Parking form the 10K...
OUR COLLABORATIONS
Through December 31, 2002, we have entered into the following licenses and
collaborations:
ASTRAZENECA UK LIMITED
Effective November 29, 2001, we entered into a three-year agreement with
AstraZeneca UK Limited, in which AstraZeneca gained limited access to our
HAP-TM- Technology to investigate associations between our HAP-TM- Markers and
disease susceptibility, in exchange for a specified, onetime payment. We granted
AstraZeneca a perpetual exclusive license to use those HAP-TM- Markers that are
shown to have a predictive association with a certain disease, for discovering,
developing, manufacturing, marketing and selling of AstraZeneca drugs. We also
granted AstraZeneca a perpetual, co-exclusive license, with us, to use the
predictive HAP-TM- Markers for discovering, developing, manufacturing, marketing
and selling prognostic products used in connection with the sale or prescription
of AstraZeneca drugs. In exchange for these license grants, AstraZeneca granted
us options, which expire in 2011, to obtain licenses under its intellectual
property for making, using, marketing and selling prognostic and diagnostic
products that detect these predictive HAP-TM- Markers.
BD (BECTON, DICKINSON AND COMPANY)
Effective December 18, 2002, we entered into a training and license
agreement with BD. Under the terms of the agreement, we acquired a
non-exclusive, non-transferable license to BD's proprietary BDProbeTec-TM- ET
platform and Strand Displacement Amplification Technology. The license is fully
paid up for our internal research and development activities, which are limited
to the United States, is royalty-bearing for selling products and services
world-wide for genotyping HAP-TM- Markers in certain fields of use. BD will
provide equipment, certain reagents and training on the development of tests.
BIOGEN, INC.
Effective December 21, 2001, we entered into an agreement with
Biogen, Inc., in which Biogen gained non-exclusive access to selected HAP-TM-
Markers from our HAP-TM- Database solely for research and development purposes.
We receive payments based upon the HAP-TM- Markers that Biogen selects.
Effective January 31, 2002, we entered into a second agreement with
Biogen, Inc., in which we are applying our HAP-TM- Technology to a study of the
pharmacogenetic basis of variability in response to
Amevive-Registered Trademark- (alefacept), a biologic developed for the
treatment of adults with moderate-to-severe chronic plaque psoriasis who are
candidates for systemic therapy or phototherapy. We granted Biogen an exclusive,
fee-bearing license to use our HAP-TM- Markers, which are shown to be predictive
of response to this biologic, to develop diagnostic tests for use in connection
with marketing Amevive-Registered Trademark-. We also granted Biogen an
exclusive option, for a limited time, to acquire an exclusive license to use
particular HAP-TM- Markers for developing and commercializing other products.
Biogen agreed to pay us a non-refundable initial fee, research funding and
milestone payments based upon the achievement of predetermined goals, as well as
payments for the commercial use of our HAP-TM- Markers in conjunction with the
sale of Amevive-Registered Trademark-. The agreement will automatically
terminate after a defined number of years. Biogen received certain early
termination rights and either party may terminate the agreement early if the
other party breaches the agreement. In December 2002, we amended the agreement
to define additional work that we would perform as part of the original research
plan and for which Biogen agreed to pay us additional research funding.
JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, A DIVISION OF
JANSSEN PHARMACEUTICA, N.V.
Effective November 22, 2000, we entered into a collaboration agreement with
Janssen Research Foundation, referred to as J&J PRD, under which we granted J&J
PRD a non-exclusive license to our HAP-TM- Technology in exchange for the
payment of annual subscription fees and other fees described below. We installed
our DECOGEN-REGISTERED TRADEMARK- Informatics System at one of their sites. We
are collaborating with J&J PRD in research projects to identify HAP-TM- Markers
associated with a patient's response to certain J&J PRD drugs. For each of the
first two years of the agreement, we received a minimum fee for providing
HAP-TM- Typing services and we continue to be paid for providing our HAP-TM-
Typing services as part of this collaboration. For the first three research
projects, we defined product license fees, milestone and royalty payments for
drug and diagnostic products that result from these research projects. The
agreement will automatically terminate after three years. Either party may
terminate the agreement early if the other party breaches the agreement. In
November 2002, we amended the agreement with Johnson & Johnson Pharmaceutical
Research & Development, the successor to the Janssen Research Foundation. Under
the terms of the amendment, we granted J&J PRD exclusive commercial licenses to
use HAP-TM- Marker associations with certain drugs in exchange for specified
fees.
PHARMACIA & UPJOHN COMPANY
Effective December 12, 2002, we entered into an agreement with Pharmacia &
Upjohn Company, in which Pharmacia received a non-exclusive license to selected
HAP-TM- Markers from our HAP-TM- Database solely for internal research purposes
and to specific components of our DECOGEN-REGISTERED TRADEMARK- Informatics
System, one of which is a proprietary algorithm to build haplotypes, and access
to our HAP-TM- Typing services for genotyping their clinical samples from a
specific project. We installed the DECOGEN-REGISTERED TRADEMARK- Informatics
System at one of their sites. We receive payments based upon the HAP-TM- Markers
that Pharmacia selects and for genotyping their clinical samples and annual fees
for access to our DECOGEN-REGISTERED TRADEMARK- Informatics System. We expect to
complete the genotyping in 2003.
