Exhibit 10.15
LICENSE AND SUPPLY AGREEMENT
This license and supply agreement is entered into as of August 31 ,
1995 (the "Effective Date") between Cambridge Biotech Corporation, debtor and
debtor in possession, Case No. 00-00000-XXX, Xxxxxx Xxxxxx Bankruptcy Court
for the District of Massachusetts, Western Division, a Delaware corporation,
having offices at 000 Xxxxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000, and
Progenics Pharmaceuticals, Inc., a Delaware corporation having offices at 000
Xxx Xxx Xxxx Xxxxx Xxxx, Xxxxxxxxx, Xxx Xxxx 00000 (each singularly a "Party"
and collectively the "Parties") with reference to the following:
RECITALS
WHEREAS, CBC is performing research and development in the field of
purified saponin extracts from the tree Quillaja saponaria, production
processes therefor and uses thereof as an immune adjuvant; and
WHEREAS, Progenics is performing research and development in the field
of vaccines for human cancers and is interested in licensing CBC's rights to
such purified saponin extracts for use as an immune adjuvant with such
vaccines;
THEREFORE, the parties agree as follows:
1. DEFINITIONS. The following terms shall have the following meanings for
purposes of this Agreement:
1.1 "ACTIVE DEVELOPMENT EFFORT" is defined in Section 5.1.
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1.3 "ADJUVANT REQUIREMENTS" means the amount of Adjuvant in bulk
which Progenics and its sublicensees may require pursuant to the
provisions hereof for all research and development, pre-clinical
and human clinical testing of Licensed Products and, after
Commercial Introduction, production of Licensed Products for
comme'rcial sales.
1.4 "AFFILIATE" means any corporation, firm, partnership or other
entity, whether de jure or de facto, which directly or indirectly
owns, is owned by, or is under common ownership with a party to
this Agreement to the extent of at least fifty percent (50%) of
the equity (or such lesser percentage which is the maximum
allowed to be owned by a foreign corporation in a particular
jurisdiction) having the power to vote on or direct the affairs
of the entity and any person, firm, partnership, corporation or
other entity actually controlled by, controlling, or under common
control with a party to this Agreement.
1.5 "AGREEMENT" means this License and Supply Agreement, including
any exhibits, schedules or other attachments thereto, as any of the
foregoing may be validly amended from time to time.
1.6 "CBC" means Cambridge Biotech Corporation, a Delaware corporation,
its Affiliates, and its successors and permitted assigns.
1.7 "cGLPs" means the current Good Laboratory Practices for Finished
Pharmaceuticals pursuant to 21 C.F.R. 58 et seq., as amended from
time to time.
1.8 "cGMPs" means the current Good Manufacturing Practices for
Finished Pharmaceuticals pursuant to 21 C.F.R. 210 et seq., as
amended from time to time.
1.9 "COMMERCIAL INTRODUCTION" means on a country-by-country basis the
date of first commercial sale (other than for purposes of
obtaining regulatory approval) of a Licensed Product by Progenics
or its sublicensees in such country.
1.10 "EFFECTIVE DATE" is defined in the introductory paragraph.
1.11 "FIELD OF USE" means vaccines containing purified GM2 and GD2
ganglioside preparations (whether alone or in combination with each
other) for the prevention or treatment of human cancers.
1.12 "FULLY BURDENED MANUFACTURING COST" means the actual cost of
Manufacture by CBC of the Adjuvant under a Manufacturing Process in
compliance with cGMPs, if applicable, which actual cost shall be
comprised of the cost of goods produced as determined in
accordance with United States generally accepted accounting
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principles, and shall include direct labor, direct material and
allocable manufacturing overhead but shall exclude selling,
general and administrative, research and development and interest
expenses; Fully-Burdened Manufacturing Cost shall include, to the
extent applicable, the cost to CBC of having some portion or all
of the Manufacturing Process performed by a third party.
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1.15 "KNOWHOW" means materials, data, results, formulae, designs,
specifications, methods, processes, improvements, techniques,
ideas, discoveries, technical information, process information,
clinical information and any other information, whether or not
any of the foregoing is patentable, known to and which is
confidential (in accordance with Section 9.1 hereof) and
proprietary to CBC now or hereafter during the Term, to the extent
that any of the foregoing relates to any Licensed Patent Rights or
the development, manufacture, use or sale of Adjuvant in connection
with the development, manufacture, use or sale of any Licensed
Product; provided however, that the term "Knowhow" shall not include
any of the foregoing that is subject to proprietary rights of third
parties.
1.16 "LICENSED PATENT RIGHTS" means any and all patent applications
and patents (including inventor's certificates and utility models)
throughout the world, including any substitutions, extensions,
reissues, reexaminations, renewals, divisions, continuations and
continuation-in-parts of the foregoing, which CBC now or hereafter
during the Term owns or controls (solely or jointly) or under which
CBC has the fight to grant sublicenses (regardless of any royalty or
other payments to a third party required of CBC), to the extent that
any of the foregoing covers, in whole or in part, the development,
manufacture, use or sale of Adjuvant in connection with the
development, manufacture, use or sale of any Licensed Product.
"Licensed Patent Rights" shall include, without limitation,
the patent listed on Exhibit "A" attached and incorporated into
this Agreement.
1.17 "LICENSED PRODUCT" means any vaccine or vaccines formulated using
Licensed Patent Rights or Knowhow in the Field of Use.
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1.18 "LICENSED TERRITORY" means the world.
1.19 "MANUFACTURE" OR "MANUFACTURING PROCESS" means the aseptic
storage, handling, production, processing and packaging of
Adjuvant in accordance with this Agreement.
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1.21 "OPTION" is defined in Section 3.2.
1.22 "PARTY" AND "PARTIES" are defined in the introductory paragraph.
1.23 "PLA-ENABLING HUMAN CLINICAL TRIAL" means as to a specific
Licensed Product, a controlled and lawful study of the efficacy
of such Licensed Product by administration of such Licensed
Product to human beings where the principal purpose of such trial
is to provide statistically significant efficacy data to serve as
pivotal support for an application to the United States Food
and Drug Administration for approval of a Licensed Product for the
indication being investigated by the trial.
1.24 "PROGENICS" means Progenics Pharmaceuticals, Inc., a Delaware
corporation, its Affiliates and its permitted successors and
assigns.
1.25 "PROGENICS SHARES" is defined in Section 3.2.
1.26 "SPECIFICATIONS" is defined in Section 8.3(a).
1.27 "TERM" is defined in Section 10.1.
1.28 "VALID CLAIM" means a claim in an issued, unexpired patent in the
Licensed Patent Rights, which has not been held invalid,
unpatentable or unenforceable in an unappealed or unappealable
decision of a court or other governmental body of
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competent jurisdiction, which has not been rendered unenforceable
through disclaimer or otherwise, and which has not been lost
through an interference proceeding.
2. LICENSE.
2.1 GRANT OF LICENSE RIGHTS. CBC hereby grants to Progenics a
worldwide license that is exclusive as to all parties [***],
to use the Knowhow and practice the Licensed Patent Rights
to develop, manufacture, have manufactured, use, sell, and
have sold Licensed Products.
2.2 SUBLICENSES. Progenies shall have the right to grant sublicenses
of its rights under this Agreement with respect to Licensed
Products (but not the Adjuvant alone) (a "Sublicense") only as
follows:
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(c) Progenies shall promptly notify CBC of the execution of
each sublicensee and shall provide CBC with a copy of same.
2.3 ON-GOING TRANSFER OF KNOWHOW AND LICENSED PATENT RIGHTS.
CBC shall promptly transfer to Progenics existing Knowhow
and Licensed Patent Rights for purposes of Progenics'
research and development (including but not limited to
pre-clinical trials and human clinical trials but excluding
Knowhow relating to the Manufacture of the Adjuvant) with
respect to Licensed Products. On an on-going basis during
the Term, CBC shall identify and disclose to Progenics in
writing any and all Knowhow (exclusive of Knowhow relating
to the Manufacturing the Adjuvant) then existent, whether or
not potentially patentable, and any and all Licensed Patent Rights
then existent.
