AMENDED AND RESTATED PSMA/PSMP LICENSE AGREEMENT by and among PROGENICS PHARMACEUTICALS, INC., CYTOGEN CORPORATION and PSMA DEVELOPMENT COMPANY LLC Dated April 20, 2006
EXHIBIT
10.1
AMENDED
AND RESTATED PSMA/PSMP LICENSE AGREEMENT
by
and among
PROGENICS
PHARMACEUTICALS, INC.,
CYTOGEN
CORPORATION
and
PSMA
DEVELOPMENT COMPANY
LLC
Dated
April 20, 2006
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PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION
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
|
14
|
|
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
|
15
|
|
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
|
17
|
|
5.4
|
Reduction
of Royalties if Third Party License Required
|
18
|
|
5.5
|
Payments
Associated with Existing Third Party Agreements
|
19
|
|
5.6
|
Other
Products
|
19
|
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CONFIDENTIAL TREATMENT REQUESTED
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PORTION OMITTED AND FILED SEPARATELY WITH THE
COMMISSION
i
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
|
20
|
|
7.3
|
Calculation
of Royalties and Other Payments
|
20
|
|
7.4
|
Currency
Control Restrictions
|
21
|
|
7.5
|
Books
and Records
|
21
|
|
8.
|
TAXATION
OF PAYMENTS
|
21
|
|
9.
|
PRODUCT
LIABILITY DISCLAIMERS
|
22
|
|
9.1
|
Product
Liability Disclaimer by Progenics
|
22
|
|
9.2
|
Product
Liability Disclaimer by CYTOGEN
|
22
|
|
9.3
|
Producty
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
|
25
|
|
13.
|
EXPORT
LICENSES
|
25
|
|
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
|
27
|
|
14.7
|
No
Implied Rights
|
27
|
|
14.8
|
No
Waiver
|
27
|
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COMMISSION
ii
14.9
|
Publicity
|
28
|
|
14.10
|
Promotion
and Advertising
|
28
|
|
14.11
|
Arbitration
|
28
|
|
14.12
|
Confidentiality
|
29
|
|
14.13
|
No
Third Party Beneficiaries
|
30
|
|
14.14
|
Governing
Law
|
30
|
|
14.15
|
SKICR
Agreement
|
30
|
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iii
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 000 Xxx Xxx Xxxx Xxxxx Xxxx,
Xxxxxxxxx, XX 00000 (“Progenics”),
CYTOGEN Corporation, a Delaware corporation having its place of business
at 000
Xxxxxxx Xxxx Xxxx, XX 5308, Xxxxxxxxx, XX 00000 (“CYTOGEN”),
and
PSMA Development Company LLC, a Delaware limited liability company having
its
principal place of business at 000 Xxx Xxx Xxxx Xxxxx Xxxx, Xxxxxxxxx, XX
00000
(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
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1
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.
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PORTION OMITTED AND FILED SEPARATELY WITH THE
COMMISSION
2
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”.
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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
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4
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,
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PORTION OMITTED AND FILED SEPARATELY WITH THE
COMMISSION
5
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.
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PORTION OMITTED AND FILED SEPARATELY WITH THE
COMMISSION
6
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) the tenth (10th)
anniversary 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 Xxxxx-Xxxxxxxxx Institute for Cancer Research, a New York membership
corporation having its principal place of business at 0000 Xxxx Xxxxxx, Xxx
Xxxx, Xxx Xxxx 00000.
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.
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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.
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(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
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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, nor are any proceedings threatened by CYTOGEN or,
to
CYTOGEN’s knowledge, SKICR alleging any such violation or infringement.
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(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 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
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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 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. Progenics
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 Progenics 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 incorporation or by-laws
of
Progenics 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 Progenics, 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.
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2.4 By
All Parties.
Each
Party represents and warrants to each of the others, as of the date hereof,
that
it has not breached or violated, and is not in breach or violation of, the
Original Agreement.
3. LICENSES.
3.1 Grant
by CYTOGEN.
Subject
to the terms and conditions herein contained, CYTOGEN hereby grants to the
LLC,
to the extent (but only to the extent) of the Field, the exclusive (even
as to
CYTOGEN) right and license throughout the Territory under the Licensed CYTOGEN
Patents and the CYTOGEN Technical Information to develop, make, have made,
distribute, use, offer for sale, sell, have sold, import or export Licensed
Products. The Parties acknowledge and agree that the LLC shall not be restricted
in its use for any purpose of Technical Information developed or otherwise
acquired by it, except to the extent such Technical Information is CYTOGEN
Technical Information, in which case it will be treated in accordance with
the
immediately preceding sentence.
3.2 Sublicenses.
The
LLC
shall have the right to grant sublicenses of the rights granted hereunder,
provided
that:
(i) each Sublicensee shall have agreed in writing to keep books and records
and
permit CYTOGEN to review such books and records pursuant to the relevant
provisions, and to comply with all terms of this Agreement expressly applicable
to a Sublicensee of the LLC; and (ii) within 15 days of granting any such
sublicense the LLC shall give written notice of such grant to CYTOGEN and
provide CYTOGEN with a copy of such sublicense. No consent or approval of
CYTOGEN shall be required in connection with the granting of such sublicenses.
Upon reasonable request of any Sublicensee of the LLC, CYTOGEN shall cooperate
with such Sublicensee to execute, acknowledge, and deliver all documentation,
further assurances and other instruments solely with respect to the existence
and good standing of this Agreement, including without limitation copies
of the
SKICR Agreement, as amended through the relevant date, and correspondence
relating thereto; provided,
that,
subject to Section 3.4, CYTOGEN will not (i) be or become obligated to pay
any
fees or unreimbursed expenses; (ii) incur any additional obligations; or
(iii)
be required to amend or deemed to have amended this Agreement or the SKICR
Agreement, solely by reason thereof. Without limiting the generality of the
foregoing, it is understood and agreed that the LLC may grant sublicenses
to its
Affiliates (“Affiliate
Sublicensees”)
of all
or any part(s) of its rights hereunder, in accordance with this Section 3.2;
provided,
that it
shall be a condition to any such sublicense to such an Affiliate Sublicensee
that such Affiliate Sublicensee agrees to make available directly to CYTOGEN,
upon the prior written request of CYTOGEN, such portion of sums owing by
such
Affiliate Sublicensee to the LLC under the relevant sublicense agreement
to
which CYTOGEN is entitled under Article 5 hereof.
3.3 Guarantee
of Performance of Sublicensee.
The
LLC
hereby unconditionally guarantees to CYTOGEN the performance of any of its
Sublicensees’ financial obligations hereunder, including making all payments
due, and making all reports required, under this Agreement to be made by
reason
of sales of Licensed Products by its Sublicensees and their compliance with
all
applicable terms of this Agreement. In any such sublicense, the Sublicensee
shall agree that in the event of a breach by the Sublicensee in
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the
observance of any applicable terms of this Agreement, CYTOGEN shall be entitled
to proceed against such Sublicensee or directly against the LLC, as CYTOGEN
may
determine, in its sole discretion, to enforce this Agreement.
