CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
AMENDED AND RESTATED PSMA/PSMP LICENSE AGREEMENT
BY AND AMONG
PROGENICS PHARMACEUTICALS, INC.,
CYTOGEN CORPORATION
AND
PSMA DEVELOPMENT COMPANY LLC
Dated April 20,
2006
<PAGE>
TABLE OF CONTENTS
PAGE
1.
DEFINITIONS.............................................................2
2.
REPRESENTATIONS AND
WARRANTIES..........................................8
2.1
By the
LLC.......................................................8
2.2
By
CYTOGEN.......................................................9
2.3
By
Progenics....................................................12
2.4
By All
Parties..................................................13
3.
LICENSES...............................................................13
3.1
Grant by
CYTOGEN................................................13
3.2
Sublicenses.....................................................13
3.3
Guarantee
of Performance of Sublicensee.........................13
3.4
Cure of
Breach by Sublicensee...................................14
3.5
[**]............................................................14
3.6
Reservation of
Rights...........................................15
3.7
No Other
Rights.................................................15
3.8
Competition Not
Prohibited......................................15
4. CERTAIN
COVENANTS......................................................15
4.1
No Waivers
or Grant of Further Rights...........................15
4.2
Summary
Reports.................................................15
4.3
Breach of
SKICR Agreement.......................................15
4.4
Notices
under the SKICR Agreement...............................16
4.5
Compliance
with Terms of the SKICR Agreement; Assignment........16
4.6
Termination of Services
Agreement...............................16
5.
ROYALTIES AND OTHER
PAYMENTS...........................................16
5.1
Milestone
Payments..............................................16
5.2
Royalties.......................................................17
5.3
Royalty
Buydown.................................................18
5.4
Reduction
of Royalties if Third Party License Required..........19
5.5
Payments
Associated with Existing Third Party Agreements........19
5.6
Other
Products..................................................19
i
<PAGE>
6. PATENT
PROSECUTION AND MAINTENANCE,
ETC................................19
6.1
Prosecution and
Maintenance.....................................19
6.2
Disclosure
Regarding Patent Activities..........................20
7. REPORTS
AND ROYALTY PAYMENTS; BOOKS AND
RECORDS........................20
7.1
Reports.........................................................20
7.2
Royalty
Payments................................................21
7.3
Calculation of Royalties and Other
Payments.....................21
7.4
Currency
Control Restrictions...................................21
7.5
Books and
Records...............................................21
8.
TAXATION OF
PAYMENTS...................................................22
9. PRODUCT
LIABILITY
DISCLAIMERS..........................................22
9.1
Product
Liability Disclaimer by Progenics.......................22
9.2
Product
Liability Disclaimer by CYTOGEN.........................22
9.3
Product
Liability Disclaimer by the LLC.........................22
10.
INDEMNIFICATION AND
INFRINGEMENT.......................................22
10.1
Indemnification.................................................22
10.2
Infringement of
Licensed CYTOGEN Patents........................23
10.3
Procedure.......................................................23
11. TERM AND
TERMINATION...................................................24
11.1
Term............................................................24
11.2
Termination.....................................................24
11.3
Accrued Rights
and Obligations..................................25
12. EFFECT OF
TERMINATION ON SUBLICENSEE...................................26
13. EXPORT
LICENSES........................................................26
14.
MISCELLANEOUS
PROVISIONS...............................................26
14.1
Assignability,
Etc..............................................26
14.2
Notices.........................................................26
14.3
Independent
Contractors.........................................27
14.4
Counterparts....................................................27
14.5
Entire
Understanding............................................27
14.6
Headings........................................................28
14.7
No Implied
Rights...............................................28
14.8
No
Waiver.......................................................28
ii
<PAGE>
14.9
Publicity.......................................................28
14.10
Promotion and
Advertising.......................................29
14.11
Arbitration.....................................................29
14.12
Confidentiality.................................................29
14.13
No Third Party
Beneficiaries....................................30
14.14
Governing
Law...................................................31
14.15
SKICR
Agreement.................................................31
iii
<PAGE>
AMENDED AND RESTATED PSMA/PSMP LICENSE AGREEMENT
THIS
AMENDED AND RESTATED
PSMA/PSMP LICENSE AGREEMENT (this "Agreement"),
---------
dated April 20, 2006, is made by and among Progenics Pharmaceuticals, Inc., a
Delaware corporation
having its place of business at 777 Old Saw Mill River
Road, Tarrytown,
NY 10591 ("Progenics"), CYTOGEN Corporation, a Delaware
---------
corporation having its
place of business at
650 College
Road East,
CN 5308,
Princeton, NJ 08540
("CYTOGEN"), and PSMA
Development Company
LLC, a Delaware
-------
limited liability
company having its principal place of business at 777 Old Saw
Mill River Road, Tarrytown, NY 10591 (the "LLC"). Progenics,
CYTOGEN and the LLC
---
may each be referred to herein individually as a "Party" and
collectively as the
"Parties".
