreement or would enjoin or grant other equitable relief
against the Action Party. Each Party shall cooperate (including by
executing any documents required to enable the other Party to initiate such
litigation) with the other Party in any action or suit for infringement of any
Ono Collaboration Patent Right brought by the other Party against a Third Party
in accordance with this Section 7.2.7(c) (Enforcement of Ono Collaboration
Patent Rights) and shall have the right to consult with the other Party and to
participate in and be represented by independent counsel in such litigation at
its own expense. Neither Party shall incur any liability directly to
the other Party as a consequence of such litigation or any unfavorable decision
resulting therefrom, including any decision holding any Ono Collaboration Patent
Right invalid or unenforceable. However, the Party exercising the
right to bring an action or suit shall indemnify and hold the other Party
harmless from any liability to a Third Party as a consequence of such action or
suit or any unfavorable decision resulting therefrom. Any recovery
obtained by either Party as a result of any such proceeding against a Third
Party infringer shall be allocated as follows:
(i) [*];
and
(ii) [*].
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(d) Ono shall
continue to pay Progenics all royalties and any other payments due under this
Agreement during the pendency of any suit brought pursuant to this Section 7.2.7
(Enforcement of Patent Rights).
7.2.8. Infringement
and Third Party Licenses.
(a) Infringement of Third Party Patents -
Course of Action. If the performance of the Licensed
Activities by Ono or any of its Affiliates is alleged by a Third Party to
infringe a Third Party’s patent or other intellectual property right, the Party
becoming aware of such allegation shall promptly notify the other
Party. Additionally, if either Party determines that, based upon the
review of a Third Party’s patent or patent application or other intellectual
property rights, it may be desirable to obtain a license from such Third Party
with respect thereto so as to avoid any potential suit between either Party and
such Third Party, such Party shall promptly notify the other Party and the JSC
of such determination and initiate discussions to determine whether such license
is desirable.
(b) Ono Option to
Negotiate. Subject to Section 7.2.8(c) (Third Party
Infringement Suit) and Section 6.4.3 (Third Party Agreements), in the event that
Ono determines that, in order for Ono or its Affiliates to engage in the
Licensed Activities, it is necessary or desirable for Ono or its Affiliate to
obtain a license under one or more patents or patent applications or other
intellectual property rights owned or controlled by a Third Party (collectively,
“Third Party IP
Rights”), Ono shall have the first right, but not the obligation, to
negotiate and enter into an agreement with such Third Party, whereby Ono is
granted a license under such Third Party IP Rights permitting Ono and its
Affiliates to practice such Third Party IP Rights in connection with the
Licensed Activities and the performance of any of its obligations or the
exercise of any of its rights under this Agreement; provided, however, that in no
event shall Ono enter into such agreement without Progenics’ prior written
consent, which consent shall not be unreasonably withheld.
(c) Third Party Infringement
Suit. If a Third Party sues Ono or any of Ono’s Affiliates
(each Person so sued being referred to herein as a “Sued Party”),
alleging that the Licensed Activities of Ono or any of Ono’s Affiliates during
the Term of and pursuant to this Agreement infringe or will infringe such Third
Party’s patent, then, upon Ono’s request and in connection with the Sued Party’s
defense of any such Third Party infringement suit, Progenics shall provide
reasonable assistance to the Sued Party for such defense.
7.2.9. Compliance. Subject
to the specific provisions of this Agreement, Ono shall be responsible for, and
use Commercially Reasonable Efforts to make, all filings required by any
Regulatory Authority in the Territory.
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7.3. Trademarks. Ono
shall, subject to the review of the JSC as set forth in Section 3.2.3 (Specific
Responsibilities of the JSC), select and own all Product-related trademarks
(other than the RELISTOR trademark which is the subject of the next sentence),
trade dress, copyrights and names to be used in connection with the marketing,
promotion and sale of any Product in the Territory under this
Agreement. Subject to the assignment by Wyeth to Progenics of the
RELISTOR trademark in the Territory, Progenics shall license to Ono any rights
that Progenics may have to the RELISTOR trademark in the
Territory. The royalty for such license shall be included in the
royalties payable to Progenics pursuant to Section 6.4 (Royalty
Payments).
8.
|
CONFIDENTIALITY.
|
8.1. Confidentiality. Except
to the extent expressly authorized by this Agreement or otherwise agreed in
writing, the Parties agree that, for the Term and for five (5) years thereafter,
each Party (the “Receiving Party”)
receiving any Confidential Information of the other Party (the “Disclosing Party”)
under this Agreement shall keep such Confidential Information confidential and
shall not publish or otherwise disclose or use such Confidential Information for
any purpose other than as provided for in this Agreement, except for
Confidential Information that the Receiving Party can establish:
(a) was
already known by the Receiving Party (other than under an obligation of
confidentiality) at the time of disclosure by the Disclosing Party and the
Receiving Party has documentary evidence to that effect;
(b) was
generally available to the public or otherwise part of the public domain at the
time of its disclosure to the Receiving Party;
(c) became
generally available to the public or otherwise part of the public domain after
its disclosure or development, as the case may be, other than through any act or
omission of the Receiving Party or any of its Affiliates;
(d) was
disclosed to the Receiving Party, other than under an obligation of
confidentiality, by a Third Party who had no obligation to the Disclosing Party
not to disclose such information to the Receiving Party; or
(e) was
independently discovered or developed by or on behalf of the Receiving Party
without the use of any Confidential Information belonging to the Disclosing
Party and the Receiving Party has documentary evidence to that
effect.
8.2. Authorized
Disclosure.
8.2.1. Disclosure. Notwithstanding
the provisions of Section 8.1 (Confidentiality), each Party may disclose
Confidential Information belonging to the other Party to the extent such
disclosure is reasonably necessary to:
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(a) file or
prosecute patent applications as contemplated by this Agreement,
(b) prosecute
or defend litigation,
(c) exercise
its rights under this Agreement, including conducting clinical trial, provided
such disclosure is covered by terms of confidentiality similar to those set
forth herein, and
(d) comply
with applicable governmental laws and regulations.
8.2.2. Notice of
Disclosure. In the event a Party shall deem it reasonably
necessary to disclose Confidential Information belonging to the other Party
pursuant to this Section 8.2 (Authorized Disclosure), the Disclosing Party shall
to the extent possible give reasonable advance written notice of such disclosure
to the other Party and take reasonable measures to ensure confidential treatment
of such Confidential Information.