3. SCHEDULE OF PAYMENTS TO CBC.
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3.2 RESTRICTED SHARES. As additional consideration for the rights
granted hereunder, Progenies shall issue to CBC simultaneously
with the execution of this agreement sixty thousand (60,000)
shares of Progenies' common stock (the "Progenies Shares). Each
of the Progenies Shares shall be subject to the restriction (the
"Transfer Restriction") that no holder of such share shall sell,
assign or transfer (collectively a "Transfer") a Progenies Share
during the period of time that the Transfer Restriction is in force
and effect as to such share. Upon the occurrence of certain
milestone events, as set forth below, the Transfer Restriction
shall lapse as to the number of Progenies Shares which remain
restricted set forth opposite the respective milestone.
MILESTONE NUMBER OF PROGENICS SHARES AS
TO WHICH RESTRICTION LAPSES
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Progenies shall promptly give CBC notice of the occurrence of
each milestone. Notwithstanding the foregoing, a holder of
Progenies Shares may Transfer all (but not less than all) of the
Progenies Shares which are subject to the Transfer Restriction to
a transferee of all or substantially all of the business division to
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which this license pertains or to such holder's legal successor
upon a merger, reorganization, consolidation, dissolution or
liquidation of such holder. In the event that the license
hereunder shall terminate pursuant to the provisions of either
Section 5.1 or Section 10, then CBC (or its permitted transferee or
successor pursuant to the next preceeding sentence) shall reconvey
to Progenics all of the Progenics Shares which on the effective date
of such termination remain subject to the Transfer Restriction.
3.3 ROYALTIES. Subject to the other terms of this agreement,
Progenics shall pay to CBC royalties as follows:
(a) [***] by Progenics of any Licensed Product
covered by a Valid Claim of Licensed Patent Rights,
payable on a country-by-country basis until the expiration
of the last-to-expire of the Valid Claims covering a
Licensed Product in the country of manufacture or sale.
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(b) In the event that Progenics should enter into a
Sublicense, CBC will receive [***]
(c) If Licensed Patent Rights existing in a given country are
not sufficient to afford a given Licensed Product
sufficient protection from competition by a vaccine in the
Field of Use manufactured by a third party using an adjuvant
based on Quillaja Saponaria and such third party holds
at least one-third of the market for such vaccine in the
Field of Use in such country, then the royalty rate payable
by Progenies to CBC will be [***]
(d) In any country in which there are no Licensed Patent
Rights, Progenics shall pay to CBC a royalty equal to [***]
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4. ROYALTY PAYMENTS, REPORTS AND RECORDS.
4.1 COMMERCIAL INTRODUCTION. Progenies shall promptly give CBC notice
of the occurrence of Commercial Introduction of each Licensed
Product.
4.2 ROYALTY PAYMENTS.
(a) PAYMENTS; DEDUCTION OF TAXES. After the date of Commercial
Introduction of the first Licensed Product, royalties
under this Agreement on Net Sales of any Licensed Product
for a given calendar quarter will be due and payable from
Progenies to CBC within thirty (30) days after the end of
such calendar quarter. Royalties due under Section 3.3(b)
attributable to sublicense fees shall be payable at the end
of the quarter when such license fees are payable. Progenies
will remit any such royalty payment due to CBC under this
Agreement by check payable to CBC. Any tax paid or required
to be withheld by Progenies on account of royalties
payable to CBC under this Agreement shall be deducted from
the amount of royalties otherwise due. Progenies shall make
any applicable withholding payments due on behalf of CBC
and shall promptly provide CBC with written documentation
of any such taxes withheld and paid by Progenies or its
sublicensees for the benefit of CBC.
(b) FOREIGN CURRENCY CONVERSION. For sales of any Licensed
Product that occur in a currency other than United States
dollars ("foreign currency sales"), the quarterly royalty
payment will be calculated as follows:
(A/B) X C = United States dollars royalty payment on
foreign currency sales, where
A = foreign currency "Net Sales" per quarter
B = foreign exchange conversion rate, expressed in local
currency per United States dollar (using as the applicable
foreign exchange conversion rate the average of the rate
published in the Wall Street Journal or any other mutually
agreed-upon source for the last business day of each of the
three (3) months of the quarter); and
C = the royalty rate applicable to such Net Sales under
Section 3.2.
4.3 ROYALTY REPORTS. After the date of Commercial Introduction of the
first Licensed Product Progenies shall render to CBC, together
with the royalty payment due under Section 4.2 for a given
calendar quarter, a written account for such calendar
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quarter showing (a) total gross sales and Net Sales of Licensed
Products sold by Progenics and its sublicensees, and the total
gross royalty and license fee revenues paid to Progenies by any
sublicensee(s) during such calendar quarter, and (b) a calculation
of the royalty rate and royalties payable under Section 3.3
(including, in the case of foreign currency sales, the total
foreign currency Net Sales during such calendar quarter, the
applicable foreign exchange conversion rate(s) and the total
United States dollar royalty payment amount).
4.4 PROGENICS' RECORDKEEPING AND INSPECTION. After the date of
Commercial Introduction of the first Licensed Product, Progenics
shall keep for at least three (3) years records of all sales of
Licensed Products in sufficient detail to permit CBC to confirm
the accuracy of Progenics' royalty calculations. At the request of
CBC no more frequently than once per year, upon at least five (5)
business days' prior written notice to Progenics from CBC, and at
the expense of CBC (except as otherwise provided below), Progenics
shall permit a nationally recognized, independent, certified
public accountant selected by CBC and acceptable to Progenics to
inspect, during regular business hours, any such Progenics records
for the then-preceding three (3) years solely to the extent
necessary to verify such calculations, provided that such accountant
in advance has entered into a confidentiality agreement with
Progenics (substantially similar to the confidentiality provisions
of this Agreement) limiting the disclosure of such information to
authorized representatives of the Parties. Results of any such
inspection shall be made available to both Parties. If such
inspection reveals a deficiency in the calculation of royalties
resulting in an underpaymeat to CBC by five percent (5%) or more,
Progenics shall pay all costs and expenses of such inspection.
5. DUE DILIGENCE.
5.1 Maintenance of License. In order to maintain the license granted
pursuant to Section 2.1 with respect to a designated Licensed
Product, Progenics agrees to use its best efforts to:
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If Progenics shall fail to achieve any of the above objectives
and such failure shall remain unremedied for a period of sixty
(60) days after notice of such failure to Progenics by CBC (the
"Grace Period"), this license shall automatically terminate at
the end of the Grace Period (except with respect to the first
Licensed Product if Progenics has fulfilled the obligations set
forth in subparagraphs (a)-(d) of this section 5.1).
Notwithstanding the foregoing, if such failure is a result of
Progenics not having obtained a third party license necessary
to make, use or sell Licensed Products and reasonable evidence is
submitted by Progenics to CBC that such license can be obtained in a
reasonable period of time, Progenics may request that the Grace
Period be extended for a period of time set forth in the request.
CBC shall not unreasonably withhold its consent to such extension
but in no event shall the Grace Period exceed one year.
CBC shall not unreasonably withhold its consent to any reasonable
revision in the preceding schedule requested in writing by Progenics
and supported by reasonable evidence of technical difficulties or
delays in the clinical studies or regulatory process that could have
not have been reasonably anticipated or avoided, (as for example,
should the clinical studies for the first Licensed Product be
unsuccessful, the parties shall establish a reasonable schedule
for the second Licensed Product). Notwithstanding the foregoing,
CBC shall not have the right to terminate the license for failure
of Progenics to meet a goal if such failure is a result of.'
(i) CBC's failure to meet its obligations hereunder, or (ii) an
action brought by a third party claiming that the use of the
Adjuvant in Licensed Products infringed a patent of such
third party.
5.2 PRE-CLINICAL AND CLINICAL PROGRAMS. Subject to the other terms of
this Agreement (including but not limited to Section 8.7), with
respect to all Licensed Products, Progenics or its sublicensees
shall be solely responsible for the conduct of pre-clinical and
human clinical testing, regulatory filings, applications
and approvals, and expenses in connection with all of the foregoing.
