REDACTED VERSION
[CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR PORTIONS OF
THIS EXHIBIT]
PURCHASE AND LICENSE AGREEMENT
This agreement is made by and between Molecular Innovations, Inc. ("MI"), a
Delaware Corporation organized and existing in the State of Colorado, and
Lifecodes, Inc. ("Lifecodes") a Delaware Corporation organized and existing in
the State of Connecticut.
WHEREAS, M1 is the owner of patent applications and know how relating to
XtraBind and XtraEasy technology, and is desirous of licensing rights to
Lifecodes for marketing XtraBind and XtraEasy; and
WHEREAS, Lifecodes is interested in acquiring MI's XtraBind and XtraEasy for
exclusive marketing in the forensic, HLA and paternity testing fields of use;
NOW THEREFORE, both parties agree as follows:
1. DEFINITIONS
X. Xxxxx Sales shall mean gross revenue from sales of XtraBind and
XtraEasy by Lifecodes or a Lifecodes affiliate, less customer
allowances and returned goods.
B. Lifecodes Affiliate shall mean any organization in which Lifecodes
owns or controls, directly or indirectly, at least fifty percent (50%)
of its voting stock or similarly owns or controls Lifecodes.
C. M1 Affiliate shall mean any organization in which MI owns or controls
directly or indirectly, at least fifty percent (50%) of its voting
stock or which similarly owns or controls M1,
D. Licensed Patents shall mean those patents and patent applications
relating to the MI XtraBind and XtraEasy technology.
E. XtraBind shall mean Molecular Innovation's patent pending nucleic acid
binding material.
F. XtraEasy shall mean a 96 well format containing pre-dispensed XtraBind
in an amount that provides up to 10 amplification reactions for each
sample.
2. LICENSE
A. MI hereby grants to Lifecodes an exclusive worldwide license to make
(under MI authorization only), as provided below, use and sell
products incorporating XtraBind and XtraEasy technology in the
following fields of use: Forensics, HLA Paternity products
incorporating (the "Licensed Fields"); providing that in connection
with its existing and any renewed Navy, DKMS, NMDP or Department of
Defense contract, Lifecodes may use samples on which it has conducted
tests within one or more Licensed Fields to conduct diagnostic
testing,
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in other fields. Otherwise, Lifecodes shall have no rights under this
License with respect to fields outside the Licensed Fields.
B. Lifecodes shall have no right to manufacture products except as
specifically authorized below, or to sublicense, assign or otherwise
transfer its rights under this license except to a subsidiary of
Lifecodes or to a successor in interest to substantially all of the
assets of Lifecodes, whether by purchase, merger or operation of law.
These rights require prior written approval of MI.
C. If MI is unable to supply the needs of Lifecodes for products using
the XtraBind or XtraEasy technology, under this License, for a
continuous period of at least 60 days, then Lifecodes may manufacture
products for the use and sale within the scope of this License;
provided, that Lifecodes shall pay MI a royalty on such products equal
to a percentage (as agreed to by the parties or determined by
arbitration to be a reasonable royalty) of the Gross Sales of such
products. Royalties shall be paid quarterly based on Gross Sales
invoiced during the quarter.
3. COMPENSATION
A. Lifecodes shall pay MI a [____________] license fee in two initial
installments:
(1) [_____________] upon the signing of the license agreement
(2) [_____________] upon the receipt of an acceptable protocol for
utilizing samples collected in the common preservatives, EDTA,
Citrate or Heparin, and from buccal swabs.
B. Costs of validation of the XtraBind and XtraEasy for licensed
applications will be assumed by Lifecodes according to a mutually
agreed upon protocol. (As described in Attachment I)
C. The license obligation shall continue until the later of (1) Five
years after the first commercial sale of XtraBind and XtraEasy, or (2)
The expiration of all Licensed Patents, including any extension
thereof
D. Lifecodes shall remit to MI payment in full for all products delivered
within 30 days.
E. MI shall have the right to have an independent auditor, mutually
agreed upon by MI and Lifecodes, to review Lifecodes books and records
once each calendar year for the purpose of verifying markets and field
of use allowed under the license exclusivity, and (as applicable)
royalty payments.
4. GENERAL PROVISIONS
A. This agreement is not assignable by Lifecodes except to a Lifecodes
affiliate.
B. All Product will include end user package labeling indicating
Molecular Innovations, Inc. as the original product manufacturer and
patent owner.
C. Lifecodes will promptly notify MI of any actual or expected
infringement of Licensed Patents. MI makes no warrantees concerning
infringement.
