PARTIAL TERMINATION AND LICENSE AGREEMENT
Execution
Version
Exhibit 10.30
This
Partial Termination and License Agreement (the “Agreement”) is
entered into this 16th day of October, 2008 (the “Effective Date”), by
and among Wyeth, acting through its Wyeth Pharmaceuticals Division, a
corporation organized and existing under the laws of the State of Delaware and
having a principal place of business at 000 Xxxxxx Xxxx, Xxxxxxxxxxxx,
Xxxxxxxxxxxx 00000, Wyeth-Whitehall Pharmaceuticals, Inc., a corporation having
a principal place of business at Road Xx. 0, Xxxxxxxxx 000.0, Xxxxxxx, Xxxxxx
Xxxx 00000, and Wyeth-Ayerst Lederle, Inc. a corporation having a principal
place of business at 65th Infantry Road, Kilometer 9.7, Carolina, Puerto Rico
00987-4904 (collectively, “Wyeth”) and Progenics
Pharmaceuticals, Inc., a corporation organized and existing under the laws of
the State of Delaware and having a principal place of business at 000 Xxx Xxx
Xxxx Xxxxx Xxxx, Xxxxxxxxx, XX 00000 and 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 (collectively, “Progenics”). Wyeth
and Progenics may each be referred to herein individually as a “Party” and
collectively as the “Parties.”
BACKGROUND
X. Xxxxx
Pharmaceuticals is the pharmaceutical division of Wyeth, a global company
devoted, among other businesses, to discovering, developing, manufacturing and
marketing human pharmaceutical products.
X. Xxxxx-Whitehall
Pharmaceuticals, Inc. and Wyeth-Ayerst Lederle, Inc. are indirect subsidiaries
of Wyeth.
C. Progenics
is a biopharmaceutical company focusing on the development and commercialization
of innovative therapeutic products. Progenics and Wyeth are
developing [*] for the treatment of post-operative bowel dysfunction and
opioid-induced constipation associated with chronic pain and advanced medical
illness.
D. Progenics
Pharmaceuticals Nevada, Inc. (“ProNev”) is a direct,
wholly-owned subsidiary of Progenics Pharmaceuticals, Inc.
X. Xxxxx
and Progenics are parties to a certain License and Co-Development Agreement
dated as of December 23, 2005 pursuant to which Progenics granted to Wyeth an
exclusive worldwide license to Develop and Commercialize [*] (the “Progenics-Wyeth
Agreement”).
F. Section
2.8 of the Progenics-Wyeth Agreement (Japan) provides that Wyeth give Progenics
notice [*] of Wyeth’s election not to Develop the Products in
Japan.
X. Xxxxx
notified Progenics of its determination not to Develop the Products in Japan
(either directly or through a Sublicensee) pursuant to Section 2.8 of the
Progenics-Wyeth Agreement.
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H. Section
2.8 of the Progenics-Wyeth Agreement also provides that, in the event Wyeth
notifies Progenics that it has determined not to Develop the Products in Japan
(either directly or through a Sublicensee), then (i) the license granted to
Wyeth in Section 2.1 of the Progenics-Wyeth Agreement (Exclusive License from
Progenics to Wyeth) shall terminate with respect to Japan only and (ii) the
requirements set forth in clauses (a) through (f) of Section 10.4.1 of the
Progenics-Wyeth Agreement shall apply as if there were a Partial Termination
pursuant to Section 10.2.1 of the Progenics-Wyeth Agreement with respect to all
the Products in Japan only.
X. Xxxxx
and Progenics agreed, pursuant to a letter agreement dated April 12, 2007 (the
“Letter
Agreement”), that, notwithstanding the provisions of Section 2.8 of the
Progenics-Wyeth Agreement, no change would occur in the license granted to Wyeth
in Section 2.1 of the Progenics-Wyeth Agreement until such time as Progenics
notified Wyeth that it intends to Develop or Commercialize the Products in Japan
(the “Progenics
Notice”) whereupon the license granted to Wyeth in Section 2.1 of the
Progenics-Wyeth Agreement would terminate with respect to Japan only and the
provisions of Section 10.4.1 of the Progenics-Wyeth Agreement would apply as if
there were a Partial Termination with respect to all the Products in Japan
only.