In connection with all of the foregoing:
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(a) CBC COOPERATION. CBC shall cooperate with and assist
Progenies in the preparation and filing of information
with respect to the Adjuvant for use in any Investigational
New Drug application, Product License Application or any
other regulatory filings throughout the Licensed Territory
with respect to any Licensed Product. Without limiting the
generality of the foregoing, for purposes of supporting
all pre-clinical and human clinical trials and all
regulatory filings, applications and approvals on the part
of Progenics with respect to any Licensed Product,
CBC hereby agrees that on an on-going basis during the Term:
(i) CBC shall permit Progenics and its sublicensees to
reference CBCs drug master file for the Adjuvant with
the United States Food and Drug Administration; (ii) to the
extent not subject to the proprietary rights of third
parties, CBC shall provide Progenics with all pre-clinical
and clinical data, results and other relevant information
with respect to the Adjuvant (including but not limited to
information regarding the toxicity, safety and stability of
the Adjuvant) that is (A) submitted by CBC in connection with
any Investigational New Drug application or other regulatory
filing with respect to the Adjuvant from time to time during
the Term or (B) otherwise in CBC's possession from time to
time during the Term; and (iii) a CBC representative,
at Progenics' request, shall attend periodic meetings to
discuss the progress of clinical trials of any Licensed
Products. Progenies will reimburse CBC for the foregoing
assistance only (i) for its reasonable out-of-pocket
expenses, including but not limited to travel, and (ii)
CBC's fully burdened costs of performing technical studies
or engaging outside services subject to the prior approval
of Progenies.
(b) ADVERSE EVENTS REPORTING. On an on-going basis during the
Term and for at least ten (10) years after the expiration
or termination of this Agreement, each Party agrees to
provide the other Party with any written information in
its possession which indicates adverse effects in humans
associated with the Adjuvant or any products using the
Adjuvant (including but not limited to Licensed Products).
(c) PROGENICS' ERGULATORY REPORTS. Within thirty (30) days of
the Effective Date and on an annual basis thereafter
(commencing with the first anniversary of the Effective
Date), Progenics will provide CBC with (i) a written report
summarizing the regulatory filings, applications and
approvals with respect to any Licensed Product that Progenics
or its sublicensees (a) have made, sought or obtained in the
prior twelve (12)-month period, and (b) reasonably expect
to make, seek or attempt to obtain in the ensuing twelve
(12)- month period following the date of the report,and
(ii) results of clinical trials conducted by Progenics
using QS-21. Any
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and all such reports shall be considered confidential and
proprietary information of Progenics in accordance with
Section 9, provided, however, that CBC may share relevant
safety data with its other QS-21 licensees in a manner
intended not to disclose any other proprietary information of
Progenics.
6. REPRESENTATIONS AND WARRANTIES OF PROGENICS; REGISTRATION RIGHTS.
6.1 Progenics represent and warrants to CBC as follows:
(a) ORGANIZATION, STANDING AND AUTHORITY. Progenics is a
corporation duly organized, validly existing and in good
standing under the laws of the state of Delaware.
Progenics has all requisite corporate power to own and
operate its properties and assets and to carry on its
business as presently being conducted and as proposed to be
conducted. Progenics has, and will have on all relevant
dates, all requisite legal and corporate power to execute
and deliver this Agreement, to issue the Progenics Shares,
and to carry out and perform its obligations under the terms
of this Agreement.
The execution and delivery of this Agreement and the
performance of the transactions contemplated hereby have
been duly authorized by all appropriate Progenics
corporate action. The performance by Progenics of any of
the terms and conditions of this Agreement on its part to be
performed does not and will not constitute a breach or
violation of any other agreement or understanding, written
or oral, to which it is a party.
(b) CAPITALIZATION. The authorized capital stock of Progenics
at December 31, 1994 consisted of: (i) 40,000,000 common
shares, par value of $.001 per share, of which 12,000,000
shares have been designated Common Stock, of which
2,999,550 shares are issued and outstanding and 5,000,000
shares have been designated Class A Common Stock, of which
no shares are issued and outstanding; and (ii) 20,000,000
preferred shares, par value $.001 per share, of which
4,000,000 shares have been designated Series A Preferred
Stock, of which 2,308,000 shares are issued and outstanding
and 2,500,000 shares have been designated Series B
Preferred Stock, of which 1,982,830 shares are issued and
outstanding. Progenics has reserved 2,348,313 shares of
Progenies Common stock for stock options outstanding at
December 31, 1994. Progenics has reserved 150,000 shares
of Progenics Common Stock for a warrant outstanding
at December 31, 1994.
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Except as set forth above, there are (i) no share
of capital stock or other voting securities of Progenics
authorized or outstanding, (ii) no subscriptions, options,
conversation or exchange rights, warrants, repurchase or
redemption agreements or other agreements, claims or
commitments of any nature whatsoever obligating Progenies to
issue, transfer, deliver or sell, repurchase or redeem or
cause to be issued, transferred, delivered, sold,
repurchased or redeemed, additional shares of its capital
stock or other securities or obligating Progenics to grant,
extend or enter into any such agreement or commitment: (iii)
no voting trusts or other agreements or understandings with
respect to the voting of the capital stock of Progenics or
agreements or understandings, restrictions on disposition of
the capital stock of Progenics to which Progenics is a party
or is bound or, to the actual knowledge of Progenics, to
which any other party is bound; and (iv) except as set forth
herein, no agreements granting any registration fights
including "piggy-back" fights to any person or entity. All
issued and outstanding shares of common stock have been duly
authorized and validly issued and are fully paid and
nonassessable.
(c) FINANCIAL STATEMENTS. Progenics has delivered to CBC copies
of the following financial statements:
(i) Progenics' audited balance sheet at December 31, 1994,
and its audited statements of operations,
stockholders' equity and cash flows for the year then
ended certified by Coopers & Xxxxxxx LLP. 6.2
Registration Rights.
(a) INCIDENTAL REGISTRATION. IfProgenics at any time proposes to
file a registration statement under the Securities Act with
respect to an offering for its own account or on behalf of
holders of its securities of any class of equity security
(excluding an initial public offering which does not include
securities registered for the account of so-called "selling
shareholders" or a registration relating solely either to the
sale of securities to employees of Progenics pursuant to a
stock purchase, stock option or similar plan or a merger,
recapitalization or reorganization), Progenics shall promptly
give CBC or any holder of Progenies Shares pursuant to a
transfer permitted under Section 3.2 (collectively a
"Holder") written notice of such registration at least 10
days prior to the anticipated filing date and such notice
shall offer the Holder the opportunity to register such
number of Progenics Shares as the Holder may request. Upon
the written request of Holder given within 10 days after
receipt of such notice delivered by Progenies, Progenics
shall use its best efforts to cause to be registered
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under the Securities Act all of the Progenics Shares that
Holder has requested to be registered.
(b) UNDERWRITING REQUIREMENTS. In connection with any offering
involving an underwriting of shares herein issued by
Progenics, Progenics shall not be required under
paragraph 6.2(a) to include any of the Progenics Shares in
such underwriting unless Holder accepts the terms of the
underwriting as agreed upon between Progenics and the
underwriters selected by it, and then only in such quantity
as will not, in the written opinion of the underwriters,
jeopardize the success of the offering by Progenics. In
connection with any offering pursuant to paragraph 6.2(a).
if the total amount of shares requested by Holder to be
included in such offering exceeds the amount of securities
sold other than by Progenics that the underwriters reasonably
believe is compatible with the success of the offering, then
Progenics shall be required to include in the offering only
that number of shares that the underwriters believe will not
jeopardize the success of the offering, (the shares so
included to be apportioned pro rata among all stockholders
of Progenics selling in the offering according to the total
amount of shares owned by each such stockholder or in such
other proportions as shall be agreed upon by such
stockholders).
(c) EXPENSES OF REGISTRATION. Progenics shall bear and pay all
expenses incurred in connection with any registration, filing
or qualification of shares with respect to registrations
pursuant to this paragraph 6.2 for Holder, including, without
limitation, all registration, filing, qualification, printing
and accounting fees relating or apportionable thereto, but
excluding underwriting discounts and commissions relating to
shares being registered, applicable transfer taxes and
expenses of counsel to any of the Holders, which shall be
borne by the stockholders selling shares being registered.
