EXECUTION COPY
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
EXCLUSIVE DISTRIBUTION AGREEMENT
--------------------------------
This Exclusive Distribution Agreement (the "AGREEMENT") is entered into as
of April 21, 2006 (the "EFFECTIVE DATE"), between Savient Pharmaceuticals, Inc.,
a Delaware corporation having offices at One Tower Center, East Brunswick, New
Jersey 08816 ("SAVIENT") and Cytogen Corporation., a Delaware corporation having
offices at 650 College Road East, Suite 3100, Princeton, New Jersey 08540
("CYTOGEN").
RECITALS
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WHEREAS, Savient's wholly owned subsidiary, Rosemont Pharmaceuticals Ltd.
("ROSEMONT"), has developed a tamoxifen oral solution for the treatment of
hormonally sensitive breast cancer;
WHEREAS, Savient owns certain intellectual property relating to Rosemont's
proprietary tamoxifen formulation;
WHEREAS, Savient has registered its oral liquid tamoxifen product in the
United States;
WHEREAS, Cytogen is interested in obtaining an exclusive license to market,
promote and sell Savient's tamoxifen product in the United States;
WHEREAS, on February 8, 2006, the parties executed a letter of intent,
which set forth the parties' intention to negotiate and enter into this
Agreement; and
WHEREAS, Savient, Rosemont and Cytogen are entering into a Manufacture and
Supply Agreement contemporaneously herewith.
NOW, THEREFORE, in consideration of the premises and the mutual promises
and covenants set forth below, the receipt and sufficiency of which are hereby
acknowledged, Savient and Cytogen mutually agree to as follows:
I. DEFINITIONS
For the purposes of this Agreement, the following terms, when written with
an initial capital letter, shall have the meaning ascribed to them below. All
references to particular Appendices, Articles and Sections shall mean the
Appendices to, and Articles and Sections of, this Agreement, unless otherwise
specified.
1.1 "ADVERSE EVENT REPORTS" has the meaning set forth in Section 3.2.
1.2 "AFFILIATES" means 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.
1.3 "APPLICATION" means a new application, or a supplement or an
amendment to an existing application, for marketing approval for a Licensed
Product in the Territory.
1.4 "BANKRUPTCY CODE" has the meaning set forth in Section 12.3(c).
1.5 "BREACHING PARTY" has the meaning set forth in Section 12.2.
1.6 "COMMERCIAL LAUNCH" means 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 and named patient sales shall not be considered in determining
the date of Commercial Launch.
1.7 "COMPETING PRODUCT" has the meaning set forth in Section 4.5.
1.8 "CONFIDENTIAL INFORMATION" means all proprietary information
(including but not limited to trade secrets) and materials (including but not
limited to data, results, technical or financial information) disclosed by a
party to the other party.
1.9 "CONTROLLED" means, with respect to any intellectual property right,
that the party has a license to such intellectual property right and has the
ability to grant to the other party a sublicense to such intellectual property
right as provided for herein without violating the terms of any agreement or
other arrangements with any Third Party existing at the time such party would be
first required hereunder to grant the other party such sublicense.
1.10 "COVER" (including variations thereof such as "Covering" or
"Covered") means that the manufacture, use, sale, offer for sale, or importation
of a particular product would infringe a Valid Claim of a patent in the absence
of rights under such patent. The determination of whether a particular product
is Covered by particular Valid Claims shall be made on a country-by-country
basis.
1.11 "CYTOGEN KNOW-HOW" has the meaning set forth in Section 8.4.
1.12 "CYTOGEN PATENTS" has the meaning set forth in Section 2.2.
1.13 "CYTOGEN TRADE DRESS" has the meaning set forth in Section 9.2.
1.14 "DISCLOSING PARTY" has the meaning set forth in Section 13.1.
1.15 "FDA" means the United States Food and Drug Administration and any
successor agency thereto, and/or any equivalent foreign governmental agency,
depending on the context.
1.16 "FIELD" means all human oncology uses.
1.17 "FILING PARTY" has the meaning set forth in Section 10.2(b).
1.18 "INDEMNIFIED PARTY" has the meaning set forth in Section 15.3.
1.19 "INDEMNIFYING PARTY" has the meaning set forth in Section 15.3.
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1.20 "JOINT INVENTIONS" means any inventions relating to the Licensed
Product, whether patented or not, that are jointly made during the period
beginning on the Effective Date and continuing until the end of the Term by at
least one (1) Savient employee or person (either under a contractual obligation
or under the work-for-hire doctrine) required to assign or license patent rights
covering such inventions to Savient or its Affiliate and at least one (1)
Cytogen employee or person (either under a contractual obligation or under the
work-for-hire doctrine) required to assign or license patent rights covering
such inventions to Cytogen or its Affiliate, whether or not other persons are
also joint inventors.
1.21 "JOINT PATENTS" means any patents or patent applications Covering one
or more Joint Inventions.
1.22 "LICENSED HOUSE MARKS" means (i) the corporate names of Savient and
its Affiliates, (ii) their trade names, service marks, domain names, and
associated logos and designs, and (iii) all trademarks identifying a product
line of Savient or its Affiliate, where such mark is owned by Savient or its
successor-in-interest and is used in connection with the sale or promotion of
Licensed Product in the Territory.
1.23 "LICENSED KNOW-HOW" means, except as otherwise set forth in this
Section 1.23, all inventions, discoveries, trade secrets, information,
experience, data, formulas, procedures and results in the Field, and
improvements thereon, including any information (whether patented, patentable or
otherwise) regarding all product specifications, processes, product designs,
plans, trade secrets, ideas, concepts, manufacturing, engineering and other
manuals and drawings, standard operating procedures, flow diagrams, chemical,
pharmacological, toxicological, pharmaceutical, physical and analytical, safety,
efficacy, stability, quality assurance, quality control and clinical data,
research records, compositions, annual product reviews, process validation
reports, analytical method validation reports, specifications for stability
trending and process controls, testing and reference standards for impurities in
and degradation of products, technical data packages, chemical and physical
characterizations, dissolution test methods and results, formulations for
administration, clinical trial reports, regulatory communications and labeling
and all other confidential or proprietary technical and business information,
whether written or oral and in whatever format kept of Licensed Product
(collectively, "KNOW-HOW IN THE FIELD"), that is owned or Controlled by Savient
or its Affiliates as of the Effective Date or that is developed or Controlled by
Savient or its Affiliates during the Term, and which Know-How in the Field is
reasonably required for using or selling Licensed Product.
1.24 "LICENSED PATENTS" means all patent applications owned or Controlled
by Savient alone or with any Third Party and all patent applications resulting
from Joint Inventions Covering the importation, sale or offer for sale of the
Licensed Product in the Territory or any foreign jurisdiction or the use of the
Licensed Product in the Field, including any addition, continuation,
continuation-in-part or division thereof or any substitute application therefor;
any patent issued with respect to such patent application, any reissue,
extension or patent term extension of any such patent, and any confirmation
patent or registration patent or patent of addition based on any such patent. A
list of the current Licensed Patents is attached as Schedule 1.24.
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1.25 "LICENSED PRODUCT" means Savient's oral liquid tamoxifen product in
all dosage forms and formulations for use in the Field.
1.26 "LICENSED TRADEMARKS" means all trademarks, and all trademark
registrations and applications therefor, and all goodwill associated therewith,
owned by Savient (except for any Savient housemarks or trade names) and used in
connection with the sale or promotion of Licensed Product in the Territory. A
list of such Licensed Trademarks is attached as Schedule 1.26.
1.27 "LOSSES" has the meaning set forth in Section 15.1.
1.28 "MINIMUM ROYALTY PAYMENT" has the meaning set forth in Section 6.3.
1.29 "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 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.
1.30 "NON-BREACHING PARTY" has the meaning set forth in Section 12.2.
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1.31 "NON-FILING PARTY" has the meaning set forth in Section 10.2(b)
1.32 "NON-PUBLISHING PARTY" has the meaning set forth in Section 13.5.
1.33 "PROJECTED PENETRATION PERCENTAGE" has the meaning set forth in
Section 6.3.
1.34 "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.
1.35 "PRESCRIBER DATA" shall mean data which measures prescriptions
written for the Licensed Product by each Target Prescriber in the Territory
during a specified time period from a source mutually agreed in writing by the
parties.
1.36 "PROMOTION" means those activities normally undertaken by a
pharmaceutical company to implement promotion plans and strategies aimed at
encouraging the appropriate use of a particular prescription pharmaceutical
product under a common trademark, up to the point of offering the product for
sale. When used as a verb, "Promote" shall mean to engage in such activities.
1.37 "PROMOTIONAL MATERIALS" has the meaning set forth in Section 9.4.
1.38 "PROMOTION PLAN" means the then-current marketing and promotion plan
established by Cytogen relating to the Promotion of Licensed Product, as further
described in Section 4.1(b).
1.39 "PUBLICATION" has the meaning set forth in Section 13.5.
1.40 "PUBLISHING PARTY" has the meaning set forth in Section 13.5.
1.41 "QUARTERLY TRX" shall mean the total number of tamoxifen
prescriptions written during a specified calendar quarter, as reported by a
reliable, national pharmaceutical market research company mutually agreed upon
by the parties.
1.42 "REASONABLE DILIGENCE" means commercially reasonable efforts
consistent with those used by pharmaceutical companies similarly situated to
Cytogen in marketing and selling other pharmaceutical products similarly
situated to the Licensed Product.
1.43 "RECEIVING PARTY" has the meaning set forth in Section 13.1.
1.44 "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.
1.45 "ROSEMONT" means Savient's wholly owned subsidiary, Rosemont
Pharmaceuticals Ltd.
1.46 "SUPPLY AGREEMENT" has the meaning set forth in Section 5.1.
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1.47 "TAIL PERIOD" has the meaning set forth in Section 12.9(b).
1.48 "TERRITORY" means the United States, including its territories and
possessions.
1.49 "TERM" has the meaning set forth in Section 12.1.
