LICENSE AND CO-DEVELOPMENT AGREEMENT by and among WYETH, acting through its WYETH PHARMACEUTICALS DIVISION, WYETH-WHITEHALL PHARMACEUTICALS, INC., WYETH- AYERST LEDERLE, INC., and PROGENICS PHARMACEUTICALS, INC. and PROGENICS PHARMACEUTICALS NEVADA,...
Exhibit
10.26
LICENSE
AND CO-DEVELOPMENT AGREEMENT
by
and
among
WYETH,
acting
through its
WYETH
PHARMACEUTICALS DIVISION,
WYETH-WHITEHALL
PHARMACEUTICALS, INC.,
WYETH-AYERST
LEDERLE, INC.,
and
PROGENICS
PHARMACEUTICALS, INC.
and
PROGENICS
PHARMACEUTICALS NEVADA, INC.
Dated
as
of December 23, 2005
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PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
TABLE
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SCHEDULES
Schedule
1.10 Chemical
Drawing of Compound
Schedule
8.4.2 Press
Release
Schedule
9.2 Progenics
Disclosure Schedule
EXHIBITS
EXHIBIT
A
Co-Promotion Agreement
[*]
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PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
i
LICENSE
AND CO-DEVELOPMENT AGREEMENT
This
License and Co-Development Agreement (the “Agreement”)
is
entered into this 23rd
day of
December, 2005 (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 (“Progenics”)
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 (“ProNev”).
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 is developing [*] (“[*]”), for the
treatment of post-operative bowel dysfunction and opioid-induced constipation
associated with chronic pain and advanced medical illness.
D. ProNev
is
a direct, wholly-owned subsidiary of Progenics.
E. Progenics
owns or has rights under certain patents, patent applications, other valuable
technology and know-how relating to [*] and has conducted and is conducting
certain clinical trials for [*].
X. Xxxxx
and
Progenics wish to collaborate regarding the development of [*] and Progenics
wishes to grant to Wyeth, and Wyeth wishes to receive from Progenics, an
exclusive worldwide license to develop and commercialize [*].
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
1. |
Capitalized
terms not otherwise defined herein shall have the following
meanings:
1.1. 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 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.
1.2. 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.
1.3. Calendar
Year.“Calendar
Year” means any calendar year.
1.4. Claim.
“Claim”
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.
1.5. Collaboration.“Collaboration”
means the Development and Commercialization activities of the Parties under
this
Agreement.
1.6. 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 a second compound or biologic as an active
ingredient (either as a single fixed dose or as separate doses).
1.7. Commercialization.“Commercialization”
means all activities related to the commercial exploitation of the Compound
and
the Products, including without limitation the manufacture, supply, use,
importation, exportation, marketing, promotion, distribution, pre-launch,
launch, sale, offering for sale and conducting Phase 4 Clinical Trials of the
Products. When used as a verb, “Commercialize” or “Commercializing” means to
engage in Commercialization.
1.8. 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, taking into
account issues of [*].
[*]
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PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
2
1.9. Committee.
“Committee”
means the JSC, JDC, and/or JCC as the context requires.
1.10. 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
1.10.
1.11. 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 such Party, its
Affiliates or Sublicensees and information otherwise designated by such Party
as
Confidential Information of such Party hereunder.
1.12. 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.
1.13. Co-Promotion
Territory.“Co-Promotion
Territory” means
the
United States of America, including its territories and
possessions.
1.14. Development.“Development”
means all activities related to the development of Products and obtaining
Regulatory Approval for Products, including, without limitation, all activities
related to research, development, preclinical testing, stability testing,
toxicology, formulation, clinical trials, regulatory affairs, statistical
analysis, report writing, manufacturing process and scale up, qualification
and
validation activities, quality assurance/quality control development and
regulatory filing creation and submission related to obtaining Regulatory
Approval for Products. When used as a verb “Develop” means to engage in
Development.
1.15. 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, [*].
1.16. FDA.“FDA”
means the United States Food and Drug Administration or any successor agency
thereto.
1.17. FD&C
Act.“FD&C
Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended,
and the rules and regulations promulgated thereunder.
1.18. Field.“Field”
means all prophylactic or therapeutic pharmaceutical uses of Compound for the
diagnosis, treatment or prevention of disease in humans.
1.19. First
Commercial Sale.“First
Commercial Sale” means, with respect to any Product and with respect to any
country of the Territory, the first sale of such Product to a Third Party in
such country after such Product has been granted Regulatory Marketing Approval
by a Regulatory Authority having jurisdiction for such country.
[*]
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PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
3
1.20. FTE.“FTE”
means the full time equivalent effort of one Progenics employee who participates
directly in the activities under an approved Development Plan. For purposes
of
this definition, “full time equivalent effort” shall mean
[*]
of work per year with reimbursement based on actual hours worked.
1.21. FTE
Rate. “FTE
Rate” means the hourly rate of $[*] per hour for Development work to be
performed by Progenics during Calendar Year 2006, increasing at the beginning
of
each subsequent Calendar Year over the prior year amount by the increase of
the
Consumer Price Index- All Urban Consumers during the prior year.
1.22. GAAP.“GAAP”
means U.S. generally accepted accounting principles consistently
applied.
1.23. GMP.“GMP”
means good manufacturing practices, as such term is defined in the FD&C Act,
applicable to the manufacture of the Products and the Compound.
1.24. IND.“IND”
means an Investigational New Drug Application, as defined in the FD&C Act,
that is required to be submitted with the FDA before beginning clinical testing
in human subjects, or an equivalent foreign filing.
1.25. IV
Product.“IV
Product” means any Product that is formulated to be administered
intravenously.
1.26. JCC.“JCC”
means the Joint Commercialization Committee established in accordance with
Section 3.4
(Joint
Commercialization Committee (JCC)).
1.27. JDC.
“JDC”
means the Joint Development Committee established in accordance with Section
3.3
(Joint
Development Committee (JDC)).
1.28. Joint
Know-How. “Joint
Know-How” means any Know-How made or created in the course of Collaboration
jointly by (i) employees or agents of Progenics or any of its Affiliates, and
(ii) employees or agents of Wyeth or any of its Affiliates.
1.29. 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 Wyeth or any of its Affiliates, as determined in accordance with
Section 7.1.1 (Inventorship).
1.30. Joint
Technology. “Joint
Technology” means the Joint Know-How and the Joint Patent Rights.
1.31. JSC.“JSC”
means the Joint Steering Committee established in accordance with Section
3.2
(Joint
Steering Committee (JSC)).
1.32. Know-How.“Know-How”
means any confidential unpatented or unpatentable invention, development,
discovery, technology, cell line, biological material, compound,
probe,
[*]
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PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
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sequence,
technical information, method, biological material, or other confidential
information or material.
1.33. Licensed
Activit(y/ies).“Licensed
Activit(y/ies)” means, collectively, the Development and Commercialization of
any Product, the practice of any Progenics Technology or Joint Technology or
the
exercise of any other right granted by Progenics to Wyeth under this Agreement,
in each case as permitted under this Agreement.
1.34. Major
Market Country. A
“Major
Market Country” means any of [*].
1.35. [*].
1.36. Net
Sales.“Net
Sales” means the gross amounts invoiced for sales of all Products by Wyeth, its
Affiliates and Sublicensees (each a “Selling
Person”)
to
Third Parties which are not Sublicensees, less the following deductions, in
each
case to the extent specifically related to the 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 to the extent included
in the invoice price to the buyer;
(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 and rebates 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; and
(vi) documented
customs duties actually paid by the Selling Person.
Products
provided by Wyeth, its Affiliates or Sublicensees, 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
Wyeth, its Affiliates and Sublicensees 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 Wyeth in accordance with GAAP and if any accrual is
reversed by Wyeth a corresponding credit will be made to Net Sales in the period
in which the reversal is made.
[*]
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PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
5
Bundling.
Where a
Product is “bundled” for sale together with one or more other products in a
country 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 Wyeth, its Affiliate
or Sublicensee (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 a country 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) [*].
1.37. NDA.
“NDA”
means a New Drug Application, as defined in the FD&C Act, that is filed with
the FDA to formally propose that the FDA approve a new drug for sale and
marketing in the U.S., or an equivalent application or submission.
1.38. Non-Royalty
Sublicense Income. “Non-Royalty
Sublicense Income” means [*]consideration received by Wyeth or a Wyeth Affiliate
in consideration for the grant of any Sublicense, [*]. Non-Royalty Sublicense
Income includes, without limitation, [*] paid to Wyeth or a Wyeth Affiliate
by
or on behalf of the Sublicensee in consideration for the Sublicense (other
than
[*] for Development of the Products in [*]). In addition to excluding [*]
Non-Royalty Sublicense Income will exclude payments received in consideration
for [*], including without limitation payments made to Wyeth or its Affiliates
(i) in consideration of [*].
1.39. Oral
Product.“Oral
Product” means any Product that is formulated to be taken orally.
1.40. Outside
Contractor.“Outside
Contractor” means any person other than a Sublicensee contracted by Progenics or
Wyeth to provide products or services relating to the Collaboration, including,
without limitation, 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
[*]
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PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
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Wyeth
could include or might reasonably be expected to include in any document or
report, including, without limitation, a Registrational Filing, submitted to
a
Government Authority or be subject to review by a Government Authority,
including, without limitation the FDA.
1.41. Patent
Rights.“Patent
Rights” means any and all (a) U.S. or foreign patents, (b) U.S. or foreign
patent applications, including, without limitation, all provisional
applications, substitutions, continuations, continuations-in-part, divisions,
renewals, and all patents granted thereon, (c) U.S. or foreign
patents-of-addition, reissues, reexaminations and extensions or restorations
by
existing or future extension or restoration mechanisms, including, without
limitation, supplementary protection certificates or the equivalent thereof,
and
(d) other forms of government-issued right substantially similar to any of
the
foregoing.
1.42. Person.“Person”
means any individual or legal entity.
1.43. Phase
3 Clinical Trial.“Phase
3
Clinical Trial” means a human clinical study on sufficient numbers of patients
that is designed to establish that a pharmaceutical product is safe and
efficacious for its intended use, and to define warnings, precautions and
adverse reactions that are associated with the pharmaceutical product in the
dosage range to be prescribed, and to support Regulatory Approval of such
pharmaceutical product or label expansion of such pharmaceutical
product.
1.44. Phase
4 Clinical Trial.“Phase
4
Clinical Trial” means product support clinical trials of a Product not for the
purpose of obtaining Regulatory Marketing Approval, which are commenced before
or after receipt of Regulatory Marketing Approval of such Product.
1.45. Product.“Product”
means a product containing the Compound as an active ingredient, including
without limitation a Combination Product.
1.46. Progenics
Change of Control.“Progenics
Change of Control” means the occurrence of any of the following events: (i)
Progenics directly or indirectly sells, conveys or otherwise disposes of all
or
substantially all of Progenics’ assets or business to a Top 15 Pharmaceutical
Company or any Affiliate of a Top 15 Pharmaceutical Company; (ii) Progenics
or
any of its controlling Affiliates merges with or into or consolidates with
any
Top 15 Pharmaceutical Company or any Affiliate of a Top 15 Pharmaceutical
Company; (iii) any other transaction or series of related transactions as a
result of which a Top 15 Pharmaceutical Company or an Affiliate of a Top 15
Pharmaceutical Company is able to elect a majority of the members of the board
of directors of Progenics or any of its controlling Affiliates. For the purpose
of this definition, a “controlling Affiliate” is an Affiliate that “controls”
Progenics, as such term is used in the definition of Affiliates in Section
1.1
(Affiliates).
1.47. Progenics
Development Costs.“Progenics
Development Costs” means expenses
of Progenics incurred in accordance with an approved Development Plan and
Progenics Development Cost Budget approved by the JSC or agreed by the Parties,
consisting of (i) the cost of actual direct FTEs, as recorded in the Progenics
[*] time reporting system or any other mutually agreed and auditable time
tracking system, costed at the FTE Rate, and (ii) direct out-of-pocket expenses
incurred in the performance of activities assigned to Progenics under such
Development Plan.
[*]
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7
1.48. Progenics
Development Cost Budget. “Progenics
Development Cost Budget” means the three-year, quarter-by-quarter rolling budget
for Progenics Development Costs approved annually by the JSC. The initial
Progenics Development Cost Budget has been agreed by the Parties simultaneously
with the execution of this Agreement.
1.49. 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 Compound
or a
Product or to the use of the
Compound or a Product; provided,
however,
that if
a Third Party 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” (as defined in Section
1.46
(Progenics Change of Control), “Progenics Know-How” will not include any
Know-How that was Controlled by such Third Party (and not by Progenics) prior
to
the completion of such transaction or series of related
transactions.
1.50. Progenics
Patent Rights.“Progenics
Patent Rights” means any Patent Right 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 Compound, or
any
Product; provided,
however,
that if
a Third Party 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” (as defined in Section
1.46
(Progenics Change of Control), “Progenics Patent Rights” will not include any
Patent Rights that were Controlled by such Third Party prior to the completion
of such transaction or series of related transactions. Progenics Patent Rights
as of the Effective Date are identified on Schedule
9.2.
1.51. Progenics
Technology.“Progenics
Technology” means the Progenics Know-How and the Progenics Patent
Rights.
1.52. 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 Compound or any
Product,
including without limitation the agreements listed in Schedule
9.2(C)
under
the heading “Progenics Third Party Agreements.”
1.53. 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.
1.54. Registrational
Filing.“Registrational
Filing” means an application submitted to the appropriate Regulatory Authority
seeking a Regulatory Marketing Approval.
[*]
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1.55. 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 Product in a
regulatory jurisdiction,
including, without limitation, INDs, NDAs, or Biologic License Applications
(“BLAs”),
supplements and amendments, pre- and post- approvals, pricing and third party
reimbursement approvals, labeling approvals, and drug master files
(“DMFs”).
1.56. Regulatory
Authority.“Regulatory
Authority” means, with respect to a country in the Territory, any national
(e.g., the FDA), supra-national (e.g., the European Commission, the Council
of
the European Union, or the European Agency for the Evaluation of Medicinal
Products), regional, state or local regulatory agency, department, bureau,
commission, council or other governmental entity involved in the granting of
a
Regulatory Approval for such country or countries.
1.57. Regulatory
Marketing Approval.“Regulatory
Marketing Approval” means, with respect to any Product in any country or region
and in any indication, Regulatory Approval authorizing the marketing of such
Product in such country or region for such indication. For the sake of clarity,
Regulatory Marketing Approval shall be deemed to have occurred when the FDA
or
its foreign equivalent sends a Letter of Approval or its foreign
equivalent.
1.58. Regulatory
Pricing Approval.“Regulatory
Pricing Approval” means, with respect to any Product in any country or region,
the achievement of all applicable pricing and reimbursement approvals with
respect to such Product in such country or region.
1.59. Royalty
Period.“Royalty
Period” means with respect to any particular Product in any particular country,
the period of time beginning on [*] and extending until the later of
(a) [*],
(b)
[*], and (c) [*].
1.60. SC
Product.“SC
Product” means any Product that is formulated to be administered by a
subcutaneous injection.
1.61. Sublicense.“Sublicense”
means, directly or indirectly, to sublicense, grant any other right with respect
to, or agree not to assert, any right licensed to Wyeth under this Agreement.
When used as a noun, “Sublicense” means any agreement to Sublicense.
1.62. Sublicensee.“Sublicensee”
means any Third Party who is granted a Sublicense.
1.63. Territory.“Territory”
means the entire world.
1.64. Third
Party.“Third
Party” means any Person other than Wyeth, Progenics or their respective
Affiliates.
1.65. Title
11.“Title
11” shall have the meaning set forth in Section 10.5.3
(Rights
to Intellectual Property).
1.66. Top
5 EU Market Country.
A “Top 5
EU Market Country” means any of [*].
[*]
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1.67. Top
15 Pharmaceutical Company.
Top 15
Pharmaceutical Company means, at any given time, any of the fifteen (15) largest
pharmaceutical or biopharmaceutical companies in world (other than Wyeth),
measured by the stock market value of the equity capitalization of the companies
at that time.
1.68. Unauthorized
Generic Product.“Unauthorized
Generic Product” means, with respect to any Product, a pharmaceutical product
(other than the Product itself) sold by an unlicensed Third Party that contains
the Compound and gains Regulatory Marketing Approval for one of the same
indications as such Product without de
novo
evidence
of safety and efficacy, such as through an abbreviated new drug application
as
defined in 21 U.S.C. 355(j) or an application submitted pursuant to 21 U.S.C.
355(b)(2) (or their equivalents outside the United States).
1.69. Unauthorized
Generic Product Market.“Unauthorized
Generic Product Market” means, with respect to any Product in any country in the
Territory, the sum of [*]. Unauthorized Generic Product sales shall be
determined using independent market data (where available), such as that
published by IMS.
1.70. 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.
1.71. Wyeth
Collaboration Know-How. “Wyeth
Collaboration Know-How” means Know-How relating to the Collaboration or the
Compound or the Products, Controlled as of the Effective Date or at any time
during the Term by Wyeth or its Affiliates, that is made or created in the
course of the Collaboration solely by employees or agents of Wyeth or any of
its
Affiliates or Sublicensees, other than Progenics Know-How and Joint Know-How.
