EXHIBIT 10.2
March 22, 2001
Geng-Xxxxx Xx, Ph.D.
Unotech Diagnostics, Inc.
0000 Xxxxxxxxx Xxx. Suite 220
San Leandro, CA 94577
Re: Contract Manufacturing Arrangement
Dear Xxx:
This letter confirms the terms and conditions of a Contract Manufacturing
Arrangement between Unotech Diagnostics, Inc. of San Leandro, California and
Matritech, Inc. of Newton, Massachusetts. Would you please sign both copies and
return one original to me.
Purpose:
Matritech is interested in having its Matritech NMP22 Point-of-Care Test (POC),
manufactured in sufficient quantities to satisfy the requirements of its
distributors and other customers. Matritech is interested in securing a
long-term stable manufacturer for this product and is willing to make the
commercial commitments included in this contract.
Unotech is a manufacturer of various point-of-care testing devices and is able
to manufacture the NMP22 POC Test in the quantities projected by Matritech and
is willing to make the commercial commitments included in this contract.
Product:
The Matritech NMP22 POC Test (the "Product") is a lateral flow
immunochromatographic assay that measures the nuclear matrix protein NuMA
(nuclear mitotic apparatus protein) in freshly voided, untreated urine. The
device employs two monoclonal antibodies that recognize different epitopes on
the NuMA molecule.
Minimum Purchases and Pricing:
Matritech will pay the following prices:
For orders of [**] to [**] units, $[**] per unit
For orders of [**] to [**] units, $[**] per unit
For orders of [**] or more units, $[**] per unit.
Matritech will provide the necessary reagents to test intermediate and final
product and will supply the antibodies incorporated in the product based on
Unotech's forecasted requirements.. These prices are F.O.B. Unotech's dock.
JDoherty
Unotech Agreement Draft 4-19-01 04/19/01
Page 1
Matritech agrees to purchase the following minimum purchases from Unotech:
in the first year of agreement, a minimum of $[**] (includes product for
clinical trial purposes); in the second year of the agreement, a minimum
of $[**] and in the third year and subsequent years of the agreement, a
minimum of $[**].
These prices are based on standard packaging which encloses each cassette in a
sealed plastic pouch with dropper and desiccant. The pouches will be ink-jet
labeled with lot # and expiration date; packed 25 tests in a small box and 80
boxes in a carton of 20X20X20. Any additional special instructions may add
additional cost to the unit price.
Advanced Payment
Within 10 days of the signing of this agreement, Matritech will pay Unotech
$[**] which will be used by Unotech solely to defray initial expenditures
associated with the manufacture of the Product. The mold used to produce the
product's plastic housing has already been paid for by, and is owned by
Matritech but may be used by Unotech for other products without any payment to
Matritech. This advance payment will be returned to Matritech or credited
against the next order when the cumulative product purchases by Matritech reach
$[**].
Payment Terms:
Matritech will pay Unotech's invoices within [**] days of receipt for all
product which has been received by Matritech from lots which have been tested
and found to be in conformance by Matritech.
Unotech's Manufacturing Responsibilities:
Unotech is responsible for manufacturing sufficient amounts of product to
fulfill Matritech's purchase orders. The product must comply with Matritech's
specifications, which are included in this Agreement as Schedule A, applicable
U.S. FDA regulations and meet Matritech's quality control standards.
Ordering Requirements:
Matritech will provide written purchase orders as far in advance of need as
possible and will order in lot sizes at least equal to those necessary to earn
the prices stated in this letter.
Delivery Requirements:
Unotech will accept Matritech's orders within [**] days of receipt and will ship
finished product to Matritech or, if requested by Matritech, to a single
customer's address within [**] days of receiving Matritech's purchase order.
Unotech will ship the complete order unless partial shipments have been agreed
with Matritech.
During the first year of this agreement, Unotech will be permitted to ship up to
[**]% more units than the amounts ordered on Matritech's purchase orders. After
the first year of this agreement, Unotech may ship up to [**]% more units than
ordered on Matritech's purchase orders.