1.50 "THIRD PARTY" means any person or entity other than Savient, Cytogen,
and their respective Affiliates.
1.51 "VALID CLAIM" means a claim in any issued patent that has not been
disclaimed or held unenforceable or invalid by a decision of a court or
governmental agency of competent jurisdiction by a decision beyond right of
review.
II. GRANT OF RIGHTS
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2.1 Grants to Cytogen.
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(a) Patent and Know-How License. Subject to the terms and conditions
---------------------------
of this Agreement, Savient grants to Cytogen, during the Term, the exclusive
(even as to Savient and its Affiliates) right and license, with the right to
sublicense, under the Licensed Know-How and Licensed Patents to import, sell,
offer to sell, market, distribute, promote and detail Licensed Product in the
Territory solely for use in the Field. If during the Term, Cytogen or its
Affiliate challenges the validity or enforceability in the Territory of any
patent within the Licensed Patents, then Savient shall have the right (but not
the obligation) to terminate all licenses to Cytogen under this Agreement.
(b) Trademark License. Subject to the terms and conditions of this
-----------------
Agreement, Savient grants to Cytogen, during the Term, (i) the exclusive right
and license, with the right to sublicense, to use the Licensed Trademark(s)
solely in connection with the marketing, promotion and sale of the Licensed
Product in the Territory for use in the Field, and (ii) the non-exclusive right
and license, with the right to sublicense, to use the Licensed House Mark(s)
solely in connection with the marketing, promotion and sale of the Licensed
Product in the Territory for use in the Field. Cytogen acknowledges that all of
its uses of the Licensed Trademark(s) and Licensed House Mark(s) shall inure to
the benefit of Savient, and that Cytogen shall not acquire any ownership rights
in and to the Licensed Trademark(s) or the Licensed House Mark(s) by virtue of
its uses of those trademarks hereunder.
(c) Right to Sublicense. Cytogen may sublicense its rights and
-------------------
licenses granted under Sections 2.1(a) and 2.1(b) to any Affiliate without
Savient's written consent. However, Cytogen may sublicense its rights and
licenses granted under Sections 2.1(a) and 2.1(b) to a Third Party only with
Savient's express written consent, such consent not to be unreasonably withheld,
conditioned or delayed. It shall be deemed reasonable to withhold consent to
sublicense a Third Party that is actively selling a competitive pharmaceutical
product with a similar indication in the Territory. If Cytogen sublicenses its
rights and licenses under this Agreement, Cytogen shall nevertheless continue to
be liable for the performance of its obligations under this Agreement, and shall
be fully responsible for the actions of its sublicensees.
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2.2 Grants to Savient. Cytogen shall grant a non-exclusive,
---------------------
non-royalty-bearing license, during the Term, in the Field, in the Territory, to
any Cytogen patents Covering the making, use, importation, sale, offer to sell,
marketing, distribution, promotion, detailing or development of Licensed Product
where such patents are either (i) owned or Controlled by Cytogen as of the
Effective Date, or (ii) mature from any patent applications filed during the
Term or claim any inventions conceived or reduced to practice during the Term
(collectively, the "CYTOGEN PATENTS"). At Savient's written request, Cytogen
shall grant a license (outside the Field, or outside the Territory, or
subsequent to the Term of this Agreement) to any Cytogen Patent selected by
Savient under fair and reasonable terms to be negotiated by the parties in good
faith. The royalty rate or other financial terms of any such license agreement
shall be no less favorable to Savient than the royalty rate or financial terms
of any license agreement between Cytogen and a Third Party relating to the same
Cytogen Patent licensed to Savient. This Section 2.2 shall survive termination
of this Agreement.
2.3 Third Party Licenses. In the event that Cytogen reasonably believes
--------------------
that a Third Party license is required for the making, using, selling, offering
to sell, or importing of the Licensed Product in the Territory under such Third
Party's intellectual property, it shall so inform Savient and Savient shall have
the obligation to obtain such license or sublicense on such terms agreed by the
parties in order to avoid infringing the Valid Claim of a Third Party. In the
event that Savient fails to obtain such Third Party license for any reason, then
Cytogen may obtain such Third Party license, whereupon [**]. In any event,
Savient shall be responsible for any royalties or other payments (e.g.,
milestone payments, etc.) that become due to any Third Party with respect to the
making, using, selling, offering to sell, or importing of a Licensed Product in
the Field in the Territory (except to the extent such license is needed solely
in connection with Detailing, in which case Cytogen shall be solely responsible
for any and all costs associated with such license). For clarity, any such
payments to a Third Party shall in no event be included in the calculation of
the Cost of Goods or as a deduction from Net Sales.
III. DEVELOPMENT; REGULATORY ISSUES
------------------------------
3.1 Development by Savient.
----------------------
(a) Development in the Field. Savient and/or its Affiliates shall be
------------------------
solely responsible, at their sole cost and expense, for obtaining and
maintaining Regulatory Approvals for commercial sale of the Licensed Product in
the Field in the Territory.
(b) Labeling Change. Savient shall use commercially reasonable
----------------
efforts to file a sNDA (which requests a labeling change that would allow [**].
If Savient fails to file such a sNDA on or before [**], then Cytogen's royalty
payment obligation under section 6.2 shall be [**] until such time as Savient
files a sNDA. When Savient files such a sNDA (whether or not the FDA ultimately
approves the sNDA), the royalty obligation shall be restored to the full royalty
rates specified in section 6.2.
(c) Development in Canada. If Savient should seek approval to market
---------------------
the Licensed Product in Canada, then Cytogen shall have a right of first
negotiation to license rights to Licensed Product in Canada. The parties shall
negotiate in good faith the terms of such license. The terms of such a license
agreement shall include an upfront payment to Savient equal to the
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greater of [**] times Savient's fully burdened expenses in obtaining marketing
authorization in Canada, including the costs of any clinical trials. If after
three (3) months of good faith negotiations, the parties are unable to reach
agreement on the terms of a license agreement, then Savient shall be free (i) to
market, promote, detail and/or sell the Licensed Product in Canada, or (ii) to
enter into an agreement with a Third Party to market, promote, detail and/or
sell the Licensed Product in Canada.
(d) Other Development. Savient and/or its Affiliates, at their sole
------------------
discretion and their sole cost and expense, may develop the Licensed Product for
indications outside the Field and/or develop other products for the treatment of
breast cancer. If Savient or its Affiliate decides to (i) develop the Licensed
Product for indications outside the Field or (ii) develop an oral liquid product
for the treatment of breast cancer, then Savient (or its Affiliate, as the case
may be) shall keep Cytogen reasonably informed about such clinical development,
but Savient shall retain all decision-making authority with regard to such
development. In such case, the parties shall negotiate in good faith to amend
this Agreement to extend the scope of Cytogen's license to include such other
indications or other oral liquid products. If the parties fail to reach
agreement on terms relating to the extension of the scope of Cytogen's license,
the parties shall negotiate in good faith to amend this Agreement to address the
issue of off-label use and cannibalization of sales of the Licensed Product in
oncology by the new oral liquid tamoxifen product in the new indication.
(e) Ownership of Data and Regulatory Approvals. Except as otherwise
-------------------------------------------
set forth in this Agreement, all data and information generated by Savient
development activities pursuant to this Section 3.1 shall be owned by Savient
and/or its Affiliates and shall be deemed Licensed Know-How. Savient and/or its
Affiliates shall own all Regulatory Approvals. Savient shall grant to Cytogen
the sole and exclusive right to market the Licensed Product under Savient's
and/or its Affiliates' Regulatory Approvals in the Field in the Territory.
Cytogen shall own all Prescriber Data, marketing (including the Promotion Plan),
sales, distribution and other commercialization data and other marketing, sales,
distribution and commercialization information resulting from the distribution
of the Licensed Product by Cytogen following the Effective Date. Upon request,
Cytogen shall make available to Savient any data or information within Cytogen's
(or Cytogen's Affiliates') possession or control that Savient may need to comply
with FDA reporting requirements and other regulations; Cytogen shall provide
copies of any documents, in electronic or paper form as requested by Savient,
within three (3) business days of Savient's request. Upon termination or
expiration of this Agreement for any reason other than Savient's breach, Cytogen
shall (to the extent that Cytogen has a right to do so) transfer ownership to
Savient of all then-current Prescriber Data, marketing (including the Promotion
Plan), sales, distribution and other commercialization data and other marketing,
sales, distribution and commercialization information resulting from the
distribution of the Licensed Product by Cytogen. If the Agreement is terminated
because of Savient's breach, then Savient shall pay Cytogen fair and reasonable
compensation to be negotiated in good faith by the parties (but not to exceed
Cytogen's reasonable out-of-pocket expenses incurred in transferring such data
and information) to compensate Cytogen for its efforts to transfer to Savient
the above-described data and information.
3.2 Adverse Event Reporting. Cytogen and Savient shall notify each other
-----------------------
of all information coming into its possession concerning any and all side
effects, injury, toxicity,
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pregnancy or sensitivity event associated with commercial or clinical uses,
studies, investigations or tests with Licensed Product, throughout the world,
whether or not determined to be attributable to Licensed Product ("ADVERSE EVENT
REPORTS"). Each party agrees to share relevant information it receives (either
directly or indirectly) with the other party in a timely manner so as to allow
such other party to comply with its responsibility to process pharmacovigilance
information under this Section 3.2.
IV. COMMERCIALIZATION
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4.1 Commercialization By Cytogen.
