Exhibit 10.2
Confidential Materials omitted and field separately with the
Securities and Exchange Commission. Asterisks denote omissions.
AMENDED AND RESTATED
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MANUFACTURING AND SUPPLY AGREEMENT
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THIS AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT (this
"Agreement") made effective as of January 1, 2004 (the "Effective Date") between
Bristol-Myers Squibb Medical Imaging, Inc., a Delaware corporation, having a
place of business at 331 Treble Cove Road, North Billerica, MA 01862
(hereinafter "BMS") and Cytogen Corporation, a Delaware corporation, having its
principal place of business at 650 College Road East, Suite 3100, Princeton, NJ
08540 (hereinafter "Cytogen").
WHEREAS, BMS manufactures, supplies and distributes the Product
(defined herein) for Cytogen pursuant to the terms and conditions set forth in
such agreement under the Manufacturing and Supply Agreement (the "Supply
Agreement") entered into by BMS and Cytogen as of the Effective Date; and
WHEREAS, the parties desire to amend and restate the Supply Agreement
as amended and restated herein..
NOW THEREFORE, IN CONSIDERATION of the rights conferred and the
obligations assumed herein, and intending to be legally bound, the parties
hereby agree as follows:
1. DEFINITIONS
The following terms shall, unless the context otherwise requires, have
the following meanings, respectively:
1.1 "Active Pharmaceutical Ingredient" or "API" means the chemical
compound samarium-153 complexed with ethylene diaminetetramethylene-phosphoric
acid ("EDTMP").
1.2 "Additional Batch" shall have the meaning ascribed to such term in
Section 3.2.
1.3 "Affiliate" means any corporation or other entity which controls,
is controlled by, or is under common control with a party to this Agreement. A
corporation or other entity shall be regarded as in control of another
corporation or entity if it owns or directly or indirectly controls more than
fifty percent (50%) of the voting stock or other ownership interest of the other
corporation or entity, or has the power to elect or appoint more than fifty
percent (50%) of the members of the governing body of the corporation or other
entity.
1.4 "Batch" means one manufacturing process run within the validated
scale (as defined in the NDA) within BMS' usual range of actual yield.
1.5 "BMS Intellectual Property" means all patents, trademarks, and
other intellectual property rights, including know-how, manufacturing methods,
discoveries, inventions, processes, or methodologies, in any form or stage of
development (and all related documentation), which are proprietary to BMS.
1.6 "Change" shall have the meaning ascribed to such term in Section
2.7(a).
1.7 "Claims" shall have the meaning ascribed to such term in Section
7.1(a).
1.8 "Components" means EDTMP, all labeling material, packaging
material, starting material and intermediates and excipients required for the
manufacture, labeling, and packaging of the Product.
1.9 "Confidential Information" means a party's technology, data,
know-how, or information whether written or oral, technical or non-technical,
including financial statements, reports, pricing, trade secrets, secret
processes, formulas, customer data (including customer lists) and the like, that
relates to the manufacture, packaging, Order processing or distribution of the
Product, and that is disclosed to the other party.
1.10 "cGMP" means current good manufacturing practices as promulgated
under United States Federal Food, Drug and Cosmetic Act at 21 CFR (Chapters 210
and 211).
1.11 "Cost of Manufacture" or "COM" means BMS' cost of manufacture as
described in Section 3.1(a).
1.12 "Cost of Support Services" or "COSS" means BMS' cost of customer
support services as described in Section 3.1(a).
1.13 "Cytogen Included Technology" means all patents, trademarks, and
other intellectual property rights and all know-how and other information
necessary or useful for the manufacture, development, use or sale of the Product
in the Territory to the extent owned, controlled or in-licensed by Cytogen
during the term of this Agreement.
1.14 "Effective Date" shall have the meaning ascribed to such term in
the introductory paragraph.
1.15 "EDTMP" shall have the meaning ascribed to such term in Section
1.1.
1.16 "External Quality Agreement" shall mean the External Quality
Agreement which is attached hereto as Schedule 1 and incorporated herein by
reference.
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1.17 "FDA" means the United States Food and Drug Administration, or any
successor entity thereto.
1.18 "Forecast" shall have the meaning ascribed to such term in Section
2.5(a).
1.19 "Inventory" means all inventories of Components and
work-in-process produced or held by or on behalf of BMS in connection with the
manufacture, packaging and labeling of the Product in accordance with the
Specifications and contract requirements, but shall not include the API.
1.20 "MDPH-RCP" means Massachusetts Department of Public
Health-Radiation Control Program, or any successor entity thereto.
1.21 "NDA" means the approved New Drug Application for Product, as it
may be supplemented or amended from time to time, and documents incorporated
therein by reference.
1.22 "NRC" means the United States Nuclear Regulatory Commission, or
any successor entity thereto.
1.23 "Order(s)" shall mean orders placed for Product (i) for the
benefit of, or on behalf of, Cytogen's customers, or (ii) by Cytogen for
giveaways, clinical use, sales or other uses as Cytogen may deem appropriate.
For the sake of clarity, the parties acknowledge and agree that [**].
1.24 "[**]" shall have the meaning ascribed to such term in Section
3.1(d).
