CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE OMISSIONS.
EXHIBIT 10.4
MANUFACTURING AND SUPPLY AGREEMENT
THIS AGREEMENT made effective as of January 1, 1999, among DuPont
Pharmaceuticals Company, a Delaware general partnership, having a place of
business at 331 Treble Cove Road, North Billerica, MA 01862 (hereinafter
"DuPont"), Berlex Laboratories, Inc. a Delaware corporation having offices at
300 Fairfield Road, Wayne, NJ 07470 (hereinafter "Berlex") and Cytogen
Corporation, a Delaware corporation, having its principal place of business at
600 College Road East, Princeton, NJ 08540 (hereinafter "Cytogen").
WHEREAS, Cytogen owns or holds licenses to patents, patent
applications, manufacturing and marketing authorizations and know-how relating
to the Product, and has exclusively licensed same to Berlex;
WHEREAS, Berlex desires DuPont to manufacture and distribute Product as
directed by Berlex;
WHEREAS, DuPont is capable of manufacturing, processing and packaging
Product, and possesses the requisite plant, equipment and personnel to produce
Product in accordance with necessary governmental authorizations and in
accordance with the Specifications; and
WHEREAS, the parties agree that DuPont will undertake the manufacture,
distribution, order processing and customer service relating to the Product
specified under this Agreement solely for the account of Berlex and in
accordance with all of the terms and conditions specified below.
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:
1.0 DEFINITIONS
The following terms shall, unless the context otherwise requires, have the
following meanings, respectively:
1.01 "ACTIVE PHARMACEUTICAL INGREDIENT" or "API" means the chemical compound
samarium-153 complexed with ethylene diamineteiramethylene-phosphonic
acid ("EDTMP").
1.02 "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 bias
the power to elect or appoint more than fifty percent (50%) of the
members of the governing body of the corporation or other entity.
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1.03 "CHANGE" shall have the meaning set forth in Section 2.8(a).
1.04 "COMPONENTS" means EDTMP, all labeling material, packaging material,
starting material and intermediates and excipients required for the
manufacture of Product.
1.05 "CONFIDENTIAL INFORMATION" means a party's technology, data, know-how,
or information whether written or oral, technical or ton-technical,
including financial statements, reports, prig, 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.
1.06 "COST OF MANUFACTURE OR COM" means Dupont's cost of manufacture as
described on Exhibit A.
1.07 "COST OF SUPPORT SERVICES OR COSS" means DuPont's cost of customer
support services as described on Exhibit A.
1.08 "FDA" means the United States Food and Drug Administration.
1.09 "INVENTORY" means all inventories of Components and work-in-process
produced or held by or on behalf of DuPont in connection with the
manufacture of the Product in accordance with the Specifications and
contract requirements, but, for greater certainty, shall not include
the API.
1.10 "KNOW-HOW" means the trade-secrets, know-how, processes, formulae,
techniques, procedures, test data and other technical information owed
by a party hereto relating to the Product.
1.11 "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 font without the
prior written approval of Cytogen and Berlex.
1.12 "PRODUCT" means a formulation containing API manufactured according
to the Specifications and in finished dosage form.
1.13 "BATCH" means one manufacturing process run within the validated scale
(as defined in the NDA) within DuPont's usual range of actual yield.
1.14 "EFFECTIVE DATE" means the date first shown above.
1.15 "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.
1.16 EXHIBITS. The following exhibits are attached hereto and incorporated
in and are deemed to be an integral part of this Agreement:
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Exhibit A - Prices
2.0 MANUFACTURE AND SUPPLY OF PRODUCTS
2.1 Manufacture. Berlex appoints DuPont its manufacturer of the Product,
and DuPont accepts such appointment. DuPont will manufacture on behalf
of Berlex, one Batch of Product per week for such weeks that Berlex and
its customers submit orders. Notwithstanding anything to the contrary,
Berlex may qualify others for the manufacture and supply of Product,
and may qualify itself to manufacture Product. DuPont will provide
reasonable assistance, at Berlex's cost, in support of any such
qualification.
2.2 Scheduling. In consultation with Berlex, and in accordance with orders
submitted for the Product, DuPont will determine scheduling of Batch
runs and shipment of Product.
