CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
DATED: APRIL 21, 2006
SAVIENT PHARMACEUTICALS, INC.,
ROSEMONT PHARMACEUTICALS LIMITED
AND
CYTOGEN CORPORATION
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MANUFACTURE & SUPPLY AGREEMENT
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INDEX
DEFINITIONS 1
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GRANT OF RIGHTS 2
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TERM OF THE AGREEMENT 3
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FINISHED PRODUCT PRICE 4
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SUPPLY 5
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ACCEPTANCE OF THE PRODUCT 6
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MANUFACTURE, TRANSPORT, STORAGE AND DISTRIBUTION OF THE
PRODUCTS 7
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ADVERSE DRUG EVENTS 8
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RECALLS 9
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INSPECTION OF THE PLANT AND OF THE WAREHOUSE 10
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INTELLECTUAL PROPERTY 11
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CONFIDENTIALITY 12
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TERMINATION 13
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ARBITRATION 14
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FORCE MAJEURE 15
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NOTICES 16
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PROPER LAW AND COURT OF JURISDICTION 17
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ASSIGNMENT 18
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SUCCESSION 19
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RELATIONSHIP OF THE PARTIES 20
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ENTIRE AGREEMENT 21
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VARIATION OF AGREEMENT 22
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WAIVER 23
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SEVERANCE 24
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RIGHTS OF THIRD PARTIES 25
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THIS MANUFACTURE & SUPPLY AGREEMENT (this "AGREEMENT") is made this 21st day of
April, 2006 (the "EFFECTIVE DATE").
BETWEEN:
1. SAVIENT Pharmaceuticals, Inc., a company incorporated pursuant to the
laws of the State of Delaware in the United States and having a
principal place of business at One Tower Center, East Brunswick, New
Jersey 08816, United States ("SAVIENT"),
2. ROSEMONT Pharmaceuticals Limited, a wholly owned subsidiary of SAVIENT
and a company incorporated in the United Kingdom whose company number
is 009242648 and whose registered office is at ROSEMONT House,
Yorkdale Industrial Park, Braithwaite Street, Leeds LS11 9XE, United
Kingdom ("ROSEMONT")
and
3. CYTOGEN Corporation, a company incorporated pursuant to the laws of
the State of Delaware in the United States and having a principal
place of business at 650 College Road East, Suite 3100, Princeton, New
Jersey 08540, United States ("CYTOGEN").
WHEREAS:
A. SAVIENT owns certain intellectual property relating to its proprietary
tamoxifen oral liquid formulation, a treatment for hormonally
sensitive breast cancer, and has registered its oral liquid tamoxifen
product in the United States;
B. Concurrently with this Agreement, SAVIENT has entered into an
Exclusive Distribution Agreement with CYTOGEN dated as of the
Effective Date (the "EXCLUSIVE DISTRIBUTION AGREEMENT") which
contemplates providing to CYTOGEN the exclusive license to import,
market, promote, detail, distribute, sell and offer to sell the
Licensed Product (as defined below) in the Territory (as defined
below);
C. ROSEMONT is engaged in the development, manufacture, distribution and
marketing of the Licensed Product;
D. CYTOGEN is engaged in the business of, among other things, marketing,
selling and distributing finished medicinal products; and
E. CYTOGEN wishes to purchase the Licensed Product from ROSEMONT on an
exclusive basis and ROSEMONT is willing to supply the Licensed Product
to CYTOGEN on an exclusive basis, so as to allow CYTOGEN to import,
receive, store, sell, deliver, transfer, promote, market, detail and
otherwise distribute the Licensed Product solely within the Territory
on the terms and conditions of this Agreement and in accordance with
the terms of the Exclusive Distribution Agreement.
Now therefore in consideration of the premises and mutual covenants set forth
herein, the parties, intending to be legally bound, agree as follows:
-1-
1. DEFINITIONS
1.1 In this Agreement the following terms will have the meanings set out
below:
"ACT" shall mean the U.S. Federal Food, Drug and Cosmetic Act as
amended from time to time;
"AE" shall mean with respect to the Licensed Product, any adverse
event associated with the use of the Licensed Product in a patient or
clinical investigation, whether or not considered drug related,
including the following: an adverse event occurring in the course of
the use of the Licensed Product in professional practice; an adverse
event occurring from drug overdose whether accidental or intentional;
an adverse event occurring from drug abuse; an adverse event occurring
from drug withdrawal; and any significant and consistent failure of
expected pharmacological action. AE shall include, without limitation,
any unfavorable and unintended sign, an exacerbation of a pre-existing
condition, intercurrent illness, drug interaction, significant
worsening of a disease under investigation or treatment, significant
failure of expected pharmacological or biological action, symptom or
disease temporally associated with the use of the Licensed Product,
whether or not considered related to the Licensed Product.
Notwithstanding anything foregoing to the contrary, with respect to
the Territory in which the Licensed Product is marketed, AEs shall
include any experience required to be reported to a relevant authority
in any such country;
"AFFILIATE" shall mean any corporation or other business entity
controlled by, controlling, or under common control with another
entity, with "control" meaning direct or indirect beneficial ownership
of more than fifty percent (50%) of the voting stock of, or more than
a fifty percent (50%) interest in the income of, such corporation or
other business entity;
"CERTIFICATE OF ANALYSIS" shall mean a document, which is signed and
dated by a duly authorized representative of ROSEMONT certifying that
the Licensed Product conforms to the Product Specifications;
"COMMERCIAL LAUNCH" shall mean the first commercial sale of a Licensed
Product by CYTOGEN to a Third Party in the Territory after Regulatory
Approval in the Territory. For avoidance of doubt, sales of Licensed
Product for use in clinical trials shall not be considered in
determining the date of Commercial Launch;
"CONFIDENTIAL INFORMATION" shall mean and include all information
(including but not limited to trade secrets) and materials (including
but not limited to data, results, technical, financial/business
information or marketing strategies) which may be disclosed by one
party to the other party but does not include information which the
other party can show through contemporaneous written documentation:
(a) either is or becomes available to the public other than as a
result of disclosure by the other party, or a Third Party not
under an obligation of confidentiality; or
(b) at the time of receipt is already in the possession of the other
party or becomes lawfully available to the other party on a
non-confidential basis from a Third Party entitled to make that
disclosure;
(c) is independently developed by the receiving party without the use
of the other party's Confidential Information;
2
(d) is subsequently disclosed to the receiving party or its
Affiliate, without obligation to keep it confidential, by a Third
Party lawfully in possession thereof and having the right to so
disclose; or
(e) is disclosed pursuant to a court order, law, or regulation,
provided that the receiving party provides the other party prior
written notice of the required disclosure and takes reasonable
steps to limit such disclosure to the minimum required by such
court order, law, or regulation and to obtain, or cooperate with
the other party in obtaining, a protective order or other similar
order requiring that such Confidential Information be used only
for the purposes required by such court order, law, or
regulation;
"COST OF GOODS" shall mean [**] of ROSEMONT's direct cost of
manufacturing (including material, labor, personnel, equipment,
depreciation, workshop, quality control, waste disposal and production
management) directly related to the Licensed Product for both
commercial sale and for samples, as well as a reasonable allocation of
indirect costs allocable to the manufacturing process (including
indirect labor and materials, facilities expense (including occupancy
costs, utilities expense and depreciation of property, plant and
equipment), manufacturing management and administration costs, in
accordance with ROSEMONT's accounting methods consistently applied for
its pharmaceutical products, which shall comprise the cost of goods
produced as determined by ROSEMONT for each stage of the manufacturing
process conducted by ROSEMONT in accordance with GAAP. Cost of Goods
shall not include any cost attributable to general corporate or
operational activities (including but not limited to, executive
management, investor relations, business development, legal affairs
and finance). Cost of Goods for any stage of the manufacturing process
conducted by a Third Party shall be equal to ROSEMONT's out-of-pocket
cost therefor;
"DOSSIER" shall mean any and all technical information pertaining to
the Licensed Products and includes, without limitation, data in
support of registered indications, bio-equivalency data and
information, clinical data, pharmaco-toxicological data, analytical
methods, stability and pharmaceutical data concerning the Licensed
Product in the possession of ROSEMONT from time to time and includes
the open part of the drug master file ("DMF") and the DMF supporting
information contained therein, and the chemical, pharmaceutical and
biological documentation (including any expert report) and any
certificate of free sale and certificate of pharmaceutical products;
"EQUIVALENT PRODUCT" shall mean any liquid dosage form of tamoxifen
other than the Licensed Product;
"FDA" shall mean the United States Food and Drug Administration and
any successor agency thereto, and/or any equivalent foreign
governmental agency, depending on the context;
"FIELD" shall mean all human oncology uses;
"FINANCIAL YEAR" shall mean the year from 1st January to 31st
December, inclusive;
"FINISHED PRODUCT PRICE" shall mean the Cost of Goods of the Licensed
Product plus [**] as such amounts are set forth on the Attached
Schedule 2, such Finished Product Price [**];
