LICENSE AGREEMENT
Exhibit
10.3
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 0 Xxxx Xxxxx Xxxxxx, Xxxxx # 000, Xxxxxxxx,
Xxxxxxx, and QUEST DIAGNOSTICS, INCORPORATED, a Delaware corporation
(“LICENSEE”), having a place of business at 0 Xxxxxxx Xxxxx, Xxxxxxx, Xxx Xxxxxx
00000.
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.
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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.
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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.
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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 ($*)
of the Milestone Fee shall be reimbursed to LICENSEE within forty five (45) days
of the date of such FDA Clearance.
5.3.3. If,
upon FDA Clearance, the Milestone Fee had been paid after becoming
due and payable during a period less than three (3) months prior to
the date of FDA Clearance, the full Milestone Fee shall be reimbursed to
LICENSEE within forty five (45) days of the date of such FDA
Clearance.
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5.4 Study
Fees. In partial consideration for the license granted
hereunder, LICENSEE shall reimburse LICENSOR for fees and costs related to the
Validation Study of the Licensed Technology, estimated to be approximately *
United States Dollars (US$*) 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.
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6.2 Audits.
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. The accounting firm shall disclose to LICENSOR
only whether the records are correct or not and the details concerning any
specific discrepancies. No other information shall be
shared.
6.2.2 If
such accounting firm concludes that additional royalties were owed during such
period, LICENSEE shall pay the additional royalties within thirty (30) days of
the date LICENSOR delivers to LICENSEE such accounting firm’s written report
documenting the royalty underpayment. The fees charged by such
accounting firm shall be paid by LICENSOR; provided, however, if the audit
discloses that the royalties payable by LICENSEE for the audited period are more
than one hundred ten percent (110%) of the royalties actually paid for such
period, and the difference between royalties payable and royalties paid is
greater than Five Thousand Dollars ($5,000), then LICENSEE shall pay the
reasonable fees and expenses charged by such accounting firm.
6.3 Confidential Financial
Information. LICENSOR shall treat all financial information
subject to review under this Article 6 as Confidential Information pursuant
to Article 8 below, and shall cause its accounting firm to retain all such
financial information in confidence.
ARTICLE
7
PAYMENTS
7.1 Payment
Terms. Royalties shown to have accrued by each royalty report
provided for under Article 6 of this Agreement shall be due and payable on
the date such royalty report is due. Payment of royalties in whole or
in part may be made in advance of such due date.
7.2 Payment
Method. All payments by LICENSEE to LICENSOR under this
Agreement shall be paid in United States dollars, and all such payments shall be
originated from a United States bank located in the United States and made by
bank wire transfer in immediately available funds to such account as LICENSOR
shall designate before such payment is due.
7.3 Exchange
Control. If at any time legal restrictions prevent the prompt
remittance of part or all royalties with respect to any country where the Use is
sold, payment shall be made through such lawful means or methods as LICENSOR
reasonably shall determine.
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ARTICLE
8
CONFIDENTIALITY
8.1 Confidential
Information. During the Royalty Term of the Agreement, and for
a period of three (3) years following the expiration or earlier termination
hereof, each party shall maintain in confidence all written information and data
provided by one party to the other hereunder and marked “Confidential” or, if
information disclosed orally, visually or in some other form, which is
summarized in writing, is confirmed in writing as “Confidential” to the other
party within thirty (30) days of such disclosure (the “Confidential
Information”), and shall not use, disclose or grant the use of the Confidential
Information except on a need-to-know basis to those directors, officers,
employees, agents and permitted assignees, to the extent such disclosure is
reasonably necessary in connection with such party’s activities as expressly
authorized by this Agreement. To the extent that disclosure is
authorized by this Agreement, prior to disclosure, each party hereto shall
obtain written agreement of any such Person to hold in confidence and not make
use of the Confidential Information for any purpose other than those permitted
by this Agreement.