WHEREAS, Progenics and
CYTOGEN established a
collaboration to
pursue the
development and
commercialization of
immunotherapeutic
products and
services
based on PSMA
and/or PSMP and, in order to implement such collaboration,
Progenics and CYTOGEN
caused the LLC to be
organized and each became the owner
of 50% of the outstanding ownership interests thereof;
WHEREAS, in furtherance of the collaboration, each of Progenics and
CYTOGEN
granted rights to the LLC, pursuant to the PSMA/PSMP License
Agreement, entered
into by and among the LLC, Progenics and CYTOGEN (the "Original Agreement"),
-------------------
dated as of June 15, 1999, with respect to intellectual property
rights owned or
thereafter acquired
by Progenics or CYTOGEN in the Field (as hereinafter
defined);
WHEREAS, CYTOGEN
had previously granted to Prostagen Corporation, a
Delaware corporation
("Prostagen"),
an exclusive license to certain rights
---------
related to PSMA
pursuant to a PSMA
Therapeutics
Sublicense Agreement,
dated
December 9,
1996, by and between CYTOGEN and Prostagen (the "Prostagen
---------
Agreement");
---------
WHEREAS, Prostagen had
previously
granted to Northwest
Clinicals LLC, a
Washington limited
liability company ("NWC"), an exclusive sublicense to
---
produce, process or
otherwise manufacture
and sell PSMA and PSMP pursuant to a
PSMA Production
Sublicense
Agreement,
dated as of July 16,
1997 (the "NWC
---
Agreement"), which has been terminated;
---------
WHEREAS, prior to the
formation of the LLC,
CYTOGEN acquired 100%
of the
outstanding equity interests in Prostagen, and CYTOGEN and Prostagen
terminated
the Prostagen Agreement to the extent of the Field;
WHEREAS, in
order to pursue the research and development programs
contemplated by
the above-referenced collaboration between Progenics and
CYTOGEN, Progenics,
CYTOGEN and the LLC entered into a Services Agreement dated
June 15, 1999,
pursuant to which Progenics agreed to perform certain
research
and development services (the "Services Agreement");
------------------
WHEREAS,
simultaneously with the execution and delivery of this
Agreement,
Progenics has
purchased all of CYTOGEN's interest in the LLC by way of
that
certain Membership
Interest Purchase
Agreement, dated the
date hereof, by and
between Progenics and
1
<PAGE>
CYTOGEN (the
"Purchase Agreement"), and the Parties have agreed to
amend and
-------------------
restate the Original
Agreement as set forth herein (as so amended and restated,
this "Agreement").
---------
NOW,
THEREFORE,
in consideration of
the foregoing premises and the mutual
covenants contained herein, the Parties agree as follows:
1.
DEFINITIONS. For
the purposes of this Agreement, the following
-----------
terms, whether
used in the
singular or plural, shall have the following
meanings:
AFFILIATE. The term
"Affiliate" shall mean any Person, corporation,
---------
company, partnership, joint venture and/or firm which controls, is
controlled by
or is under common
control with, a Party. For purposes of this definition,
"control" shall mean (a) in the case of corporate entities, direct or indirect
ownership of at least 50% of the stock or participating
shares entitled to
vote
for the election of directors, and (b) in the case of
non-corporate
entities,
direct or indirect
ownership of at least
50% of the equity
interest with the
power to direct the management and policies of such non-corporate
entity.
AGREEMENT. The term
"Agreement" shall have the meaning set forth in
---------
the recitals.
AMENDMENT EFFECTIVE DATE. The term "Amendment Effective Date" shall
-------------------------
mean the date of this
Agreement, as set
forth in the
introductory
paragraph
hereof.
ANNUAL NET SALES. The
term "Annual Net Sales" shall mean, with
-----------------
respect to a Licensed
Product, the Net Sales
of such Licensed Product during a
Contract Year.
ANTIBODY PRODUCT.
The term "Antibody Product" shall mean any
------------------
Licensed Product for use in the Field which includes a Field
Antibody.
COMBINATION PRODUCT.
The term "Combination Product" means a Licensed
-------------------
Product that contains
more than one active
ingredient
and where at least
one
active ingredient that would, in the absence of a license,
infringe one or
more
claims of a Licensed
CYTOGEN Patent (such active ingredient(s), the "Licensed
--------
Ingredient(s)"), and
where the other active
ingredient(s) would not, in and of
-------------
itself (or themselves), in the absence of a license, infringe one
or more claims
of a Licensed CYTOGEN Patent.