(d) PROGENICS WITHDRAWAL OF REGISTRATION. Progenics shall have
no liability to Holder for Progenics' withdrawal of any
registration as to which Holder has registration rights
under the paragraph 6.2 provided such withdrawal is made
in good faith by Progenies and not for the purpose of
impairing any of Holder's rights under this paragraph 6.2.
(e) OBLIGATIONS OF PROGENICS. Whenever required under this
paragraph 6.2 to effect the registration of any shares,
Progenies shall, as expeditiously as reasonably possible:
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(i) prepare and file with the SEC a registration statement
with respect to such shares and use its best efforts
to cause such registration statement to become
effective;
(ii) prepare and file with the SEC such amendments and
supplements to such registration statement and the
prospectus used in connection therewith as may be
necessary to comply with the provisions of the
Securities Act with respect to the disposition of all
securities covered by such registration statement;
(iii) furnish to Holder such number of copies of a
prospectus, including a preliminary prospectus,
in conformity with the requirement of the Securities
Act and such other documents as they may reasonably
request in order to facilitate the disposition of the
shares owned by them and covered by a registration
statement flied under this paragraph 6.2;
(iv) use its best efforts to register and qualify the
securities covered by such registration statement
under such other securities or Blue Sky laws of such
jurisdiction as shall be reasonably requested by
Holder, provided that Progenics shall not be required
in connection therewith or as a condition thereto to
qualify to do business or to file a general consent
to service of process in any such states or
jurisdictions;
(v) in the event of any underwritten public offering,
enter into and perform its Obligations under an
underwriting agreement, in usual and customary form,
with the underwriter(s) of such offering who shall be
chosen by Progenics (and Holder shall also enter into
and perform its obligations under such an underwriting
agreement); and
(vi) notify Holder as promptly as possible at any time when
a prospectus relating thereto is required to be
delivered under the Securities Act of the happening
of any event as a result of which the prospectus
included in such registration statement, as then in
effect, includes an untrue statement of a material
fact or omits to state a material fact required to be
stated therein or necessary to make the statements
therein, in light of the circumstances under which
they were made, not misleading.
(f) OBLIGATIONS OF HOLDER. In connection with any registration
required to be effected pursuant to this paragraph 6.2,
Holder shall furnish to Progenies
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such information regarding itself, the shares held by it and
the intended method of disposition of such securities as
shall be required to effect the registration of their shares.
(g) LOCK-UP AGREEMENT. CBC hereby agrees that in connection with
any registration of equity securities relating to an
underwritten offering thereof to the general public, CBC
shall not, whether or not CBC is participating in such
registration, to the extent requested by Progenies or the
underwriter of such offering, sell or otherwise transfer or
dispose of (other than to donors who agree to be similarly
bound) any Progenies Shares (other than those shares which
are in fact included, in such registration) without the prior
written consent of Progenics or such underwriters. as the
case may be, for such period of time (not to exceed 120 days)
from the effective date of the registration statement for
such registration as Progenies or such underwriters may
specify in writing.
(h) INDEMNIFICATION. Progenies may require, as a condition to
including any Progenies Shares in any registration statement
filed pursuant to this paragraph 6.2, that Progenics shall
have received an undertaking satisfactory to it from (i) the
prospective seller of such securities, to indemnify and hold
harmless Progenics, each officer and director of each such
underwriter and each other person, if any, who controls
Progenies or the underwriter, and (ii) each such underwriter
of such securities, to indemnify and hold harmless Progenics,
each officer and director of Progenics, each prospective
seller, each officer and director or each prospective seller
and each other person, if any, who controls Progenies or
any such prospective seller within the meaning of Section 15
of the Securities Act or Section 20 of the Exchange Act,
with respect to any statement in or omission from such
registration statement, any preliminary prospectus, final
prospectus or summary prospectus included therein, or any
amendment or supplement thereto, if such statement or
omission was made in reliance upon and in conformity with
written information furnished by such prospective seller
or underwriter, as the ease may be, to Progenics for use in
the preparation of such registration statement, preliminary
prospectus, final prospectus, summary prospectus, amendment
or supplement. Such indemnity shall remain in full force and
effect regardless of any investigation made by or on behalf
of Progenics or any such director, officer or controlling
person and shall survive the transfer of such securities by
such seller.
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7. CBC REPRESENTATIONS AND WARRANTIES.
7.1 CBC represents and warrants to Progenies as follows:
(a) ORGANIZATION, STANDING AND AUTHORITY. CBC is a corporation
duly organized, validly existing and in good standing under
the laws of the state of Delaware. CBC has all requisite
corporate power to own and operate its properties and assets
and to carry on its business as presently being conducted
and as proposed to be conducted. CBC has, and will have on
all relevant dates, all requisite legal and corporate power
to execute and deliver this Agreement.
The execution and delivery of this Agreement and the
performance of the transactions contemplated hereby have
been duly authorized by all appropriate CBC corporate action.
The performance by CBC of any of the terms and conditions of
this Agreement on its part to be performed does not and will
not constitute a breach or violation of any other agreement
or understanding, written or oral, to which it is a party.
CBC has the full right and legal capacity to provide in the
Licensed Territory all rights to the Knowhow and Licensed
Patent Rights granted to Progenics hereunder.
(b) PROCEEDINGS OR CLAIMS. There are no adverse proceedings,
claims or actions pending, or to the best of CBC's knowledge,
threatened, relating to the Knowhow and/or Licensed Patent
Rights and at the time of disclosure and delivery thereof to
Progenies, CBC shall have the full right and legal capacity
to disclose and deliver the Knowhow and Licensed Patent
Rights to Progenics without violating the fights of third
parties.
(c) INVESTMENT. CBC is acquiring the Progenics Shares for
investment and not with a view to the distribution thereof
nor with any present intention of distributing or selling any
Progenics Shares except in compliance with the Securities
Act.
8. MANUFACTURE AND SUPPLY.
8.1 GENERAL. The terms of the exclusive license granted to Progenics
under Section 2 notwithstanding, Progenics agrees that CBC
retains the right to Manufacture the Adjuvant for use in Licensed
Products. CBC agrees to supply Progenies with one hundred percent
(100%) of its Adjuvant Requirements for purposes of research and
development, pre-clinical and human clinical trials and
commercial sales of all Licensed Products. CBC also agrees to
supply each of Progenics sublicensees with all of its Adjuvant
Requirements provided such sublicensee enters a supply
-17-
agreement with CBC containing substantially the same terms
pertaining to supplyas set forth herein. CBC hereby agrees, at
its sole expense, to commit allreasonably necessary facilities,
appropriately trained personnel, machinery, equipment, utilities
and other CBC resources required to satisfy its obligations under
this Agreement. CBC may contract with a third party to fulfill
its obligations hereunder and/or may assign or sublicense all or
any portion of its rights and obligations under this Section 8
with respect to Manufacture and supply of Adjuvant Requirements.
For all purposes under this Section 8, the term CBC,.shall be
deemed to include any such third party, assignee or sublicensee
of CBC.
8.2 CBC TRANSFER PRICE OF ADJUVANT.
(a) THROUGH FILING OF PRODUCT LICENSE APPLICATION. With respect
to each and every Licensed Product, CBC shall supply one
hundred percent (100%) of Adjuvant Requirements prior to
Commercial Introduction of such Licensed Product, including
for purposes of all research and development, pre-clinical
trials and human clinical trials (including PLA-Enabling
Human Clinical Trials) of such Licensed Product. CBC agrees
to supply Adjuvant under this Section 8.2(a) at a transfer
price to Progenics [***]. In order to verify the production
cost of the Adjuvant, Progenics will have the right to pay
for an independent certified public accountant to inspect the
records of CBC once per year during regular business hours,
provided that such accountant has entered into a
confidentiality agreement with CBC limiting the disclosure
of such information to authorized representatives of the
Parties.
(b) COMMERCIAL INTRODUCTION AND SALES. With respect to each and
every Licensed Product, CBC shall supply [***] of Adjuvant
Requirements for commercial sales of suchLicensed Product
upon and after its Commercial Introduction. CBC agrees to
supply Adjuvant under this Section 8.2(b) at a transfer
price [***].