1.25 "Primary Representative" shall have the meaning ascribed to such
term in Section 2.5.
1.26 "Product" means Cytogen's Quadramet(R) (Samarium -153 lexidronam
injection), a formulation containing API manufactured using 3 mL fill in 10 cc
vials by BMS according to the Specifications.
1.27 "Specifications" means the Product, synthesis, formula, processing
specifications, packaging specifications, quality control provisions and quality
assurance provisions contained within the NDA for Product, EDTMP, API, samarium
chloride, all forms of samarium oxide and Components. Specifications shall not
be changed by BMS without the prior written approval of Cytogen.
1.28 "Supply Agreement" shall have the meaning ascribed to such term in
the first Recital.
1.29 "Territory" means the United States, including its territories and
possessions, and Canada.
1.30 "Written Procedure" shall have the meaning ascribed to such term
in Section 4.4.
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2. MANUFACTURE AND SUPPLY OF PRODUCTS
2.1 Manufacture. Subject to the terms and conditions of this Agreement,
Cytogen appoints BMS as its manufacturer of the Product, and BMS accepts such
appointment. In accordance with the terms of this Agreement and as set forth in
Section 2.5(a), BMS will manufacture on behalf of Cytogen, a minimum of [**]
of Product per week.
2.2 Scheduling. In consultation with Cytogen, and in accordance with
Orders submitted for the Product, BMS will determine scheduling of Batch runs
and shipment of Product in accordance with Section 2.5(a). In the event that
either party determines that it is necessary to modify the scheduling of Batch
runs and shipment of Product, the parties will negotiate such modifications in
good faith.
2.3 Packaging. BMS will package Product in the packaging containers and
with labels, package inserts and other labeling that are approved by Cytogen.
Cytogen shall, at its sole discretion, propose changes to labels and packaging,
Product inserts and other labeling for the Product, which changes shall be
submitted by Cytogen to all applicable governmental agencies and other third
parties responsible for the approval of the Product, if required, except that
BMS will submit any such changes to the Commonwealth of Massachusetts. BMS shall
not be required to implement such packaging and/or labeling changes until all
applicable approvals are obtained. Cytogen will be responsible for any and all
costs relating to any and all labeling and packaging changes.
2.4 Quality Control and Assurance.
(a) BMS shall manufacture and supply the Product in
accordance with the Specifications and cGMP.
(b) BMS shall perform such quality control and quality
assurance testing as is required by the Specifications, cGMP, and in accordance
with the External Quality Agreement.
(c) BMS shall perform the approved stability program, as
agreed upon by the parties, for the Product as further set forth in the External
Quality Agreement.
(d) Stability testing for EDTMP used in the production of the
Product shall be performed by a third party, as managed by Cytogen and set forth
in the External Quality Agreement.
(e) BMS will promptly notify Cytogen in the event any test
reveals confirmed out of specifications results, deviations, contamination, lack
of sterility, or degradation beyond Specifications in any Batch. Cytogen will
file any reports required by the applicable regulations.
2.5 Primary Representatives. Each party shall appoint a primary
representative ("Primary Representative") who will coordinate work carried out
hereunder with the other party's representative. The Primary Representatives
shall be the day-to-day contacts between the parties hereto and shall receive
copies of all written correspondence exchanged between the parties with respect
to the designated work. In the event either party identifies an issue relating
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to the manufacture, quality, delivery, customer service, or the like with
respect to Product, the Primary Representatives shall promptly confer to resolve
such issue. If a Primary Representative leaves the employ of a party, an equally
competent, mutually acceptable, Primary Representative shall be assigned by such
party.
(a) Forecast; Firm Order. At least thirty (30) days before
each quarter during the term of this Agreement, Cytogen shall submit a good
faith, estimated rolling forecast of the quantity of Product Cytogen expects to
require from Orders for production during the next thirteen (13) weeks and each
of the succeeding thirty nine (39) weeks after such thirty (30) day period (each
such forecast, a "Forecast"); thereafter, Cytogen shall submit a revised fifty
two (52) week forecast 30 days before the beginning of every quarter during the
term of this Agreement. Each Forecast shall be non-binding, with the exception
of the Forecast for the first thirteen (13) week period reflected in each Order,
which shall be considered a firm order. Cytogen's first Forecast shall be
provided to BMS as soon as practicable after the Effective Date. Notwithstanding
the foregoing, at a minimum, Cytogen hereby firmly orders from BMS [**] during
the term of this Agreement. In addition, Cytogen shall provide BMS with eight
(8) weeks advance notice in the event that a weekly Order is reasonably expected
to exceed [**].
(b) Lack of Orders. In the event BMS determines that, based on
a lack of Orders in a particular week, Cytogen will not require manufacture of a
Batch, then BMS shall promptly so inform Cytogen. After receiving confirmation
from Cytogen, BMS shall use commercially reasonable efforts to minimize variable
cost expenditures for such particular week. In such circumstances, Cytogen shall
pay BMS as required under Section 3.1.
2.6 Raw Materials. In accordance with the terms of this
Agreement, BMS will be responsible for providing all Components for the Product
and all costs associated with such Components for the Product.