COMMERCIAL SALE.
The term "Commercial Sale" shall mean the
-----------------
commercial sale,
by the LLC or its
Sublicensees,
of a Licensed
Product to a
Third Party. The sale
of a Licensed Product
distributed
or used for
clinical
trials or experimental purposes only shall not be considered a
Commercial Sale.
CONTRACT PERIOD. The
term "Contract
Period" shall mean the period
----------------
beginning on the Effective Date and ending on the date on
which this
Agreement
shall expire or
terminate in accordance with the provisions of Section 11
hereof.
CONTRACT QUARTER.
The term "Contract Quarter" shall mean each
-----------------
calendar quarter
ending on March 31st,
June 30th, September
30th and December
31st.
2
<PAGE>
CONTRACT YEAR. The
term "Contract Year"
shall mean
each calendar
--------------
year ending on December 31, or applicable subpart thereof in the first or last
Contract Year.
CYTOGEN. The term
"CYTOGEN" shall have the meaning set forth in the
-------
recitals of this Agreement.
CYTOGEN
TECHNICAL
INFORMATION. The
term "CYTOGEN Technical
--------------------
Information" shall
mean Technical
Information to the
extent, but only to
the
-----------
extent, used or useful
in the Field in which
CYTOGEN had, as of the
Effective
Date, a licensable right under the SKICR Agreement, and for the period from the
Effective Date until the Amendment Effective Date, only to the
extent previously
conveyed under Section 3.3 of the Original Agreement.
EFFECTIVE DATE. The
term "Effective Date" shall mean June 15, 1999,
--------------
the date of the Original Agreement, as set forth on the first page
thereof.
FDA. The term "FDA" shall mean the U.S. Food and Drug
Administration.
---
FIELD. The
term "Field" shall mean: (a) any and all means of
-----
developing, making,
having made, distributing, using, offering for sale,
selling, having sold,
importing or exporting
any Field Immunogen and/or any
vaccine incorporating
any Field Immunogen as a therapeutic, but excluding
vaccines for prostate cancer that are antigen presenting cells isolated from a
patient's blood, bone marrow or spleen and pulsed ex vivo with a
Field Immunogen
for return to the
patient; and (b) any and all means of
developing,
making,
having made,
distributing,
using, offering for sale, selling, having sold,
importing or exporting any Field Antibody as a therapeutic.
FIELD ANTIBODY.
The term "Field
Antibody" shall mean any peptide
---------------
that includes a complementarity determining region of an antibody recognizing
one or more Field Immunogens, including, without limitation, antibodies,
antibody fragments, antibody derivatives such as humanized
antibodies and single
chain antibodies,
and conjugates of any
of the foregoing,
but excluding MoAb
7E11.
FIELD IMMUNOGEN. The
term "Field Immunogen" shall mean any immunogen
---------------
that derives its immunogenicity wholly or in significant part from
PSMA or PSMP
or mimetopes thereof, or any combination of such immunogens.
FIRST COMMERCIAL SALE.
The term "First
Commercial Sale" shall
mean
----------------------
with respect to any
Licensed Product and with respect to any country in the
Territory, the first
Commercial
Sale of such Product
to a Third Party in such
country after such Licensed Product has been granted
Regulatory
Approval by a
Regulatory Authority having jurisdiction for such country.
LICENSED CYTOGEN PATENTS. The term "Licensed CYTOGEN
Patents" shall
-------------------------
mean the Patent rights
listed on Annex A
attached hereto,
together with any
other Patent
within the Field in which CYTOGEN had, as of the Amendment
Effective Date, a licensable right under the SKICR Agreement.
LICENSED INGREDIENT(S). The term "Licensed Ingredient" shall have
--------------------
the meaning set forth in the definition of "Combination
Product".
3
<PAGE>
LICENSED PRODUCT. The term "Licensed Product" shall mean any
product,
----------------
apparatus, method or service, the manufacture, use, sale, provision or
practice
of which would,
in the absence of a
license, infringe one
or more claims of a
Licensed CYTOGEN Patent.
LLC. The term "LLC"
shall have the meaning set forth in the recitals
---
of this Agreement.
LLC AGREEMENT. The
term "LLC Agreement" shall mean the Limited
-------------
Liability Company Agreement, dated as of June 15, 1999, by and
among Progenics,
CYTOGEN and the LLC, and any amendments thereto.
MANUFACTURING RIGHTS.
The term "Manufacturing Rights" shall have the
--------------------
meaning set forth in Section 2.2(n) hereof.