1.72. Wyeth
Collaboration Patent Rights.“Wyeth
Collaboration Patent Rights” means any Patent Right Controlled by Wyeth or its
Affiliates that claim inventions invented solely by employees or agents of
Wyeth
or any of its Affiliates or Sublicensees (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, other than
Progenics Patent Rights and Joint Patent Rights.
1.73. Wyeth
Independent Patent Rights.“Wyeth
Independent Patent Rights” means any Patent Right Controlled by Wyeth 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 Wyeth Collaboration Patent Rights, the
Progenics Patent Rights and the Joint Patent Rights.
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1.74. Additional
Definitions. Definitions
for each of the following defined terms are set forth in the section of this
Agreement indicated below:
Definition
|
Section
|
Agreement
|
Introduction
|
Commercialization
Payments
|
6.4
|
Co-Promotion
Agreement
|
5.1
|
Co-Promotion
Option
|
5.1
|
Debtor
Party
|
10.5.1
|
Designated
Countries
|
7.2.1
|
Development
Account
|
6.2.2
|
Development
Cost Summary
|
6.2.2
|
Development
Payments
|
6.3
|
Development
Plan
|
4.1
|
Disclosing
Party
|
8.1
|
Effective
Date
|
Introduction
|
Estimated
Quarterly Development Costs
|
6.2.2
|
Executive
Officers
|
3.1.3
|
Indemnified
Party
|
11.3
|
Indemnifying
Party
|
11.3
|
Liability
|
11.1
|
Licensed
Progenics Patent Rights
|
9.2(a)
|
Negotiation
Period
|
2.3.2(d)
|
Non-Debtor
Party
|
10.5.1
|
Owned
Progenics Patent Rights
|
9.2(a)
|
Partial
Termination
|
10.2.1
|
Party
Vote
|
3.1.3
|
Permitted
Deductions
|
1.36
|
Progenics
|
Introduction
|
Progenics
Indemnified Party
|
11.1
|
Progenics
Regulatory Filings/Approvals
|
12.1.4(a)
|
ProNev
|
Introduction
|
Receiving
Party
|
8.1
|
Responsible
Executive
|
13.19
|
[*]
|
Background
|
Selling
Person
|
1.36
|
[*]
|
1.36
|
Sued
Party
|
7.2.7(c)
|
Term
|
10.1
|
Terminated
Products
|
10.4.3
|
Terminated
Territory
|
10.4.1(f)
|
Third
Party IP Rights
|
7.2.7(b)
|
Transferred
Regulatory Filings/Approvals
|
12.1.4(b)
|
UR
Labs Acquisition Agreements
|
9.2(e)
|
UR
Labs-Progenics Agreement
|
10.6.1
|
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Working
Group
|
3.3.4
|
Wyeth
|
Introduction
|
Wyeth
Non-Defaulting Termination
|
10.6.2
|
Wyeth
Indemnified Party
|
11.2
|
2. |
LICENSE
GRANTS AND RELATED
MATTERS.
|
2.1. Exclusive
License from Progenics to Wyeth.
Subject
to the terms and conditions of this Agreement, Progenics hereby grants to Wyeth
in the Field an exclusive (even as to Progenics, other than as set forth in
Section 2.2
(Retained Rights)) license under the Progenics Technology and Joint Technology,
with the right to sublicense as set forth in Section 2.3.1
(Sublicenses), to make, have made, use, Develop, sell, offer to sell, have
sold,
import, export, and otherwise exploit and Commercialize the Compound and
Products in the Territory.
Wyeth
acknowledges that with respect to those Progenics Patent Rights that are
Controlled by Progenics pursuant to the Third Party Agreements, the foregoing
license is subject to the rights of the Third Party licensors under such Third
Party Agreements.
2.2. Retained
Rights. Subject
to the terms and conditions of this Agreement, Progenics retains the
non-exclusive, non-transferable, non-licensable right under the Progenics
Technology and Joint Technology only (i) to make, have made, import, export
and
use the Compound and Develop the Compound and the Products for the purpose
of
performing its obligations under this Agreement, and (ii) to make and use the
Compound and use the Products for research and development purposes and quality
control and quality assurance related to the development and commercialization
of the Excluded Molecules. Other than as set forth in this Section 2.2,
no
right is retained by Progenics to offer for sale or sell the Compound to any
Third Party in the Territory or to make, have made, use, sell, offer for sale,
import, export or otherwise exploit or Commercialize Products in the
Territory.
2.3. Sublicenses
2.3.1. General.
Wyeth
shall have the right to grant Sublicenses of any and all rights granted to
Wyeth
under this Agreement to its Affiliates in the Territory, without the requirement
of any prior approval by Progenics. Except as provided in Section 2.8
([*]),
Wyeth may not Sublicense its obligation to Develop the Products in any Major
Market Country to a Third Party. In addition, Wyeth shall have the right to
grant Sublicenses of any and all rights granted to Wyeth under this Agreement
to
Commercialize the Products after Regulatory Marketing Approval to any Third
Party for countries outside the Major Market Countries, without the requirement
of prior written approval of Progenics. Wyeth shall also have the right on
a
Product-by-Product basis to grant Sublicenses of any and all rights granted
to
Wyeth under this Agreement to Commercialize Products, after Regulatory Marketing
Approval, in the Major Market Countries, with the prior written consent of
Progenics, not to be unreasonably withheld or delayed. It is understood and
agreed that Progenics’ consent may be reasonably withheld in the event that
Wyeth seeks to Sublicense its rights to a Third Party that Commercializes a
prescription pharmaceutical product in a Major Market Country that
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competes
with or addresses similar indications to any Product. Any Sublicense by Wyeth
in
the United States shall only be for the purpose of augmenting the
Commercialization activities in the United States and shall not be for the
purpose of replacing Wyeth’s Commercialization activities in the United States.
Wyeth will provide to Progenics a complete and final English language draft
of
any Sublicense for comments by Progenics at least ten (10) business days prior
to entering into such Sublicense and will provide to Progenics a complete and
final English language copy of each Sublicense within ten (10) business days
after entering into the Sublicense. Wyeth shall remain responsible for the
payment to Progenics of all royalties payable under this Agreement with respect
to Net Sales made by all Wyeth Affiliates or Sublicensees. In connection with
the granting of any Sublicense, Progenics shall provide Wyeth and the
Sublicensee (or prospective Sublicensee), at the request of Wyeth, Progenics’
written confirmation of Wyeth’s ongoing rights under this Agreement, including
the right to grant Sublicenses. Wyeth shall be responsible for the making of
all
payments due, and the making of all reports under this Agreement by reason
of
the sales of any Products by its Sublicensees. Each Sublicensee shall agree
in
writing to keep books and records in accordance with the relevant provisions
of
this Agreement. Wyeth shall ensure that each of its Affiliates and permitted
Sublicensees accepts and complies with all of the terms and conditions of this
Agreement as if they were a party to this Agreement.
2.3.2. Progenics
Right of First Negotiation. Wyeth
hereby grants to Progenics a right of first negotiation to be the Sublicensee
under any Sublicense that Wyeth may elect to grant to any Third Party in any
Major Market Country (other than [*]), but only if Wyeth determines, in its
sole
discretion, that Progenics is capable of performing the activities covered
by
the Sublicense in the relevant country or countries, which right of first
negotiation is granted on the following terms and conditions:
(a) |
General.
Wyeth shall not grant a Sublicense to any Third Party in any Major
Market
Country (other than [*]), unless and until
Wyeth provides a written notice to Progenics (a “Sublicense
Notice”),
which notice will identify the general scope and purpose of the Sublicense
that Wyeth proposes to grant and the Major Market Country or Countries
to
which it will apply and will either (A) invite Progenics to negotiate
regarding such a Sublicense; or (B) inform Progenics that Wyeth has
determined that Progenics is not capable of performing the activities
covered by the proposed Sublicense in the relevant country or countries.
If the Sublicense Notice invites Progenics to negotiate regarding
a
Sublicense, Wyeth shall not grant Sublicense to any Third Party in
the
relevant country or countries
until:
|
(i) |
Progenics
notifies Wyeth that it declines the opportunity to negotiate with
Wyeth
regarding such a Sublicense;
|
(ii) |
Progenics
does not respond to Wyeth within thirty (30) days after receipt of
the
Sublicense Notice; or
|
(iii) |
the
Negotiation Period (as defined below) expires before Wyeth and Progenics
have entered into a Sublicense.
|
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(b) |
Capability
/ Refusal / Failure to Respond.
If
(A) Wyeth determines that Progenics is not capable of performing
the
activities covered by the proposed Sublicense in the relevant country
or
countries, or (B) Progenics responds to the Sublicense Notice by
declining
to negotiate with Wyeth regarding the proposed Sublicense, or (C)
Progenics does not respond to a Sublicense Notice within the thirty
(30)
day period provided for in clause (ii) of Section 2.3.2(a) (General),
then
Wyeth will have no obligation to negotiate with Progenics with respect
to
any Sublicense in the relevant country or countries, and Wyeth will
be
free to grant one or more Sublicense to one or more Third Parties
in such
country or countries at Wyeth’s sole
discretion.
|
(c) |
Consultation
Regarding Capabilities. Wyeth
shall not determine that Progenics is not capable of performing the
activities covered by the proposed Sublicense in the relevant country
or
countries unless and until Wyeth has given Progenics a reasonable
opportunity to make a presentation to Wyeth demonstrating its
capabilities. Once Wyeth has provided such opportunity to Progenics,
however, Wyeth may determine whether Progenics is capable of performing
the activities covered by the Sublicense in the relevant country
or
countries in its sole discretion.
|
(d) |
Negotiation
Period.
If
the Sublicense Notice invites Progenics to negotiate regarding such
a
Sublicense and Progenics notifies Wyeth, within thirty (30) days
after
receipt of the Sublicense Notice that it desires to negotiate with
Wyeth
regarding the proposed a Sublicense, the Parties shall negotiate
in good
faith with each other for sixty (60) days (or such longer period
as
mutually agreed by the parties) (the “Negotiation
Period”)
regarding a mutually satisfactory Sublicense. Neither party shall
be
obligated to enter into a Sublicense.
In
the event that the Negotiation Period expires before Wyeth and Progenics
have entered into a Sublicense, Wyeth
will have no further obligation to negotiate with Progenics with
respect
to any Sublicense in the relevant country or countries, and Wyeth
will be
free to grant one or more Sublicenses to one or more Third Parties
in such
country or countries at Wyeth’s sole discretion, subject to the terms and
conditions of Section 2.3.1
(Sublicenses; General). However, if negotiations between the Parties
end
without the Parties executing a Sublicense agreement for such country
or
countries, then Wyeth shall not enter into any Sublicense of comparable
scope in such country or countries containing financial terms that
are
more favorable to the third party than the financial terms that Progenics
last offered to Wyeth during the Negotiation Period without first
offering
Progenics such Sublicense containing such financial terms; provided,
however,
that Wyeth shall not be obligated to first offer such more favorable
financial terms to Progenics if Wyeth determines, in its sole discretion,
that Progenics is no longer capable of performing the activities
covered
by the Sublicense in the relevant country or countries after once
again
giving Progenics an opportunity to make a presentation to Wyeth in
accordance with Section 2.3.2(c)
(Consultation Regarding Capabilities).
|
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(e) |
Termination
of Right.
The right of first negotiation granted to Progenics in this Section
2.3.2
(Progenics Right of First Negotiation) shall be extinguished upon
the
occurrence of a Progenics Change of
Control.
|
2.3.3. Non-Royalty
Sublicense Income. Wyeth
shall pay Progenics [*] percent
([15]%) of all Non-Royalty Sublicense Income that Wyeth and its Affiliates
receive from Sublicensees. Wyeth shall pay Progenics the required percentage
of
Non-Royalty Sublicense Income within [*] ([*]) days of receiving such
Non-Royalty Sublicense Income.
2.4. Direct
Licenses to Affiliates.
Wyeth
may at any time request and authorize Progenics to grant licenses as to
countries outside the United States directly to Affiliates of Wyeth outside
the
United States by giving written notice designating to whom a direct license
is
to be granted. Upon receipt of any such notice, Progenics shall enter into
and
sign a separate direct license agreement with such designated Affiliate of
Wyeth. All such direct license agreements shall be consistent with the terms
and
conditions of this Agreement, except for such modifications as may be required
by the laws and regulations in the country in which the direct license will
be
exercised; provided,
however,
that
Progenics shall have no obligation to enter into any such direct license
agreement if the effect of entering into such agreement (and continuing as
a
Party to this Agreement) would be to increase the level of obligations owed
by
or risks assumed by Progenics, or decrease the consideration owed to Progenics,
relative to the obligations owed by, risks assumed by, or consideration owed
to
Progenics under this Agreement or otherwise adversely affect Progenics. In
countries where validity of the direct license agreement requires prior
government approval or registration, such direct license agreement shall not
become binding between the parties thereto until such approval or registration
is granted, which approval or registration shall be obtained by Wyeth. All
costs
of making a direct license, including Progenics' reasonable attorneys fees,
under this Section 2.4
shall be
borne by Wyeth.
Wyeth
shall be responsible to Progenics for the performance of its Affiliates under
these direct licenses.
2.5. Fully
Paid-Up, Royalty Free License.
After
expiration of the Royalty Period for any Product in a country, including any
extended period under Section 6.5.2 (Extended Exclusivity Based on Wyeth
Independent Patent Rights), the license granted to Wyeth under Section
2.1
(Exclusive License from Progenics to Wyeth) with respect to such Product in
such
country shall be a fully paid-up, perpetual, non-exclusive, irrevocable,
royalty-free license, provided,
however,
in the
event that the Royalty Period is resumed under the provisions of Section
1.59
(Royalty
Period) the license granted to Wyeth shall revert to its original form until
the
Royalty Period resumption ends.
2.6. 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 Wyeth. Without the prior
written consent of Wyeth, Progenics shall not voluntarily (i) amend or modify,
or consent to any action that may be taken under, any Progenics Third Party
Agreement, the effect of which would adversely affect Wyeth’s rights under this
Agreement, or (ii) terminate or engage in any act or omission that constitutes
or would constitute, with or without the giving of notice or the passage of
time, an event that would permit the licensor under the Progenics Third Party
Agreements to
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terminate
the Progenics Third Party Agreements. Progenics shall immediately notify Wyeth
of any such event or of the receipt by Progenics of any notice of breach or
termination of any Progenics Third Party Agreement. Progenics shall take all
reasonable actions necessary, or permit such actions to be taken in its name
by
Wyeth, to maintain and enforce Progenics' rights under the Progenics Third
Party
Agreements in a manner consistent with the terms of this Agreement. Wyeth
will reimburse Progenics for any non-de
minimis
out-of-pocket expenses incurred by Progenics to comply with the previous
sentence.
2.7. Know-How
Transfer.
2.7.1. Disclosure
of Know-How. Commencing
promptly after the Effective Date, Progenics shall disclose the then existing
Progenics Know-How to Wyeth. During the Term of the Agreement, Progenics shall
disclose to Wyeth all Progenics Know-How and Joint Know-How that is developed
by
Progenics or otherwise comes into Progenics’ Control other than Know-How related
exclusively to the Excluded Molecules. Furthermore, during the Term of the
Agreement, Wyeth shall disclose to Progenics any Joint Know-How and Wyeth
Collaboration Know-How that is related to Progenics Development and
Commercialization activities under the Agreement or that the JDC or JSC
determines should be disclosed to Progenics. Any such Know-How disclosure shall
be accomplished through periodic delivery of documentation and
meetings/telephone calls on a reasonable schedule agreed by the Parties in
accordance with Section 2.7.2
(Transfer of Know-How).
2.7.2. Transfer
of Know-How.
Without
limiting the generality of Section 2.7.1
(Disclosure of Know-How), on a mutually agreed periodic basis or at a Party’s
request within a reasonable time not to exceed thirty (30) days from the date
of
the request, each Party shall deliver to the requesting Party copies (for
documentation and information) or samples (for tangible materials) of any
documents,
files, diagrams, plans, specifications, designs, recipes, schematics, reports,
notes, data, models, prototypes, chemical or biological materials, or other
documentation or tangible materials recording or embodying the Know-How in
its
possession required to be disclosed to the requesting Party pursuant to Section
2.7.1
(Disclosure of Know-How) or otherwise under this Agreement. In
addition, on a mutually agreed periodic basis or at a Party’s request,
technically qualified scientists and engineers from each Party will meet and/or
participate in telephone conference calls on a reasonable mutually agreed
schedule as reasonably necessary to fully disclose all such Know-How. An officer
of Progenics and a representative of Wyeth shall mutually agree from time to
time on the most appropriate method for the disclosure of Know-How between
the
Parties.
2.8. [*].
