CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS
PRODUCT
PURCHASE AND SUPPLY AGREEMENT
This Product Purchase and Supply Agreement (together with its exhibits, the
"AGREEMENT") is entered into by and between Cytogen Corporation ("CYTOGEN"),
with offices at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ and
Oncology Therapeutics Network, J.V., (the "DISTRIBUTOR"), a Delaware limited
partnership, with offices at ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇., ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, effective as of June 20, 2006 (the "Effective
Date").
R E C I T A L S
- - - - - - - -
WHEREAS, Cytogen, or its licensors, will from time to time file
applications with the United States Food and Drug Administration for approval to
market and sell its pharmaceutical products, in the United States; and
WHEREAS, Cytogen intends to appoint Distributor to provide distribution
services to users of its products listed in EXHIBIT A; and
WHEREAS, Distributor, together with its third party logistics provider (if
applicable), possesses the expertise to warehouse and distribute pharmaceutical
products; and
WHEREAS, Cytogen is willing to appoint Distributor as a distributor of its
products on the terms and conditions set forth in this Agreement and Distributor
is willing to accept such appointment.
NOW, THEREFORE, in consideration of the above recitals, the terms and
conditions hereinafter set forth, and other good and valuable consideration, the
receipt and sufficiency of which are acknowledged, the Parties agree as follows:
1.0 DEFINITIONS
1.1. "Agreement" means this Product Purchase and Supply Agreement,
---------
together with all exhibits, appendices and statements of work
attached hereto, as amended from time to time by the Parties in
accordance with Section 14.5.
1.2. "Applicable Law" means all applicable ordinances, rules,
----------------
regulations, laws, guidelines, guidance, requirements and court
orders of any kind whatsoever of any United States government,
state government (including, without limitation, any State Board
of Pharmacy) as amended from time to time.
1.3. "Confidential Information" has the meaning set forth in Section
-------------------------
11.3.
1.4. "Cytogen Contracts" means those contracts between Cytogen and
------------------
customers of Distributor.
1.5. "Cytogen Indemnities" has the meaning set forth in Section 7.2.
-------------------
1.6. "Distributor Indemnitees" has the meaning set forth in Section
------------------------
7.1.
1.7. "Parties" means Cytogen and Distributor together, and "Party"
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means either of them as the context requires.
1.8. "United States" means the fifty United States and the District of
-------------
Columbia.
1.9 "Product(s)" means the pharmaceutical products distributed under
----------
this Agreement, as set forth in the Product List attached
hereto as EXHIBIT A, as may be added to from time to time.
1.10 "Product Attachment" has the meaning set forth in Section 2.2.
------------------
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2.0 PURCHASE AND SUPPLY COMMITMENTS
2.1. Appointment as Distributor. Cytogen hereby appoints Distributor,
--------------------------
and Distributor hereby accepts appointment, as the exclusive
Distributor of Products listed in EXHIBIT A in the United States.
Products will be added to the Agreement upon the mutual written
agreement of the parties, in accordance with Section 2.2.
Distributor shall not sell Products other than under the terms of
this Agreement without the prior written consent of Cytogen.
Distributor will maintain all facilities, personnel and
infrastructure within compliance of all Applicable Law.
2.2. Product Attachment. For each Product added to the Product List, a
------------------
Product Attachment, in the form of EXHIBIT B (a "Product
Attachment"), will be executed by both parties. When executed,
the Product Attachment will be incorporated in and will become a
part of this Agreement. In the event of any conflict between the
terms of this Agreement and the terms of a Product Attachment,
the Product Attachment will govern.
2.3. Shipping, Distribution and Delivery.
-----------------------------------
2.3.1 Cytogen (or its contract supplier) shall ship Products
to Distributor's warehouse or other facility identified
in its purchase order at such times as may be mutually
agreed when reasonably necessary to fill Distributor's
orders. Henceforth, references in the Agreement to
purchases of Product by Distributor shall include,
where applicable, purchases of Product by a third party
logistics provider. Expedited shipments to Distributor
will require written notification to Cytogen and may
require payment of additional fees. Except for
consignment inventory, title and risk of loss to each
order of Products shipped to Distributor hereunder
shall pass to Distributor at the point of delivery to
Distributor's designated warehouse facilities (F.O.B.
Distributor's warehouse facilities, freight prepaid).
In addition, Distributor shall charge Cytogen, and
Cytogen shall pay, all shipping costs associated with
shipments of Product to customers for orders taken on
behalf of Cytogen.
2.3.2 Cytogen agrees to use its commercially reasonable
efforts to provide Distributor's requirements for
Products in a timely fashion without interruption.
In the event of a shortage of Products, Cytogen
reserves the right to allocate available supplies of
Products amongst all purchasers in its sole discretion.