8.2 Permitted
Disclosures. The confidentiality obligations contained in
Section 8.1 of this Agreement shall not apply to the extent that (a) any
receiving party (the “Recipient”) is required (i) to disclose information by
law, order or regulation of a governmental agency or a court of competent
jurisdiction, or (ii) to disclose information to any governmental agency for
purposes of obtaining approval to test or market a product, provided in either
case that the Recipient shall provide written notice thereof to the other party
and sufficient opportunity to object to any such disclosure or to request
confidential treatment thereof; or (b) the Recipient can demonstrate that
(i) the disclosed information was public knowledge at the time of such
disclosure to the Recipient, or thereafter became public knowledge, other than
as a result of actions or inaction of the Recipient in violation hereof;
(ii) the disclosed information was rightfully known by the Recipient (as
shown by its written records) prior to the date of disclosure to the Recipient
by the other party hereunder; or (iii) the disclosed information was
disclosed to the Recipient on an unrestricted basis from a source unrelated to
any party to this Agreement and not under a duty of confidentiality to the other
party.
8.3 Equitable
Relief. Each party hereby acknowledges that, in the event of
any breach or threatened breach of this Article 8 by the Recipient, the
disclosing party may suffer irreparable injury for which damages at law may not
be an adequate remedy. Accordingly, without prejudice to any other
rights and remedies otherwise available to the disclosing party, the disclosing
party shall be entitled to seek equitable relief, including injunctive relief
and specific performance, for any breach or threatened breach of this Article 8
by the Recipient, its Affiliates, or any of its or their employees, directors,
officers, members, agents, or representatives.
8.4 Non-Use of Names;
Confidentiality of Agreement. Neither party shall make any
public announcement, issue any press release or publish any study (collectively,
all such communications, “Publication”) concerning the transactions contemplated
herein, or make any Publication which includes the name of the other party or
any of its Affiliates, or otherwise use the name or names of the other party or
any of their employees or any adaptation, abbreviation or derivative of any of
them, whether oral or written, related to the terms, conditions or subject
matter of this Agreement, without the prior written permission of such other
party, except as may be required by law or judicial order (and then only
following consultation with the other party).
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8.5 Compliance with Laws;
Reporting Obligation with Respect to Protected Health
Information. Each party shall comply with all Applicable
Laws. “Applicable Laws” are the international, federal, state, and
local laws, rules and regulations that relate to the conduct of the parties’
business and the performance by the parties of their respective obligations
under this Agreement. If either party or its permitted
representatives gain access to protected health information (“PHI”), as that
term is defined under The Health Insurance Portability and Accountability Act of
1996, that is not required for performance of this Agreement, each party shall
immediately report to the other party any incidents of access to PHI or any
incidents of use, reproduction or disclosure of PHI of which it or its Permitted
Representatives become(s) aware.
ARTICLE
9
PATENTS
9.1 Patent Prosecution and
Maintenance. LICENSOR shall be responsible for and shall have
the right to control the preparation, filing, prosecution and maintenance of the
Licensed Patent Rights, and shall be responsible for paying all costs
thereof. To the extent that LICENSOR holds exclusive rights
encompassing the Field, but does not exclusively own any portion of the Licensed
Patent Rights, LICENSOR shall make all reasonable efforts to ensure that the
Licensed Patent Rights are maintained. LICENSOR shall provide
LICENSEE with a copy of each patent application subject to this Section
9.1. In the event that HDC is unable or unwilling to maintain any one
or more of the Licensed Patent Rights, LICENSEE may pay the fees for maintaining
the indicated patents or patent applications within Licensed Patent Rights and
deduct such payment from any amounts owed by LICENSEE to LICENSOR under this
License Agreement. LICENSOR shall notify LICENSEE before any Licensed
Patent Rights terminate with sufficient time to permit LICENSEE to take action
to maintain the patent, if it so chooses.