3.4 Cure
of Breach by Sublicensee.
Upon
notification to CYTOGEN by the LLC of the grant by the LLC of any sublicense
under this Agreement, CYTOGEN shall become obligated to notify in writing
any
such Sublicensee of any breach by the LLC hereunder, or of any purported
termination by CYTOGEN, with such notice to be sent to such Sublicensee (at
the
address specified by the LLC) at the same time as notice is sent to the LLC.
In
the event that the LLC breaches this Agreement, which breach remains uncured
through the expiration of any applicable cure period, any Sublicensee of
the LLC
hereunder shall have the right, but not the obligation, during a period of
45
days after the expiration of the aforesaid cure period, to cure such breach
in
its own name, and, upon curing such breach, such Sublicensee shall have the
right to be substituted for the LLC as a direct sublicensee under the Licenses
to the exclusion of, and on the same terms as, the LLC to the extent of the
sublicense. A provision to the effect of the foregoing shall be included
in any
sublicense granted hereunder.
3.5 [*]
(a) Notice
of Proposed Transfer.
The LLC
shall (x) deliver to CYTOGEN a written notice (the “Notice”)
stating: (i) the LLC’s intention to sublicense the Potential IP; (ii) the
Proposed IP to be sublicensed; and (iii) the price and/or consideration (the
“Offer
Price”)
and
the material terms and condition of the proposed sublicense (the “Offer
Terms”)
contained in the bona
fide
Offeror
offer; and (y) offer the Proposed IP at the Offer Price and on the Offer
Terms
to CYTOGEN; provided,
however,
if the
Offer Price is for consideration other than cash, then CYTOGEN shall have
the
right to offer substantially similar consideration as the Offer Price or
with a
consideration at least as favorable to the LLC, in the reasonable judgment
of
the LLC, as the Offer Price consideration from such Offeror.
(b) Exercise
of Right of First Refusal.
At any
time within 30 calendar days after receipt by CYTOGEN of the Notice (the
“Response
Period”),
CYTOGEN may, by giving written notice to the LLC, elect to sublicense the
Proposed IP. The consideration payable by CYTOGEN in respect of the Proposed
IP
sublicense shall be the Offer Price and the terms and conditions of the
sublicense shall be in all material respects, at least as favorable to the
LLC
as the Offer Terms taken as a whole. If (i) CYTOGEN indicates during the
Response Period that it has no interest in exercising its Right of First
Refusal
or (ii) CYTOGEN fails to provide the LLC with notice of exercise prior to
the
expiration of the Response Period, the LLC shall thereafter be free, without
any
further obligation to CYTOGEN, to sublicense the Proposed IP to an Offeror
on
terms no more favorable to the Offeror than the Offer Price and Offer Terms;
provided,
however,
the LLC
must execute a definitive agreement with the Offeror with such Offer Price
and
on such Offer Terms within 180 calendar days after the expiration of the
Response Period (the “Termination
Period”).
If
such agreement is not executed prior to the expiration of the Termination
Period, then CYTOGEN shall have the right to receive again the Notice set
forth
in Section 3.5(a) above, and CYTOGEN shall have the right to the Response
Period
set forth in this Section 3.5(b).
3.6 Reservation
of Rights.
CYTOGEN
reserves the right to practice and use the CYTOGEN Technical Information
and to
develop, make, have made, and use Licensed Products, in each case, without
cost
and subject to the confidentiality provisions of this Agreement, for
non-commercial internal research and development purposes.
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3.7 No
Other Rights.
Except
as expressly provided herein, no right, title or interest is granted by CYTOGEN
under the Licensed CYTOGEN Patents or CYTOGEN Technical Information or
otherwise. CYTOGEN expressly does not grant, and nothing contained herein
is
intended to grant, or shall be construed as granting, any right, title or
interest outside of the Field.
3.8 Competition
Not Prohibited.
No
license granted under this Agreement, and no other provision contained herein,
shall be deemed to prohibit the LLC or CYTOGEN or any of their respective
Affiliates from engaging in any activity outside of the Field.
4. CERTAIN
COVENANTS.
4.1 No
Waivers or Grant of Further Rights.
CYTOGEN
will not, without the prior written consent of the LLC, terminate, amend,
modify
or grant any waivers or consents under any the SKICR Agreement with respect
to
the Field, or grant any further rights to the Licensed CYTOGEN Patents or
CYTOGEN Technical Information in the Field except to the LLC, or take any
other
action with respect to the Licensed CYTOGEN Patents or the CYTOGEN Technical
Information that could adversely affect the rights granted to the LLC
hereunder.
4.2 Summary
Reports.
For so
long as the LLC is developing Licensed Products, the LLC shall keep CYTOGEN
informed through written summary reports about the status of the development
of
Licensed Products. Such reports shall be provided to CYTOGEN on a quarterly
basis, with the first report due on June 30, 2006. The sole remedy for breach
of
this Section 4.2, is compliance by the LLC with this Section 4.2 upon notice
by
CYTOGEN.
4.3 Breach
of SKICR Agreement.
In the
event that CYTOGEN shall be in breach of or default under any of the material
terms, conditions or agreements contained in the SKICR Agreement to be kept,
observed or performed by it, or receives notice of breach or termination
of or
default under such agreements, it shall immediately notify the LLC thereof.
If
CYTOGEN has not cured such breach or default within 30 days after the effective
date of any notice of termination issued with respect to such breach or default,
the LLC shall have the right, but not the obligation, to cure any such breach
or
default in its own name, and the LLC shall have the right to be substituted
for
CYTOGEN as direct licensee in the Field under either such agreement to the
exclusion of, and on the same terms as, CYTOGEN. If the LLC elects not to
cure
such breach or default or fails to cure such breach or default within 40
days of
the notice, then Progenics shall have the right, but not the obligation,
to cure
any such breach or default in its own name, and Progenics shall have the
right
to be substituted for CYTOGEN as direct licensee in the Field under either
such
agreement to the exclusion of, and on the same terms as, CYTOGEN. The 30-day
and
40-day periods described above shall be extended on a one-for-one basis as
a
result of any extension to the cure period set forth in Section IV.D.1 of
the
SKICR Agreement agreed to in writing by SKICR.
4.4 Notices
under the SKICR Agreement.
CYTOGEN
shall require SKICR to furnish copies of all notices and other communications
required or permitted under such the SKICR Agreement (including without
limitation notices of breach or termination) to the LLC and, upon the request
of
the LLC, to such Sublicensee(s) of the LLC or as the LLC shall specify. In
addition, CYTOGEN will furnish copies of all notices and communications to
the
LLC and, upon the request of the LLC, to such Sublicensee(s) of the LLC as
the
LLC shall specify.
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4.5 Compliance
with Terms of the SKICR Agreement; Assignment.