8.3 CBC'S REPRESENTATIONS, WARRANTIES AND COVENANTS REGARDING
MANUFACTURING. CBC hereby represents and warrants to Progenics
and its sublicensees as follows:
(a) PRE-CLINICAL TRIAL USE. CBC shall Manufacture or cause to be
Manufactured all Adjuvant Requirements for use in any vaccine
used in
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*** Confidential Treatment Requested
connection with any pre-clinical trial of any Licensed
Product (i) strictly in compliance with (A) this Agreement,
(B) the specifications for the Manufacture of Adjuvant, as
may from time to time be required by the Food and Drug
Administration (the "Specifications") the current version of
which is set forth in Exhibit B, and (C) all applicable laws
and regulations.
(b) HUMAN CLINICAL TRIAL USE. CBC shall Manufacture or cause to
be Manufactured all Adjuvant Requirements for use in any
vaccine used in connection with any human clinical trial of
any Licensed Product (i) strictly in compliance with (A) this
Agreement, (B) all Specifications, and (C) all applicable
laws and regulations, including but not. limited to cGMPs,
to the extent applicable. Notwithstanding the foregoing, the
parties acknowledge and agree that the Adjuvant which is
being delivered to Progenics in the first lot (approximately
one gram) has been manufactured by CBC for use in Phase 1
and Phase 2 clinical trials in a manner which CBC believes
to be appropriate for such level of clinical trial. It shall
be the responsibility of Progenics to obtain such assurances
from regulatory authorities as it may deem necessary or
appropriate for the use of such Adjuvant in the trials it is
planning to conduct.
(c) COMMERCIAL USE. CBC shall Manufacture or cause to be
Manufactured all Adjuvant Requirements for use in the
commercialization of any Licensed Product (i) strictly in
compliance with (A) this Agreement, (B) all Specifications,
and (C) all applicable laws and regulations, including but
not limited to cGMPs, to the extent applicable.
(d) CERTIFICATE OF ANALYSIS; NON-COMPLYING ADJUVANT. Before,
during and after Manufacture of Adjuvant Requirements, CBC
shall obtain samples, monitor the Manufacturing Process and
the environment of such Manufacture, and keep such technical
books and records of all of the foregoing as are required
under the Specifications and all applicable laws and
regulations, including but not limited to cGLPs or cGMPs (as
appropriate and applicable). CBC shall test each lot of
Adjuvant Requirements Manufactured for Progenics as required
under the Specifications. Together with each such lot of
Adjuvant Requirements, CBC shall provide a written
certificate of analysis which shall set forth the results of
such testing by CBC and CBC's quality control approval of
such lot of Adjuvant Requirements. CBC's obligations under
this Section 8.3(d) shall be at CBC's sole expense. Progenies
shall be entitled to test any such Adjuvant Requirements in
accordance with the Specifications, at Progenics' sole
expense. Without limiting any of Progenics' other rights
or remedies under this Agreement, with respect to any
Adjuvant Requirements supplied
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hereunder that do not comply with applicable
representations and warranties under this Section 8.3, the
Parties agree that: (i) neither Progenies nor its
sublicensees shall be obligated to pay CBC the transfer
price applicable to such non-complying Adjuvant
Requirements; (ii) if Progenies or its sublicensee has
already paid for such non-complying Adjuvant Requirements,
Progenies or its sublicensee shall be entitled to a credit
against future purchases for the amount paid to CBC
therefor; (iii) CBC on a priority basis shall Manufacture
and supply to Progenics or its sublicensee, as applicable,
replacement Adjuvant Requirements in full compliance with
this Section 8.3; and (iv) CBC shall bear the full cost of
returning or destroying the non-complying Adjuvant
Requirements. Progenies shall be deemed to have accepted
any Adjuvant provided hereunder and such Adjuvant shall be
deemed to comply with the provisions hereof unless
Progenies shall notify CBC of the rejection of such
Adjuvant and the reasons for such rejection within the
forty-five days (45) of delivery of such Adjuvant.
8.4 PROCEDURES FOR ESTIMATING, ORDERING AND SUPPLYING ADJUVANT REQUIREMENTS.
Subject to the other terms of this Agreement:
(a) ANNUAL DEMAND FORECAST FOR EACH MANUFACTURING YEAR. During
the Term, commencing on October 1, 1995 and on an on-going
quarterly basis as described below, Progenics will provide
CBC with a written rolling annual demand forecast of Adjuvant
Requirements for each calendar year which shall be binding as
to the first quarter and non-binding as to the remaining
three (3) quarters. Thereafter, Progenics shall provide an
updated annual demand forecast on a quarterly basis no later
than ninety (90) days in advance of the commencement of the
first (and binding) quarter covered by such annual demand
forecast. The Parties also agree that the variance, if any,
between the binding forecast of a given quarter and the last
non-binding forecast for such quarter shall be between
[***] and [***], meaning that Progenies' binding forecast for
such quarter must be at least [***] but not more than [***]
of such last non-binding forecasted amount for such quarter.
(b) PURCHASE ORDERS. Except as set forth in Section 8.4(a),
Progenics shall place a firm purchase order or purchase
orders with CBC setting forth (i) the quantities of Adjuvant
Requirement to be Manufactured and supplied hereunder, (ii)
the schedule for receipt from CBC of such batch(es) of
Adjuvant Requirements, and (iii) instructions for shipping
and packaging. Each such firm purchase order shall be
submitted no later than thirty (30)
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*** Confidential Treatment Requested
days in advance of the first scheduled date of receipt
thereof. Subject to the other terms of this Agreement,
Progenics shall be obligated to place firm purchase orders
with CBC for, and CBC hereby commits to Manufacture and
supply hereunder pursuant to such firm purchase orders, no
less than one hundred percent (100%) of the amount of
Adjuvant Requirements in the then-binding quarter of each
annual demand forecast under Section 8.4(b); provided,
however, that: (A) the Parties may mutually agree in writing
to amend any such firm purchase order; (B) CBC, in its
discretion, may agree to supply additional amounts of
Adjuvant Requirements in excess of the then-binding amount,
provided that Progenies place firm purchase order(s) for such
excess Adjuvant Requirements on a timely basis; and (C) CBC
agrees to provide Progenics with as much advance written
notice as possible (and in any case at least thirty (30)
days' written advance notice) ifCBC determines that any
scheduled delivery of Adjuvant Requirements pursuant to any
purchase order will be delayed for any reason of which CBC
becomes aware.
(c) [***]
*** Confidential Treatment Requested
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8.5 ALLOCATION.
(a) ALLOCATION AMONG CUSTOMERS. CBC and Progenics hereby
agree and acknowledge that, in the event that CBC is
unable to satisfy in full its obligations under this
Agreement to supply one hundred percent (100%) of Adjuvant
Requirements as well as CBC's obligations to third parties
with respect to supply of Adjuvant, CBC shall allocate
proportionately all available Adjuvant among Progenies and
its sublicensees and such third parties with highest
priority for the supply of Adjuvant given to outstanding
firm purchase orders for comparable delivery time frames.
(b) INABILITY TO SUPPLY. In the event CBC shall fail to fill
one hundred percent (100%) of Progenics' allowable xxxx
purchase orders for two successive calendar quarters (an
"Inability to Supply") then, notwithstanding Section 8.1,
Progenics may either purchase its Adjuvant Requirements
from a third party or manufacture for its own use its
Adjuvant Requirements, in either case only until such time
as CBC shall demonstrate (if such demonstration shall be
made within one (I) year after the end of the second
consecutive quarter of such shortfall) that it is willing
and able to supply Progenics' Adjuvant Requirements
(provided that Progenics shall not be require. d to
purchase additional Adjuvant from CBC until such time as
it has satisfied commitments of reasonable scope and
duration made for purchase or manufacture of Adjuvant
during such period). In the event Progenics elects to
manufacture the Adjuvant, CBC shall transfer to Progenics
all information and Knowhow reasonably necessary to
manufacture the Adjuvant and CBC shall fully cooperate
with regulatory authorities to qualify Progenics as a
manufacturer of the Adjuvant. Progenics' fight to
manufacture under this section shall be its exclusive
remedy for any damages or losses it incurs as a result of
any interruption in the supply of Adjuvant under this
Agreement. Without limiting the generality of the
foregoing, CBC shall not be liable to Progenics for
consequential damages or lost profits.