9.2 Enforcement of Patent
Rights. LICENSOR, at its sole expense, shall have the right,
but not the obligation, to enforce the Licensed Patent Rights or otherwise xxxxx
the infringement thereof and to control any litigation or other enforcement
action and shall consider, in good faith, the interests of LICENSEE in so
doing. LICENSEE shall cooperate with LICENSOR in the planning and
execution of any action to enforce the Licensed Patent
Rights. LICENSOR shall not settle the suit in a manner that
diminishes or affects the rights or interests of LICENSEE without the express
written consent of LICENSEE.
9.3 Improvements.
9.3.1. LICENSEE
shall disclose to LICENSOR any and all improvements made by or on behalf of
LICENSEE directly related to the Licensed Technology that are
conceived or reduced to practice by or on behalf of LICENSEE as a result of
activities engaged in pursuant to the terms of this Agreement (“Licensee
Improvements”).
9.3.2. LICENSOR
shall disclose to LICENSEE any and all improvements made by or on behalf of
LICENSOR (“Licensor Improvements”) related to the Licensed Technology
that are conceived or reduced to practice by or on behalf of LICENSOR as a
result of activities engaged in pursuant to the terms of this
Agreement. LICENSEE acknowledges, however, that this Agreement is a
non-exclusive license and that LICENSOR has granted or will grant other licenses
to third party(ies) for use of the Licensed Technology and, further that certain
Licensor Improvements to the Licensed Technology, although they may be of
benefit to LICENSEE, may arise in conjunction with such third party
licenses. In such cases, disclosure of such Licensor Improvements may
be restricted or prohibited, or disclosure to LICENSEE may be delayed due to
LICENSOR’s obligations under the third party license. In such cases,
to the extent permitted, LICENSOR will disclose the Licensor Improvement as soon
as practicable.
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9.3.3. LICENSEE
shall not publish or disclose Licensor Improvements to third parties or to the
public through any communication including, but not limited to, academic
publication or other exchanges of information without first providing the
LICENSOR with the opportunity to review the communication and to make
arrangements for protecting such Licensor Improvements by patent or other
appropriate means prior to disclosure. Similarly, LICENSOR shall not publish or
disclose Licensee Improvements to third parties or to the public through any
communication including, but not limited to, academic publication or other
exchanges of information without first providing the LICENSEE with the
opportunity to review the communication and to make arrangements for protecting
such Licensee Improvements by patent or other appropriate means prior to
disclosure.
9.3.4. All
Licensor Improvements shall be owned by LICENSOR. LICENSEE agrees to
provide any assistance and take such acts as are reasonably requested by
LICENSOR to enable LICENSOR to obtain a letters patent for or respecting any
Licensor Improvement, to protect such patent right, to conduct further research
and to publish.
9.3.5. All
Licensee Improvements, or jointly made by LICENSOR and LICENSEE, shall be owned
by LICENSEE to the extent that such Licensee Improvements do not incorporate
Licensed Technology. LICENSOR shall provide any assistance and take
such acts as are reasonably requested by LICENSEE to enable LICENSEE to obtain a
letters patent for or respecting any Licensee Improvement, to protect such
patent right, to conduct further research and to publish.
9.3.6. All
Licensor Improvements shall automatically become subject to the grant in Section
4.1 above and any patent rights therein shall be deemed to be Licensed Patent
Rights for the purposes of this Agreement, subject to the same rights and
obligations applicable to Licensed Technology under the Agreement.
9.3.7. All
Licensee Improvements shall become subject to a grant-back from LICENSEE to
LICENSOR of a perpetual, non-exclusive, sublicensable, worldwide license to
make, have made, use, perform, sell or offer for sale any Licensee Improvement
in the field of clinical diagnostics applications using urine RNA express-based
rebiopsy assays, subject to a commercially reasonable royalty to be negotiated
in good faith by the parties.
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ARTICLE
10
TERMINATION
10.1 Expiration. Subject
to the provisions of Sections 10.2 and 10.3 of this Agreement, this Agreement
shall expire on the termination of LICENSEE’s obligation to pay royalties to
LICENSOR under Article 5 of this Agreement.