PFIZER INC
Effective August 31, 2001, we entered into a one-year agreement with
Pfizer Inc., in which Pfizer gained non-exclusive access to selected data from
our HAP-TM- Database. We receive payments based upon the HAP-TM- Markers that
Pfizer selects. In May 2002 and February 2003, we amended the agreement to
extend the terms of the agreement first through February 2003 and now through
August 31, 2004, respectively.
INTEC WEB & GENOME INFORMATICS CORPORATION
Effective February 4, 2002, we entered into a two-year agreement with Intec
Web and Genome Informatics Corporation, referred to as Intec W&G, in which we
appointed Intec W&G as a non-exclusive, authorized sales representative with
responsibility for the Japanese market. We agreed to pay Intec W&G a fixed
commission on all payments, excluding royalties, we receive from agreements
concluded through Intec W&G with Japanese companies. To date, Intec W&G has not
brokered any agreements for us.
VISIBLE GENETICS, A PART OF BAYER HEALTHCARE LLC
Effective November 21, 1996, we granted to Visible Genetics, Inc. a
worldwide, exclusive license to our patented technology relating to the coupled
amplification and sequencing, or CAS, of DNA for diagnostic use. This technology
is not part of our HAP-TM- Technology. Under the terms of the agreement, Visible
Genetics paid us a one-time licensing fee and continues to pay us royalties
based on global sales of products using the licensed technology. Visible
Genetics incorporated the CAS technology in its TruGene-TM- HIV diagnostic kit,
which they designed to perform pharmacogenomic analysis of HIV and to customize
HIV and AIDS therapy for particular patient sub-groups. The FDA granted market
clearance for the TruGene-TM- HIV diagnostic kit on September 26, 2001. In
March 2000, we amended the agreement to, among other things, reduce the amount
of royalties payable under the agreement and expand the field of the license to
the research products market. In return for the reduction of royalties and
broadening of the field, Visible Genetics paid us an additional one-time fee of
$2 million. The term of the agreement extends until the last of the patents
covered by the agreement expires. Either party may terminate the agreement early
if the other party breaches the agreement, and we can terminate the agreement
early if Visible Genetics fails to make any payments. In October 2002,
Leverkusen Bayer through its Bayer Corporation completed the acquisition of
Visible Genetics, Inc., which is now part of the Diagnostics Division of Bayer
HealthCare LLC, and assumed the obligations and rights of Visible Genetics under
this agreement.
SEQUENOM
Effective May 28, 2000, we entered into a three-year collaboration agreement
with Sequenom, Inc., under which we committed to use Sequenom's MassARRAY-TM-
system as our exclusive equipment platform for high-throughput SNP analysis in
our HAP-TM- Typing facility. In return, Sequenom provided equipment and supplies, as well as ongoing access to information about new
technology and products in development by Sequenom. In addition, we had the
option to be a test site for these new technologies and products. The agreement
required us to purchase a minimum number of MassARRAY-TM- systems and allowed
for predetermined pricing of consumables. The agreement would have automatically
terminated after three years. In November 2002, we terminated the collaboration
agreement and also received notice from Sequenom that we could use purchased
Sequenom products to provide commercial services, as part of our
pharmacogenomics support services, to third parties, which are not part of our
HAP-TM- Partnership program, without any additional payment or compensation due
to Sequenom for such use.
Through March 11, 2003, we have entered into the following additional
licenses and collaborations:
BAYER AG AND BAYER HEALTHCARE LLC
Effective January 15, 2003, we entered into a research collaboration and an
exclusive license agreement with Bayer AG and with Bayer Healthcare LLC through
its Diagnostics Division to develop pharmacogenomic markers of drug safety and
efficacy for a defined drug category and for certain disease fields. Under the
terms of the agreement, each party has contributed portions of intellectual
property derived from its respective programs. We will receive funding to apply
our HAP-TM- Technology to Bayer's clinical samples. Bayer will receive exclusive
rights to develop and market diagnostic tests based on the results of the
collaboration. We are entitled to receive royalties and rights to perform these
diagnostic tests in our CLIA-licensed diagnostic laboratory. There are mutual
royalty provisions for any pharmaceutical drugs derived from the collaboration.
The collaboration will terminate at the end of defined safety and efficacy
studies. The agreement will terminate upon the expiration of all licenses and
other granted rights and of the obligation to pay royalties. Either party may
terminate the agreement early if the other party breaches the agreement.
MILLENNIUM PHARMACEUTICALS, INC.
Effective January 7, 2003, we entered into a multi-year agreement with
Millennium Pharmaceuticals, Inc., under which we granted Millennium a
non-exclusive license to our HAP-TM- Technology in exchange for the payment of
annual subscription fees. Millennium granted us certain rights to support their
DNA biomarkers and pharmacogenomic efforts. Millennium has an option to pay
specified annual fees to extend the agreement beyond the defined expiration
date. Either party may terminate the agreement early if the other party breaches
the agreement.
WAYNE STATE UNIVERSITY
Effective March 11, 2003, we entered into an agreement with Wayne State
University (WSU) to support WSU's research contract with the National Institute
of Child Health and Human Development's Perinatology Research Branch (PRB),
which is located at the WSU School of Medicine in Detroit, Michigan. Under the
agreement, WSU gained access to specific HAP-TM- Markers and obtained a limited
license to use our DECOGEN-Registered Trademark- Informatics System. We will
develop assays for the selected HAP-TM- Markers and provide high-throughput
genotyping on clinical samples provided by WSU and the PRB. We receive a license
fee and other payments from WSU. Either party may terminate the agreement early
if the other party breaches the agreement. We expect to complete the genotyping
in 2003... |