2.3 Packaging. DuPont will package Product in the packaging containers and
with labels, package inserts and other labeling that are approved by
Berlex. Berlex may propose changes to labels, Product inserts and other
labeling for the Product, which changes shall be submitted by the NDA
holder to all applicable governmental agencies and other third parties
responsible for the approval of the Product, if required, provided that
DuPont will submit to the Commonwealth of Massachusetts. Berlex will be
responsible for any and all costs relating to any and all labeling
changes, except for regulatory activities conducted by Cytogen, the
costs of which shall be borne by Cytogen.
2.4 Quality Control and Assurance.
(a) DuPont shall manufacture and supply the Product in accordance
with the Specifications.
(b) DuPont shall perform such quality control and quality
assurance testing as is required by the Specifications.
(c) DuPont shall perform the approved stability program for the
Product.
(d) DuPont will promptly notify Berlex and Cytogen in the event
any test reveals contamination, lack of sterility, or
degradation beyond Specifications in any Back Cytogen will,
with the concurrence of Berlex, fide any reports required by
the applicable regulations.
2.5 Primary Representatives. Each party shall appoint a primary
representative ("Primary Representative") who shall 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 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.
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2.6 Firm Order.
(a) Berlex hereby firmly orders front DuPont a maximum of one Batch of
Product per week as needed to fill orders received during the term of
this Agreement.
(b) In the event DuPont determines based on a lack of orders that in a
particular week Berlex will not require manufacture of a Batch, then
DuPont shall promptly so inform Berlex. After receiving confirmation
from Berlex, DuPont will use reasonable efforts to minimize variable
cost expenditures. In such circumstances Berlex shall pay DuPont as
required under Section 3.1(b).
2.7 Raw Materials. DuPont will be responsible for purchasing all Components
and the API.
2.8 Change in Specifications
(a) Except as provided below, DuPont will not be responsible for any
cost increases associated with 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 Berlex (except that Cytogen
shall be responsible for costs associated with regulatory
activities relating to Changes that are carried out by Cytogen),
and shall be paid to DuPont prior to implementation of any
change. Moreover, after the first year, any increase in cost per
Batch associated with implementation of any Change shall be
passed directly to Berlex. The price change shall become
effective only with respect to those orders of Product which are
manufactured in accordance with the revised Specifications.
Berlex shall not be responsible for the cost of changes made
solely for the convenience of DuPont.
(b) Notwithstanding any Change implemented in accordance with the
terms of (a) above, Berlex agrees to purchase Product
manufactured by DuPont based upon any "old" Specifications at the
then-current price for that Product. In addition, Berlex agrees
to purchase, at DuPont's cost, all Inventory and Components,
utilized under the "Old" Specifications and purchased or
maintained by DuPont in order to fill firm written orders, to the
extent that such Inventory and/or Components can to longer be
utilized under the revised Specifications and cannot be utilized
in any other products of DuPont and cannot be returned to the
supplier. Open purchase orders for Components no longer required
under any revised Specifications which were placed by DuPont 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 Berlex. This section 2.8(b) shall not be applicable to any
Change made solely for the convenience of DuPont.
2.9 Shipments. DuPont shall ship and deliver the Product C.I.P. DuPont's
shipping point to such locations as are specified in orders received by
DuPont pursuant to INCOTERMS 1990. The common carrier used and method
of shipment shall be agreed with Berlex. After 1999, Berlex shall
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either pay the common carrier directly or reimburse DuPont for the
shipping cost, as evidenced by invoices of common carriers.
2.10 Invoices. DuPont shall promptly notify Berlex of each shipment of
Product hereunder. Berlex will be responsible for invoicing the
customer.
2.11 Other DuPont Obligations. In addition to manufacture of Product, DuPont
will provide certain additional services relating to customer support
and technical support. DuPont will take Product orders directly from
Berlex's customers; ship ordered Product to Berlex's customers (as
provided in Section 2.9); carry out license verification of customers
and common carriers; provide technical support; and provide Berlex with
a written or electronic, if within the capabilities of DuPont and at
the option of Berlex, report detailing names of customers ordering
Product and quantities ordered. Within the capabilities of DuPont,
DuPont will provide such additional information relating to ordering
and shipping of Products as Berlex may reasonably request from time to
time.
2.12 Waste. The parties acknowledge and agree that DuPont shall not have any
responsibility for waste generated after Product is shipped from font's
site, except as provided in Section 4.8 and 4.9. Notwithstanding
anything to the contrary, Berlex will be responsible for all costs
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 DuPont's manufacturing site, which is the responsibility of
DuPont.