2.9. 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 face-to-face no less than three times per year in
the
first two years following the Effective Date, and twice per year thereafter,
with additional meetings to be called by either co-chairperson of the JSC on
an
ad-hoc basis. The JDC shall meet face-to-face no less than three times annually,
with additional meetings to be called by either co-chairperson of the JDC on
an
ad-hoc basis. The JCC shall meet face-to-face no less than three times annually
through the first two years after the First Commercial Sale of a Product in
the
U.S., and thereafter no less than twice annually, with additional meetings
to be
called by the chairperson of the JCC or, as necessary, Progenics on an ad hoc
basis. Ad-hoc meetings may be held face-to-face, by teleconference, video or
Webex, as determined by the Committee chairpersons. Each face-to-face meeting
of
the JSC and JDC shall be held alternatively at Wyeth’s facilities in
Collegeville, Pennsylvania and Progenics’ facilities in Tarrytown, New York or
at such locations as the Committee may otherwise agree. Each face-to-face
meeting of the JCC shall be held at Wyeth’s facilities in Collegeville,
Pennsylvania or at such locations as the JCC may otherwise agree. Other
employees of each Party involved in the Development, Commercialization or
intellectual property protection of Products may attend meetings of such
Committee as non-voting participants with the permission of the co-chairpersons,
and, with the consent of each Party, consultants, representatives, or advisors
involved in the same activities may attend meetings of such Committee as
non-voting observers; provided,
however,
that
such Third Party representatives are under obligations of confidentiality and
non-use applicable to the Confidential Information of each Party that are at
least as stringent as those set forth in Section 8 (Confidentiality).
Each Party shall be responsible for all its own expenses of participating in
any
Committee.
3.1.3. Decision
Making. Each
Party’s designees on the JSC and JDC 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,
each of
the JSC and JDC shall decide as to all matters within its jurisdiction by
unanimous Party Vote; provided,
however,
that
neither the JSC nor the JDC shall have the authority to amend or modify, or
waive compliance with, this Agreement. In the event of a tie Party Vote of
the
designees of Wyeth and Progenics on the JDC as to matters within such the
jurisdiction of such Committee, the co-chairpersons of the JDC shall refer
the
matter to
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the
JSC
for resolution. In the event that such a matter cannot be resolved by the JSC
within ten (10) business days of it being referred to the JSC, or in the event
of a tie Party Vote of the designees of Wyeth 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 within [*] ([*]) business days, then the matter
shall be referred to the [*]. If after good faith discussions by the [*],
agreement cannot be reached within [*] ([*]) business days, then the [*] shall
decide upon a mechanism to resolve the matter.
3.1.4. Meeting
Agendas.
Each
Party will have an equal right to place items on the JSC and JDC agendas through
the co-chairperson of the JSC or JDC designated by such Party. Wyeth shall
generally set the agenda for the JCC, but Progenics may place particular topics
on the agenda for discussion at any JCC meeting by giving the JCC chairperson
written notice of Progenics’ desire to discuss such topic. Each Party will
disclose to the other Party its proposed agenda items along with appropriate
information at least five (5) business days in advance of each Committee
meeting; provided,
however,
that
under exigent circumstances requiring JSC or JDC input, a Party may provide
its
agenda items for a JSC or JDC 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 or JDC 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 or JDC meeting.
3.2. Joint
Steering Committee (JSC).
3.2.1. Formation
and Purpose. Within
fifteen (15) days after the Effective Date, Wyeth and Progenics shall establish
the JSC, which shall coordinate the Parties’ key activities under this Agreement
and have the additional responsibilities provided for in this
Agreement.
The JSC
will dissolve upon the expiration of the Term of this Agreement.
3.2.2. Membership
and Chairpersons. Each
party shall designate two (2) senior executives 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 Wyeth 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 thirty (30) 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 without
limitation:
(a) [*];
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(b) [*];
(c) [*];
(d) [*];
(e) [*];
(f) [*];
(g) [*];
(h) [*];
and
(i) [*].
3.3. Joint
Development Committee (JDC).
3.3.1. Formation
and Purpose.
Within
fifteen (15) days after the Effective Date, the Parties shall establish the
JDC,
which shall oversee, coordinate and expedite the Development of, and the making
of regulatory submissions for, the Products in order to obtain Regulatory
Approvals. At any time that any Products are 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,
excluding Phase 4 Clinical Trials which shall be the sole responsibility of
Wyeth.
3.3.2. Membership
and Chairpersons. Each
Party shall designate three (3) 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 Wyeth. 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 thirty (30) 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.
3.3.3. Specific
Responsibilities of the JDC.
The JDC
shall have responsibility for overseeing, coordinating and expediting the
Development of the Compound and the Products, including without
limitation:
(a) [*];
(b) [*];
(c) [*];
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(d) [*];
(e) [*];
(f) [*];
(g) [*];
(h) [*];
(i) [*];
(j) [*];
and
(k) [*].
3.3.4. Working
Groups.
From
time to time the JDC may establish and delegate duties to other committees,
sub-committees, or directed teams (each a “Working
Group”)
on an
“as needed” basis to oversee particular projects or activities. Each such
Working Group shall be constituted and shall operate as the JDC determines.
Working Groups may be established on an ad hoc basis for purposes of a specific
project for the life of a Product, or on such other basis as the applicable
Committee may determine. Each Working Group and its activities shall be subject
to the oversight, review and approval of, and shall report to the JDC. In no
event shall the authority of any Working Group exceed that specified for the
JDC
in this Section 3 (Governance
of the Collaboration).
3.4. Joint
Commercialization Committee (JCC).
3.4.1. Formation
of JCC.
Within
sixty (60) days of the Effective Date, the Parties shall establish the JCC,
which shall facilitate the exchange of information between the Parties regarding
the Commercialization of the Products.
3.4.2. Membership.
The
JCC
shall be composed of representatives selected by both Parties in number and
function according to the responsibilities of each Party. The chairperson of
the
JCC shall be designated by Wyeth.
3.4.3. Responsibilities
of the JCC.
The JCC
shall have responsibility for facilitating open communication between the
Parties on matters relating to the Commercialization of Products. The JCC shall
not be a voting body. Decisions with respect to Commercialization of the Product
will be made solely by Wyeth consistent with this Agreement and the Co-Promotion
Agreement.
4. |
DEVELOPMENT
|
4.1. Development
Plan. The
Development of the Products will be conducted by or on behalf of the Parties
pursuant to a mutually agreed development plan that will govern all aspects
of
Development of the Products worldwide (as such plan is in effect from time
to
time, the
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“Development
Plan”).
An
outline of the initial Development Plan for a SC Product, IV Product and Oral
Product has been agreed by the Parties. This outline shall not include a
development plan for [*]. The JDC shall be responsible for reviewing and
endorsing the Development Plan. The Development Plan for the Products shall
be
updated on an as-needed basis, but in no event less than once
annually.
The
Parties shall cause the JDC to complete the initial Development Plan for the
SC
Product, IV Product and Oral Product within ninety (90) days of the Effective
Date. [*]. In addition, unless such information is included in the Development
Plan itself, with each update of the Development Plan Wyeth shall provide the
JDC with a written summary of the human resources that Wyeth expects to deploy
to accomplish its responsibilities under the Development Plan.
4.2. Development
Responsibilities of the Parties.
4.2.1. Progenics
Development Responsibilities.
Progenics shall be responsible for and shall use Commercially Reasonable Efforts
to:
(a) Develop
the SC Product and the IV Product in the United States in accordance with the
Development Plan and the Progenics Development Cost Budget until these Products
receive Regulatory Marketing Approval in the U.S., including without limitation
(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 SC Product and IV Product;
(b) perform
the work to be performed by Progenics under the Development Plan in accordance
with their estimated timelines;
(c) perform
any other work necessary and appropriate as determined by the JDC and otherwise
cooperate with Wyeth in support of Wyeth’s efforts under the Development
Plan;
(d) disclose
to Wyeth all data, information and other Progenics Know-How and Joint Know-How
reasonably necessary in support of Development of the Products; and
(e) manufacture
through contract manufacturers (approved in the Development Plan or by agreement
of the Parties) 100% of the Parties’ requirements of the Compound and/or
Products for Development; it being understood and agreed that any Compound
and/or Product supplied by Progenics for clinical use shall be manufactured
under GMP conditions. The Parties will transfer responsibility for the supply
of
the Compound and or Products for Development to Wyeth at a mutually agreed
time
as soon as reasonably and commercially practicable consistent with Progenics’
current contractual obligations. The
Parties will enter into a Quality Agreement for clinical trial supplies of
Compound and/or Product within sixty (60) days of the Effective
Date.
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4.2.2. Wyeth
Development Responsibilities.
Wyeth
shall be responsible for and shall use Commercially Reasonable Efforts
to:
(a) Develop
the Oral Product in the Territory in accordance with the Development Plan,
including without limitation (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 Oral Product;
(b) Develop
the SC Product and IV Product outside the United States in accordance with
the
Development Plan, including without limitation (i) preparing and submitting
and/or revising and amending Registrational Filings, (ii) conducting and
managing all clinical trials included in the Development Plan, and (ii)
obtaining and maintaining Regulatory Approvals for the SC Product and IV
Product;
(c) perform
the work to be performed by Wyeth under the Development Plan in accordance
with
their estimated timelines;
(d) perform
any other work necessary and appropriate as determined by the JDC and otherwise
cooperate with Progenics in support of Progenics' efforts under the Development
Plan;
(e) disclose
to Progenics all data, information and other Wyeth Collaboration Know-How and
Joint Know-How reasonably necessary in support of Development of the Products;
(f) determine,
in Wyeth’s sole discretion, whether to perform any Phase 4 Clinical Trials for
any Product, and conduct and manage any such Phase 4 Clinical Trial and any
Phase 4 Clinical Trial required by any Regulatory Authority;
(g) if
the
JSC determines to Develop any Combination Product or Product formulation other
than the Oral Product, SC Product or IV Product, or any other indication for
a
Product, Develop such Product or indication in accordance with the Development
Plan, including without limitation (i) preparing and submitting and/or revising
and amending Registrational Filings for such Product, (ii) conducting and
managing all clinical trials included in the Development Plan for such Products,
and (iii) obtaining and maintaining Regulatory Approvals for such Products;
and
(h) upon
the
transfer of responsibility for the supply of the Compound and/or Products for
Development from Progenics to Wyeth as required by 4.2.1(e)
(Progenics Development Responsibilities) and the transfer of Know-How and the
assignment of agreements as required by Section 5.3.2
(Transfer of Manufacturing Know-How) and 5.3.3
(Assignment of Supply and License Agreements), manufacture either directly
through a contract manufacturer
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100%
of
the Parties’ requirements of Compound and/or Products for Development, it being
understood that all Compound and/or Product supplied by Wyeth for clinical
use
shall be manufactured under GMP conditions.
4.2.3. Efforts.
Wyeth’s
obligations under Section 4.2.2 (Wyeth Development Responsibilities) to use
Commercially Reasonable Efforts will be satisfied if Wyeth uses Commercially
Reasonable Efforts in the Major Market Countries. Wyeth shall not be in breach
of its obligation under this Section 4.2
(Development Responsibilities of the Parties) for failing to use Commercially
Reasonable Efforts in countries other than the Major Market Countries.
Furthermore, Wyeth shall be relieved of its obligation to use Commercially
Reasonable Efforts in any particular country if a Third Party Controls Patent
Rights that would be infringed by the making, using, or selling of a Product
in
such country and Wyeth or its Affiliates or Sublicensee(s) are unable to obtain
a license under such Patent Rights on commercially reasonable terms or configure
the Product so as to avoid infringement through the use of Commercially
Reasonable Efforts.
4.3. Unforeseen
Events.
The
Parties recognize that the Development Plan and the objectives set forth therein
are based upon numerous assumptions which are not in the control of the Parties.
In view of the numerous assumptions underlying the Development Plan, the
proposed timeframe for achieving the objectives and events described in the
Development Plan will be regularly reviewed by the JDC to reflect unforeseen
matters. In the event that despite the use of Commercially Reasonable Efforts
by
the Parties, safety, toxicology, formulation, manufacturing, regulatory, or
other issues beyond the control of the Parties arise that prevent either Party
from fulfilling the objectives of the Development Plan within the timeframe
set
forth in the Development Plan, the JDC will discuss any appropriate revisions
to
the Development Plan, which revisions the other Party shall not unreasonably
oppose, provided that the Party can demonstrate its use of Commercially
Reasonable Efforts to Develop the Product.
4.4. Subcontracting.
Each
Party may contract with one or more Outside Contractors to perform any or all
of
its obligations under the Development Plan; provided,
however,
that
(i) except as otherwise agreed to by the JDC each Outside Contractor shall
be approved by the JDC for the proposed work, such approval not to be
unreasonably withheld; and (ii) the contracting Party provides the other
Party with a true and accurate copy of each agreement pursuant to which such
Outside Contractor is engaged promptly after execution thereof.
4.5. Records.
Each
Party 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 Products, as consistent with the
responsibilities of such Party under this Agreement, and all results of any
trials, studies and other investigations conducted under this Agreement by
or on
behalf of such Party, and its Affiliates and Outside Contractors, as
applicable.
4.6. Reports
on Development.
For so
long as either Party continues to Develop a Product under this Agreement, it
shall provide the other Party and 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 such Party. In addition, through its representatives on the JDC,
each Party shall make periodic oral reports to
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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.
5.1. Co-Promotion
Option. Subject
to the terms and conditions of this Section 5.1
and the
other provisions of this Agreement, Wyeth hereby grants to Progenics an option
(the "Co-Promotion
Option")
to
enter into a Co-Promotion Agreement with Wyeth substantially in the form
attached to this Agreement as Exhibit
B
(the
“Co-Promotion
Agreement”),
under
which Progenics would detail one or more Products to the defined audiences
in
the Co-Promotion Territory. Progenics
may exercise the Co-Promotion Option by providing Wyeth with written notice
of
exercise of the Co-Promotion Option (which notice shall indicate the initial
number of sales representatives that Progenics desires to field), at least
[*]
([*]) months prior to the beginning of the Calendar Year during which Progenics
wishes to co-promote the Products, except in the case where Progenics wishes
to
commence co-promotion with the launch of a Product, in which case Progenics
shall provide Wyeth with written notice no later than [*] ([*]) days after
the
filing of the NDA related to the Product. Upon the exercise of the Co-Promotion
Option, the Parties shall promptly enter into the Co-Promotion
Agreement.
5.2. Wyeth’s
Commercialization Responsibilities and Efforts.
5.2.1. Responsibilities.
Wyeth
shall be responsible for the Commercialization of the SC, IV and Oral Products
and such other Products as the JSC shall determine it is advisable to Develop
throughout the Territory and, subject to Section 6.2 (Post-Effective Date
Development Expenses), shall pay 100% of the costs of Commercialization of
the
Products. Except as provided in the Co-Promotion Agreement, Wyeth shall be
solely responsible for the Commercialization of Products throughout the
Territory. Without limiting the foregoing, Wyeth shall be solely responsible
for
distribution and pricing of Products and shall book all sales of Products in
the
Territory.
§ Efforts.
Wyeth
shall use Commercially Reasonable Efforts to pre-launch, launch, promote,
market, distribute, sell in finished pharmaceutical form, and otherwise
Commercialize Products in the Territory. Commercially Reasonable Efforts
expended by a Sublicensee in a given country which is not a Major Market Country
shall satisfy Wyeth’s efforts obligations in that country. Wyeth’s
Commercialization efforts shall include, without limitation, using Commercially
Reasonable Efforts to commit sales, marketing and detail resources and provide
marketing and promotional materials and efforts for the Products. Wyeth’s
obligations under this Section 5.2 (Wyeth’s Commercialization Responsibilities
and Efforts) to use Commercially Reasonable Efforts will be satisfied if Wyeth
uses Commercially Reasonable Efforts in the Major Market Countries. Wyeth shall
not be in breach of its obligation under this Section 5.2
(Wyeth’s
Commercialization Responsibilities and Efforts) for failing to use Commercially
Reasonable Efforts outside the Major Market Countries. Furthermore, Wyeth shall
be relieved of its obligation to use Commercially Reasonable Efforts with
respect to a Product in any particular country if a Third Party Controls Patent
Rights that would be infringed by the making, using, or selling of such Product
in such country and
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Wyeth
or
its Affiliates or Sublicensee(s) are unable to obtain a license under such
Patent Rights on commercially reasonable terms or configure the Product so
as to
avoid infringement through the use of Commercially Reasonable
Efforts.
5.3. Supply.
5.3.1. Supply.
Wyeth
shall be solely responsible at its expense for the manufacture and supply of
100% of the Compound and finished Products for Commercialization both as bulk
active pharmaceutical ingredient (API) and as finished and packaged
products.
5.3.2. Transfer
of Manufacturing Know-How. Progenics
will disclose to Wyeth, a Wyeth Affiliate, and/or Wyeth’s Third Party contract
manufacturer all relevant Progenics Know-How relating to the manufacture of
the
Compound and/or Products. Without limiting the generality of the foregoing,
at
Wyeth’s request, Progenics will deliver to Wyeth, a Wyeth Affiliate, and/or
Wyeth’s Third Party contract manufacturer copies (for documents and information)
and samples (for materials) of any documents,
files, diagrams, plans, specifications, designs, recipes, schematics, reports,
models, prototypes, chemical or biologic materials, or other tangible
documentation or material in Progenics’ possession relating to the manufacture
of the Compound and Products.
