*
Certain portions of this exhibit have been omitted pursuant to
a request for confidential treatment and those portions have
been filed separately with the Securities and Exchange
Commission.
RESEARCH
AND LICENSE AGREEMENT
by
and between
MERCK
& CO., INC.
And
ZNOMICS,
INC.
*
Certain portions of this exhibit have been omitted pursuant to
a request for confidential treatment and those portions have
been filed separately with the Securities and Exchange
Commission.
|
TABLE OF CONTENTS
|
|
|
1.DEFINITIONS
|
1
|
|
2.RESEARCH
|
5
|
|
2.1
General |
5
|
|
2.2
Conduct of Research |
5
|
|
2.3
Use of Research Funding |
6
|
|
2.4
Records and Reports |
6
|
|
2.5
Research Information and Inventions |
7
|
|
2.6
Research Term |
7
|
|
3.
EXCHANGE OF INFORMATION; LICENSE;
|
7
|
|
3.1
* |
7
|
|
3.2
Exercise of Option |
7
|
|
3.3
Licenses |
7
|
|
3.4
Rights of MERCK to an Exclusive License |
8
|
|
3.5
No Implied Licenses |
8
|
|
3.6
Bankruptcy |
8
|
|
4.
CONFIDENTIALITY AND PUBUCATION
|
9
|
|
4.1
Nondisclosure Obligation |
9
|
|
4.2
ZNOMICS Know-How |
9
|
|
4.3
Publication |
10
|
|
4.4
Publicity/Use of Names |
11
|
|
5.
PAYMENTS; ROYALTIES AND REPORTS
|
12
|
|
5.1
Research Funding |
12
|
|
5.2
* |
|
|
5.3
* |
12
|
|
5.3
Payments for MERCK Research Milestones |
13
|
|
6.
REPRESENTATIONS AND WARRANTIES
|
14
|
|
6.1
Representations and Warranties |
14
|
|
7.
PATENT PROVISIONS
|
14
|
| |
|
|
* The confidential portion has been omitted and filed separately
with the Securities and Exchange Commission
|
|
*
Certain portions of this exhibit have been omitted pursuant to
a request for confidential treatment and those portions have
been filed separately with the Securities and Exchange
Commission.
|
7.1
Filing, Prosecution and Maintenance of Patents |
14
|
|
7.2
Option of MERCK to Prosecute and Maintain Patents |
15
|
|
7.3
Interference, Opposition, Reexamination and Reissue |
15
|
|
7.4
Enforcement and Defense |
16
|
|
7.5
Patent Term Restoration |
17
|
|
8.
TERM AND TERMINATION
|
18
|
|
8.1
Term and Expiration |
18
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|
8.2
Termination by MERCK |
18
|
|
8.3
Termination for Cause |
18
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|
8.4
Effect of Expiration or Termination; Survival |
19
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|
9.
MISCELLANEOUS
|
19
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|
9.1
Force Majeure |
19
|
|
9.2
Assignment |
19
|
|
9.3
Severability |
20
|
|
9.4
Notices |
20
|
|
9.5
Applicable Law |
21
|
|
9.6
Dispute Resolution |
21
|
|
9.7
Entire Agreement; Amendments |
22
|
|
9.8
Headings |
23
|
|
9.9
Independent Contractors |
23
|
|
9.10
Waiver 23 |
|
9.11
Cumulative Remedies |
23
|
|
9.12Waiver
of Rule of Construction |
23
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|
9.13Counterparts |
23
|
| |
| SCHEDULE
1.27 PATENT
RIGHTS |
25
|
|
SCHEDULE
2.1 RESEARCH
|
25
|
*
Certain portions of this exhibit have been omitted pursuant to a
request for confidential treatment and those portions have been
filed separately with the Securities and Exchange
Commission.
RESEARCH AND LICENSE AGREEMENT
THIS
AGREEMENT, effective as of November 15, 2005 (the "Effective
Date"), by and between MERCK & CO., INC., a corporation
organized and existing under the laws of New Jersey ("MERCK")
and ZNOMICS, INC., a corporation organized and existing under
the laws of Delaware ("ZNOMICS").