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3
"FORMULATION" shall mean the chemical and pharmacological formulation
of the Licensed Product;
"GAAP" shall mean generally accepted accounting principles in the
United States;
"GMP" shall mean the good manufacturing practice in the Territory, any
requirements of the relevant regulatory authority in the Territory for
the new drug application, and the requirements of any GMP license
granted to ROSEMONT in the country of manufacture of the Licensed
Product provided however, where no GMP codes prevail in the Territory
or the GMP code prevailing in the Territory is less onerous than that
specified for good manufacturing practice in the European Union, GMP
will include the good manufacturing practice in the European Union. In
the event of a conflict, the GMP code of the United States shall
prevail;
"INDEPENDENT ANALYST" shall mean an independent testing laboratory
approved in the NDA to test the Licensed Product, which is selected on
a timely basis by the mutual good faith agreement of the parties;
"INTELLECTUAL PROPERTY RIGHTS" shall mean all rights and interests,
vested or subsequently arising out of any patent, copyright, design,
trade mark, trade secrets, database right, goodwill or Confidential
Information rights whether arising by common law or by statute and any
right to apply for registration under a statute in respect of those or
like rights as such rights are owned and held by SAVIENT as they
relate to the Licensed Product;
"LICENSED PRODUCT" shall mean oral liquid tamoxifen in all
indications, dosage forms and formulations for use in the Field
meeting the Product Specifications;
"NDA" shall mean new drug application granted / approved from the FDA
for the importation, storage, marketing, promotion, sale, delivery,
transfer or other distribution of the Licensed Product in the
Territory, including all additions, supplements, extensions and
modifications thereto;
"NET SALES" means the total gross sales of Licensed Product in the
Territory invoiced by Cytogen, its Affiliates or sublicensees (other
than Savient and its Affiliates hereunder) to Third Parties, net of,
where applicable, any deductions specifically related to a Licensed
Product and actually allowed, incurred, paid or taken for (1) quantity
or trade discounts actually granted, but specifically excluding prompt
payment and/or cash discounts; (2) amounts repaid or credited, cash,
credit or free goods allowances given by reason of chargebacks, vendor
chargebacks, patient vouchers or coupons, retroactive price reductions
including, without limitation, any price reductions imposed by courts
or governmental authorities, correction of billing errors, and rebates
or payments; (3) amounts refunded or credited for Licensed Product
that was rejected, spoiled, damaged, outdated, recalled, or returned,
or any reasonable returned goods allowance offered in lieu of the
right of a customer to return outdated Licensed Product; (4)
wholesaler fees under vendor managed inventory agreements and pharmacy
benefit management fees for services; (5) actual shipping costs to the
extent billed directly by Cytogen to its customers and supported by
shipper's invoice; and (6) actual sales tax billed by Cytogen to its
customers as a separate line item on an invoice, as documented by
actual invoices. If Cytogen, its Affiliates or sublicensees receive
non-cash consideration for Licensed Product sold or otherwise
transferred (in any event excluding any samples or
4
Promotional
Materials) to an independent Third Party that is not an Affiliate of
Cytogen, the fair market value of such non-cash consideration on the
date of the transfer as known to Cytogen, or as reasonably estimated
by Cytogen if unknown, shall be included the Net Sales for such
Licensed Product sold or otherwise transferred.
If a Licensed Product is sold or offered for sale in combination with
other products of Cytogen at a price that is reduced or discounted
from the normal selling price of Cytogen for such Licensed Product by
a percentage that is greater than that offered on such other products,
and if that discount is only available with or is conditioned upon the
purchase of such other products, the Net Sales determined as provided
for in this Section shall be adjusted as if the discount or reduction
had been applied to all products of such combination equally. For
greater certainty, the amount of (i) any cash or early payment
discounts, or (ii) quantity discounts, rebates or allowances, granted
or taken with respect to the total sales to a customer for multiple
products that include Licensed Product shall not be deducted in
calculating Net Sales.
"NSP" shall mean the net sales price for the Licensed Product in a
specified calendar quarter, and shall be calculated by dividing the
Net Sales of the Licensed Product during such quarter by the total
number of units of Licensed Product sold during such quarter.
"PRODUCT SPECIFICATIONS" shall mean the latest approved specifications
of the Licensed Product by the FDA in the Territory, which may also
include, where relevant, specifications for manufacturing,
performance, quality control release, packaging material, labeling and
Licensed Product information all as set forth in the attached Schedule
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1;
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"REGISTRATION FILE" shall mean the file derived from the Dossier
together with the results of any bioequivalence study and the
stability study and any supplementary data required by the FDA in the
Territory;
"REGULATORY APPROVAL" means the granting of all governmental
regulatory approvals required, if any, for the sale of a Licensed
Product in a given country or jurisdiction within the Territory.
"TECHNICAL AGREEMENT" shall mean the separate agreement between the
parties to this Agreement signed within ten business (10) days of the
Effective Date of this Agreementand being an agreement (a) required
under European Good Manufacturing Practice Legislation 91/356/EEC
Article 12 to cover manufacture by ROSEMONT and supply to CYTOGEN for
distribution in the Territory and (b) suitable for submission to the
regulatory authority in the Territory; the Technical Agreement is also
known as a Quality Agreement in the United States;
"TERM" shall mean the Initial Term and any Renewal Term during which
this Agreement is in force and effect;
"TERRITORY" shall mean the United States and its territories and
possessions; and
"THIRD PARTY" shall mean any person or entity other than SAVIENT,
CYTOGEN, and their respective Affiliates.
1.2 In this Agreement, unless the context otherwise requires:
5
(a) headings and underlinings are for convenience only and do not
effect the interpretation of this Agreement;
(b) words imparting the singular include the plural and vice versa;
(c) words imparting a gender include any gender;
(d) a reference to a part, clause, party, annexure, exhibit or
schedule is a reference to a part, clause, party, annexure,
exhibit or schedule to, this Agreement; and
(e) a reference to a person includes any individual or individuals,
corporation, partnership or other body, entity or other legal
person.
2. GRANT OF RIGHTS
2.1 CYTOGEN and SAVIENT have contemporaneously herewith entered into the
Exclusive Distribution Agreement in which SAVIENT has granted to
CYTOGEN all the Intellectual Property Rights necessary in order to
allow CYTOGEN to import, sell, offer to sell, market, distribute,
promote and detail the Licensed Product. The parties hereto agree that
to the extent any terms or provisions of this Agreement conflict with
the terms and provisions or the Exclusive Distribution Agreement, the
terms and provisions of the Exclusive Distribution Agreement shall
control, except to the extent that this Agreement expressly and
specifically states an intent to supersede a certain provision of the
Exclusive Distribution Agreement on a specific matter.
2.2 ROSEMONT hereby agrees to sell to CYTOGEN on an exclusive basis within
the Territory the Licensed Product in finished, packaged form solely
for the purposes of importing into, storing, selling, offering to
sell, marketing, distributing and detailing such Licensed Product in
the Territory. For purposes of clarity, the exclusivity referred to in
the section pertains to sales of the Licensed Product within the
Territory only and nothing herein shall be construed to prevent
ROSEMONT, subject to Clause 5.2, from selling the Licensed Product in
any country outside the Territory.
2.3 CYTOGEN shall purchase the Licensed Product on an exclusive basis from
ROSEMONT and ROSEMONT shall supply to CYTOGEN all its requirements for
Licensed Product in the Territory and, except as otherwise provided
for herein, CYTOGEN shall not purchase the Licensed Product or an
Equivalent Product for use in the Field in the Territory from any
other source except as otherwise set forth herein.
3. TERM OF THE AGREEMENT
3.1 This Agreement will come into force and effect as of the Effective
Date and will continue in force until the later to occur of (i) the
expiry of the last-to-expire patent covering the Licensed Product in
the Territory; or (ii) ten (10) years from the date of Commercial
Launch of the Licensed Product in the Territory (the "INITIAL TERM")
unless previously terminated in accordance with the provisions
contained herein; or (iii) the termination or expiration of the
Exclusive Distribution Agreement. Thereafter, this Agreement will be
automatically renewed for one further period of one (1) year (the
"RENEWAL TERM") unless either party confirms in writing its intention
not to renew this Agreement and such notice of this intention not to
renew this Agreement is given to the other party at least twelve (12)
months prior to the expiry of the then-current Term.
6
4. FINISHED PRODUCT PRICE
4.1 The Finished Product Price of the Licensed Product (including trade
packages and samples) charged by ROSEMONT to CYTOGEN will be that
specified in Schedule 2. Such Finished Product Price will remain fixed
----------
for [**] from the Effective Date of the Agreement; provided, however,
that in the event that during any [**] period the Cost of Goods
fluctuates by an amount equal to or greater than [**] of the Cost of
Goods component of the previously agreed upon Finished Product Price,
then notwithstanding the prior temporal restriction, the Parties shall
promptly review and agree upon a new Finished Product Price which
reflects the actual increase or decrease in the Cost of Goods of the
Licensed Product; provided, that ROSEMONT shall [**]. ROSEMONT and
CYTOGEN agree to review and mutually approve the Finished Product
Price specified in Schedule 2 not less than [**] days prior to the
-----------
next [**] anniversary of the Effective Date of this Agreement. Such
Finished Product Prices will be negotiated on the basis of actual
decreases or increases in the Cost of Goods of the Licensed Product.