2.3.3 Distributor shall carefully examine Products upon
delivery and shall notify Cytogen no later than [**]
days following receipt of goods visibly damaged in
transit or receipt of goods that have been in transit
for a period greater than [**]. Along with notice of
any defects, Distributor shall furnish to Cytogen a
detailed description of the nature of the defect. Upon
receipt of notice of any defect, Cytogen, at its
option, shall physically examine and/or issue a return
authorization and replace any defective Product or
issue Distributor a credit in the amount of the
purchase price, less any prompt payment discount and
processing fees. Distributor will, at Cytogen's written
request (in the form of a disposition letter from
Cytogen's Quality Assurance Department) and expense,
follow Cytogen's instructions to dispose of any Product
delivered to Distributor that contains a defect and
will provide Cytogen with a Certificate of Destruction.
Cytogen shall not be otherwise liable to Distributor.
In the absence of written notice from Distributor to
Cytogen in accordance with the terms of this Section
2.3.3, a shipment of any Product shall be deemed to
have been delivered and accepted by Distributor as
complete and in satisfactory condition. Distributor
shall cooperate with Cytogen in investigating the cause
of any defect in a Product.
2.3.4 Distributor agrees to store Products, at all times, in
accordance with the storage requirements [**] set
forth in the approved product labeling for each
Product, which will be provided by Cytogen as part of
the Product Attachment, and which may be amended or
supplemented from time to time by Cytogen in writing.
Distributor will require its customers to comply with
the terms of the approved product labeling for each
Product as a condition of sale. Distributor will ship
Product to its customers using qualified shipping
-2-
procedures and containers so as to maintain the
labeled temperature requirements of the Product.
Distributor also agrees to notify Cytogen immediately
upon excursions in storage conditions at Distributor's
facilities or as reported by Distributor's customers.
Distributor will keep Cytogen informed regarding all
temperature excursion investigations, including,
without limitation, providing Cytogen with all related
documents and reports.
2.3.5 Distributor shall be solely responsible for
implementing and maintaining health and safety
procedures for handling of Products at Distributor's
facilities. Such procedures shall comply with all
applicable laws and regulations. Cytogen shall have no
responsibility for developing, implementing or
overseeing Distributor's health and safety programs.
Cytogen shall provide Distributor with all
information regarding known or potential hazards
associated with Products, and Cytogen shall comply
with all current legislation and regulations concerning
the shipment of Products by land, sea or air.
2.3.6 Cytogen shall accept returns of [**] to obtain, at
Cytogen's option, replacement goods or credit.
Distributor shall, at Cytogen's request, follow
Cytogen's instructions to destroy any such Product and
will provide upon request, a Certificate of Destruction
for all destroyed Product. Cytogen has the right to
change its return policy upon [**] prior written notice
to Distributor.
2.3.7 For any returned drug products (as defined in 21
CFR ss. 211.204), Distributor shall supply to Cytogen
the lot number (or control number or batch number) of
such product, reason for the return, quantity returned,
date of return, and the name of the customer returning
the product.
2.3.8 Cytogen agrees that during the term of this Agreement
or any renewal thereof, it shall not discontinue sale
of Products to Distributor except on [**] prior written
notice unless otherwise required by law or by order of
any governmental or judicial body having jurisdiction
over Cytogen, or in connection with a termination
pursuant to Section 13.
2.3.9 Distributor agrees to use its commercially reasonable
efforts to successfully distribute Products in the
United States.
2.3.10 Distributor agrees to provide written notification to
Cytogen of sales to unrelated third party distributors
and wholesalers within [**] of each such sale.
2.3.11 In the event that a Distributor customer requests drop
shipment of a Product, Distributor agrees to send a
drop shipment request in writing via facsimile to
Cytogen identifying the Distributor customer requesting
the drop shipment, the Distributor customer's address
and phone number to Cytogen's designated drop shipper.
If Cytogen accepts such drop shipment request, Cytogen
shall charge Distributor [**] plus shipping charges
for each drop shipment made to a Distributor customer.
2.3.12 Cytogen shall have the right to designate a third party
to receive notice and manage Cytogen's obligations
under Sections 2.3.3, 2.3.6 or 2.3.7 of this Section 2.
2.3.13 Not more often than [**], Cytogen, or its authorized
representative, will have the right, at Cytogen's sole
cost and expense and upon giving reasonable notice to
Distributor, to visit Distributor's warehouse and other
facilities. During any such visit, Cytogen will have
the right to: (a) inspect the storage facilities; (b)
inspect storage procedures; (c) inspect records,
reports and other documentation pertinent to the
transport or storage of Products (including any
internal quality control audits or reviews conducted
by Distributor), during normal business hours; and (d)
perform a physical count of goods. Notwithstanding
anything to the contrary, Cytogen or its authorized
representative, will have the right to: (A) [**]; and
(B) conduct more than [**] per year where additional
inspection is necessary (i) due to the receipt by
Distributor of any communication from a relevant
regulatory authority threatening supply of the Products
as a result of compliance deficiencies at the storage
facilities, or (ii) if Distributor was
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found to be in material non-compliance of this
Agreement in the last inspection where such
non-compliance relates to the storage of the Products.