----------------------------
(a) General. During the Term and in the Territory, Cytogen shall use
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Reasonable Diligence, at its sole cost and expense, for:
(i) the marketing, Promotion, and Detailing of Licensed Product
for use in the Field;
(ii) accepting and filling orders for Licensed Product received
by it or its Affiliates, including the distribution of Licensed Product to fill
such orders (provided that Savient shall inform and transfer to Cytogen any and
all orders it or its Affiliates receive for the Licensed Products in the
Territory);
(iii) booking all sales of Licensed Product attributable to such
orders;
(iv) managing, and performing visits to, national accounts,
including managed care, trade and government accounts;
(v) responding to medical questions or inquiries from members
of the medical and paramedical professions and consumers regarding Licensed
Product, including the distribution of standard medical information letters
resulting from the marketing activities of Cytogen's Sales Representatives,
provided, however, that the parties shall work together to formulate, and shall
mutually agree upon, responses to such inquiries; and
(vi) any other activities reasonably related to the marketing,
Promotion, Detailing, sale or distribution of the Licensed Product, including
the handling/processing of returns, refunds, rebates and wholesaler charge-backs
and administration of managed care contracts, federal and state government
contracts, rebate contracts, long-term care contracts, performance-based
contracts and hospital purchasing contracts.
(b) Promotion and Marketing Plan. At least [**] prior to the
-------------------------------
beginning of each calendar year during the Term, Cytogen shall provide to
Savient a written Promotion Plan and Savient shall have an opportunity to
comment on the proposed plan, which shall include the following information:
(i) number of Sales Representatives and composition of sales
force;
(ii) projected Details of Target Prescribers for the coming
calendar year, broken down by calendar quarter and broken out into First
Position Details, Second Position Details and all other Details;
(iii) a list of Target Prescribers;
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(iv) non-binding budget for Promotion expenses for the coming
calendar year, broken down by calendar quarter;
(v) timing and quantity of distribution of samples of Licensed
Product;
(vi) description of the then-current sales force compensation
plan for Cytogen's Sales Representatives, sales managers, directors and other
sales supervisors; and
(vii) Prescriber Data supporting Cytogen's Promotion Plan.
(c) Updates. Cytogen shall keep Savient reasonably informed of its
-------
commercialization activities, including any updates to its annual Promotion
Plan. Cytogen shall also notify Savient in writing of any significant changes in
the market for the Licensed Product (promptly after such change becomes known to
Cytogen) and of Cytogen's decision to implement any significant changes in
Cytogen's marketing activities (prior to implementation of such changes) related
to the Licensed Product.
4.2 Compliance with Law. Cytogen shall comply with all legal requirements
-------------------
applicable to the marketing, promotion or sale of the Licensed Product in the
Territory, including, without limitation, any applicable statutory or regulatory
requirements relating to the Promotional Materials of the Licensed Product in
the Territory. Savient shall maintain responsibility for labeling compliance and
maintenance of the Licensed Product, and notify Cytogen of any changes to
labeling at the time of FDA approval thereof; and Cytogen shall seek Savient's
written approval prior to adopting or changing any packaging or labeling for the
Licensed Product.
4.3 Promotional Materials. Cytogen shall provide samples of Promotional
---------------------
Materials to Savient at the time of first using or distributing of such
Promotional Materials in the Territory. Cytogen shall own all right, title and
interest in and to any Promotional Materials created by Cytogen relating to the
Licensed Products, but excluding the Licensed Trademark(s) and the Licensed
House Marks; provided, that the Promotional Materials shall be used exclusively
in connection with the Licensed Products in accordance with the terms of this
Agreement. All Promotional Materials, including all written communications to
prescribers and other healthcare providers and patients, shall be submitted to
Savient for review and approval; preliminary drafts of Promotional Materials
shall be provided to Savient at least [**] in advance of planned dissemination,
and final drafts of Promotional Materials shall be provided to Savient at least
[**] in advance of planned dissemination. Where required by law, Savient shall
submit Promotional Materials to the FDA (DDMAC) for review and approval or, at
Savient's option (but with Cytogen's consent), Savient shall designate Cytogen
as Savient's agent for the purpose of submitting Promotional Materials to the
FDA (DDMAC). In the event that the FDA issues a letter objecting to any
promotional activities by Cytogen that require corrective actions (e.g.,
issuance of Dear Healthcare Professional letters, recall of Promotional
Materials and/or dissemination of corrected Promotional Material), Cytogen will
bear all the cost related to these corrective activities.
4.4 Pricing. As between the parties, Cytogen has the sole right to
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determine the price for Licensed Product for use in the Field. However, subject
to applicable legal requirements and limitations and competitive factors,
Cytogen shall use Reasonable Diligence to maximize revenues from sales of the
Licensed Product in the Territory.
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4.5 Non-Compete. During the Term and for a period of [**], Cytogen shall
-----------
not market, distribute, Promote, Detail or sell any [**] in the Territory.
Notwithstanding the above, Cytogen is not precluded from entering into a merger
or acquisition of an entity that markets, distributes, Promotes, Details or
sells a Competing Product in the Territory, provided that the primary purpose of
the merger or acquisition transaction was not to acquire rights to the [*].
However, upon entering into such a transaction, Cytogen shall have [**] of such
merger or acquisition to divest any and all [**].
V. MANUFACTURING
-------------
5.1 Commercial Supply. Savient shall ensure that Rosemont shall supply to
-----------------
Cytogen all its requirements for Licensed Product (including samples and
clinical supplies), subject to Cytogen's obligation to make royalty payments in
accordance with Section 6.2 and Finished Product Price payments pursuant to the
Supply Agreement. Concurrently with this Agreement, Rosemont and Cytogen shall
enter into a manufacture and supply agreement, in substantially the form
attached hereto as Exhibit A (the "SUPPLY AGREEMENT"), governing the commercial
supply of Licensed Product (including samples and clinical supplies) by Rosemont
to Cytogen (including the procedures for providing forecasts of Cytogen's
requirements, for ordering Licensed Product, and for return and replacement of
Licensed Product that does not meet product specifications). For purposes of
clarity, all Licensed Product (other than samples and clinical supplies)
supplied by Savient and/or Rosemont to Cytogen hereunder shall be in finished
form and packaged in primary packaging, ready to sell. If Savient divests
Rosemont to a Third Party purchaser, Savient shall ensure that the Third Party
purchaser assumes Savient's obligations under this Section 5.1.
VI. PAYMENTS
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6.1 Upfront Payment. Cytogen shall pay to Savient the sum of two million
---------------
dollars ($2,000,000), of which two hundred thousand dollars ($200,000) was paid
upon execution of the letter of intent between the parties, and the remainder of
which shall be paid within five (5) business days after the Effective Date. This
upfront payment shall be non-refundable and non-creditable, and shall be in
addition to the other payments set forth below.
6.2 Royalties. During the Term, Cytogen shall pay Savient royalties based
---------
on Cytogen's Net Sales of the Licensed Product. All royalty payments shall be
due within [**] after the close of each calendar quarter. 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
---------------- ------------
Less than or equal to [**] [**]%
Over [**] [**]%
-11-
6.3 Minimum Royalties. Beginning in 2007, Cytogen shall pay Savient
-----------------
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:
Projected Penetration Percentage Year
-------------------------------- ----
[**] [**]
[**] [**]
[**] [**] and later
(a) During any quarter in which the royalty payment due Savient as
calculated pursuant to Section 6.2 is less than the Minimum Royalty Payment
calculated pursuant to this Section 6.3, then Cytogen shall pay Savient the
Minimum Royalty Payment rather than the royalty payments due under Section 6.2 .
(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 [**].
6.4 Sales Milestone Payments. Cytogen shall pay to Savient 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 [**] after the end of the calendar quarter in
which each milestone was achieved. For example, after cumulative Net Sales reach
[**], Cytogen shall pay $[**] to Savient within [**] after the end of the
calendar quarter in which cumulative Net Sales reached [**].
Cumulative Net Sales Payment
-------------------- -------
[**] $[**]
[**] $[**]
[**] $[**]
6.5 Third Party License Payments. Cytogen shall be solely responsible for
----------------------------
any Third Party license payments required to Detail the Licensed Product.
Savient shall be solely
-12-
responsible for any Third Party license payments required for manufacturing,
using, selling, offering to sell, or importing in the Territory of the Licensed
Product.
6.6 Payments on Termination. If this Agreement is terminated (for any
------------------------
reason), Cytogen shall continue to be responsible for payment of any undisputed
amounts accrued under this Agreement or the Supply Agreement prior to the date
of termination (including any royalty or sales milestone payments). Any such
undisputed amounts shall be due and payable within thirty (30) days after
termination. If Cytogen is permitted to sell its inventory of Licensed Product
pursuant to Section 12.9, then Cytogen shall pay Savient royalties pursuant to
Section 6.2 and sales milestones pursuant to Section 6.4 for any cumulative
sales milestones achieved after termination (during the Tail Period). Such
payments shall be paid within [**] of the end of the calendar quarter during
which such sales were made or during which such sales milestone was achieved.
6.7 Sublicenses. Any Net Sales or gross sales by a Cytogen sublicensee
-----------
shall be treated as Net Sales and gross sales, respectively, of Cytogen, for the
purposes of payments under this Article VI. If Cytogen grants any sublicenses
under this Agreement, then Cytogen shall obtain the written commitment of such
sublicensees to abide by all applicable terms and conditions of this Agreement,
but Cytogen shall remain responsible to Savient for the performance by such
sublicensee of any and all terms.
6.8 Interest. In the event that Cytogen is late in paying to Savient any
--------
amounts due under this Agreement within the applicable time period set forth
herein, such payment shall bear interest at the average one-month London
Interbank Offered Rate (LIBOR) as reported by Datastream (or a successor or
similar organization) from time to time, unless such amounts are being disputed
by Cytogen in good faith.
VII. PAYMENTS, REPORTS, AND ACCOUNTING
---------------------------------
7.1 Monthly Royalty Payments and Reports. Cytogen agrees to make payments
------------------------------------
within [**] after the end of each calendar quarter covering all sales of
Licensed Product in the Territory by Cytogen for which invoices were sent during
such calendar quarter. Cytogen agrees to provide written reports to Savient
within [**] 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 Savient for such month
pursuant to Article VI.