8.3. SEC Filings and Other
Disclosures. Either Party may disclose the terms of this
Agreement (a) to the extent required, in the reasonable opinion of such Party’s
legal counsel, to comply with applicable laws, including, without limitation,
the rules and regulations promulgated by the United States Securities and
Exchange Commission, any Regulatory Authority in Japan or any stock exchange,
and (b) in connection with a prospective acquisition, merger or financing of
such Party, to prospective acquirers or merger candidates or to existing or
potential investors, provided that prior to such disclosure each such
prospective acquirer, candidate or investor shall agree in writing to be bound
by obligations of confidentiality and non-use no less restrictive in scope than
those set forth in this Section 8 (Confidentiality). Notwithstanding
the foregoing, before disclosing this Agreement or any of the terms hereof
pursuant to clause (a) above, the Parties will consult with one another on the
terms of this Agreement to be redacted in making any such
disclosure. If a Party discloses this Agreement or any of the terms
hereof in accordance with clause (a) above, such Party agrees, at its own
expense, to seek such confidential treatment of portions of this Agreement or
such terms, as may be reasonably requested by the other Party.
8.4. Public
Announcements; Publications.
8.4.1. Coordination. The
Parties agree on the importance of coordinating their public announcements
respecting this Agreement and the subject matter hereof (other than academic,
scientific or medical publications that are subject to the publication provision
set forth below). Progenics and Ono shall, from time to time, and at
the request of the other Party, discuss and agree on the general information
content relating to this Agreement (including relating to the Development and/or
Commercialization of the Product) which may be publicly disclosed (including by
means of any printed publication or oral presentation).
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8.4.2. Press Release. The
Parties may simultaneously release their agreed-upon announcements regarding the
signing of this Agreement.
8.4.3. Publications. During
the Term, Ono will submit to Progenics for prior review and approval all
proposed academic, scientific and medical publications and public presentations
relating to the Development and/or Commercialization of any Product, for review
in connection with preservation of Progenics Patent Rights, Wyeth Collaboration
Joint Patent Rights, Wyeth Collaboration Patent Rights, Joint Patent Rights, Ono
Collaboration Patent Rights and/or to determine whether any of such other
Party’s Confidential Information should be modified or
deleted. Written copies of such proposed publications and
presentations shall be submitted, in English, to Progenics no later than [*]
days before submission for publication or presentation and Progenics shall
provide its comments with respect to such publications and presentations within
[*] days of its receipt of such written copy. The review period may
be extended for an additional [*] days in the event Progenics can demonstrate
reasonable need for such extension, including, but not limited to, the
preparation and filing of patent applications. By mutual agreement,
this period may be further extended. Ono and Progenics will each
comply with standard academic practice regarding authorship of scientific
publications and recognition of contribution of other persons in any
publications relating to the Development and/or Commercialization of any
Product. During the Term, each Party shall provide to the other Party for its
information any academic, scientific and medical publications relating to the
Compound or any product containing the Compound of which such Party is
aware.
9.
|
REPRESENTATIONS
AND WARRANTIES.
|
9.1. Representations and Warranties of
Each Party. Each of Progenics and Ono hereby represents,
warrants, and covenants to the other Party as follows:
(a) it is a
corporation duly organized and validly existing under the laws of the state or
country of its incorporation;
(b) the
execution, delivery and performance of this Agreement by such Party has been
duly authorized by all requisite corporate action and does not require any
shareholder action or approval;
(c) it has
the power and authority to execute and deliver this Agreement and to perform its
obligations under this Agreement;
(d) the
execution, delivery and performance by such Party of this Agreement and its
compliance with the terms and provisions hereof do not and will not conflict
with or result in a breach of any of the terms and provisions of or constitute a
default under (i) a loan agreement, guaranty, financing agreement, agreement
relating to one or more Patent Rights or other agreement or instrument binding
or affecting it or its property; (ii) the provisions of its charter or operative
documents or bylaws; or (iii) any law, regulation, order, writ, injunction or
decree of any court or governmental authority entered against it or by which any
of its property is bound; and
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(e) it shall
at all times comply with all material laws and regulations applicable to its
activities under this Agreement.
9.2. Additional Representations and
Warranties of Progenics. In addition to the
representations and warranties made by Progenics elsewhere in this Agreement,
Progenics, hereby represents, warrants and covenants to Ono that:
(a) Schedule 9.2(A)
identifies all Progenics Patent Rights owned by Progenics in the Territory (the
“Owned Progenics
Patent Rights”), and Schedule 9.2(B)
identifies all Progenics Patent Rights which Progenics licenses from Third
Parties in the Territory (the “Licensed Progenics Patent
Rights”), in each case along with the following information with respect
to each identified Patent Right, as applicable: (i) country, (ii) title, (iii)
application number, (iv) application filing date, (v) patent number, (vi) patent
issue date, (vii) listed inventor(s), and (viii) current owner. Schedule 9.2(C)
identifies each Progenics Third Party Agreement that provides for Patent Rights
or Know-How necessary for the Development and Commercialization of the Compound
and Products in the Territory. The Owned Progenics Patents Rights and
the Licensed Progenics Patent Rights identified on Schedules 9.2 (A) and
(B)) constitute
all of the Progenics Patent Rights as of the Effective Date.
(b) To its
knowledge and except as described in Schedule 9.2(D),
Progenics exclusively owns all rights, title, and interest in the Owned
Progenics Patent Rights and owns or Controls the Progenics Know-How existing as
of the Effective Date in the Territory free and clear of any licenses, or other
claim of right or ownership by any Third Party. Neither any license
granted by Progenics to any Third Party, nor any license granted by any Third
Party to Progenics, conflicts with the license grants to Ono under this
Agreement.
(c) Progenics
has and will have the full right, power and authority to grant the licenses
granted or to be granted to Ono under this Agreement.
(d) There are
no Progenics Third Party Agreements that provide for Patent Rights or Know-How
necessary to engage in the Licensed Activities other than the agreements
identified in Schedule
9.2(C). As of the Effective Date, no Third Party has any
right, title or interest in or to, or any license under, any of the Progenics
Patent Rights in the Territory other than as provided in Progenics Third Party
Agreements or the Wyeth Agreement.
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(e) To the
extent that any of the Progenics Patent Rights arose from work funded in whole
or in part by United States federal funding, to Progenics’ knowledge all
requirements necessary to (i) vest the entire right, title and interest in
Progenics or Progenics’ licensor of such Progenics Patent Rights, and (ii) grant
the licenses to Progenics under Patent Rights licensed to Progenics, have been
satisfied.