2.3.14 Distributor shall aid Cytogen in all Product-related
investigations relative to Adverse Events and Product
Complaints.
2.3.15 Distributor shall secure any governmental or regulatory
approvals, at its own expense, necessary for its
purchase, use or resale of the Products and provide
proof of regulatory notification or approval as
requested by Cytogen.
2.3.16 The intent of the parties with respect to the flow of
inventory under this Agreement is set forth in the flow
chart attached as EXHIBIT D.
3.0 PRICING
3.1. Distributor agrees to pay for each Product based on the purchase
price schedule in the Product Attachment in EXHIBIT B for such
Product, which may be amended from time to time at Cytogen's
discretion. Distributor shall pay Cytogen invoices in accordance
with due dates as specified in EXHIBIT C ("FEE SCHEDULE").
Cytogen agrees to pay OTN minimum management fees of [**] to
cover costs associated [**]. Any commissions or management fees
paid to OTN will be deducted from this amount.
3.2. Distributor will recognize and administer Cytogen Contracts
pursuant to which Cytogen and Cytogen customers have established
prices at which the customer may purchase Product, subject to the
continued validity of Cytogen Contracts in accordance with
applicable law, including without limitation the Federal
Anti-kickback statute, 42 U.S. ss.1320a-7b. The wholesale
acquisition cost to be charged by Cytogen to Distributor for
Product shall be set forth in the Product Attachment in EXHIBIT B
for such Product.
4.0 OTHER SERVICES
4.1 Cytogen and Distributor may develop and enter into one or more
Statements of Work incorporating a description of additional
services requested by Cytogen (each, and as modified by the
parties from time to time, an "SOW"). Such services shall be paid
---
on a fee-for-service basis and each SOW will set forth project
scope, schedule, project activities and tasks, payment terms,
Distributor personnel to be dedicated to the Work and roles and
responsibilities of the parties. Distributor will provide the
services described in each SOW (the "Work"). To the extent there
----
are any conflicts between this Agreement and any SOW, the
provisions of this Agreement shall control.
5.0 GENERAL WARRANTIES
5.1 Cytogen Representations and Warranties. Cytogen represents and
----------------------------------------
warrants that upon delivery to Distributor, Products shall: (a)
be in compliance with applicable law and all regulatory
requirements of the Food and Drug Administration ("FDA"),
including those related to the adulteration or misbranding of
products within the meaning of Sections 501 and 502 of the Food
Drug and Cosmetics Act ("FDCA"); (b) not be articles which may
not be introduced into interstate commerce pursuant to the
requirements of Sections 505, 514, 515, 516 or 520 of the FDCA;
and (c) be manufactured in accordance with current FDA Good
Manufacturing Practices as required by 21 C.F.R. ▇▇.▇▇. 210 and
820.
THE WARRANTIES IN SECTION 5.1 ARE THE SOLE AND EXCLUSIVE
WARRANTIES OF CYTOGEN AS TO THE PRODUCTS, AND ARE EXPRESSLY IN
LIEU OF ANY OTHER WARRANTIES, ORAL OR IMPLIED, INCLUDING WITHOUT
LIMITATION ANY ORAL OR IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR PARTICULAR PURPOSE.
-4-
5.2 Distributor Representations and Warranties. Distributor
-------------------------------------------------
represents and warrants that: (a) it possesses and will maintain
all federal, state and local licenses and permits necessary to
its performance of this Agreement and agrees to comply, in all
material respects, with all Applicable Law; (b) Distributor is
not now nor has in the past been debarred by the United States
Food and Drug Administration under the Generic Drug Enforcement
Act of 1992; (c) Distributor shall properly supervise all persons
performing the services hereunder and shall ensure that any and
all such persons comply with the terms of this Agreement; (d) the
services to be performed under this Agreement will be performed
in a good and workmanlike manner in accordance with standard
industry custom; (e) Distributor has adequate staff and
facilities to complete the services in a timely manner; (f)
Distributor will not infringe the intellectual property rights on
any third party during the performance of its duties hereunder
and the services hereunder; (g) for the duration of the
Agreement, Distributor's warehouse facilities for the Products
shall comply with Applicable Law; and (h) it shall not make any
representation to a third party concerning the Products which has
not been approved or endorsed by Cytogen.