10.2 Termination by
LICENSEE. LICENSEE may terminate this Agreement, in its sole
discretion, upon ninety (90) days prior written notice to LICENSOR.
10.3 Termination for
Cause. Except as provided in Article 12 of this Agreement, a
party may terminate this Agreement upon or after the breach of any material
provision of this Agreement by the other party if the other party has not cured
such breach within forty five (45) days after written notice thereof by the
non-breaching party.
10.4 Effect of Expiration or
Termination. Expiration or termination of this Agreement shall
not relieve the parties of any obligation accruing prior to such expiration or
termination, and the provisions of Articles 8, 9, 11, 13, and 14 shall
survive the expiration or termination of this Agreement.
ARTICLE
11
INDEMNIFICATION AND
INSURANCE
11.1 Indemnification. LICENSEE
shall indemnify and hold LICENSOR harmless from all losses, liabilities, damages
and expenses (including reasonable attorneys’ fees and costs) incurred by
LICENSOR as a result of any Third Party claim, demand, action or other
proceeding arising directly out of the use or sale of any Licensed Use by
LICENSEE or its Affiliates, or their respective distributors, customers or
end-users. LICENSOR shall indemnify and hold LICENSEE harmless from
all losses, liabilities, damages and expenses (including reasonable attorneys’
fees and costs) incurred by LICENSEE as a result of any Third Party claim,
demand, action or other proceeding related to breach by LICENSOR of the
warranties set forth in Sections 2.4 or 2.5, or any legal action filed in a
Federal District Court based upon the allegation that LICENSEE’s use of the
Licensed Technology infringes upon such Third Party’s intellectual property
rights. If either party proposes to seek indemnification from
the other party under the provisions of this Section 11.1, it shall notify the
indemnifying party in writing within thirty (30) days of receipt of notice of
any such claim or suit. The indemnifying party shall have the right
but not the obligation to participate in the defense of such claim, and the
parties shall mutually agree upon counsel and monetary settlement terms with
respect to any such claim.
11.2 Insurance. LICENSEE
shall maintain liability insurance, or self-insurance, including product
liability insurance with respect to the research, development, manufacture and
sales of Licensed Uses by LICENSEE in such amount as LICENSEE customarily
maintains with respect to the research, development, manufacture and sales of
its other products. LICENSEE shall maintain such insurance (or
self-insurance) for so long as it continues to manufacture or sell any Licensed
Uses, and thereafter for so long as LICENSEE maintains insurance (or
self-insurance) for itself covering the research, development, manufacture or
sales of its other products.
- 11
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ARTICLE
12
FORCE
MAJEURE
Neither
party shall be held liable or responsible to the other party nor be deemed to
have defaulted under or breached this Agreement for failure or delay
in fulfilling or performing any term of this Agreement to the extent, and for so
long as, such failure or delay is caused by or results from causes beyond the
reasonable control of the affected party including but not limited to fire,
floods, embargoes, war, acts of terror, acts of war (whether war be declared or
not), insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or other party.
ARTICLE
13
LIMITATION OF
LIABILITY
EXCEPT
AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, IN NO EVENT SHALL EITHER
PARTY BE LIABLE TO THE OTHER FOR ANY INDIRECT, INCIDENTAL, SPECIAL OR
CONSEQUENTIAL DAMAGES, OR DAMAGES FOR LOSS OF PROFITS, REVENUE, DATA OR USE,
INCURRED BY EITHER PARTY OR ANY THIRD PARTY, WHETHER IN AN ACTION IN CONTRACT OR
TORT, EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES. EACH PARTY’S LIABILITY FOR DAMAGES HEREUNDER SHALL IN NO
EVENT EXCEED THE AMOUNT OF FEES PAID (OR PAYABLE) BY LICENSEE UNDER THIS
AGREEMENT.
