LICENSE AGREEMENT
THIS LICENSE AGREEMENT dated as of January 30,
2009 (this “Agreement”), is entered into between HEALTH
DISCOVERY CORPORATION, a Georgia corporation
(“LICENSOR”), having a place of business at 2 East
Bryan Street, Suite # 601, Savannah, Georgia, and QUEST
DIAGNOSTICS, INCORPORATED, a Delaware corporation
(“LICENSEE”), having a place of business at 3 Giralda
Farms, Madison, New Jersey 07940.
W I T N E S S E T H :
WHEREAS, LICENSOR has rights in the Licensed
Technology covering genomic biomarkers related to prostate cancer
(as more specifically defined below).
WHEREAS, LICENSEE desires to obtain, and
LICENSOR is willing to grant, a non-exclusive license under
LICENSOR’S rights in the Licensed Technology to develop and
commercialize Licensed Uses (as defined below) for use in the Field
(as defined below) in the Territory (as defined below) on the terms
and conditions of this Agreement.
NOW, THEREFORE, in consideration of the
foregoing premises and the mutual covenants herein contained, the
parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
For purposes of this Agreement, the terms
defined in this Article 1 shall have the respective meanings set
forth below:
1.1 “
Affiliate ” shall mean, with respect to any Person,
any other Person which directly or indirectly controls, is
controlled by, or is under common control with, such
Person. A Person shall be regarded as in control of
another Person if it owns, or directly or indirectly controls, at
least thirty five percent (35%) of the voting stock or other
ownership interest of the other Person, or if it directly or
indirectly possesses the power to direct or cause the direction of
the management and policies of the other Person by any means
whatsoever.
1.2 “
Combination Use ” means a Licensed Use that is
sold together in combination with one (1) or more diagnostic
products, processes or services which are not Licensed
Uses.
1.3 “
Field ” shall mean clinical diagnostic applications
using biomarkers in urine for differentiating clinically
significant prostate cancer from other prostate conditions,
including without limitation clinical laboratory testing and
clinical trials, but expressly excluding manufacture of in
vitro diagnostic kits.
1.4 “
First Commercial Sale ” shall mean, with respect to
any Licensed Use, the first sale for use or consumption by the
general public of such Licensed Use.
Confidental treatment has been
requested pursuant to Rule 24b-2 promulgated under the Securities
Exchange Act of 1934.
This exhibits has been provided to
the Securities and Exchange Commission in unredacted
form.
1.5 “
Licensed Know-How ” shall mean all information and
data owned by or licensed to LICENSOR as of the date of this
Agreement relating to the four (4) biomarkers identified in Exhibit
B, which is not generally known including, but not limited to,
formulae, procedures, protocols, techniques and results of
experimentation and testing, which are necessary to practice the
inventions claimed in the Licensed Patent Rights; all to the extent
and only to the extent that LICENSOR has the right to grant
licenses, immunities or other rights thereunder.
1.6 “
Licensed Patent Rights ” shall mean (a) all patent
applications listed on Exhibit A hereto which are owned by or
licensed to LICENSOR; (b) all patents that have issued or in
the future shall issue therefrom, including utility, model and
design patents and certificates of invention; and (c) all
divisionals, continuations, continuations-in-part, reissues,
renewals, reexaminations, extensions or additions to any such
patent applications and patents to the extent that the patent
applications listed cover the four (4) biomarkers identified in
Exhibit B.
1.7 “
Licensed Use ” shall mean a product, process or
service, for use in the Field, which, if made, used,
performed, offered for sale, sold or imported in the Territory,
would infringe a Valid Patent Claim but for the license granted by
this Agreement. Except in connection with the
calculation of royalties pursuant to Section 1.9 and Article 5
below, Licensed Use shall mean either an individual Licensed Use or
a Combination Use.
1.8 “
Licensed Technology ” shall mean, collectively, the
Licensed Patent Rights and the Licensed Know-How.