5.3 Representations and Warranties of the Parties. Each of the
--------------------------------------------------
Parties represents and warrants to the other party as follows:
(a) it is duly organized, validly existing and in good standing
under the laws of the state in which it is organized; (b) , (2)
it has the power and authority to carry on its business as it is
now being conducted; (c) it has the power and authority and the
legal right to enter into this Agreement and to perform its
obligations hereunder; (d) it has taken all necessary action on
its part to authorize the execution and delivery of this
Agreement and the performance of its obligations hereunder; (d)
it is in compliance with all requirements of Applicable Laws,
except to the extent that any noncompliance would not materially
adversely affect such party's ability to perform its obligations
under the Agreement; (e) this Agreement has been duly executed
and delivered on behalf of such Party, and constitutes a legal,
valid, binding obligation, enforceable against such Party in
accordance with its terms; (f) all necessary consents, approvals
and authorizations of all regulatory authorities and other
persons required to be obtained by such party in connection with
the Agreement have been obtained; (g) the execution and delivery
of this Agreement and the performance of such Party's obligations
hereunder do not conflict with or violate any requirement of
Applicable Laws and do not materially conflict with, or
constitute a material default or require any consent under, any
contractual obligation of such Party.
6.0 REGULATORY MATTERS
6.1 FDA Clearance. Cytogen represents that, upon delivery to
--------------
Distributor, Products will have been approved by the FDA to be
marketed in the United States, and that all international,
federal and state approvals and permits for the manufacture,
importation, design, testing, inspection, labeling, and
instructions for use, sale and distribution of Products in the
United States have been obtained. Cytogen agrees that it shall be
solely responsible for, and comply with, all applicable
international, federal and state laws governing the regulation of
the manufacture, importation, design, testing, inspection,
labeling, sale, and instructions for use of the Product in the
United States and its Territories.
6.2 Inspections.
-----------
6.2.1 Distributor agrees to cooperate with any inspection
of Product shipment conducted by a governmental agency.
6.2.2 Distributor shall notify Cytogen immediately of any
inspection by any international, federal, state or
local regulatory or governmental representative
concerning Products and shall provide Cytogen with a
copy of the results of such inspection and such
actions, if any, taken to remedy conditions cited in
such inspections. Distributor shall keep Cytogen
informed of all relevant events during any governmental
inspection. Cytogen may, at its discretion and with
agreement of Distributor regulatory personnel, be
present for any governmental inspection should the need
arise.
6.3 Complaints, Adverse Reactions, Recalls.
--------------------------------------
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6.3.1 Each Party agrees to inform the other Party promptly
(but in no event later than [**] after becoming
aware) of any information concerning complaints
involving a Product complaint (as defined in 21 CFR ss.
211.198). Distributor shall supply the name of the drug
product, lot number, name of complainant, and nature of
complaint.
6.3.2 Each Party agrees to inform the other Party promptly
(but in no event later than [**] after becoming aware)
of any information concerning adverse drug experiences
(as defined in 21 CFR ss. 314.80), injury, toxicity,
sensitivity reaction associated with the clinical use
of a Product, whether or not considered related to a
Product, or adulteration or misbranding of a Product by
any distributor, wholesaler or other third party. All
notifications under this Section shall be made by
calling ▇-▇▇▇-▇▇▇-▇▇▇▇ and shall, upon request, be
confirmed by facsimile on Cytogen's designated adverse
event forms (FDA Med Watch Form, 3500A).
6.3.3 If there is a recall or withdrawal of a Product,
Distributor agrees to stop shipping recalled lots
immediately, and in no event later than [**] after
Distributor receives written notification of such
recalls. Distributor shall cooperate fully in any such
recall.
6.3.4 Cytogen agrees to reimburse Distributor for any
documented reasonable costs or expenses (including
reasonable attorneys' fees) that Distributor actually
may incur due to recalls, withdrawals, or replacements
of any Product imposed by Cytogen or the FDA.
Distributor shall prepare a detailed invoice of such
costs or expenses, and undisputed amounts shall be paid
by Cytogen within thirty (30) days of its receipt of
such invoice. Pursuant to Section 8, Cytogen shall have
the right to conduct an audit, or have an independent
auditor conduct and audit, of Distributor's books and
records to verify that such costs and expenses are
properly chargeable in accordance with generally
accepted accounting principles.
6.4 Compliance with Law. Distributor shall at all times during the
--------------------
term of this Agreement comply, with all international, federal
and state laws, regulations and orders applicable to its
operations as a wholesale and/or retail Distributor including,
without limitation, the Federal Anti-kickback Statute, 42 U.S.C.
ss. 1320(a)-7b, and the Federal Self-Referral Law, 42 U.S.C. ss.
1395nn.
6.5 Compliance with Fee, Rebate and Discount Laws. Distributor shall
---------------------------------------------
disclose all fees and/or discounts required to be disclosed under
any state or federal program which provides cost or charge based
reimbursement to Distributor for the Products provided under this
Agreement as required by the applicable laws, including 42 U.S.C.
ss.1320(a)-7b. Distributor further represents and warrants that
it, and any of its Affiliates, are in compliance with, and during
the term of this Agreement covenants that it and its Affiliates
shall remain in compliance with, any federal or state laws
applicable to the fees, rebates or discounts paid by Cytogen
pursuant to this Agreement, including without limitation, any
laws requiring the proper disclosure and/or reporting of fees,
rebates or discounts. Without limiting the generality of the
foregoing, Distributor shall comply with any applicable reporting
requirements to any health care corporation, health care insurer,
other third party payor, or patient pursuant to any federal or
state laws and regulations.