(f) To
Progenics’ knowledge, as of the Effective Date and except for the Patent Rights
that Progenics has previously disclosed to Ono in writing, the Development and
Commercialization by Ono of the Initial Formulation and the Product do not
infringe any issued patent owned or possessed by any Third Party in the
Territory. As of the Effective Date, there are no outstanding orders,
judgments or settlements against or owed by Progenics relating to the Progenics
Technology that would adversely affect Ono’s ability to engage in the Licensed
Activities, and there is no pending or, to the best of its knowledge,
threatened, claims or litigation, relating to the Progenics Technology that
would adversely affect Ono’s ability to engage in the Licensed
Activities.
(g) As of the
Effective Date, the Progenics Third Party Agreements that provide for Patent
Rights or Know-How necessary for the Development and Commercialization of the
Compound and Products in the Territory are in full force and effect, and
Progenics is in compliance in all material respects with such Progenics Third
Party Agreements. To Progenics’ knowledge, no event or omission has occurred,
and no circumstances exist, which, with or without the giving of notice and/or
the passage of time, would permit the counterparty to terminate any such
Progenics Third Party Agreement.
(h) During
the Term (i) Progenics will use Commercially Reasonable Efforts not to take or
omit to take any actions the taking or omission of which would breach any
Progenics Third Party Agreement, or other agreements between Progenics and Third
Parties, that provide for Patent Rights or Know-How necessary for the
Development and Commercialization of the Compound and Products in the Territory,
and (ii) Progenics will, subject to any obligations of confidentiality, provide
Ono promptly with notice of any allegation that Progenics has breached any such
agreement. During the Term, Progenics will not enter into any
agreement with any Third Party adversely affecting the rights granted to Ono
under this Agreement.
9.3. Additional Representation and
Warranty of Ono. In addition to the representations and
warranties made by Ono elsewhere in this Agreement, Ono, hereby represents,
warrants and covenants to Progenics that, as of the Effective Date, Ono has no
product or compound in pre-clinical or clinical development that would be
competitive with, or is intended to treat similar indications to those of, any
Product.
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9.4. Representation by Legal
Counsel. Each Party hereto represents that it has had the
opportunity to consult with counsel in connection with the review, drafting and
negotiation of this Agreement. Accordingly, the rule of construction
that any ambiguity in this Agreement shall be construed against the drafting
Party shall not apply. In interpreting and applying the terms and
provisions of this Agreement, the Parties agree that no presumption shall exist
or be implied against the Party which drafted such terms and
provisions.
9.5. No Inconsistent
Agreements. Neither Party has in effect, and after the
Effective Date neither Party shall enter into, any oral or written agreement or
arrangement that is or would be inconsistent with its obligations under this
Agreement.
10.
|
TERM
AND TERMINATION
|
10.1. Term. The term of
this Agreement (the “Term”) will commence
on the Effective Date and extend on a Product-by-Product basis, unless this
Agreement is terminated earlier in accordance with this Section 10 (Term and
Termination), until the last to expire of the applicable [*] Royalty Period or
[*] Royalty Period for any Product in the Territory.
10.2. Termination
by Progenics.
10.2.1. General. Progenics
may terminate this Agreement at any time by giving written notice to Ono in the
event that Ono commits a material breach of its representations, warranties,
covenants or obligations, including [*] as provided for in Section 4.3 ([*]
Development Activities), under this Agreement and such material breach remains
uncured for ninety (90) days (or thirty (30) days for a breach of a payment
obligation) measured from the date written notice of such material breach is
given to Ono; provided,
however, that if any breach other than non-payment is curable, but not
reasonably curable within ninety (90) days, and so long as Ono is using
Commercially Reasonable Efforts to cure such breach, such termination shall be
delayed for a reasonable period of time in order to permit Ono reasonable time
to cure such breach.
10.2.2. Payment
Breaches. Without limitation, failure by Ono to pay any amount
in excess of [*] within the cure period specified in this Section 10.2
(Termination by Progenics) shall constitute a material breach of this
Agreement. If the alleged material breach relates to non-payment of
an amount that is subject to a bona fide good faith dispute between the Parties
as to whether such payment is due, the thirty (30) day cure period shall be
tolled pending resolution of such dispute; provided, however, that if
such amount is part of a larger payment due, only the cure period for the amount
in dispute shall be tolled.
10.3. Termination
by Ono.
10.3.1. Termination by Ono Because of Serious
Safety, Efficacy or Commercial Reasons. If one or more safety, efficacy
or commercial issues arise with respect to a Product which are sufficiently
serious that Ono would cease Development or Commercialization of the Product if
the Product were a product or proposed product owned solely by it, or to which
it had exclusive rights, that were of similar commercial potential and at a
similar stage in its development or product life, Ono shall promptly inform
Progenics of such safety, efficacy or commercial issues(s) and convene a meeting
of the JDC or, as appropriate, JCC to discuss such safety, efficacy or
commercial issues and their implications for Development and Commercialization
of the Product. If the JDC or JCC is unable to agree on a plan to
continue Development and Commercialization of the Product, then the matter will
be referred to the JSC for discussion. If the JSC is unable to agree
on a plan to continue Development and Commercialization of the Product, [*] will
discuss whether there is any viable alternative to ceasing Development and
Commercialization and decide how to resolve any dispute or controversy between
the Parties relating to this matter.
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10.3.2. Termination by Ono for
Cause. Ono may terminate this Agreement in its entirety for
cause at any time by giving written notice to Progenics in the event that
Progenics commits a material breach of its representations, warranties,
covenants or obligations under this Agreement and such material breach remains
uncured for ninety (90) days measured from the date written notice of such
material breach is given to Progenics; provided, however, that if
any breach other than non-payment is curable, but not reasonably curable within
ninety (90) days, and so long as Progenics is using Commercially Reasonable
Efforts to cure such breach, such termination shall be delayed for a reasonable
period of time in order to permit Progenics reasonable time to cure such
breach.
10.4. Effects
of Expiration or Termination.
