EXHIBIT 10.21
-------------
AMENDED AND RESTATED DISTRIBUTION AGREEMENT
-------------------------------------------
DISTRIBUTION
AGREEMENT dated as of October 18, 2002 and as amended November
8, 2003 (the "Agreement") is between
MATRITECH, INC., a Delaware corporation,
having its principal place of business at
330 Nevada Street, Newton,
Massachusetts 02460, U.S.A. ("MATRITECH")
and CYTOGEN CORPORATION, a Delaware
corporation having its principal place of
business at 650 College Road East,
Princeton, New Jersey 08540
("CYTOGEN").
INTRODUCTION
------------
1. MATRITECH has developed a version
of its NMP22(R)Test Kit for bladder
cancer known as BladderChek(TM).
2. CYTOGEN desires to become the
distributor for BladderChek(TM) within
the Field and Non Exclusive Field and in
the Territory, as defined below.
3. In consideration of the mutual
covenants and promises contained in this
Agreement and other good and valuable
consideration, MATRITECH and CYTOGEN agree
as follows:
ARTICLE I
- DEFINITIONS
-----------------------
As used in this
Agreement, the following terms, whether used in the
singular or plural, shall have the
following meanings:
1.1 "Affiliate"
means, with respect to any entity, any corporation,
company, partnership, joint venture and/or
firm which controls, is controlled by
or is under common control with such
entity. For purposes of this Section 1.1,
"control" shall mean (a) in the case of
corporate entities, direct or indirect
ownership of at least fifty percent (50%)
of the stock or shares entitled to
vote for the election of directors; and (b)
in the case of non-corporate
entities, direct or indirect ownership of
at least fifty percent (50%) of the
equity interest with the power to direct
the management and policies of such
non-corporate entities.
1.2 "Effective
Date" means November 8, 2003.
1.3 "FDA" means
U.S. Food and Drug Administration.
1.4 "Field"
means the market for the Product comprised solely of
oncologists.
<PAGE>
-2-
1.5 "Non
Exclusive Field" means the market for the Product comprised
solely
of urologists.
1.6 "Product"
means MATRITECH's non-instrumented, single test, qualitative
NMP22 (R) test for bladder cancer known as
BladderChek(TM) including any
enhanced, improved or modified version of
BladderChek. A unit of Product is one
BladderChek test.
1.7 "Technical
Information" means all scientific and engineering data owned
by MATRITECH or which MATRITECH has the
right to use, patentable or otherwise,
relating to the Product, including without
limitation, technology licensed or
sublicensed to MATRITECH; all inventions,
cell sources, cultures, strains,
organisms and parts thereof; antibodies,
clones, plasmids, vectors, progeny,
derivatives and parts thereof; formulae;
classes, sources and clone numbers of
antibodies; methods, procedures and
processes; materials and reagents;
components, equipment, equipment design,
animal studies, clinical or other
evaluations, analytical results, and
quality control or other safety procedures
in each case relating to the production,
use or manufacture of the Product.
1.8 "Term" shall
have the meaning set forth in Section 8.1
1.9 "Territory"
means the United States of America, including the 50
states, Puerto Rico, U.S. Virgin Islands
and Washington, D.C., but excluding all
other territories and possessions.
1.10 "CYTOGEN's
Net Sales" shall mean amounts invoiced to customers of
CYTOGEN for the sale of Product excluding
returns and product allowances, free
samples, shipping, taxes, insurance and
handling.
ARTICLE II - THE PRODUCT
------------------------
2.1
Commercialization. Within the Field, CYTOGEN shall exert
reasonable
efforts, at its own expense, to:
(a) market and
promote the Product in the Territory (taken as a whole); and
(b) up to
December 31, 2003, provide an adequate level of customer
service
in the Field including, without limitation,
rendering prompt and willing service
with respect to the Product and handling
all customer inquiries ("Customer
Support") with reasonable assistance of
MATRITECH in a manner consistent with
the prevailing practices in the industry
and from January 1, 2004 onward,
MATRITECH shall have the obligation to
provide Customer Support.