6.6. [**].
7.0 INDEMNIFICATION
7.1 Cytogen will indemnify, defend, and hold harmless Distributor,
its affiliates, parents, subsidiaries, directors, officers,
agents and employees (collectively, "DISTRIBUTOR INDEMNITEES")
from and against, and reimburse Distributor Indemnitees for, any
and all claims, demands, actions, causes of action, losses,
judgments, damages, costs and expenses (including, but not
limited to, reasonable attorneys' fees, court costs and costs of
settlement) arising out of claims against Distributor Indemnitees
arising out of: (a) Cytogen's manufacture of a Product; (b) the
death of, or bodily injury to, any person on account of the use
of a Product, to the extent such death or bodily injury results
from a defect in the design, workmanship or manufacture of that
Product; (c) any recall or withdrawal of a Product; (d) Cytogen's
violation of any applicable law or government regulation;
-6-
(e) any claims that the Distributor's distribution or sale of a
Product infringes the patent or other intellectual property
rights of any third party; or (f) any breach by Cytogen of any of
its representations, warranties, covenants or agreements in this
Agreement. Notwithstanding the foregoing, Cytogen shall have no
indemnification obligation or liability to the Distributor
Indemnitees for loss or damage resulting from any negligent act
or omission or willful misconduct by the Distributor Indemnitees
related to the performance of services under this Agreement.
7.2 Distributor will indemnify, defend, and hold harmless Cytogen,
its affiliates, parents, subsidiaries, directors, officers,
agents and employees (collectively "CYTOGEN INDEMNITEES") from
and against, and reimburse Cytogen Indemnitees for, any and all
claims, demands, actions, causes of action, losses, judgments,
damages, costs and expenses (including, but not limited to,
reasonable attorneys' fees, court costs and costs of settlement)
arising out of claims against Cytogen Indemnitees arising out of:
(a) the death of, or bodily injury to, any person on account of
the use of a Product, to the extent such death or bodily injury
results from Distributor's negligence or willful misconduct; (b)
Distributor's violation of any applicable law or governmental
regulation; or (c) any breach by Distributor of any of its
representations, warranties, covenants or agreements in this
Agreement. Notwithstanding the foregoing, Distributor shall have
no indemnification obligation or liability to the Cytogen
Indemnitees for loss or damage resulting from any negligent act
or omission or willful misconduct by the Cytogen Indemnitees
related to the performance of services under this Agreement.
7.3 Each Party agrees to notify the other Party within [**] of
receipt of any claims made for which the other Party might be
liable under Section 7.1 or 7.2, as the case may be. The
indemnifying Party shall have the right, but not the obligation,
to defend, negotiate and settle such claims; provided; however,
that the indemnified Party shall be entitled to participate in
the defense of such matter and to employ counsel at its expense
to assist therein. The Party seeking indemnification shall
provide the indemnifying Party with such information and
assistance as the indemnifying Party may reasonably request at
the expense of the indemnifying Party. The Parties understand
that no insurance deductible shall be credited against losses for
which a Party is responsible under this Section 6.
7.4 Neither Party shall be responsible or bound by any settlement of
any claim or suit made without its prior written consent;
provided, however, that the indemnified Party shall not
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unreasonably withhold or delay such consent.
8.0 RECORDS AND ACCOUNTING
8.1 During the term hereof and for [**] thereafter, or such longer
period as may be required by law, the Parties shall maintain
accurate records as required to meet applicable local, state and
federal laws and regulations. For the same period, except as
otherwise required by any such laws or regulations, each Party
shall provide the other Party, upon reasonable notice, access to
any requested documentation related to the performance of this
Agreement during reasonable business hours.
9.0 INSURANCE
9.1 Cytogen will maintain in effect during the term of this Agreement
(and for at least [**] thereafter for claims made coverage) a
comprehensive general liability policy and products liability
policy on each Product. This comprehensive insurance policy shall
be in an amount not less than [**] combined Single Limit Bodily
Injury and Property Damage covering its duties and obligations
under the Agreement. Cytogen shall use commercially reasonable
efforts to provide [**] notice to Distributor in the event of any
material modifications, cancellation, or termination thereof.
Cytogen agrees to provide Distributor upon request with a
certificate of insurance evidencing compliance with this Section
9.1 within [**] of execution of this Agreement or any Product
Attachment hereunder.