RECITALS:
*
WHEREAS, MERCK and ZNOMICS desire to enter into an agreement
to *;
WHEREAS, MERCK desires to obtain a license under the Patent
Rights and ZNOMICS Know-How, upon the terms and conditions set
forth herein and ZNOMICS desires to grant such a
license;
NOW, THEREFORE, in consideration of the foregoing premises
and the mutual covenants herein contained, the Parties hereby agree
as follows:
1. DEFINITIONS
Unless
specifically set forth to the contrary herein, the following
terms, whether used in the singular or plural, shall have the
respective meanings set forth below:
1.1
"Act" shall
mean, as applicable, the United States Federal Food, Drug and
Cosmetic Act, 21 U.S.C. §§ 301 et seq., and/or the Public
Health Service Act, 42 U.S.C. §§ 262 et seq., as such may
be amended from time to time.
1.2
"Affiliate"
shall mean (i) any corporation or business entity of which fifty
percent (50%) or more of the securities or other ownership
interests representing the equity, the voting stock or general
partnership interest are owned, controlled or held, directly or
indirectly, by MERCK; or (ii) any corporation or business entity
which, directly or indirectly, owns, controls or holds fifty
percent (50%) (or the maximum ownership interest permitted by law)
or more of the securities or other ownership interests representing
the equity, the voting stock or, if applicable, the general
partnership interest, of MERCK.
1.3
"Calendar
Year" shall mean each successive period of twelve (12)
months commencing on January 1 and ending on December
31.
1.4
"Control" 1
"Controls" or "Controlled by" - shall mean with respect to
any item of
or
right under Patent Rights or ZNOMICS Know-How or MERCK
Know-How, the possession of (whether by ownership or license,
other than pursuant to this Agreement),
* The confidential portion has been omitted and filed separately
with the Securities and Exchange Commission
*
Certain portions of this exhibit have been omitted pursuant to a
request for confidential treatment and those portions have been
filed separately with the Securities and Exchange
Commission.
or
the ability of a Party to grant access to, or a license or
sublicense of, such item or right as provided for herein without
violating the terms of any agreement or other arrangement with any
Third Party existing at the time such Party would be required
hereunder to grant the other Party such access or license or
sublicense.
1.5
"Directed"
shall mean that a compound or biological modulates the activity of
the Target.
1.6 *
1.7
"Effective
Date" shall mean the date of the last Party to sign this
Agreement.
1.8
"Escrow
Agent" shall mean a third party that is mutually agreed upon
by the Parties and agrees, pursuant to a written agreement, to (a)
abide by the confidentiality and non-use provisions of this
Agreement; and (b) hold the list of Merck Pre-existing Programs, as
updated from time to time, in escrow on behalf of the
Parties.
1.9
"Final
Report" shall mean the report as more fully described in
Section 2.4.3.
1.10
"First Commercial
Sale" shall mean, with respect to any Product, the first
sale for end use or consumption of such Product in the Territory,
excluding, however, any sale or other distribution for use in a
Clinical Trial.
1.11
"Full Time
Equivalent" or "FTE" shall mean the equivalent of a
full-time scientist's work time over a twelve-month period
(including normal vacations, sick days and holidays). The portion
of an FTE year devoted by a scientist to the Research shall be
determined by dividing the number of full days during any
twelve-month period devoted by such employee to the Research by the
total number of working days during such twelvemonth
period.
1.12
"Funded Patent
Rights" shall have the meaning set forth in Section
7.1.1.
1.13
"Gene"
shall mean a nucleotide sequence that *.
1.14
"Improvement" means any
enhancement, whether or not patentable, made by ZNOMICS or others
acting on behalf of ZNOMICS in the *.
1.15
"Information" shall
mean any and all information and data, including without limitation
all MERCK Know-How, ZNOMICS Know-How, and all other scientific,
pre-clinical, clinical, regulatory, manufacturing, marketing,
financial and commercial information or data, whether communicated
in writing or orally or by any other method, which is provided by
one Party to the other Party in connection with this
Agreement.
1.16
"Initiates"
shall mean, with respect to a Clinical Trial, the administration of
the first dose to a patient in such Clinical Trial.
1.17
"Invention"
shall mean any process, method, composition of matter, article
of
* The confidential portion has been omitted and filed separately
with the Securities and Exchange Commission
* Certain portions of this exhibit have been omitted pursuant to a
request for confidential treatment and those portions have been
filed separately with the Securities and Exchange
Commission.
manufacture,
discovery or finding that is conceived and/or reduced to
practice as a result of the Research.