In
addition, at Wyeth’s request, and on a commercially reasonable schedule and at a
commercially reasonable venue to be agreed on by the Parties, technically
qualified personnel from each Party will meet and/or participate in telephone
conference calls as reasonably necessary to exchange knowledge necessary to
fully disclose all such Progenics Know-How.
5.3.3. Assignment
of Supply and License Agreements.
At
Wyeth’s written request in connection with the transfer of responsibility for
manufacture under Section 4.2.1(e)
(Progenics Development Responsibilities), Progenics shall use Commercially
Reasonable Efforts to promptly assign and transfer to Wyeth any existing supply
agreements related to the supply of the Compound or the Products, including
its
supply agreements with Mallinckrodt Inc. and
DSM
Pharmaceuticals,
Inc. Furthermore, to the extent necessary to permit Wyeth to manufacture the
Compound and Products as contemplated by this Agreement, Progenics shall use
Commercially Reasonable Efforts to Sublicense to Wyeth any license agreement
under which Progenics licenses any intellectual property rights from any Third
Party related to the manufacture of the Compound or the Products. If the terms
of any of the agreements referred to in the previous two sentences require
the
consent of the other party thereto to affect its assignment, then upon Wyeth’s
request for an assignment, until Progenics is able to obtain such consent and
affect such assignment Progenics will exercise its rights under such agreements
for the benefit of Wyeth and as reasonably requested by Wyeth. In the event
of
any assignment to Wyeth under this Section 5.3.3,
Wyeth
shall assume full responsibility for satisfying all obligations of Progenics
under any assigned agreement to the extent arising after such assignment and
assumption.
5.4. Marketing
Materials and Corporate Branding.
Wyeth
shall be solely responsible at its expense for all pre-marketing and marketing
efforts and for creating all
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packaging
and promotional materials for the Products. Subject to Progenics’ reasonable
approval, the corporate name of Progenics shall appear on all Product packaging
in the Territory and the Progenics corporate name and logo shall appear on
the
package insert for all Products in the Co-Promotion Territory, subject, in
each
case, to compliance with applicable law and regulatory requirements.
In
addition, if the Parties enter into the Co-Promotion Agreement, the Progenics
corporate name and logo shall appear on all promotional materials for the
Products in the Co-Promotion Territory, subject to compliance with applicable
law and regulatory requirements.
5.5. Sharing
of Information; Progenics Commercial Organization.
5.5.1. Sharing
of Information. Wyeth
shall provide Progenics with a copy of Wyeth’s commercialization plan for the
Products and any updates thereof, including without limitation information
regarding strategies for Commercialization and detailing of Products, market
research and strategy, promotional activities, and sales plans and forecasts,
and shall report to Progenics on the progress in its implementation of the
commercialization plan through the JCC. Commencing on the Effective Date,
Progenics shall have the right to have a representative of Progenics attend
meetings of Wyeth’s sales and marketing team for the Product at Progenics’
expense.
All such
commercial information shall be Wyeth’s Confidential Information for the
purposes of Section 8.1
(Confidentiality).
5.5.2. Progenics
Commercial Goals. Wyeth
recognizes Progenics’ long term desire to build a commercial organization and
shall assist Progenics in Progenics’ planning to establish its commercial
organization. Commencing on the Effective Date, Progenics shall have the right
to have a representative of Progenics participate as a regular, full-time member
of the Wyeth brand team for the Products at Progenics’ expense. Wyeth shall
provide such Progenics representative with a regular office at its Collegeville,
PA facility to facilitate his or her participation on the brand team, but such
representative shall at all times remain a Progenics employee.
6. |
PAYMENTS
BY WYETH TO PROGENICS.
|
6.1. Reimbursement
of Pre-Effective Date Development Costs.
Wyeth
shall pay Progenics sixty million dollars ($60,000,000) within five (5) business
days of the Effective Date as partial reimbursement of research and development
costs incurred by Progenics to Develop the Compound prior to the Effective
Date.
This
payment is nonrefundable and noncreditable.
6.2. Post-Effective
Date Development Costs.
6.2.1. Assumption
of Progenics Development Costs.
Beginning on January 1, 2006, Wyeth shall reimburse to Progenics 100% of the
Progenics Development Costs in addition to paying 100% of Wyeth’s own
Development costs and expenses,
subject
to the terms and conditions of this Section 6.2.
6.2.2. Payment
of Expenses; Development Accounts; Reimbursement.
Progenics shall be responsible and pay for all Progenics Development Costs,
subject to
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reimbursement
by Wyeth as provided in this Section 6.2
(Post-Effective Date Development Expenses). Subject to the limitations set
forth
in Section 6.2.3
(Expense
Limitations), Progenics shall charge all Progenics Development Costs incurred
by
it or its Affiliates to a separate account created by Progenics on its books
and
records solely for the purpose of tracking Progenics Development Costs (the
“Development
Account”).
Before the start of each Calendar Quarter, Progenics shall submit to Wyeth,
based on the most recent Progenics Development Cost Budget approved by the
JSC
or agreed by the Parties, a written good faith estimate of expenses that will
be
charged to its Development Account during such Calendar Quarter. Wyeth shall
pay
to Progenics the amount of that estimate (the “Estimated
Quarterly Development Costs”)
within
thirty (30) days of start of the Calendar Quarter. Within fifteen (15) days
after the end of each Calendar Quarter, Progenics shall submit to the Wyeth
a
written summary of all expenses actually charged to its Development Account
during such Calendar Quarter together with reasonable supporting documentation
for such expenses (the summary and documentation, collectively, the
“Development
Cost Summary”).
If
the estimated payment for that Calendar Quarter was less than the amount of
Progenics Development Costs actually incurred by Progenics in that Calendar
Quarter, Wyeth shall make a reconciling payment to Progenics at the same time
as
Wyeth pays Progenics Estimated Quarterly Development Costs for the following
Calendar Quarter. If the estimated payment for that Calendar Quarter was more
than the amount of Progenics Development Costs actually incurred by Progenics
in
that Calendar Quarter, Wyeth shall offset the amount of such excess against
the
payment of the Estimated Quarterly Development Costs for the following Calendar
Quarter.
If
Progenics fails to submit the Development Cost Summary for a Calendar Quarter
within fifteen (15) days of the end of such Calendar Quarter as required by
this
Section 6.2.2,
then
Wyeth may delay payment of the Estimated Progenics Development Costs for the
following Calendar Quarter by the number of days that such Development Cost
Summary is late.
6.2.3. Expense
Limitations and Progenics Development Cost Budget.
Wyeth
shall not be required to reimburse Progenics for any Progenics Development
Costs
to the extent that they exceed the amount budgeted for that Calendar Year in
the
most recent Progenics Development Cost Budget approved by the JSC or agreed
by
the Parties, unless the JDC approves such excess Progenics Development Costs.
The efforts of the employees of Progenics or its Affiliates in performing
activities under this Agreement shall be charged to Progenics’ Development
Account at the FTE Rate. Only those efforts that are contemplated by the
applicable Development Plan shall be chargeable by Progenics to its Development
Account. All payments made by Progenics to a Third Party in connection with
the
performance of its activities under a Development Plan shall be charged to
Progenics’ Development Account at Progenics’ actual out-of-pocket
cost.
At the
time of the annual update of the Development Plan for the Products, the
Progenics Development Cost Budget shall also be approved, as determined by
the
JSC. If the JSC is unable to agree on any changes to the Progenics Development
Cost Budget, then Progenics shall be entitled to continue its spending for
activities budgeted in the most recent Progenics Development Cost Budget
approved by the JSC or agreed by the Parties for which Wyeth shall reimburse
Progenics in
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accordance
with Section 6.2.2 (Payment of Expenses; Development Accounts;
Reimbursement).
6.2.4. Payments
Under Third Party Agreements.
Progenics shall be solely responsible for all obligations under the Progenics
Third Party Agreements (including, without limitation, any such obligations
that
relate to the Progenics Technology). Wyeth shall be solely responsible for
any
obligations under agreements with Third Parties entered into by Wyeth or its
Affiliates or its Sublicensees after the Effective Date related to the
Development or Commercialization of the Products. As to the [*], Progenics
shall
be responsible for [*] under the [*] if no Product is developed that would
require the payment of a royalty under the [*]. In the event that the JSC
determines to Develop a Product that [*], Wyeth shall [*].
6.2.5. Records
and Audits.
Progenics shall keep and maintain accurate and complete records showing the
expenses incurred by it in performing its activities under the Development
Plan
during the three (3) preceding Calendar Years, which books and records shall
be
in sufficient detail such that Development Expenses can accurately be
determined. Upon fifteen (15) days prior written notice from Wyeth, Progenics
shall permit an independent certified public accounting firm of nationally
recognized standing, selected by Wyeth and reasonably acceptable to Progenics,
to examine, at Wyeth’s sole expense, the relevant books and records of Progenics
and its Affiliates as may be reasonably necessary to verify the reports
submitted by the Audited Party in accordance with Section 6.2.2
(Payment
of Expenses; Development Accounts; Reimbursement). An examination by Wyeth
under
this Section 6.2.5 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 three (3) years before the date of the request. The accounting firm
shall be provided access to such books and records at Progenics’ facility(ies)
where such books and records are normally kept and such examination shall be
conducted during Progenics’ normal business hours. Progenics’ may require the
accounting firm to sign a standard non-disclosure agreement before providing
the
accounting firm access to the Audited Party’s facilities or records. Upon
completion of the audit, the accounting firm shall provide both Wyeth and
Progenics a written report disclosing whether the reports submitted by Progenics
are correct or incorrect and the specific details concerning any discrepancies.
No other information shall be provided to Wyeth. If the accounting firm
concludes that Progenics overstated its Development Expenses and Wyeth overpaid
Progenics for Progenics Development Costs as a result, Progenics shall promptly
pay Wyeth the amount of such overpayment 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 two percent (2%) per annum. Additionally, if the
accounting firm concludes that any report submitted by Progenics overstated
the
Progenics Development Costs by more than [*] percent ([*]%), Progenics shall
reimburse Wyeth for the out-of-pocket expenses incurred by Wyeth in conducting
the audit. Wyeth shall not reveal to such accounting firm the conditions under
which the audit expenses are to be reimbursed hereunder. If the accounting
firm
concludes that Progenics understated its Development Expenses and Wyeth
underpaid
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Progenics
for Progenics Development Costs as a result, Wyeth shall promptly pay such
amount to Progenics, without interest.
6.2.6. Confidentiality.
All
financial information of Progenics which is subject to review under this Section
6
(Payments by Wyeth to Progenics) shall be deemed to be Progenics’ Confidential
Information subject to the provisions of Section 8
(Confidentiality) hereof, and Wyeth 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
Wyeth to Progenics hereunder; provided,
however,
that
such Confidential Information may be disclosed by Wyeth to Third Parties only
to
the extent necessary to enforce Wyeth's rights under this
Agreement.
6.3. Development
Payments.
In
partial consideration for the licenses granted to Wyeth under Section
2
(License
Grants and Related Matters) hereof, Wyeth shall pay to Progenics the following
one-time nonrefundable, noncreditable research and development payments
(“Development
Payments”)
within
thirty (30) days of the satisfaction of each of the following conditions.
[*].
Condition
|
Payment
|
SC
Product:
|
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
IV
Product:
|
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
Oral
Product:
|
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
29
· [*]
|
$[*]
|
· [*]
|
$[*]
|
*
Condition satisfied only upon the occurrence of both (a) Regulatory Marketing
Approval and (b) the earlier of Regulatory Pricing Approval or the First
Commercial Sale of the applicable Product.
+
No
Development Payment will be due to Progenics under this Agreement for the
achievement of these milestones in [*] if the license granted to Wyeth under
Section 2.1
(Exclusive License from Progenics to Wyeth) terminates with respect to [*]
and
rights to Develop and Commercialize the Products in [*] revert to Progenics
pursuant to Section 2.8
([*]).
6.4. Commercialization
Milestone Payments. In
partial consideration for the licenses granted to Wyeth under Section
2
(License
Grants and Related Matters) hereof, Wyeth shall pay to Progenics the following
one-time nonrefundable, noncreditable commercialization milestone payments
(“Commercialization
Payments”)
within
thirty (30) days of the satisfaction of each of the following conditions. Each
Commercialization Payment is payable one time only, regardless of the number
of
times the condition is satisfied.
Condition
|
Payment
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
· [*]
|
$[*]
|
6.5. Royalty
Payments.
6.5.1. Royalties.
In
partial consideration for the licenses granted to Wyeth under Section
2
(License
Grants and Related Matters) hereof, during the Royalty Period, Wyeth shall
pay
to Progenics royalties in the amount of the Applicable Net Sales Percentage
(as
set forth below) of the Net Sales made during the Royalty Period, which
Applicable Net Sales Percentage will increase as Net Sales of Products in the
relevant territory increase during each Calendar Year during the Royalty Period
as follows:
U.S.
Combined Net Sales of
All
Products
|
Applicable
Net Sales
Percentage
|
[*]
|
[*]%
|
[*]
|
[*]%
|
[*]
|
[*]%
|
[*]
|
[*]%
|
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
30
[*]
|
[*]%
|
Ex-U.S.
Worldwide Combined Net
Sales
of All Products
|
Applicable
Net Sales
Percentage
|
[*]
|
[*]%
|
[*]
|
[*]%
|
[*]
|
[*]%
|
6.5.2. Extended
Exclusivity Based on Wyeth Independent Patent Rights.
If the
Royalty Period has expired (and has not resumed) for a particular Product in
a
particular country but (A) the manufacture, use, sale, or importation of such
Product by an unlicensed Third Party in such country would infringe a Valid
Claim of a Wyeth Independent Patent Right, and (B) no Third Party has yet
offered for sale any Unauthorized Generic Product with respect to the particular
Product in such country, then
Wyeth
shall pay to Progenics royalties in an amount equal to [*] percent ([*]%) of
the
Net Sales of such Product in such country for so long as such Product continues
to be covered by a Valid Claim of a Wyeth Independent Patent and there is no
such Unauthorized Generic Product in such country.
6.5.3. Disclaimers.
Each
Party acknowledges and agrees that nothing in this Agreement (including, without
limitation, any exhibits or attachments hereto) shall be construed as
representing an estimate or projection of either (a) the number of Products
that
will or may be successfully Developed or Commercialized or (b) anticipated
sales
or the actual value of any Product. EACH PARTY MAKES NO REPRESENTATION OR
WARRANTY, EITHER EXPRESS OR IMPLIED, THAT IT WILL BE ABLE TO SUCCESSFULLY
DEVELOP OR COMMERCIALIZE ANY PRODUCT OR, IF COMMERCIALIZED, THAT ANY SUCH
PRODUCT WILL ACHIEVE ANY PARTICULAR SALES LEVEL, OR THAT, EXCEPT AS EXPRESSLY
AGREED IN THIS AGREEMENT, ANY DEVELOPMENT PLAN, THE CO-PROMOTION AGREEMENT
OR
THE SAFETY AGREEMENT, IT WILL DEVOTE ANY LEVEL OF DILIGENCE OR RESOURCES TO
COMMERCIALIZING ANY SUCH PRODUCT.
6.5.4. Royalty
Adjustments.
The
following adjustments shall be made, on a Product-by-Product and
country-by-country basis, to the royalties payable pursuant to Section 6.5.1
(Royalties) hereof:
(a) Extended
Exclusivity. So
long
as no Person is selling an Unauthorized Generic Product in the U.S., beginning
on [*], the Applicable Net Sales Percentage for all Products in the U.S. shall
be [*] on such anniversary and each subsequent anniversary for a maximum of
[*];
provided,
however,
that in
no event shall the Applicable Net Sales Percentage [*] for Net Sales. For
example, [*]. If any increases under this Section do not occur due to sales
of
an Unauthorized Generic Product, such increases shall be tolled while there
are
sales
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
31
of
an
Unauthorized Generic Product, but shall resume if and when sales of such
Unauthorized Generic Products are discontinued.
(b) Progenics
Third Party Agreements.
In the
event that Progenics fails to pay any amount due under any Third Party Agreement
and Wyeth makes such payment on Progenics’ behalf, Wyeth shall be entitled to
credit such amount against any amount owed by Wyeth to Progenics under this
Agreement.