-7-
9.2 Distributor and, if applicable, logistics provider, collectively
will maintain in effect during the term of this Agreement a
comprehensive general liability policy. This comprehensive
insurance policy shall be in an amount not less than [**] per
occurrence and [**] in the aggregate. Distributor and, if
applicable, logistics provider, shall use commercially reasonable
efforts to insure that insurer will provide [**] notice to
Cytogen in the event of any material modifications, cancellation,
or termination thereof. Distributor agrees to provide Cytogen
upon request with a certificate of insurance evidencing
compliance with this Section 9.2 within [**] of execution of this
Agreement or any Product Attachment hereunder.
10.0 FORCE MAJEURE
10.1 Notwithstanding any provision contained herein to the contrary,
neither Party shall be deemed to be in default hereunder for
failing to perform or provide any of the services or other
obligations to be performed or provided pursuant to this
Agreement if such failure is the result of any labor dispute, act
of God, inability to obtain labor or materials, governmental
restrictions or any other event which is beyond the reasonable
control of the Party. In the event of a force majeure occurrence,
the Party unable to perform shall promptly notify the other Party
in writing and shall use commercially reasonable diligent efforts
to resume performance.
11.0 CONFIDENTIALITY
11.1 Each Party agrees to maintain as confidential both during the
term of this Agreement and thereafter all Confidential
Information provided to it pursuant to this Agreement and shall
not, without the specific written consent of the other Party,
disclose it to any third party (except as required by law) or use
it for its own purpose (except as contemplated herein).
11.2 Each Party acknowledges that it may have heretofore received and
may from time to time hereafter receive Confidential Information
of the other Party, and such Party receiving such Confidential
Information shall do the following:
11.2.1 maintain such Confidential Information in confidence
and not disclose such Information to any third party;
11.2.2 not use such Confidential Information other than in
performance of this Agreement;
11.2.3 disclose such Confidential Information to its employees
or to employees of its affiliates only to the extent
that such employees need to know such Confidential
Information to carry out the receiving Party's
obligations under this Agreement; and
11.2.4 return within [**] of the termination of this
Agreement, or at the request of the other Party, all
documents, papers and other tangible goods and
property, including all copies or reproductions thereof
which contain or reflect Confidential Information.
11.3 As used in this Section 11, "CONFIDENTIAL INFORMATION" shall mean
any and all information including, but not limited to, the terms
and conditions of this Agreement that is or has been disclosed in
writing or orally by either Party to the other Party which is
either confidential or proprietary in nature including any
reports generated herewith; provided, however, that "Confidential
Information" shall not include information which:
11.3.1 is or becomes generally available to the public through
no fault of the receiving Party;
11.3.2 was or becomes known to, or was or is independently
developed by, the receiving Party; provided that it
was or is not acquired, directly or indirectly, from
the disclosing Party or was or is developed without the
use of any Confidential Information of the disclosing
Party; or
11.3.3 is disclosed in good faith to the receiving Party by a
third party lawfully in possession of such information
and who was not under an obligation of nondisclosure to
the disclosing Party with respect of such information.
-8-
11.4 Nothing in this Section 11 shall preclude the following: (a)
disclosures to counsel to a Party for the purpose of monitoring
regulatory compliance or rendering legal advice pertaining to
this Agreement; (b) disclosures to internal or independent
auditors of a Party or (c) disclosures made in accordance with or
pursuant to law, regulation or legal directive including
subpoenas or governmental investigatory inquiry, provided
however, that: (1) such disclosures are limited in scope, (ii)
that company is notified before such disclosure; and (iii) that
the disclosing Party seeks confidential treatment of any
confidential information required to be disclosed.
12.0 JOINT PUBLICITY
12.1 If either Party wishes to make a public announcement concerning
this Agreement or the relationship established hereunder and such
disclosure mentions the other Party by name or description, such
other Party shall be provided with an advance copy of the
disclosure and shall have [**] within which to approve or
disapprove such use of its name or description (including mention
of the name of a Product). Approval shall not be unreasonably
withheld by either Party. Absent approval, no public disclosure
shall use the name of or otherwise describe such Party except to
the extent required by law, or to the extent that the description
of the other Party is limited to public information about the
availability of a Product.
13.0 TERM AND TERMINATION OF AGREEMENT
13.1 Term. This Agreement shall commence upon the Effective Date and
----
shall continue for a term of three (3) years. This Agreement
shall automatically renew for successive additional one (1) year
terms unless, not less than ninety (90) days prior to the
anniversary date, either Party notifies the other of its intent
to terminate this Agreement as of the anniversary date.
13.2 Termination. The initial term of this Agreement or any renewal
-----------
term or any Product Attachment may be terminated only as follows:
13.2.1 Without Cause. This Agreement may be terminated by
--------------
either Party without cause upon one hundred eighty
(180) days' prior written notice to the other Party.
13.2.2 Event of Material Breach: Good Cause. This Agreement
--------------------------------------
may be terminated by either Party if the other Party
shall default in the performance of any of its material
obligations under this Agreement, upon forty-five (45)
days' prior written notice to the other, specifying the
nature of the default, unless such other Party shall
cure that default within the forty-five (45) day notice
period.