CYTOGEN
shall fulfill each of its obligations under the SKICR Agreement. The LLC
shall
undertake the efforts required of CYTOGEN under Section VIII.A.1 of the SKICR
Agreement within the Field. Without limiting the generality of the foregoing,
within 30 days of the execution of this Agreement, CYTOGEN shall notify SKICR
of
the execution of this Agreement and provide SKICR with the LLC’s name and
address as required by Section III.D.3 of the SKICR Agreement. CYTOGEN will
not
assign any interests under the SKICR Agreement unless the assignee expressly
agrees to take such interest subject to the interest of the LLC
hereunder.
4.6 Termination
of Services Agreement.
The
Parties hereby terminate, in its entirety, the Services Agreement and each
Party
releases each other Party from any obligations thereunder and from any
liabilities relating thereto.
5. ROYALTIES
AND OTHER PAYMENTS. In
further consideration for the exclusive licenses granted by CYTOGEN to the
LLC
pursuant to the provisions of Section 3.1 hereof, the LLC agrees to make
the
following payments to CYTOGEN as follows:
5.1 Milestone
Payments.
The
LLC
shall make the following one-time payments to CYTOGEN upon achievement of
the
milestone events set forth below:
(a) Antibody
Product Milestones:
[*]:
Milestone
Event For Antibody Products:
|
Payment
Amount
|
Upon
[*] of [*] in the [*]:
|
$[*]
|
[*]:
Milestone
Events For Antibody Products:
|
Payment
Amount
|
Upon
[*] for the [*] of at least $[*]:
|
$[*]
|
Upon
[*] for [*] of at least $[*]:
|
$[*]
|
(b) Vaccine
Product Milestones:
[*]:
Milestone
Events For Vaccine Products:
|
Payment
Amount
|
Upon
[*] of any [*] in the [*]:
|
$[*]
|
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE
COMMISSION
16
[*]:
Milestone
Events For Vaccine Products:
|
Payment
Amount
|
Upon
[*] for the [*] of at least $[*]:
|
$[*]
|
Upon
[*] for the [*] of at least $[*]:
|
$[*]
|
Each
of
the Regulatory Approval milestone payments payable under this Section 5.1
shall
be payable only [*] in relation to Antibody Products and only [*] in relation
to
Vaccine Products, regardless of [*]. [*] milestones payable under this Section
5.1 shall be payable only [*] in respect of [*] and only [*] in respect of
[*].
5.2 Royalties.
(a) Subject
to Section 5.3, commencing with the First Commercial Sale of an Antibody
Product, and thereafter during the relevant Royalty Term, the LLC shall pay
to
CYTOGEN, on an Antibody Product-by-Antibody Product basis in the Territory,
royalties in the amount of [*]% of Annual Net Sales of such Antibody
Product.
(b) Subject
to Section 5.3, commencing with the First Commercial Sale of a Vaccine Product,
and thereafter during the relevant Royalty Term, the LLC shall pay to CYTOGEN
the following royalties on a Vaccine Product-by-Vaccine Product basis in
the
Territory for Annual Net Sales of such Vaccine Product:
Incremental
Annual Net Sales of a Vaccine Product (on a Vaccine-Product-by-Vaccine
Product basis) in the Territory during the applicable Calendar
Year:
|
Royalty
Rate
|
For
the portion of Annual Net Sales less than $[*]:
|
[*]%
|
For
the portion of Annual Nets Sale equal to or greater than $[*],
but less
than $[*]:
|
[*]%
|
For
the portion of Annual Net Sales equal to or greater than
$[*]:
|
[*]%
|
5.3 Royalty
Buydown.
(a) The
LLC
shall have the option (the “Royalty
Buydown Option”)
as set
forth below, based on the stage of development (the “Option
Stage”)
of the
first Antibody Product and first Vaccine Product, respectively, to reach
such
Option Stage, to pay to CYTOGEN the amount indicated below, to prospectively
relieve the LLC of the financial obligation to pay any royalties on Annual
Net
Sales of all Antibody Products and Annual Net Sales of all Vaccine Products,
respectively (the “Royalty
Buydown”):
[*]
CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE
COMMISSION
17
Option
Stage
|
Antibody
Product
|
Vaccine
Product
|
Prior
to [*].
|
$[*]
|
$[*]
|
Upon
and following [*]
|
$[*]
|
$[*]
|
Upon
and following [*]
|
$[*]
|
$[_]
|
Upon
and following [*]
|
$[*]
|
$[*]
|
(b) The
LLC
shall give written notice of its intent to exercise a Royalty Buydown Option
for
an Antibody Product or Vaccine Product to CYTOGEN during an Option Stage.
Payment to CYTOGEN from the LLC shall be made within 30 days of delivery
of such
written notice and such payment shall constitute full and final satisfaction
of
the LLC’s royalty payment obligations under Section 5.2 in respect of all
Antibody Products in the case of an Option Stage payment for an Antibody
Product, or all Vaccine Products in the case of an Option Stage payment for
a
Vaccine Product. The Royalty Buydown shall become effective immediately upon
receipt of notice of the Royalty Buydown Option by CYTOGEN. Notwithstanding
the
foregoing, the LLC shall pay to CYTOGEN: (i) all milestone payments, payable
under Section 5.1, but only upon achievement of the events as set forth in,
and
in accordance with, Section 5.1; and (ii) royalty payments which accrued
before
the effective date of the Royalty Buydown, in accordance with Section
5.2.
5.4 Reduction
of Royalties if Third Party License Required.
If the
LLC determines that it cannot reasonably develop or commercialize a Licensed
Product in a particular country in the Territory without obtaining a Third
Party
License and the LLC thereafter obtains and pays for the Third Party License,
the
LLC shall be entitled to reduce, on a [*], the applicable royalty payable
under
Section 5.2; provided,
however,
that in
no event shall this deduction cause the amounts payable to CYTOGEN, in respect
of such Licensed Product in such country, to be less than [*]% of the amount
otherwise payable to CYTOGEN for such Contract Quarter in respect of such
Licensed Product in such country. Any amount which would have reduced a royalty
payment pursuant to the immediately preceding sentence, but was not applied
due
to the [*]% limit therein, shall be credited against royalties payable in
subsequent Contract Quarters, subject to the foregoing percentage restriction,
until all such amounts have been credited. The Third Party License costs
provided above shall be discounted for purposes of this Section 5.4 if such
Third Party License is applicable to products of the LLC or any Sublicensee
other than the Licensed Products (“Non-Licensed
Products”)
as
follows: such discount shall be determined at the time payments are made
under
the Third Party License and shall be based on the relation of (i) the economic
value of the rights applicable to the Non-Licensed Products to (ii) the economic
value of the rights applicable to the Licensed Products.
[*]
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CONFIDENTIAL
PORTION OMITTED AND FILED SEPARATELY WITH THE
COMMISSION
18
5.5 Payments
Associated with Existing Third Party Agreements. The
LLC
shall pay earned royalties to CYTOGEN, under the SKICR Agreement, at the
minimum
royalty rate(s) required to be paid and at the times any such payments are
due.