2.7 Change in Specifications.
(a) Except as provided below, BMS will not be responsible for
any cost increases associated with development, validation, and implementation
of any change in the Specifications, Components, API or manufacturing process
("Change"), regardless of the reason for the change. Any and all such cost
increases will be borne by Cytogen, and shall be paid to BMS prior to
implementation of any Change. Moreover, any increase in cost per Batch
associated with implementation of any Change shall be passed directly to
Cytogen. The price change shall become effective only with respect to those
Orders of Product which are manufactured in accordance with the implemented
Change. Notwithstanding the foregoing, Cytogen shall not be responsible for the
cost of changes made solely for the convenience of BMS.
(b) Notwithstanding any Change implemented in accordance with
the terms of Section 2.7(a), Cytogen agrees to purchase Product manufactured by
BMS based upon any prior Specifications at the then current price for that
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Product. In addition, Cytogen agrees to purchase, at BMS' cost, all Inventory,
Components and API, utilized under the prior Specifications and purchased or
maintained by BMS in order to fill firm written orders, to the extent that such
Inventory, Components and/or API can no longer be utilized under the revised
Specifications and cannot be utilized in any other products of BMS and cannot be
returned to the supplier. Open purchase orders for Components and/or API no
longer required under any revised Specifications which were placed by BMS with
suppliers in order to fill firm written orders shall be cancelled where
possible, and where such orders are not subject to cancellation without penalty,
shall be assigned to and satisfied by Cytogen. This Section 2.7(b) shall not be
applicable to any change made solely for the convenience of BMS.
2.8 Shipments. BMS shall ship and deliver the Product [**] BMS'facility
located in North Billerica, Massachusetts to such locations as are specified in
Orders received by BMS. Cytogen shall either pay the common carrier directly or
reimburse BMS for the shipping cost, as evidenced by invoices of common
carriers.
2.9 Invoices. BMS shall promptly notify Cytogen of each shipment of
Product hereunder. Cytogen will be responsible for invoicing the customer.
2.10 Other BMS Obligations. In addition to the manufacture and
distribution of the Product, BMS will provide certain additional services
relating to customer support and technical support at the rates set forth in
Section 3.1(a). BMS will take Orders directly from Cytogen's customers; ship
ordered Product to Cytogen's customers (as provided in Section 2.8); carry out
license verification of Cytogen's customers and any common carriers utilized;
provide technical support; and provide Cytogen with a written or electronic, (at
the option of Cytogen), report, at a frequency to be mutually agreed upon by the
parties, detailing names of customers ordering Product and quantities ordered
and any other information as Cytogen may reasonably request, in accordance with
all applicable laws, rules and regulations. BMS will provide such additional
information relating to ordering and shipping of the Product as Cytogen may
reasonably request from time to time.
2.11 Waste. The parties acknowledge and agree that BMS shall not have
any responsibility for waste generated after Product is delivered to the common
carrier, except as provided in Sections 4.8 and 4.9. Notwithstanding anything to
the contrary, Cytogen will be responsible for all costs (including handling
third-party and/or governmental entity claims) associated with clean-up and
removal of unused Product and/or waste related to Product and/or waste arising
from use of Product, other than waste at BMS' manufacturing site, which is the
responsibility of BMS.
2.12 Back-Up Manufacturer. In the event that, for a period of thirty
(30) days, BMS is unable to supply or distribute the quantities of Product
ordered, Cytogen shall have the right to arrange for supply and distribution of
Product by a third party. At the request of Cytogen, BMS agrees to use its
commercially reasonable efforts to assist Cytogen, at BMS' expense, in
qualifying a third party selected by Cytogen to supply and distribute the
Product during the period that BMS is unable to do so.
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2.13 International Supply. The parties recognize that the Product is
presently approved for marketing in the Territory. In addition, Cytogen intends
to market the Product in other countries of North America and South America as
the marketing approvals that Cytogen is pursuing at its sole cost and expense
are obtained in such countries, at which point, the parties shall discuss
whether the Territory should be expanded to include such countries. After the
marketing approvals for such additional countries of North America and South
America are obtained and the Territory has been expanded by mutual agreement of
the parties, BMS shall cooperate with Cytogen as is reasonable in the
circumstances in respect to packaging and labeling the Product for distribution
in countries other than the Territory. BMS and Cytogen will cooperate in
providing documentation required by governmental authorities relating to the
export of the Product from the United States and the import of the Product into
countries other than the United States. Cytogen shall promptly reimburse BMS for
any and all incremental costs incurred by BMS under this Section 2.13.
2.14 License to Cytogen Included Technology. Cytogen grants to BMS a
non-exclusive, royalty-free, fully-paid up, sublicenseable (with Cytogen's prior
written consent, which shall not be unreasonably withheld or delayed),
transferable (solely to BMS permitted assignees as set forth in Section 9.7)
license under the Cytogen Included Technology, solely to the extent required to
make, use (in accordance with the terms and conditions herein and/or the
External Quality Agreement) distribute, have made, sell, or have sold the
Product in the Territory to fill Orders. The parties agree and acknowledge, that
unless otherwise expressly granted herein, all right, title and interest in and
to Cytogen Included Technology, including, but not limited to, any enhancements,
modifications, or improvements thereto, shall be the sole and exclusive property
of Cytogen and shall vest solely with Cytogen. The parties further agree and
acknowledge that all right, title and interest in and to the BMS Intellectual
Property, including, but not limited to, any enhancements, modifications, or
improvements thereto, shall be the sole and exclusive property of BMS and shall
vest solely with BMS.