MOAB 7E11. The term
"MoAb 7E11" shall mean that certain antibody to
---------
PSMA known as MoAb
7E11-C5, which such
antibody is claimed in United States
Patent No. 5,162,504,
granted November 10, 1992, and entitled "Monoclonal
Antibodies to a New Antigenic Marker in Epithelial Prostatic Cells and Serum of
Prostate Cancer
Patients." The term "MoAb 7E11" includes all subclones claimed
in such Patent.
NDA. The term "NDA" shall mean an application submitted to a
---
Regulatory Authority
for marketing approval
of a product,
including (a) a New
Drug Application,
Product License
Application or Biologics License Application
filed with FDA or any
successor applications
or procedures, (b) any foreign
equivalent thereof,
and (c) all
supplements
and amendments that
may be filed
with respect to the foregoing.
NET SALES. The
term "Net Sales" shall mean, with respect to a
---------
Licensed Product, the gross amount invoiced by or on behalf of the
LLC or of its
Sublicensees, for
Licensed Products sold to Third Parties in BONA FIDE,
arm's-length
transactions, less the
following
(collectively, the
"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; (vi)
documented
customs
duties actually paid
by the Selling Person;
and (vii) any other
reduction or
specifically
identifiable amounts
included in the
Licensed Product's gross
invoice that are creditable for reasons substantially equivalent to
those listed
above. Sales between
or among the LLC or its Sublicensees shall be disregarded
for purposes of calculating Net Sales.
The following provisions apply to sales of Combination Products.
If a Licensed Product is sold as a Combination Product (a
"Combination
-----------
Sale"), the Net Sales
for such Licensed
Product shall be the
----
4
<PAGE>
portion of the Net Sales amount attributable to the Combination
Sale
allocable to the Licensed Ingredient determined as follows:
(1) Except
as provided below, the Net Sales amount for a
Combination Sale
shall equal the gross amount invoiced for the
Combination Sale,
reduced by the Permitted Deductions (the "Net
---
Combination Sale Amount"), multiplied by the fraction A/(A+B),
where:
-----------------------
A is the
invoice price,
in the country where
such Combination
Sale
occurs, of the Licensed Ingredient(s), if sold as a separate Licensed
Product consisting
solely of the Licensed Ingredient(s) in such
country by the Selling
Person; and B is the
aggregate of the invoice
price or prices, in
such country,
of such one or more
other active
ingredients included
in the Combination Product if sold separately in
such country by the Selling Person.
(2) 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 that portion of the Net Combination Sale Amount reasonably
determined in good
faith by the Parties
as properly reflecting
the
value of the
Licensed Ingredient(s) included in the Combination
Product.
NON-LICENSED PRODUCTS.
The term "Non-Licensed
Products" shall
have
---------------------
the meaning set forth in Section 5.4.
NWC. The term "NWC"
shall have the meaning set forth in the recitals
---
of this Agreement.
NWC Agreement. The
term "NWC Agreement"
shall have the meaning
set
-------------
forth in the recitals of this Agreement.
OPTION STAGE. The term
"Option Stage"
shall have
the meaning
set
------------
forth in Section 5.3.
ORIGINAL AGREEMENT.
The term "Original
Agreement"
shall have the
-------------------
meaning set forth in the recitals of this Agreement.
OTHER PRODUCT. The
term "Other
Product" shall
mean any Licensed
--------------
Product for use in the
Field which is not an Antibody Product or a Vaccine
Product.
PATENT. The
term "Patent"
shall mean
(i) unexpired letters
patent
------
(including inventor's
certificates) which
have not lapsed or been held invalid
or unenforceable by a
court or
administrative body of
competent
jurisdiction
from which no appeal
can be taken or has been taken within the required time
period,
including,
without
limitation, any
substitution,
extension,
registration,
confirmation, reissue, reexamination, renewal or any like filing
thereof and (ii) pending applications for letters patent
that have not been the
subject of a rejection notice from which an appeal cannot be taken
or in respect
of which the applicable period of appeal has expired,
5
<PAGE>
including, without
limitation, any continuation,
division
or
continuation-in-part thereof and any provisional applications.
PERMITTED DEDUCTIONS.
The term "Permitted Deductions" shall have the
--------------------
meaning set forth in the definition of Net Sales.
PERSON. The
term "Person"
shall mean
any corporation,
limited or
------
general
partnership,
limited liability
company, joint venture, trust,
unincorporated association, governmental body, authority,
bureau or agency, any
other entity or body, or an individual.
PHASE I STUDY. The
term "Phase I
Study" shall mean a study of a
--------------
Licensed Product
in human volunteers or patients the purpose of which is
preliminary
determination of the safety and tolerability of a dosing regime
and
for which there are no primary endpoints (as recognized by FDA)
in the protocol
relating to efficacy.