(c) Wyeth
Third Party Agreements. Wyeth
shall be responsible for all obligations under its agreements with Third Parties
that are (i) in effect as of the Effective Date or (ii) except as provided
below
in this Section 6.5.4(c),
that
are entered into by Wyeth during the Term of this Agreement, and, in each case,
no adjustment to the royalties payable by Wyeth under Section 6.5.1
(Royalties) shall be made on account of any such obligations. Notwithstanding
the foregoing if during the Term of this Agreement, Wyeth enters into an
agreement with a Third Party to license Patent Rights in any country that would,
but for such license, likely be infringed by the Development, manufacture,
use,
sale, offering for sale, importation, exportation or other Commercialization
or
exploitation of one or more Products, then, upon entry into any such agreement
and thereafter, the applicable royalty payable under Section 6.5.1
(Royalties) and 6.5.2
(Extended Exclusivity Based on Wyeth Independent Patent Rights) in such country
shall be reduced by [*] percent ([*]%) of the royalties payable by or on behalf
of Wyeth, its Affiliates and Sublicensees to such Third Party(ies) under such
license agreement resulting from Net Sales of such one or more Products in
such
country; provided,
however,
that
the effective Applicable Net Sales Percentage payable to Progenics under Section
6.5.1
(Royalties) and royalty rate payable under Section 6.5.2 (Extended Exclusively
Based on Wyeth Independent Patent Rights) on Net Sales of Products in such
countries shall not be reduced by more than [*] ([*]) percentage points in
the
aggregate as a result of such reductions.
6.6. Reports
and Payments.
6.6.1. 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.
6.6.2. Royalty
Statements and Payments.
Within
sixty (60) days of the end of each Calendar Quarter, Wyeth shall deliver to
Progenics a report, setting forth in reasonable detail for such Calendar
Quarter, the following information, on a Product-by-Product, country-by-country
and worldwide basis: (a) Net Sales of each Product, (b) in the United States,
the amounts and types of Permitted Deductions taken, (c) in the United States,
the amount and types of Products provided at no charge, and (d) the royalty
due
under this Agreement for the sale of each such Product. No such reports shall
be
due for any such Product before the First Commercial Sale of such Product.
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
32
The
total
royalty due for the sale of all such Products during such Calendar Quarter
shall
be remitted at the time such report is delivered.
6.6.3. 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 Wyeth is so required to make any deduction or
withholding from payments due to Progenics, Wyeth will (i) promptly notify
Progenics of such requirement, (ii) 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
(iii) promptly forward to Progenics an official receipt (or certified copy)
or
other documentation reasonably acceptable to Progenics evidencing such payment
to such authorities.
6.6.4. Currency.
All
amounts payable and calculations under this Agreement shall be in United States
dollars. As applicable, Net Sales and any royalty deductions shall be translated
into United States dollars at the exchange rate used by Wyeth for public
financial accounting purposes in accordance with GAAP. If, due to restrictions
or prohibitions imposed by national or international authority, payments cannot
be made as provided in this Section 6
(Payments by Wyeth to Progenics) with respect to sales occurring outside of
the
United States, the Parties shall consult with a view to finding a prompt and
acceptable solution, and Wyeth will deal with such monies as Progenics may
lawfully direct.
6.6.5. Record
Keeping.
Wyeth
shall keep and shall cause its Affiliates and Sublicensees to keep books and
accounts of record in connection with the sale of Products, 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. Wyeth
and its Affiliates shall maintain such records for a period of at least three
(3) years after the end of the Calendar Quarter in which they were generated,
provided, however, that if any records are in dispute and Wyeth has received
written notice from Progenics of the records which are in dispute, Wyeth shall
keep such records until the dispute is resolved.
6.6.6. Audits.
Upon
thirty (30) days prior written notice from Progenics, Wyeth shall permit an
independent certified public accounting firm of nationally recognized standing
selected by Progenics and reasonably acceptable to Wyeth, to examine, at
Progenics' sole expense, the relevant books and records of Wyeth and its
Affiliates as may be reasonably necessary to verify the amounts reported by
Wyeth in accordance with Section 6.6.2
(Royalty
Statements and Payments) and the payment of royalties under Section 6.5
(Royalty
Payments) and Non-Royalty Sublicensing Income under Section 2.3.3
(Non-Royalty Sublicensing Income). An examination by Progenics under this
Section 6.6.6
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 three
(3)
years before the date of the request. The accounting firm shall be
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
33
provided
access to such books and records at Wyeth’s facility(ies) where such books and
records are normally kept and such examination shall be conducted during Wyeth’s
normal business hours. Wyeth may require the accounting firm to sign a standard
non-disclosure agreement before providing the accounting firm access to Wyeth’s
facilities or records. Upon completion of the audit, the accounting firm shall
provide both Wyeth and Progenics a written report disclosing any discrepancies
in the reports submitted by Wyeth or the royalties paid, and, in each case,
the
specific details concerning any discrepancies. No other information shall be
provided to Progenics.
6.6.7. Underpayments/Overpayments.
If such
accounting firm concludes that additional royalties were due to Progenics,
Wyeth
shall pay to Progenics the additional royalties within forty-five (45) days
of
the date Wyeth 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 two percent (2%) per annum. If such
underpayment exceeds [*] percent ([*]%) of the royalties that were to be paid
to
Progenics, Wyeth 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 Wyeth overpaid royalties
to
Progenics, Progenics will refund such overpayments to Wyeth, within forty-five
(45) days of the date Progenics receives such accountant’s report. No interest
shall be due Wyeth on such overpayment.
6.6.8. Confidentiality.
All
Progress Reports and financial information of Wyeth which is subject to review
under this Section 6
(Payments by Wyeth to Progenics) shall be deemed to be Wyeth’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
Wyeth 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.
7.1.1. Inventorship.
Inventorship
of any invention and any Patent Right claiming such invention shall be
determined in accordance with rules and guidelines regarding inventorship as
established under United States patent law, including case law and regulations
associated therewith.
Authorship of any work subject to copyright protection shall be determined
in
accordance with U.S. Copyright law.
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 Right.
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
34
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.
7.2. Patent
Rights.
7.2.1. Progenics
Patent Rights. Progenics
shall use Commercially Reasonable Efforts to prepare, file, prosecute and
maintain the Progenics Patent Rights (including provoking, instituting or
defending interference, opposition, revocation, reexamination and similar
proceedings related to the Progenics Patent Rights) in all countries requested
by Wyeth consistent with the intellectual property strategy developed by the
JSC
at Wyeth’s expense.
The
Parties shall cause their patent counsel to communicate regularly regarding
the
prosecution and maintenance of the Progenics Patent Rights. Without limiting
the
generality of the foregoing, Progenics shall provide to Wyeth copies of all
communications sent to and received from any patent office pertaining to
Progenics 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 Progenics Patent Rights and provide Wyeth with
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
Progenics Patent Rights (including decisions relating to interference,
opposition, revocation, reexamination and similar proceedings related to the
Progenics Patent Rights), Wyeth shall make such decision. In no event, however,
shall Wyeth instruct Progenics to take any action that would cause Progenics
to
breach any Progenics Third Party Agreement. Wyeth’s rights under this Section
shall be in addition to any other rights and remedies which Wyeth may have
as a
result of Progenics' failure to satisfy its obligations under this
Agreement.
7.2.2. Joint
Patent Rights. The
Parties agree to discuss in good faith and implement a mutually agreeable patent
strategy with respect to all Joint Technology that may be patentable, and shall
cause their patent counsel to communicate regularly regarding the prosecution
and maintenance of the Joint Patent Rights. 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. Progenics shall serve as the lead Party to prosecute and maintain all
applications covering Joint Patent Rights (including provoking,
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
35
instituting
or defending interference, opposition, revocation, reexamination and similar
proceedings related to the Joint Patent Rights) at Wyeth’s expense, 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), Wyeth shall make such decision.
In all cases, each Party shall provide reasonable assistance to the other Party,
at Wyeth’s expense, with respect to any activities determined by Wyeth to be
necessary or desirable to obtain patent protection for such Joint
Technology.
7.2.3. Wyeth
Patent Rights.
Wyeth
shall be solely responsible for the prosecution of the Wyeth Collaboration
Patent Rights and Wyeth Independent Patent Rights and the maintenance of any
patents included within the Wyeth Collaboration Patent Rights and Wyeth
Independent Patent Rights at Wyeth’s expense. However, Wyeth shall provide to
Progenics copies of all communications sent to and received from any patent
office pertaining to the prosecution of Wyeth Collaboration Patent Rights
including, but not limited to, draft patent applications, filing receipts,
office actions, responses and/or amendments, and notices of allowance, and
the
Parties shall cause their patent counsel to communicate regularly in advance
regarding the prosecution of the Wyeth Collaboration Patent Rights.
7.2.4. Orange
Book Listings.
(a) SC
Product and IV Product. At
least
fifteen (15) business days prior to the expiration of the time period under
21
C.F.R. § 314.53 for submitting patent information pertaining to Progenics Patent
Rights or Joint Patent Rights with respect to the SC Product and the IV Product,
Progenics shall submit to Wyeth any such draft submission, including any forms
such as Form FDA 3542, Form FDA 3542a or any equivalent thereof, for Wyeth’s
review and comment. Progenics shall consider in good faith any comments made
by
Wyeth 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, Wyeth shall make such decision.
(b) Oral
Product. At
least
fifteen (15) business days prior to the expiration of the time period under
21
C.F.R. § 314.53 for submitting patent information pertaining to Progenics Patent
Rights or Joint Patent Rights with respect to the Oral Product, Wyeth shall
submit to Progenics any such draft submission, including any forms such as
Form
FDA 3542, Form FDA 3542a or any equivalent thereof, for Wyeth’s review and
comment. Wyeth shall consider in good faith any comments made by Progenics
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, Wyeth shall make such decision.
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
36
7.2.5. Application
for Patent Term Extension. At
least
fifteen (15) business days prior to the expiration of any statutory or other
regulatory time period for submitting an application for patent term extension
pertaining to Progenics Patent Rights and Joint Patent Rights, including
applications for interim extension and supplemental protection certificate
(SPC)
in the U.S. or in any foreign country, Progenics shall submit to Wyeth any
such
draft application for Wyeth’s review and comment. Progenics shall also promptly
provide to Wyeth all correspondences received from any patent office or
regulatory office concerning such application for extension, and Wyeth shall
have at least fifteen (15) business days to review and comment on all
correspondences sent to any patent office or regulatory office pertaining to
such application. Progenics shall consider in good faith any comments made
by
Wyeth 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 including the patent to apply for extension, Wyeth shall
make
such decision.
7.2.6. Enforcement
of Patent Rights.
(a) Notice.
If
either Wyeth or Progenics becomes aware of any infringement, anywhere in the
world, of any issued patent within the Progenics Patent Rights or the 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
infringement by such Third Party.
(b) Enforcement
of Progenics Patent Rights and Joint Patent Rights.
Except
as otherwise provided in this Section 7.2.6(b),
Wyeth shall have the first right but not the obligation, at its own expense,
to
take action to obtain a discontinuance of infringement or bring suit against
a
Third Party infringer of any Progenics Patent Rights or any Joint Patent Rights.
Such right shall remain in effect until ninety (90) days after the date of
notice given under Section 7.2.6(a)
(Notice). Wyeth may join Progenics as a party plaintiff to any such suit,
provided that Wyeth shall bear all the expenses of such suit, including those
reasonable expenses incurred by Progenics as a participant (other than its
own
independent counsel). Wyeth 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 Progenics (not to be unreasonably withheld or delayed)
if such judgment or settlement includes a finding or agreement that any
Progenics Patent Right or Joint Patent Right is invalid, unenforceable, or
not
infringed, grants a Third Party Sublicense other than as permitted by Section
2.3
(Sublicenses), or would enjoin or grant other equitable relief against
Progenics. Wyeth shall bear all the expenses of any such suit brought by Wyeth
claiming infringement of any Progenics Patent Rights or Joint Patent Rights.
If,
after the expiration of the ninety (90) day period, Wyeth has not obtained
a
discontinuance of the infringement of the Progenics Patent Rights or Joint
Patent Rights or filed suit against any such Third Party infringer of the
Progenics Patent Rights or Joint Patent Rights, or provided Progenics with
information and arguments demonstrating to Progenics’ reasonable satisfaction
that there is insufficient basis
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
37
for
the
allegation of such infringement of the Progenics Patent Rights or Joint Patent
Rights, then Progenics shall have the right, but not the obligation, to bring
suit against such Third Party infringer of the Progenics Patent Right or Joint
Patent Right. 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 Wyeth (which consent shall not unreasonably be withheld)
if
such judgment or settlement materially impacts any of Wyeth’s rights under this
Agreement or would enjoin or grant other equitable relief against Wyeth. 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 suit
for infringement of any Progenics Patent Right or Joint Patent Right brought
by
the other Party against a Third Party in accordance with this Section
7.2.6(b)
(Enforcement of Progenics Patent Rights and Joint 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 to the other Party as a consequence
of
such litigation or any unfavorable decision resulting therefrom, including
any
decision holding any Patent Right invalid or unenforceable. However, the Party
that brings a suit shall indemnify and hold the other Party harmless from any
liability to a Third Party as a consequence of such litigation 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) [*];
(ii) [*]:
(A) [*];
and
(B) [*].
(iii) [*].
(c) Wyeth
shall continue to pay Progenics all royalties due under this Agreement during
the pendency of any suit brought pursuant to this Section 7.2.6
(Enforcement of Patent Rights).
7.2.7. Infringement
and Third Party Licenses.
(a) Infringement
of Third Party Patents - Course of Action.
If the
performance of the Licensed Activities by Wyeth or any of its Affiliates or
Sublicensees 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
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
38
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) Wyeth
Option to Negotiate.
Subject
to Section 7.2.7(c)
(Third
Party Infringement Suit), in the event that Wyeth determines that, in order
for
Wyeth, its Affiliates or Sublicensees to engage in the Licensed Activities,
it
is necessary or desirable for Wyeth 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”),
Wyeth
shall have the first right, but not the obligation, to negotiate and enter
into
an agreement with such Third Party, whereby Wyeth is granted a license under
such Third Party IP Rights permitting Wyeth, its Affiliates and Sublicensees
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.
(c) Third
Party Infringement Suit.
If a
Third Party sues Wyeth or any of Wyeth’s Affiliates or Sublicensees (each Person
so sued being referred to herein as a “Sued
Party”),
alleging that the Licensed Activities of Wyeth or any of Wyeth’s Affiliates or
Sublicensees during the Term of and pursuant to this Agreement infringe or
will
infringe such Third Party’s patent, then, upon Wyeth’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. Wyeth shall be solely responsible for expenses incurred in defending
against any such suit and for payment of any damages or other awards that may
result therefrom.
7.2.8. Patent
Certifications.
Each
Party shall immediately give written notice to the other Party of any
certification filed by a Third Party pursuant to 21 U.S.C. § 355(b)(2)(A) or §
355(j)(2)(A)(vii) (or any amendment or successor statute thereto) of which
it
becomes aware claiming that any Patent Right of either Party related to this
Agreement has expired or is invalid, unenforcable or uninfringed. Wyeth shall
control any such action using counsel of its own choice at its
expense.
7.3. Trademarks.
Wyeth
shall, in its sole discretion and expense and 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, trade dress, copyrights and names to be
used
in connection with the marketing, promotion and sale of any Product under this
Agreement. Progenics shall neither use nor seek to register, anywhere in the
world, any trademarks which are confusingly similar to any trademarks, trade
names, trade dress or logos used by or on behalf of Wyeth, its Affiliates or
Sublicensees in connection with any Product.
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 of this Agreement and for five
(5)
years thereafter, each Party (the “Receiving
Party”)
receiving any Confidential Information
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39
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:
(a) file
or
prosecute patent applications as contemplated by this Agreement,
(b) prosecute
or defend litigation,
(c) exercise
its rights under this Agreement 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
information.
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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, the New York Stock
Exchange and NASDAQ and (b) in connection with a prospective acquisition, merger
or financing for such Party, to prospective acquirers or merger candidates
or to
existing or potential investors, provided that prior to such disclosure each
such candidate or investor shall be 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 (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 Wyeth 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 Products) which may be publicly disclosed (including,
without limitation, by means of any printed publication or oral
presentation).
8.4.2. Press
Release.
Both
Parties may release the announcement attached to this Agreement as Schedule
8.4.2
regarding the signing of this Agreement.
8.4.3. Publications.
During
the term of this Agreement, each Party will submit to the other Party for 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 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 to the non-publishing Party no later than
forty-five (45) days before submission for publication or presentation and
the
non-publishing Party shall provide its comments with respect to such
publications and presentations within thirty (30) days of its receipt of such
written copy. The review period may be extended for an additional thirty (30)
days in the event the non-publishing Party 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.
Wyeth and Progenics will each comply with standard academic practice regarding
authorship of scientific publications and recognition of contribution of other
parties in any publications relating to the Development and/or Commercialization
of any Product.
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9. |
REPRESENTATIONS
AND WARRANTIES.
|
9.1. Representations
and Warranties of Each Party. Each
of
Progenics and Wyeth 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
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 does 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 order, writ, injunction or decree of any
court
or governmental authority entered against it or by which any of its property
is
bound; and
(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 Wyeth
that:
(a) Schedule
9.2(A)
identifies all Progenics Patent Rights owned by Progenics (the “Owned
Progenics Patent Rights”),
and
Schedule
9.2(B)
identifies all Progenics Patent Rights which Progenics licenses from Third
Parties (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,
(ii) 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. The Owned Progenics Patents
Rights and the Licensed Progenics Patent Rights identified on Schedule
9.2
(meaning
Schedules (A), (B) and (C) together) constitute all of the Progenics Patent
Rights as of the Effective Date.