4.2 CYTOGEN will pay ROSEMONT for the Licensed Product within [**] of
acceptance of the Licensed Products as such acceptance is governed
pursuant to Clause 6.2.
4.3 ROSEMONT will have the right to charge interest at [**] per month on
any payments still outstanding after [**] days up to the maximum
amount permitted by law.
4.4 During the Term, CYTOGEN shall pay to ROSEMONT royalties based on
CYTOGEN's Net Sales of the Licensed Product. All royalty payments
shall be due within [**] days after the close of each calendar
quarter. CYTOGEN agrees to provide written reports to ROSEMONT within
[**] days after the end of each calendar month covering all sales of
Licensed Product in the Territory by CYTOGEN for which invoices were
sent during such calendar month. Each report shall state for the
period in question: (a) for Licensed Product disposed of by sale, the
gross sales of Licensed Product, and the detailed calculation of Net
Sales; (b) for Licensed Product disposed of other than by sale, the
quantity, description, and nature of the disposition; and (c) the
calculation of the amount due to ROSEMONT for such month pursuant to
this Clause. Each quarterly royalty payment shall be equal to the
applicable royalty rate (as set forth in the table below) multiplied
by the Net Sales of Licensed Product for that quarter.
Annual Net Sales Royalty Rate
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to ROSEMONT
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Less than or equal to [**] [**]%
Over [**] [**]%
4.5 Minimum Royalties. Beginning in 2007, CYTOGEN shall pay ROSEMONT
------------------
quarterly minimum royalties equal to [**] multiplied by the Projected
Penetration Percentage multiplied by the total number of tamoxifen
prescriptions written during such calendar quarter ("QUARTERLY TRX")
multiplied by the NSP of the Licensed Product during such calendar
quarter ("MINIMUM ROYALTY PAYMENT"). The applicable Projected
Penetration Rate shall be determined by reference to the following
table:
7
Projected Penetration Percentage Year
-------------------------------- ----
[**] [**]
[**] [**]
[**] [**] and later
(a) During any quarter in which the royalty payment due ROSEMONT
pursuant to Clause 4.4 herein is less than the Minimum Royalty Payment
calculated pursuant to this Clause 4.5, then CYTOGEN shall pay to ROSEMONT the
Minimum Royalty Payment rather than the royalty payments due under Clause 4.4
herein.
(b) For example, if the Quarterly TRx for the first quarter of [**]
scripts, and the NSP for that quarter is [**] per unit, then the Minimum
Royalty Payment for that quarter would be [**].
4.6 Sales Milestone Payments. CYTOGEN shall pay to ROSEMONT the following
------------------------
non-refundable, non-creditable sales milestone payments upon reaching
the cumulative sales milestones in the amounts set forth below based
on the corresponding cumulative Net Sales of Licensed Products. Each
milestone payment is due and payable no later than [**] days after the
end of the calendar quarter in which each milestone was achieved.
Cumulative Net Sales Payment
-------------------- -------
[**] $[**]
[**] $[**]
[**] $[**]
4.7 These quarterly payments and, where applicable, sales milestone
payments, shall be paid by CYTOGEN to ROSEMONT even if some or all of
the Licensed Product is supplied by a Third Party manufacturer during
such quarter and even if ROSEMONT performs no manufacturing services
for CYTOGEN during such quarter. Furthermore, these quarterly payments
and, where applicable, sales milestone payments, shall continue to be
paid by CYTOGEN to ROSEMONT even if this Agreement is terminated
including by reason of ROSEMONT's breach. Subject to other provisions
of this Agreement, such quarterly payments and, where applicable,
sales milestone payments, shall continue until such time as CYTOGEN is
no longer marketing or selling the Licensed Product.
4.8 The provisions of this Clause 4 shall survive the termination of this
Agreement.
5. SUPPLY
8
5.1 ROSEMONT will use commercially reasonable efforts to maintain adequate
stocks of the Licensed Product to fulfill its obligations under this
Agreement, and will supply to CYTOGEN or its nominated Affiliates or
delegates all of CYTOGEN'S requirements for the Licensed Product, in
finished, packaged form, for the Territory.
5.2 ROSEMONT will not supply the Licensed Product to any other party which
it knows, or has reasonable grounds for suspecting, will supply the
Licensed Product within the Territory and shall use commercially
reasonable efforts to ensure that none of its Affiliates or commercial
partners will supply such competing entities with the Licensed Product
for marketing or distribution within the Territory. CYTOGEN shall not
supply, and shall ensure that no sublicensee shall supply, the
Licensed Product to any Third Party which it knows, or has reasonable
grounds for suspecting, will supply the Licensed Product outside the
Territory and shall use commercially reasonable efforts to ensure that
none of its Affiliates or commercial partners will supply any third
parties with the Licensed Product for marketing or distribution
outside of the Territory. Additionally, CYTOGEN agrees that it shall
not purchase any Equivalent Product from any Third Party during the
Term of this Agreement except as otherwise provided herein.
5.3 CYTOGEN shall provide to ROSEMONT within [**] after the Effective Date
a Firm Order (as such term is defined below) for launch quantities of
the Licensed Product for commercial distribution and sale within the
Territory. CYTOGEN shall submit a Firm Order for samples separately.
5.4 Commencing at least [**] prior to the delivery date of the first Firm
Order , CYTOGEN shall submit to ROSEMONT on a [**] basis on or before
the first business day of each [**], a [**] non-binding rolling
forecast that sets forth the total quantity of Licensed Product
CYTOGEN either has ordered, desires to order, or expects to order from
ROSEMONT within the next [**] period ("Product Forecast"). In the
Product Forecast, CYTOGEN shall include a breakdown of the total
quantity of Licensed Product by [**] and [**] for the [**] period.
5.5 The breakdown by [**] and [**] of the [**] Product Forecast shall
consist of: (i) firm irrevocable orders for the [**] of the Product
Forecast ("Firm Order"), which shall each be the subject of a Purchase
Order delivered in accordance with Clause 5.6 and (ii) a rolling [**]
forecast for the remaining [**] (i.e. [**]) of the Product Forecast
[**].
5.6 CYTOGEN will accompany its [**] update of the Product Forecast with a
written purchase order ("Purchase Order") for each new Firm Order that
was only a Firm Forecast in the previous [**] Product Forecast. Each
Purchase Order shall specify the Licensed Product ordered and the
time, manner and address of delivery, all of which shall be subject to
this Agreement.
5.7 CYTOGEN shall be entitled at any time up until and including the time
that any such Firm Forecast becomes a Firm Order to increase or
decrease a Firm Forecast for Licensed Product by up to an aggregate of
[**]. Once a Firm Forecast becomes a Firm Order, CYTOGEN may not
reduce it, but upon request that ROSEMONT increase the quantity of
Licensed Product subject to a Firm Order, ROSEMONT shall use
commercially reasonable efforts to fill the increased order subject to
the batch quanitities limitation in Schedule 3.
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9
5.8 ROSEMONT may, in accordance with Clause 5.9, reject only that portion
of any Firm Order which ROSEMONT will be unable to fill due to (i) the
occurrence of a force majeure event or (ii) which, when added to other
Firm Orders placed during a given [**] period, exceed then current
Product Forecast covering such period by more than [**] pursuant to
Clause 5.47.
5.9 For each Firm Order provided by CYTOGEN or its Affiliates, ROSEMONT
will be deemed to have confirmed such Firm Order if advice to the
contrary, in writing, is not provided to CYTOGEN within [**] from the
date of receipt of such Firm Order by ROSEMONT.
5.10 ROSEMONT will use its best endeavours to supply the ordered quantities
of the Licensed Product by the confirmed delivery dates, which dates
shall not be earlier than [**] from the date that ROSEMONT receives a
Firm Order from CYTOGEN. All order quantities shall reflect nominal
batch sizes as specified in Schedule 3. Orders will be accepted by
CYTOGEN at [**] ordered quantities, provided that such Licensed
Product meets the Product Specifications and the requirements of
Clauses 7.1 and 7.2.
5.11 In the event that ROSEMONT is aware or anticipates that it will be
unable to meet any Firm Order, either in whole or in part, for
whatever reason, ROSEMONT shall promptly inform CYTOGEN in writing of
such inability. In particular, ROSEMONT shall promptly inform CYTOGEN
of any notice, written or oral, received from any materials supplier
regarding a possible shortage or inability to supply. In the event of
a shortage of the materials necessary to manufacture the Licensed
Product, CYTOGEN shall be allocated quantities of such materials in an
amount which is equivalent to the proportion of Licensed Product
ordered within the immediately preceding [**] period as such amount is
expressed as a percentage of the total amount of oral liquid tamoxifen
ordered from ROSEMONT from all sources in the preceding [**] period;
provided further that in the event that there is a failure to
substantially satisfy CYTOGEN's orders for Licensed Product, then
ROSEMONT and CYTOGEN will immediately work together, in good faith, to
identify an appropriate alternative source of supply for Licensed
Product.