PHASE II STUDY. The
term "Phase
II Study" shall mean (a) a dose
----------------
exploration, dose
response, duration of
effect, kinetics, dynamic relationship
or preliminary
efficacy and safety
study of a Licensed
Product in the
target
patient population, or
(b) a controlled dose ranging clinical trial to evaluate
further the
efficacy and safety of a Licensed
Product in the target
patient
population and to define the optimal dosing regimen.
Phase III Study. The
term "Phase III Study" shall mean a controlled
---------------
pivotal clinical study of a Licensed Product that is prospectively
designed to
demonstrate
statistically whether
such Licensed Product
is effective and safe
for use in a particular indication in a manner
sufficient to obtain
Regulatory
Approval to market such product.
PROGENICS. The term
"Progenics" shall have
the meaning set forth in
---------
the recitals of this Agreement.
PROSTAGEN. The term
"Prostagen" shall have
the meaning set forth in
---------
the recitals of this Agreement.
PROSTAGEN AGREEMENT.
The term "Prostagen
Agreement" shall have
the
--------------------
meaning set forth in the recitals of this Agreement.
PSMA. The term
"PSMA" shall mean
prostate specific membrane antigen
----
as described in CANCER RESEARCH, 53:227-230 (1993) and as described
in the U.S.
Patent
Application
Serial Nos.
08/973,337
and 08/394,152, including
continuations and
continuations-in-part,
splice variations
thereof, species
variations thereof,
allelic variations thereof, and nucleic acids encoding the
same.
PSMP. The term "PSMP" shall mean prostate specific membrane
peptides,
----
which include any
peptide sequence
appearing in a PSMA protein and unique
to
PSMA proteins, and nucleic acids encoding the same.
REGULATORY APPROVAL.
The term "Regulatory Approval" shall mean, with
-------------------
respect to a Licensed
Product in a country,
the approval of the applicable
Regulatory Authority
necessary for the marketing and sale of such Licensed
Product in such country.
6
<PAGE>
REGULATORY AUTHORITY.
The term "Regulatory
Authority"
shall mean
---------------------
the applicable
governmental authority (which, in the United States, is the
FDA)
that is responsible
for approval for
manufacturing,
marketing or importing
a
therapeutic agent in a particular country for human use.
[**].
ROYALTY BUYDOWN. The
term "Royalty Buydown" shall have the meaning
---------------
set forth in Section 5.3.
ROYALTY BUYDOWN OPTION. The term "Royalty Buydown Option" shall
-------------------------
have the meaning set forth in Section 5.3.
ROYALTY TERM. The term
"Royalty Term" shall
mean with respect to
-------------
any particular
Licensed Product in any particular country, the period of time
commencing on the First Commercial Sale of such Licensed Product in
such country
and extending
until the later of:
(a) the expiration of
the last to expire of
any Valid Claim
included in any Licensed CYTOGEN Patent in such country which
would be infringed by
an unlicensed
Third Party's manufacture, use, sale,
importation,
development or
commercialization of
the Licensed Product
or (b)
[**] of the First Commercial Sale of the Licensed Product in such
country.
SELLING PERSON. The
term "Selling Person"
shall mean any or all
of
--------------
the LLC or
its Sublicensees, as appropriate, selling a Licensed Product
(including a Licensed
Product which is part
of a Combination
Product) or the
active ingredients and/or components thereof.
SERVICES AGREEMENT.
The term "Services
Agreement"
shall have
the
-------------------
meaning set forth in the recitals of this Agreement.
SKICR. The term
"SKICR" shall mean the Sloan-Kettering Institute for
-----
Cancer Research, a New York membership corporation having its
principal place of
business at 1275 York Avenue, New York, New York 10021.
SKICR AGREEMENT. The term "SKICR Agreement" shall mean the Option
and
---------------
License Agreement,
effective July 1, 1993, by and between SKICR and CYTOGEN, as
amended by amendment no. 1 thereto effective as of November 22,
1993.
SKICR LICENSE.
The term "SKICR License" shall mean the license
-------------
granted to CYTOGEN pursuant to the SKICR Agreement.
SUBLICENSEE. The term
"Sublicensee" shall mean a Person to which the
-----------
LLC grants a sublicense under Section 3.2.
TECHNICAL INFORMATION.
The term "Technical Information" shall mean
---------------------
unpublished research
and development information, unpatented inventions,
formulae, processes, know-how, trade secrets and technical
data.
TERRITORY. The term
"Territory" shall mean the entire world.
---------
7
<PAGE>
THIRD PARTY. The term
"Third Party" shall mean any Person other than
-----------
Progenics, CYTOGEN,
the LLC and their
respective
Affiliates
and, except for
CYTOGEN, their respective Sublicensees.
THIRD PARTY LICENSE.