7.2 Accounting. Cytogen agrees to keep full, clear and accurate records
----------
for a period of at least [**], setting forth the sales and other disposition of
Licensed Product in sufficient detail to enable royalties and compensation
payable to Savient hereunder to be determined.
-13-
7.3 Audit. Cytogen further agrees to permit its books and records to be
-----
examined by a nationally recognized independent certified public accounting firm
selected by Savient and reasonably acceptable to Cytogen and retained solely for
the purpose of auditing the same at Savient's expense to verify records provided
for in this Article VII. Such audit shall be conducted exclusively for the
purpose of verifying the accuracy of reports delivered by Cytogen to Savient
pursuant to Sections 7.1 and 7.2 and the accuracy of Cytogen's determination of
the amounts payable or paid by Cytogen to Savient hereunder. Such audit shall
not be performed more frequently that [**] nor more frequently than [**] with
respect to records covering any specific period of time. Such examination is to
be made at the expense of Savient, except in the event that the results of the
audit reveal a discrepancy in favor of Cytogen of [**] or more over the period
being audited, in which case reasonable audit fees for such examination shall be
paid by Cytogen. Cytogen shall pay to Savient within thirty (30) days after the
delivery of the accountant's report pursuant to this Section any undisputed
amounts determined by the accountant, and verified by Cytogen, to be payable by
Cytogen to Savient. If the accountant determines that Cytogen has overpaid
Savient, Savient shall, at the election of Cytogen, credit Cytogen in an amount
equal to such overpayment on the immediately succeeding invoice rendered to
Cytogen, or pay Cytogen such amount within [**] after receipt of an invoice
therefor.
7.4 Methods of Payments. All payments due under this Agreement shall be
-------------------
paid in United States dollars by wire transfer to a bank in the United States
designated in writing by Savient. For the purpose of Net Sales for Licensed
Product sold in a currency other than United States dollars, Cytogen shall
convert the amount of Net Sales in foreign currencies using the average exchange
rate (as reported by Reuters or other reliable source of exchange rate
information, as agreed to by the parties) for the quarter in which the sales
occurred (in the case of royalty payments) or for the relevant time period for
any other payments.
7.5 Taxes. If provision is made in law or regulation of any country of
-----
the Territory for withholding of taxes of any type, levies or other charges with
respect to the any amounts payable hereunder to Savient, Cytogen shall promptly
pay such tax, levy or charge for and on behalf of Savient to the proper
governmental authority, and shall promptly furnish Savient with receipt of such
payment. Cytogen shall have the right to deduct any such tax, levy or charge
actually paid from payment due Savient or be promptly reimbursed by Savient if
no further payments are due Savient. Cytogen agrees to assist Savient in
claiming exemption from such deductions or withholdings under double taxation or
similar agreement or treaty from time to time in force and in minimizing the
amount required to be so withheld or deducted. Cytogen shall be solely
responsible for any sales or use taxes attributable to sale or disposition of
Licensed Product by Cytogen, including any taxes relating to Licensed Product
samples.
VIII. OWNERSHIP OF TECHNOLOGY AND INTELLECTUAL PROPERTY
-------------------------------------------------
8.1 Ownership. Ownership of the Licensed Know-How and the Licensed
---------
Patents shall remain vested at all times in Savient. Savient expressly reserves
under this Agreement all rights to use the Licensed Know-How, the Licensed
Patents, the Joint Patents, and any other Savient patents to make, have made,
use, import, offer to sell and sell Licensed Product outside of the Territory.
Each party shall promptly disclose to the other party all Inventions made by it
during the Term. The determination of inventorship for inventions shall be made
in accordance
-14-
with applicable laws relating to inventorship set forth in the patent laws of
the United States (Title 35, United States Code).
8.2 Savient Inventions. As between the parties, Savient shall own any
------------------
and all inventions invented, either solely or jointly with Third Parties, by the
employees or agents of Savient, and any patents Covering such inventions. To the
extent that any such patent Covers the use, importation, sale or offer to sell
the Licensed Product in the Field, such patent shall be deemed a Licensed
Patent, and Cytogen shall have an exclusive license to such patent pursuant to
Section 2.1(a).
8.3 Joint Inventions. Savient and Cytogen shall each own an undivided
-----------------
equal interest in any Joint Invention and any Joint Patents. Both parties shall
at all times have the co-exclusive right within the Territory to practice, or to
make, have made, use, import, offer for sale or sell any Joint Invention outside
the Field under any Joint Patent, and neither party shall be obligated to
account to the other. As used herein, a right to practice any Joint Patent
without any obligation to account shall include the right to grant licenses
without the consent of: the other party; provided that a written notice will be
promptly provided. To the extent either party needs the consent of the other
party to exploit its co-exclusive or exclusive rights with respect to Joint
Patents, including the right to sublicense or enforce such Joint Patents, the
other party shall cooperate with the party making such a request and promptly
supply all needed consents, signatures and the like.
8.4 Cytogen Technology. If during the Term, Cytogen develops any know-how
------------------
relating to the use, manufacture, marketing, promotion, distribution or sale of
the Licensed Product (the "CYTOGEN KNOW-HOW"), Cytogen shall immediately grant a
non-exclusive, non-royalty-bearing license to Savient, during the Term, in the
Field, in the Territory to use such know-how for the Licensed Product in the
Field; Savient and Cytogen shall mutually agree upon reasonable financial
compensation to Cytogen in connection with the grant of such license to Savient
for any use outside the Field or outside the Territory or after the Term. Such
license shall be with immediate effect upon development of such know-how without
the need for execution of a separate agreement or other formal document
memorializing the grant of such license. At Savient's written request, Cytogen
shall grant a license (outside the Field, or outside the Territory, or
subsequent to the Term of this Agreement) to Cytogen Know-How under fair and
reasonable terms to be negotiated by the parties in good faith. The royalty rate
or other financial terms of any such license agreement shall be no less
favorable to Savient than the royalty rate or financial terms of any license
agreement between Cytogen and a Third Party relating to the same Cytogen
Know-How licensed to Savient. If Cytogen, subsequent to entering into such a
license agreement with Savient, licenses the same Cytogen Know-How to a Third
Party under financial terms that are more favorable to the licensee than the
terms of the license to Savient, the parties shall amend such license agreement
to include the more favorable financial terms. This Section 8.4 shall survive
termination of this Agreement.
IX. Trademarks.
----------
9.1 Ownership. Savient shall exclusively own all Licensed Trademarks and
---------
the Licensed House Marks, and shall retain the right to use the Licensed House
Marks in the Territory in connection with the marketing and Promotion of any
products other than the
-15-
Licensed Product. Savient shall also retain the right to use the Licensed
Trademark(s) in connection with the marketing and Promotion of the Licensed
Product outside the Field. Cytogen shall have no right to use the Licensed
Trademark(s), or any other marks confusingly similar to the Licensed
Trademark(s), in connection with the Promotion, sale or marketing of any product
other than the Licensed Product.
9.2 Trade Dress. Notwithstanding the foregoing, as soon as reasonably
-----------
practicable after the Effective Date, Cytogen shall prepare and submit to
Savient for Savient's approval (which shall not be unreasonably withheld,
conditioned, or delayed) a sample of Cytogen's trade dress to be utilized to
distribute the Licensed Products in the Territory (the "CYTOGEN TRADE DRESS")
which shall be in accordance with all applicable laws. Cytogen hereby grants to
Savient the right to use, with the right to grant its Affiliates the right to
use, such Cytogen Trade Dress in the Territory solely for the purpose of
performing its obligations under this Agreement. Cytogen shall own and retain
all rights to the Cytogen Trade Dress and all goodwill associated therewith. The
Cytogen Trade Dress shall be used only pursuant to the terms of this Agreement
to identify, and in connection with, the distribution of the Licensed Products
in the Territory, and shall not be used by either party to identify, or in
connection with, the marketing of any other products. Except as otherwise set
forth in this Agreement, Savient's (and its Affiliates') right to use the
Cytogen Trade Dress shall automatically terminate upon the termination or
expiration of this Agreement.
9.3 Selection, Prosecution and Maintenance. The parties shall jointly
----------------------------------------
select a trademark or trademarks to use for marketing and Promotion of the
Licensed Product in the Territory. If it has not already done so, Savient shall
file trademark registration applications for the selected trademark(s) in the
Territory, as the parties agree. All such applications and registrations shall
be deemed to be Licensed Trademarks. Savient shall be responsible for, and have
full control over, the prosecution and maintenance of the Licensed Trademark(s)
and the Licensed House Marks.
9.4 Quality Control. Savient shall exercise full control with respect to
---------------
the nature and quality of the Licensed Product and shall be entitled to monitor
any and all advertising and promotional materials used in connection with the
Licensed Product and bearing the Licensed Trademark(s) and/or Licensed House
Marks, including without limitation, advertisements, press releases, labels,
tags, signs, documents, stationery and product packaging ("PROMOTIONAL
MATERIALS"). Cytogen acknowledges that Savient's trademarks have established
valuable goodwill and are well recognized in the minds of the relevant class of
customers, and Cytogen agrees that the Licensed Products shall substantially
equal to the standard of quality heretofore established and maintained by
Savient and its Affiliates in the operation of its business.
(a) At Savient's reasonable written request, Cytogen shall: (i)
provide specimens of the Licensed Products, Promotional Materials and other
materials reasonably sufficient to enable Savient to further monitor the quality
of the Licensed Products and Promotional Materials offered by Cytogen in
connection with the Licensed Trademark(s) and the Licensed House Marks; and (ii)
permit Savient to inspect [**], during regular business hours and on reasonable
prior written request, the portions of the premises and facilities (except with
respect to current Third Party subcontractors, in such case Cytogen shall only
be required to use commercially reasonable efforts to cause such Third Party to
allow such inspection) where the
-16-
Licensed Products will be stored under the Licensed Trademark(s) and the
Licensed House Marks.