3. PRICE, PAYMENT AND COST
3.1 Invoice; Payment.
(a) As consideration for BMS' services, including the
manufacture and supply of Product and the provision of customer service and
support, as described in Section 2, Cytogen shall pay BMS: (i) $[**] per Batch
of Product (as adjusted in accordance with Section 3.1(d), hereinafter referred
to as the "COM"); and (ii) $[**] per Order (as adjusted in accordance with
Section 3.1(d), hereinafter referred to as the "COSS"). BMS will invoice Cytogen
following the manufacturing and release of each Batch. Such payments shall be
due and payable net thirty (30) days post Cytogen's receipt of invoice.
(b) In the event that BMS receives no Orders for Product
during a particular week, then Cytogen shall pay BMS [**]. As an example, if (i)
BMS receives no Orders for a particular week and (ii) BMS is able to avoid
purchase of certain raw materials for such week and (iii) BMS does not
manufacture a Batch in that week, then Cytogen would pay BMS, as if such Batch
were manufactured, as follows: [**].
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(c) In the event BMS is unable to manufacture Batches, Cytogen
shall not be required to pay BMS under Section 3 until such time as BMS resumes
manufacture and delivery of Batches. Also, Cytogen shall have no obligation to
pay BMS for Batches that do not meet Specifications or quality control and
assurance testing requirements as specified in the External Quality Agreement.
(d) Each year on January 1st, or as soon as practicable
thereafter, the COM and COSS shall be adjusted for that year on an annual basis
[**]. For the sake of clarity, the increase [**] for the then-current year shall
be determined [**] and shall be calculated as soon as reasonably practicable
after January 1st of each year based on the last full twelve (12) calendar
months [**].
3.2 Additional Batches. The manufacture of Batches beyond the amounts
set forth in Cytogen's firm orders in Section 2.5(a) (each an "Additional
Batch") shall be undertaken only with the agreement of BMS, which agreement
shall not be unreasonably withheld. Cytogen shall pay BMS an amount equal to
$[**] for each Additional Batch manufactured at Cytogen's request. Upon each
anniversary of this Agreement, the price for each Additional Batch shall be
increased in accordance with the COM as set forth in Section 3.1(d). BMS will
invoice Cytogen following the manufacturing and release of each Additional
Batch. Such payments shall be due and payable net thirty (30) days post
Cytogen's receipt of invoice.
4. RECORDS, AUDITS, RECALLS, RETURNS
4.1 Records and Accounting by BMS. BMS shall keep records of the
manufacture, testing and shipping of the Product as required by any applicable
laws, including those required by the FDA, the NRC, the MDPH-RCP and the
Commonwealth of Massachusetts. Copies of such records and samples shall be shall
be retained by BMS for a period of one (1) year following the date of product
expiry, or longer if required by law and made available as soon as reasonably
practicable to Cytogen after BMS' receipt of Cytogen's written request for
access to such records and/or samples.
4.2 Regulatory Inspections. BMS will inform Cytogen promptly, but in no
event later than twenty four (24) hours, of any inspection or audit by any
governmental agency, including, but not limited to, the FDA, that is
specifically related to the Product. Moreover, BMS will inform Cytogen of the
result of any such audit or inspection within twenty four (24) hours of the
conclusion of such audit or inspection. BMS will promptly provide Cytogen with
copies of any government issued inspection observation reports, including FDA
form 483s, and related correspondence, that specifically effect the Product. BMS
and Cytogen will cooperate in resolving any concerns with the FDA or other
governmental agency in the Territory.
4.3 Inspections. Cytogen has the right, no more than once in each year,
unless otherwise required or imposed by applicable law or regulatory authority
(or more frequently if agreed to by the parties hereto such agreement not to be
unreasonably withheld), and on reasonable prior notice, to inspect those BMS
facilities used in the manufacturing, packaging, storage, testing, shipping or
receiving of Product. Such inspections may include, but will not be limited to,
cGMP inspections, quality audits, and system audits, including observation of
the actual process of manufacture of the Product. Representatives of Cytogen
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will have access during such inspections to all Product related documents,
records, reports, data, procedures, facilities, and all other information
required to be maintained by FDA regulations or the requirements of other
governmental agencies.
4.4 Coordination of Safety and Complaint Reporting. The parties agree
to comply with all legal obligations imposed in the United States concerning the
collection, investigation, and governmental reporting of adverse reactions and
complaints relating to the Product, including without limitation with respect to
the United States 21 C.F.R. 312.32 and 21 C.F.R. 314.80(a) and any other
corresponding law, rule or regulation in any other country in the Territory. The
respective departments of the parties responsible for handling adverse reaction
monitoring and complaints will jointly develop a written procedure to govern
their communications concerning such matters, such that each of the parties will
have the ability to comply with its legal obligations and contractual
undertakings (the "Written Procedure"). The Written Procedure is attached hereto
as Schedule 2 and incorporated herein by reference.