10.4.1. Upon Termination by
Progenics. On termination of this Agreement by Progenics
pursuant to Section 10.2 (Termination by Progenics), the following shall
occur:
(a) Ono
shall, within [*] days of the effective date of the termination, at its own
cost, transfer to Progenics copies of all data, reports, records and materials
in the possession or control of Ono or its Affiliates that relate to any Product
or the Compound and return to Progenics, or destroy at Progenics’ request, all
relevant records and materials in Ono’s or its Affiliates’ possession or control
containing Confidential Information of Progenics;
(b) Ono shall
assign to Progenics ownership and control of all Registrational Filings and
Regulatory Approvals made or filed or obtained for any Product and the Compound
and all clinical, technical and other relevant reports and data relating to any
Product and the Compound, each to the extent they are owned, Controlled or held
in the name of Ono or its Affiliates;
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(c) All
licenses granted by Progenics to Ono and its Affiliates with respect to any
Product and the Compound shall immediately terminate;
(d) Ono shall
assign to Progenics for no additional consideration, within [*] days of the
effective date of the termination, the trademarks relating solely to any Product
or the Compound owned by Ono and its Affiliates, and be responsible for the
costs of recording trademark assignments in the Territory;
(e) The
Parties shall negotiate in good faith a supply agreement for all Products on
commercially reasonable terms to ensure that Progenics shall have for a period
of [*] years a continuous supply of the Product in finished form ready for sale
and, in addition, to the extent permitted under the terms of such agreements,
Ono shall use Commercially Reasonable Efforts to assign to Progenics, at
Progenics’ request, any of Ono’s rights under any agreements for the supply or
manufacture of the Product or packaging or the supply of API of the Compound
and, furthermore, at Progenics’ request, Ono shall sell to Progenics any of the
inventory (including manufactured Product, packaging materials, promotional
materials and any other Commercial items) held by Ono or its Affiliates at a
price equal to their cost, and, in any case, Ono shall assign, license or
sublicense to Progenics or its designee at no cost all documentation and
technology in Ono’s Control necessary to enable Progenics or its designee to
manufacture the Product;
(f) To the
extent permitted by applicable law, Progenics shall have the right to continue
to use, in accordance with applicable law, supplies of materials carrying the
name or trademark of Ono or its Affiliates until those supplies have been
depleted;
(g) Ono shall
grant Progenics a fully paid-up, perpetual, irrevocable, royalty-free,
non-exclusive license (with the right to grant sublicenses) in the Field under
the Ono Collaboration Patent Rights, Ono Collaboration Know-How and Ono’s
interest in the Joint Technology to make, have made, use, Develop, sell, offer
to sell, have sold, import, export and otherwise exploit and Commercialize the
Compound and any Product in the Territory, and Ono shall not assert any Ono
Independent Patent Right against Progenics, its Affiliates or its sublicensees
relating to the Development, Commercialization or other exploitation of any
Product;
(h) In the
event Ono fails to effect any assignment or license required under this Section
10.4.1 (Upon Termination by Progenics) within a reasonable period, Ono hereby
appoints Progenics as its attorney-in-fact for such purpose; and
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(i) Ono shall
pay to Progenics damages for Ono’s breach of this Agreement as provided by
law.
10.4.2. Upon Termination by Ono for Serious
Safety, Efficacy or Commercial Reasons. On termination of this
Agreement by Ono pursuant to Section 10.3.1 (Termination by Ono Because of
Serious Safety, Efficacy or Commercial Reasons), the following shall
occur:
(a) Ono
shall, within [*] days of the effective date of the termination, at its own
cost, transfer to Progenics copies of all data, reports, records and materials
in the possession or control of Ono or its Affiliates that relate to any Product
and the Compound and return to Progenics, or destroy at Progenics’ request, all
relevant records and materials in the possession or control of Ono and its
Affiliates containing Confidential Information of Progenics;
(b) Ono shall
assign to Progenics ownership and control of all Registrational Filings and
Regulatory Approvals made or filed or obtained for any Product and the Compound
and all clinical, technical and other relevant reports and data relating to the
Product and the Compound, each to the extent they are owned, Controlled or held
in the name of Ono or its Affiliates;
(c) All
licenses granted by Progenics to Ono and its Affiliates with respect to any
Product and the Compound shall immediately terminate;
(d) Ono shall
assign to Progenics for no additional consideration, within [*] days of the
effective date of the termination, the trademarks relating solely to the Product
owned by Ono and its Affiliates. Progenics shall be responsible for the costs of
recording trademark assignments in individual countries;
(e) The
Parties shall negotiate in good faith a supply agreement for all Products on
commercially reasonable terms to ensure that Progenics shall have for a period
of [*] years a continuous supply of the Product in finished form ready for sale
and, in addition, to the extent permitted under the terms of such agreements,
Ono shall use Commercially Reasonable Efforts to assign to Progenics, at
Progenics’ request, any of Ono’s rights under any agreements for the supply or
manufacture of the Product or packaging or the supply of API of the Compound
and, furthermore, at Progenics’ request, Ono shall sell to Progenics any of the
inventory (including manufactured Product, packaging materials, promotional
materials and any other Commercial items) held by Ono or its Affiliates at a
price equal to their cost, and, in any case, Ono shall assign, license or
sublicense to Progenics or its designee at no cost all documentation and
technology in Ono’s Control necessary to enable Progenics or its designee to
manufacture the Product;
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(f) To the
extent permitted by applicable law, Progenics shall have the right to continue
to use, in accordance with applicable law, supplies of materials carrying the
name or trademark of Ono or its Affiliates until those supplies have been
depleted;
(g) Ono shall
grant Progenics a fully paid-up, perpetual, irrevocable, royalty-free,
non-exclusive license (with the right to grant sublicenses) in the Field under
the Ono Collaboration Patent Rights, Ono Collaboration Know-How and Ono’s
interest in the Joint Technology to make, have made, use, Develop, sell, offer
to sell, have sold, import, export and otherwise exploit and Commercialize the
Compound and any Product in the Territory, and Ono shall not assert any Ono
Independent Patent Right against Progenics, its Affiliates or its sublicensees
relating to the Development, Commercialization or other exploitation of the
Product; and
(h) In the
event Ono fails to effect any assignment or license required under this Section
10.4.2 (Upon Termination by Ono for Serious Safety, Efficacy or Commercial
Reasons) within a reasonable period, Ono hereby appoints Progenics as its
attorney-in-fact for such purpose.