In addition, the LLC will pay to CYTOGEN fees equal in amount to the minimum
amount of any minimum royalty (to the extent such royalty exceeds earned
royalties) or other fees required to be paid by CYTOGEN under the SKICR
Agreement at the times any such payments are due. Any fees (but excluding
earned
royalties) payable by the LLC to CYTOGEN pursuant to this Section 5.5 shall
be
discounted by [*]% to reflect the value of rights sublicensed by SKICR to
CYTOGEN but not sublicensed by CYTOGEN to the LLC.
5.6 Other
Products.
Other
Products shall be deemed to be Antibody Products (i) for purposes of determining
royalties payable under Section 5.2 with respect to Commercial Sales of Other
Products, and (ii) for purposes of the Royalty Buydown under Section 5.3.
For
the avoidance of doubt, in the event that the LLC exercises the Royalty Buydown
Option in respect of an Antibody Product, such Royalty Buydown shall also
relieve the LLC of financial obligations to pay any royalties on Annual Net
Sales of all Other Products.
6. PATENT
PROSECUTION AND MAINTENANCE, ETC.
6.1 Prosecution
and Maintenance.
To the
fullest extent legally and contractually entitled, CYTOGEN hereby grants
to the
LLC the exclusive right to prepare new applications based on CYTOGEN Technical
Information licensed hereunder, prepare continuing patent applications which
contain claims directed to subject matter in the Field and claim priority
to the
Licensed CYTOGEN Patents, file, and prosecute patent applications that are
Licensed CYTOGEN Patents, maintain or extend the term of any issued patent
that
is a Licensed CYTOGEN Patent, and defend against any conflicts, oppositions
or
interferences involving Third Party challenges to the Licensed CYTOGEN Patents.
The cost of such activities shall be borne by the LLC; provided,
however,
that if
less than all of the rights to any such Patent has been licensed to the LLC
pursuant hereto, the LLC shall bear only that portion of the cost of such
activities as reflects the proportionate economic value, as agreed upon in
good
faith by the Parties, of the rights licensed to the LLC. CYTOGEN shall
cooperate, at the LLC’s expense, with all reasonable requests of the LLC in all
such activities. If at any time the LLC determines not to prepare, file or
prosecute a Patent licensed to the LLC hereunder, maintain or extend the
term of
any Patent licensed to the LLC hereunder or defend against any conflicts,
oppositions or interferences involving Third Party challenges to any Patent
licensed to the LLC hereunder, the LLC shall notify CYTOGEN of any such
determination and grant back to CYTOGEN the right to conduct any such activity.
If the right to prepare, file or prosecute any Patent licensed by CYTOGEN
to the
LLC hereunder, or to maintain or extend or to defend against any Third Party
conflicts, oppositions or interferences involving any Patent licensed to
the LLC
hereunder cannot be granted to the LLC, CYTOGEN shall use commercially
reasonable efforts diligently to perform, or cause to be performed, in
consultation with the LLC, such activities. In
addition, to the fullest extent legally and contractually entitled, CYTOGEN
grants to the LLC the right to review and comment on the
prosecution and maintenance of patents and patent applications which claim
priority to or are otherwise related to the Patents licensed to the LLC
hereunder. The cost of such activities shall be borne by the LLC; provided,
however,
that if
less than all of the rights to any such Patent has been licensed to the LLC
pursuant hereto, the LLC shall bear only that portion of the cost of such
activities as reflects the proportionate economic value, as agreed upon in
good
faith by the Parties,
[*]
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PORTION OMITTED AND FILED SEPARATELY WITH THE
COMMISSION
19
of
the
rights licensed to the LLC. The
LLC
also grants to CYTOGEN the right to review and comment on the
prosecution and maintenance of patents and patent applications which claim
priority to or are otherwise related to the Patents licensed to the LLC
hereunder. The cost of such activities shall be borne by CYTOGEN. Upon issuance
of a patent based upon any pending patent application listed in Annex A,
or any
continuation in whole or in part derived therefrom, Annex A shall be revised
to
reflect the issuance of such patent. In the event such an issued patent contains
claims directed only to subject matter which falls entirely outside of the
Field, the patent shall be removed from Annex A. For purposes of clarity,
upon
removal of a patent from Annex A, the patent shall be considered to fall
outside
the definition of Licensed CYTOGEN Patents.
6.2 Disclosure
Regarding Patent Activities.
Each
Party which engages in patent activities of the nature described in section
6.1
hereof shall promptly provide the other Parties with all correspondence
(including any filings sent or received) and all other information concerning
such activities which comes into such Party’s possession, and shall periodically
update the other Parties on all relevant information concerning the actions
described in Section 6.1 hereof. In addition to the foregoing, each Party
required to disclose information pursuant to this Section 6.2 shall provide
to
the other Parties a reasonable opportunity to review any materials to be
submitted or filed with any patent or governmental authority or in connection
with any such proceeding and to comment on such materials and will discuss
and
consider such comments in good faith. The Parties consent to the disclosure
of
such correspondence by the LLC, at its discretion, to any and all of its
Affiliates and any Sublicensee, provided
that
such Affiliates and Sublicensees shall receive such correspondence under
a
confidential disclosure agreement reasonably satisfactory in form and substance
to Progenics or CYTOGEN, as the case may be.
7. REPORTS
AND ROYALTY PAYMENTS; BOOKS AND RECORDS
7.1 Reports.
On or
before the last day of each February, May, August, and November commencing
with
the first such date following the First Commercial Sale, and thereafter
throughout the Contract Period, the LLC shall furnish CYTOGEN with a written
report, signed by an authorized officer or agent of the LLC, showing all
Commercial Sales with respect to which earned royalties are due to CYTOGEN
hereunder with respect in each case to the immediately preceding Contract
Quarter.
7.2 Royalty
Payments.
With
each such quarterly report, the LLC shall remit to CYTOGEN the total amount
of
earned royalties shown thereby to be due. All payments (and all payments
under
Section 5) shall be made in lawful funds of the United States of
America.
7.3 Calculation
of Royalties and Other Payments.
In
order to permit the LLC to calculate the amount of royalties and other payments
payable pursuant to Section 5 hereof, CYTOGEN shall provide to the LLC true
and
complete copies of the SKICR Agreement. CYTOGEN will also furnish the LLC
with a
written report, signed by an authorized officer, stating product sales by
each
of the other licensees or Sublicensees (if any) covered by the SKICR Agreement
(to the extent available to, and not subject to legal or contractual
restrictions on disclosure by, CYTOGEN), and will make its respective personnel
available to answer questions and otherwise provide information with respect
to
any matters reasonably necessary for the LLC to calculate amounts due by
the LLC
to CYTOGEN under Section 5 hereof.
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PORTION OMITTED AND FILED SEPARATELY WITH THE
COMMISSION
20
7.4 Currency
Control Restrictions.