4.5 Recall Action. As the NDA holder for the Product, Cytogen shall be
responsible for conducting Product recalls, and shall notify BMS should there be
a need to recall the Product. To the extent necessary, BMS shall use its
commercially reasonable efforts to assist Cytogen in conducting any Product
recalls. BMS shall promptly notify Cytogen if it receives any notice, including
a recall notice, which relates to the Product. The parties will assist each
other in their respective investigations to determine the cause and extent of
the problem. All FDA contacts and coordination of any recall activities will be
handled by Cytogen. Notwithstanding anything to the contrary, in the event BMS
recommends initiating a recall, but Cytogen does not agree to commence such
recall, then BMS shall bear absolutely no liability whatsoever with respect to
any Batch of Product that was the subject of BMS' recall recommendation.
4.6 Recall Expenses. If a recall, withdrawal or field correction is
required because of Product that did not conform to the Specifications at the
time of shipment from BMS, then [**] for such recall, withdrawal or field
correction. [**] occasioned by such recall, withdrawal or field correction. [**]
responsible for the manufacture and distribution of replacement Product. [**]
any and all costs associated with a recall, withdrawal or field correction for
any other reason, including [**].
4.7 Records. BMS will maintain complete and accurate records for such
periods as may be required by applicable law or regulation, but not less than
one (1) year of all Product supplied under this Agreement.
4.8 Product Returns. BMS will have the responsibility for handling
customer returns of the Product in accordance with a procedure to be agreed with
Cytogen. Cytogen shall, at its sole, cost, expense and discretion, be
responsible for processing customer credit for returns or arranging for
replacement Product to be produced and shipped by BMS pursuant to Section 2.9.
In the event that a Product must be returned for such Product's failure to
conform to the Specifications, BMS shall replace such Product and reship the
Product to Cytogen's customer (or such other recipient as Cytogen may designate)
at BMS' sole cost and expense.
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4.9 Testing and Certificate of Analysis. BMS shall provide a
certificate of analysis ("Certificate of Analysis") to Cytogen or its designated
agent with each Batch of Product made hereunder. Such Certificate of Analysis
shall certify with respect to each Batch of Product (identified by Batch/lot or
control number): (i) the quantity of the Batch, and (ii) that the Product
delivered was manufactured in accordance with the Specifications and the
External Quality Agreement and documented according to requirements of
applicable laws, rules and regulations.
4.10 Waste. In its performance of this Agreement, BMS shall comply with
all laws and regulations applicable to the generation, storage, shipment and
disposal of waste generated in the manufacture of Product while the Product is
still on BMS premises, thereafter such responsibility shall be assumed
exclusively by Cytogen.
5. TERM, RENEWAL AND TERMINATION
5.1 Term. Unless terminated early in accordance with Section 5.1, 5.2,
or 5.3, this Agreement will be in effect and will continue for a period of five
(5) years unless terminated by BMS or Cytogen on twenty four (24) months prior
written notice. Thereafter, this Agreement will automatically renew for five (5)
successive one (1) year periods unless terminated by BMS or Cytogen on twenty
four (24) months written notice, or terminated in accordance with Section 5.2 or
5.3. If either party terminates this Agreement with twenty four (24) months
notice, this Agreement shall remain in effect for those twenty four (24) months
and then shall terminate. The parties acknowledge and agree that during the
renewal periods of the Agreement, the COM and COSS shall continue to be adjusted
[**] as set forth in Section 3.1(d). This agreement may be terminated at any
time with the mutual written agreement of the parties.
5.2 Breach. Either Cytogen or BMS may terminate this Agreement at any
time on written notice to the other party, if such party breaches a material
term of this Agreement and if breaching party fails to remedy the breach within
sixty (60) days of receiving written notice of the breach.
5.3 Insolvency. BMS or Cytogen may terminate this Agreement immediately
in its entirety if Cytogen (in the case of termination by BMS) or BMS (in the
case of termination by Cytogen) files a petition of bankruptcy, is adjudged
bankrupt, takes advantage of any insolvency act, or executes a bill of sale,
deed of trust, or assignment for the benefit of creditors.
5.4 Survival. The rights and obligations contained in Sections 4, 5.4,
6, 7, 8 and 9 (which include warranties, indemnification and confidentiality)
will survive termination of this Agreement, as will any rights to payment or
other rights or obligations have accrued under this Agreement prior to
termination. Termination will not affect a party's liability by reason of any
act, default, or occurrence to termination.
5.5 Repurchase at Termination. If this Agreement is terminated, Cytogen
shall purchase, at BMS' out-of-pocket cost, the Inventory, the Components and
the API applicable to the Product which were purchased, produced or maintained
by BMS in contemplation of filing firm written orders, prior to notice of
termination being given. In addition to the foregoing, Cytogen shall reimburse
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BMS for any non-cancelable expenses incurred by BMS in connection with the
services rendered by BMS hereunder.
5.6 Consequences of Termination. Upon the expiration or any earlier
termination of this Agreement, no later than thirty (30) days after the date of
expiration or termination of this Agreement, each party shall return to the
other party all copies and embodiments, whether physical or electronic, of such
other party's Confidential Information in such party's possession and control;
provided, however, that each party shall be entitled to retain one archival copy
of such Confidential Information solely for purposes of monitoring such party's
compliance with its obligation under Section 8.