10.4.3. Effect of Termination by Ono for
Cause. If Ono terminates this Agreement pursuant to Section
10.3.2 (Termination by Ono for Cause) all licenses granted by Progenics to Ono
under this Agreement shall survive such termination and become a fully paid-up,
perpetual, exclusive license under the Progenics Technology, Progenics’ interest
in the Joint Technology, Progenics’ interest in the Wyeth Collaboration Joint
Patent Rights and Progenics’ interest in the Wyeth Collaboration Joint Know-How,
and a nonexclusive license under the Wyeth Collaboration Patent Rights, Wyeth
Collaboration Know-How and Wyeth’s interest in the Wyeth Collaboration Joint
Patent Rights and Wyeth Collaboration Joint-Know-How. Notwithstanding
the foregoing, Ono’s non-exclusive license under the Wyeth Collaboration Patent
Rights, Wyeth Collaboration Know-How and Wyeth’s interest in the Wyeth
Collaboration Joint Patent Rights and Wyeth Collaboration Joint Know-How shall
at all times remain subject to the Wyeth Agreement and the Partial Termination
Agreement. In addition, in such event, Progenics shall, and shall
cause its Affiliates to, assign and delegate to Ono or its designated Affiliate,
and Ono or its designated Affiliate shall assume from Progenics, all of
Progenics’ rights and obligations under the Progenics Third Party
Agreements.
10.4.4. Effect of
Expiration. If this Agreement terminates because its Term has
expired under Section 10.1 (Term), Section 2.7 (Fully Paid-up, Royalty-Free
License) shall apply.
10.4.5. Accrued
Rights. Expiration or termination of this Agreement for any
reason shall be without prejudice to any right which shall have accrued to the
benefit of either Party prior to such termination, including, without
limitation, damages arising from any breach under this Agreement or the
obligation to make Development Milestone Payments, Commercialization Payments,
Royalty Payments or any other payments required under this Agreement as to
events or sales of Product occurring prior to the effective date of any
expiration or termination of this Agreement. Expiration or
termination of this Agreement shall not relieve either Party from any obligation
which is expressly indicated to survive such expiration or
termination.
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10.4.6. Survival. The
following Sections of this Agreement shall survive expiration or termination of
this Agreement for any reason: 1 (Definitions), 6.5.8
(Confidentiality), 7.1 (Ownership of Intellectual Property), 8 (Confidentiality)
excluding Section 8.4, 10.5 (Provision for Insolvency) and 11 (Indemnification
and Insurance). The following Sections of this Agreement shall
survive for the period specified or intended in such Sections: 2 (License Grants
and Related Matters), 6.5.5 (Record Keeping), 6.5.6 (Audits), 6.5.7
(Underpayments/Overpayments), 7.3 (Trademarks), 10.4 (Effects of Expiration or
Termination), 12 (Regulatory Matters; Product Safety Issues; Product Recalls),
and 13 (Miscellaneous).
10.5. Provision
for Insolvency.
10.5.1. Termination. This
Agreement may be terminated by written notice by either Party (the “Non-Debtor Party”) at
any time during the Term (a) upon the declaration by a court of competent
jurisdiction that the other Party (the “Debtor Party”) is
bankrupt and the Debtor Party’s assets are to be liquidated, (b) upon the filing
or institution of bankruptcy, liquidation or receivership proceedings (other
than reorganization proceedings under Chapter 11 of the United States Bankruptcy
Code) with respect to the Debtor Party, (c) upon an assignment of a substantial
portion of the assets for the benefit of creditors by the Debtor Party, (d) in
the event a receiver or custodian is appointed for the Debtor Party’s business,
or (e) if a substantial portion of the Debtor Party’s business is subject to
attachment or similar process; provided, however, that in
the case of any involuntary bankruptcy proceeding such right to terminate shall
become effective only if the proceeding is not dismissed within sixty (60) days
after the filing thereof. To the extent permitted by applicable law,
the effect of a termination under this Section 10.5.1 (Termination) shall be as
described in Section 10.4.1 (Upon Termination By Progenics) in case of the
Debtor Party is Ono, and in Section 10.4.3 (Effect of Termination by Ono for
Cause) in the event the Debtor Party is Progenics.
10.5.2. Effect on
Licenses. All rights and licenses granted under or pursuant to
this Agreement are licenses of rights to “intellectual property” as defined in
Section 365(n) of Title 11 of the United States Code (“Title
11”). Each Party agrees that the other Party, as licensee of
such rights under this Agreement shall retain and may fully exercise all of its
rights and elections under Title 11. Each Party agrees during the
Term, to create and maintain current copies or, if not amenable to copying,
detailed descriptions or other appropriate embodiments, to the extent feasible,
of all such intellectual property. If a case is commenced by or
against the Debtor Party under Title 11, the Debtor Party (in any capacity,
including debtor-in-possession) and its successors and assigns (including,
without limitation, a Title 11 trustee) shall:
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(a) as the
Non-Debtor Party may elect in a written request, immediately upon such
request:
(i) perform
all of the obligations provided in this Agreement to be performed by the Debtor
Party including, where applicable and without limitation, providing to the
Non-Debtor Party portions of such intellectual property (including embodiments
thereof) held by the Debtor Party and such successors and assigns or otherwise
available to them; or
(ii) provide
to the Non-Debtor Party all such intellectual property (including all
embodiments thereof) held by the Debtor Party and such successors and assigns or
otherwise available to them; and
(b) not
interfere with the rights of the Non-Debtor Party under this Agreement, or any
agreement supplemental hereto, to such intellectual property (including such
embodiments), including any right to obtain such intellectual property (or such
embodiments) from another entity, to the extent provided in Section 365(n) of
Title 11.
10.5.3. Rights to Intellectual
Property. If (a) a Title 11 case is commenced by or against
the Debtor Party, (b) this Agreement is rejected as provided in Title 11, and
(c) the Non-Debtor Party elects to retain its rights under this Agreement as
provided in Title 11, then the Debtor Party (in any capacity, including
debtor-in-possession) and its successors and assigns (including, without
limitation, a Title 11 trustee) shall provide to the Non-Debtor Party all such
intellectual property (including all embodiments thereof) held by the Debtor
Party and such successors and assigns, or otherwise available to them,
immediately upon the Non-Debtor Party’s written request. Whenever the
Debtor Party or any of its successors or assigns provides to the Non-Debtor
Party any of the intellectual property licensed under this Agreement (or any
embodiment thereof) pursuant to this Section 10.5 (Provision for Insolvency),
the Non-Debtor Party shall have the right to perform the obligations of the
Debtor Party under this Agreement with respect to such intellectual property,
but neither such provision nor such performance by the Non-Debtor Party shall
release the Debtor Party from any such obligation or liability for failing to
perform it. The Parties hereto acknowledge and agree that the
Development Milestone Payments to be paid under Section 6.2 (Development
Milestone Payments) (and any other payment by Ono to Progenics under this
Agreement other than the royalties to be paid under Section 6.4 (Royalty
Payments) and Commercialization Payments to be paid under Section 6.3
(Commercialization Milestone Payments)) do not constitute “royalties” within the
meaning of Title 11 or relate to licenses of intellectual property under this
Agreement.