8.6 REGULATORY APPROVAL OF MANUFACTURING. CBC shall be responsible,
at sole cost and expense, for obtaining all necessary regulatory
approvals particular to the Adjuvant for Manufacture and supply
of Adjuvant Requirements. Progenics shall advise CBC of any new
requirements specified by the United States Food and Drug
Administration or the Federal Food, Drug and Cosmetic Act (or the
equivalent regulatory authority or law in other countries) with
respect to any Licensed Product. At any time when any portion of
the Adjuvant Requirements is being Manufactured by CBC for
Progenics, Progenics shall have the right to have its personnel
observe all phases and areas of such Manufacture and the CBC
facility,
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and CBC shall not modify in any manner any Specifications without
Progenics' prior written consent (which consent shall not be
unreasonably withheld).
8.7 CBC RECORDKEEPING AND INSPECTION.
(a) TECHNICAL RECORDS. With respect to any Manufacture and supply of
Adjuvant Requirements, CBC shall, at its expense, keep properly
completed technical books and records, test data and reports as
required under the Specifications and all applicable laws and
regulations, including but not limited to cGLPs or cGMPs (as
appropriate), and in any case shall maintain such technical
information for at least two (2) years from the expiration date
of the relevant Licensed Product or longer if required under
applicable laws and regulations (including but not limited to
cGLPs and cGMPs, as applicable). During regular business hours
and upon reasonable advance written request, CBC shall make any
such technical information available to Progenics for inspection
and copying.
(b) FINANCIAL RECORDS. During the Term, CBC shall keep for at
least three (3) years records of its Fully Burdened
Manufacturing Costs, and the calculations thereof in
sufficient detail to permit Progenics to confirm the accuracy
thereof. At the request of Progenics, and not more frequently
than once per year, upon at least five (5) business days'
prior written notice, and at the expense of Progenics (except
as otherwise provided below), CBC shall permit a nationally
recognized, independent, certiffied public accountant selected
by Progenics and acceptable to CBC to inspect (during regular
business hours) any such CBC records for the then-preceding
three (3) years solely to the extent necessary to verify such
costs, margins and calculations, provided that such accountant
in advance has entered into a confidentiality agreement with
CBC and Progenics substantially similar to the confidentiality
provisions of this Agreement, limiting the use and disclosure
of such information to authorized representatives of the
Parties. Results of any such inspection shall be made
available to both Parties. If such inspection reveals a
deficiency in the calculation of CBC's Fully Burdened
Manufacturing Cost resulting in an overpayment to CBC of the
transfer price by five percent (5%) or more, CBC shall pay all
costs and expenses of such inspection.
(c) QUALITY AUDIT. To the extent required by law, CBC shall permit
Progenics to audit, in cooperation with CBC's personnel,
production, packaging, and quality control facilities of CBC
and any of its significant suppliers as they relate to
production of the Adjuvant to allow Progenics to verify CBC's
compliance with its responsibilities under this Agreement.
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8.8 LIABILITY.
(a) INDEMNIFICATION BY PROGENIES. Except as otherwise provided in
Sections 8.8(b) or (c), Progenics will defend, indemnify and
hold harmless CBC against any and all claims, actions,
liabilities, damages, loses, costs or expenses, including
reasonable attorneys' fees, based upon or arising out of the
sales or use of any Licensed Product by Progenics or a
sublicensee, unless CBC should fail to give Progenics prompt
notice thereof in writing and such failure materially
prejudices CBC's abilities to defend against such claim. CBC
shall permit Progenics to control the investigation,
preparation and defense thereof(including any compromise or
settlement thereof and any appeal) and provide reasonable
assistance to Progenics, at Progenics' expense, in that regard.
(b) LIABILITY. Each Party assumes full responsibility and
liability for any injury, damage or expense which it or its
employees, agents and invitees incur and which arise from its
manufacture, handling and use of the Adjuvant or Licensed
Products, except to the extent such injury, damage or expense
arises from the negligence or willful misconduct of the other
Party.
(c) INDEMNIFICATION BY CBC. CBC will defend, indemnify and hold
harmless Progenics against any and all claims, actions,
liabilities, damages, losses, costs or expense (including
reasonable attorneys' fees) based upon the failure of the
Adjuvant to conform to the Specifications; of CBC, unless
Progenics shall fail to give CBC prompt notice thereof in
writing and such failure materially prejudices Progenics'
ability to defend against said claim. Progenics shall permit
CBC to control the investigation, preparation and defense
thereof (including any compromise or settlement thereof and
any appeal) and provide reasonable assistance to CBC, at CBC's
expense, in that regard.
9. CONFIDENTIALITY.
9.1 CONFIDENTIALITY. The Parties acknowledge that during the Term,
either Party may receive from the other Party information which is
proprietary, confidential and of significant commercial value to
the disclosing Party. Except to the extent expressly authorized by
this Agreement, the Parties agree that, for the Term and for five
(5) years thereafter, the receiving Party shall keep completely
confidential and shall not publish or otherwise disclose and shall
not use for any purpose (except those related to this agreement)
any information furnished to it by the other Party pursuant to this
Agreement, except to the extent that it can be
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established by the receiving Party by competent proof (including
written records) that such information:
(a) was already known to the receiving Party, other than under an
obligation of confidentiality, at the time of disclosure by
the other Party;
(b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving
Party;
(c) became generally available to the public or otherwise part of
the public domain after its disclosure and other than through
any act or omission of the receiving Party in breach of this
Agreement;
(d) was subsequently lawfully disclosed to the receiving Party by
a third party; or
(e) was subsequently independently developed by receiving Party.
9.2 PERMITTED DISCLOSURES. Each Party may disclose the other Party's
information to the extent such disclosure is reasonably necessary
in prosecuting or defending litigation, filing, prosecuting or
maintaining patent applications or patents, complying with
applicable laws or regulations, or, in the case of Progenics and
its sublicensees, conducting preclinical or clinical trials or
preparing or filing regulatory filings with respect to Licensed
Products; provided, however, that if a Party is required to make
any disclosure of the other Party's information furnished pursuant
to this Agreement, it will give reasonable advance notice of such
disclosure requirements to the other Party and, except to the
extent inappropriate as in the case of patent applications, will
use its best efforts to secure confidential treatment of such
information required to be disclosed.
10. TERM; TERMINATION.
10.1 TERM. This Agreement shall commence as of the Effective Date and,
unless sooner terminated as provided in this Section 10, shall
expire on the date royalties are not longer payable by Progenics to
CBC under Section 3.3 (the "Term"), upon which expiration Progenics
shall thereafter have in perpetuity a royalty-free license in the
Licensed Territory to use the Knowhow and practice the Licensed
Patent Rights to develop, make, have made, use and sell Licensed
Products without any accounting to CBC.
10.2 MATERIAL BREACH. Subject to Section 13.6, failure by either Party
to comply with any of the material obligations contained in this
Agreement shall entitle the other
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Party to give to the Party in default notice specifying the nature
of the default and requiring it to cure such default. If such
default is not cured within sixty (60) days after the receipt of
such notice, the notifying Party shall be entitled, without
prejudice to any of its other rights conferred on it by this
Agreement and in addition to any other remedies available to it by
law or in equity, to terminate this Agreement effective upon
written notice to the other Party. The right of a Party to
terminate this Agreement, as hereinabove provided, shall not be
affected in any way by its waiver or failure to take action with
respect to any previous default.