1.18
"Joint Information
and Inventions" shall mean all protocols, formulas, data,
Inventions, know-how and trade secrets, patentable or otherwise,
resulting from the Research developed or invented jointly by
employees of MERCK and ZNOMICS or others acting on behalf of MERCK
and ZNOMICS.
1.19
"Library"
shall mean *.
1.20
"Major Market
Countries" shall mean the United States, Canada, Japan, and
the following EP designated countries: France, Germany, Italy,
Spain and the United Kingdom. Each individually, a "Major Market
Country."
1.21
"MERCK Information
and Inventions" shall mean all protocols, formulas, data,
Inventions, know-how and trade secrets, patentable or otherwise,
provided by MERCK to ZNOMICS or developed or invented solely by
employees of MERCK or other persons not employed by ZNOMICS acting
on behalf of MERCK, including but not limited to, all mammalian
Druggable Genes identified in the Merck Pre-existing
Program.
1.22
"MERCK
Know-How" shall mean any information and materials,
including but not limited to discoveries, improvements, processes,
methods, protocols, formulas, data, inventions (including without
limitation MERCK's Information and Inventions and MERCK's rights in
Joint Information and Inventions), know-how and trade secrets,
patentable or otherwise, which during the term of this Agreement,
(i) are in MERCK's Control, (ii) are not generally known and (iii)
are in MERCK's opinion necessary to ZNOMICS in the performance of
its obligations under the Research.
1.23 *
1.24 *
1.25 *
1.26
"Party"
shall mean MERCK and ZNOMICS, individually, and "Parties" shall
mean MERCK and ZNOMICS, collectively.
1.27
"Patent
Rights" shall mean any and all patents and patent
applications in the Territory
* The confidential portion has been omitted and filed separately
with the Securities and Exchange Commission
*
Certain portions of this exhibit have been omitted pursuant to
a request for confidential treatment and those portions have
been filed separately with the Securities and Exchange
Commission.
(which
for the purposes of this Agreement shall be deemed to include
certificates of invention and applications for certificates of
invention) which are Controlled by ZNOMICS, including, but not
limited to, those listed on Schedule 1.27, which: * ZNOMICS
Information and Inventions, or Joint Information and
Inventions *, and any Improvements related to the foregoing;
or (ii) are divisionals, continuations, continuations-in-part,
reissues, renewals, substitutions, registrations,
re-examinations, revalidations, supplementary protection
certificates, pediatric exclusivity periods, any other patent
term extensions and exclusivity periods and the like of any
such patents and patent applications, and any and all foreign
equivalents of the foregoing.
1.28
"Phase I Clinical
Trial" shall mean a human clinical trial in any country that
would satisfy the requirements of 21 CFR 312.21(a).
1.29 *
1.30 *
1.31
"Regulatory
Authority" shall mean any applicable government regulatory
authority involved in granting approvals for the manufacturing,
marketing. reimbursement and/or pricing of a Product in the
Territory, inclUding. in the United States, the United States Food
and Drug Administration and any successor governmental authority
having substantially the same function.
1.32
"Related
Party" shall mean each of MERCK, its Affiliates, and their
respective sublicensees (which term does not include distributors),
as applicable.
1.33
"Research"
shall mean the activities undertaken by ZNOMICS * for and on behalf
of MERCK as set forth in Article 2 and Schedule
2.1.
1.34 *
1.35
"Research
Term" shall mean the duration of the Research and "Extended
Research Term" shall mean any period of the Research as it may be
extended by mutual agreement of the Parties, as described more
fully in Section 2.6.
1.36 *
1.37
"Territory"
shall mean all of the countries in the world, and their territories
and possessions.
* The confidential portion has been omitted and filed separately
with the Securities and Exchange Commission
*
Certain portions of this exhibit have been omitted pursuant to
a request for confidential treatment and those portions have
been filed separately with the Securities and Exchange
Commission.
1.38
"Third
Party" shall mean an entity other than MERCK and its Related
Parties, and ZNOMICS.