<PAGE>
-3-
2.2 Compliance
with Laws. In performing this Agreement, each of the parties
agree that it will comply in all material
respects with applicable governmental
laws, rules, regulations and policies and
will hold the other party harmless and
indemnify the other party from the failure
to do so. Repeated non-compliance by
a party or its employees or Affiliates with
this Section 2.2 shall be deemed to
constitute a material, irremediable breach
of the terms of this Agreement,
justifying immediate termination under
Section 8.2(a)(iii) hereof.
2.3 Technical
Services. MATRITECH shall provide assistance to CYTOGEN, with
clinical marketing of the Product during
the Term of this Agreement, including
without limitation, those activities that
define and support clinical usage.
MATRITECH will provide reasonable technical
support services, at its own
expense, in furtherance of CYTOGEN's sales
efforts at CYTOGEN'S request.
2.4 Bladderchek
Customer Information. In consideration for MATRITECH's
agreement to remove all minimum purchase
commitments and other good and valuable
consideration, CYTOGEN shall deliver to
MATRITECH all Product leads, inquiries,
customer lists and complete ordering and
pricing history for all urologist
customers for the Product, currently in
CYTOGEN's possession, upon execution of
this Agreement and shall promptly deliver
to MATRITECH any such leads and
inquiries from non-oncologists received by
CYTOGEN or its agents thereafter and
for the remaining term of this Agreement.
In consideration for CYTOGEN's
agreement to limit scope of the Field, and
other good and valuable
consideration, MATRITECH shall deliver to
CYTOGEN all leads, inquiries, customer
lists and complete ordering and pricing
history for all oncologist customers for
the Product upon execution of this
Agreement and shall promptly deliver to
CYTOGEN any such leads and inquiries from
oncologists received by MATRITECH or
its agents thereafter and for the remaining
term of this Agreement.
ARTICLE III - MARKETING FEE AND INITIAL PURCHASE ORDER
------------------------------------------------------
3.1 Marketing
Fees. In consideration of the grant of the Marketing Rights
set forth in this Agreement, the parties
acknowledge that CYTOGEN has paid to
MATRITECH $150,000 on October 18, 2002 and
no other payments are due for
granting the Marketing Rights.
ARTICLE IV - MARKETING RIGHTS
-----------------------------
4.1 Marketing
Rights. CYTOGEN shall have (i) the exclusive right to sell or
otherwise distribute the Product in the
Territory within the Field; and (ii) the
<PAGE>
-4-
non exclusive time limited right, until
December 31, 2003, to sell or otherwise
distribute the Product in the Territory
within the Non Exclusive Field
(collectively, "Marketing Rights"). CYTOGEN
shall not sell or otherwise
distribute the Product to any person or
entity in the Territory if CYTOGEN has
reason to believe that such person or
entity intends to resell or redistribute
the Product outside of the Territory, Non
Exclusive Field or the Field, as
applicable. The rights granted herein shall
not be construed to confer any
license rights upon CYTOGEN, by
implication, estoppel or otherwise, to use or
practice any of MATRITECH's patents or
other intellectual property or use any
Technical Information. If and to the extent
that CYTOGEN performs its rights and
obligations under this Agreement,
including, without limitation, its Marketing
Rights, through an Affiliate, CYTOGEN shall
cause such Affiliate to be bound in
writing by all the terms and conditions of
this Agreement. MATRITECH shall not
sell or otherwise distribute the Product to
any person or entity if MATRITECH
has reason to believe that such person or
entity intends to resell or
redistribute the Product within the Field
in the Territory. Subject to Section
8.4, MATRITECH and its licensee(s) reserve
the right to market and sell other
non-point of care formats of the NMP22 test
within the Field in the Territory.
4.2 Sales
Price.
(a) The base
price per unit of Product shall be fixed at $ [**] per unit
F.O.B. MATRITECH's place of manufacture or
supply (the "Base Price"). Commencing
in 2004 and continuing for the Term of the
Agreement, the price per unit of
Product will be the Base Price plus [**] %
of CYTOGEN's Net Sales of the
Product. Thirty (30) days after the end of
each calendar quarter, CYTOGEN shall
furnish MATRITECH a report indicating unit
sales of Product for the prior
calendar quarter. In addition, CYTOGEN
shall tender payment to MATRITECH of the
[**] % payments of CYTOGEN's Net Sales on a
quarterly basis no more than 30 days
after the end of each calendar quarter.