JDoherty
Unotech Agreement Draft 4-19-01 04/19/01
Page 2
Returns of Defective Product:
Matritech will have the right to return defective product to Unotech. A
defective product is one that does not perform according to the labeling
provided by Matritech and the specifications included in Schedule A which have
been agreed to by Unotech.
JDoherty
Unotech Agreement Draft 4-19-01 04/19/01
Page 3
Quality Control and FDA Requirements:
Matritech will assist Unotech in defining processes and procedures necessary to
assure compliance with all FDA requirements for Good Manufacturing Practices.
Unotech will maintain a complete device history file as well as the records
identified by Matritech including information regarding quantities, lot numbers
and shipping data for at least [**] years beyond the expiration date of the
product. Copies of all records not deemed by Unotech to be confidential will be
supplied to Matritech for inclusion in a duplicate device history record.
Prior to any product delivery, Unotech will send Matritech 10 units from the
beginning of the production run 10 units from the middle of the run and 10 units
from the end of the run for quality control testing at Matritech. In addition,
Unotech will provide 20 units selected randomly from the production run.
Matritech will have the right to audit Unotech's facility at agreed times and
Matritech will be permitted to be present in the facility during the manufacture
of the first three production lots in order to insure compliance with Good
Manufacturing Practices (GMP). Unotech will reserve the right to refuse to
disclose to Matritech personnel any proprietary information pertinent to the
manufacture of the product.
Intellectual Property Ownership:
Unotech and Matritech will retain ownership of their own intellectual property.
Matritech grants to Unotech a fully paid-up, non-exclusive license to use its
NMP22 patents in the manufacture of the product solely to be sold to Matritech
for the term of this agreement. Unotech agrees to keep this proprietary
information confidential.
Royalty Obligations:
Matritech will be responsible for [**]. Matritech will also be responsible for
[**].
Term of Arrangement:
This agreement will be for an initial term of [**] years. The agreement can be
extended by mutual agreement for successive, one-year periods after the initial
term. This agreement can be terminated by either Unotech or Matritech if either
party violates a major term of the agreement and the violation is not corrected
within 60 days from the time the injured party gives notice.
Continuity of Supply:
Unotech will provide Matritech with a fully paid-up default license to use
Unotech's proprietary intellectual property to manufacture the NMP22
POINT-OF-CARE product. Matritech will have the right to use this license only in
the event that Unotech is unable to supply product to Matritech. The
intellectual property will be reduced to writing and left in escrow with an
attorney or other trusted individual of Unotech's choice and agreed to by
Matritech.
JDoherty
Unotech Agreement Draft 4-19-01 04/19/01
Page 4
In the event that Unotech is unable to supply Product to Matritech and Matritech
elects to produce Product under this default license, Matritech will pay Unotech
an initial payment of $[**] within [**] days of receiving Unotech's written
intellectual property and a royalty of $[**] per year for the following [**]
years.
In the event that Unotech is able to supply Product but decides not to do so for
any reason, Unotech must give Matritech [**] months notice before ceasing
production.
Technical Support:
Matritech will be responsible for the support of customers using the Product.
Whenever requested by Matritech, Unotech agrees to assist in providing necessary
technical support to these customers.
Would you please signify your acceptance of this agreement by signing below and
returning an original copy of this agreement.
Sincerely,
/s/ Xxxxx Xxxxxx
--------------------
Xxxxx Xxxxxx
President, Matritech, Inc.
Agreed and accepted:
/s/ Geng-Xxxxx Xx Date: 4/22/01
-----------------
Geng-Xxxxx XX, Ph.D.
Unotech Diagnostics, Inc.
JDoherty
Unotech Agreement Draft 4-19-01 04/19/01
Page 5
Schedule A - Product Specifications
NMP22 POINT-OF-CARE Design Inputs
[**]
JDoherty
Unotech Agreement Draft 4-19-01 04/19/01
page 6