(b) Cytogen agrees to comply with applicable laws and regulations
relating to the use of the Licensed Trademark(s), including, but not limited to,
those laws and regulations which require Cytogen to indicate that it is a
licensee of the Licensed Trademark(s), that Savient owns the Licensed
Trademark(s) and/or Licensed House Marks, and/or that Savient is the source of
the products and/or services sold thereunder.
(c) Cytogen shall comply with all applicable international, federal,
state and local laws, regulations, standards, statutes and guidelines, and
obtain all foreign and domestic government approvals, pertaining to the
publication, sale, distribution, provision, advertising and Promotion of the
Licensed Products.
(d) Cytogen shall not, by any act or omission, tarnish, disparage,
degrade, dilute or injure the reputation of the Licensed Trademark(s) owned by
Savient or its Affiliate and/or the goodwill associated therewith.
9.5 Trademark Marking. If requested by Savient, Cytogen shall use the
------------------
initials "TM" (or (TM)) in association with the Licensed Trademark(s), until
such time as Cytogen is informed that a form of the Licensed Trademark(s) has
been registered for any one or more of the Licensed Products. Within a prompt
and reasonable time thereafter, if requested by Savient, Cytogen shall use the
notation (R) in association with each such registered form of the Licensed
Trademark(s) for any such goods; provided that Savient shall be solely
responsible for the cost of any repackaging of the Licensed Products, if
applicable.
9.6 Trademark Legend. To the extent practicable based on the nature and
----------------
size of the Promotional Material in question, Cytogen shall place on all
Promotional Materials which show the Licensed Trademark(s) and/or the Licensed
House Marks, including product packaging, the legend "The trademarks [list
relevant trademarks] are owned by Savient Pharmaceuticals, Inc. [and/or Rosemont
Pharmaceuticals Ltd.] and are licensed by Cytogen, Inc."
X. PATENT PROSECUTION
------------------
10.1 Savient Patents.
---------------
(a) Savient shall, at its sole cost and expense, prosecute and
maintain all of the patents and applications included within the Licensed
Patents, to the extent it has the rights to do so. Savient shall retain control
over such prosecution and maintenance, including selection of patent prosecution
counsel, but will confer in good faith with Cytogen in developing and
implementing a patent procurement strategy.
(b) If Savient fails to prosecute and maintain the patents and
applications included within the Licensed Patents, Cytogen shall have the right,
but not the obligation, to prosecute and maintain on behalf of Savient such
patents and applications (with Savient's full cooperation). In such case,
Savient shall reimburse Cytogen for all reasonable costs and expenses (including
attorneys' fees) associated with the prosecution of the Licensed Patents and
incurred after the Effective Date. Savient shall (1) make such reimbursement
payments within [**] an
-17-
invoice from Cytogen detailing such costs, or (2) at the election of Cytogen,
credit Cytogen in an amount equal to such reimbursement on the immediately
succeeding invoice rendered to Cytogen.
(c) Cytogen shall cooperate, in all reasonable ways, in connection
with the prosecution of all patent applications included within the Licensed
Patents hereunder.
10.2 Joint Inventions.
----------------
(a) The parties shall keep each other fully and promptly informed as
to such Joint Inventions. Savient will have the first right of election to file
priority patent applications Covering Joint Inventions in any country in the
world except for the Territory and if Savient declines to file such applications
then Cytogen may do so. Cytogen will have the first right of election to file
priority patent applications Covering Joint Inventions in the Territory and if
Cytogen declines to file such applications then Savient may do so.
(b) The party performing the priority patent filings (the "FILING
PARTY") for Joint Inventions pursuant to this Section 10.2 undertakes to perform
the corresponding convention filings from case to case, after having discussed
the countries for foreign filings with the other party. The party not performing
the priority patent filings (the "NON-FILING PARTY") for Joint Inventions
pursuant to this Section 10.2 undertakes, without cost to the Filing Party, to
obtain all necessary assignment documents for the Filing Party, to render all
signatures that shall be necessary for such patent filings and to assist the
Filing Party in all other reasonable ways that are necessary for the issuance of
the patents involved as well as for the maintenance and prosecution of such
patents. The Non-Filing Party shall on request be authorized by the Filing Party
to have access to the files concerning such patents in any patent offices in the
world.
(c) Should the Filing Party decide that it is no longer interested in
maintaining or prosecuting a Joint Patent, it shall promptly advise the other
party thereof. On the written request of such other party, such Joint Patent
shall be assigned to the other party at mutually agreeable terms. If any such
patents or patent applications are assigned to Cytogen, Savient and its
Affiliates shall be granted a worldwide immunity from suit thereunder; and if
any such patents or patent applications are assigned to Savient, Cytogen and its
Affiliates shall be granted a worldwide immunity from suit thereunder.
10.3 General Procedures. Until termination of this Agreement, the parties
------------------
shall observe the following procedures for prosecution of patent applications
for inventions arising from this Agreement:
(a) As soon as one of the parties concludes that it wishes to file a
patent application covering a Joint Invention, it shall immediately inform the
other party thereof and consult about the filing procedures concerning such
patent application. For this purpose, such party will provide the other party
with the determination of inventors and scope of claims as early as possible. If
a party is faced with possible loss of rights if a priority application is not
filed immediately, such communications may take place promptly after filing a
convention application.
(b) The Filing Party shall be obliged to prosecute and reasonably
maintain such applications and any patents resulting therefrom. On request of
the Filing Party, the Non-Filing Party shall cooperate (and cause its employees,
consultants and subcontractors to cooperate with
-18-
the Filing Party), in all reasonable ways, in connection with the prosecution of
all such patent applications relating to Joint Inventions. The Filing Party
shall advise the Non-Filing Party of any substantial action or development in
the prosecution of its patent applications and patents, in particular of the
question of scope, the issuance of, or the rejection of, an interference
involving or an opposition to any respective patent application or patent.
(c) Inventions and other intellectual property made by either party
outside the Field shall be excluded from the provisions of this Agreement and
shall belong solely to the party having made the invention or other intellectual
property.
10.4 Reimbursement for Costs.
-----------------------
(a) Prosecution Costs. For clarity, [**] after the Effective Date in
-----------------
connection with the prosecution and/or maintenance in the Territory of patent
applications and patents included within the Licensed Patents. [**] related to
any Joint Patents incurred after the Effective Date during the Term in
connection with (i) filing and prosecuting such Joint Patents (including patent
applications therefor), and (ii) maintaining such Joint Patents within the
Territory (including, without limitation, patent term extension).
10.5 No Reimbursement of Cytogen Prosecution Costs. Cytogen shall be
-------------------------------------------------
responsible for all costs and expenses incurred by Cytogen in connection with
the prosecution and maintenance in the Territory of any patent applications and
patents solely owned by Cytogen.
XI. ENFORCEMENT AND DEFENSE OF PATENTS
----------------------------------
11.1 Enforcement of Patent Rights.
----------------------------
(a) Notice. If either party becomes aware of any Third Party
------
activity in the Territory that infringes a Licensed Patent or a Joint Patent,
then that party shall give prompt written notice to the other party within ten
(10) business days after gaining knowledge of such infringement or violation.
(b) Savient's Primary Right to Bring Action. Savient shall have the
----------------------------------------
primary right, but not the obligation, to institute, prosecute or control any
action or proceeding, with respect to such Third Party activity, by counsel of
its own choice. If Savient institutes such an action, Cytogen shall confer with
Savient, and Cytogen shall have the right (but not the obligation), at its sole
option, to elect to participate in such action and to pay up to [**] of
Savient's ongoing litigation expenses associated with such action. Cytogen
agrees to be joined as a party to the litigation if it is necessary or
strategically advantageous (as determined by the parties in consultation with
their respective patent litigation counsel) for Cytogen to be included as a
party. Cytogen shall bear its own costs if it is joined as a party to the
litigation.
(c) Allocation of Recovery. In the event that Cytogen decides to pay
----------------------
a portion of Savient's litigation expenses as provided in Section 11.1(b), any
damages or monetary awards (including any settlement payments) recovered by
Savient shall first be applied to reimburse pro rata each party's reasonable
litigation expenses, and the balance shall be shared by the parties in
proportion to the costs and expenses borne by each party. In the event that
Cytogen decides not to pay a portion of Savient's litigation expenses, any
damages or monetary awards (including any
-19-
settlement payments) recovered shall first be applied to reimburse Savient an
amount equal to its reasonable costs and expenses in connection with such
litigation, and then to reimburse Cytogen for its reasonable costs and expenses
in connection with such litigation. Savient shall then retain any remaining
damages or monetary award (including settlement payments), except that Cytogen
shall be entitled to receive [**] of any remaining damages attributable to lost
profits, with Savient receiving the remaining [**] of the lost profits award;
Savient shall be entitled to receive [**] any punitive damages recovered, with
Cytogen receiving the remaining [**] of the punitive damages award.
(d) Cytogen's Right to Bring Action. If Savient fails to bring an
---------------------------------
infringement action under the Licensed Patents or the Joint Patents within a
period of [**] after delivery of the notice set forth in Section 11.1(a), then
Cytogen shall have the right, but not the obligation, to bring and control an
action, with respect to such Third Party activity, by counsel of its own choice.
Savient shall pay or reimburse [**] of Cytogen's ongoing litigation expenses
associated with such action. Any damages or monetary awards recovered shall
first be applied to reimburse Savient an amount equal to its reasonable costs
and expenses in connection with such litigation, and then Savient and Cytogen
shall share that portion of any remaining damages or monetary award, with
Cytogen receiving [**] and Savient receiving [**]. In addition, the net proceeds
of any settlement or award received by Cytogen shall be included in Net Sales
for purposes of determining royalty payments and sales milestone payments for
the period Cytogen received such proceeds; specifically, any amounts received as
damages or in settlement of patent litigation shall be included in Net Sales
during the quarter in which such amounts are received by Cytogen.
(e) Right to Counsel. In any event, the party not bringing an
-----------------
infringement action shall have the right to participate in such action and to be
represented by counsel of its own choice. Except as otherwise set forth herein,
the party not bringing such an infringement action agrees to be joined as a
party to the suit, at the request and expense of the party bringing such action,
and to provide reasonable assistance in any such action, at the requesting
party's expense.