(b) Progenics
exclusively owns all rights, title, and interests in the Owned Progenics Patent
Rights and owns or Controls the Progenics Know-How existing as of the Effective
Date free and clear of any liens, charges,
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encumbrances,
licenses, or, to its knowledge, 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 Wyeth 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 Wyeth under this Agreement.
(d) There
are
no Progenics Third Party Agreements other than the agreements identified in
Schedule 9.2(C),
true
and complete copies of which have been provided to Wyeth. 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 other than as provided in Progenics
Third Party Agreements. As of the Effective Date, the Progenics Third Party
Agreements are in full force and effect, and Progenics is in compliance in
all
material respects with the Progenics Third Party Agreements. To Progenics’
knowledge, no event has occurred or omission made, 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 Progenics Third Party
Agreement.
(e) The
Agreement and Plan of Reorganization dated as of December 22, 2005 by and among
Progenics, Progenics Pharmaceuticals Nevada, Inc., UR Labs, Inc., and the
shareholders of UR Labs, Inc. and all “Collateral Agreements” (as defined
therein) entered into pursuant thereto (collectively, the “UR
Labs Acquisition Agreements”)
have
been duly and validly executed and delivered by the parties thereto and
represent the legal, valid and binding obligations of the parties thereto
enforceable in accordance with their terms, subject to applicable bankrupcty,
reorganization, moratorium and similar laws affecting creditors’ rights and
remedies generally. Progenics and its Affiliates are not, and to the knowledge
of Progenics, no Third Party to any of the UR Labs Acquisition Agreements is,
in
violation or default of any UR Labs Acquisition Agreement. No event or
circumstance has occurred that constitutes or, after notice or lapse of time
or
both, would constitute, a material violation or default thereunder on the part
of Progenics or its Affiliates, or, to the knowledge of Progenics, any Third
Party thereto, or which would result in the rescission of or a loss of rights
under any UR Labs Acquisition Agreement.
(f) To
the
extent that any of the Progenics Patent Rights arose from work funded in whole
or in part by U.S. federal funding, to Progenics’ knowledge all requirements
necessary to (a) vest the entire right, title and interest in Progenics or
Progenics’ licensor of such Progenics Patent Rights, and (b) grant the licenses
to Progenics under Patent Rights licensed to Progenics, have been
satisfied.
(g) As
of the
Effective Date, the Progenics Patent Rights are existing and, to the best of
its
knowledge, are not invalid or unenforceable, in whole or in part.
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(h) To
Progenics’ knowledge, as of the Effective Date and except for the patents and
patent applications that Progenics has previously disclosed to Wyeth in writing:
the Development and Commercialization of the Compound, the SC Product and the
IV
Product, and the [*] Oral Product, each as such Product is contemplated by
the
outline of the Development Plan agreed by the Parties as of the Effective Date
and as previously described to Wyeth, (A) does not infringe any issued patent
owned or possessed by any Third Party; and (B) would not infringe any pending
claim in a pending patent application owned or possessed by a Third Party if
such claim were an issued claim of an issued patent. As of the Effective Date,
there are no outstanding orders, judgments or settlements against or owed by
Progenics relating to the Progenics Technology, and there is no pending or,
to
the best of its knowledge, threatened, claims or litigation, relating to the
Progenics Technology.
(i) During
the Term of this Agreement, (i) Progenics will use Commercially Reasonable
Efforts not to take or omit to take any actions that would breach any Progenics
Third Party Agreement or other agreements between Progenics and Third Parties
that provide for intellectual property rights necessary for the Development
and
Commercialization of the Compound and Products, and (ii) Progenics will provide
Wyeth promptly with notice of any allegation that Progenics has breached any
such agreement. During the Term of this Agreement, Progenics will not enter
into
any agreement with any Third Party adversely affecting the rights granted to
Wyeth under this Agreement.
9.3. Additional
Representations and Warranties of Wyeth.
In
addition to the representations and warranties made by Wyeth elsewhere in this
Agreement, Wyeth, hereby represents, warrants and covenants to Progenics
that:
(a) [*];
and
(b) as
of the
Effective Date, Wyeth has no compound in pre-clinical or clinical development
that would be competitive with or addresses similar indications to any
Product.
9.4. Representation
by Legal Counsel.
Each
Party hereto represents that it has been represented by legal counsel in
connection with this Agreement and acknowledges that it has participated in
the
drafting hereof. 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.
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10. |
TERM
AND TERMINATION
|
10.1. Term.
The term
of this Agreement (the “Term”)
will
commence on the Effective Date and extend on a country-by-country and
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 any Royalty Period for any Product
in such country and any extended period of royalty payment under Section
6.5.2
(Extended Exclusivity Based on Wyeth Independent Patent Rights).
10.2. Termination
by Progenics.
10.2.1. General.
Progenics may terminate this Agreement at any time by giving written notice
to
Wyeth in the event that Wyeth commits a material breach of its representations,
warranties or obligations under this Agreement and such material breach remains
uncured for ninety (90) days (thirty (30) days for a breach of a payment
obligation) measured from the date written notice of such material breach is
given to Wyeth; provided,
however,
that if
any breach other than non-payment is not reasonably curable within ninety (90)
days and so long as Wyeth is using Commercially Reasonable Efforts to cure
such
breach, such termination shall be delayed for a reasonable period of time in
order to permit Wyeth reasonable time to cure such breach. Notwithstanding
the
foregoing, if the material breach by Wyeth giving rise to such termination
is a
failure to use Commercially Reasonable Efforts pursuant to Section 4.2.2
(Responsibilities of Wyeth) or 5.2 (Commercialization Responsibilities and
Efforts by Wyeth) in a Major Market Country other than the United States, then
Progenics may only terminate this Agreement on a Product-by-Product and
country-by-country basis in the applicable Major Market Country where such
material breach occurred (a “Partial
Termination”),
and
such Partial Termination shall not affect Wyeth’s rights under this Agreement in
other countries in the Territory or with respect to other Products.
10.2.2. Payment
Breaches.
Failure
by Wyeth 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.
Notwithstanding the foregoing, the thirty (30) day cure period shall not be
tolled for any dispute regarding a failure by Wyeth to pay any amounts due
pursuant to Section 6.2.2
(Payment
of Expenses; Development Account; Reimbursement) so long as the Progenics
Development Costs in question are consistent with the Progenics Development
Cost
Budget approved by the JSC or agreed by the Parties. The previous sentence
shall
not apply, however, to any dispute regarding the amount of any offset taken
by
Wyeth pursuant to Section 6.2.2
(Payment
of Expenses; Development Account; Reimbursement) offsetting an overpayment
of
Progenics Development Costs in a Calendar Quarter against the Estimated
Quarterly Development Costs for the following Calendar Quarter.
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10.3. Termination
by Wyeth.
10.3.1. Termination
by Wyeth for Convenience.
Wyeth
may, with or without cause, terminate this Agreement in its entirety by
providing Progenics with at least three hundred and sixty (360) days prior
written notice of such termination; provided,
however, that
regardless of the notice given to Progenics, no such termination shall be
effective prior to the second anniversary of the First Commercial Sale of the
first Product in the U.S.
10.3.2. Termination
by Wyeth Because of Serious Safety and Efficacy Issues. If
one or
more safety or efficacy issues arise with respect to a Product which are
sufficiently serious that Wyeth would cease Development or Commercialization
of
the Product if the Product were a product or proposed product owned by it or
to
which it had rights that was of similar commercial potential and at a similar
stage in its development or product life, Wyeth shall promptly inform Progenics
of such safety or efficacy issues(s) and convene a meeting of the JDC to discuss
such safety or efficacy issues and their implications for Development and
Commercialization of the Product. If the JDC 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. Thereafter, Wyeth may terminate this Agreement with respect
to such Product throughout the Territory on thirty (30) days prior written
notice.
10.3.3. Termination
by Wyeth for Cause. Wyeth
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 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 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 or Termination by Wyeth For Convenience.
On
termination of this Agreement by Progenics pursuant to Section 10.2 (Termination
by Progenics) or termination of this Agreement by Wyeth pursuant to Section
10.3.1 (Termination by Wyeth for Convenience), the following shall occur;
provided,
however,
that in
the case of a Partial Termination, each of the following shall occur only with
respect to the terminated Product and in the terminated country or
countries:
(a) Wyeth
shall, within thirty (30) days of the event giving rise to the termination,
transfer to Progenics copies of all data, reports, records and
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materials
in its possession or control that relate to the Products or Compound and, except
in the case of a Partial Termination, return to Progenics, or destroy at
Progenics’ request, all relevant records and materials in Wyeth’s or its
Affiliates’ possession or control containing Confidential Information of
Progenics.
(b) Wyeth
shall use Commercially Reasonable Efforts to transfer to Progenics ownership
and
control of all Registrational Filings and Regulatory Approvals made or filed
or
obtained for the Products and Compound and all clinical, technical and other
relevant reports and data relating to the Products and Compound, each to the
extent they are owned, controlled or held in the name of Wyeth or its
Affiliates.
(c) Except
as
provided in Section 10.4.6
(Effect
of Termination by Progenics on Sublicensees), all licenses granted by Progenics
to Wyeth and its Affiliates with respect to the Products and Compound shall
immediately terminate; provided,
however,
that in
the case of a Partial Termination relating to less than all Products in a
country, the licenses granted by Progenics to Wyeth with respect to the Compound
in such country shall survive and become non-exclusive solely for the purpose
of
Developing, Commercializing and otherwise exploiting the Products that have
not
been terminated in such country. Wyeth shall use Commercially Reasonable Efforts
to assign to Progenics for no additional consideration, within thirty (30)
days
of the event giving rise to the Termination, the trademarks 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 individual
countries.
(d) As
to
Products then being manufactured by or on behalf of Wyeth or its Affiliates,
the
Parties shall negotiate in good faith a supply agreement for such Products
on
commercially reasonable terms to ensure that Progenics shall have for a period
[*] ([*]) years a continuous supply of such Products. In addition, except in
the
case of a Partial Termination, to the extent permitted under the terms of such
agreements, Wyeth shall use Commercially Reasonable Efforts to assign to
Progenics, at Progenics’ request, any of Wyeth’s rights under any agreements for
the supply or manufacture of Products or packaging or the supply of API. In
the
case of a Partial Termination, Wyeth shall cooperate with Progenics in good
faith to arrange for the supply of API to Progenics and shall waive any
exclusivity right it may have with such suppliers as necessary to permit
Progenics to enter into direct supply agreements with such suppliers.
Furthermore, except in the case of a Partial Termination, at Progenics’ request,
Wyeth shall sell to Progenics any of the inventory (including manufactured
Product, packaging materials, promotional materials and any other Commercial
items) held by Wyeth or its Affiliates or Sublicensees at a price equal to
their
cost. And in any case, 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.
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(e) Progenics
shall have the right to continue to use supplies of materials carrying the
name
or trademark of Wyeth, its Affiliates or Sublicensees until those supplies
have
been depleted, but in no event for a period of more than [*] ([*])
days.
(f)
Wyeth shall grant Progenics a fully paid-up, perpetual, irrevocable,
royalty-free license (with the right to grant sublicenses) in the Field under
the Wyeth Collaboration Patent Rights, Wyeth Collaboration Know-How and Wyeth’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 the Products in the Terminated Territory. In the case of a Partial
Termination, the foregoing license shall be a non-exclusive license (with the
right to grant sublicenses), and in the case that this Agreement is terminated
in its entirety the foregoing license shall be a sole license (meaning that
Progenics will be the only licensee in the Field, but that the license will
not
be exclusive as to Wyeth and its Affiliates). “Terminated Territory”
shall mean worldwide in the event that this Agreement is terminated
in its
entirety and shall mean the country or countries in which the Agreement is
terminated in the event of a Partial Termination. Furthermore, Wyeth shall
not
assert any Wyeth Independent Patent Right against Progenics, its Affiliates
or
its sublicensees relating to the Development, Commercialization or other
exploitation of any Product in the Terminated Territory.
10.4.2. Upon
Termination by Progenics.
In
addition to the requirements of Section 10.4.1
(Upon
Termination by Progenics or Termination by Wyeth for Convenience), on
termination of this Agreement by Progenics pursuant to Section 10.2
(Termination by Progenics), either in its entirety or for a particular country
or Product, Progenics will suffer costs, expenses and damages that would be
of
uncertain amount and difficult to prove. Therefore, if Progenics terminates
this
Agreement pursuant to Section 10.2
(Termination by Progenics) with respect to a particular Product or country
or in
its entirety, Wyeth shall reimburse Progenics, as liquidated damages, [*];
provided,
however,
that
Wyeth shall have no further obligation to reimburse Progenics for Development
of
a Product effective upon the date [*].
10.4.3. Upon
Termination By Wyeth For Serious Safety and Efficacy Reasons.
On
termination of this Agreement by Wyeth with respect to one or more Products
(the
“Terminated
Products”)
pursuant to Section 10.3.2 (Termination by Wyeth Because of Safety and Efficacy
Issues), the following shall occur:
(a) Wyeth
shall, within thirty (30) days of the effective date of the termination,
transfer to Progenics copies of all data, reports, records and materials in
the
possession or control of Wyeth or its Affiliates that relate to the Terminated
Products and return to Progenics, or destroy at Progenics’ request, all relevant
records and materials in the possession or control of Wyeth and its Affiliates
containing Confidential Information of Progenics exclusively related to the
Terminated Products.
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(b) Wyeth
shall use Commercially Reasonable Efforts to transfer to Progenics ownership
and
control of all Registrational Filings and Regulatory Approvals made or filed
or
obtained for the Terminated Products and all clinical, technical and other
relevant reports and data relating to the Terminated Products, each to the
extent they are owned, controlled or held in the name of Wyeth or its
Affiliates.
(c) All
licenses granted by Progenics to Wyeth and its Affiliates with respect to the
Terminated Products shall immediately terminate; provided,
however,
that in
the case of a termination relating to less than all Products, the licenses
granted by Progenics to Wyeth with respect to the Compound shall survive and
become non-exclusive solely for the purpose of Developing, Commercializing
and
otherwise exploiting the Products other than the Terminated Products. Wyeth
shall use Commercially Reasonable Efforts to assign to Progenics for no
additional consideration, within thirty (30) days of the effective date of
the
termination, the trademarks relating solely to the Terminated Products owned
by
Wyeth and its Affiliates. Progenics shall be responsible for the costs of
recording trademark assignments in individual countries.
(d) 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.
In the case of a termination with respect to all Products, to the extent
permitted under the terms of such agreements, Wyeth shall use Commercially
Reasonable Efforts to assign to Progenics, at Progenics’ request, any of Wyeth’s
rights under any agreements for the supply or manufacture of Products or
packaging or the supply of API. In the case of a termination with respect to
less than all Products, Wyeth shall cooperate with Progenics in good faith
to
arrange for the supply of API to Progenics and shall waive any exclusivity
right
it may have with such suppliers as necessary to permit Progenics to enter into
direct supply agreements with such suppliers.
(e)
Wyeth shall grant Progenics a fully paid-up, perpetual, irrevocable,
royalty-free license (with the right to grant sublicenses) in the Field under
the Wyeth Collaboration Patent Rights, Wyeth Collaboration Know-How and Wyeth’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
Terminated Products in the Territory. In the case of a termination for some
but
not all Products, the foregoing license shall be a non-exclusive license (with
the right to grant sublicenses), and in the case of termination with respect
to
all Products the foregoing license shall be a sole license (meaning that
Progenics will be the only licensee in the Field, but that the license will
not
be exclusive as to Wyeth and its Affiliates). Furthermore, Wyeth shall not
assert any Wyeth Independent Patent Right against Progenics, its Affiliates
or
its sublicensees relating to the Development, Commercialization or other
exploitation of any Terminated Product.
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10.4.4. Effect
of Termination by Wyeth for Cause.
If Wyeth
terminates this Agreement pursuant to Section 10.3.3 (Termination by Wyeth
for Cause) all
licenses granted by Progenics to Wyeth under this Agreement shall survive such
termination and become fully paid-up, perpetual, non-exclusive, irrevocable,
royalty-free licenses. In addition, in such event:
(a)
Progenics shall, and shall cause its Affiliates to, assign and delegate to
Wyeth
or its designated Affiliate, and Wyeth or its designated Affiliate shall assume
from Progenics, all of Progenics’ rights and obligations under the Progenics
Third Party Agreements; and
(b) Progenics
shall use Commercially Reasonable Efforts to transfer to Progenics ownership
and
control of all Registrational Filings and Regulatory Approvals made or filed
or
obtained for the Products and Compound and all clinical, technical and other
relevant reports and data relating to the Products and Compound, each to the
extent they are owned, controlled or held in the name of Progenics or its
Affiliates.
10.4.5. Effect
of Expiration. If
this
Agreement terminates because its Term has expired under Section 10.1 (Term)
all
licenses granted by Progenics to Wyeth under this Agreement shall survive such
termination and become fully paid-up, perpetual, non-exclusive, irrevocable,
royalty-free licenses.