In the
event that the LLC is precluded from transferring royalties due CYTOGEN
hereunder at any time during the Contract Period because the LLC has failed
after commercially reasonable due diligence to obtain the approval of such
transfer from the appropriate governmental agency responsible for control
of
currency exchanges of a particular country in which the LLC has sold Licensed
Products, then the LLC agrees (a) to deposit or to cause the deposit of such
royalties to the account of CYTOGEN in a bank in such country designated
by the
beneficiary of such deposit; (b) to provide or to cause to be provided to
such
beneficiary documentary evidence of such deposits; and (c) to remit or to
cause
remittance of such deposits to such beneficiary immediately upon the subsequent
approval of such transfers by such governmental agency. The LLC further agrees
that the form of such depository account shall permit such beneficiary to
withdraw the deposited amounts at will, but shall permit the LLC to withdraw
the
deposited amounts solely for the purpose of remitting such amounts to such
beneficiary pursuant to the provisions of this Section 7.4.
7.5 Books
and Records.
The LLC
agrees to keep adequate and complete records showing all Commercial Sales
and/or
other revenues with respect to which earned royalties and/or other payments
are
due CYTOGEN hereunder. Such records shall include all information necessary
to
verify the total amount and computation of earned royalties and/or other
payments hereunder, and shall be open to inspection by CYTOGEN during reasonable
business hours upon reasonable notice to the extent necessary to verify the
amount thereof. Such inspection by CYTOGEN shall be made not more often than
once each Contract Year at the request of CYTOGEN (unless good cause is shown
by
CYTOGEN of the need for more frequent inspection) by an auditor appointed
by
CYTOGEN and to whom the LLC has no reasonable objection, provided
that
such auditor shall be under a confidentiality obligation to the LLC to reveal
only that information, and only to CYTOGEN, necessary to verify the royalties
due hereunder. In addition, such inspection shall be limited to a period
not to
extend beyond three years after the date of receipt by the requesting Party
of a
report from the LLC relating to such records pursuant to Section 7.1 hereof.
After such three-year period, any such report and the records upon which
such
report was based shall be deemed presumptively correct. The expenses of any
such
audit shall be borne by the party requesting the audit unless the audit
determines a discrepancy in favor of CYTOGEN of at least 10%, in which event
the
audit expenses shall be borne by the LLC. Notwithstanding the foregoing,
CYTOGEN
shall, at reasonable times and upon reasonable notice, be granted access
after
such three-year period to such records (to the extent retained by the LLC)
for
purposes of preparing tax returns and related materials.
8. TAXATION
OF PAYMENTS.
Insofar
as any earned royalties which are due CYTOGEN hereunder are subject to taxation
by any country under the provisions of the tax laws of that country, then
CYTOGEN hereby authorizes the LLC to withhold such taxes from the payments
which
are payable to CYTOGEN in accordance with this Agreement if the LLC is either
required to do so under such country’s tax laws or directed to do so by an
agency of such country’s government. Whenever the LLC deducts such tax from any
payments due CYTOGEN, the LLC shall furnish CYTOGEN with a tax certificate
showing the payment of such tax to the government of such country. In the
event
such taxes are assessed against the LLC by reason of its failure to withhold
such taxes from any payments which have been paid to CYTOGEN in accordance
with
this Agreement, then CYTOGEN agrees to reimburse the LLC for such tax assessment
but not for any fine, penalty, fee or interest related to the LLC’s failure to
withhold, pay or make timely payment of such taxes.
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COMMISSION
21
9. PRODUCT
LIABILITY DISCLAIMERS.
9.1 Product
Liability Disclaimer by Progenics.
Progenics assumes no responsibility for the manufacture, product specifications,
end use or provision of any Licensed Products that are manufactured or provided
by or for, or sold by, the LLC or any Sublicensee. All warranties in connection
with such Licensed Products made or provided by the LLC or any Sublicensee
shall
not directly or impliedly obligate Progenics in any manner whatsoever under
such
warranties or otherwise.
9.2 Product
Liability Disclaimer by CYTOGEN.
CYTOGEN
assumes no responsibility for the manufacture, product specifications, end
use
or provision of any Licensed Products that are manufactured or provided by
or
for, or sold by, the LLC or any Sublicensee. All warranties in connection
with
such Licensed Products made or provided by the LLC or any Sublicensee shall
not
directly or impliedly obligate CYTOGEN in any manner whatsoever under such
warranties or otherwise.
9.3 Product
Liability Disclaimer by the LLC.
The LLC
assumes no responsibility for the manufacture or product specifications of
any
products which are manufactured by or for Progenics or CYTOGEN except for
the
manufacture or product specifications of materials made by or for the LLC.
Any
warranties in connection with such products made by Progenics or CYTOGEN
as user
of such products shall not directly or impliedly obligate the LLC.
10. INDEMNIFICATION
AND INFRINGEMENT.
10.1 Indemnification.
10.1.1
By
Progenics.
Progenics shall indemnify, defend and hold CYTOGEN and its Affiliates harmless
from and against any and all claims, suits or demands for liability, damages,
losses, costs and expenses, including the reasonable costs and expenses of
counsel (collectively, “Losses”),
arising out of any breach of the representations and warranties, or the failure
to perform when and as required any of the covenants or agreements, made
by
Progenics in this Agreement.
10.1.2
By
CYTOGEN.
CYTOGEN
shall indemnify, defend and hold the LLC, its Affiliates and any Sublicensee
of
the LLC hereunder harmless from and against any and all Losses arising out
of
(i) any breach of the representations and warranties, or the failure to perform
when and as required any of the covenants or agreements, made by CYTOGEN
in this
Agreement or (ii) any infringement or purported infringement of Third Party
intellectual property rights by practicing the Licensed CYTOGEN Patents or
the
CYTOGEN Technical Information.
10.1.3
By
the LLC.
The LLC
shall indemnify, defend and hold CYTOGEN and its Affiliates harmless from
and
against any and all Losses arising out of (i) any breach of the representations
and warranties, or the failure to perform when and as required any of the
covenants or agreements, made by the LLC in this Agreement or (ii) any claim
by
a Third Party that any Licensed Product made, used or sold by or on behalf
of
the LLC or any sublicense thereof infringes patent rights of such Third Party
(except insofar as any such claim gives rise to an indemnification obligation
of
Progenics under Section 10.1.1 hereof or of CYTOGEN under Section 10.1.2
hereof).
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PORTION OMITTED AND FILED SEPARATELY WITH THE
COMMISSION
22
10.2 Infringement
of Licensed CYTOGEN Patents.
In the
event that any Party becomes aware that any Third Party is infringing any
claim
or claims of any issued patent included within the Licensed CYTOGEN Patent
or
CYTOGEN Technical Information, then such Party shall immediately advise the
other Parties, and the Parties shall consult with each other as to the most
effective way of proceeding. Under such circumstances:
(a)
the LLC,
as the exclusive licensee of the Licensed CYTOGEN Patents, shall have the
right,
but not the obligation, and subject to any applicable Third Party rights,
to
commence and prosecute an action under the Licensed CYTOGEN Patents against
any
such Third Party infringer, in which event the LLC shall bear the costs of
such
action and shall be entitled to retain any recovery resulting
therefrom;
(b)
if the
LLC declines or fails to commence and/or prosecute such action, then CYTOGEN
shall be entitled to commence and prosecute an action under the appropriate
Licensed CYTOGEN Patents against such Third Party infringer, in which event
CYTOGEN shall bear the costs of such action and shall be entitled to retain
any
recovery resulting therefrom.