11.2 Defense of Third Party Claims.
-----------------------------
(a) Notice. If a patent infringement claim is brought by a Third
------
Party against Savient or Cytogen that any activity conducted pursuant to this
Agreement or the use, manufacture, sale, offer for sale, or importation of the
Licensed Product in the Field in the Territory infringes the intellectual
property rights of such Third Party, such party will give prompt written notice
to the other party of such claim.
(b) Indemnification; Reimbursement. If such claim is based solely on
------------------------------
the manufacture, sale, offer for sale, or importation of the Licensed Product,
then Savient shall defend and hold harmless Cytogen against any such claim and
any resulting suit at its expense and shall indemnify Cytogen against any
resulting judgments and settlements. In such case, Savient shall have full
control the defense of the lawsuit, including the selection of patent litigation
counsel, provided that Savient shall not settle any claim or suit in a manner
that would negatively affect Cytogen without obtaining Cytogen's prior written
consent, which shall not be unreasonably withheld, conditioned, or delayed. It
shall be deemed reasonable for Cytogen to withhold consent if any proposed
settlement does not grant Cytogen and its Affiliates a full and unconditional
release of all claims.
-20-
(c) Cytogen's Defense of Certain Actions. Cytogen shall defend at its
------------------------------------
own cost any infringement suit that may be brought against Savient or Cytogen
based solely on Cytogen's method of marketing, promoting, detailing,
distributing or selling the Licensed Product, and shall indemnify and hold
Savient harmless against any such patent or other infringement suits, and any
claims, losses, damages, liabilities, expenses, including reasonable attorneys'
fees and cost, that may be incurred by Savient therein or in settlement thereof.
Cytogen shall have full control the defense of the lawsuit, including the
selection of patent litigation counsel, provided that Cytogen shall not settle
any claim or suit in a manner that would negatively affect Savient without
obtaining Savient's prior written consent, which shall not be unreasonably
withheld, conditioned, or delayed. It shall be deemed reasonable for Savient to
withhold consent if any proposed settlement does not grant Savient and its
Affiliates a full and unconditional release of all claims.
11.3 Right to Counsel. Each party to this Agreement shall always have the
----------------
right to be represented by counsel of its own selection and its own expense in
any suit or other action instituted by the other for infringement, under the
terms of this Agreement.
XII. TERM AND TERMINATION
--------------------
12.1 Term. Unless earlier terminated pursuant to the terms of this Article
----
XII, this Agreement shall go into effect on the Effective Date and shall
continue until the later of: (i) the expiry of the last-to-expire Licensed
Patent Covering the Licensed Product in the Territory; or (ii) [**] from the
date of Commercial Launch of the Licensed Product in the Territory. The period
of time from the Effective Date until the date of expiration or termination
shall be referred to as the "TERM" (inclusive of any Renewal Term).
(a) Renewal Term. The Term shall automatically extend for an
-------------
additional one (1) year period (the "Renewal Term") unless either Party notifies
the other Party in writing at least [**] prior to any scheduled expiration of
the original Term or any Renewal Term that the Party does not wish to extend the
Term of this Agreement.
12.2 Termination for Breach. Each non-breaching 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 undisputed payment defaults, within [**]
after provision of written notice thereof by the Non-Breaching Party. The
effective date of termination under this Section 12.2 for an unremedied breach
of a material obligation shall be the date [**] (or, in the case of an
unremedied undisputed payment default, [**] after provision of written notice
thereof by the Non-Breaching Party.
12.3 Termination for Insolvency. 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,
-21-
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) the other party 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;
(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
(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. For avoidance of doubt,
all rights and licenses granted under or pursuant to any section of this
Agreement are, and shall otherwise be deemed to be, for purposes of Section
365(n) of the U.S. Bankruptcy Code, licenses of "intellectual property" as
defined thereunder. The parties shall retain and may fully exercise all of their
respective rights and elections under the Bankruptcy Code; provided, however,
that should Savient become a party to a bankruptcy proceeding and such
proceeding is not dismissed within [**] then, to the extent permitted by law,
this Agreement and the licenses granted by Savient hereunder shall be adopted by
any bankruptcy trustee or relevant third party charged with the disposition of
same, and shall not be rejected by same, it being the parties' intent that, in
such event, Cytogen and its Affiliates and sublicensees shall be entitled to
retain the rights granted to them hereunder by Savient.
12.4 Termination Based on Sales. If the total TRx (tamoxifen
--------------------------------
prescriptions) for [**] is less than [**], then either party shall have the
right, upon written notice to the other party, to demand a meeting with the
other party to discuss the impact of the decline in tamoxifen prescriptions on
this Agreement. In such event and after receipt of such written notice, the
parties shall negotiate in good faith for a period of [**] in order to agree on
the impact on this Agreement and to agree on an amendment, if appropriate, to
the terms of this Agreement to account for such impact. If the parties are
unable to reach an agreement after [**] of negotiation, then either party may
terminate this Agreement upon [**] written notice to the other party.
12.5 Termination by Savient. Savient shall have the right (but not the
------------------------
obligation), upon [**] written notice to either (i) terminate this Agreement in
its entirety, or at Savient's option, (ii) convert Cytogen's exclusive license
to a non-exclusive license if Cytogen ceases to market the Licensed Product in
the Territory (other than for safety reasons) for a period of six months or
more, except where Cytogen's inability to market the Product in the Territory is
caused by Savient's or Rosemont's actions or failure to meet their obligations
under this Agreement or under the Supply Agreement respectively.
12.6 Termination by Cytogen. Cytogen may terminate this Agreement in its
-----------------------
entirety, (a) upon [**] written notice, if the Licensed Product is withdrawn
from the market or recalled in
-22-
the Territory for safety reasons, and has been off the market for at least six
(6) months, and the parties agree that there is no reasonable prospect for the
reintroduction of the Licensed Product.
12.7 Mutual Termination. This Agreement may be terminated at any time by a
------------------
written agreement signed by both Parties.
12.8 Termination for Force Majeure Event. Notwithstanding anything to the
-----------------------------------
contrary contained in this Agreement, in the event a force majeure event shall
have occurred and be continuing for [**], 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.
12.9 Consequences of Termination.
---------------------------
(a) Upon termination of this Agreement, any and all affected rights
and licenses granted by Savient to Cytogen shall terminate on the effective date
of termination, except as otherwise set forth herein. For avoidance of doubt,
any licenses granted by Cytogen to Savient shall continue and shall survive
termination of this Agreement.
(b) 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 to market and sell all Licensed Product which are fully
manufactured and in Cytogen's (including its Affiliates') and/or its
sublicensees' inventory at the date of such expiry or termination for a period
of time not to exceed [**] (the "TAIL PERIOD") (provided that such sales shall
be subject to the royalties and milestone payment obligations under Article VI
of this Agreement, as well as all payment obligations under the Supply
Agreement).
(c) Upon 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.
(d) Upon termination of this Agreement due to a material breach by
Cytogen, at Savient's sole discretion, Savient may offer to purchase all or part
of Cytogen's remaining inventory of Licensed Product at Cytogen's cost;
provided, however, that if Savient does not purchase Cytogen's inventory, then
Savient shall grant Cytogen a license to continue selling the Licensed Product
for a period of time not to exceed [**], subject to Savient's receipt of
royalties and milestone payments for such sales in accordance with Article VI of
this Agreement, as well as all payment obligations under the Supply Agreement.
(e) Upon expiry or termination of this Agreement for any reason other
than Savient's breach, Cytogen shall assign to Savient, at no cost to Savient,
all rights and title to: (i) the Cytogen Trade Dress; (ii) the Prescriber Data;
and (iii) all know-how, data and information related to the marketing, Promotion
or Detailing of the Licensed Product. If the Agreement is terminated because of
Savient's breach, then Savient shall pay Cytogen fair and reasonable
compensation to be negotiated in good faith by the parties (but not to exceed
Cytogen's reasonable out-of-pocket expenses incurred in transferring such data
and information) to compensate Cytogen for its transfer to Savient of the
above-described rights, data and information.
-23-
12.10 Non-Exclusive Remedy for Breach. In the event of breach, the
----------------------------------
Non-Breaching Party may terminate this Agreement, as specified in Section 12.2,
but may also seek damages or other remedies to which the Non-Breaching Party may
be entitled. The provisions of Section 12.2 are not intended to be exclusive and
are without prejudice to the rights of the parties to enforce any other rights,
and seek any other remedies, which they may have under this Agreement or
otherwise..
12.11 Survival. Unless expressly provided to the contrary, the provisions
--------
of Sections 2.2, 4.2, 4.7, 7.2, 7.3, 7.4, 7.5, 11.2, 12.8 and 12.10, and
Articles VI, VIII, X, XIII, XIV and XV shall survive the termination of this
Agreement and shall expire on their own terms, or if no expiration is expressly
indicated therein, shall continue indefinitely.
XIII. CONFIDENTIALITY, DISCLOSURE AND PUBLICATIONS
--------------------------------------------
13.1 Treatment of Confidential Information. Except as provided below, the
-------------------------------------
parties agree that during the Term, and for a period of [**] thereafter, each
party (the "RECEIVING PARTY") shall (i) 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), (ii) not disclose such Confidential
Information to any Third Party without prior written consent of the Disclosing
Party, except for disclosures made in confidence to any Third Party, and (iii)
not use such Confidential Information for any purpose except those permitted by
this Agreement. Each party shall neither disclose to the other party nor induce
the other party to use any secret or Confidential Information belonging to a
Third Party.