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10.5.4. Additional
Rights. All rights, powers and remedies of the Non-Debtor
Party provided herein are in addition to and not in substitution for any and all
other rights, powers and remedies now or hereafter existing at law or in equity
(including, without limitation, Title 11) in the event of the commencement of a
Title 11 case by or against the Debtor Party. The Non-Debtor Party,
in addition to the rights, power and remedies expressly provided herein, shall
be entitled to exercise all other such rights and powers and resort to all other
such remedies as may now or hereafter exist at law or in equity (including,
without limitation, Title 11) in such event. The Parties agree that
they intend the foregoing rights to extend to the maximum extent permitted by
law, including, without limitation, for purposes of Title 11:
(a) the right
of access to any intellectual property (including all embodiments thereof) of
the Debtor Party, or any Third Party with whom the Debtor Party contracts to
perform an obligation of the Debtor Party under this Agreement, and, in the case
of the Third Party, which is necessary for the research, Development,
manufacture and Commercialization of the Product in the Territory;
and
(b) the right
to contract directly with any Third Party to complete the contracted
work.
11.
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INDEMNIFICATION
AND INSURANCE.
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11.1. Indemnification by
Ono. Ono will indemnify, defend and hold harmless Progenics,
each of its Affiliates, and each of its and its Affiliates’ employees, officers,
directors and agents (each, a “Progenics Indemnified
Party”) from and against any and all liability, loss, damage, expense
(including reasonable attorneys’ fees and expenses) and cost (collectively, a
“Liability”)
that the Progenics Indemnified Party may be required to pay to one or more Third
Parties resulting from or arising out of: (a) any intentional misconduct or
gross negligence on the part of Ono or its Affiliates in performing any activity
contemplated by this Agreement; (b) personal injury or death of any person as a
result of use of any Product containing the Compound supplied or sold by Ono or
its Affiliates in the Territory; or (c) the material breach by Ono of any of its
representations, warranties or covenants set forth in this Agreement; except, in
each case ((a), (b), and (c)), to the extent caused by the gross negligence or
intentional misconduct of Progenics or any Progenics Indemnified
Party.
11.2. Indemnification by
Progenics. Progenics will indemnify, defend and hold harmless
Ono, its Affiliates, distributors and each of its and their respective
employees, officers, directors and agents (each, a “Ono Indemnified
Party”) from and against any and all Liabilities that the Ono Indemnified
Party may be required to pay to one or more Third Parties resulting from or
arising out of: (a) any intentional misconduct or gross negligence on the part
of Progenics or its Affiliates in performing any activity contemplated by this
Agreement; (b) personal injury or death of any person as a result of use of any
Product containing the Compound supplied or sold by Progenics outside the
Territory; or (c) the material breach by Progenics of any of its
representations, warranties or covenants set forth in this Agreement; except, in
each case ((a), (b), and (c)), to the extent caused by the gross negligence or
intentional misconduct of Ono or any Ono Indemnified Party.
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11.3. 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 11 (Indemnification and Insurance), 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 (a) the Indemnifying Party and
the Indemnified Party shall have mutually agreed to the retention of such
counsel or (b) 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.
12.
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REGULATORY
MATTERS, PRODUCT SAFETY ISSUES, PRODUCT
RECALLS
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12.1. Regulatory
Matters.
12.1.1. Cooperation and Sharing of
Information. The Parties shall cooperate to support all
interactions with any Regulatory Authority related to the Product in the
Territory. Each Party will keep the other informed of its
interactions with the Regulatory Authorities in the Territory, including by
providing copies of correspondence and submissions with the Regulatory
Authorities in the Territory. Each Party shall give the other
reasonable opportunity to review and comment on submissions relating to any
Product or the Compound in the Territory to Regulatory Authorities prior to
making such submissions.
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12.1.2. Interactions with Regulatory
Authority in the Territory. Ono shall be responsible for
coordinating all interactions with the Regulatory Authority in the Territory
that are related to scientific and medical questions, including but not limited
to labeling, Compound and Product specifications, chemistry and manufacturing
control matters, post-approval studies and other post-approval
commitments. Upon the request of Ono and accepted by the JDC,
Progenics will support Ono to prepare fully electronic submissions (eCTD) to the
Regulatory Authority in the Territory, subject to Section 2.10 (Costs of
Assistance).
12.1.3. Ownership of Regulatory
Approvals. Ono shall own all right,
title and interest in all Registrational Filings and Regulatory Approvals for
any Product and any applications therefor in the Territory.
12.1.4. Ono’s
Affiliates. Nothing in this Section shall limit Ono’s ability
to authorize any Ono Affiliate to seek or obtain any Regulatory Approval in the
Territory for any Product or own any such Regulatory Approval obtained as a
result of any such application or Ono’s ability to assign ownership of any
Regulatory Approval or application therefore.
12.1.5. Right of
Reference. Each Party hereby grants to the other a “right of
reference,” as that term is defined in 21 C.F.R. § 314.3(b), to any data
controlled by such Party that relates to any Product, and each Party shall
provide a signed statement to this effect, if requested by the other Party, in
accordance with 21 C.F.R. § 314.50(g)(3).
12.2. Medical and Customer
Inquiries. During Commercialization of any Product, Ono and its Affiliates, as
appropriate, shall be responsible for responding to all inquiries related to
such Product raised by health care professionals or other customers in the
Territory.
12.3. Safety
Agreement. After the Effective Date, and before the filing of
any IND in the Territory by Ono, the Parties shall in good faith negotiate and
enter into a Safety Agreement within [*] days after the Effective
Date.
12.4. Product
Recalls.
12.4.1. Product Recalls in the
Territory. Ono shall be solely responsible at Ono’s expense
for all contact with Regulatory Authorities in the Territory relating to any
Recall of any Product in the Territory. Ono shall be solely
responsible at Ono’s expense for implementing, directing and administering any
Recall of any Product in the Territory required or recommended by any Regulatory
Authority in the Territory or court of competent jurisdiction, or determined by
Ono, in its sole discretion, to be necessary or advisable. If Ono is
required or voluntarily decides to initiate a Recall in the Territory with
respect to any Product, whether or not such Recall has been requested or ordered
by any Regulatory Authority in the Territory, Ono shall promptly notify
Progenics of such requirement or decision. Further, Ono shall
promptly notify Progenics of any event that Ono believes affects continuation of
development and/or commercialization of any Product outside the
Territory.