1.9 “
Net Sales ” shall mean:
(i) with
respect to Licensed Uses sold or performed individually, the sales
price invoiced to Third Parties of all Licensed Uses sold or
performed by LICENSEE and/or its Affiliates, less the following
items as applicable to such Licensed Uses to the extent actually
allowed and taken: (a) contractual allowances such as Medicare,
MediCal, and Medicaid; (b) charges for shipping and insurance; (c)
discounts customary in the trade; (d) credits or refunds; and (e)
bad debt up to 6% of Net Sales; and
(ii) with
respect to Combination Uses, the sales price invoiced to Third
Parties of such Combination Uses sold or performed by LICENSEE
and/or its Affiliates, less: the allowances and adjustments
referred to in Sections 1.9(i)(a)-(e), multiplied by the fraction
A/A+B, where A is the list price of the Licensed Use sold
separately during the royalty period in question, and B is the list
price of the other included diagnostic products, processes or
services which are not Licensed Uses sold separately during the
royalty period in question.
1.10 “
Person ” shall mean an individual, corporation,
partnership, limited liability company, trust, business trust,
association, joint stock company, joint venture, pool, syndicate,
sole proprietorship, unincorporated organization, governmental
authority or any other form of entity not specifically listed
herein.
1.11 “
Royalty Term ” shall mean, with respect to each
Licensed Use, the term for which a Valid Patent Claim remains in
effect which would be infringed by the manufacture, use,
offer for sale, sale or import of such Licensed Use but for the
license granted by this Agreement.
1.12 “
Territory ” shall mean the United States, its
territories and possessions.
1.13 “
Third Party ” shall mean any Person other than
LICENSOR, LICENSEE and their respective Affiliates.
1.14 “
Valid Patent Claim ” shall mean either (a) a
claim of an issued and unexpired patent included within the
Licensed Patent Rights, which has not been held permanently
revoked, unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal, and which has not
been admitted to be invalid or unenforceable through reissue or
disclaimer or otherwise or (b) a claim of a pending patent
application included within the Licensed Patent Rights, which claim
was filed in good faith and has not been abandoned or finally
disallowed without the possibility of appeal or refiling of such
application.
ARTICLE 2
REPRESENTATIONS AND WARRANTIES OF
LICENSOR
LICENSOR hereby represents and warrants to
LICENSEE as follows:
2.1
Corporate Existence and Power . LICENSOR
(a) is a corporation duly organized, validly existing and in
good standing under the laws of the State of Georgia; (b) has
the corporate power and authority and the legal right to own and
operate its property and assets, to lease the property and assets
it operates under lease, and to carry on its business as it is now
being conducted and (c) is in compliance with all requirements
of applicable law, except to the extent that any noncompliance
would not have a material adverse effect on the properties,
business, financial or other condition of it and would not
materially adversely affect its ability to perform its obligations
under this Agreement.
2.2
Authorization and Enforcement of Obligations
. LICENSOR (a) has the corporate power and
authority and the legal right to enter into this Agreement and to
perform its obligations hereunder and (b) has taken all
necessary corporate action on its part to authorize the execution
and delivery of this Agreement and the performance of its
obligations hereunder. This Agreement has been duly
executed and delivered on behalf of LICENSOR, and constitutes a
legal, valid, binding obligation, enforceable against LICENSOR in
accordance with its terms.
2.3
No Consents . All necessary consents, approvals
and authorizations of all governmental authorities and other
Persons required to be obtained by LICENSOR in connection with this
Agreement have been obtained.
2.4
Rights in Licensed Technology . LICENSOR is the
legal and beneficial owner of all right, title and interest in and
to the Licensed Technology, having good title thereto, free and
clear of any and all mortgages, liens, security interest and
charges, and no Person has any claim of ownership with respect to
the Licensed Technology.
2.5
No Infringement . To the best of LICENSOR’s
knowledge, neither the use of the Licensed Technology nor the
granting of this license practice under the Licensed Technology
violates, infringes or otherwise conflicts or interferes with any
patent or any other intellectual property or proprietary right of
any Third Party. To the best of LICENSOR’s
knowledge, no Third Party is currently infringing upon
the Licensed Technology in the Field.