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:
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1.
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Definitions
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All
capitalized terms used, but not otherwise defined herein, shall have the
meanings ascribed to such terms in the Progenics-Wyeth Agreement.
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2.
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Partial Termination of
the Progenics-Wyeth Agreement as to
Japan
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By
entering into this Agreement, Progenics hereby gives Wyeth the Progenics Notice
and Wyeth waives its right to give a Wyeth Notice (as defined in the Letter
Agreement). The Parties hereby acknowledge and agree that Wyeth’s
license pursuant to Section 2.1 of the Progenics-Wyeth Agreement (Exclusive
License from Progenics to Wyeth) terminates as of the Effective Date of this
Agreement with respect to Japan only, and accordingly, the Territory as defined
in the Progenics-Wyeth Agreement is hereby amended to mean the entire world
other than Japan.
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3.
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Partial Termination
Covenants
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3.1. Transfer of Documents and Data
Related to the Products in Japan. Wyeth shall, within thirty
(30) days after the Effective Date of this Agreement, transfer to Progenics
copies of all data, reports, records and materials in Wyeth’s possession or
control that relate to the Products or the Compound in Japan.
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3.2. Transfer of Registrational Filings
and Regulatory Approvals. Promptly following the Effective
Date of this Agreement, Wyeth shall use Commercially Reasonable Efforts to
transfer to Progenics ownership and control of all Registrational Filings and
Regulatory Approvals made, filed or obtained for the Products and the Compound
in Japan and all clinical, technical and other relevant reports and data
relating to the Products and the Compound in Japan, each to the extent they are
owned, controlled by or held in the name of Wyeth or its
Affiliates.
3.3. Supply of
Product. Wyeth and Progenics shall negotiate in good faith a
supply agreement on commercially reasonable terms pursuant to which Wyeth shall
supply Progenics with any Products being manufactured by Wyeth as of the
Effective Date of this Agreement for a period of [*] ([*]) years. In
addition, Wyeth shall cooperate with Progenics in good faith to arrange for the
supply of API to Progenics. Wyeth shall, and hereby does, waive any
exclusivity right that Wyeth has with any suppliers of API as necessary to
permit Progenics, its Affiliates, licensees and/or sublicensees to enter into
direct supply agreements with such suppliers.
3.4. Documentation and
Technology. Promptly following the Effective Date of this
Agreement, Wyeth shall use Commercially Reasonable Efforts to transfer, license
or sublicense to Progenics or its designee at no cost all documentation and
technology in Wyeth’s Control necessary to enable Progenics or its designee to
manufacture [*] Products. [*]
3.5. Assignment of
Trademarks. Wyeth shall use Commercially Reasonable Efforts to
assign to Progenics for no additional consideration, within thirty (30) days of
the Effective Date of this Agreement, the trademarks in Japan relating solely to
the Products or the Compound owned by Wyeth and its
Affiliates. Progenics shall be responsible for the costs of recording
trademark assignments in Japan. Wyeth and Progenics shall use
Commercially Reasonable Efforts to enter into a Trademark Cooperation Agreement
substantially in the form of Exhibit A hereto simultaneously with such
assignment.