13.2.3. Change in Law. This Agreement may be terminated
---------------
immediately by either Party upon providing written
notice to the other if any existing federal or state
law or regulation is changed, if any new law or
regulation is promulgated or if there is made any new
or changed interpretation of any law or regulation such
that the effect of such changed or new law, regulation
or interpretation of any law or interpretation thereof
in connection with this Agreement, would materially
affect either Party's business, pricing policies or the
manner in which either Party does business (including
among such effects a requirement that Cytogen gives to
others any benefit given to Distributor under this
Agreement).
13.2.4. Failure to Comply with Law. Either Party may
--------------------------------
immediately terminate this Agreement upon providing
written notice to the other if any performance under it
by the other Party of this Agreement fails to comply in
all material respects with any Applicable Law,
including without limitation, the laws governing the
testing, approval, sale, storage, packaging or
distribution of a Product or the Anti-kickback Law as
may be amended, supplemented or modified.
13.2.5. Best Price Modification. In the event that the Parties
------------------------
are unable to negotiate a modification of this
Agreement resulting from the establishment of a new
"best price" for a Product or as otherwise required by
law within ten (10) days of Cytogen's notice,
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Cytogen may terminate this Agreement, or the relevant
Product Attachment, immediately.
13.2.6. Insolvency. This Agreement may be terminated by either
----------
Party immediately upon notice to the other, if the
other Party shall make an assignment for the benefit of
creditors, shall file a petition in bankruptcy, is
adjudicated insolvent or bankrupt, or if a receiver or
trustee is appointed with respect to a substantial part
of such other Party's property or a proceeding is
commenced against it which will substantially impair
its ability to perform hereunder.
13.2.7. Effect of Termination. Upon termination or expiration
-----------------------
of this Agreement, Distributor shall return to Cytogen
all Confidential Information of Cytogen.
13.3 Remedies. Each of the Parties to this Agreement shall be entitled
--------
to enforce its rights under this Agreement to recover damages and
costs (including reasonable attorneys' fees) caused by any breach
of any provision of this Agreement and to exercise all other
rights existing in its favor, regardless of any termination of
this Agreement by such breaching Party pursuant to Section 13.
14.0 MISCELLANEOUS
14.1 Choice of Law. This Agreement shall be governed by, interpreted
-------------
and construed under the laws of the State of New York, without
regard to any choice of law principle that would dictate the
application of the law of another jurisdiction.
14.2 Assignment. This Agreement may not be assigned or otherwise
----------
transferred by either Party without the prior written consent of
the other Party; provided, however, that either Party may,
without such consent, but with notice to the other Party, assign
this Agreement, in whole or in part, (a) in connection with the
transfer or sale of all or substantially all of the assets of
such Party or the line of business or a Product to which this
Agreement relates, (b) to the successor entity or acquirer in the
event of the merger, consolidation or change of control of a
Party hereto, or (c) to any Affiliate of the assigning Party. Any
purported assignment in violation of the preceding sentence shall
be void. Any permitted assignee shall assume the rights and
obligations of its assignor under this Agreement.
14.3 Waiver. No waiver of any default hereunder by either Party or any
------
failure to enforce any rights hereunder shall be deemed to
constitute a waiver of any subsequent default with respect to the
same or any other provision hereof. No waiver shall be effective
unless made in writing with specific reference to the relevant
provision(s) of this Agreement and signed by a duly authorized
representative of the Party granting the waiver.
14.4 Notice. All communications and notices from one Party to the
------
other shall be in writing and shall be given by addressing the
same to the other at the address or facsimile number set forth in
this Agreement, or at such address or facsimile number as either
may specify in writing to the other. Communications and notices
to Cytogen will be marked "ATTENTION LEGAL DEPARTMENT." All
notices shall become effective when deposited in the United
States mail with proper postage for first class Registered or
Certified Mail prepaid, return receipt requested, or commercial
courier or when delivered personally, or, if promptly confirmed
by mail or commercial carrier as provided above, when dispatched
by facsimile.
14.5 Amendment. Neither this Agreement nor any of the terms hereof may
---------
be terminated, amended, supplemented, waived or modified orally,
except by an instrument in writing signed by each Party.
14.6 Survival of Provisions. Sections 6.2, 6.3, 7, 8, 9, 11, 12, 13
-----------------------
and 14 herein shall survive the expiration or other
termination of this Agreement.
14.7 Relationship of Parties. Distributor's relationship with Cytogen
-----------------------
hereunder shall be that of independent contractor, and neither
Party shall be considered the agent, partner or employee of or a
joint venture with the other Party, in its performance of all
duties under this Agreement.
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14.8 Cumulative Remedies. Except as expressly provided in this
--------------------
Agreement, and to the extent permitted by law, any remedies
described in this Agreement are cumulative and not alternative to
any other remedies available at law or in equity.