2.13 Back-Up Manufacturer. In the event that DuPont is unable to supply or
distribute the quantities of Product ordered, Berlex shall have the
right to arrange for supply of Product by a third party. At the request
of Berlex, DuPont agrees to take reasonable steps to assist Berlex, at
Berlex's expense (reimbursement to be limited to DuPont's out of pocket
expenses), in qualifying a third party selected by Berlex to
manufacture and distribute the Product during the period that DuPont is
unable to do so.
2.14 International Supply. The parties recognize that the Product is
presently approved for marketing in the United States and Canada, and
that Berlex will be marketing the Product in Canada as well as the
United States. In addition, Berlex intends to market the Product in
other countries of North America and South America as marketing
approvals are obtained in such countries. DuPont agrees to cooperate
with Berlex and Cytogen as is reasonable in the circumstances in
respect to packaging and labeling the Product for distribution in
countries other than the United States. DuPont, Berlex 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. Berlex shall promptly reimburse DuPont for any and all
incremental costs incurred by DuPont under this Section 2.14.
3.0 PRICE, PAYMENT AND COST
3.1 Payment.
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(a) As consideration for DuPont's manufacture and supply of Product
and the provision of customer service and support, as described
in Section 2.0, Berlex shall pay DuPont the amounts shown on
Exhibit A. Such payments shall be due and payable within thirty
(30) days following the end of each month.
(b) The parties acknowledge that in the first year of this Agreement
Berlex is obligated to pay the fixed monthly fee described in
Exhibit A, regardless of whether DuPont actually manufactures
Product. In the years following the first year of this Agreement
Berlex will pay DuPont an amount equal to COM plus COSS plus a
certain margin, as described in Exhibit A. In those later years
the parties still intend that DuPont receive payments even in
those weeks when Berlex does not require manufacture of Product.
Therefore, in the event that DuPont receives no orders for
Product during a particular week, then Berlex shall pay DuPont
the full amount otherwise due under Section 3.1(a) less any
amount DuPont is able to save on variable cost. As an example, if
in the fifth year of this Agreement (i) DuPont receives no orders
for a particular week and (ii) DuPont is able to avoid purchase
of certain raw materials for such week and (iii) DuPont does not
manufacture a Batch in that week, then Berlex would pay DuPont as
follows: (COM + [**]%) plus (COSS + [**]%) less any savings
DuPont realized by avoiding purchases the certain raw materials.
(c) After the first year of this Agreement, in the event DuPont is
unable to manufacture Batches for a period grater than thirty
(30) days, then following such thirty (30) day period, Berlex's
obligation to pay DuPont under Section 3.1(a) shall be suspended
until such time as DuPont resumes manufacture of Batches. Also,
after the first year Berlex shall have no obligation to pay
DuPont for Batches that do not meet Specifications.
3.2 Additional Batches. The manufacture of Batches beyond the commitment of
DuPont set forth in Section 2.1 (each an "Additional Batch") shall be
undertaken only with the agreement of DuPont. In the first year of this
Agreement, Berlex shall pay DuPont an amount equal to $[**] for each
Additional Batch manufactured at Berlex's request. In the following
years, Berlex shall pay DuPont an amount per Batch based on the monthly
costs as set forth on Exhibit A. Payments under this Section 3.2 shall
be due and payable within thirty (30) days following the end of the
month during which the Additional Batch was manufactured.
4.0 RECORDS, AUDITS, ADERS, RECALLS, RETURNS
4.1 Records and Accounting by DuPont. DuPont shall keep records of the
manufacture, testing and shipping of the Product as required by law,
including those required by the FDA, the NRC and the Commonwealth of
Massachusetts. Copies of such records and samples shall be made
available to Berlex and/or Cytogem upon its request and shall be
retained by DuPont and be available to Cytogen and Berlex for a period
of one (1) year following the date of product expity, or longer if
required by law.
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4.2 Regulatory Inspections. DuPont will inform Berlex and Cytogen promptly
of any inspection or audit by any governmental agency, including the
FDA, related to the Product. Moreover, DuPont will inform Berlex and
Cytogen of the result of any such audit or inspection within 24 hours
of the conclusion of such audit or inspection. DuPont will promptly
provide Berlex and Cytogen with copies of any government-issued
inspection observation reports, including FDA form 483s, and related
correspondence, that affect the Product DuPont, Cytogen and Berlex will
cooperate in resolving any concerns with the FDA or other governmental
agency.