1.39
"Valid Patent
Claim" shall mean a claim of an issued and unexpired patent
included within the Patent Rights which claims a Product as a
composition of matter, which claim has not been revoked or held
unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction (which decision is
not appealable or has not been appealed within the time allowed for
appeal), and which claim has not been disclaimed, denied or
admitted to be invalid or unenforceable through reissue,
reexamination or disclaimer or otherwise.
1.40
"ZNOMICS
Information and Inventions" shall mean all protocols,
formulas, data, Inventions, know-how and trade secrets, patentable
or otherwise, resulting from the Research developed or invented
solely by employees of ZNOMICS or other persons not employed by
MERCK acting on behalf of ZNOMICS.
1.41
"ZNOMICS
Know-How" shall mean all information and materials,
including but not limited to discoveries, improvements, processes,
methods, protocols, formulas, data, inventions (including without
limitation ZNOMICS Information and Inventions and ZNOMICS rights in
Joint Information and Inventions), know-how and trade secrets,
patentable or otherwise. which during the term of this Agreement
(i) are in the Control of ZNOMICS, (ii) are not generally known and
(iii) are necessary or useful to MERCK in connection with the
Research, and the research, development, manufacture, use or sale
of Products in the Territory; excluding, however, any MERCK
Know-How and the Final Report.
2. RESEARCH
2.1
General
ZNOMICS
and MERCK shall engage in the Research upon the terms and
conditions set forth in this Agreement. The activities to be
undertaken in the course of the Research are set forth in
Schedule 2.1, which may be amended from time to time upon
mutual written agreement by authorized representatives of the
Parties.
2.2
Conduct
of Research
ZNOMICS
shall proceed diligently with the work set out in the Research
by using good faith efforts to allocate sufficient time,
effort, equipment and facilities to the Research and * with
sufficient skills and experience as are required to accomplish
the Research in accordance with the terms of this Agreement
and Schedule
2.1 .
ZNOMICS
shall conduct the Research in compliance with all applicable
laws, rules and regulations. In addition, if animals are used
in research hereunder, ZNOMICS will comply with the Animal
Welfare Act or any other applicable local, state, national and
international laws and regulations relating to the care and
use of laboratory animals. MERCK encourages ZNOMICS to use the
highest standards, such as those set forth in the Guide for
the Care and Use of
* The confidential portion has been omitted and filed separately
with the Securities and Exchange Commission
*
Certain portions of this exhibit have been omitted pursuant to
a request for confidential treatment and those portions have
been filed separately with the Securities and Exchange
Commission.
Laboratory
Animals (NRC, 1996), for the humane handling, care and
treatment of such research animals. Any animals which are used
in the course of the Research, or products derived from those
animals, such as eggs or milk, will not be used for food
purposes, nor will these animals be used for commercial
breeding purposes; provided, however, that these restrictions
do not apply to any Library that is not utilized for the
Research. ZNOMICS shall notify MERCK in writing of any
deviations from applicable regulatory or legal requirements.
ZNOMICS hereby certifies that it has not employed or otherwise
used in any capacity, and will not employ or otherwise use in
any capacity, the services of any person debarred under United
States law, including but not limited to Section 21 USC 335a,
in performing any portion of the Research. ZNOMICS shall not
use human tissue in the performance of the
Research.
ZNOMICS
shall be entitled to utilize the services of Third Parties to
perform its Research activities only upon MERCK's prior
written consent or as specifically set forth in Schedule 2.1"
Notwithstanding any such consent, ZNOMICS shall remain at all
times fully liable for its respective responsibilities under
the Research.
2.3
Use of
Research Funding
ZNOMICS
shall apply the research funding it receives from MERCK under
this Agreement solely to carry out its Research activities in
accordance with Schedule 2.1 and the terms and conditions of
this Agreement.
2.4
Records
and Reports
2.4.1
Records.
ZNOMICS shall maintain records, in sufficient detail and in good
scientific manner appropriate for patent and regulatory purposes,
which shall fully and properly reflect all work done and results
achieved in the performance of the Research by
ZNOMICS.
2.4.2
Copies
and Inspection of Records. MERCK shall have the right,
during normal business hours and upon reasonable notice, to inspect
and copy all such records of ZNOMICS referred to in Section 2.4.1.