The
Parties shall cooperate fully with each other in any such proceedings,
consulting as to litigation strategies and other matters related to any such
proceedings, and shall, among other things, furnish information and evidence
when so requested by the other, including testimony by the requested Party,
its
agents and employees, as may be required by the Party commencing and prosecuting
such action.
10.3 Procedure.
Each
Party shall promptly 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 10, such Party (the “Indemnified
Party”)
shall
promptly notify the other Party (the “Indemnifying
Party”)
in
writing and the Indemnifying Party and Indemnified Party shall meet to discuss
how to respond to any claims that are the subject matter of such proceeding.
The
Indemnified Party shall cooperate fully with the Indemnifying Party in defense
of such matter. The Indemnifying Party, upon request of the Indemnified Party,
shall retain counsel reasonably satisfactory to the Indemnified Party to
represent the Indemnified Party and shall pay the fees and expenses of such
counsel related to such proceeding. In any such claim, the Indemnified Party
shall have the right to retain its own counsel, but the fees and expenses
of
such counsel shall be at the expense of the Indemnified Party unless (i)
the
Indemnifying Party and the Indemnified Party shall have mutually agreed to
the
retention of such counsel or (ii) the named parties to any such claim (including
any impleaded parties) include both the Indemnifying Party and the Indemnified
Party and representation of both Parties by the same counsel would be
inappropriate due to actual or potential differing interests between them.
All
such fees and expenses shall be reimbursed as they are incurred. The
Indemnifying Party shall not be liable for any settlement of any claim effected
without its written consent, but, if settled with such consent or if there
be a
final judgment for the plaintiff, the Indemnifying Party agrees to indemnify
the
Indemnified Party from and against any loss or liability by reason of such
settlement or judgment. The Indemnifying Party shall not, without the written
consent of the Indemnified Party, effect any settlement of any pending or
threatened claim in respect of which the Indemnified Party is, or arising
out of
the same set of facts could have been, a party and indemnity could have
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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. TERM
AND
TERMINATION.
11.1 Term.
Unless
sooner terminated in accordance with Section 11.2, the Original Agreement
shall
continue as amended and restated hereby, and shall cease upon the last to
subsist of any Valid Claim of any Licensed CYTOGEN Patents; provided,
however,
that
this Agreement shall not terminate until the end of the last Royalty Term
unless
sooner terminated in accordance with Section 11.2; provided,
further,
that
the provisions of Sections 7.1, 7.5, 9, 10, 11.1, 12 and 14 hereof shall
survive
any such termination or expiration.
11.2 Termination.
This
Agreement may be terminated at any time prior to the end of the term set
forth
in Section 11.1 hereof, as follows:
11.2.1
For
Breach.
In the
event either the LLC or Progenics on the one hand, or CYTOGEN on the other
hand,
shall breach any of the material representations or warranties or any material
term, condition or agreement contained herein made or to be kept, observed
or
performed by it, then the other such Party may terminate this Agreement,
at its
option and without prejudice to any of its other legal or equitable rights
and
remedies, by giving the other such Party 60 days’ notice in writing, identifying
with reasonable specificity the breach, unless (in the case of a breach of
any
term, condition or agreement) the notified Party within such 60-day period
shall
have cured the breach.
11.2.2
For
Bankruptcy. (a)
In the
event (i) Progenics or the LLC on the one hand, or CYTOGEN on the other hand,
shall suspend business, or shall file a voluntary petition or any answer
admitting the jurisdiction of the court and the material allegations of,
or
shall consent to an involuntary petition pursuant to or purporting to be
pursuant to any reorganization or insolvency law of any jurisdiction, or
shall
make an assignment for the benefit of creditors, or shall apply for or consent
to the appointment of a receiver or trustee of a substantial part of its
property, and (ii) no Affiliate of such Party shall undertake to assume its
obligations under the provisions of this Agreement within 90 days from the
date
on which such Party becomes so disabled, then to the extent permitted by
law the
other such Party may thereafter immediately terminate this Agreement by giving
written notice of termination to the other Parties.
(b) In
the
event this Agreement is terminated under Section 11.2.2(a) as a result of
an
event covered thereby with respect to CYTOGEN, and the LLC terminates this
Agreement under Section 11.2.2(a) or CYTOGEN rejects this Agreement pursuant
to
Section 365 of the U.S. Bankruptcy Code, all rights and licenses granted
under
or pursuant to this Agreement by CYTOGEN, to the LLC are, and shall otherwise
be
deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code,
licenses of rights to “intellectual property” as defined under Section 101(35A)
of the U.S. Bankruptcy Code. CYTOGEN agrees that the LLC, as licensee of
such
rights under this Agreement, shall retain and may fully exercise all of its
rights and elections under the U.S. Bankruptcy Code. The Parties further
agree
that, in the event of the commencement of a bankruptcy proceeding by or against
CYTOGEN under the U.S. Bankruptcy Code, the LLC shall be entitled to a complete
duplicate of (or complete access to, as appropriate) any such
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intellectual
property and all embodiments of such intellectual property upon written request
therefor by the LLC. Such intellectual property and all embodiments thereof
shall be promptly delivered to the LLC (i) upon any such commencement of
a
bankruptcy proceeding upon written request therefor by the LLC, unless CYTOGEN
elects to continue to perform all of its obligations under this Agreement
or
(ii) if not delivered under (i) above, upon the rejection of this Agreement
by
or on behalf of CYTOGEN upon written request therefor by the LLC. CYTOGEN
shall
not interfere with the rights of the LLC as provided in this Agreement, or
any
agreement supplementary hereto, to such intellectual property (including
all
such embodiments thereof), including any right of the LLC to obtain such
intellectual property (or such embodiment) from any other entity.
11.2.3
The
LLC Upon Termination of the SKICR License.
The LLC
may terminate this Agreement by giving CYTOGEN 30 days written notice upon
the
termination of the SKICR License; provided
that,
without limiting the other rights and remedies of the Parties, each of Progenics
and CYTOGEN may seek an appropriate remedy against the other if the other
is
responsible for the termination of the SKICR License.
11.2.4
Effect
of Termination or Expiration.
Upon
the expiration of the Royalty Term applicable to any Licensed Product in
a
country, the Licensed CYTOGEN Patent and CYTOGEN Technical Information with
respect to such Licensed Product in such country shall convert to a perpetual,
irrevocable, non-exclusive, transferable, paid-up, royalty-free license with
the
right to sublicense in such country to develop and commercialize such Licensed
Product in such country.
11.3 Accrued
Rights and Obligations.
Termination of this Agreement shall not relieve any Party of any rights or
obligations then accrued hereunder or which by the terms hereof extend beyond
the date of such termination.
12. EFFECT
OF TERMINATION ON SUBLICENSEE.