4.3 Inspections. Berlex and Cytogen will each have the right, no more than
once in each year (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 DuPont facilities used in the
manufacturing, packaging, storage, testing, shipping or receiving of
Product Such inspections may include GMP inspections and system audits,
including observation of the actual process of manufacture of the
Product. Representatives of Berlex and Cytogen will have access during
audits 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 CFR 312.32 and
21 CFR 314.80(a). Promptly following the Effective Date the respective
departments of the parties responsible for handling adverse reaction
monitoring and complaints will jointly develop a written procedure to
govern their communication concerning such matters, such that each of
the parties will have the ability to comply with its legal obligations
and contractual undertakings.
4.5 Recall Action. Only the NDA holder, and Berlex if Cytogen is the NDA
holder, may initiate a recall action. DuPont shall inform the NDA
holder and Berlex if DuPont determines it is necessary to initiate a
recall, withdrawal or field correction. If Berlex or Cytogen should
decide to initiate a Product recall, withdrawal or field correction
because of supply by DuPont of Product that does not conform to the
Specifications, it will notify DuPont and the other party and provide
DuPont and the other party a copy of its recall letter prior to
initiation of the recall. DuPont will assist Berlex and Cytogen in
their investigation to determine the cause and extent of the problem.
All FDA contacts and coordination of any recall activities will handled
by Berlex. Notwithstanding anything to the contrary, in the event
DuPont recommends initiating a recall, but Cytogen and/or Berlex do not
agree to commence such recall, then DuPont shall bear absolutely no
liability whatsoever with respect to any Batch of Product that was the
subject of DuPont's recall recommendation, and Section 7.1(b) shall not
apply to such Batch of Product.
4.6 Recall Expenses. If a recall, withdrawal or field correction is
required because of Product that did not conform to the Specifications
at time of shipment from DuPont, then DuPont shall pay for its own
out-of-pocket expenses for such recall, withdrawal or field correction.
DuPont also shall be responsible for Berlex's and Cytogen's reasonable
out of pocket expenses occasioned by such recall, withdrawal or field
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correction. DuPont shall also be responsible for the manufacture and
distribution of replacement Product. The NDA holder will be responsible
for any and all costs associated with a recall, withdrawal or field
correction for any other reason, including DuPont's reasonable out of
pocket expenses.
4.7 Records. DuPont will maintain complete and accurate records for such
periods as may be required by applicable law or regulation, but not
less than 1 year, of all Product supplied under this Agreement.
4.8 Product Returns. DuPont will have the responsibility for handling
customer returns of the Product in accordance with a procedure to be
agreed with Berlex. Customer credit for returns will be at the sole
discretion of Berlex.
4.9 Waste. In its performance of this Agreement, DuPont shall comply with
all laws and regulations applicable to the generation, storage,
shipment and disposal of waste generated in the manufacture of Product.
5.0 TERM, RENEWAL AND TERMINATION
5.1 Term. Unless terminated early in accordance with any of Sections 5.1,
5.2, 5.3, or 5.5, this Agreement will be in effect and will continue
for a period of five (5) years. This Agreement will automatically renew
for two (2) year periods unless terminated by DuPont on two (2) years'
written notice or terminated in accordance with any of Sections 5.2,
5.3, or 5.5. Berlex shall have the farther right to terminate this
Agreement at any time on two (2) years written notice to DuPont. This
agreement may be terminated at any time with the mutual agreement of
the parties.
5.2 Breach. Either Berlex or DuPont may terminate this Agreement at any
time on written notice if another party breaches a material term of
this Agreement and fails to remedy the breach within sixty (60) days
after receiving written notice of the breach.
5.3 Insolvency. DuPont or Berlex may terminate this Agreement immediately
in its entirety if Berlex (in the vase of termination by DuPont) or
DuPont (in the case of termination by Berlex) 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 covering
warranties, indemnification and confidentiality will survive
termination of this Agreement, as will any rights to payment or other
rights or obligations that have accrued under this Agreement prior to
termination. Termination will not affect a Party's liability by reason
of any act, default, or occurrence prior to termination.
5.5 Berlex's Further Right to Terminate. Berlex shall have the further
right to terminate this Agreement with respect to Berlex's obligations
on sixty (60) days notice to DuPont and Cytogen in the event that
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Berlex's license agreement with Cytogen for Product is terminated.
5.6 Repurchase at Termination. If this Agreement is terminated, Berlex
shall purchase, at DuPont's out of pocket cost, the Inventory and the
API applicable to the Product which were purchased, produced or
maintained by DuPont in contemplation of filing firm written orders,
prior to notice of termination being given.