The term "Third Party
License" shall mean an
--------------------
agreement between (i)
the LLC or one of its Affiliates or Sublicensees and (ii)
a Third Party that grants intellectual property rights that are necessary or
advisable and that would, in the commercially reasonable judgment of the LLC,
but for such license, be infringed by the manufacture, use, sale, importation,
development or
commercialization of
Licensed Product by
the LLC or one of its
Sublicensees.
VACCINE PRODUCT. The
term "Vaccine Product"
shall mean any Licensed
----------------
Product for use in the
Field which
includes a Field
Immunogen and is not an
Antibody Product.
VALID CLAIM.
The term "Valid
Claim" shall mean a claim (a) of any
------------
issued, unexpired
Patent that has not
been revoked or held
unenforceable
or
invalid by
a decision of a court or governmental agency of competent
jurisdiction from
which no appeal
can be taken,
or with respect to which an
appeal is not taken
within the time
allowed for appeal,
and that has not been
disclaimed or
admitted to be invalid or unenforceable through reissue,
disclaimer or
otherwise,
or (b) of any Patent
Application
that has not been
cancelled, withdrawn
or abandoned, or has
not been pending for more than seven
(7) years.
2.
REPRESENTATIONS AND WARRANTIES.
2.1
BY THE LLC.
----------
The
LLC represents
and warrants to CYTOGEN, as of the date hereof, as
follows:
(a) DUE
ORGANIZATION.
The LLC is a limited liability company
-----------------
organized and validly existing under the laws of the State of
Delaware.
(b) POWER TO ACT. The LLC has all necessary corporate power under
the
------------
laws of the State of Delaware to enter into and perform its obligations under
this Agreement and has
taken all necessary
corporate action under
the laws of
the State of Delaware and its certificate of formation and
operating
agreement
to authorize the execution of, and performance of its obligations
under, this
Agreement.
(c) NO DEFAULT. The
LLC is not in default under, or in conflict with
----------
respect to, its
certificate of formation or operating agreement or any term or
provision of any
agreement, mortgage or
indenture to which it is a party or by
which any of its
properties
are bound or any statute, rule, order, writ,
injunction, decree or
regulation applicable to it or any of its properties that
will preclude the
performance of its
obligations
under this Agreement
in any
material respect.
(d) NO MATERIAL CONTRACTS. The LLC is not subject to any
contract or
---------------------
agreement that will preclude or otherwise conflict with the performance of its
obligations under this Agreement in any material respect.
8
<PAGE>
(e) NO CONFLICTS.
Neither
the execution nor delivery of this
------------
Agreement, the
consummation of the
transactions
herein contemplated nor the
fulfillment of or
compliance
with the terms and
provisions
hereof will (i)
require the consent,
approval or authorization of, or notice, declaration,
filing or registration
with, any governmental or regulatory authority, or
violate any
provisions
of law, administrative regulation or court decree
applicable to the LLC
or (ii) conflict with,
result in a breach of
any of the
terms, conditions or provisions of or constitute a default under
the certificate
of formation or operating agreement of the LLC or of any agreement
or instrument
to which it is a party or by which any of its property is
bound.
(f) EXECUTION AND DELIVERY; ENFORCEABILITY. This Agreement has been
--------------------------------------
duly executed
and delivered and constitutes the legal, valid and binding
obligation of the LLC,
enforceable
against it in accordance with the terms
hereof, subject,
as to enforcement, to bankruptcy, fraudulent conveyance,
insolvency,
reorganization,
moratorium and other laws relating to or affecting
creditors' rights generally and by general equitable
principles.
2.2
BY CYTOGEN.
----------
CYTOGEN represents and warrants to the LLC, as of the date hereof,
as
follows:
(a) DUE ORGANIZATION.
CYTOGEN is a
corporation duly
organized and
----------------
validly existing under the laws of the State of Delaware.
(b) POWER TO ACT. CYTOGEN has all necessary corporate power under
the
------------
laws of the State of Delaware to enter into and perform its obligations under
this Agreement and has
taken all necessary
corporate action under
the laws of
the State of Delaware
and its certificate of incorporation and by-laws to
authorize the execution of, and performance of its obligations under, this
Agreement. CYTOGEN has
the full right, power
and authority to grant all of the
right, title and interest in the licenses granted, or contingent licenses that
may be granted, by CYTOGEN under Section 3 hereof.
(c) NO DEFAULT.
CYTOGEN is not in default under, or in conflict with
----------
respect to, its certificate of incorporation or by-laws or any term
or provision
of any agreement,
mortgage or indenture
to which it is a party or by which any
of its properties
are bound or any
statute, rule,
order, writ, injunction,
decree or regulation applicable to it or any of its properties that will
preclude the performance of its obligations under this Agreement in
any material
respect.