13.2 Exceptions. Notwithstanding the foregoing, the Receiving Party shall
----------
have no such confidentiality obligations with respect to any portion of the
Confidential Information of the Disclosing Party that:
(a) at the time of disclosure by the Disclosing Party to the
Receiving Party, was generally available to the public, or after such
disclosure, becomes generally available to the public through no fault
attributable to the Receiving Party or its Affiliates; or
(b) was known to the Receiving Party or its Affiliate, without
obligation to keep it confidential, prior to when it was received from the
Disclosing Party; or
(c) 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
(d) is demonstrated by the Receiving Party by competent written
proof, has been independently developed by the Receiving Party or its Affiliate
who do not have access to or knowledge of such Confidential Information; 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
-24-
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.
13.3 Authorized Disclosures. Nothing in this Agreement shall prohibit the
-----------------------
Receiving Party from disclosing Confidential Information of the Disclosing
Party, as well as the terms and conditions of this Agreement, to:
(a) the Receiving Party's Affiliates, officers, employees, agents,
consultants, sublicensees, advisors (other than professional advisors), clinical
institution and investigators, and contract manufacturers and suppliers, if any,
but only on a need-to-know basis for purposes provided for in this Agreement,
provided such disclosure occurs pursuant to a confidentiality agreement
containing provisions at least as protective as those of this Article XIII;
(b) the Receiving Party's board of directors and professional
advisors (such as attorneys and accountants) bound by a duty of confidentiality;
or
(c) potential collaborators, acquirers or merger candidates, provided
such disclosure occurs pursuant to a confidentiality agreement containing
provisions at least as protective as those of this Article XIII.
13.4 Publicity. All publicity, press releases, and other public
---------
announcements relating to this Agreement or the performance hereunder other than
publications described in Section 13.5 below shall be reviewed in advance by,
and subject to the approval of, both parties (which approval shall not be
unreasonably withheld, conditioned, or delayed); provided, however, that any
disclosure which a party is required by law or any listing or securities trading
agreement concerning its publicly traded securities, based upon advice of such
party's counsel, may be made without the prior consent of the other party,
although the other party shall be given prompt notice (but in no event later
than the time the actual disclosure is made) of any such legally required
disclosure and to the extent practicable, the disclosing party shall provide the
other party an opportunity to comment on the proposed disclosure. .
13.5 Publications.
------------
(a) Each party agrees that it shall not publish or present to the
public the results of non-clinical scientific studies or clinical trials related
to the Licensed Product in the Field without the opportunity for prior review by
the other party.
(b) If a party (the "PUBLISHING PARTY") wishes to publish or to
present to the public such results, then it shall provide the other Party (the
"NON-PUBLISHING PARTY") the opportunity to review the Publishing Party's
proposed abstracts, manuscripts or presentations (including public oral
presentations) that relate to any Licensed Product at least [**] prior to its
intended submission for publication or presentation. The Non-Publishing Party
shall review the abstract, manuscript or presentation (the "PUBLICATION") to
determine whether the Publication contains subject matter for which patent
protection should be sought, or whether the manuscript contains Confidential
Information belonging to the Non-Publishing Party. If the Non-Publishing Party
consents publishing or presenting the Publication or fails to object to the
Publication within
-25-
[**] after receipt of the Publication, then the Disclosing Party shall be free
to submit, publish or otherwise disclose such Publication.
(c) If the Non-Publishing Party believe the Publication discloses
Confidential Information or a patentable invention belonging to the
Non-Publishing Party, then prior to the expiration of the [**] period from the
date of receipt of such Publication by the Non-Publishing Party, the
Non-Publishing Party shall notify the Publishing Party in writing of its
determination that such Publication contains Confidential Information or subject
matter for which patent protection should be sought. On receipt of such written
notice, the Publishing Party shall either: (i) redact any Confidential
Information identified by the Non-Publishing Party (if the Non-Publishing
Party's objection is that the Publication contains Confidential Information
belonging to the Non-Publishing Party), or (ii) delay public disclosure or
submission of the Publication for an additional period of sixty (60) days to
permit preparation and filing of a patent application on the disclosed subject
matter (if the Non-Publishing Party has identified potentially patentable
subject matter). For clarity, a party may publicly disclose without regard to
the preceding requirements of this Section 13.5 any information that was
previously disclosed in a publication pursuant to this Section 13.5.
XIV. DISPUTE RESOLUTION
------------------
14.1 Arbitration. 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")
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 [**] of receipt of notice of the intent to arbitrate. If the issues in
dispute involve 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 [**] 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 [**] of the
service of the award.
14.2 Waiver. 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
-26-
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.
14.3 No Limitation on Injunctive Relief. 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.
XV. INDEMNIFICATION
---------------
15.1 Indemnification by Cytogen. Cytogen agrees to defend, indemnify and
--------------------------
hold harmless Savient, its trustees, directors, officers, agents and employees
from and against any and all Third Party suits, claims, acts, liabilities,
demands, damages, expenses, and losses of any kind ("Losses"), including those
resulting from death, personal injury, illness or property damage arising (i)
out of the distribution, use, testing/handling, promotion, marketing, sale or
storage, by Cytogen, an Affiliate of Cytogen, or any distributor, sublicensee or
representative of Cytogen or anyone in privity therewith (other than Savient),
of any Licensed Product in the Territory, except where such Loss is proximately
caused by Savient's revisions to Promotional Materials, which revisions were
specifically objected in writing to by Cytogen; (ii) out of any breach by
Cytogen of any representation, warranty or covenant of this Agreement; (iii) out
of any violation of applicable law by an action, policy or procedure of Cytogen
or its Affiliates; or (iv) out of any negligence or willful misconduct of
Cytogen or its Affiliates; in each case except to the extent that such Losses
are subject to indemnification by Savient pursuant to Section 15.2.
15.2 Indemnification by Savient. Savient agrees to defend, indemnify and
--------------------------
hold harmless Cytogen, its trustees, directors, officers, agents and employees
harmless from and against any and all Third Party Losses, including those
resulting from death, personal injury, illness or property damage arising (i)
out of the development, manufacture, distribution, use, testing/handling,
promotion, marketing, storage, or sale or other disposition, by Savient, an
Affiliate of Savient, or any distributor, sublicensee or representative of
Savient or anyone in privity therewith (other than Cytogen), of any Licensed
Product; (ii) out of any breach by Savient of any representation, warranty or
covenant of this Agreement; (iii) out of any violation of applicable law by an
action, policy or procedure of Savient or its Affiliates; (iv) out of any
negligence or willful misconduct of Savient or its Affiliates; (v) as a result
of any claim of infringement, misuse, or misappropriation of any proprietary
rights of a Third Party, including patent and trademark infringement, relating
to the manufacture or sale of Licensed Product, or to any of the Licensed House
Marks, Licensed Know-How, Licensed Patents, or Licensed Trademarks hereunder;
(vi) out of any acts or omissions of the sales representatives of Savient
(including its Affiliates) or its Third Party licensees in promoting the
Licensed Product outside the Territory; or (vii) any failure by Savient to
implement a withdrawal or recall of the Licensed Product in the Territory.
15.3 Procedure. In the event of a claim by a Third Party against a party
---------
entitled to indemnification under this Agreement ("INDEMNIFIED PARTY"), the
Indemnified Party shall promptly notify the other party ("INDEMNIFYING PARTY")
in writing of the claim and the Indemnifying Party shall undertake and solely
manage and control, at its sole expense, the
-27-
defense of the claim and its settlement. The Indemnified Party shall cooperate
with the Indemnifying Party, including, as requested by the Indemnifying Party
and at the Indemnifying Party's cost, entering into a joint defense agreement.
The Indemnified Party may, at its option and expense, be represented in any such
action or proceeding by counsel of its choice. The Indemnifying Party shall not
be liable for any litigation costs or expenses incurred by the Indemnified Party
without the Indemnifying Party's written consent. The Indemnifying Party shall
not settle any such claim unless such settlement fully and unconditionally
releases the Indemnified Party from all liability relating thereto, unless the
Indemnified Party otherwise agrees in writing.
XVI. MISCELLANEOUS
-------------
16.1 Mutual Representations and Warranties. Each party represents and
---------------------------------------
warrants to the other party hereto that, except as may otherwise be disclosed in
writing to such party:
(a) it has the full right and authority to enter into this Agreement
and to perform its obligations hereunder;
(b) it is duly organized, validly existing, and in good standing
under the laws of its jurisdiction of incorporation;
(c) this Agreement is a legal and valid obligation binding upon it
and is enforceable in accordance with its terms, subject to applicable
limitations on such enforcement based on bankruptcy laws and other debtors'
rights;
(d) its execution, delivery and performance of this Agreement will
not conflict in any material fashion with the terms of any other agreement or
instrument to which it is or becomes a party or by which it is or becomes bound,
nor violate any law or regulation of any court, governmental body or
administrative or other agency having authority over it;
(e) neither it, nor any of its employees or agents performing
hereunder, are listed on the debarment list maintained by the FDA pursuant to 21
U.S.C. ss. 335(a) and ss. 335(b).
(f) such party has obtained all consents, approvals and
authorizations of all government authorities and other persons required to be
obtained by it as of the Effective Date in connection with the execution,
delivery and performance of this Agreement; and
(g) no agent, broker, investment banker, financial advisor or other
person, is or will be entitled to any brokers' or finder's fee or any other
commission or similar fee in connection with any of the transactions
contemplated by this Agreement from such party.
16.2 Cytogen Covenants, Representations and Warranties.
-------------------------------------------------
(a) Compliance with Law. Cytogen covenants that it shall comply, and
-------------------
cause its employees, sublicensees and agents to comply, with all federal, state,
provincial, territorial, governmental, and local laws, rules, and regulations
applicable to the Promotion, Detailing, and commercialization of the Licensed
Product, including without limitation, with respect to the Territory, the
Prescription Drug Marketing Act, the Federal Food, Drug and Cosmetics Act of
-28-
1938, as amended (the "ACT"), the Health Insurance Portability and
Accountability Act ("HIPAA"), the Federal Anti-Kickback Statute, and any
applicable FDA regulations relating to sampling practices.