5.12 In the event that ROSEMONT (i) anticipates an inability to supply
ordered quantities of the Licensed Product for a period of [**] (with
prompt notice being provided to CYTOGEN by ROSEMONT) or (ii) shall
fail to supply ordered quantities of the Licensed Product (in
compliance of this Agreement, including the Product Specifications or
the requirements of Clauses 7.1 and 7.2) to CYTOGEN for [**]
(hereinafter, "Supply Failure"), then CYTOGEN shall have the right,
but not the obligation, to utilize the services of a Third Party
contract manufacturer (hereinafter "CMO"), the identity of which shall
be agreed upon in advance by ROSEMONT (which agreement shall not be
unreasonably withheld, delayed or conditioned), to manufacture the
Licensed Product for CYTOGEN'S benefit. ROSEMONT shall reasonably
cooperate in order to effectuate a technology transfer to such CMO to
enable such party to manufacture the Licensed Product for CYTOGEN;
provided, however, that CYTOGEN shall be responsible for, and shall
pay to ROSEMONT, all costs associated with the technology transfer
contemplated herein. The foregoing notwithstanding, CYTOGEN shall not
purchase any quantities of the Licensed Product from the CMO except
for during a Supply Failure or thereafter. The CMO shall not have any
rights by virtue of this Agreement to manufacture for, sell or
otherwise dispose of the Licensed Product to any Third Parties. In the
event that ROSEMONT or any of its Affiliates establish an alternate
facility to manufacture the Licensed Product for itself or Third
Parties for sale outside the Territory, then
10
ROSEMONT shall offer to CYTOGEN to have the Licensed Product
manufactured for CYTOGEN at such facility in addition to ROSEMONT'S
Leeds facility referenced below; CYTOGEN shall have the right to audit
any alternate facility established pursuant to this Clause.
5.13 The supply of the Licensed Product will be shipped [**].
5.14 ROSEMONT shall label and package the Licensed Product for shipment to
CYTOGEN in accordance with Product Specifications applicable to the
Licensed Product.
6. ACCEPTANCE OF THE PRODUCT
6.1 ROSEMONT will supply via electronic mail a Certificate of Analysis
related to each delivery of the Licensed Product demonstrating that
the Licensed Product conforms with the Product Specifications, the
Technical Agreement, the applicable laws and Clauses 7.1 and 7.2; such
Certificate of Analysis shall be provided prior to the delivery of the
Licensed Producy by ROSEMONT to CYTOGEN. CYTOGEN shall be under no
obligation to accept any shipment of Licensed Product for which
ROSEMONT has not provided a Certificate of Analysis. ROSEMONT has
provided to CYTOGEN a correct copy of the quality control release and
packaging specifications existing as of the Effective Date for the
Licensed Products to enable CYTOGEN to compare the Certificates of
Analysis to the relevant specifications. ROSEMONT shall provide
updated quality control release and packaging specifications to
CYTOGEN promptly following any change to such specifications.
6.2 Subject to Clause 6.6, CYTOGEN shall have the right, but not the
obligation, to ascertain whether the Licensed Product conforms to
Product Specifications and the requirements of Clauses 7.1 and 7.2; if
CYTOGEN so elects it shall only use a qualified and validated cGMP
laboratory which has been duly qualified to test the Licensed Product
using validated tests and methods for the testing of the Licensed
Product and such laboratory having been approved in advance by
ROSEMONT (hereinafter the "Testing Laboratory"), such approval not to
be unreasonably withheld. If the Testing Laboratory determines that
the Licensed Product does not conform to the Product Specifications,
CYTOGEN may reject the Licensed Product by giving ROSEMONT written
notice of its rejection within [**] of delivery of the Licensed
Product. In the absence of any such written notice of rejection where
such notice sets forth the reasons for such rejection with
specificity, CYTOGEN will, for the purposes of Clause 4.2 only, be
deemed to have accepted the Licensed Product upon the expiration of
the [**] period. CYTOGEN shall promptly notify ROSEMONT of any
damages, shortage and other defects discovered by CYTOGEN following
CYTOGEN's discovery thereof. In addition, in the case of Licensed
Product with defects not readily discoverable prior to the shipment of
any Licensed Product to CYTOGEN, or thereafter within the [**] period
specified above, each party shall notify the other party of any such
defects discovered by such party promptly following such party's
discovery thereof, and such Licensed Product shall be treated the same
as the non-conforming Licensed Products set forth herein. Anything to
the contrary notwithstanding, any damage to the Licensed Product
occurring after delivery has been made to CYTOGEN in accordance with
the terms hereof shall be CYTOGEN'S responsibility and shall not be
deemed defective Licensed Product.
6.3 Subject to Clause 6.6, If CYTOGEN gives written notice to ROSEMONT
under Clause 6.2 or 6.3, CYTOGEN may, in addition to any other rights
or remedies it may have
11
hereunder, elect for ROSEMONT to (a) provide CYTOGEN with replacement
products as soon as is reasonably possible after such notice, and to
the extent that CYTOGEN has previously remitted payment for such
rejected Licensed Product the replacement Licensed Product will be
free of charge, or (b) refund the Finished Product Price for the
quantity of such defective Licensed Product.
6.4 Subject to Clause 6.6, ROSEMONT may: (i) at its cost (a) reclaim the
rejected Licensed Product within [**] of ROSEMONT'S receipt of notice
of the rejection of the Licensed Product; (b) provide notice to
CYTOGEN within [**] of ROSEMONT'S receipt of notice of the rejection
of the Licensed Product that CYTOGEN may destroy the rejected Licensed
Product, such destruction and disposal to comply with all applicable
laws, rules and regulations, or; (ii) provide written notice to
CYTOGEN of ROSEMONT'S election to challenge the rejection of the
Licensed Product and submit such rejected Licensed Product to an
Independent Analyst. In the case of either (i)(a) or (i)(b) above,
ROSEMONT shall be responsible for the cost of storage of such rejected
Licensed Product. For purposes of clarification, if the rejected
Licensed Product is the subject of testing by the Independent Analyst,
CYTOGEN shall not destroy such products and the costs for any storage
shall be allocated according to the provisions of Clause 6.7.
6.5 If ROSEMONT reclaims the rejected Licensed Product pursuant to Clause
6.4, ROSEMONT agrees not to re-supply CYTOGEN with any of that
rejected Licensed Product.
6.6 In the event that CYTOGEN gives written notice of the rejection of the
shipment of the Licensed Product or any part thereof to ROSEMONT under
Clause 6.2 or 6.3 and the parties are unable, within [**] of that
notice, to agree upon whether the Licensed Product complies with the
Product Specifications and the requirements of Clauses 7.1 and 7.2,
the parties agree to submit a sample of the Licensed Product to an
Independent Analyst within a further [**] period and such Independent
Analyst shall perform its own testing of the samples, utilizing NDA
specified test methods , in order to determine whether the Licensed
Product complies with the Product Specifications and the requirements
of Clauses 7.1 and 7.2, and provide both parties with a written report
of its findings and opinion. Both parties shall be entitled to have
representatives present at such testing and the assessment of the
Independent Analyst shall be binding upon the parties solely for the
purpose of determining whether such Licensed Product may be rightfully
rejected as non-conforming, damaged (when Licensed Product is
delivered to CYTOGEN in accordance with the terms herein) or otherwise
defective.
6.7 The cost of the report of the Independent Analyst will be paid [**].
If the Independent Analyst determines that the Licensed Product
complies the Product Specifications and the requirements of Clauses
7.1 and 7.2 and CYTOGEN elects for ROSEMONT to provide CYTOGEN with
replacement products under Clause 6.3, [**].
6.8 Replacement of rejected Licensed Product is in addition to any other
obligations, indemnities or warranties given by ROSEMONT to CYTOGEN
under this Agreement.
7. MANUFACTURE, TRANSPORT, STORAGE AND DISTRIBUTION OF THE PRODUCTS
7.1 ROSEMONT shall supply the Licensed Product to CYTOGEN in the form set
out in the applicable Regulatory Approval for each Licensed Product.
ROSEMONT shall deliver all
12
Licensed Product hereunder with labelling that conforms with the FDA
approved labelling therefor. CYTOGEN shall supply to ROSEMONT, at
CYTOGEN'S sole cost and expense, the artwork which shall be printed
on: the label which shall be affixed to each bottle of Licensed
Product, the carton of each individual bottle of Licensed Product, and
the outer carton which shall contain the [**] of Licensed Product,
each such bottle being contained in its own carton (or such other
format as agreed upon by the parties). Each of ROSEMONT and SAVIENT
shall review and reasonably approve within [**] after receipt, any
such artwork provided by CYTOGEN in accordance with this Clause;
however, ROSEMONT or SAVIENT may reject any proposed artwork whose
appearance or content would violate any law, rule or regulation of the
country of manufacture or of the Territory.