(d) NO MATERIAL CONTRACTS. CYTOGEN is not subject to any
contract or
---------------------
agreement that will preclude or otherwise conflict with the performance of its
obligations under this Agreement in any material respect.
(e) NO CONFLICTS. Neither the execution nor delivery of this
-------------
Agreement, the
consummation of the
transactions
herein contemplated nor the
fulfillment of or
compliance
with the terms and
provisions
hereof will (i)
require the consent,
approval or authorization of, or notice, declaration,
filing or registration
with, any governmental or regulatory authority, or
violate any
provisions
of law, administrative regulation or court decree
applicable to CYTOGEN
or (ii) conflict with,
result in a breach of
any of the
terms, conditions or provisions of or constitute a
9
<PAGE>
default under the certificate of incorporation or by-laws of CYTOGEN or of
any
agreement or
instrument to which it
is a party or by which any of its property
is bound.
(f) EXECUTION AND DELIVERY; ENFORCEABILITY. This Agreement has been
---------------------------------------
duly executed
and delivered and constitutes the legal, valid and binding
obligation of
CYTOGEN, enforceable against it in accordance with the terms
hereof, subject,
as to enforcement, to bankruptcy, fraudulent conveyance,
insolvency,
reorganization,
moratorium and other laws relating to or affecting
creditors' rights generally and by general equitable
principles.
(g) SKICR AGREEMENT. (i) Attached as Exhibit 1 is a true and
complete
---------------
copy of the SKICR
Agreement including
all amendments
thereto. Copies of all
material
correspondence between
CYTOGEN and SKICR through the Amendment
Effective Date have
been delivered
by CYTOGEN to the LLC and
Progenics.
No
provision of the SKICR Agreement has been amended, modified or
waived, except as
set forth in Exhibit 1. All of the rights granted under the SKICR
Agreement to
CYTOGEN are valid and
enforceable, and
neither this Agreement nor the Purchase
Agreement contravene
any provision of the SKICR Agreement or give rise to a
termination right
thereunder.
(ii) Except as set forth in Exhibit 1, to
CYTOGEN's knowledge,
the representations and warranties made by SKICR in
the
SKICR Agreement were true in all material respects when made; there
has occurred
no act or failure to act that would render such representations untrue in any
material respect
if made on and as of
the date hereof;
and there exists no
breach or anticipatory breach by SKICR of any of its material
obligations under
the SKICR Agreement.
(iii) The SKICR Agreement is in full force and effect, and
CYTOGEN has complied in all material respects with its obligations
thereunder.
There does not exist any default by CYTOGEN under such agreement that, after
notice or the
lapse of time or both,
would constitute a material event of
default or give rise to a right of termination thereunder. (iv) CYTOGEN has
neither given nor
received any notice of termination or breach under such
agreements. (v) In the
event of any
misrepresentation or breach of warranty by
SKICR under the SKICR
Agreement, CYTOGEN
will cooperate
with all reasonable
requests of the LLC or its Affiliates regarding the assertion of any claim or
cause of action against SKICR for such misrepresentation or breach of
warranty;
provided, that the LLC
shall bear any and all costs, expenses, liabilities or
--------
obligations of CYTOGEN in connection therewith or arising
therefrom.
(h) NO LITIGATION, CLAIMS OR CONFLICTS. (i) There is no action,
suit,
----------------------------------
claim or proceeding
pending or
threatened
against CYTOGEN or, to CYTOGEN's
knowledge, SKICR with
respect to any of the Licensed CYTOGEN Patents or CYTOGEN
Technical Information,
either at law or in equity, before any court or
administrative agency or before any governmental department,
commission, board,
bureau, agency or instrumentality, whether United States or
foreign, relating to
validity,
infringement,
ownership or
otherwise, and neither
CYTOGEN nor, to
CYTOGEN's knowledge,
SKICR has received any notice that any person may
bring
such a claim, and CYTOGEN has no belief that any basis or grounds
exists for any
such actions,
suits or claims.
(ii) Except as
disclosed to the LLC by counsel
for the LLC, to CYTOGEN's knowledge there are no conflicts with or
violations or
infringements of any
rights or asserted rights of any other person with respect
to the Licensed
CYTOGEN Patents or the
CYTOGEN Technical
Information.
(iii)
There are no
proceedings or claims
pending in which
CYTOGEN or, to
CYTOGEN's
knowledge, SKICR
alleges that any person is infringing upon, or otherwise
violating, any of the Licensed CYTOGEN Patents or CYTOGEN Technical
Information,
10
<PAGE>
nor are any proceedings threatened by CYTOGEN or, to CYTOGEN's
knowledge, SKICR
alleging any such violation or infringement.
(i) SUBSISTING RIGHTS.