10.3 ACCRUED RIGHTS, SURVIVING OBLIGATIONS; SUBLICENSEES. Expiration or
any termination of this Agreement for any reason shall be without
prejudice to any rights which shall have accrued to the benefit of
either Party prior to such expiration or termination. Such
expiration or termination shall not relieve either Party from
obligations which are expressly indicated to survive expiration or
termination of this Agreement, which obligations include, without
limitation, those under Sections 4.4, 5,2(b), 7, 8.7, 8.8, 9, 11
and 12. [***]
10.4 TERMINATION BY PROGENICS. Progenics may terminate this Agreement by
giving 90 days written notice to CBC: provided Progenics shall be
obligated to fulfill its obligations under any binding purchase
order outstanding; and further provided that upon such termination
all rights to Know-how and Licensed Patent Rights shall revert to
CBC.
11. PATENTS.
11.1 INVENTIONS. Title to any Licensed Patent Rights will follow
inventorship, which will in turn be determined in accordance with
United States laws of inventorship and written evidence of the
Parties. Designation of inventors on any patent application is a
matter of law and will be solely within the discretion of qualified
patent counsel of CBC and Progenics.
11.2 PATENT PROSECUTION STRATEGY. Subject to the other terms of this
Agreement:
(a) CBC SOLELY OWNED LICENSED PATENT RIGHTS. During the Term, the
filing, prosecution and maintenance of Licensed Patent Rights
solely owned by CBC will be under the control of CBC, at its
sole cost and expense.
(b) JOINTLY OWNED LICENSED PATENT RIGHTS. During the Term, the
filing, prosecution and maintenance of any Licensed Patent
Rights jointly owned
*** Confidential Treatment Requested
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by the Parties will be under the control of the Party from
whom the majority of the data underlying such Licensed Patent
Rights arose (the "controlling Party"), and the controlling
Party is authorized to undertake such filings, prosecutions
and maintenance at its sole cost and expense, using patent
counsel reasonably satisfactory to the non-controlling Party
and with the reasonable cooperation of the non-controlling
Party and its employees, provided that: (i) the controlling
Party notifies the non-controlling Party reasonably prior to
the filing of any such Licensed Patent Rights by the
controlling Party and permits review of such proposed Licensed
Patent Rights by the non-controlling Party; (ii) the
controlling Party provides the non-controlling Party promptly
with copies of all communications received by the controlling
Party; (iii) the controlling Party keeps the non-controlling
Party reasonably informed of the status of such Licensed
Patent Rights, and (iv) the controlling Party provides the
non-controlling Party notice at least thirty (30) days in
advance of taking or failing to take any action that would
affect the scope or validity of any such Licensed Patent
Rights (including but not limited to substantially narrowing
or canceling any claim, abandoning any such Licensed Patent
Rights or not filing or perfecting the filing of any such
Licensed Patent Rights in any country), with prior written
notice of such proposed action or inaction so that the
non-controlling Party has a reasonable opportunity to review
and make comments. Either Party may assign its rights to any
jointly owned Licensed Patent Rights to the other Party, who
will have the right, in its discretion, to assume the
prosecution and maintenance thereof at its sole expense and as
the sole owner thereof.
(c) [***]
*** Confidential Treatment Requested
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[***]
11.3 THIRD PARTY INFRINGEMENT. Either Party promptly shall notify the
other Party in writing of any alleged infringement of the Licensed
Patent Rights and of any available evidence thereof. The Parties
shall consult as to a potential litigation strategy or strategies
against any alleged infringer. If the Parties commence and
prosecute a suit jointly, they shall share all associated
attorneys' fees and out-of-pocket litigation expenses equally. If
the Parties do not decide to jointly commence an action within
thirty (30) days of the notice specified above, or otherwise
terminate the alleged infringement, CBC shall have the right, at
its expense, to bring suit against the allegedly infringing party.
[***]
11.4 TRADEMARKS. Progenics, at its expense, shall be responsible for the
selection, registration and maintenance of all trademarks and
tradenames which it employs in connection with Licensed Products.
The terms "trademark" or "tradename" shall include, without
limitation, the name or names of any Licensed Products, the design
of the packaging of any Licensed Products, and the appearance of
dosage forms of any Licensed Product. Progenics shall own such
tradenames and trademarks and shall retain such ownership upon
termination of this Agreement.
12. ARBITRATION.
Any dispute, controversy or claim between the Parties, arising out of or
relating to this Agreement or the Parties' respective rights and
obligations hereunder either during or after the Term (including the
question as to whether any such matter is arbitrable) shall be subject
to binding arbitration in accordance with then-existing commercial
arbitration rules of the American Arbitration Association. The Parties
agree that, in the course of any such
*** Confidential Treatment Requested
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arbitration, service of any notice at their respective addresses in
accordance with Section 13.11 of this Agreement shall be valid and
sufficient, and any arbitration hereunder shall be in the jurisdiction
of the defendant Party, which in the case of Progenics shall be New York
and in the case of CBC shall be Massachusetts. In any such arbitration,
an award shall be rendered by a majority of the members of a board of
arbitration consisting of three (3) members, one (1) of whom shall be
chosen by each of Progenics and CBC and the third of whom shall be
appointed by mutual agreement of such two (2) arbitrators. In the event
of failure of such two (2) arbitrators to agree within sixty (60) days
after the commencement of arbitration (as defined below) upon
appointment of the third arbitrator, or in the event that either Party
shall fail to appoint an arbitrator within thirty (30) days after the
commencement of the arbitration proceedings, the third arbitrator or
(upon request of the other Party) the second arbitrator and the third
arbitrator, as the case may be, shall be appointed by the American
Arbitration Association in accordance with its then existing commercial
arbitration rules. For purposes of this Section, the "commencement of
the arbitration proceeding" shall mean the date upon which the
defendant Party receives from the American Arbitration Association a
copy of the request for arbitration filed by the party desiring to have
recourse to arbitration. The decision of the arbitrators shall be in
writing and shall set forth the basis therefor. The Parties shall abide
by all awards rendered in arbitration proceedings, and such awards may
be enforced and executed upon in any court having jurisdiction over the
Party against whom enforcement of such award is to be sought. The
Parties shall divide equally the administrative charges, arbitrators'
fees, and related expenses of arbitration, but each Party shall pay its
own legal fees incurred in connection with any such arbitration;
provided, however, if the arbitrators determine that one Party prevailed
clearly and substantially over the other Party, then the non-prevailing
Party shall also pay the reasonable attorneys' fees and expert witness
costs and other arbitration costs of the prevailing Party.
13. MISCELLANEOUS PROVISIONS.
13.1 NO PARTNERSHIP. Nothing in this Agreement is intended or shall be
deemed to constitute a partnership, distributorship, agency,
employer-employee or joint venture relationship between the
Parties. No Party shall incur any debts or make any commitments for
the other, except to the extent, if at all, specifically provided
herein.
13.2 ASSIGNMENTS. Except as set forth in Section 8 hereof, neither Party
shall assign any of its right or obligations hereunder or this
Agreement, except that either Party may do so: (a) as incident to
the merger, consolidation, reorganization or acquisition of stock
or assets affecting substantially all of the assets or voting
control of such Party; (b) to any wholly-owned subsidiary if such
Party remains liable and responsible for the performance and
observance of all of the subsidiary's duties and obligations
hereunder; (c) with the prior written consent of the other
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Party; (d) as incident to a joint venture between Progenics and a
major corporate partner; or (e) as incident to any reorganization
of CBC; including any reorganization under the provisions of
Chapter 11 of the United States Bankruptcy Code and any merger,
spin-off, sale of assets or other transaction. This Agreement shall
be binding upon the successors and permitted assigns of the Parties
and the name of a Party appearing herein shall be deemed to include
the names of such Party's successors and permitted assigns to the
extent necessary to carry out the intent of this Agreement. Any
assignment not in accordance with this Section 13.2 shall be void.
13.3 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as
may be necessary or appropriate in order to carry out the purposes
and intent of this Agreement. Without limiting the generality of
the foregoing, CBC agrees to provide a letter to FDA authorizing
Progenics to cross reference CBC's drug master flies for QS-21.
13.4 NO NAME OR TRADEMARK RIGHTS. Except as otherwise provided herein,
no right, express or implied, is granted by this Agreement to use
in any manner the names "Cambridge Biotech Corporation" or
"Progenics Pharmaceuticals, Inc." or any contraction thereof or any
other trade name or trademark of CBC or Progenics in connection
with the performance of this Agreement.