D. All information exchanged under the terms of this agreement shall be
considered confidential by the receiving party for a period of ten
(10) years from the date of receipt of such information and shall be
subject to any existing confidentiality agreement. Absent any other
more restrictive agreement, the information considered confidential
under this agreement is that information which:
(1). is clearly marked as "confidential" or if verbal, is verified in
writing and marked "confidential", with a clear reference made to the
verbal information;
(2). is not already known by the receiving party from its own research
or from a third party who has the right to disclose the information to
the receiving party;
(3). is not or does not become the subject of a patent issued by a
third party;
(4). is not or does not become open to the public by means including
disclosure in patents or publications, or public use or sale, except
by breach of the Agreement; or
(5). is not required to be disclosed to government agencies or to
third parties under an appropriate confidentiality agreement anywhere
in the world for legitimate commercial or legal purposes relating to,
inter alia, registration, marketing and patent application filing in
such countries as permitted under this agreement.
E. Any provision herein to the contrary notwithstanding neither party
hereto shall be liable to the other for any loss, injury, delay or
damages or casualty suffered or incurred by any such party to strikes,
riots, storms, fires, acts of God action by any local, state or
federal government body or agency or any other cause which is beyond
the reasonable control of the party, the performance of whose
obligations is effected by such cause.
5. TERMINATION
A. This agreement may be terminated at any time by mutual consent of the
parties.
B. If either party is in breach or default of any of the provisions of
the
Agreement and does not rectify the breach or default within two (2)
months after receipt of the written notice from the other party
requesting rectification of the breach or default, the other party may
terminate this agreement by written notice to the party in breach or
default.
C. Any termination of this agreement, by written notice of one party to
the other for any reason whatsoever, shall operate as termination of
the licenses granted hereunder.
D. Except for breaches of confidentiality, the parties will be required
to exhaust internal negotiations to resolve all disputes before
pursuing third party arbitration.
IN WITNESS WHEREOF, the parties through their authorized officers have executed
this Agreement as of the date shown below.
MOLECULAR INNOVATIONS, INC. LIFECODES, INC.
By ______________________________ By _______________________________
Title ____________________________ Title ____________________________
Date _____________________________ Date _____________________________
Attachment I
Molecular Innovations, Inc. offers an exclusive license to Lifecodes for a
limited number of fields of use. In exchange for this license, Molecular
Innovations offers the following fee and payment schedule, and Lifecodes agrees
to disclose to MI and permit MI to use all improvements and developments to the
MI technology. This agreement includes a two part initial license fee, financial
support for a field of use validation plan and a minimum order and delivery
commitment for the first three years of license.
Fields of use: To include all applications XtraBind and XtraEasy in the fields
of human forensic, HLA paternity testing and related diagnostic testing as
authorized by MI on the same sample.
Territory : Worldwide
Compensation:
License Fee: [_____________] provided in two equal installments.
1. [________________] upon signing the License Agreement
2. [________________] upon the receipt of an acceptable protocol
for utilizing samples collected in the common preservatives,
EDTA, Citrate or Heparin, and from buccal swabs. A protocol will
be considered acceptable if it meets the following criteria:
Validation/Optimization:
1 Optimization of XtraEasy with Lifecodes primer sets.
Molecular Innovations will optimize each primer set for the
XtraEasy amplification system. Lifecodes will provide all
necessary reagents with the exception of XtraEasy reagents.
Ml will perform the optimization of each primer set
requested by Lifecodes for a [_________] fee for each primer
set/specimen type.
The isolated DNA can be amplified by MI for Lifecodes' HLA
AMP-FLP and STR kits using quantities for genomic DNA and by
generating amplified product(s) in similar quantities those
obtained with commercial isolation DNA kits such as
Lifecodes' E-Z Prep.
2. Typing results for each primer set will be confirmed using
XtraEasy amplified DNA compared to IAD's standard extraction
protocol. MI will use eight (8) specimens in triplicate for
each primer set/specimen. A protocol will be written, and
Lifecodes will confirm this in their lab using the same
eight (8) specimens typed with their standard protocol as
well as using XtraEasy plates and reagents supplied to
Lifecodes. Total fee will be billed to Lifecodes at IAD's at
standard pricing.
3. 192 NMDP specimens selected to represent all allelic
combination will be typed at Lifecodes using XtraEasy and
the standard MI protocol. The results will be provided to
MI.
4. 30 buccal and blood samples will be validated at Lifecodes
for XtraEasy paternity testing according to the AABB
standard protocol. ( 10 Cases including; mother, father and
child). The results will be provided to MI.
Initial Purchase Agreement and Stocking Order
1. The initial purchase agreement will have a three year
minimum commitment period, with non-binding forecasts
updated 90 days in advance of each year's anniversary. A
twelve-month rolling purchase forecast will be provided on
the first day of each fiscal quarter.
2. The first year minimum purchase order will total at least
1300 XtraEasy kits and associated reagents representing
approximately 250,000 individual tests. The initial stocking
order will include 650 XtraEasy kits and reagents.
3. Pricing: The XtraEasy system will initially be available
with two different nucleic acid extraction reagent systems.
The extraction system will be agreed upon by Lifecodes prior
to the final transfer from pilot to product. The transfer
price to Lifecodes for the slurry format will be [________]/
XtraEasy kit.