Upon
termination of this Agreement by the LLC or CYTOGEN pursuant to Section 11.2.1
or Section 11.2.2 hereof, any Third Party licensee of the LLC which has not
breached in any material respect its sublicense related to the Licensed CYTOGEN
Patents or the CYTOGEN Technical Information shall be entitled to receive
a
license to the Licensed CYTOGEN Patents and the CYTOGEN Technical Information
directly from CYTOGEN granting rights substantially the same as those granted
in
such sublicense and containing obligations as a licensee similar to those
set
forth in this Agreement.
13. EXPORT
LICENSES.
This
Agreement is subject to any restrictions concerning the export of products
or
technical information from the United States which may be imposed by the
United
States. Accordingly, each Party agrees that it will not export, directly
or
indirectly, any technical information acquired under this Agreement or any
products utilizing any such technical information to any country for which
the
United States Government or any agency thereof at the time of export requires
an
export license or other governmental approval, without first obtaining the
written consent to do so from the Department of Commerce or other agency
of the
United States Government when required by an applicable statute or
regulation.
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14. MISCELLANEOUS
PROVISIONS.
14.1 Assignability,
Etc..
Except
as expressly provided herein, neither this Agreement nor any interest hereunder
shall be assignable by any Party without the written consent of the others,
and
any attempted assignment without such consents shall be null and void. Without
the consent of any other Party, this Agreement may be assigned by any Party
to
any wholly owned subsidiary of such Party that agrees in writing with each
other
Party to be jointly and severally liable with the assigning Party for the
timely
satisfaction of all obligations of the assigning Party hereunder; provided,
however,
that no
such assignment shall relieve the assigning Party of its obligations hereunder,
including in connection with an assignment by the LLC to Progenics or any
of
Progenics’ Affiliates. Notwithstanding the foregoing, without the consent of any
other Party, this Agreement may be assigned by the LLC to Progenics or any
of
Progenics’ Affiliates. This Agreement shall be binding upon the successors and
permitted assignees of the Parties. Any such successor or permitted assignee
shall be subject to the same rights and obligations as the original Party
hereunder. Notwithstanding the foregoing, a sale of assets by the LLC related
to
the Licensed Products shall be deemed to be an assignment under this Section
14.1.
14.2 Notices.
All
notices and other communications provided for hereunder shall be in writing
and
shall be mailed or delivered to the business address of the respective Parties
aforementioned, or to such other address or addresses as either Party shall
designate in writing to the others. All such notices and communications shall
be
considered given and/or delivered: (i) when given if delivered in person
or sent
by facsimile and acknowledged by a responsible person at the office of the
recipient; (ii) one day after being sent by a major overnight courier; or
(iii)
four days after being mailed by registered mail, return receipt requested,
at
the business address of the respective Parties as specified above. All notices
or communications required or permitted to be given or sent to the LLC shall
also be given or sent to Progenics (if such notice or communication is given
or
sent by CYTOGEN) or to CYTOGEN (if such notice or communication is given
or sent
by Progenics).
If
to
Progenics or the LLC, to:
Progenics
Pharmaceuticals, Inc.
000
Xxx
Xxx Xxxx Xxxxx Xxxx
Xxxxxxxxx,
Xxx Xxxx 00000
Telecopy:
000-000-0000
Attention:
Xxxx X. Xxxxx, Senior Vice President & General Counsel
with
a
copy (which shall not constitute notice) to:
Xxxxx
Xxxxxxxxxx LLP
0000
Xxxxxx xx xxx Xxxxxxxx
Xxx
Xxxx,
Xxx Xxxx 00000
Telecopy:
000-000-0000
Attention:
Xxxxxx
Xxxxxx
Xxxxxxx
X. Xxxxxxxxxx
If
to
CYTOGEN, to:
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Cytogen
Corporation
000
Xxxxxxx Xxxx Xxxx
Xxxxxxxxx,
Xxx Xxxxxx 00000x
Telecopy:
000-000-0000
Attention:
Xxxxxxx
X. Xxxxxx, Senior Vice President
and
General Counsel
with
a
copy (which shall not constitute notice) to:
Xxxxxx,
Xxxxx & Xxxxxxx LLP
000
Xxxxxxxx Xxxxxx
Xxxxxxxxx,
Xxx Xxxxxx 00000
Telecopy:
000-000-0000
Attention:
Xxxxxxx X. Xxxxxxx
or
to
such other address or addresses as any such party may from time to time
designate as to itself by like notice.
14.3 Independent
Contractors.
No
agency, partnership or joint venture is hereby established. None of Progenics,
CYTOGEN or the LLC shall enter into, or incur, or hold itself out to Third
Parties as having authority to enter into or incur on behalf of the other
Parties any contractual obligations, expenses or liabilities whatsoever,
except
as expressly provided herein.
14.4 Counterparts.
This
Agreement may be executed simultaneously in multiple counterparts, each of
which
shall be deemed to be an original but all of which together shall constitute
one
and the same agreement.
14.5 Entire
Understanding.
This
Agreement constitutes the entire understanding between the Parties with respect
to the subject matter hereof. No modifications, extensions, or waiver of
any
provisions hereof or any release of any right hereunder shall be valid, unless
the same is in writing, contains reference to this Agreement and sets forth
the
plan or intention to modify same, and is consented to by all
Parties.
14.6 Headings.
The
headings in this Agreement are intended solely for convenience of reference
and
shall be given no effect in the construction or interpretation of this
Agreement.
14.7 No
Implied Rights.
Except
as expressly provided for in this Agreement, nothing contained herein shall
be
construed as conferring any license or other rights, by implication or estoppel,
under any patent (including design patent and utility model patent) or patent
application, or any copyrights, trademarks, trade names or trade
dress.
14.8 No
Waiver.
The
failure of any Party at any time or times to require performance of any
provision hereof shall in no manner affect the right of such Party at a later
time to enforce the same. No waiver by any Party of any condition, or of
the
breach of any provision, term, covenant, representation or warranty contained
in
this Agreement, whether by conduct or otherwise, in any one or more instances,
shall be deemed to be or construed as a further or
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continuing
waiver of any such condition or of the breach of any other provision, term,
covenant, representation or warranty of this Agreement.
14.9 Publicity.
(a) In
the
absence of prior written approval of the other Parties, no Party shall originate
any publicity, news release, or other public announcement, written or oral,
whether to the public press, to stockholders or otherwise, relating to this
Agreement, to any amendment or activities hereunder, unless such announcement
is
required by law to be made, in which case the provisions of Section 14.9(b)
shall apply. The Party making any such announcement shall give the other
Parties
an opportunity to review the announcement before it is made.
(b) A
Party
may only disclose the terms of this Agreement or any further amendments to
the
Agreement if such Party reasonably determines, based on advice from its counsel,
that it is required to make such disclosure by applicable law, regulation
or
legal process, including without limitation by the rules or regulations of
the
U.S. Securities and Exchange Commission (“SEC”) or similar regulatory agency in
a country other than the U.S. or of any stock exchange or NASDAQ, in which
event
such Party shall provide prior notice of such intended disclosure to the
other
Parties sufficiently in advance to enable the other Parties to seek confidential
treatment or other protection for such information unless the disclosing
Party
is prevented by law or regulation from providing such advance notice and
shall
disclose only such terms of this Agreement or such further amendment(s) as
such
disclosing Party reasonably determines, based on advice from its counsel,
are
required by applicable law, regulation or legal process to be disclosed.