MERCK shall maintain such records and the information disclosed
therein in confidence in accordance with Section 4.1. MERCK shall
have the right to arrange for its employees and/or consultants
involved in the activities contemplated hereunder to visit the
offices and laboratories of ZNOMICS and any of its Third Party
contractors as permitted under Section 2.2 during normal business
hours and upon reasonable notice, and to discuss the Research work
and its results in detail with the technical personnel and
consultants of ZNOMICS. Upon request, ZNOMICS shall provide copies
of the records described in Section 2.4.1 above.
2.4.3
Final
Report. Within thirty (30) days following the end of the
Research Term, ZNOMICS shall provide a written Final Report to
MERCK. MERCK and its Affiliates shall be permitted to use
information contained in such Final Report which use by MERCK shall
be solely for the purpose of internal research, discovery and
development, unless MERCK exercises the Non-Exclusive Option or
Exclusive Option in accordance with Section 3.2. Such Final Report
shall include the *
* The confidential portion has been omitted and filed separately
with the Securities and Exchange Commission
*
Certain portions of this exhibit have been omitted pursuant to
a request for confidential treatment and those portions have
been filed separately with the Securities and Exchange
Commission.
2.5
Research
Information and Inventions
The
entire right, title and interest in:
(a) ZNOMICS
Information and Inventions shall be owned solely by
ZNOMICS;
(b) MERCK
Information and Inventions shall be owned solely by MERCK;
and
|
|
(c)
|
Joint
Information and Inventions shall be owned jointly by ZNOMICS and
MERCK. Inventorship will be determined in accordance with United
States patent laws.
|
ZNOMICS
shall promptly disclose to MERCK in writing the development,
making, conception or reduction to practice of ZNOMICS
Information and Inventions and Joint Information and
Inventions.
2.6
Research
Term
Except
as otherwise provided herein, the term of the Research shall
commence on the Effective Date and continue for *. The Parties
may extend the term of the Research Term by mutual written
agreement of the authorized representative of the Parties, and
shall, in such case, amend Schedule 2.1 as
applicable.
3. EXCHANGE
OF INFORMATION; LICENSE
3.1 *
3.2
Exercise
of Option .
MERCK
shall have the exclusive right to obtain an exclusive or
non-exclusive license pursuant to Section 3.3 for * by
exercising an Exclusive Option or Non-Exclusive Option for *
pursuant to procedures set forth in this Section 3.2. MERCK
may, at any time following receipt of * pursuant to Section
3.1, submit to ZNOMICS a written notification of MERCK's
intent to obtain a license pursuant
* The confidential portion has been omitted and filed separately
with the Securities and Exchange Commission
*
Certain portions of this exhibit have been omitted pursuant to
a request for confidential treatment and those portions have
been filed separately with the Securities and Exchange
Commission.
to
Section 3.3.1 (an "Exclusive Option") or Section 3.3.2 (a
"Non-Exclusive Option"). The Exclusive Option and
Non-Exclusive Option are exclusive to Merck for the *. The
determination of whether MERCK shall exercise an Exclusive
Option or Non-Exclusive Option shall be at MERCK's sale
discretion. In providing such written notice to ZNOMICS, MERCK
shall supply to ZNOMICS written information sufficient to *.
The Exclusive Option or Non-Exclusive Option for a *, as
applicable, shall be deemed to be exercised upon MERCK
providing such written notice to ZNOMICS.
3.3
Licenses
3.3.1 Exclusive
License Grant . Upon exercise by
MERCK of an Exclusive Option pursuant to Section 3.2 for *, and
subject to the terms and conditions set forth in this Section 3.3,
ZNOMICS hereby grants to MERCK, an exclusive (even as to ZNOMICS)
sublicenseable for the duration of the MERCK license, license to *
in the Territory under the Patent Rights and ZNOMICS Know-how for
any and all uses, including but not limited to, MERCK's activities
in the research, discovery and development of biological and
pharmaceutical products to make, have made, use, offer to sell,
sell or import any *.
3.3.2 Non-Exclusive
License Grant. Upon exercise by
MERCK of a Non-Exclusive Option pursuant to Section 3.2 for *, and
Subject to the terms and conditions set forth in this Section 3.3,
ZNOMICS hereby grants to MERCK, a nonexclusive license,
sublicenseable to Affiliates of MERCK for the duration of the MERCK
license, * in the Territory under the Patent Rights and ZNOMICS
Know-how for any and all uses, including but not limited to MERCK's
activities in the research, discovery and development of biological
and pharmaceutical products to make, have made, use, offer to sell,
sell or import any *. Such non-exclusive license shall be further
sublicenseable by MERCK and its Affiliates to entities performing
research for and on behalf of MERCK or its Affiliates.