(b) Financial Condition. Cytogen represents and warrants that it
--------------------
presently has the financial and operational resources to commercialize the
Licensed Products in the Territory in accordance with this Agreement. Cytogen
further represents and warrants that, as of December 31, 2005, Cytogen had on
hand approximately $30.3 million in cash, cash equivalents and short-term
investments.
16.3 Savient Covenants, Representations and Warranties
-------------------------------------------------
(a) Exclusivity, NDA and Intellectual Property. Savient hereby
----------------------------------------------
represents and warrants to Cytogen that, with respect to the Licensed Product,
as of the Effective Date: (i) it has not previously granted, and is not
currently obligated to grant, to any Third Party the rights granted to Cytogen
hereunder in the Field in the Territory with respect to the Licensed Product,
(ii) NDA # 21-807 is owned by Savient and is in effect with respect to the
Licensed Product, (iii) Savient Controls all patents and patent applications
listed on Schedule 1.24, and (iv) to the best of Savient's knowledge as of the
Effective Date, no person other than Savient or its Affiliates has any right,
title or interest in any of the Licensed Know-How or Licensed Patents, in each
case Controlled by Savient or its Affiliates as of the Effective Date.
(b) Compliance with Law. Savient covenants that it shall comply, and
-------------------
cause its employees and agents to comply, with all federal, state, provincial,
territorial, governmental, and local laws, rules, and regulations applicable to
the development, manufacture, Promotion, use and sale of the Licensed Product,
including without limitation, with respect to the Territory, the Prescription
Drug Marketing Act, the Act, HIPAA, the Federal Anti-Kickback Statute, and any
applicable FDA regulations in connection therewith. Savient and its Affiliates
have complied, and will continue to comply, in all material respects, with all
applicable laws, permits, governmental licenses, registrations, approvals,
concessions, franchises, authorizations, orders, injunctions and decrees,
including the Act, in the development, manufacture, Promotion, use and sale of
the Licensed Products in the Territory.
16.4 Assignment.
----------
(a) By Cytogen. Cytogen may assign this Agreement and the licenses
----------
herein granted to: (i) any Affiliate without Savient's consent; (ii) any Third
Party purchaser of all or substantially all of Cytogen's business to which this
Agreement relates, without Savient's consent but with prior written notice to
Savient at least sixty (60) days prior to consummation of such transaction; or
(iii) any Third Party other than a Third Party purchaser of Cytogen's business,
only with the prior written consent of Savient, such consent not to be
unreasonably withheld; provided, however, that, in all cases, Cytogen remains
fully liable for the performance of its obligations hereunder by such assignee.
(b) By Savient. Savient may assign this Agreement and its rights
-----------
hereunder to: (a) any Affiliate without Cytogen's consent, provided that Savient
remains fully liable for the performance of its obligations hereunder by such
Affiliate, (b) any Third Party purchaser of all or
-29-
substantially all of Savient's business to which this Agreement relates or of
all or substantially all of Rosemont's business to which this Agreement relates,
without Cytogen's consent; or (c) any Third Party other than a Third Party
purchaser of Savient's business, only with the prior written consent of Cytogen,
such consent not to be unreasonably withheld. If Savient assigns this Agreement
to a Third Party purchaser of Savient's or Rosemont's business, then Savient
shall ensure that such Third Party purchaser agrees to be responsible for the
obligations set forth in this Agreement to the extent that such obligations are
incurred after the effective date of such assignment.
(c) This Agreement shall be binding on and shall inure to the benefit
of the permitted successors and assigns of the parties hereto.
16.5 Entire Agreement; Modification. This Agreement (including its
---------------------------------
schedules, exhibits and appendices) together with the Supply Agreement,
constitutes the entire agreement between the parties hereto with respect to the
subject matter herein and supersedes all previous agreements, whether written or
oral. This Agreement shall not be changed or modified orally, but only by an
instrument in writing signed by both parties.
16.6 Force Majeure. If either party is delayed, interrupted in or
--------------
prevented from the performance of any obligation hereunder by reason of force
majeure, including an act of God, fire, flood, earthquake, war (declared or
undeclared), public disaster, act of terrorism, governmental enactment, rule or
regulation, or any other cause beyond such party's control, such party shall not
be liable to the other therefor; and the time for performance of such obligation
shall be extended for a period equal to the duration of the force majeure which
occasioned the delay, interruption or prevention. The party invoking such force
majeure rights of this Section 16.6 must (a) notify the other party by courier
or overnight dispatch (e.g., Federal Express) within a period of [**] of both
the first and last day of the force majeure unless the force majeure renders
such notification impossible in which case notification will be made as soon as
possible and (b) uses commercially reasonable efforts to cause the event of the
force majeure to terminate, be cured or otherwise ended, to the extent possible.
16.7 Severability. If any provision of this Agreement is declared invalid
------------
by an arbitrator pursuant to Article XIV or by a court of last resort or by any
court or other governmental body from the decision of which an appeal is not
taken within the time provided by law, then this Agreement will be deemed to
have been terminated only as to the portion thereof that relates to the
provision invalidated by that decision and only in the relevant jurisdiction,
but this Agreement, in all other respects and all other jurisdictions, will
remain in force; provided, however, that if the provision so invalidated is
essential to the Agreement as a whole, then the parties shall negotiate in good
faith to amend the terms hereof as nearly as practical to carry out the original
intent of the parties, and, failing such amendment, either party may submit the
matter to arbitration for resolution pursuant to Section 14.1.
16.8 Notices. Any notice or report required or permitted to be given under
-------
this Agreement shall be in writing and shall be mailed by certified or
registered mail, or telexed or telecopied and confirmed by mailing, as follows
and shall be effective five (5) days after such mailing:
-30-
If to Savient: Savient Pharmaceuticals, Inc.
One Tower Center, 14th floor
East Brunswick, New Jersey 08816
Attention: Chief Executive Officer
with a copy to: Savient Pharmaceuticals, Inc.
One Tower Center, 14th floor
East Brunswick, New Jersey 08816
Attention: General Counsel
with a second copy to: Rosemont Pharmaceuticals Ltd.
Rosemont House, Yorkdale Industrial Park
Braithwaite Street
Leeds LS11 9XE
England
Attention: Managing Director
If to Cytogen: Cytogen Corporation
650 College Road East, Suite 3100
Princeton, New Jersey 08540
Attention: Chief Executive Officer
with a copy to: Morgan, Lewis & Bockius LLP
502 Carnegie Center
Princeton, New Jersey 08540
Attention: Randall B. Sunberg, Esq.
16.9 Choice of Law. The validity, performance, construction, and effect of
-------------
this Agreement shall be governed by the laws of the State of New Jersey without
regard to any conflicts of law principles.
16.10 Publicity. The parties agree to issue press releases in an
---------
agreed-upon form and format concerning their entry into this Agreement, with the
content of such releases to be approved in advance by the parties. In all other
respects, no party to this Agreement shall use the name of the other parties in
any publicity release without the prior written permission of such other party,
which shall not be unreasonably withheld. The other party shall have a
reasonable opportunity to review and comment on any such proposed publicity
release. Except as required by law, no party hereto shall publicly disclose the
terms of this Agreement or its terms and conditions unless expressly authorized
to do so by the other party, which authorization shall not be unreasonably
withheld. In the event that disclosure is authorized, the parties will work
together to develop a mutually acceptable disclosure.
16.11 Further Assurances. 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),
-31-
all as the other party may reasonably request for the purpose of carrying out
the intent of this Agreement.
16.12 Expenses. 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.
16.13 Independent Contractor. Neither party is, nor will be deemed to be an
----------------------
employee, agent or representative of the other party for any purpose. Each party
is an independent contractor, not an employee or partner of the other party.
Neither party shall have the authority to speak for, represent or obligate the
other party in any way without prior written authority from the other party.
16.14 No Waiver. Any omission or delay by either party at any time to
----------
enforce any right or remedy reserved to it, or to require performance of any of
the terms, covenants or provisions hereof, by the other party, shall not
constitute a waiver of such party's rights to the future enforcement of its
rights under this Agreement. Any waiver by a party of a particular breach or
default by the other party shall not operate or be construed as a waiver of any
subsequent breach or default by the other party.
16.15 No Implied Licenses. 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.
16.16 No Strict Construction. This Agreement has been prepared jointly by
----------------------
the parties and shall not be strictly construed against either party.
16.17 Headings. The captions used herein are inserted for convenience of
--------
reference only and shall not be construed to create obligations, benefits, or
limitations.
16.18 Counterparts. 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.)
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IN WITNESS WHEREOF, the parties have executed this Exclusive Distribution
Agreement through their duly authorized representatives to be effective as of
the Effective Date.
SAVIENT PHARMACEUTICALS, INC. CYTOGEN CORPORATION
By: /s/ Philip K. Yachmetz By: /s/ William J. Thomas
-------------------------------------- --------------------------------
Name: Philip K. Yachmetz Name: William J. Thomas
------------------------------------- -----------------------------
Title: EVP, and Chief Business Officer Title: SVP & General Counsel
----------------------------------- ----------------------------
Date: April 21, 2006 Date: April 21, 2006
------------------------------------- -----------------------------
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SCHEDULE 1.24
LICENSED PATENTS
----------------
- --------------------------------------------------------------------------------
TITLE INVENTOR APP. NO. FILING DATE PATENT NO. ISSUE DATE
- --------------------------------------------------------------------------------
Oral Liquid Roger Tully 09/106,172 6/26/98 6,127,425 10/3/00
Medicine Solution
- --------------------------------------------------------------------------------
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SCHEDULE 1.26
LICENSED TRADEMARKS
-------------------
- --------------------------------------------------------------------------------
TRADEMARK APP. NO. FILING DATE REG. NO. ISSUE DATE
- --------------------------------------------------------------------------------
SOLTAMOX 78/401,536 4/14/04 N/A N/A
- --------------------------------------------------------------------------------
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EXHIBIT A
FORM OF MANUFACTURE AND SUPPLY AGREEMENT
----------------------------------------
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