10.4.6. Effect
of Termination by Progenics on Sublicenses. On
termination of this Agreement by Progenics pursuant to Section 10.2 (Termination
by Progenics), any Sublicense granted under this Agreement will become a direct
license from Progenics to the Sublicensee, provided that the Sublicensee is
not
in breach of the Sublicense agreement. In such event, the direct license under
the Progenics Technology and Progenics’ interest in the Joint Technology (or the
subset of such technology that was sublicensed to the Sublicensee) from
Progenics to the Sublicensee will be in the sublicensed field, and will
otherwise be on the terms and conditions of the sublicense agreement between
Company and Sublicensee, except that Progenics will be excused from performing
any of Wyeth’s obligations under the sublicense agreement to the extent that
such obligations are more than immaterially different from Progenics’
obligations under this Agreement.
10.4.7. 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 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 time 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.
10.4.8. Survival.
The
following sections of this Agreement shall survive expiration or termination
of
this Agreement for any reason: 6.2.5
(Records
and Audits) 6.2.6
(Confidentiality) 6.6.5
(Record
Keeping) 6.6.6
(Audits)
6.6.7
(Underpayments/Overpayments) 6.6.8
(Confidentiality) 7.1
(Ownership of Intellectual Property) 7.3
(Trademarks) 8
(Confidentiality) 10.4
(Effects
of Termination or Expiration) 10.5
(Provision for Insolvency) 11
(Indemnification and Insurance) 12
(Regulatory Matters; 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 of this Agreement (i) upon the declaration by a court
of
competent jurisdiction that the other Party (the “Debtor
Party”)
is
bankrupt and, pursuant to the U.S. Bankruptcy Code, the Debtor Party’s assets
are to be liquidated, (ii) upon the filing or institution of bankruptcy,
liquidation or receivership proceedings (other than reorganization proceedings
under Chapter 11 of the U.S. Bankruptcy Code) with respect to the Debtor Party,
(iii) upon an assignment of a substantial portion of the assets for the benefit
of creditors by the Debtor Party, (iv) in the event a receiver or custodian
is
appointed for the Debtor Party’s business, or (v) 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 shall be as described in Section
10.4.1 (Upon Termination by Progenics or Termination by Wyeth) or 10.4.4
(Upon
Termination by Wyeth for Cause) and 10.4.6
(Effect
of Termination by Progenics on Sublicensees), as the case may be.
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 of this Agreement, 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:
(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
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(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 (i) a Title 11 case is
commenced by or against the Debtor Party, (ii) this Agreement is rejected as
provided in Title 11, and (iii) 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, 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 Progenics Development Costs to be paid under
Section 6.2 (Post-Effective Date Development Expenses) and the Development
Payments to be paid under Section 6.3 (Development Payments) (and any other
payment by Wyeth to Progenics under this Agreement other than the royalties
to
be paid under Section 6.5 (Royalty Payments) and Commercialization Payments
to
be paid under Section 6.4 (Commercialization Milestone Payments)) do not
constitute “royalties” within the meaning of Title 11 or relate to licenses of
intellectual property under this Agreement.
10.5.4. Additional
Rights.
All
rights, powers and remedies of the Non-Debtor 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
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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 Products; and
(b) the
right
to contract directly with any Third Party to complete the contracted
work.
10.6. Effect
of Termination of the UR Labs-Progenics Agreement
10.6.1. Background.
Progenics
and UR Labs, Inc., a Nevada corporation, entered into a Sublicense Agreement
dated as of September 21, 2001, as amended (the “UR
Labs-Progenics Agreement”),
under
which UR Labs granted Progenics a license, with the right to further sublicense,
under certain Progenics Technology. On December 22, 2005, UR Labs assigned
the
UR Labs-Progenics Agreement together with all Patent Rights and Know-How
licensed thereunder to ProNev, Progenics’ wholly-owned subsidiary.
10.6.2. Direct
License To Wyeth. Solely
for the purpose of maintaining the continuity of the licenses granted by
Progenics to Wyeth under this Agreement in the event that the UR Labs-Progenics
Agreement is terminated for any reason other than as a result of Wyeth’s uncured
material breach of this Agreement (a “Wyeth
Non-Defaulting Termination”),
ProNev hereby grants and agrees to grant to Wyeth a direct license under all
Progenics Patent Rights and Progenics Know-How Controlled by ProNev. In such
event, the foregoing license shall be on the terms and conditions of the UR-Labs
Progenics Agreement (as amended) as supplemented by this Section 10.6
(Effect
of Termination of the UR Labs-Progenics Agreement). Furthermore, the license
granted by ProNev to Wyeth under this Section 10.6.2
shall
remain in effect for the duration of the license granted by Progenics to Wyeth
under this Agreement. Progenics hereby consents to ProNev’s grant of such a
license to Wyeth. For purposes of this Section 10.6.2,
the UR
Labs-Progenics Agreement shall be deemed terminated on either (i) the date
of
termination pursuant to the UR Labs-Progenics Agreement after giving effect
to
any cure or grace periods, or (ii) in the event that Progenics initiates
litigation or arbitration challenging the existence of a termination event,
the
date of a final determination of termination by a court of competent
jurisdiction or binding arbitration panel.
10.6.3. Termination
of Direct License to Wyeth. If
and to
the extent that the license granted by Progenics to Wyeth under this Agreement
is terminated, in whole or in part, by Progenics pursuant to Section
10.2
(Termination by Progenics), the license granted by ProNev to Wyeth under Section
10.6.2
(Direct
License to Wyeth) shall likewise be automatically terminated to the same
extent.
10.6.4. Payments
in the Event of Termination of the UR Labs-Progenics Agreement.
In
consideration of the direct license granted by ProNev to Wyeth under Section
10.6.2
(Direct
License to Wyeth), in the event of a Wyeth Non-Defaulting Termination of the
UR
Labs-Progenics Agreement, Wyeth shall pay to ProNev any
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payments
which Progenics would have been required to pay to ProNev under the UR
Labs-Progenics Agreement (had the UR Labs-Progenics Agreement remained in
effect) in connection with the license granted by Progenics to Wyeth under
this
Agreement at such times as such payments would have otherwise become due under
the UR Labs-Progenics Agreement. Wyeth shall be entitled to deduct any amount
owed to ProNev under this Section 10.6.4
from any
amounts that Wyeth owes to Progenics under this Agreement.
10.6.5. Restatement
of License Agreement. In
the
event of a Wyeth Non-Defaulting Termination of the UR Labs-Progenics Agreement,
at Wyeth’s request, Wyeth and ProNev shall enter into an agreement memorializing
and restating the direct license granted to by ProNev to Wyeth under Section
10.6.2
(Direct
License to Wyeth) on the terms and conditions provided for in this Section
10.6
(Effect
of Termination of the UR Labs-Progenics Agreement).
11. |
INDEMNIFICATION
AND INSURANCE.
|
11.1. Indemnification
by Wyeth.
Wyeth
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 Wyeth 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 sold
by
Wyeth, its Affiliates or Sublicensees; or (c) the material breach by Wyeth
of
any of its representations, warranties or covenants set forth in this Agreement;
except, in each case, 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 Wyeth, its Affiliates,
sublicensees, distributors and each of its and their respective employees,
officers, directors and agents (each, a “Wyeth
Indemnified Party”)
from
and against any and all Liabilities that the Wyeth 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)
the material breach by Progenics of any of its representations, warranties
or
covenants set forth in this Agreement; or (c) personal injury or death of any
person as a result of use of any Product supplied by Progenics for use in
clinical trials to the extent caused by a manufacturing defect, except, in
each
case ((a), (b), and (c)), to the extent caused by the gross negligence or
intentional misconduct of Wyeth or any Wyeth Indemnified Party.
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
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discuss
how to respond to any Claims that are the subject matter of such proceeding.
The
Indemnified Party shall cooperate fully with the Indemnifying Party in defense
of such matter. The Indemnifying Party, upon request of the Indemnified Party,
shall retain counsel reasonably satisfactory to the Indemnified Party to
represent the Indemnified Party and shall pay the fees and expenses of such
counsel related to such proceeding. In any such Claim, the Indemnified Party
shall have the right to retain its own counsel, but the fees and expenses of
such counsel shall be at the expense of the Indemnified Party unless (i) the
Indemnifying Party and the Indemnified Party shall have mutually agreed to
the
retention of such counsel or (ii) the named parties to any such Claim (including
any impleaded parties) include both the Indemnifying Party and the Indemnified
Party and representation of both Parties by the same counsel would be
inappropriate due to actual or potential differing interests between them.
All
such fees and expenses shall be reimbursed as they are incurred. The
Indemnifying Party shall not be liable for any settlement of any Claim effected
without its written consent, but, if settled with such consent or if there
be a
final judgment for the plaintiff, the Indemnifying Party agrees to indemnify
the
Indemnified Party from and against any loss or liability by reason of such
settlement or judgment. The Indemnifying Party shall not, without the written
consent of the Indemnified Party, effect any settlement of any pending or
threatened Claim in respect of which the Indemnified Party is, or arising out
of
the same set of facts could have been, a party and indemnity could have been
sought hereunder by the Indemnified Party, unless such settlement includes
an
unconditional release of the Indemnified Party from all liability on claims
that
are the subject matter of such proceeding.
11.4. Insurance.
Progenics agrees to use Commercially Reasonable Efforts to obtain and maintain,
during the Term of this Agreement, commercial general liability insurance,
including products liability insurance, with reputable and financially secure
insurance carriers to cover its indemnification obligations under 11.2
(Indemnification by Progenics), in each case with limits of not less than [*]
per occurrence and in the aggregate. Insurance shall be procured with carriers
having an A.M. Best Rating of A-VII or better.
12. |
REGULATORY
MATTERS, PRODUCT SAFETY ISSUES, PRODUCT
RECALLS
|
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 Products in the Territory. Each Party will keep the
other informed of their interactions with the FDA and Regulatory Authorities
in
the following countries: [*], including by providing copies of correspondence
and submissions and timely notice of and invitations to attend meetings with
the
FDA and other such Regulatory Authorities. Each Party shall give the other
reasonable opportunity to review and comment on submissions to the FDA and
other
such Regulatory Authorities prior to making such submissions.
12.1.2. FDA
Interaction Related To SC Product and IV Product. Progenics
shall be primarily responsible for coordinating all interactions with the FDA
with respect to the SC Product and IV Product up to the time of FDA Regulatory
Marketing Approval. Progenics shall be responsible for the content and responses
to the FDA that
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are
related to scientific and medical questions. Wyeth shall be responsible for
the
content and responses to the FDA that are related to labeling, Compound and
Product specifications, chemistry and manufacturing control matters,
post-approval studies and other post-approval commitments. Progenics and Wyeth
will cooperate to prepare fully electronic submissions (eCTD) to the FDA. Once
the SC Product receives Regulatory Marketing Approval in the U.S. from the
FDA,
Wyeth shall assume primary responsibility for all regulatory interactions for
both the IND and NDA with the FDA with respect to the SC Product,
and
likewise, once the
IV
Product receives Regulatory Marketing Approval in the U.S. from the FDA, Wyeth
shall assume primary responsibility for all regulatory interactions with the
FDA
with respect to the IV Product
12.1.3. Other
Regulatory Interactions. Except
as
set forth in Section 12.1.2
(FDA
Interaction Related to SC Product and the IV Product) with respect to the SC
Product and the IV Product, beginning on the Effective Date, Wyeth shall have
sole responsibility for all investigational and Registrational Applications
and
other applications for Regulatory Approval and all interaction with any
Regulatory Authority in the Territory with respect to any Product.
For
clarity, with respect to the SC Product and the IV Product, beginning on the
Effective Date, Wyeth shall have sole responsibility for all Registrational
Applications and other applications for Regulatory Approval outside the U.S.
and
all interactions with any Regulatory Authority outside the U.S.
12.1.4. Ownership
of Regulatory Approvals.
(a) Progenics
shall remain the owner of all right, title and interest in all FDA
Registrational Filings and FDA Regulatory Approvals for the SC Product and
IV
Product in the U.S. (the “Progenics
Regulatory Filings/Approvals”).
Progenics and Wyeth shall each use Commercially Reasonable Efforts to take
such
actions as are necessary to enable Wyeth efficiently to take on the role
described in Section 12.1.2
(FDA
Interactions Related to SC Product and IV Product), including without limitation
submitting with the FDA all of the documents, letters, and information
reasonably necessary or advisable to enable Wyeth to efficiently perform its
responsibilities.
(b) Except
as
otherwise provided in Section 12.1.4(a)
with
respect to the Progenics Regulatory Filings/Approvals, which shall remain the
property of Progenics, Wyeth shall own all right, title and interest in all
Registrational Filings and Regulatory Approvals for any Product and any
applications therefore throughout the Territory. Promptly after the Effective
Date, Progenics shall (i) transfer to Wyeth all Registrational Filings and
Regulatory Approvals (if any) for any Product throughout the Territory and
any
applications therefore, other than the Progenics Regulatory Filings/Approvals
(the “Transferred
Regulatory Filings/Approvals”),
and
(ii) take such actions as are necessary to enable Wyeth to take on the role
described in Sections 12.1.2
(FDA
Interaction Related to SC Product and IV Product) and 12.1.3
(Other
Regulatory Interactions). Wyeth shall reimburse Progenics for its
non-de
minimis
out-of-pocket costs incurred in
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complying
with the foregoing sentence. Wyeth and Progenics shall, at Wyeth’s expense, take
any and all actions required by the relevant Regulatory Authorities to effect
the transfer of the Transferred Regulatory Filings/Approvals from Progenics
to
Wyeth as soon as reasonably practicable after the Effective Date, including
without limitation filing with appropriate Regulatory Authorities all of
documents, letters and information required by the Regulatory Authorities to
effect such transfer. Progenics may retain archival copies of the Transferred
Regulatory Filings/Approvals, including supplements and records relating
thereto.
12.1.5. Wyeth
Affiliates and Sublicensees.
Nothing
in this Section shall limit Wyeth’s ability to authorize any Wyeth Affiliate or
Wyeth Sublicensee to seek or obtain any Regulatory Approval outside the United
States for any Product or own any such Regulatory Approval obtained as a result
of any such application or Wyeth’s ability to assign ownership of any Regulatory
Approval or application therefore.
12.1.6. 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,
Wyeth,
its Affiliates and Sublicensee, as appropriate, shall be responsible for
responding to all inquiries related to such Product raised by health care
professionals or other customers.
12.3. Safety
Agreement.
After
the Effective Date the Parties shall enter into a Safety Agreement substantially
in the form of the Wyeth form of Safety Agreement previously agreed by the
Parties (the “Safety
Agreement”)
providing for, among other things, the maintenance by Progenics of an adverse
event database for the SC Product and the IV Product until FDA Regulatory
Marketing Approval, AE or ADR reporting including literature review and
associated reporting; AE or ADR follow-up reporting; preparation and submission
of all safety reports to the regulatory authorities as required by local laws
and/or regulations in the Territory; global safety database maintenance; product
quality complaint handling; all interactions with health authorities, including
a formal process to adequately communicate urgent issues regarding safety and
labeling; periodic submissions; labeling modifications; safety monitoring and
detection; and safety measures (e.g., Dear Doctor Letter, restriction on
distribution).
12.4. Product
Recalls. Wyeth
shall be solely responsible at Wyeth’s expense for all contact with Regulatory
Authorities relating to any Recall of any Product. Wyeth shall be solely
responsible at Wyeth’s expense for implementing, directing and administering any
Recall of any Product required or recommended by any Regulatory Authority or
court of competent jurisdiction, or determined by Wyeth, in its sole discretion,
to be necessary or advisable. If Wyeth is required or voluntarily decides to
initiate a Recall with respect to any Product, whether or not such Recall has
been requested or ordered by any Regulatory Authority, Wyeth shall promptly
notify Progenics of such requirement or decision.
12.5. Cost
of Recalls. Wyeth
shall be solely responsible for the cost of any Recall.
13. |
MISCELLANEOUS.
|
13.1. Change
of Control. If
a Top
15 Pharmaceutical Company acquires control of Progenics in a Progenics Change
of
Control transaction, then Wyeth shall have the right to terminate the
Co-Promotion Agreement by providing written notice to Progenics within [*]
([*])
days of the receipt of notice by Wyeth of the Change in Control, and Sections
5.1
(Co-Promotion Option) and 5.5
(Sharing
of Information; Progenics Commercial Organization) of this Agreement shall
cease
to have any effect and the JCC shall be disbanded.
13.2. Assignment.
Neither
this Agreement nor any interest under this Agreement shall be assignable by
any
party to this Agreement without the prior written consent of the other parties,
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. ProNev may
assign its rights and obligations under this Agreement only in connection with
a
sale of Progenics or the sale of a substantial portion of the business of
Progenics and ProNev 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 to this Agreement shall promptly notify
the other Party of any assignment or transfer under the provisions of this
Section. 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
13.2
(Assignment) shall be void.
13.3. 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.