(b) After 2003,
the Base Price may be renegotiated semi-annually per
calendar year commencing in 2004, but only
if the Council of Medical Services
reimbursement to the end user changes more
than [**] % (upward or downward) from
the then current amount. The renegotiated
Base Price shall not apply
retroactively.
4.3 Terms and
Conditions. All orders of Product by CYTOGEN from MATRITECH
during the term of this Agreement shall be
subject to the terms and conditions
of this Agreement and shall be subject to
acceptance by MATRITECH, as set forth
<PAGE>
-5-
in Section 4.4 below. Nothing contained in
any purchase order or similar
document submitted by CYTOGEN to MATRITECH
shall in any way modify or add to the
terms and conditions contained in this
Agreement. Invoices are payable within
[**] days after the date of invoice.
4.4 Order and
Acceptance.
(a) All orders
for Product submitted by CYTOGEN shall be initiated by
written orders sent to MATRITECH and
requesting a delivery date during the term
of this Agreement. Any order initially
placed orally or by e-mail must be
confirmed in writing.
(b) To
facilitate MATRITECH's production scheduling, CYTOGEN shall
submit
purchase orders to MATRITECH at least [**]
days prior to the requested date of
delivery. No order shall be binding upon
MATRITECH until accepted by MATRITECH
in writing, and MATRITECH shall have no
liability to CYTOGEN with respect to
purchase orders that are not accepted.
MATRITECH reserves the right to allocate
the supply of the Product PRO RATA, based
approximately on the relative numbers
of Product ordered, without incurring any
liability to CYTOGEN for commissions,
damages or otherwise. MATRITECH shall
notify CYTOGEN of the acceptance or
rejection of an order and of the assigned
delivery date for accepted orders
within fifteen (15) days of receipt of an
order from CYTOGEN. No partial
shipment of an order shall constitute the
acceptance of the entire order, absent
the written acceptance of such entire
order. MATRITECH shall use its reasonable
efforts to deliver the Product at the times
specified either in its quotation or
in its written acceptance of CYTOGEN's
orders.
4.5 Cancellation
of Orders. If MATRITECH accepts any cancellation request
made within ten (10) days of the scheduled
ship date, CYTOGEN agrees to bear
MATRITECH's restocking fee of up to [**]
percent ( [**] %) of the total order;
provided, however, such restocking fee
shall not apply to the return of Product
(lot numbers 122272 and 043091) as
specified in Section 4.7.
4.6 F.O.B.
Point, Title and Risk of Loss. All prices are F.O.B. either
MATRITECH's distribution facility or place
of manufacturing (the "F.O.B.
Point"). Product shall be purchased at the
F.O.B. Point. Title and risk of loss
of such Product shall pass to CYTOGEN at
said location. MATRITECH shall provide
CYTOGEN with written invoices for all
Product when shipped. The foregoing
notwithstanding, however, CYTOGEN shall, as
between itself and its customers, be
acting as principal and not as an agent of
MATRITECH.