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12.4.2. Product Recalls outside the
Territory. Progenics shall promptly notify Ono of any event
that Progenics believes affects continuation of Development and/or
Commercialization of any Product in the Territory, and any Recall of any Product
outside the Territory, including, subject to any applicable confidentiality
obligations, promptly disclosing to Ono any and all information related to any
such Recall of any Product provided to Progenics by Wyeth.
12.5. Cost of
Recalls. Ono shall be solely responsible for the cost of any
Recall in the Territory.
13.
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MISCELLANEOUS.
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13.1. Scope of
License. Unless otherwise expressly provided for herein, Ono
may only engage in the Licensed Activities in the Territory.
13.2. Documents and
Information. Notwithstanding anything herein to the contrary,
wherever this Agreement calls for the exchange of any documentation (including
copies) and/or information, such documentation and/or information shall be
shared in the English language (or, if time is of the essence, and a full
translation of documents from Japanese to English is not possible, a summary
translated version of such documentation and information pending delivery of
full translation). Each Party shall bear its own costs in
interpreting such documents and/or information into English. Whenever
an interpreted document is provided to the other Party, an original copy of the
document in the original language shall also be provided to the other
Party.
13.3. Assignment. Neither
this Agreement nor any interest under this Agreement shall be assignable by
either Party to this Agreement without the prior written consent of the other
Party, except as follows: Either Party may assign its rights and
obligations under this Agreement by way of sale of such Party itself or the sale
of a substantial portion of the business of such Party to which this Agreement
relates, through merger, sale of assets and/or sale of stock or ownership
interest, provided 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 Agreement or the business of the
Party. Each Party shall promptly notify the other Party of any
assignment or transfer under the provisions of this Section 13.3
(Assignment). This Agreement shall be binding upon the successors and
permitted assigns of the Parties to this Agreement and the name of a Party to
this 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 Agreement. Any assignment not in accordance with
this Section 13.3 (Assignment) shall be void.
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13.4. Further
Actions. Each Party to this Agreement agrees to execute,
acknowledge and deliver such further instruments, and to do all such other acts,
as may be necessary or appropriate in order to carry out the purposes and intent
of the Agreement.
13.5. 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
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.
13.6. Correspondence
and Notices.
13.6.1. Ordinary
Notices. Correspondence, reports, documentation, and any other
communication in writing between the Parties in the course of ordinary
implementation of this 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.
13.6.2. Extraordinary
Notices. Extraordinary notices and communications (including,
without limitation, 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.
All
correspondence to Ono shall be addressed as follows:
Ono
Pharmaceutical Co., Ltd.
0-0,
Xxxxxxxxxxxx 0-xxxxx
Xxxx-xx,
Xxxxx 000-0000, Xxxxx
Attn:
Senior Director, Business Development & Licensing
Fax: x00(0)0-0000-0000
with a
copy to:
Ono
Pharma USA, Inc.
0000
Xxxxx Xxxxx
Xxxxxxxxxxxxx,
XX 00000, XXX
Attn:
President
Fax: x0
(000) 000-0000
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All
correspondence to Progenics shall be addressed as follows:
Progenics
Pharmaceuticals, Inc.
000 Xxx
Xxx Xxxx Xxxxx Xxxx
Xxxxxxxxx,
Xxx Xxxx 00000
Attn:
Chief Executive Officer
Fax: x0
(000) 000-0000
with a
copy to:
Progenics
Pharmaceuticals, Inc.
000 Xxx
Xxx Xxxx Xxxxx Xxxx
Xxxxxxxxx,
Xxx Xxxx 00000
Attn:
General Counsel
Fax: x0
(000) 000-0000
13.7. Amendment. No
amendment, modification or supplement of any provision of this Agreement shall
be valid or effective unless made in writing and signed by a duly authorized
officer of each Party.
13.8. Waiver. No
provision of the 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.
13.9. Severability. If
any clause or portion thereof in this Agreement is for any reason held to be
invalid, illegal or unenforceable, the same shall not affect any other portion
of this Agreement, as it is the intent of the Parties that this 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 Agreement shall be construed as if such clause or portion thereof had never
been contained in this 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 Agreement to the fullest extent permitted by applicable
law.
13.10. Descriptive Headings. The
descriptive headings of this Agreement are for convenience only and shall be of
no force or effect in construing or interpreting any of the provisions of this
Agreement.
13.11. Entire Agreement. Except
for that certain Reciprocal Confidentiality and Nondisclosure Agreement among
the Parties dated as of September 19, 2008, this 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.
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13.12. Independent Contractors. Both
Parties are independent contractors under this 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 Agreement, neither Party
shall have any implied fiduciary to the other Party.
13.13. Counterparts. This
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.
13.14. Future Relationships. Nothing
contained in this 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 Agreement. Further, other than 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.
13.15. 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.” 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 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 Agreement. References to dollar amounts shall be
deemed to indicate United States Dollars.
13.16. No Third Party Rights or
Obligations. No provision of this 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 Agreement.
13.17. Governing Law. This
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.
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13.18. Alternative
Dispute Resolution; Jurisdiction for Actions Related to Intellectual Property;
Venue; Service of Process.
13.18.1. General
Claims. Except as provided in Section 13.18.2 (Jurisdiction
for Actions Related to Intellectual Property) and 13.19 (Waiver of Jury Trial),
any Claim between the Parties arising in whole or in part under or in connection
with this Agreement shall be settled by binding arbitration administered by the
American Arbitration Association under its Commercial Arbitration Rules;
provided, however, that the Parties hereby agree that the time schedule for the
appointment of arbitrators and the time schedule for submission of the statement
of defense shall follow the arbitration rules of the International Chamber of
Commerce. The judgment on the award rendered by the arbitrator may be
entered in any court having jurisdiction thereof. The arbitration
shall be commenced when one Party serves the other Party with a written demand
to arbitrate.
13.18.2. Jurisdiction for Actions Related to
Intellectual Property. Each Party to this 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 relating to
Patent Rights or Know-How arising in whole or in part under or in connection
with this 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
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.