6. REPRESENTATIONS AND WARRANTIES
6.1 Authority. Each party represents and warrants that it has the full
right and authority to enter into this Agreement, that it is not aware of any
impediment that would inhibit its ability to perform its obligations hereunder,
and that entering into this Agreement will not violate or breach any other
agreement or arrangement with any third party. Each party further warrants that
it shall perform hereunder in accordance with all applicable law and
regulations. Each Party shall maintain in full force and effect all necessary
license, permits and other authorizations required by law to carry out its
duties and obligations under this Agreement. BMS and Cytogen each shall keep all
records and reports required to be kept by applicable laws. The Parties shall
reasonably cooperate with one another with the goal of ensuring full compliance
with applicable laws. Each party shall cooperate with the other to provide such
letters, documentation, and other information on a timely basis as the other
party may reasonably require to fulfill its reporting and other obligations
under applicable laws to applicable regulatory authorities.
6.2 Further Assurances. BMS and Cytogen each hereby agrees to use its
commercially reasonable efforts to take, or cause to be taken, all actions and
to do, or cause to be done, all things necessary or proper to make effective the
transactions contemplated by this Agreement, including such actions as may be
reasonably necessary to obtain approvals and consents of governmental entities
and other persons; provided, that no party shall be required to (i) pay money
(other than as expressly required pursuant to the terms and conditions of this
Agreement); or (ii) assume any other material obligation not otherwise required
to be assumed by this Agreement.
6.3 Manufacturing Warranty. BMS represents and warrants that each Batch
supplied pursuant to the terms of this Agreement, will be manufactured, handled,
stored, and shipped in accordance with the Specifications. BMS further
represents and warrants that each Batch shall have a sufficient shelf life, at
the time the Batch is tendered to the common carrier for delivery to Cytogen
and/or its customers, such that the Product may be properly administered to a
patient.
6.4 Debarment. BMS covenants that neither its employees nor, to the
knowledge of BMS, any agent or other third party performing the services
hereunder are (i) under any investigation by any government regulatory authority
for a debarment action, or (ii) presently debarred pursuant to local laws or
statutes or has a disqualification hearing pending. BMS shall notify Cytogen
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promptly by telefax upon any inquiry or investigation concerning any such
employee, agent or other third party or upon the commencement of any such
proceeding against any such employee, agent or other third party.
6.5 Cytogen Included Technology Representation/Warranty. Cytogen
represents and warrants to BMS that Cytogen is (i) an owner of and has right,
title and interest in and to the Cytogen Included Technology, (ii) a lawful
licensee of the Cytogen Included Technology (with rights to sublicense the
Cytogen Included Technology to BMS as set forth herein and that the license by
which Cytogen received its rights to the Cytogen Included Technology remains in
full force and effect, and Cytogen shall use its commercially reasonable efforts
to keep any such license in full force and effect throughout the term of this
Agreement without revisions or amendments that will materially adversely effect
the rights granted to BMS hereunder, except in cases where BMS has given its
consent), (iii) as of the Effective Date the registered intellectual property
included within the Cytogen Included Technology is valid, enforceable and in
full force and effect, (iv) as of the Effective Date, Cytogen has not
transferred or assigned the Cytogen Intellectual Property in a manner which will
materially adversely effect the rights granted to BMS hereunder, and (v) as of
the Effective Date and to Cytogen's knowledge, no third party has questioned or
challenged the scope or validity of the Cytogen Included Technology.
6.6 Disclaimer. ALL WARRANTIES GRANTED BY BMS AND CYTOGEN HEREUNDER ARE
IN LIEU OF AND EXCLUDE ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, ARISING BY
OPERATION OF LAW OF OR OTHERWISE INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
7. INDEMNITY
7.1 (a) By Cytogen. Cytogen shall indemnify and hold harmless BMS, its
directors, officers, agents, and employees, from and against any and all loss,
damage, claim, injury, cost or expense including attorneys' fees and reasonable
expenses of litigation ("Claims"), arising out of Claims made by third parties
in connection with (i) a material breach of Cytogen's representations and
warranties, and/or (ii) any sale, use or disposition of Product by Cytogen,
including, without limitation, Claims arising in connection with patent
infringement or trademark infringement (arising from a U.S. patent or
trademark), product liability theories, or any illness or personal injury,
including death or property damage.
(b) By BMS. BMS shall indemnify and hold harmless Cytogen and
its directors, officers, agents, and employees, from and against any and all
Claims made by third parties relating to a material breach of BMS'
representations and warranties, or covenants (as such covenants are set forth in
Section 6.4 hereof).