In the
event that either Party determines that it must publicly file this Agreement
or
such further amendment(s) with the SEC, such Party shall (i) initially file
a
redacted copy of this Agreement or such further amendment(s) in a form mutually
agreeable to the Parties, (ii) request, and use commercially reasonable efforts
to obtain, confidential treatment of all terms redacted from such Agreement
or
such further amendment(s), (iii) permit the other Party to review and approve
such initial request for confidential treatment and any subsequent
correspondence with respect thereto at least two (2) business days prior
to its
submission to the SEC, and (iv) promptly deliver to the other Party any written
correspondence received by it or its representatives from the SEC with respect
to such confidential treatment request and promptly advise the other Party
of
any other material communications between it or its representatives with
the SEC
with respect to such confidential treatment request.
14.10 Promotion
and Advertising.
Nothing
contained in this Agreement shall be construed as conferring on any Party
any
right to use in advertising, publicity or other promotional activities any
name,
tradename, trademark, service xxxx or other designation (including any
contraction, abbreviation or simulation of any of the foregoing of any other
Party); and, each Party agrees not to use any designation of any other Party
in
any promotional activity associated with this Agreement, or with a Licensed
Product, without the express written approval of such other Party.
14.11 Arbitration.
Any
dispute arising out of or relating to any provisions of this Agreement shall
be
finally settled by arbitration to be held in New York, New York, under the
auspices and the current commercial arbitration rules of the American
Arbitration Association. Arbitration shall be initiated by delivery of a
notice
(an “Arbitration
Notice”)
by any
Party to the other Parties. Such arbitration shall be conducted by one
arbitrator mutually selected and approved
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by
the
Parties to the dispute. If within 20 calendar days after receipt of the
Arbitration Notice the Parties to the dispute have not agreed on a mutually
acceptable arbitrator, the American Arbitration Association in New York,
New York shall be retained to appoint an arbitrator within 30 calendar days
after the receipt of the Arbitration Notice. The arbitrator’s authority shall be
limited to determining the issue or question presented in each instance and
shall not extend to any other aspect of this Agreement or the Parties’
relationship generally. Judgment upon any award rendered may be entered in
any
court having jurisdiction, or application may be made to such court for a
judicial acceptance of the award and an order of enforcement, as the case
may
be.
14.12 Confidentiality.
14.12.1
As
used
in this Section 14.12, “Confidential Information” means confidential and
proprietary business, technical or financial information relating to the
collaboration contemplated hereby, including the CYTOGEN Technical Information,
of any other Party (the “Confidential
Information”).
14.12.2
In
order
to protect the Confidential Information of any Party (in such capacity, the
“Disclosing
Party”)
that
has become available to any other Party (in such capacity, the “Receiving
Party”),
each
Party agrees as follows:
(a) Each
Party agrees that it will make no use of any Confidential Information except
in
furtherance of the purposes contemplated by this Agreement.
(b) Each
Party agrees that it will not, without the prior written consent of the other
Parties, disclose to any Third Party Confidential Information (which for
purposes of this Section 14.12.2(b) shall include the terms or existence
of this
Agreement or of the LLC Agreement or the Services Agreement or other matters
relating to the collaboration contemplated hereby and thereby) received in
its
capacity as a Receiving Party during the Contract Period and for a period
of
five years thereafter.
(c) Notwithstanding
the foregoing:
(i)
Each
Party may disclose Confidential Information to those of its representatives,
employees and agents (“Representatives”)
who
have a need to know such Confidential Information in relation to the matters
discussed herein and who are under obligations of confidentiality and non-use
consistent with those set forth herein. Any unauthorized disclosure of
Confidential Information by a Party’s Representatives shall be a breach by such
Party of this Section 14.12.
(ii)
Disclosure of Confidential Information is permitted to the extent that such
disclosure is required pursuant to applicable laws, rules or regulations
or
government requirement or court order, provided however, that the Receiving
Party shall promptly notify the Disclosing Party in writing of the existence
or
imposition of any such requirement or order and cooperate with the Disclosing
Party in seeking an appropriate protective order or other reliable assurance
that confidential treatment will be accorded the Confidential
Information.
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14.12.3
The
provisions governing confidentiality and non-use contained in this Section
14.12
shall not apply to any Confidential Information which:
(a) the
Receiving Party can establish was known to the Receiving Party prior to
disclosure under or in connection with this Agreement by the Disclosing
Party;
(b) was
in
the public domain or the subject of public knowledge at the time of disclosure
under or in connection with this Agreement;
(c) becomes
part of the public domain or the subject of public knowledge through no breach
by or act of default of the Receiving Party;
(d) is
obtained by the Receiving Party from a Third Party other than in breach of
a
legal or contractual obligation of confidentiality owed by such Third Party
to
the Disclosing Party in respect thereof, the existence of which such obligation
was known or should have been known by the Receiving Party; or
(e) the
Receiving Party can establish was independently developed by it without
reference to Confidential Information received.
14.12.4
Termination
of this Agreement shall not affect the obligations concerning confidentiality
and non-use of the Confidential Information as set forth in this Section
14.12.
14.13 No
Third Party Beneficiaries.
This
Agreement is solely for the benefit of the Parties and should not be construed
to confer upon any other Person any remedy, claim, liability, right of
reimbursement, claim of action or other right.
14.14 Governing
Law.
This
Agreement shall be interpreted, construed, and governed in accordance with
the
laws in effect in the State of New York, without reference to conflict of
laws
principles.
14.15 SKICR
Agreement.
Pursuant to Section III.D.4 of the SKICR Agreement, the Parties hereby reference
the SKICR Agreement and all rights which revert to SKICR upon termination
of the
SKICR Agreement. In accordance with Section III.D.8 of the SKICR Agreement,
this
Agreement shall automatically be modified or terminated, in whole or in part,
upon any relevant modification, in whole or in part, of the SKICR Agreement.
Such modification or termination of this Agreement shall be consistent with
and
reflect the relevant modifications or terminations of the SKICR
Agreement.
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IN
WITNESS WHEREOF, the Parties have each caused these presents to be signed
by
their respective officers thereunto duly authorized.
PROGENICS
PHARMACEUTICALS, INC.
By:
/s/
Xxxx
X. Xxxxx
Name: Xxxx
X.
Xxxxx
Title:
|
Senior
Vice President, General Counsel
|
&
Secretary
CYTOGEN
CORPORATION
By:
/s/
Xxxxxxx X. Xxxxxx
Name:
Xxxxxxx X. Xxxxxx
Title:
President and Chief Executive Officer
PSMA
DEVELOPMENT COMPANY LLC
By:
/s/
Xxxx
X. Xxxxx
Name:
Xxxx X. Xxxxx
Title:
Assistant Secretary
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1