7.2 All quantities of the Licensed Product supplied by ROSEMONT to CYTOGEN
pursuant to this Agreement will:
(a) conform in all respects to the Products Specifications in effect
at the time the relevant order for the Licensed Product is
accepted by ROSEMONT;
(b) be manufactured in conformity with Products Specifications, GMP,
the Technical Agreement, all applicable laws (including the Act),
as they are in effect at the time the relevant order for the
Licensed Product is accepted by ROSEMONT; and
(c) have a shelf life of at least [**] from the date of dispatch from
ROSEMONT's facility, provided, however, that in the event that
extended expiry dating is approved for the Licensed Product that
such Licensed Product with extended expiry dating shall be
provided to CYTOGEN;
(d) not be adulterated or misbranded within the meaning of the Act,
and is not an article which may not, under the Act, be introduced
into interstate commerce;
(e) be free and clear of any security interest, liens and
encumbrances at the time that title to such Licensed Product
passes to CYTOGEN; and
(f) be stored and handled in accordance with all applicable legal and
regulatory provisions concerning the storage and handling of the
Licensed Product.
7.3 Any quantities of the Licensed Product not conforming with the
requirements of Clause 7.1 or 7.2 will, for the purposes of this
Agreement, be deemed to be rejected.
7.4 ROSEMONT and CYTOGEN agree to enter into and execute the Technical
Agreement within [**] of the Effective Date hereof. ROSEMONT shall not
undertake the manufacture of any Licensed Product on behalf of CYTOGEN
until such a time as the Technical Agreement has been executed by both
parties.
7.5 ROSEMONT shall perform, or cause to be performed at ROSEMONT's cost
and expense, on each batch of Licensed Product all tests required by
the Licensed Product Specifications before shipment of any Licensed
Product from that batch to CYTOGEN. ROSEMONT shall properly store and
retain appropriate samples (identified by batch number) of Licensed
Product that it supplies to CYTOGEN in conditions and for times
consistent with all applicable regulatory standards and to permit
appropriate or required internal and regulatory checks and references
(collectively, the "Shipment Samples").
13
ROSEMONT shall provide CYTOGEN with reasonable access to and portions
of the Shipment Samples for testing and other purposes upon CYTOGEN's
request, such testing to be performed by the Testing Laboratory.
Copies of any results provided by the Testing Laboratory shall be
provided to ROSEMONT within [**] of receipt by CYTOGEN.
7.6 ROSEMONT will supply CYTOGEN with adequate written directions
concerning suitable conditions for storage and transportation of the
Licensed Product and CYTOGEN warrants it will store and transport the
Licensed Product in accordance with those directions. Any language to
the contrary notwithstanding, in the event that CYTOGEN fails to
follow the shipping, storage and transportation instructions in all
material respects, as such written instructions are provided by
ROSEMONT in advance, CYTOGEN shall indemnify ROSEMONT for any and all
losses or damages arising from Third Party claims (except to the
extent caused by any gross negligence or willful misconduct of
ROSEMONT or its Affiliates), except for any special, punitive,
incidental, indirect or consequential damages (including, but not
limited to the loss of opportunity, loss of use, or loss of revenue or
profit, in connection with or arising out of this agreement).
7.7 Subject to Clause 6.2, in the event that either of the Parties becomes
aware of any defect in the Licensed Product or believes that the
Licensed Product is unsuitable for the indication designated in the
NDA, it will immediately notify the other party and provide them with
a full disclosure of that defect or perceived unsuitability.
7.8 ROSEMONT assumes all risk of loss and indemnifies and holds harmless
CYTOGEN and any of its Affiliates (including their respective
directors, officers, employees, agents, successors, assigns and
delegates) from and against any and all proven and reasonable loss,
liability, damage, fee, cost, expense, suit, claim, demand, judgement
and prosecution (hereinafter "Damages") directly or indirectly arising
from or resulting from (a) any defect in the Licensed Product,
including any materials or samples thereof, (other than a defect
arising as a result of the shipping, storage, transportation and
distribution of the Licensed Product by CYTOGEN or its Affiliates or
delegates which is not in accordance with the directions given to
CYTOGEN under Clause 7.6 or otherwise as a result of the gross
negligence or wilful misconduct on the part of CYTOGEN, its Affiliates
or delegates), (b) the gross negligence or willful misconduct or
wrongdoing of ROSEMONT or SAVIENT or any person for whose actions or
omissions ROSEMONT or SAVIENT is legally liable, or (c) a breach by
ROSEMONT of its representations, warranties and/or covenants
hereunder; or (d) a use of the Licensed Product which is permitted by
the NDA.
7.9 ROSEMONT will procure at its own expense from a mutually acceptable
insurer, and maintain in full force and effect throughout the
continuance of this Agreement and for 5 years thereafter, products
liability insurance with a single limit liability of not less than
[**] per claim and in the aggregate, for bodily injury, death or
property damage, insuring CYTOGEN, and its Affiliates or delegates
from and against any and all Damages set forth in Clause 7.8; provided
that this provision does not limit ROSEMONT's liability under Clause
7.8. ROSEMONT will, prior to supplying the Licensed Product to CYTOGEN
for the first time, provide to CYTOGEN a copy of such policy or a
certificate of insurance evidencing the required coverage and will
further provide CYTOGEN with evidence from time to time that the
policy remains in force.
14
7.10 CYTOGEN assumes all risk of loss and indemnifies and holds harmless
ROSEMONT and SAVIENT from and against any and all Damages directly or
indirectly arising from or resulting from the storage, transportation
or distribution of the Licensed Product by CYTOGEN or its Affiliates
or delegates which is not in accordance with the directions given to
CYTOGEN under Clause 7.6 or otherwise as a result of the gross
negligence or wilful misconduct on the part of CYTOGEN, its Affiliates
or delegates.
7.11 CYTOGEN will procure at its own expense from a mutually acceptable
insurer, and maintain in full force and effect throughout the
continuance of this Agreement and for 5 years thereafter, products
liability insurance with a single limit liability of not less than
[**] per claim and in the aggregate for bodily injury, death or
property damage, insuring ROSEMONT and its Affiliates and delegates
from and against any and all Damages directly or indirectly arising
from or resulting from the storage and distribution of the Licensed
Product by CYTOGEN or its Affiliates or delegates which is not in
accordance with the written directions given to CYTOGEN under Clause
7.6; provided that this provision does not limit CYTOGEN'S liability
under Clause 7.6. CYTOGEN will provide to ROSEMONT a copy of such
policy or a certificate of insurance evidencing the required coverage
and will further provide ROSEMONT with evidence from time to time that
the policy remains in force.
7.12 The parties will consult from time to time on the Product
Specifications during the continuance of this Agreement. In the event
that the parties agree to make changes to the Product Specifications,
and such changes are at the request of CYTOGEN, then CYTOGEN shall be
responsible for and shall pay to ROSEMONT and SAVIENT any and all
amounts incurred by ROSEMONT and SAVIENT respectively in implementing
a change to the Product Specifications; provided, that ROSEMONT and
SAVIENT provide such documentation of their costs and expenses as may
be reasonably requested by CYTOGEN; and provided further, that
ROSEMONT and SAVIENT will use commercially reasonable efforts to
minimize their costs associated with any Product Specification change.
ROSEMONT and SAVIENT shall notify CYTOGEN before making any material
changes in the Product Specifications. ROSEMONT and SAVIENT shall
promptly notify CYTOGEN of any request ROSEMONT or SAVIENT (or an
Affiliate) receives from the FDA to change the Product Specifications.
CYTOGEN retains the right and responsibility for final written
approval of those Product Specifications which are requested by
CYTOGEN and agreed to by ROSEMONT and SAVIENT and that do not require
FDA approval prior to implementation by ROSEMONT and SAVIENT. If
ROSEMONT or SAVIENT (or an Affiliate) is required by the FDA to make
any change to the Product Specifications or manufacturing procedures
for a Licensed Product, SAVIENT as the NDA holder shall (or shall
cause its Affiliate to), at the expense of SAVIENT, file any amendment
or supplement to the NDA required to effect such change. ROSEMONT
agrees to reimburse CYTOGEN for the Finished Product Price actually
paid for any Licensed Product inventory held by CYTOGEN that CYTOGEN
is unable to sell in the ordinary course as a direct result of any
change in Product Specifications that is not required by the FDA.
7.13 Notwithstanding Clause 7.7, where any defect or unsuitability in the
Licensed Product arises either partially or wholly as a result of a
defect or unsuitability in raw material supplied to ROSEMONT by a
Third Party, ROSEMONT will use best efforts to have the Third Party
conform to any demands of the relevant regulatory authority concerning
the defect; provided that ROSEMONT remains fully liable for the
proportion of Licensed Product defects directly attributable to any
such Third Party supplier.
15
8. ADVERSE DRUG EVENTS
8.1 The obligations of the parties for when an AE occurs are set out in
the Technical Agreement.
9. RECALLS
9.1. If CYTOGEN determines that any quantity of the Licensed Product should
be recalled for any reason, CYTOGEN will give to ROSEMONT and SAVIENT
written notice of its intention to recall that quantity and specify
its reasons for its belief that there is a need to carry out the
recall; provided, however, that CYTOGEN shall not initiate any recall
pursuant to this Clause 9.1 without the express written consent of
SAVIENT; provided, further, that if SAVIENT does not provide consent,
and if CYTOGEN has reasonably determined in good faith, based on
results obtained from a mutually reasonably acceptable independent
laboratory testing, or advice of mutually reasonably acceptable
regulatory consultant or counsel, that such recall is necessary for
reasons regarding the safety or efficacy of Licensed Product or
potential material liability to Third Parties arising in connection
with the Licensed Product, then CYTOGEN shall be excused from its
distribution obligations set forth in the Exclusive Distribution
Agreement.