3.6. License from Wyeth to Progenics of
the Wyeth Collaboration Patent Rights, the Wyeth Collaboration Know-How and
Wyeth’s Interest in the Joint Technology in Japan. Effective
as of the Effective Date of this Agreement, Wyeth shall, and hereby does, grant
to Progenics a fully paid-up, perpetual, irrevocable, royalty-free,
non-exclusive license (with the right to grant sublicenses) in the Field under
the Wyeth Collaboration Patent Rights, the Wyeth Collaboration Know-How and
Wyeth’s interest in the Joint Technology (i) to make, have made, use, Develop,
sell, offer to sell, have sold, import and otherwise exploit and Commercialize
the Compound and the Products in Japan, and (ii) to make and have made the
Compound and the Products outside Japan in unlabeled form solely for import
into, and Development and Commercialization in, Japan (and to export the
Compound for such purpose). Wyeth shall not, directly or indirectly,
make, have made, use, Develop, sell, offer to sell, have sold, import, export or
otherwise exploit or Commercialize the Compound or the Products for or in
Japan.
3.7. Non-Assertion of
Rights. Following the Effective Date of this Agreement, Wyeth
agrees not to assert any Wyeth Independent Patent Rights against Progenics, its
Affiliates, its licensees or its sublicensees relating to the Development,
Commercialization or other exploitation of any Product in Japan.
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3.8. Pharmacovigilance
Agreement. Wyeth and Progenics will, following the grant by
Progenics of any sublicense of the rights granted by Wyeth pursuant to Section
3.6 hereof, address pharmacovigilance activities pursuant to the existing
Wyeth/Progenics Pre-Approval Pharmacovigilance Agreement and Post-Approval
Pharmacovigilance Agreement, as may be amended from time to time.
4. Intellectual
Property
4.1. Progenics Patent Rights and Joint
Patent Rights in Japan. Further to, and
notwithstanding anything to the contrary in, Sections 7.2.1 (Progenics Patent
Rights) and 7.2.2 (Joint Patent Rights) of the Progenics-Wyeth Agreement, in the
event Wyeth elects not to prepare, file, prosecute or maintain any Progenics
Patent Rights or Joint Patent Rights in Japan, Wyeth shall give Progenics notice
to this effect sufficiently in advance of any applicable deadline to permit
Progenics, at Progenics’ expense, to undertake such preparation, filing,
prosecution and maintenance without a loss of rights. Such
Progenics Patent Rights or Joint Patent Rights in Japan that Wyeth no longer
wishes to prepare, file, prosecute and maintain at Wyeth’s expense shall in this
Section 4 and hereinafter be referred to as the “Subject Patent
Rights”. Progenics may, upon written notice to Wyeth, file and
prosecute patent applications and maintain the Subject Patent Rights, including
provoking, instituting or defending opposition, revocation, reexamination and
similar proceedings related to the Subject Patent Rights, all at Progenics’
expense. The Parties shall cause their patent counsel to communicate
regularly regarding the prosecution and maintenance of the Subject Patent
Rights. Without limiting the generality of the foregoing, Progenics
shall provide to Wyeth copies of all communications sent to and received from
the Japanese Patent Office pertaining to the Subject Patent Rights, including,
but not limited to, draft patent applications, filing receipts, office actions,
responses and/or amendments, and notices of allowance. Wyeth 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. Progenics also
shall keep Wyeth advised on the maintenance of any patents included within the
Subject Patent Rights and provide Wyeth with a reasonable opportunity to comment
on maintenance. Notwithstanding anything to the contrary in Section
7.2.1 (Progenics Patent Rights) or 7.2.2 (Joint Patent Rights) of the
Progenics-Wyeth Agreement, in the event that the Parties, after good faith
discussions, cannot agree with respect to any decision to be made with respect
to the Subject Patent Rights (including decisions relating to opposition,
revocation, reexamination and similar proceedings related to the Subject Patent
Rights in Japan), Progenics shall make such decision, provided that such
decision shall not be inconsistent with, and will not negatively impact, the
Parties’ intellectual property strategy outside of Japan. For the
avoidance of doubt, the Parties acknowledge and agree that Progenics, at
Progenics’ expense, may pursue an intellectual property strategy in Japan with
respect to the Subject Patent Rights that is designed to take advantage of
differences in Japanese patent law as compared to other jurisdictions throughout
the world (including pursuing claims of different scope), provided the positions
so taken by Progenics are not inconsistent with, and will not negatively impact,
the Parties’ intellectual property strategy outside of Japan. For the
avoidance of doubt, the Parties agree that the provisions of Sections 7.2.1 and
7.2.2 of the Progenics-Wyeth Agreement shall remain in full force and effect for
the Progenics Patent Rights and Joint Patent Rights in Japan that are not
Subject Patent Rights.