The Licensed CYTOGEN
Patents in existence on
-----------------
the date hereof are in full force and effect, have been maintained to date and
are not invalid or
unenforceable, in
whole or in part. No act has been done or
omitted to be done which had or could have the effect of impairing
or dedicating
to the public, or
entitling any U.S. or foreign government authority or any
other person to
cancel, forfeit, modify or consider abandoned any of the
Licensed CYTOGEN
Patents, or give any person any rights with
respect thereto.
All of CYTOGEN's
rights under the SKICR
Agreement,
and CYTOGEN's ownership
rights in the Patents
listed in paragraph 2 of Annex A hereof, are valid,
enforceable and free of defects.
(j) CONFIDENTIALITY;
EFFECTIVE WAIVERS. (i)
Neither CYTOGEN nor, to
----------------------------------
CYTOGEN's knowledge, SKICR has divulged, furnished to or made accessible to
any
person any trade
secrets included in
the Licensed CYTOGEN
Patents or CYTOGEN
Technical Information
without prior thereto having obtained an agreement of
confidentiality from
such person. CYTOGEN
and, to CYTOGEN's
knowledge, SKICR
have obtained
from all individuals who participated in any respect in the
invention or authorship of any Licensed CYTOGEN Patents or CYTOGEN Technical
Information (as employees, consultants or otherwise)
effective waivers of any
and all ownership
rights of such
individuals in such rights and assignments to
CYTOGEN or SKICR, as applicable, all rights with respect
thereto.
(k) PATENT PROSECUTION
DISCLOSURE. CYTOGEN
has disclosed to the LLC
------------------------------
all of the prosecution
files of all of the
patents and patent applications
licensed to the LLC by CYTOGEN hereunder.
(l) PATENTS IN THE FIELD. To CYTOGEN's knowledge, on the date
hereof,
--------------------
CYTOGEN does not have
a licensable
right to any Patent
used or useful in
the
Field except as disclosed on Annex A hereto.
(m) NO PRIOR TRANSFER. CYTOGEN has not sublicensed, assigned,
-------------------
transferred, conveyed
or otherwise
encumbered its right, title and interest in
any of the Licensed CYTOGEN Patents or CYTOGEN Technical
Information other
than
pursuant to the Original Agreement.
(n) NWC. The NWC
Agreement has been terminated and no rights in the
---
Field remain
outstanding under the
NWC Agreement.
All rights in the
Field to
Patents and
Technical Information granted thereunder (the "Manufacturing
-------------
Rights") have been reacquired by CYTOGEN. There are no subsisting
liabilities to
------
NWC stemming from or relating to termination of the NWC
Agreement.
(o) MANUFACTURING
RIGHTS. Without
limiting the
generality
of the
--------------------
license granted to the
LLC under Section 3.1, the Licensed CYTOGEN Patents and
CYTOGEN Technical
Information include Manufacturing Rights to the extent of the
Field. CYTOGEN hereby retains all Manufacturing Rights outside of
the Field.
(p) EXCLUSIVE OWNER,
ETC. CYTOGEN is the sole and exclusive licensee
--------------------
of the rights licensed to CYTOGEN under the SKICR Agreement of the
rights to the
Patents listed
11
<PAGE>
in Annex A hereof,
which sets forth a complete and accurate list of Licensed
CYTOGEN Patents as of
date hereof, all of
which Patents listed in Annex A are,
to CYTOGEN's
knowledge,
owned free and clear of any liens, charges and
encumbrances, and no
other person, corporation or other private or governmental
entity or subdivision thereof has or shall have any claims of ownership
whatsoever with
respect to such rights. There are no judgments or
settlements
against or owed by CYTOGEN relating to such rights.
(q) ORIGINAL AGREEMENT. CYTOGEN has complied in all material
respects
------------------
with Section 4.6 of the Original Agreement.
2.3
BY PROGENICS.
Progenics represents and warrants to CYTOGEN, as of
------------
the date hereof, as follows:
(a) DUE ORGANIZATION.
Progenics is a corporation duly organized and
----------------
validly existing under the laws of the State of Delaware.
(b) POWER TO ACT.
Progenics has all necessary corporate power under
------------
the laws of the State of Delaware to enter into and perform its obligations
under this Agreement and has taken all necessary corporate action
under the laws
of the State of Delaware and its certificate of incorporation and by-laws to
authorize the execution of, and performance of its obligations under, this
Agreement. Progenics has the full right, power and authority to
grant all of the
right, title and interest in the licenses granted, or contingent licenses that
may be granted, by Progenics under this Agreement.
(c) NO DEFAULT.
Progenics is
not in default
under, or in
conflict
----------
with respect to, its
certificate
of incorporation or by-laws or