ARTICLE 3
REPRESENTATIONS AND WARRANTIES OF
LICENSEE
LICENSEE hereby represents and warrants to
LICENSOR as follows:
3.1
Corporate Existence and Power . LICENSEE
(a) is a corporation duly organized, validly existing and in
good standing under the laws of the State of Delaware; (b) has
the corporate power and authority and the legal right to own and
operate its property and assets, to lease the property and assets
it operates under lease, and to carry on its business as it is now
being conducted and (c) is in compliance with all requirements
of applicable law, except to the extent that any noncompliance
would not have a material adverse effect on the properties,
business, financial or other condition of it and would not
materially adversely affect its ability to perform its obligations
under this Agreement.
3.2
Authorization and Enforcement of Obligations
. LICENSEE (a) has the corporate power and
authority and the legal right to enter into this Agreement and to
perform its obligations hereunder and (b) has taken all
necessary corporate action on its part to authorize the execution
and delivery of this Agreement and the performance of its
obligations hereunder. This Agreement has been duly
executed and delivered on behalf of LICENSEE, and constitutes a
legal, valid, binding obligation, enforceable against LICENSEE in
accordance with its terms.
3.3
No Consents . All necessary consents, approvals
and authorizations of all governmental authorities and other
Persons required to be obtained by LICENSEE in connection with this
Agreement have been obtained.
ARTICLE 4
LICENSE GRANT
4.1
Licensed Technology . LICENSOR hereby grants to
LICENSEE and its Affiliates a non-exclusive license (without the
right to grant sublicenses) under the Licensed Technology to make,
have made, use, sell, offer for sale and import Licensed Uses in
the Territory in the Field.
4.2
Research . LICENSEE shall perform primary testing
associated with a validation study of its laboratory-developed test
using the Licensed Technology in connection with * or an equivalent
academic cancer center (with the exception of tissue biopsy)
including expression testing, the PSA and send-out of the PCA-3
(the “Validation Study,” as more specifically outlined
on Exhibit C attached hereto). LICENSEE shall have the
right to perform research on remnants after all testing required
for the Validation Study is completed, and will be provided
reasonable access to the patient data related to the applicable
samples. LICENSOR shall obtain IRB approval for the
study with * by February 28, 2009 or, with an equivalent academic
institution by June 30, 2009.
4.3
Purchasing Rights . Upon issuance of FDA
clearance or approval of an in vitro diagnostic kit using
the Licensed Technology (“IVD Kit”), LICENSEE shall
have the obligation to purchase IVD Kits for reference laboratory
use from LICENSOR’s designated manufacturer or distributor
pursuant to a purchasing agreement between LICENSEE and the
applicable manufacturer or distributor, provided however that
LICENSOR shall negotiate to cause such manufacturer or distributor
to provide Most Favored Terms (similar to the terms described in
Section 5.5 below with respect to this Agreement) to
LICENSEE.
ARTICLE 5
ROYALTIES AND FEES
5.1
Royalties . In partial consideration for the
license granted hereunder, during the Royalty Term, LICENSEE shall
pay to LICENSOR running royalties equal to * percent (*%) of Net
Sales by LICENSEE or its Affiliates. Such royalties
shall be due and payable on a quarterly basis and shall be
submitted by LICENSEE along with the report as specified in Section
6.1 below.
5.2
License Fee . In partial consideration for the
license granted hereunder, within thirty (30) business days of
execution of this Agreement, LICENSEE shall pay to LICENSOR an
amount equal to * United States Dollars (US$*).
5.3
Milestone Fee . In partial consideration for the
license granted hereunder, LICENSEE shall pay to LICENSOR an amount
equal to * United States Dollars (US$*) within thirty (30) days of
the later of publication of the Validation Study (as defined in
Exhibit C, attached hereto) showing statistically significant
performance improvement over PCA-3 (“Study
Publication”) or First Commercial Sale of the first Licensed
Use. The following conditions shall apply to this
Section 5.3:
5.3.1. If neither
the Study Publication nor the First Commercial Sale occurs, or if
the FDA issues its clearance or approval of an IVD Kit (“FDA
Clearance”) prior to occurrence of the Study Publication or
First Commercial Sale, no Milestone Fee shall be due or
payable.