ARTICLE
14
MISCELLANEOUS
14.1 Notices. Any
consent, notice or report required or permitted to be given or made under this
Agreement by one of the parties hereto to the other party shall be in writing,
delivered by any lawful means, and addressed to such other party at its address
indicated below, or to such other address as the addressee shall have last
furnished in writing to the addressor and (except as otherwise provided in this
Agreement) shall be effective upon receipt by the addressee.
If to
LICENSOR:
Health
Discovery Corporation
0 Xxxx
Xxxxx Xxxxxx, Xxxxx 000
Xxxxxxxx,
Xxxxxxx 00000
Attn:
Chairman and CEO
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-
with a
copy to:
Xxxxxxxx,
Xxxx, Hargreaves & Savitch LLP
000 X
Xxxxxx, Xxxxx 0000
Xxx
Xxxxx, XX 00000
Attn: Xxxxxxx
X. Xxxxxx, Esq.
If to
LICENSEE:
Quest
Diagnostics Incorporated
0 Xxxxxxx
Xxxxx
Xxxxxxx,
Xxx Xxxxxx 00000
Attn:
General Counsel
with a
copy to:
Quest
Diagnostics, Incorporated
00000
Xxxxxx Xxxxxxx
Xxx Xxxx
Xxxxxxxxxx, Xxxxxxxxxx 00000
Attn:
Chief Intellectual Property Counsel
14.2 Governing
Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of Delaware, without regard to the
conflicts of law principles thereof.
14.3 Assignment. Neither
party shall assign its rights or obligations under this Agreement, in whole or
in part, by operation of law or otherwise, without the prior written consent of
the other party, which consent shall not be unreasonably withheld; provided,
however, that either party may assign its rights to the successor to all or
substantially all of its assets or business to which this Agreement
relates. Any purported assignment in violation of this Section 14.3
shall be void.
14.4 Waivers and
Amendments. No change, modification, extension, termination or
waiver of this Agreement, or any of the provisions herein contained, shall be
valid unless made in writing and signed by duly authorized representatives of
the parties hereto.
14.5 Entire
Agreement. This Agreement embodies the entire understanding
between the parties and supersedes any prior understanding and agreements
between and among them respecting the subject matter hereof. There
are no representations, agreements, arrangements or understandings, oral or
written, between the parties hereto relating to the subject matter of this
Agreement which are not fully expressed herein.
14.6 Severability. Any
of the provisions of this Agreement which are determined to be invalid or
unenforceable in any jurisdiction shall be ineffective to the extent of such
invalidity or unenforceability in such jurisdiction, without rendering invalid
or unenforceable the remaining provisions hereof and without affecting the
validity or enforceability of any of the terms of this Agreement in any other
jurisdiction.
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14.7 Waiver. The
waiver by either party hereto of any right hereunder or the failure to perform
or of a breach by the other party shall not be deemed a waiver of any other
right hereunder or of any other breach or failure by said other party whether of
a similar nature or otherwise.
14.8 Counterparts. This
Agreement may be executed in two or more counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same
instrument.
14.9 Relationship of
Parties. Nothing in this
Agreement or in the course of business between LICENSOR and LICENSEE shall make
or constitute either Party a partner, employee or agent of the other and the relationship between the Parties is
not a partnership, joint venture or agency. Neither party shall have
any right or authority to commit or legally bind the other in any way whatsoever
including, without limitation, the making of any agreement,
representation or warranty.
[Remainder
of page intentionally left blank.]
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IN
WITNESS WHEREOF, the parties have executed this Agreement as of the date first
set forth above.
|
LICENSOR:
|
|||
|
Health
Discovery Corporation
|
|||
|
By
/s/ Xxxxxxx X.