6.0 REPRESENTATIONS AND WARRANTIES
6.1 Authority. Each party represents and warrants that it has the full
right and authority to enter into this Agreement, and that it is not
aware of any impediment that would inhibit its ability to perform its
obligations hereunder. Each party further warrants that it shall
perform hereunder in accordance with all applicable law and
regulations.
6.2 Manufacturing Warranty DuPont warrants that each lot of Product
supplied to Berlex will be manufactured in accordance with the
Specifications.
6.3 ALL WARRANTIES GRANTED BY DUPONT HEREUNDER ARE IN LIEU OF AND EXCLUDE
ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, ARISING BY OPERATION OF LAW
OR OTHERWISE, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
7.0 INDEMNITY
7.1 (a) BY BERLEX AND CYTOGEN. Berlex and Cytogen shall each indemnify and
hold harmless DuPont, its officers, agents, and employees, from and
against any and all loss, damage, claim, injury, cost or expense
including reasonable attorneys' fees and expenses of litigation
("Claims"), which result from any sale, use or disposition of Product,
including Claims arising in connection with patent infringement,
trademark infringement, product liability theories, or any illness or
personal injury, including death or property damage.
(b) BY DUPONT. DuPont shall indemnify and hold harmless Berlex, Cytogen
and each of their respective officers, agents, and employees, from and
against any and all Claims relating to the manufacture or distribution
of Product that result solely from the material breach of this
Agreement by DuPont or the gross negligence or willful misconduct of
DuPont.
(c) SHARED LIABILITY. In the event that a Claim involves allegations
that the negligent (gross negligent or material breach, in the case of
DuPont) reckless (in the case of Berlex or Cytogen) or willful
misconduct of each of Berlex, Cytogen, and DuPont contribute materially
to any such liability, cost, loss or expense stemming from the Product,
then Cytogen, Berlex, and DuPont each shall be responsible for that
portion of said liability, cost, loss or expense to which such
misconduct contributed.
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7.2 (a) 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 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 to indemnify the indemnified party hereunder,
the indemnifying party shall have the sole right 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
party 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.
(b) SHARED LIABILITY PROCEDURE. In the event that a claim involves
allegations of shared liability pursuant to Section 7.1(c), the parties
will insofar as possible endeavor to coordinate their defense
strategies (including a joint defense agreement if warranted by the
circumstances). Expenses shall be allocated between the parties based
on the proportion of the loss attributable to each. If the parties $re
unable to agree on the division of expenses during the pendency of the
Claim; then each party shall bear its own expenses, subject to
reimbursement by or of the party following the conclusion of the Claim.
8.0 CONFIDENTIALITY
8.1 Disclosure to DuPont Promptly attar the Effective Date, Cytogen and
Berlex will provide to DuPont any and all Confidential Information
necessary for DuPont to perform hereunder.
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 Information to a third patty, 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
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undertaken by the parties in this Agreement. Section 8.2 shall survive
termination of this Agreement.
8.3 Exceptions. The obligations of Section 8.2 will not apply to any
information which (a) is in the possession of the receiving party at
the time of receipt from the disclosing party, as shown by existing
records, (b) is or becomes available to the public through no fault of
the receiving party, (c) is disclosed to the receiving party by a third
party entitled to disclose it, or (d) is independently developed by the
receiving party without reliance on information supplied by the
disclosing party, as evidenced by the records of the receiving party,
or (e) 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 disclosing party, shall to the extent
possible allow the disclosing party to seek a protective order, and
shall to the extent possible minimize the information to be disclosed.
9.0 MISCELLANEOUS
9.1 Compliance with Laws. Each party, in connection with its performance
under this Agreement, shall comply with all applicable laws, rules,
regulations, orders and guidelines.
9.2 Permit, Licenses. The NDA holder shall promptly reimburse DuPont for
all expenses relating to DuPont's obtaining and maintaining licenses
and permits specifically required for the manufacture of Product.
9.3 Trademarks. 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. DuPont will supply the NDA holder on an annual basis, product
data, including release test results, complaint test results, all
investigations (in manufacturing, testing and storage), and the like,
which are reasonably required in order to complete the Annual Product
Review report and the NDA annual report that are required to be filed
by the NDA holder with the FDA or any other report that is required to
be filed with any other government agency. A copy of any such report'
will be contemporaneously disclosed to the party to thus Agreement that
is not the NDA holder.