9.2. If within [**] of the receipt of the notice the parties are unable to
agree upon the need to carry out the recall, the parties agree to
submit a sample of the batch of the Licensed Product in dispute to an
Independent Analyst for a report; such report shall be binding upon
the Parties. In the event that CYTOGEN reasonably believes that any
batch of Licensed Product is out of Product Specifications or that
there is otherwise any issues relating to the quality of the Licensed
Product, CYTOGEN shall so notify SAVIENT and ROSEMONT in writing in
accordance with Clause 6; anything to the contrary notwithstanding,
SAVIENT shall have sole authority pursuant to this Agreement to inform
the FDA of any Field Alerts or any Licensed Product recalls; provided,
that if CYTOGEN requests a recall but SAVIENT refuses to do so,
SAVIENT shall indemnify CYTOGEN for any product liability claims
arising from or related to such failure to recall.
9.3. The cost of the report of the Independent Analyst will be paid by the
party against which the report is unfavorable.
9.4. Anything to the contrary notwithstanding, in the event that the
relevant regulatory authority with the requisite legal authority
within the Territory orders a recall of the Licensed Product, CYTOGEN
shall recall that quantity of Licensed Product at any time after the
effective issuance of such order by the relevant regulatory authority
in the Territory according to the legal provisions applicable in the
Territory and shall administer such recall in the Territory after
having given ROSEMONT prompt written notice of its intention to do so.
9.5. In the event that the reason for, and to the extent that, any recall
of the Licensed Product is that the Licensed Product does not conform
with the Product Specifications due to shipping, storage, transport or
method of distribution of the Licensed Product by CYTOGEN or its
Affiliates or delegates which is not in accordance with the written
directions given to CYTOGEN under Clause 7.6, then CYTOGEN will be
liable for the costs of the recall and any replacement quantities of
the Licensed Product (except to the extent caused by any negligence or
wilfull misconduct of ROSEMONT or its Affiliates).
16
9.6. In the event that the reason for any recall of the Licensed Product is
other than that prescribed in Clause 9.5, ROSEMONT will reimburse
CYTOGEN for all reasonable costs and expenses of such recall,
including the shipping costs actually incurred by CYTOGEN in
transporting those quantities of the Licensed Product which are
recalled, and will provide replacement quantities of such recalled
Licensed Product, free of charge, to CYTOGEN, except if, and to the
extent that, such recall is caused by any negligence or willful
misconduct of CYTOGEN or its Affiliates and provided that payment has
been received by ROSEMONT for such recalled Licensed Product.
9.7. Except to the extent that the applicable legal and/or regulatory
requirements in the Territory require otherwise, CYTOGEN shall not
recall any Licensed Product where an Independent Analyst has reported
that the subject Licensed Product conforms to the Clauses 7.2(a) and
7.2(b).
10. INSPECTION OF THE PLANT AND OF THE WAREHOUSE
10.1 Not more often than [**], CYTOGEN, or its authorized representative,
will have the right, at CYTOGEN'S sole cost and expense and upon
giving reasonable notice to ROSEMONT, to visit ROSEMONT'S
manufacturing plant or such part of it as is used for production of
the Licensed Product, during normal business hours. During any such
visit, CYTOGEN will have the right to:
(a) inspect the manufacturing facilities;
(b) inspect quality control laboratories; and
(c) inspect records, reports and other documentation pertinent to the
development, manufacture or transport of the Licensed Product
(including any internal quality control audits or reviews
conducted by ROSEMONT or SAVIENT).
Notwithstanding anything to the contrary, CYTOGEN or its authorized
representative, will have the right to conduct more than [**] where
additional inspection is necessary (i) due to the receipt by ROSEMONT
of any communication from a relevant regulatory authority threatening
supply of the Licensed Product as a result of compliance deficiencies
at the manufacturing facilities, or (ii) if ROSEMONT was found to be
in material non-compliance of this Agreement in the last inspection
where such non-compliance relates to the manufacture of the Licensed
Product.
10.2 ROSEMONT will permit the inspection by any relevant regulatory
authority of the Territory which is required as part of the NDA,
including the inspection of:
(a) the manufacturing facilities;
(b) quality control laboratories; and
(c) records and reports pertinent to the development, manufacture,
transport or pharmacovigilance of the Licensed Products.
In the event of such inspection by any relevant regulatory authority
of the Territory, ROSEMONT will (i) provide prompt notice to CYTOGEN
of the occurrence of the inspection (ii) use its commercially
reasonable efforts to ensure that CYTOGEN shall have the right to be
present during such inspection and (iii) promptly provide CYTOGEN
17
a copy of any report issued by such regulatory authority as it
pertains to the Licensed Product and any responses thereto supplied by
ROSEMONT.
10.3 If in the manufacture of the Licensed Product ROSEMONT uses raw
material supplied from a Third Party, ROSEMONT will use commercially
reasonable efforts to procure the agreement of that Third Party to
permit the inspection by any relevant regulatory authority of the
Territory, which is required as part of the NDA, including the
inspection of the Third Party's:
(a) manufacturing facilities;
(b) quality control procedures; and
(c) records and reports pertinent to the development, manufacture or
transport of the Licensed Products.
In the event of such inspection by any relevant regulatory authority
of the Territory, ROSEMONT will (i) use its commercially reasonable
efforts to ensure that CYTOGEN shall have the right to be present
during such inspection or (ii) promptly provide CYTOGEN a copy of any
report issued by such regulatory authority as it pertains to the
Licensed Product.
10.4 ROSEMONT covenants that it will (a) ensure that for the duration of
the Agreement, its manufacturing facilities for the Licensed Product
comply with the regulatory requirements for the NDA of the Territory
and GMP of the Territory, (b) maintain all regulatory and governmental
permits, licenses and approvals that may be necessary to manufacture
and ship the Licensed Product, (c) advise CYTOGEN of any information
actually received from a relevant regulatory authority which directly
relates to its manufacturing activities of the Licensed Product, and
(d) provide to CYTOGEN any information reasonably requested by
CYTOGEN, in connection with manufacture of the Licensed Product,
provided that such information is consistent with the rights granted
to CYTOGEN herein. ROSEMONT shall promptly advise CYTOGEN of any
requests by any relevant regulatory authority for inspections of any
manufacturing/processing facilities as such inspection relates to the
Licensed Product.
10.5 Not more often than [**] ROSEMONT or its authorized representative,
will have the right, at its sole cost and expense, upon giving
reasonable notice to CYTOGEN, to visit CYTOGEN'S appointed warehouse
or such part of it as is used for storage of the Licensed Product
during normal business hours. During any such visit, ROSEMONT will
have the right to:
(a) inspect the storage facilities;
(b) inspect storage procedures; and
(c) inspect records and reports pertinent to the storage of the
Licensed Product.
The foregoing notwithstanding, in the event that ROSEMONT shall have
reasonable grounds to believe that any storage condition relating to
the specifications contained in the NDA for the Licensed Product is
not being complied with then ROSEMONT may request, and CYTOGEN shall
grant, an additional inspection upon reasonable prior notice.
18
11. INTELLECTUAL PROPERTY
11.1 The parties acknowledge and agree that SAVIENT is the owner of all
Intellectual Property Rights in the Territory as they pertain to the
Licensed Product and that SAVIENT has granted to ROSEMONT all rights
which are necessary in order to allow ROSEMONT to manufacture, sell,
distribute and otherwise dispose of the Licensed Product as
contemplated in this Agreement.
11.2 The parties acknowledge and agree that CYTOGEN has entered into an
Exclusive Distribution Agreement with SAVIENT which agreement provides
CYTOGEN with an exclusive right to import, promote, market, detail,
sell, offer to sell, distribute and otherwise dispose of the Licensed
Product in the Territory.
12. CONFIDENTIALITY
12.1 During the Term, and for a period of [**] thereafter, unless
specifically authorized by the other party or by this Agreement, each
party (the "RECEIVING PARTY") shall maintain in confidence
Confidential Information of the other party (the "DISCLOSING PARTY")
to the same extent and with the same degree of care as the Receiving
Party maintains its own proprietary information of similar kind and
value (but at a minimum each party shall use commercially reasonable
efforts) and will not:
(a) disclose any Confidential Information of the Disclosing Party to
a Third Party without prior written consent of the Disclosing
Party, except for disclosures made in confidence to any Third
Party;
(b) make use, or make (or allow anyone else to make) copies, of any
Confidential Information of the Disclosing Party for any purpose
other than for the purposes set forth in this Agreement; or
(c) disclose to the Receiving Party nor induce the Receiving Party to
use any secret or Confidential Information belonging to a Third
Party.