Xxxxxxxx
|
|||
|
Title
Chief Executive
Officer
|
|||
|
LICENSEE:
|
|||
|
Quest
Diagnostics Incorporated
|
|||
|
By
|
/s/ Xxxxxxxx Xxxxx | ||
|
Title
|
Vice President of Business Development | ||
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EXHIBIT
A
LICENSED PATENT
RIGHTS
|
Country/
Region
|
Patent/Publication/
Application
No.
|
Description
|
|
U.S.
|
7,117,188
|
Method
of Identifying Patterns in Biological
Systems
and Uses Thereof
|
|
U.S.
|
12/242,264
|
Biomarkers
Overexpressed in Prostate Cancer
|
|
U.S.
|
12/025,724
|
Biomarkers
Upregulated in Prostate Cancer
|
|
U.S.
|
12/327,823
|
Methods
for Screening, Predicting and
Monitoring
Prostate Cancer
|
|
U.S.
|
12/349,437
|
Methods
for Screening, Predicting and
Monitoring
Prostate Cancer
|
- 16
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EXHIBIT
B
LICENSED
BIOMARKERS
|
Archival
Unigene ID
|
Current
Unigene ID
|
Symbol
|
Affy probe
|
Pathway
|
Target Description
|
|||||||
|
12337
|
Hs.7780
|
Hs.480311
|
DKFZp564
|
212412_at
|
Unknown
|
Consensus
includes gb:AV715767 /FEA=EST
/DB_XREF=gi:10797284
/DB_XREF=est:AV715767
/CLONE=DCBATH02
/UG=Hs.7780 Homo sapiens
mRNA;
cDNA DKFZp564A072 (from clone
DKFZp564A072)
|
||||||
|
9373
|
Hs.21293
|
Hs.492859
|
UAP1/AGX-1
|
209340_at
|
Aminosugar
metabolism
|
gb:S73498.1
/DEF=Homo sapiens AgX-1 antigen
mRNA;
complete cds. /FEA=mRNA /PROD=AgX-1 antigen /DB_XREF=gi:688010
/UG=Hs.21293 UDP-N-
acteylglucosamine
pyrophosphorylase 1
/FL=gb:AB011004.1
gb:NM_003115.1 gb:S73498.1
|
||||||
|
876
|
Hs.79037
|
Hs.476231
|
HSPD1
|
200807_s_at
|
Mitochondrial
control of apoptosis
|
gb:NM_002156.1
/DEF=Homo sapiens heat shock
60kD
protein 1 (chaperonin) (HSPD1); mRNA.
/FEA=mRNA
/GEN=HSPD1 /PROD=heat shock 60kD
protein
1 (chaperonin) /DB_XREF=gi:4504520
/UG=Hs.79037
heat shock 60kD protein 1 (chaperonin)
/FL=gb:BC002676.1
gb:BC003030.1 gb:M34664.1 gb:M22382.1 gb:NM_002156.1
|
||||||
|
1961
|
Hs.75432
|
IMPDH2
|
000000_x_xx
|
xx
xxxx xxxxxxx nucleotide biosynthesis
|
gb:NM_000884.1
/DEF=Homo sapiens IMP (inosine
monophosphate)
dehydrogenase 2 (IMPDH2); mRNA.
/FEA=mRNA
/GEN=IMPDH2 /PROD=IMP (inosine
monophosphate)
dehydrogenase 2
/DB_XREF=gi:4504688
/UG=Hs.75432 IMP (inosine
monophosphate)
dehydrogenase 2 /FL=gb:J04208.1
gb:NM_000884.1
|
- 17
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EXHIBIT
C
* Study
Design
The
designated collaborators include Principal Investigator (*), along with Albitar
(Quest) , Xxxxxxxx (HDC), potentially Madayastha and Guyon, DGX Scientific
Directors and MDACC urologists, pathologist, and a statistician (to be
named). In order to assure compliance with FDA Regulations and
Guidances and CLIA, the Parties agree to the following:
The
parties shall establish an Advisory Committee (“The Committee”) comprised of an
equal number of representatives from each party to review and guide the conduct
of the study regarding regulatory compliance and to help facilitate issues that
may arise from time to time regarding the study. The Committee shall
meet in person or by telephone at least 4 times per year or on an ad hoc basis as may be
necessary. The Parties shall document in writing any
discussions that take place in The Committee and shall generate and sign meeting
minutes within two weeks after each meeting. In particular, The
Committee shall be responsible for managing the contractual relationship,
assuring each collaborator’s compliance to FDA and CLIA regulatory requirements
within the scope of this agreement, filtering those communications among the
collaborators’ whenever necessary to assure that any communications that
could place the independence of the validation study at risk are handled in a
compliant manner and to assure LICENSEE’s independent development
processes, establishing criteria to objectively evaluate the laboratory
developed test, and developing and maintaining timelines and deliverables to
meet the project objectives.