14.9 Severability. In the event that any one or more of the provisions
------------
contained in this Agreement are for any reason held to be
invalid, illegal or unenforceable in any respect, such
invalidity, illegality or unenforceability shall not affect any
other provision of this Agreement, and this Agreement shall be
construed as if such invalid, illegal or unenforceable provision
or provisions had never been included. The parties shall, in good
faith, amend this Agreement to provide, to the extent possible,
each Party with the benefits provided by such invalid or
unenforceable provision.
14.10 Headings. The headings contained in this Agreement are for
--------
reference purposes only and shall not affect in any way the
meaning or interpretation of this Agreement.
14.11 Counterparts. This Agreement may be executed in multiple
------------
counterparts, each of which shall be deemed an original, but all
of which, when taken together, shall constitute one and the same
instrument.
14.12 Trademarks. Subject to the terms and conditions of this
----------
Agreement, Cytogen hereby grants to Distributor's the right to
use the trademarks, trade names and logos for the Products solely
in connection with its distribution of the Products hereunder.
14.13 Employment Solicitation. During the term of this Agreement and
------------------------
for a one year period thereafter, neither Party shall hire,
solicit for hire, or otherwise engage any employee of the other
Party for employment (or the provisions of services under
contract) with the first Party, nor any person that was employed
by the first Party at any time during the three-month period
preceding such hiring, solicitation, or recruitment.
Notwithstanding the foregoing, each Party shall be free to hire
any employee of the other Party who is responding to a general
solicitation.
14.13 Integration. This Agreement, together with all agreements
-----------
attached hereto, constitutes the entire agreement between the
parties with respect to the subject matter hereof, and supersedes
all prior oral or written agreements, commitments or
understandings with respect thereto.
In consideration of the mutual promises and covenants contained herein and
other good and valuable consideration, the undersigned have agreed to be bound
by the terms of this Agreement as of the Effective Date.
ONCOLOGY THERAPEUTICS CYTOGEN CORPORATION
NETWORK, J.V.L.P.
By: /s/ ▇▇▇▇▇ ▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
---------------- --------------------------------
Name: ▇▇▇▇▇ ▇▇▇▇▇ Name: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Title: Vice- President, Operations Title: President and Chief Executive
Officer
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EXHIBIT A
PRODUCT LIST
---------------------------------------------------------------------------------------------------------------------
PRODUCT NAME: SOLTAMOX 10MG/5ML ORAL SOLUTION
---------------------------------------------------------------------------------------------------------------------
PHYSICAL PROPERTIES: INGREDIENTS:
Clear colourless liquid with the odour and Tamoxifen Citrate
flavour of liquorice and aniseed Ethanol
Glycerol
Propylene Glycol
Sorbitol
Liquorice Flavour 545515E
Aniseed Flavour
Purified Water
---------------------------------------------------------------------------------------------------------------------
HAZARD INFORMATION:
Hypersensitivity to some of the ingredients may occur.
---------------------------------------------------------------------------------------------------------------------
FIRST AID: SPILL CLEAN-UP MEASURES:
EYES: Rinse with plenty of clean flowing water or saline Wearing rubber gloves, carefully mop up spilled medicine
solution for 10 minutes, holding the eyelids open. If with an absorbent cloth and rinse the cloth out well
discomfort persists, seek medical attention. under the tap, flushing down with plenty of water. For
larger spills, surround the spill with absorbent
SKIN: Remove contaminated clothing and wash before re-use. material (sand or earth), and then transfer liquid and
Wash the affected area with soap and plenty of water. If solids into a suitable container. Arrange for disposal
soreness or rashes occur, seek medical attention. as chemical waste.
INGESTION: If a significant amount has been ingested, or Once the liquid has been mopped up, wash the area with
if symptoms occur seek medical attention. plenty of water and detergent.
INHALATION: This product does not produce any harmful
fumes.
---------------------------------------------------------------------------------------------------------------------
FIRE HAZARDS: NON-FLAMMABLE
This product is an aqueous solution, and is therefore non-flammable. It may
evolve hazardous fumes under fire conditions.
---------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------------
DATE JULY 2005 VERSION NO. 3
---------------------------------------------------------------------------------------------------------------------
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EXHIBIT B
PRODUCT ATTACHMENT
PRODUCT: SOLTAMOX(R) (TAMOXIFEN CITRATE)
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
Agreed upon this day of June, 2006:
------
ONCOLOGY THERAPEUTICS CYTOGEN CORPORATION
NETWORK, J.V.L.P.
By: /s/ ▇▇▇▇▇ ▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
--------------- ---------------------
Name: ▇▇▇▇▇ ▇▇▇▇▇ Name: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Title: Vice- President, Operations Title: Senior Vice President
and General Counsel
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EXHIBIT C
FEE SCHEDULE
[**]
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