3.4
Rights of
MERCK to an Exclusive License .
ZNOMICS
hereby grants MERCK the right of first refusal for MERCK to
obtain an exclusive license for *, regardless of whether MERCK
has exercised a Non-Exclusive Option for *. Such right of
first refusal shall be exercisable by MERCK for * following
MERCK's receipt * from ZNOMICS for * that is not already
exclusively licensed to MERCK. ZNOMICS shall provide written
notice to MERCK prior to entering into discussions with a
Third Party with regard to granting any license or other
rights to a Third Party to *. Thereafter, MERCK shall have
sixty (60) days to provide written notice to ZNOMICS that it
is exercising an Exclusive Option to *. Such Exclusive Option
shall be exercised by MERCK pursuant to the procedures set
forth in Section 3.2.
3.5
No
Implied Licenses .
Except
as specifically set forth in this Agreement, neither Party
shall acquire any license or other intellectual property
interest, by implication or otherwise, in any Information
disclosed to
* The confidential portion has been omitted and filed separately
with the Securities and Exchange Commission
*
Certain portions of this exhibit have been omitted pursuant to
a request for confidential treatment and those portions have
been filed separately with the Securities and Exchange
Commission.
it
under this Agreement or under any patents or patent
applications owned or controlled by the other Party or its
Affiliates.
3.6
Bankruptcy
All
licenses and rights to licenses granted under or pursuant to
this Agreement by ZNOMICS to MERCK are, and shall otherwise be
deemed to be, for purposes of Section 365(n) of the' United
States Bankruptcy Code, licenses of rights to "intellectual
property" as defined under Section 101 (35A) of the Code. The
Parties agree that MERCK. as a licensee of such rights under
this Agreement, shall retain and may fully exercise all of its
rights and elections under the Code, and that upon
commencement of a bankruptcy proceeding by or against ZNOMICS
under the Code, MERCK shall be entitled to a complete
duplicate of, or complete access to (as MERCK deems
appropriate), any such intellectual property and all
embodiments of such intellectual property_ Such intellectual
property and all embodiments thereof shall be promptly
delivered to MERCK (i) upon any such commencement of a
bankruptcy proceeding upon written request therefor by MERCK,
unless ZNOMICS elects to continue to perform all of its
obligations under this Agreement or (ii) if not delivered
under (i) above, upon the rejection of this Agreement by or on
behalf of ZNOMICS upon written request therefor by
MERCK.
The
foregoing provisions of this Section 3.6 are without prejudice
to any rights MERCK may have arising under the Code or other
applicable law.
4. CONFIDENTIALITY
AND PUBLICATION
4.1
Nondisclosure
Obligation
All
Information disclosed by one Party to the other Party
hereunder shall be maintained in confidence by the receiving
Party and shall not be disclosed to any Third Party or used
for any purpose except as set forth herein without the prior
written consent of the disclosing Party, except to the extent
that such Information:
|
|
(a)
|
is
known by the receiving Party at the time of its receipt. and not
through a prior disclosure by the disclosing Party, as documented
by the receiving Party's business records;
|
|
|
(b)
|
is
in the public domain by use and/or publication before its receipt
from the disclosing Party, or thereafter enters the public domain
through no fault of the receiving Party;
|
|
|
(c)
|
is
subsequently disclosed to the receiving Party by a Third Party who
may lawfully do so and is not under an obligation of
confidentiality to the disclosing Party;
|
|
|
(d)
|
is
developed by the receiving Party independently of Information
received from the disclosing Party, as documented by the receiving
Party's business records;
|
|
|
(e)
|
is
disclosed to governmental or other regulatory agencies in order to
obtain patents or to gain or maintain approval to conduct clinical
trials or to market Product, but such disclosure may be only to the
extent reasonably necessary to obtain patents or
authorizations;
|
*
Certain portions of this exhibit have been omitted pursuant to
a request for confidential treatment and those portions have
been filed separately with the Securities and Exchange
Commission.
|
|
(f)
|
is
deemed necessary by MERCK to be disclosed to Related
Par
|
| 