LICENSOR
shall conduct its activities for the study under the direction of Xx. Xxxxxxxx,
who shall be primarily responsible for the supervision and administration of
LICENSOR’s activities under the study, in accordance with all applicable
policies of LICENSOR and shall be the primary contact person at LICENSOR
regarding the study.
LICENSEE
shall conduct its activities under the study under the direction of Xx. Xxxxxxx,
who shall be primarily responsible for the supervision and administration of
LICENSEE’s activities under the study, in accordance with all applicable
policies of LICENSEE and shall be the primary contact person at LICENSEE
regarding the study.
MDA shall
conduct its activities under the study under the direction of * as Principal
Investigator, who shall be primarily responsible for the supervision and
administration of MDA’s activities under the study in accordance with all
applicable policies of MDA and shall be the primary contact person at MDA
regarding the study.
The
Parties agree that each will communicate to its personnel the importance of the
independence of Licensee in development of the test and its
validation. Therefore, the Parties shall actively monitor their
activities and agree to promptly bring to the attention of The Committee any
concerns or issues that may arise regarding this topic in order to protect the
independence of this developmental and validation process. The
Committee will then convene as soon as is practicable to discuss the areas or
issues of concern and determine the correct process to follow in order to
mitigate, correct or advise the Parties regarding them and how best to proceed
in respect to the tenets of the applicable regulatory requirements.
- 18
-
The
following patient samples will be collected at * for the study:
A.
* men being admitted for
prostatectomy. Test the patients urine, and blood pre surgery and
subsequent follow-up post prostatectomy (at the first post surgical follow up,
about 1 month). Urine will be tested for the levels of expression of
the relevant gene markers and housekeeping gene, and an aliquot sent out for
PCA-3 determination. Blood will also be collected at the same time
for testing pre/post PSA levels or other markers. Prior Biopsy
results, and Prostatectomy related Biopsy results as well as other
clinical and demographic information including follow up data will be provided
by *.
B.
* men being admitted for Biopsy. We will try to collect ½
study subjects with serum PSA 2.5 to 4.0 and ½ with serum PSA> 4.0
ng/ml. Collect the patient’s urine, and blood prior to
Biopsy. Urine will be tested for the levels of expression of the
relevant gene markers, and an aliquot sent out for PCA-3
determination. Blood will be collected at the same time for testing
for PSA levels or other markers. Biopsy results, and other clinical,
demographic and laboratory data as well as follow-up information will be
provided by *.
C.
Controls consisting of * Men with <1.0 ng/mL PSA. Test the
patients Urine, and blood. Urine will be tested for the levels of
expression of the relevant gene markers, and an aliquot sent out for PCA-3
determination. Blood will be collected at the same time for PSA
levels or other markers. Clinical, demographic, and other laboratory
data as well as follow up data if available will be provided by *.
D.
Pre/Post DRE: * men who are candidates for biopsy and
agreed to pre/ post DRE urine and blood sampling prior to
biopsy. Test the patients pre and post DRE Urine, and blood pre
biopsy. Urine Pre and post DRE will be tested for the levels of
expression of the relevant gene markers, and an aliquot sent out for PCA-3
determination. Blood will also be collected at the same time for
testing PSA levels or other markers. Biopsy results as well as other
clinical and demographic information including follow up data will be provided
by *.
E.
Preclinical
Studies: Urine sediments from patients and tissue cultures will be
used for preliminary assay development and for selection of the best mRNA
preservative.
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