(c) Indemnification Procedures. Each indemnified party agrees
to give the indemnifying party prompt written notice of any Claim or discovery
of fact upon which such indemnified party intends to base a request for
indemnification under Section 7.1. Each party shall furnish promptly to the
other, copies of all papers and official documents received in respect of any
Claim. With respect to any Claim relating solely to the payment of money damages
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and which will not result in the indemnified party becoming subject to
injunctive or other relief or otherwise adversely affecting the business of the
indemnified party in any manner, and as to which the indemnifying party shall
have acknowledged in writing the obligation or indemnify the indemnified party
hereunder, the indemnifying party shall have the sole right and obligation to
defend, settle or otherwise dispose of such Claim, on such terms as the
indemnifying party, in its sole discretion, shall deem appropriate. The
indemnifying party shall obtain the written consent of the indemnified party,
which shall not be unreasonably withheld, prior to ceasing to defend, settling
or otherwise disposing of any Claim if as a result thereof the indemnified Party
would become subject to injunctive or other equitable relief or any remedy other
than the payment of money, which payment would be the responsibility of the
indemnifying party. The indemnifying shall not be liable for any settlement or
other disposition of a Claim by the indemnified party which is reached without
the consent of the indemnifying party. Except as provided above, the reasonable
costs and expenses, including reasonable fees and disbursements of counsel
incurred by any indemnified party in connection with any Claim, shall be
reimbursed on a quarterly basis by the indemnifying party, without prejudice to
the indemnifying party's right to contest the indemnified party's right to
indemnification and subject to refund in the event the indemnifying party is
ultimately held not to be obligated to indemnify the indemnified party.
7.2 Limitation of Liability. Notwithstanding any other provision of
this Agreement, neither party shall in any event be liable to the other party or
its affiliates, officers, directors, employees, stockholders, agents or
representatives on account of any breach hereof or of any indemnity obligation
set forth herein for any indirect, consequential or punitive damages (including,
without limitation, lost profits, loss of use, damage to goodwill or loss of
business).
7.3 Shared Liability/Mediation. Without limiting the foregoing in this
Section 7, in the event that BMS and Cytogen are both involved in a Claim
brought by a third party, BMS and Cytogen shall promptly initiate and
participate in good-faith discussions regarding the resolution of such Claim,
including, but not limited to, participating in a mediation of the issues
surrounding the Claim with a view to settling the allocation of responsibility
as between BMS and Cytogen. In the event that BMS and Cytogen are unable to
mutually agree upon the allocation of responsibility in connection with such
third party Claim, BMS and Cytogen each reserve their respective rights to
pursue their own defense strategy in connection with such third party Claim.
8. CONFIDENTIALITY
8.1 Disclosure to BMS. Promptly after the Effective Date, Cytogen will
provide to BMS any and all Confidential Information necessary for BMS to perform
hereunder. To the extent that Cytogen and/or DuPont disclosed any Confidential
Information to each other, or its predecessors, under the Manufacturing and
Supply Agreement dated January 1, 1999, such information shall remain
confidential and shall be governed by the confidentiality provisions herein.
8.2 Restrictions on Disclosure and Use by Both Parties. No party will
use the Confidential Information provided by the other party or disclose it to
any third party except as necessary to carry out the party's obligations under
this Agreement. If either party finds it necessary to disclose such Confidential
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Information to a third party, they will not do so without first obtaining
written consent of the other party and entering into an agreement with the third
party which binds the third party to the same obligations of restricted use and
disclosure as are undertaken by the parties in this Agreement. Section 8.2 shall
survive termination of this Agreement.
8.3 Exceptions.
(a) The obligations of Section 8.2 will not apply to any information
which (i) is in the possession of the receiving party at the time of receipt
from the disclosing party, as shown by existing records, (ii) is or becomes
available to the public through no fault of the receiving party, (iii) is
disclosed to the receiving party by a third party entitled to disclose it, or
(iv) is independently developed by the receiving party without reliance on
information supplied by the disclosing party, as evidence by the records of the
receiving party, (v) is required by law or judicial order to be disclosed, in
which case the party required to make the disclosure shall provide as much
advance notice as possible to the other party, shall to the extent possible
allow the other party to seek a protective order, and shall to the extent
possible minimize the information to be disclosed, or (vi) is necessary to
comply with receiving party's disclosure and reporting requirements under
federal and state securities laws or any other rule or regulation.
(b) In the event of a disclosure pursuant to subsection(vi) of Section
8.3(a), the party required to make the disclosure of such information by the
applicable agency or other disclosee shall: (i) promptly notify the other party
and seek confidential treatment for information reasonably requested by the
disclosing party; and (ii) provide the other party with a copy of the proposed
disclosure within a reasonable amount time to allow reasonable opportunity to
comment thereon.
9. MISCELLANEOUS
9.1 Compliance with Laws. Each party, is connection with its
performance under this Agreement, shall comply with all applicable laws, rules,
regulations, orders and guidelines.
9.2 Permit Licenses. Cytogen shall promptly reimburse BMS for all
expenses relating to BMS' obtaining and maintaining licenses and permits
specifically required for the manufacture and distribution of Product.
9.3 Trademarks. Except as provided in Section 2.14, each party hereby
acknowledges that no party has, nor shall it acquire, any interest in any of the
other party's trademarks or trade names unless otherwise expressly agreed to in
writing. The parties agree not to use any trademark or trade name of the other
party, except as specifically authorized by the other party.