12.2 The Receiving Party will:
(a) use its best endeavors to prevent unauthorized disclosure of the
Confidential Information of the Disclosing Party by its
employees; and
(b) restrict the disclosure of the Confidential Information of the
Disclosing Party to only those of its employees or employees of
its Affiliates or delegates who require the Confidential
Information for the purposes of fulfilling that party's
obligations under this Agreement and where such employees are
subject to a confidentiality agreement with terms no less
restrictive than those set forth herein and to the relevant
regulatory authority in the Territory.
12.3 Subject to Clause 12.4, all Confidential Information, whether in
permanent or magnetic/computer disk form or any other form, will be
returned to the party who disclosed the Confidential Information
within thirty (30) days of being requested to do so.
12.4 Each party may:
19
(a) disclose the Confidential Information to its board of directors
and professional advisors (such as legal advisers and
accountants) bound by a duty of confidentiality;
(b) retain one copy of such of the Confidential Information to ensure
compliance with the terms of this Agreement; and
(c) disclose Confidential Information to potential collaborators,
acquirers or merger candidates, provided such disclosure occurs
pursuant to a confidentiality agreement with terms no less
restrictive than those set forth herein.
12.5 Except as may be required by applicable laws, neither party will make
any public announcement of any information regarding this Agreement
without the prior written approval of the other party. Once any
written statement is approved for disclosure by the parties or
information is otherwise made public in accordance with the preceding
sentence, either party may make a subsequent public disclosure of the
contents of such statement without further approval of the other
party.
12.6 The terms of this Agreement shall be Confidential Information of each
party and, as such, shall be subject to the provisions of this Clause
12.
12.7 The obligations and prohibitions contained in this Clause 12 shall
survive the expiration or termination of this Agreement as set forth
in Clause 12.1, supra.
12.8 Upon expiration or termination of this Agreement, each party shall
return or destroy all copies of the other party's Confidential
Information, and certify to the other party that all copies of the
other party's Confidential Information have been returned or
destroyed, except for the purpose of Clause 12.4(b).
13. REPRESENTATIONS AND WARRANTIES
13.1 ROSEMONT represents and warrants to CYTOGEN that:
(a) ROSEMONT has provided and shall provide to CYTOGEN all pertinent
information in its possession relative to physical, environmental
and human health hazards involving the Licensed Product; and
(b) The ownership and operation of the ROSEMONT's processing facility
shall be in material compliance with cGMPs and all applicable
laws, and any further formulating, manufacturing, packaging or
other standards agreed in writing by the parties, and all waste
generated in connection with the manufacture of the Licensed
Product shall be disposed of in accordance with all applicable
laws.
13.2 Each party hereto represents and warrants to the other party as of the
Effective Date that:
(a) It has full corporate right, power and authority to enter into
this Agreement and to perform its respective obligations under
this Agreement;
(b) The execution and delivery of this Agreement by such party and
the performance of such party's obligations hereunder (a) do not
conflict with or violate any requirement of applicable laws or
regulations existing as of the Effective Date
20
and applicable to such party and (b) do not conflict with,
violate, breach or constitute a default under, and are not
prohibited or materially restricted by, any contractual
obligations of such party or any of its Affiliates existing as of
the Effective Date;
(c) Such party is duly authorized, by all requisite corporate action,
to execute and deliver this Agreement and the execution, delivery
and performance of this Agreement by such party does not require
any shareholder action or approval or the approval or consent of
any Third Party, and the person executing this Agreement on
behalf of such party is duly authorized to do so by all requisite
corporate action; and
(d) Each party represents and warrants to the other that none of its
employees, officers, directors, or agents has been: (i) debarred,
or convicted of a crime for which a person can be debarred under
the Act, or (ii) knowingly threatened with debarment or
indictment for such a crime. If any debarment or conviction
occurs while this Agreement is in force and effect, then the
party involved with such debarment or conviction shall promptly
provide written notification to the other party.
14. TERMINATION
14.1 Each Party (the "Non-Breaching Party") shall be entitled to terminate
this Agreement by written notice to the other Party (the "Breaching
Party") in the event that the Breaching Party is in default of any of
its material obligations hereunder and fails to remedy such default
within [**] (or, in the case of payment defaults, within [**] after
provision of written notice thereof by the Non-Breaching Party. The
effective date of termination under this Clause 13 for an unremedied
breach of a material obligation shall be the date [**] (or, in the
case of an unremedied payment default, [**] after provision of written
notice thereof by the Non-Breaching Party.
14.2 Either party may terminate this Agreement upon written notice to the
other party (with such termination effective upon receipt of such
written notice) if:
(a) the other party applies for, or consents to, the appointment of a
receiver, custodian, trustee or liquidator of all or a
substantial part of its business or assets, or a receiver,
custodian, trustee or liquidator of all or a substantial part of
its business or assets is actually appointed by a court of
competent jurisdiction;
(b) the other party makes a general assignment for the benefit of its
creditors;
(c) CYTOGEN commences a voluntary case under the United States
Bankruptcy Code, as now or hereinafter in effect (the "Bankruptcy
Code"), or fails to controvert in a timely manner, or acquiesces
to, any petition filed against it in an involuntary case under
the Bankruptcy Code or if ROSEMONT shall take or submit to
substantially equivalent action in accordance with the laws of
the United Kingdom;
(d) the other party files a petition seeking to take advantage of any
law relating to bankruptcy, insolvency, reorganization,
winding-up, or composition or readjustment of debts; or
21
(e) a proceeding or case is commenced against the other party in a
court of competent jurisdiction, seeking the other party's
liquidation, reorganization, dissolution or winding-up, or the
composition or readjustment of its debts, or similar relief under
the Bankruptcy Code or with the substantially equivalent laws of
the United Kingdom.
14.3 Notwithstanding anything to the contrary contained in this Agreement,
in the event a force majeure event shall have occurred and be
continuing for one hundred and eighty (180) consecutive days, the
party not suffering such force majeure event shall be entitled to
terminate this Agreement effective immediately upon written notice to
the party suffering such force majeure event.
14.4 CYTOGEN may terminate this Agreement in its entirety, (a) upon [**]
written notice, if the Licensed Product is withdrawn from the market
or recalled in the Territory for safety reasons, and has been off the
market for at least [**], and the parties agree that there is no
reasonable prospect for the reintroduction of the Licensed Product.
14.5 Except as set forth in Clauses 14.6 and 14.7, in the event that the
Exclusive Distribution Agreement is terminated by either party
thereto, and such termination is in accordance with the terms and
conditions therein contained, then this Agreement shall be terminated
upon the same date which the Exclusive Distribution Agreement is
terminated without the requirement of any further notice or action on
behalf of the terminating Party.
14.6 Upon expiration or termination of this Agreement due to reasons other
than a material breach by CYTOGEN, CYTOGEN may continue using the
licenses granted hereunder and under the Exclusive Distribution
Agreement to market and sell all Licensed Product which are fully
manufactured and in CYTOGEN (including its Affiliates) and/or its
sublicensees' inventory at the date of such expiry or termination for
a period of time not to exceed [**] from such expiry or termination
date.
14.7 Upon termination of this Agreement due to a material breach by
CYTOGEN, at ROSEMONT's or SAVIENT's sole discretion, SAVIENT may offer
to purchase all or part of CYTOGEN's remaining inventory of Licensed
Product at for an amount equal to the Finished Product Price actually
paid by CYTOGEN; provided, however, that if ROSEMONT or SAVIENT does
not purchase CYTOGEN's inventory, then ROSEMONT and SAVIENT shall
grant CYTOGEN a license to continue selling the Licensed Product for a
period of time not to exceed [**] after termination, subject to
ROSEMONT'S receipt of royalty payments for such sales in accordance
with Clause 4.4 herein.
15. ARBITRATION
15.1 Except as expressly provided herein, any claim, dispute or controversy
arising out of or in connection with or relating to this Agreement or
the breach or alleged breach thereof shall be submitted by the parties
to binding arbitration by the American Arbitration Association ("AAA")
with such arbitration taking place in New Jersey under the commercial
rules then in effect for that AAA except as provided herein.
(a) All proceedings shall be held in English and a transcribed record
prepared in English.
(b) The parties shall choose, by mutual agreement, one arbitrator
within thirty (30) days of receipt of notice of the intent to
arbitrate. If the issues in dispute involve
22
scientific or technical matters, any arbitrator chosen hereunder
shall have educational training and/or experience sufficient to
demonstrate a reasonable level of knowledge in the field of
biotechnology. If no arbitrator is appointed within the times
herein provided or any extension of time that is mutually agreed
on, the AAA shall make such appointment within thirty (30) days
of such failure.
(c) The award rendered by the arbitrator shall include costs of
arbitration, reasonable attorneys' fees and reasonable costs for
expert and other witnesses, and judgment on such award may be
entered in any court having jurisdiction thereof.
(d) Judgment on the award rendered by the arbitrator may be entered
in any court having jurisdiction thereof. Absent the filing of an
application to correct or vacate the arbitration award as
permitted by applicable law, each party shall fully perform and
satisfy the arbitration award within thirty (30) days of the
service of the award.