13.5 PUBLIC ANNOUNCEMENTS. Except as may otherwise be required by
applicable law or regulation, neither Party shall make any public
announcement concerning this Agreement or the subject matter hereof
without the prior written consent of the other Party (not to be
unreasonably withheld).
13.6 FORCE MAJEURE. If any default or delay occurs which prevents or
materially impairs a Party's performance and is due to a cause
beyond the Party's reasonable control, including but not limited to
any act of any god, flood, fire, explosion, earthquake, casualty,
accident, war, revolution, civil commotion, blockade or embargo,
injunction, law, proclamation, order, regulation or governmental
demand, the affected Party promptly shall notify the other Party in
writing of such cause and shall exercise diligent efforts to resume
performance under this Agreement as soon as possible. Neither Party
shall be liable to the other Party for any loss or damage due to
such cause. Neither Party may terminate this Agreement because of
such default or delay.
13.7 ENTIRE AGREEMENT OF THE PARTIES; AMENDMENTS. This Agreement,
including the exhibits attached hereto which are incorporated
herein, constitutes and contains the entire understanding and
agreement of the Parties and cancels and supersedes any and all
prior negotiations, correspondence, understandings and agreements,
-30-
whether verbal or written, between the Parties respecting the
subject matter hereof. No waiver, modification or amendment of any
provision of this Agreement shall be valid or effective unless made
in writing and signed by a duly authorized officer of each of the
Parties.
13.8 SEVERABILITY. In the event that any of the provisions of this
Agreement shall for any reason be held by any court or authority of
competent jurisdiction to be invalid, illegal or unenforceable,
such provision or provisions shall be validly reformed to as nearly
as possible approximate the intent of the Parties and, if
unreformable, shall be divisible and deleted in such jurisdiction;
elsewhere, this Agreement shall not be affected so long as the
Parties are still able to realize the principal benefits bargained
for in this Agreement.
13.9 CAPTIONS. The captions to this Agreement are for convenience only,
and are to be of no force or effect in construing or interpreting
any of the provisions of this Agreement.
13.10 APPLICABLE LAW. This Agreement shall be governed by and
interpreted in accordance with the laws of The Commonwealth of
Massachusetts applicable to agreements made and performed wholly
within such state without regard to its principles of conflicts of
laws.
13.11 NOTICES AND DELIVERIES. Any notice, requests, delivery, approval
or consent required or permitted to be given under this Agreement
shall be in writing and shall be deemed to have been sufficiently
given if delivered in person, transmitted by telecopy (with written
confirmation to follow via United States first class mail) or five
(5) days after being sent by United States certified mail to the
Party to whom it is directed at its address shown below or such
other address as such Party shall have last given by written notice
to the other Party in accordance with this Section.
If to CBC, addressed to:
Cambridge Biotech Corporation
000 Xxxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attention: President
Telecopy: 000-000-0000
with a copy to:
Attention: General Counsel
Telecopy: 000-000-0000
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If to Progenics, addressed to:
Progenics Pharmaceuticals, Inc.
000 Xxx Xxx Xxxx Xxxxx Xxxx
Xxxxxxxxx, XX 00000
Attention: Xxxx X. Xxxxxx, M.D., Ph.D., CEO
Telecopy: 000-000-0000
13.12 COUNTERPARTS. This Agreement may be executed simultaneously in two
or more counterparts, each of which shall be deemed an original,
but all of which together shall constitute one and the same
instrument.
13.13 COMPLIANCE WITH LAWS. Progenics and CBC each shall comply with all
applicable laws in connection with its own performance under this
Agreement. Without limiting the generality of the foregoing,
Progenics shall be responsible for compliance with all applicable
product safety, product testing, product labeling, package marking,
and product advertising laws and regulations, except with respect
to efforts performed by CBC in which case CBC shall be responsible
for its activities as governed by such laws and regulations.
13.14 SURVIVAL. The representations, warranties, covenants and
agreements made herein shall survive any investigation made by a
Party and shall be able to be relied fully on by the Parties.
13.15 BANKRUPTCY COURT APPROVAL: ESCROW. The performance of either party
of its obligations hereunder is subject to approval of this
Agreement by the United States Bankruptcy Court for the District of
Massachusetts, Western Division. Within thirty days following
execution of this Agreement, CBC will deliver to a mutually
agreeable escrow agent all documentation set forth on EXHIBIT C,
attached hereto and made a part hereof, (the "Escrow
Documentation") necessary for Progenics to manufacture the Adjuvant
pursuant to the provisions of Section 8.5(b) of this Agreement. [***]
At Progenics' expense, Progenics shall obtain a verification from
Coopers & Xxxxxxx, L.L.P. that the documentation delivered to the
Escrow Agent conforms with the definition of Escrow Documentation
as set forth in Exhibit C. The Escrow Documentation shall be held
by the escrow agent pursuant to the terms of a mutually agreeable
escrow agreement which shall
*** Confidential Treatment Requested
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provide INTER ALIA for the updating of the Escrow Documentation as
necessary by CBC to insure that the Escrow Documentation is current
and for the delivery of the Escrow Documentation to CBC upon the
effective date of CBC's reorganization plan and prior to such date
for delivery of the Escrow Documentation to Progenics in the event
of the occurrence of an Inability to Supply or in the event that
CBC's Chapter 11 bankruptcy proceeding is converted to a Chapter 7
bankruptcy proceeding. The procedures set forth in this Section
13.15 respecting escrow shall apply each and every time, if any,
that CBC enters into reorganization or bankruptcy in the future.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
signed by their respective corporate officers, duly authorized as of the day
and year first above written.
CAMBRIDGE BIOTECH CORPORATION PROGENICS PHARMACEUTICALS, INC.
By: /s/ Xxxxxx Xxxxxxx-Xxxxx By: /s/ Xxxx X. Xxxxxx
-------------------------- ---------------------------------
Name: Xxxxxx Xxxxxxx-Xxxxx Name: Xxxx X. Xxxxxx, M.D., Ph.D.
----------------------- -------------------------------
Title: President and CEO Title: CEO and Scientific Director
---------------------- ------------------------------
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EXHIBIT A
LICENSED PATENT RIGHTS
U.S. Patent No. 5,057,540, entitled "Saponin Adjuvant" inventors Xxxxxxxxx X.
Xxxxxx and Xxxxx X. Xxxxxxxx, issued October 15, 1991 (filed August 27, 1990).
COUNTRY SERIAL NUMBER
Xxxxxxxxx 00000/00
Xxxxxx 568,119
Xxxxxxx 0000/00
Europe 00000000.8
Japan 504974/1988
PCT PCT/US88/01842
EXHIBIT B
CAMBRIDGE BIOTECH CORPORATION 000 XXXXXXXXXX XX. XXXXXXXXX, XX 00000
CERTIFICATE OF ANALYSIS
[***]
*** Confidential Treatment Requested
EXHIBIT C
[***]
*** Confidential Treatment Requested
[LOGO] PROGENICS Progenics Pharmaceuticals, Inc.
Xxx Xxx Xxxx Xxxxx Xxxx
Xxxxxxxxx, Xxx Xxxx 00000
(000) 000-0000
Telefax:(000) 000-0000
September 6, 1995
Xxxxxx Xxxxxxx-Xxxxx, Ph.D.
Chief Executive Officer
Cambridge Biotech Corporation
000 Xxxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Re: Cambridge Biotech Corporation/Progenics License and Supply Agreement
(August 1995)
Dear Xx. Xxxxx,
This letter confirms our understanding that if pursuant to Paragraph 8.5(b)
of the above-referenced agreement Progenics finds it necessary to manufacture
the Adjuvant, CBC agrees that it will immediately execute and deliver a
letter as set forth in Appendix A (attached).
Sincerely,
/s/ Xxxx X. Xxxxxx
Xxxx X. Xxxxxx, M.D., Ph.D.
Chairman and CEO
Scientific Director
Accepted:
/s/ Xxxxxx Xxxxxx-Xxxxx
Xxxxxx Xxxxxxx-Xxxxx, Ph.D.
Chief Executive Officer
Cambridge Biotech Corporation
PJM/em