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4.2. Enforcement of Subject Patent
Rights. For the sake of clarity and avoidance of doubt, for
the purposes of Progenics exercising its rights pursuant to Section 7.2.6(b) of
the Progenics-Wyeth Agreement (Enforcement of Progenics Patent Rights and Joint
Patent Rights), with respect to the Subject Patent Rights Progenics may join
Wyeth as a party plaintiff to any action or suit resulting from Progenics’
exercise of such rights involving the Joint Patent Rights to the extent Wyeth is
a necessary party to such action or suit, provided that Progenics shall bear all
the expenses of such action or suit, including those reasonable expenses
incurred by Wyeth as a participant (other than its own independent
counsel). For avoidance of doubt, the Parties agree that the
provisions of Section 7.2.6 of the Progenics-Wyeth Agreement shall remain in
full force and effect for the Progenics Patent Rights and Joint Patent Rights in
Japan that are not Subject Patent Rights.
5. Miscellaneous
5.1. Successors and Assigns. This
Agreement shall be binding upon and inure to the benefit of the Parties, their
successors and permitted assigns.
5.2. Amendments. This Agreement may
be amended or modified at any time or from time to time only by an express
written agreement, signed by all Parties, and which expressly refers to this
Agreement.
5.3. Waivers. The failure of any
Party to require performance by another Party of any provision hereof, or to
enforce any remedies it may have against such other Party, shall in no way
affect the right thereafter to enforce this Agreement and require full
performance by any other Party. The waiver by a Party of any breach of any
provision of this Agreement shall not constitute a waiver of any succeeding
breach of that provision or of any other provision.
5.4. Severability. If any provision
of this Agreement shall be adjudicated to be invalid or unenforceable in any
action or proceeding for any reason, whether in its entirety or in any portion,
then such part shall be deemed amended, if possible, or deleted, as the case may
be, from this Agreement in order to render the remainder of this Agreement and
any provision hereof both valid and enforceable.
5.5. Entire Agreement. This
Agreement, together with the Progenics-Wyeth Agreement, constitutes the entire
agreement between the Parties with respect to the subject matter
hereof.
5.6. Counterparts. This Agreement
may be executed in any number of counterparts which taken together shall
constitute one and the same instrument.
5.7. Governing Law. All matters
affecting the interpretation, validity and performance of this Agreement shall
be governed by the laws the state of New York.
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5.8. Independent Contractors. In
the performance of this Agreement no Party is authorized or empowered to act as
agent for any other Party for any purpose and shall not on behalf of any other
Party enter into any contract, warranty, or other representation as to any
matter. No Party shall be bound by the acts, conduct, obligations,
representations or warranties of any other Party.
[SIGNATURE
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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 of this
Agreement.
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Wyeth,
acting through its Wyeth Pharmaceuticals Division
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Progenics
Pharmaceuticals, Inc.
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By______________________________________
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By________________________________
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Name:
Title:
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Name:
Title:
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Wyeth-Whitehall
Pharmaceuticals, Inc.
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Progenics
Pharmaceuticals Nevada, Inc.
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By______________________________________
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By________________________________
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Name:
Title:
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Name:
Title:
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Wyeth-Ayerst
Lederle, Inc.
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By______________________________________
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Name:
Title:
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Exhibit
A
TRADEMARK CO-OPERATION
AGREEMENT
[*]
Exhibit A-1