13.4. 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.
13.5. Correspondence
and Notices.
13.5.1. 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
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58
the
employee or representative of the other Party who is designated by such other
Party to receive such written communication.
13.5.2. 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 Wyeth shall be addressed as follows:
Wyeth
Pharmaceuticals Division
000
Xxxxxx Xxxx
Xxxxxxxxxxxx,
Xxxxxxxxxxxx 00000
Attn:
Senior Vice President, Corporate Business Development
Fax:
(000) 000-0000
Wyeth-Whitehall
Pharmaceuticals, Inc.
Road
No.
3, Kilometer 142.1
Guayama,
Puerto Rico 00784
Attention:
General Manager
Fax:
(000) 000-0000
Wyeth-Ayerst
Lederle, Inc.
X.X.
Xxx
0000
00xx
Xxxxxxxx Xxxx, Xxxxxxxxx 9.7
Carolina,
Puerto Rico 00987-4904
Attention:
Managing Director
Fax:
(000) 000-0000
with
a
copy to:
Wyeth
0
Xxxxxxx
Xxxxx
Xxxxxxx,
Xxx Xxxxxx 00000
Attn:
General Counsel
Fax:
(000) 000-0000
All
correspondence to Progenics and ProNev shall be addressed as
follows:
Progenics
Pharmaceuticals, Inc.
000
Xxx
Xxx Xxxx Xxxxx Xxxx
Xxxxxxxxx,
Xxx Xxxx 00000
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Attn:
Chief Executive Officer
Fax:
(000) 000-0000
with
a
copy to:
Progenics
Pharmaceuticals, Inc.
000
Xxx
Xxx Xxxx Xxxxx Xxxx
Xxxxxxxxx,
Xxx Xxxx 00000
Attn:
General Counsel
Fax:
(000) 000-0000
13.6. 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.
13.7. 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.
13.8. 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 of 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.
13.9. 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.
13.10. Entire Agreement.
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.
13.11. 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.
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13.12. 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.
13.13. 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.
13.14. 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.
13.15. 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.
13.16. 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.
13.17. Jurisdiction;
Venue; Service of Process.
13.17.1. Jurisdiction.
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 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-
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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.
13.17.2.
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 bring Claims only in
the
City of New York. Each party further waives any claim and will not assert that
venue should properly lie in any other location within the selected
jurisdiction.
13.17.3.
Service of Process.
Each
party hereby (a) consents to service of process in any Claim between the parties
arising in whole or in part under or in connection with this Agreement in any
manner permitted by New York law, (b) agrees that service of process made in
accordance with clause (a) or made by registered or certified mail, return
receipt requested, at its address specified pursuant to Section 13.5,
will
constitute good and valid service of process in any such Claim and (c) waives
and agrees not to assert (by way of motion, as a defense, or otherwise) in
any
such Claim any claim that service of process made in accordance with clause
(a)
or (b) does not constitute good and valid service of process.
13.18. 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.
13.19. 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, Wyeth or Progenics, by written notice
to the other, may have such dispute referred to their respective executive
officers
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designated
for attempted resolution by good faith negotiations (each, a “Responsible
Executive”).
For
Wyeth: [*]
For
Progenics: [*]
Any
such
dispute shall be submitted to the Responsible Executives no later than thirty
(30) days following such request by either the JSC or Wyeth or Progenics. In
the
event the Responsible Executives are not able to resolve any such dispute within
thirty (30) days after submission of the dispute to such executive officers,
Wyeth or Progenics, as the case may be, may pursue whatever measures legally
available to resolve such dispute. All negotiations pursuant to this Section
13.19 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.
13.20. Specific
Performance. The
parties to this Agreement 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.
13.21. Purchases
of Equity Securities.
13.21.1. General.
From
the
date hereof until one (1) year after the First Commercial Sale of any Product
in
the United States, except as permitted hereunder, Wyeth and its corporate
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 13.21.1
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 date
hereof;
(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;
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(d) enter
into any arrangement or understanding with others to do any of the actions
restricted or prohibited under Sections 13.21(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.
13.21.2. Exceptions
for Purchasing Securities of Progenics.
Nothing
herein shall prevent:
(a) Wyeth
from purchasing additional securities of Progenics if after such purchase Wyeth
and its corporate Affiliates would own no greater percent of the total voting
power of all voting securities of Progenics then outstanding than Wyeth and
such
corporate Affiliates owned immediately prior to the Effective Date.
(b) Wyeth
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) Wyeth
or
Wyeth’s Affiliates from purchasing securities of Progenics pursuant to (i) a
pension plan established for the benefit of Wyeth’s employees, (ii) any employee
benefit plan of Wyeth or (iii) any stock portfolios not controlled by Wyeth
or
any of its corporate Affiliates that invest in Progenics among other
companies.
(d) Wyeth
from acquiring securities of another biotechnology or pharmaceutical company
that beneficially owns any of Progenics’ securities.
13.21.3. Exceptions.
The
limitations provided in Section 13.21
(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 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;
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(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.
13.21.4. Exclusion.
No
action
or actions taken by Wyeth or any of its Affiliates pursuant to the terms of
this
Agreement or any collaboration agreement between Wyeth 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.
Wyeth,
acting through its Wyeth Pharmaceuticals Division
|
Progenics
Pharmaceuticals, Inc.
|
By_/s/
Xxxx
X. Xxx
|
By_/s/
Xxxx
X. Xxxxxx
|
Name: Xxxx
X. Xxx
Title:
Senior
Vice President-Global Business
Development
|
Name: Xxxx
X. Xxxxxx
Title:
Chief
Executive Officer
|
Wyeth-Whitehall
Pharmaceuticals, Inc.
|
Progenics
Pharmaceuticals Nevada, Inc.
|
By_/s/
Xxxxxx
X. Xxxxx
|
By_/s/
Xxxx
X. Xxxxxx
|
Name: Xxxxxx
X. Xxxxx
Title:
Assistant
Secretary
|
Name: Xxxx
X. Xxxxxx
Title:
President
|
Wyeth-Ayerst
Lederle, Inc.
|
|
By_/s/
Xxxxxx
X. Xxxxx
|
|
Name: Xxxxxx
X. Xxxxx
Title:
Assistant
Secretary
|
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1.10
CHEMICAL
DRAWING OF THE COMPOUND
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Schedule1.10
- page
1
SCHEDULE
8.4.2
PRESS
RELEASE
For
Immediate Release
Contacts:
|
Wyeth:
Media
Contact:
Xxxxxx
Xxxx
Wyeth
Pharmaceuticals
(000)
000-0000
Xxxxxxx
Xxxxxx
Wyeth
(000)
000-0000
Investor
Contacts:
Xxxxxx
Xxxxxxxx
Xxxxx
(000)
000-0000
|
Progenics
Pharmaceuticals, Inc.:
Xxxxxxx
X. Xxxxxxx, Ph.D.
VP,
Investor Relations
and
Corporate Communications
(000)
000-0000
xxxxxxxx@xxxxxxxxx.xxx
|
WYETH
AND
PROGENICS PHARMACEUTICALS ANNOUNCE WORLDWIDE COLLABORATION TO DEVELOP AND
COMMERCIALIZE METHYLNALTREXONE
-
Methylnaltrexone in late-stage clinical development for opioid-induced
constipation
and
post-operative bowel dysfunction -
Madison,
NJ and Tarrytown, NY - December 23, 2005
- Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE) and Progenics Pharmaceuticals,
Inc. (Nasdaq: PGNX) today announced that they have entered into an exclusive,
worldwide agreement for the joint development and commercialization of
methylnaltrexone (MNTX) for the treatment of opioid-induced side effects,
including constipation and post-operative bowel dysfunction. These medical
conditions are major therapeutic challenges in the management of
gastrointestinal function in individuals treated with opioids for pain or in
patients following serious or prolonged surgeries.
Under
the
terms of the collaboration, Wyeth receives worldwide rights to MNTX, and
Progenics retains an option to co-promote the product in the United States.
The
companies will collaborate on the worldwide development of MNTX. The transaction
includes an upfront payment of $60 million to Progenics with as much as an
additional $356.5 million payable upon achievement of certain milestones. Wyeth
will pay Progenics royalties on worldwide sales of MNTX and co-promotion fees
within the United States. Additionally, Wyeth is responsible for all future
development and commercialization costs.
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8.4.2
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“MNTX
fits well within our current portfolio and represents a broad treatment platform
with multiple products intended to address unmet medical needs in opioid-induced
bowel disorders,” says Xxxxxxx Xxxxxxx, President of Wyeth Pharmaceuticals and
Executive Vice President, Wyeth. “Our collaboration with Progenics strengthens
Wyeth’s leadership position in the field of gastroenterology. Importantly,
within Wyeth, we have selected MNTX for
streamlined development.”
“Our
collaboration with Wyeth maximizes the global development, commercialization,
and market potential of MNTX across a broad range of therapeutic indications,”
says Xxxx X. Xxxxxx, M.D., Ph.D., Progenics’ Founder, Chief Executive Officer
and Chief Science Officer. “Progenics and Wyeth share a vision for bringing this
important new therapy to market for the millions of patients who suffer from
the
debilitating side effects of opioid pain medications.”
Currently,
there are no therapies approved to treat the side effects of opioids. These
side
effects often prevent optimal pain control and may prolong hospitalization.
The
ability to deliver MNTX using three dosage forms and routes of administration
represents a significant benefit to patients and health care professionals.
Each
MNTX dosage form is tailored to address the needs of specific clinical
applications based on onset of action, predictability of response, dosing
flexibility and ease of use. The three MNTX product candidates are:
· |
Subcutaneous
injection for the treatment of intractable constipation in patients
with
advanced medical illness (AMI), including cancer and
AIDS;
|
· |
Intravenous
infusion for the treatment of patients with gastrointestinal tract
and
urinary dysfunction that commonly occurs after major abdominal and
prolonged surgeries; and
|
· |
Oral
formulation for the treatment of opioid-induced constipation in patients
with chronic pain, including those suffering from headaches, joint
pain,
lower-back pain, sickle-cell disease, muscle pain and other disorders
requiring opioid analgesics.
|
Progenics
is completing a second pivotal phase 3 clinical study of subcutaneous MNTX
in
AMI. In 2006, clinical studies in post-operative bowel dysfunction with
intravenous MNTX are scheduled to enter phase 3, and the oral product will
enter
phase 2 in patients receiving opioids for chronic pain. Under the terms of
the
collaboration, Wyeth will develop oral MNTX worldwide. Progenics will lead
the
U.S. development of subcutaneous and intravenous MNTX, while Wyeth will lead
development of these parenteral products outside the U.S. Wyeth and Progenics
will pursue an integrated strategy to optimize worldwide development, regulatory
approval, and commercial launch of the three MNTX products which may impact
timelines previously disclosed by Progenics. Decisions regarding the timelines
for development of the three MNTX products will be made by the Joint Development
Committee, consisting of members from both Wyeth and Progenics.
Background
Opioids
are widely used to lessen suffering in advanced cancer and other terminal
diseases. To relieve pain, narcotic medications such as morphine activate
specific opioid receptors located in the central nervous system - the brain
and
spinal cord. Opioids, however, also interact with these receptors outside of
the
central nervous system, resulting in side effects, which can be debilitating,
including constipation, urinary retention and severe itching. MNTX is designed
to block peripheral opioid receptors whose activation causes these side effects.
As MNTX does not cross the blood-brain barrier, it does not interfere with
brain-centered pain relief.
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· |
Advanced
medical illness: Approximately
1.7 million patients suffer from AMI each year in the U.S., including
patients with cancer, AIDS, sickle-cell disease and other painful
terminal
illnesses. The majority of those treated with opioids for pain suffer
debilitating constipation.
|
· |
Post-operative
bowel dysfunction: More
than 20 million surgeries occur in the U.S. each year, with more
than
two-million patients at high risk for developing post-operative bowel
dysfunction, a serious paralysis of the gastrointestinal tract.
Post-operative bowel dysfunction is a major factor in increasing
hospital
stay, as patients are typically not discharged until bowel and urinary
functions are restored.
|
· |
Chronic
pain:
Approximately five-million patients receive opioids on a chronic
basis,
and many experience chronic opioid-induced constipation.
|
Company
Profiles
Wyeth
is one
of the world’s largest research-driven pharmaceutical and health care products
companies. It is a leader in the discovery, development, manufacturing and
marketing of pharmaceuticals, vaccines, biotechnology products and
nonprescription medicines that improve the quality of life for people worldwide.
The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer
Healthcare, and Fort Dodge Animal Health.
Progenics
Pharmaceuticals, Inc.,
of
Tarrytown, NY is a biopharmaceutical company focusing on the development and
commercialization of innovative therapeutic products to treat the unmet medical
needs of patients with debilitating conditions and life-threatening diseases.
Principal programs are directed toward symptom management and supportive care
and the treatment of HIV infection and cancer. The Company has four product
candidates in clinical development and several others in preclinical
development. The Company, in collaboration with Wyeth, is
developing methylnaltrexone (MNTX) for the treatment of opioid-induced side
effects, including constipation and post-operative bowel
dysfunction.
In the
area of HIV infection, the Company is developing the viral-entry inhibitor
PRO
140, a humanized monoclonal antibody targeting the HIV coreceptor CCR5 (in
phase
1b studies). In addition, the Company is conducting research on ProVax, a novel
prophylactic HIV vaccine. In collaboration with Cytogen Corporation, the Company
is developing immunotherapies for prostate cancer, including a human monoclonal
antibody directed against prostate-specific membrane antigen (PSMA), a protein
found on the surface of prostate cancer cells. Progenics is also developing
vaccines designed to stimulate an immune response to PSMA. A recombinant PSMA
vaccine is in phase 1 clinical testing. The Company is also developing a cancer
vaccine, GMK, in phase 3 clinical trials for the treatment of malignant
melanoma.
WYETH
DISCLOSURE NOTICE: The
statements in this press release that are not historical facts are
forward-looking statements based on current expectations of future events that
involve risks and uncertainties including, without limitation, risks associated
with the inherent uncertainty of the timing and success of pharmaceutical
research, product development, manufacturing, commercialization, economic
conditions including interest and currency exchange rate fluctuations, changes
in generally accepted accounting principles, the impact of competitive or
generic products, trade buying patterns, wars or terrorist acts, product
liability and other types of lawsuits, the impact of legislation and regulatory
compliance and obtaining reimbursement, favorable drug pricing, access and
other
approvals, environmental liabilities, and patent, and other risks and
uncertainties, including those detailed from time to time in the Company’s
periodic reports, including current reports on Form 8-K, quarterly reports
on
Form 10-Q and the annual report on Form 10-K, filed with the Securities and
Exchange Commission. Actual results may vary materially from the forward-looking
statements. The Company assumes no
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obligation
to publicly update any forward-looking statements, whether as a result of new
information, future events or otherwise.
PROGENICS
DISCLOSURE NOTICE:
The
information contained in this document is current as of December 23, 2005.
This
press release contains forward-looking statements. Any statements contained
herein that are not statements of historical fact may be forward-looking
statements. When the Company uses the words ‘anticipates,’ ‘plans,’ ‘expects’
and similar expressions, it is identifying forward-looking statements. Such
forward-looking statements involve risks and uncertainties which may cause
the
Company’s actual results, performance or achievements to be materially different
from those expressed or implied by forward-looking statements. Such factors
include, among others, the risk that we will not be able to obtain funding
necessary to conduct our operations, the uncertainties associated with product
development, the risk that clinical trials will not commence, proceed or be
completed as planned, the risks and uncertainties associated with dependence
upon the actions of our corporate, academic and other collaborators and of
government regulatory agencies, the risk that our licenses to intellectual
property may be terminated because of our failure to have satisfied performance
milestones, the risk that products that appear promising in early clinical
trials are later found not to work effectively or are not safe, the risk that
we
may not be able to manufacture commercial quantities of our products, the risk
that our products, if approved for marketing, do not gain market acceptance
sufficient to justify development and commercial costs, the uncertainty of
future profitability and other factors set forth more fully in the Company’s
Annual Report on Form 10-K for the fiscal year ended December 31, 2004 and
other
reports filed with the Securities and Exchange Commission, to which investors
are referred for further information. In particular, the Company cannot assure
you that any of its programs will result in a commercial product.
Progenics
does not have a policy of updating or revising forward-looking statements and
assumes no obligation to update any forward-looking statements contained in
this
document as a result of new information or future events or developments. Thus,
it should not be assumed that the Company’s silence over time means that actual
events are bearing out as expressed or implied in such forward-looking
statements.
###
Editor’s
Note:
Additional
information on Progenics available at xxxx://xxx.xxxxxxxxx.xxx
Additional
information on Wyeth available at xxxx://xxx.xxxxx.xxx
Progenics
Pharmaceuticals issued two press releases today. The other release is entitled:
Progenics
Acquires Methylnaltrexone Royalty Rights from Licensors and Files Shelf
Registrations
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SCHEDULE 9.2
DISCLOSURE
SCHEDULE
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EXHIBIT
A
FORM
OF CO-PROMOTION AGREEMENT
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