15.2 By agreeing to this binding arbitration provision, the parties
understand that they are waiving certain rights and protections which
may otherwise be available if a dispute between the parties were
determined by litigation in court, including, without limitation, the
right to seek or obtain certain types of damages precluded by this
provision, the right to a jury trial, certain rights of appeal, and a
right to invoke formal rules of procedure and evidence.
15.3 Nothing in this Agreement shall be deemed as preventing either party
from seeking injunctive relief (or any other provisional remedy) from
any court having jurisdiction over the parties and the subject matter
of the dispute as necessary to protect either party's name,
proprietary information, trade secrets, know-how or any other
proprietary right.
16. FORCE MAJEURE
16.1 Notwithstanding any other provision of this Agreement, neither party
will be deemed to be in breach of this Agreement, or otherwise be
liable to the other, for any delay in the performance, or the
non-performance of any of its obligations under this Agreement, to the
extent that the delay or non-performance is outside the control of the
parties including acts of God, fires, floods, extreme drought, riot,
war, embargoes, government actions or government restrictions
affecting production, Formulation and/or registration of the Licensed
Product (including legislation specifically prohibiting the
importation, marketing or sale by anyone of the chemical compounds
constituting the Licensed Product) in the Territory or in the country
of manufacture of the Licensed Product, and the circumstances
constituting the force majeure were notified to the other party as
soon as possible thereafter. The party subject to force majeure will
take all reasonable steps within its power to resolve the
circumstances constituting force majeure as soon as possible.
Subject to Clause 14.3, CYTOGEN will not be deemed to be in breach of
this Agreement, or otherwise be liable to ROSEMONT, for any delay in
the performance, or the non-performance of any of its obligations
under this Agreement, arising from any dispute or litigation initiated
in the Territory which may result in the prevention of the storage,
promotion, sale and distribution of the Licensed Product by CYTOGEN in
the Territory, and these circumstances were notified to ROSEMONT.
Anything to the
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contrary notwithstanding, the non-payment of undisputed monies owed
pursuant to this Agreement, for whatever reason, shall not constitute
a force majeure.
17. NOTICES
17.1 Any notice given under this Agreement must be in writing and will be
deemed duly given or made if given to a party personally or sent by
registered post or facsimile to the address or facsimile number shown
below:
CYTOGEN Corporation
Attn: Chief Executive Officer
650 College Road East, Suite 3100
Princeton, New Jersey 08540
With a copy to:
Morgan, Lewis & Bockius LLP
Attention: Randall B. Sunberg, Esq.
502 Carnegie Center
Princeton, New Jersey 08540
and
ROSEMONT Pharmaceuticals Limited
Attn: Managing Director
ROSEMONT House
Yorkdale Industrial Park
Braithwaite Street
Leeds UK LS11 9XE
Facsimile number: +44 113 246 0738
With a copy to:
SAVIENT Pharmaceuticals, Inc.
Attention: General Counsel
One Tower Center, 14th floor
East Brunswick, New Jersey 08816
17.2 Either party may change its address or facsimile number for the
purpose of this Agreement by giving notice of the change to the other
party.
17.3 A notice will be deemed to be received by a party in the following
circumstances:
(a) The elapse of 24 hours from the dispatch of the notice by
facsimile transmission, where the transmission report confirms
that the notice has been dispatched without a transmission error
to the correct facsimile number;
(b) The elapse of 3 business days from the dispatch of the notice by
mail to a destination within the same jurisdiction; and
(c) The elapse of 7 business days from the dispatch of the notice by
mail to a destination outside the jurisdiction.
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18. PROPER LAW AND COURT OF JURISDICTION
18.1 This Agreement shall be governed by and construed in accordance with
the laws of the State of New Jersey without regard to any conflicts of
law principles.
18.2 Subject always to Clause 15.1 of this Agreement the courts in the
State of New Jersey shall have exclusive jurisdiction in relation to
all disputes between the parties hereto based on or in connection with
this Agreement.
19. ASSIGNMENT
19.1 Neither party may assign or transfer this agreement without the prior
written consent of the other party which consent shall not be
unreasonably withheld; provided, however, that either party may assign
this Agreement, in whole or in part, to any of its Affiliates if such
party guarantees the performance of this Agreement by such Affiliate;
and provided further, that either party may assign this Agreement to a
successor to all or substantially all of the assets of such party
whether by merger, sale of stock, sale of assets or other similar
transaction. This Agreement shall be binding upon, and subject to the
terms of the foregoing sentence, inure to the benefit of the parties
hereto, their permitted successors, legal representatives and assigns.
20. SUCCESSION
20.1 A reference to a party to this Agreement includes that party's
successors and permitted assigns.
21. RELATIONSHIP OF THE PARTIES
21.1 Nothing in this Agreement is intended or will be construed as
constituting a partnership, agency or joint venture relationship
between the parties. All activities by the parties hereunder will be
performed by them as independent contractors.
The parties agree that performance of any or all of a party's
obligations or the exercise of any or all of a party's rights under
this Agreement may be delegated to Affiliates and delegates of that
party. However, such delegation will not derogate from each of the
party's obligations or rights under the Agreement.
22. ENTIRE AGREEMENT
22.1 This Agreement (including every Schedule and Exhibit thereto),
together with the Exclusive Distribution Agreement, and the Technical
Agreement, contain the entire agreement between the parties with
respect to its subject matter and supersedes any prior agreement
between the parties concerning the Confidential Information.
23. VARIATION
23.1 A variation of this Agreement is of no force and effect unless it is
in writing and signed by the parties.
24. WAIVER
25
24.1 Waiver by either party of a breach of, or failure to comply with, this
Agreement by the other party is of no effect unless it is in writing
and signed by or on behalf of the first mentioned party.
25. SEVERANCE
25.1 In the event that any term or provision of this Agreement can sustain
two (2) or more interpretations, one (1) of which results in the term
or provision being valid, legal or enforceable, that term or provision
will be given that interpretation rather than an interpretation which
would or be likely to result in the term or provision being invalid,
illegal or unenforceable.
25.2 If any term or provision of this Agreement is to any extent held to be
invalid, illegal or unenforceable, the validity, legality, and
enforceability of the remaining terms or provisions (and any
Application of the said terms or provisions) will not in any way be
affected or impaired.
25.3 In the event that any term or provision of this Agreement is to any
extent held to be invalid, illegal or unenforceable, the parties will
negotiate in good faith and, if legally possible, will agree on an
alternate term or provision having regard to the original intention of
the parties.
25.4 The parties agree that the terms of this Agreement have been
negotiated at arms length by sophisticated bargaining parties and, as
such, no term shall be construed against the drafter of this
Agreement.
26. FURTHER ASSURANCES
26.1 The parties agree to reasonably cooperate with each other in
connection with any actions required to be taken as part of their
respective obligations under this Agreement, and shall (a) furnish to
each other such further information; (b) execute and deliver to each
other such other documents; and (c) do such other acts and things
(including working collaboratively to correct any clerical,
typographical, or other similar errors in this Agreement), all as the
other party may reasonably request for the purpose of carrying out the
intent of this Agreement.
27. NO IMPLIED LICENSES
27.1 Except as expressly provided herein, no right or license under any
patent application, issued patent, trademark, know-how or other
proprietary information is granted, or shall be granted, by
implication.
28. EXPENSES
28.1 Except as otherwise expressly provided in this Agreement, each party
shall pay its own expenses and costs incidental to the preparation of
this Agreement and to the consummation of the transactions
contemplated hereby.
26
29. EXECUTION
29.1 This Agreement may be executed in counterparts, all of which taken
together shall be regarded as one and the same instrument. Signatures
provided by facsimile transmission shall be deemed to be original
signatures.
[Remainder of Page Intentionally Left Blank; Signature Page Follows]
27
IN WITNESS WHEREOF the parties have caused this agreement to be signed by their
duly authorized representatives as of the Effective Date.
SIGNED by Neil Salvin /s/ Neil Salvin
Finance Director ---------------------------------------
for and on behalf of ROSEMONT PHARMACEUTICALS LIMITED
Date: April 21, 2006
---------------------------------------
SIGNED by Paul Hamelin /s/ Paul Hamelin
Managing Director ---------------------------------------
for and on behalf of ROSEMONT PHARMACEUTICALS LIMITED
Date: April 21, 2006
---------------------------------------
SIGNED by William Thomas /s/ William Thomas
Senior Vice President & General Counsel ---------------------------------------
For and on behalf of CYTOGEN CORPORATION
Date: April 21, 2006
---------------------------------------
SIGNED by Philip K. Yachmetz /s/ Philip K. Yachmetz
Executive Vice President & ---------------------------------------
Chief Business Officer
For and on behalf of SAVIENT PHARMACEUTICALS, INC.
Date: April 21, 2006
---------------------------------------
28
SCHEDULE 1
Specification for the Licensed Product at Release
-------------------------------------------------
[**]
29
SCHEDULE 2
LICENSED PRODUCT COST OF $[**]
Assumptions:
- -----------
[**]
ADDITIONAL INFO
[**]
30
SCHEDULE 3
The nominal batch size for the Licensed Product shall be [**].
31