13.18.3. Venue. Each Party
agrees that for any Claim between the Parties arising in whole or in part under
or in connection with this Agreement, such Party shall bring such Claims in New
York, New York, United States if either Party requests arbitration under Section
13.18.1 (General Claims) or if a Claim is subject to Section 13.18.2
(Jurisdiction for Actions Related to Intellectual Property). 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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13.18.4. Service of
Process. Each Party hereby (i) agrees that service of process
in any Claim between the Parties arising in whole or in part under or in
connection with this Agreement shall constitute good and valid service of
process in any such Claim if sent by registered or certified mail, return
receipt requested, at its address specified pursuant to Section 13.6
(Correspondence and Notices) and (ii) 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 (i) does not constitute good and valid
service of process.
13.19. 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 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 AGREEMENT OR ANY OF THE CONTEMPLATED TRANSACTIONS
WILL INSTEAD BE TRIED IN A COURT OF COMPETENT JURISDICTION BY A JUDGE SITTING
WITHOUT A JURY.
13.20. Dispute Resolution. Except as set forth in
Section 3.1.3 (Decision Making) with respect to tie votes regarding decisions
within the jurisdiction of the various Committees, if the Parties are otherwise
unable to resolve a dispute among them informally, Ono 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”).
For
Ono: [*]
For
Progenics: [*]
Any such
dispute shall be submitted to the Responsible Executives no later than [*] days
following such request by either the JSC or Ono or Progenics. In the
event the Responsible Executives are not able to resolve any such dispute within
[*] days after submission of the dispute to such Responsible Executives, Ono or
Progenics, as the case may be, may pursue whatever measures legally available to
resolve such dispute. All negotiations pursuant to this Section 13.20
(Dispute Resolution) 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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13.21. Specific
Performance. The Parties agree that if any of the provisions
of this 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
Agreement.
13.22. Purchases of Equity
Securities.
13.22.1. General. From the
Effective Date until one (1) year after the First Commercial Sale of any Product
in the Territory, except as permitted hereunder, Ono and its Affiliates will not
directly or indirectly in any manner:
(a) acquire,
or agree to acquire by purchase beneficial ownership (within the meaning of Rule
13d-3 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) in
any voting securities of Progenics;
(b) make, or
actively participate in any “solicitation” of “proxies” to vote (as such terms
are used in the proxy rules of the Securities and Exchange Commission (the
“SEC”)
promulgated pursuant to Section 14 of the Exchange Act) with respect to (a) a
business combination, restructuring, recapitalization or similar transaction
with Progenics or (b) election or removal of directors; provided, however, that the
prohibition in this Section 13.22.1 (Purchase of Equity Shares; General) shall
not apply to solicitations exempted from the proxy solicitation rules by Rule
14a-2 under the Exchange Act as such Rule 14a-2 is in effect as of the Effective
Date;
(c) form,
join or in any way participate in a “group” within the meaning of Section
13(d)(3) of the Exchange Act with respect to any voting securities of
Progenics;
(d) enter
into any arrangement or understanding with others to do any of the actions
restricted or prohibited under Sections 13.22.1(a), (b) or (c); or
(e) otherwise
publicly offer to Progenics or any of its stockholders any business combination,
restructuring, recapitalization or similar transaction to or with Progenics or
otherwise seek in concert with others, to control or change the board of
directors of Progenics or nominate any person as a director of Progenics who is
not nominated by the then incumbent directors, or propose any matter to be voted
upon by the stockholders of Progenics with respect to a business combination,
restructuring, recapitalization or similar transaction with
Progenics.
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13.22.2. Exceptions for Purchasing Securities
of Progenics. Nothing herein shall prevent:
(a) Ono from
purchasing additional securities of Progenics if after such purchase Ono and its
Affiliates would own no greater percent of the total voting power of all voting
securities of Progenics then outstanding than Ono and such Affiliates owned
immediately prior to the Effective Date;
(b) Ono from
acquiring securities of Progenics issued in connection with stock splits, stock
dividends or recapitalizations or on exercise of pre-emptive or other purchase
rights afforded to Progenics stockholders generally;
(c) Ono or
Ono’s Affiliates from purchasing securities of Progenics pursuant to (i) a
pension plan established for the benefit of Ono’s employees, (ii) any employee
benefit plan of Ono or (iii) any stock portfolios not controlled by Ono or any
of its Affiliates that invest in Progenics among other companies;
or
(d) Ono from
acquiring securities of another biotechnology or pharmaceutical company that
beneficially owns any of Progenics’ securities.
13.22.3. Exceptions. The
limitations provided in this Section 13.22 (Purchase of Equity Securities) shall
immediately terminate upon the occurrence of any of the following
events:
(a) the
commencement by any person of a tender or exchange offer seeking to acquire
beneficial ownership of fifty percent (50%) or more of the outstanding shares of
voting securities of Progenics;
(b) the
execution of an agreement which, if consummated, would result in either (i) the
beneficial owners of Progenics voting securities or voting power beforehand
owning less than fifty percent (50%) of the voting securities or voting power of
the surviving company in the transaction or (ii) the sale of all or
substantially all of the assets of Progenics;
(c) during
any twelve month period, there is a change in the composition of the Progenics
board of directors such that the individuals constituting such board at the
beginning of such period cease for any reason to constitute a majority of the
board; or
(d) the
adoption of a plan of liquidation or dissolution with respect to
Progenics.
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13.23. Exclusion. No
action or actions taken by Ono or any of its Affiliates pursuant to the terms of
this Agreement or any collaboration agreement between Ono or its Affiliates, on
the one hand, and Progenics or its Affiliates, on the other hand, or in
connection with exercising or enforcing rights hereunder or thereunder shall be
deemed to violate the restrictions contained herein.
[SIGNATURE
PAGE FOLLOWS]
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IN WITNESS WHEREOF, duly
authorized representatives of the Parties have duly executed this Agreement to
be effective as of the Effective Date.
Ono
Pharmaceutical Co., Ltd.
|
Progenics
Pharmaceuticals, Inc.
|
By:_____________________________________
|
By:_______________________________
|
Name:
Title:
|
Name:
Title:
|
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SCHEDULE
1
CHEMICAL DRAWING OF THE
COMPOUND
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SCHEDULE
9.2(A)
OWNED PROGENICS PATENT
RIGHTS
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Schedule
9.2(B)
Licensed Progenics Patent
Rights
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9.2(C)
Progenics Third Party
Agreements
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9.2(D)
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