5.3.2. If, upon FDA
Clearance, the Milestone Fee is determined to have been
paid after becoming due and payable during a period of time that
occurred between three (3) and six (6) months prior to the date of
FDA Clearance, * Dollars ($*) of the Milestone Fee shall be
reimbursed to LICENSEE within forty five (45) days of the date of
such FDA Clearance.
5.3.3. If, upon FDA
Clearance, the Milestone Fee had been paid after
becoming due and payable during a period less than three
(3) months prior to the date of FDA Clearance, the full Milestone
Fee shall be reimbursed to LICENSEE within forty five (45) days of
the date of such FDA Clearance.
5.4
Study Fees . In partial consideration for the
license granted hereunder, LICENSEE shall reimburse LICENSOR for
fees and costs related to the Validation Study of the Licensed
Technology, estimated to be approximately * United States Dollars
(US$*) plus an amount equal to * percent (*%) of LICENSOR’s
overhead to complete the Validation Study, such portion anticipated
to be approximately * United States Dollars (US$*), which shall be
paid within thirty (30) days of IRB approval of the study protocol
and before any steps are taken toward initiation of the
study. The cost of support vector machine data analysis
and support shall be included in the overhead portion, and shall be
provided to LICENSEE.
5.5
Most Favored Terms . The terms and conditions of
this Agreement are not, and shall not be, less favorable than the
terms and conditions pursuant to which the Licensed Technology is
licensed on a non-exclusive basis to any Third Party. If
LICENSOR grants any non-exclusive license to any Third Party on
more favorable terms and conditions than those contained herein,
this Agreement shall automatically be amended effective as of the
date of such other license to contain those more favorable terms
and conditions.
5.6
Third Party Licenses . If LICENSEE is required to
take a license under any Third Party patents (other than the RT-PCR
technology) to use the Licensed Technology, then fifty percent
(50%) of any Third Party royalty, payment or other liability for
such license (a “Third Party Payment”) may be deducted
from the royalty payments due LICENSOR (if applicable) for that
specific Licensed Use; provided, however, that the royalty
percentage due under this Agreement may not be reduced by more than
fifty percent (50%) of such royalty percentage.
ARTICLE 6
ROYALTY REPORTS AND
ACCOUNTING
6.1
Reports, Exchange Rates . During the term of this
Agreement following the First Commercial Sale of a Licensed Use,
LICENSEE shall furnish to LICENSOR a quarterly written report
showing in reasonably specific detail, (a) the gross sales of
each Licensed Use sold by LICENSEE and its Affiliates during the
reporting period and the calculation of Net Sales from such gross
sales; (b) the royalties payable in United States dollars, if
any, which shall have accrued hereunder based upon Net Sales of
each Licensed Use; (c) the withholding taxes, if any, required
by law to be deducted in respect of such sales; (d) the date
of the First Commercial Sales of each Licensed Use in each country
during the reporting period; and (e) the exchange rates used
in determining the amount of United States dollars. With
respect to sales of Licensed Uses invoiced in United States
dollars, the gross sales, Net Sales, and royalties payable shall be
expressed in United States dollars. With respect to
sales of Licensed Uses invoiced in a currency other than United
States dollars, the gross sales, Net Sales and royalties payable
shall be expressed in the domestic currency of the Person making
the sale together with the United States dollar equivalent of the
royalty payable, calculated using the average closing buying rate
for such currency quoted in the continental terms method of quoting
exchange rates (local currency per US$1) by the Wall Street Journal
on the last business day of each month in the calendar quarter
prior to the date of payment. Reports shall be due on
the sixtieth (60th) day following the close of each reporting
period. LICENSEE shall keep and require its Affiliates
to keep complete and accurate records in sufficient detail to
properly reflect all gross sales and Net Sales and to enable the
royalties payable hereunder to be determined.
6.2.1 Upon
the written request of LICENSOR and not more than once in each
calendar year, LICENSEE shall permit an independent certified
public accounting firm selected by LICENSOR and reasonably
acceptable to LICENSEE, at LICENSOR’s expense, to have access
during normal business hours to such of the records of LICENSEE as
may be reasonably necessary to verify the accuracy of the royalty
reports hereunder for any year ending not more than thirty-six (36)
months prior to the date of such request. &n