9.4 Reports. BMS will supply Cytogen on an annual basis or upon
reasonable request, Product data, including release test results, complaint test
results, all investigations (in manufacturing, testing, and storage), the Annual
Product Review report, and the like, which are reasonably required in order to
complete the NDA annual report, which is required to be filed by the NDA holder
with the FDA, or any other annual report that is required to be filed with any
other government agency.
9.5 Independent Contractors. The parties shall be deemed to be
independent contractors, and this Agreement shall not be construed to create
between BMS and Cytogen another relationship such as, by way of example only,
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that of employer-employee, principal agent, joint-venturer, co-partners or any
similar relationship, the existence of which is expressly denied by the parties
hereto.
9.6 No Waiver. A party's failure to require another party to comply
with any provision of this Agreement shall not be deemed a waiver of such
provision or any other provision of this Agreement.
9.7 Assignment. Neither party may assign this Agreement or any of its
rights or obligations hereunder except with the prior written consent of the
other parties, except that either party may assign this Agreement to (i) one of
its Affiliates without the consent of the other party, or (ii) a successor of
substantially all of the business of such party to which this Agreement relates,
whether in a merger, sale of stock, sale of assets or other similar transaction.
Any permitted successor or assignee of rights and/or obligations hereunder
shall, in a writing to the other party, expressly assume performance of such
rights and/or obligations. Any assignment or transfer, or attempted assignment
or transfer, by either party in violation of the terms of this Section 9.7 shall
be null and void and of no legal effect.
9.8 Force Majeure. No party shall be liable for the failure to perform
its obligations under this Agreement if such failure is occasioned by a
contingency beyond such party's reasonable control, including, but not limited
to, strikes or other labor disturbances, lockouts, riots, wars, terrorism, fires
floods or storms. For the purposes of this Section 9.8, failure of a vendor to
supply BMS with Components, API or raw materials shall be considered a force
majeure event. A party claiming a right to excused performance under this
Section 9.8 shall immediately notify the other party in writing of the extent of
its inability to perform, which notice shall specify the occurrence beyond its
reasonable control that prevents such performance and an estimate of the time
the inability to perform is anticipated to last.
9.9 Notices. Any notice, approval, instruction or other written
communication required or permitted hereunder shall be sufficient if made or
given to the other party by personal delivery or by sending the same by first
class mail, postage prepaid to the mailing address set forth below:
If to BMS:
Bristol-Myers Squibb Medical Imaging, Inc.
331 Treble Cove Road
North Billerica, MA 01862
Attn: Vice President, Manufacturing
With a copy to:
Bristol-Myers Squibb Company
One Squibb Drive
New Brunswick, NJ 08210
Attn: Senior Counsel, Technical Operations
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If to Cytogen:
Cytogen Corporation
600 College Road East - CN 5308
Princeton, New Jersey 08540-5308
Attn: Chief Executive Officer
With a copy to: Donald L. Novajosky, Esq.
or to such other addresses provided to the other party in accordance with the
terms of this Section 9.9. Notices hereunder shall be deemed to have been
sufficiently made or given when delivered.
9.10 Entire Agreement. This Agreement and the External Quality
Agreement constitute the full, complete, final and integrated Agreement between
the parties hereto relating to the subject matter hereof and supersedes all
previous written or oral negotiations, commitments, agreements, transactions or
understandings with respect to the subject matter hereof, including without
limitation the Supply Agreement. Any modification, amendment or supplement to
this Agreement must be in writing and signed by authorized representatives of
both parties. In addition to the foregoing, in the event of a conflict or
inconsistency between this Agreement and the External Quality Agreement, this
Agreement shall prevail and control.
9.11 Headings. The titles and headings herein are for convenience only
and shall not be used to interpret or construe the terms and conditions of this
Agreement.
9.12 Singular Terms. Except as otherwise expressly provided herein or
unless the context otherwise requires, all references to the singular shall
include the plural as well.
9.13 Execution in Counterparts. This Agreement may be executed is two
(2) counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument. The parties expressly
agree that signatures received via facsimile shall be accepted as originals.
9.14 Governing Law. This Agreement shall be construed and enforced in
accordance with the laws of the State of New Jersey, without reference to its
conflicts of law provisions, and the United States of America. The State of New
Jersey and federal courts within Delaware shall be the only courts of competent
jurisdiction.
9.15 Publicity. Each party agrees not to issue any press release or
other public statement, or any communication or response to a third party,
whether oral or written, disclosing the existence of this Agreement or any
information or activity relating to this Agreement without the prior written
consent of the other parties, except as may be required by applicable law
(including, without limitation, disclosure requirements of the SEC, NASDAQ, or
any other stock exchange) in which event the party required to make the
disclosure shall follow the procedure specified in Section 8.3(b).
[THE NEXT PAGE IS THE SIGNATURE PAGE.]
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IN WITNESS WHEREOF, the duly authorized representatives of the parties
have executed this Amended and Restated Manufacturing and Supply Agreement as of
the Effective Date.
BRISTOL-MYERS SQUIBB MEDICAL IMAGING, INC.
By: /s/Jeanne Kreiger
-----------------------------
Name: Jeanne Krieger
Title: Vice President, Manufacturing
CYTOGEN CORPORATION
By: /s/William Goeckeler
-----------------------------
Name: William Goeckeler
Title: Senior Vice President, Operations