9.5 Independent Contractors. The parties shall be deemed to be independent
contractors, and this Agreement shall not be construed to create
between DuPont and Cytogen and Berlex any other relationship such as,
by way of example only, 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.
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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 Berlex and Cytogen may assign this
Agreement to each other or their respective Affiliates without the
consent of DuPont. Assignment by DuPont shall require only the consent
of Berlex.
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,
fires, floods or storms. For the purposes of this Section 9.8, failure
of a vendor to supply DuPont with Components 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 requited 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 DuPont:
DuPont Pharmaceuticals Company
Medical Imaging Division
331 Treble Cove Road
North Billerica, MA
Attn: Vice President, Manufacturing
If to Berlex:
All notices to Berlex other than routine correspondence relating to and
including orders, revisions, routine customer-related matters, and
invoicing shall be addressed to:
Attention: Vice President, Corporate Development
Berlex Laboratories, Inc.
340 Changebridge Road
Montville, NJ 07045-1000
Address for express delivery:
340 Changebridge Road
Pine Brook, NJ 07050-9714
With a copy addressed to:
Attention: General Counsel
Berlex Laboratories, Inc.
300 Fairfield Road
Wayne, NJ 07470-7358
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Routine correspondence addressed to Berlex relating to and including
orders, revisions, customer-related matters and invoicing shall be
addressed to:
Attention: Director, Customer Services
Berlex Laboratories, Inc.
300 Fairield Road
Wayne; NJ 07470-7358
If to Cytogen:
Attention: Chief Executive Officer
Cytogen Corporation
600 College Road East - CN 5308
Princeton, New Jersey 08540-5309
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 constitutes 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. Any modification, amendment
or supplement to this Agreement must be in writing and signed by
authorized representatives of both parties.
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 in three (3)
counterparts, each of which shall be deemed an original, but all of
which together shall constitute one and the same instrument.
9.14 Governing Law. This Agreement shall be construed and enforced in
accordance with the laws of the State of Delaware, without reference to
its conflicts of law provisions, and the United States of America. The
State of Delaware 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, provided however, that
neither party will be prevented from complying with any duty of
disclosure it may have pursuant to law or governmental regulation.
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9.16 Contingent Agreement. This Agreement is made contingent upon execution
of the Amendment to the Letter Agreement, of even date, between DuPont
and Cytogen.
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IN WITNESS WHEREOF, the duly authorized representatives of the parties
have executed this Agreement as of the dates set forth below,
DUPONT PHARMACEUTICALS COMPANY
By: /s/ William J. DeLorbe
----------------------------------------------------------
Name: William J. DeLorbe
--------------------------------------------------------
Title: Executive Vice President, Medical Imaging
Date: November 13, 1998
BERLEX LABORATORIES, INC.
By: /s/ C.R. Willis, Jr.
----------------------------------------------------------
Name: C.R. Willis, Jr.
--------------------------------------------------------
Title: Vice President, Corporate Development
Date: November 13, 1998
CYTOGEN CORPORATION
By: /s/ H. Joseph Reiser, Ph.D.
----------------------------------------------------------
Name: H. Joseph Reiser, Ph.D.
--------------------------------------------------------
Title: President & Chief Executive Officer
Date: November 13, 1998
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EXHIBIT A
PRICES
------
Year Manufacture and Supply Customer Support Services
------ of Product -------------------------
----------------------
1st $[**]/month included
2nd COM plus [**]% COSS plus [**]%
3rd COM plus [**]% COSS plus [**]%
4th COM plus [**]% COSS plus [**]%
5th COM plus [**]% COSS plus [**]%
With respect to years 2-5, monthly COM and COSS shall be calculated as follows:
Monthly COM for year two shall be equal to $[**] plus the increase in the
Producer Price Index for year 1 for Industrial Commodities, Drugs and
Pharmaceuticals (06-3), published by the United States Department of Commerce
("PPI") (or if publication of such index ceases, an appropriate substitute index
agreed by the parties). For years 3, 4, and 5 the monthly COM shall be the sum
of the monthly COM for the previous year; plus the increase in the PPI for the
previous year.
Monthly COSS for year 2 shall be $[**] per order. For years 3, 4, and 5 the
monthly COSS shall be the sum of the monthly COSS for the previous year plus the
PPI for the previous year.
The increase in the PPI for the previous year shall be determined as of January
1st of each year based on the last full twelve calendar months for which data
are available.
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