<PAGE>
-6-
4.7 Returns.
CYTOGEN shall have no right of return for Product purchased
hereunder except that CYTOGEN may exercise
a right of return with respect to
that certain Product shipment consisting of
[**] tests (lot numbers 122272 and
043091) sent by MATRITECH to CYTOGEN in
August, 2003 for a full refund from
MATRITECH, provided that the Product is
returned in re-saleable condition
without further labor or cost to MATRITECH
and such Product is received by
MATRITECH within thirty (30) days of
execution of this Agreement. MATRITECH
shall provide a letter, reasonably
satisfactory to CYTOGEN, to CYTOGEN's quality
and assurance department authorizing the
disposition of the Product from
Cardinal Health to MATRITECH in accordance
with shipping and handling procedures
and conditions provided by MATRITECH to
CYTOGEN. If, however, any Product fails
to perform in accordance with the labeling
provided by MATRITECH as documented
by MATRITECH's examination of the Product
pursuant to its formal complaint
handling procedure which has been
established in accordance with standard
industry practices, CYTOGEN may return such
defective Product but in no case
later than one-hundred eighty (180) days
from the original ship date from
MATRITECH to CYTOGEN. MATRITECH shall keep
CYTOGEN apprised of its examination
of the Product pursuant to its formal
complaint handling procedures and shall
provide CYTOGEN with its finding and shall
provide the basis of its
determination in the event that MATRITECH
finds that the Product is not
defective. CYTOGEN shall have the
opportunity to raise reasonable objections to
the methods used during and shall have an
opportunity to verify MATRITECH's
findings for a period five (5) business
days after MATRITECH's determination,
which MATRITECH shall in good faith
consider when determining if an alternate
outcome is warranted. CYTOGEN hereby
agrees, at no charge other than shipping
and handling and insurance related thereto,
to provide to MATRITECH with [**]
units of the [**] units of sample which
were provided by MATRITECH to CYTOGEN.
4.8 Payment.
MATRITECH shall provide CYTOGEN with an invoice for each
shipment of Product. Invoices shall be
issued and dated on or after the date of
shipment of each order. Under no
circumstances will an invoice be issued for
Product that has not been shipped. Invoices
shall be paid within [**] days after
the date of invoice.
4.9 Taxes.
CYTOGEN's payments for the Product hereunder are payable in
full
to MATRITECH without deduction for taxes
(including any withholding tax) or
duties. In addition to such amounts,
CYTOGEN shall pay sums equal to taxes
(including, without limitation, sales,
withholding, value-added and similar
taxes) based on an end-user's use or
possession of the Product under or in
accordance with the provisions of this
Agreement, but exclusive of United States
federal, state, and local taxes based on
MATRITECH's net income.
<PAGE>
-7-
4.10 Dollars.
All amounts due MATRITECH hereunder shall be calculated and
paid in U.S. dollars.
4.11 Shipping.
All Product delivered pursuant to the terms of this
Agreement shall be suitably packed for
shipment in MATRITECH's standard shipping
cartons, marked for shipment to CYTOGEN's
address set forth above, and delivered
to CYTOGEN or its carrier agent at the
F.O.B. Point. If CYTOGEN does not specify
a carrier, MATRITECH shall select the
carrier. All freight, insurance, and other
shipping expenses shall be paid by CYTOGEN.
CYTOGEN shall also bear all
applicable taxes, duties and similar
charges that may be assessed against the
Product after delivery to the carrier at
the F.O.B. Point.
4.12 Late
Payment. Any amount not paid within the [**] days after the
date
of an invoice, except for those amounts
that both parties agree are in dispute,
shall bear interest at the rate of 1.5% per
month until paid in full.
4.13 Records. To
the extent available to it, each party shall maintain
quantity, lot numbers, customer names and
addresses, and incident reports for at
least two years beyond expiration date of
the Product. Each party shall keep,
and shall require all its Affiliates to
keep, full, true and accurate books of
accounts and other records that it
generates or obtains containing all
information and data which may be necessary
to ascertain and verify the amounts
payable hereunder and to satisfy FDA
requirements including recall and to retain
such records for at least five (5) years.
During the Term of this Agreement and
for a period of five (5) years following
its termination, each party shall have
the right from time to time (but no more
than once per calendar year) and upon
ten (10) days prior written notice, to
inspect, or have an agent, accountant or
other representative inspect, such books,
records and supporting data solely to
verify compliance with the first sentence
of this Section 4.13 during normal
business hours. The party being audited may
require any of the auditing party's
personnel to execute a confidentiality
agreement prior to giving such personnel
access to any materials.
4.14
Distribution Efforts. CYTOGEN shall be responsible, in the Field,
for
all marketing and distribution of Product
within the Territory. CYTOGEN shall be
<PAGE>
-8-
responsible, in the Non Exclusive
Field,
