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EXHIBIT 10.04
LICENSE AGREEMENT
BETWEEN
EMORY UNIVERSITY
AND
ATHEROGENICS
[*] Certain confidential information contained in this document, marked by an
asterisk within brackets has been omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment under Rule 406 of the Securities Act of 1933, as amended.
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This LICENSE AGREEMENT ("Agreement") is made and entered into
by and between EMORY UNIVERSITY, a nonprofit Georgia corporation with offices
located at 0000 Xxxxx Xxxxxx Xxxx, X.X., Xxxxxxx, Xxxxxxx 00000 ("Emory") and
ATHEROGENICS, INC. , a for profit Georgia corporation organized and existing
under the laws of the State of Georgia with offices located at 0000 Xxxxxxxxx
Xxxx, X.X., Xxxxx 0000, Xxxx Xxxxx, Xxxxxxx Financial Center, Xxxxxxx, Xxxxxxx
00000 ("AtheroGenics").
WHEREAS, EMORY is the assignee of all right, title, and
interest in inventions developed by employees of EMORY and is responsible for
the protection and commercial development of such inventions; and
WHEREAS, Xxxxxxx X. Xxxxxxx, Ph.D., M.D., Xxxxxxxx X.
Xxxxxxxx, Ph.D., M.D., R. Xxxxx Xxxxxxxxx, Ph.D., M.D., Xxxxxxx Xxxxxxxxxxxxx,
Ph.D. and Xxxxxx Xxxx, Ph.D., M.D. are employees of EMORY and are named as
inventors in certain patent United States patent applications identified in
Exhibits A and B attached hereto; and
WHEREAS, ATHEROGENICS represents that it has the necessary
expertise and will, as appropriate, acquire the necessary resources to fully
develop, obtain approval for, and market diagnostic and therapeutic products
based upon the inventions claimed in the above referenced patent applications
and additional patent applications which the parties anticipate will be filed
after the date of this Agreement and which shall be solely assigned to EMORY or
jointly assigned to EMORY and ATHEROGENICS as described herein; and
WHEREAS, EMORY wants to have such inventions developed,
commercialized, and made available for use by the public.
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NOW, THEREFORE, for and in consideration of the mutual covenants
and the premises herein contained, the parties, intending to be legally bound,
hereby agree as follows.
ARTICLE 1. EFFECTIVE DATE
This Agreement shall be effective as of January 11, 1995.
ARTICLE 2. DEFINITIONS
As used in this Agreement, the following terms shall have the
meanings indicated:
2.1 "Affiliate" shall mean any corporation or non-corporate
business entity which controls, is controlled by, or is under common control
with a party to this Agreement. A corporation or non-corporate business entity
shall be regarded as in control of another corporation if it owns, or directly
or indirectly controls at least forty percent (40%) of the voting stock of the
other corporation, or (i) in the absence of the ownership of at least forty
percent (40%) of the voting stock of a corporation or (ii) in the case of a
non-corporate business entity, or non-profit corporation, if it possesses,
directly or indirectly, the power to direct or cause the direction of the
management and policies of such corporation or non-corporate business entity, as
applicable.
2.2 "Dollars" shall mean United States dollars.
2.3 "FDA" shall mean the United States Food and Drug
Administration or successor entity.
2.4 "Field" shall mean the diagnosis, prevention and treatment of
human disease.
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2.5 "IND" shall mean an Investigational New Drug application or
its equivalent.
2.6 "Indemnitees" shall mean Emory, its directors, employees and
students, and their heirs, executors, administrators, successors and legal
representatives.
2.7 "Licensed Patents" shall mean the following subgroups: (i) the
patent applications identified in Exhibit "A" hereof and all patents which issue
thereon ("Subgroup (i)"), (ii) pending patent applications and issued patents
described in Exhibit B, Section I (which may be amended to add patent
applications filed after the date of this Agreement) and inventions and
technical approaches described in Section II of Exhibit B which may become the
subject of claims in patent applications filed after the effective date of this
Agreement, ("Subgroup (ii)"), (iii) patent applications to be filed on
inventions conceived and reduced to practice under the Sponsored Research
Agreement between Emory and AtheroGenics of even date ("Subgroup (iii)"), and
(iv) patent applications claiming inventions co-owned by AtheroGenics and Emory
which are exclusively licensed by Emory to AtheroGenics (see section 3.2 below).
Each subgroup of Licensed Patents shall include all United States and foreign
patents which issue thereon and any and all continuations, divisionals,
extensions, reissues and reexamination patents, all continuations-in-part, and
foreign counterparts thereof which issue anywhere in the world.
2.8 "Licensed Product" shall mean any process, service or product
comprising any composition of matter, design, discovery, improvement, invention,
process, method, structure or technique ("Invention") claimed in any Valid
Claim.
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2.9 "Licensed Technology" shall mean all technical information and
data, whether or not patented, presently known or learned, invented or developed
by Xxxxxxx X. Xxxxxxx, Ph.D., M.D., Xxxxxxxx X. Xxxxxxxx, Ph.D., M.D., R. Xxxxx
Xxxxxxxxx, Ph.D., M.D., Xxxxxxx Xxxxxxxxxxxxx, Ph.D., and Xxxxxx Xxxx, Ph.D.,
M.D. while an employee of Emory and obligated to assign rights in said technical
information and data to Emory, to the extent that (i) such technical information
and data is useful for the manufacture, use or sale of any Licensed Product and
(ii) Emory possesses the right to license the use of such information to
AtheroGenics for commercial purposes. Licensed Technology shall not include any
technical information or data invented or developed by any of the above named
persons when said person is acting as a consultant under Emory School of
Medicine Consulting Policies and is not obligated to assign technical
information or data invented or developed thereunder to Emory.
2.10 "Licensed Subject Matter" shall mean all Licensed Patents and
Licensed Technology.
2.11 "Licensed Territory" shall mean the world.
2.12 "NDA" shall mean a New Drug Application or its equivalent.
2.13 "Net Distributions" shall mean gross distributions for
products utilizing Licensed Patents and Licensed Technology from joint ventures
with AtheroGenics or an Affiliate of AtheroGenics, net of discounts, allowances,
sales or other similar taxes, rebates and returns, import and/or export duties,
and outbound transportation prepaid or allowed. Net Distributions shall be
calculated per product line incorporating Licensed Products and shall include
any funds or other valuable consideration received by AtheroGenics or an
Affiliate of AtheroGenics.
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2.14 "Net Revenue" shall mean Net Distributions plus Sublicensee
Royalties on Licensed Products utilizing technology developed and/or
manufactured by AtheroGenics alone or through a joint venture with AtheroGenics
or an Affiliate of AtheroGenics.
2.15 "Net Selling Price" shall mean the gross selling price paid
by a purchaser of a Licensed Product to AtheroGenics, an Affiliate or
sublicensee of AtheroGenics, or any other party (other than a joint venture in
which AtheroGenics or an Affiliate of AtheroGenics is a participant) authorized
by AtheroGenics to sell Licensed Products (net of discounts, allowances, sales
or other similar taxes, rebates and returns, import and/or export duties, and
outbound transportation prepaid or allowed) and, if applicable, the value of all
properties, rights and services received in consideration of a Sale of a
Licensed Product. Where a Sale is deemed consummated by a gift, use or other
disposition of Licensed Products for other than a selling price stated in cash,
the term "Net Selling Price" shall mean the average Net Selling Price billed by
AtheroGenics (its Affiliates, sublicensees, joint venture partners or other
third parties authorized to Sell Licensed Products) in consideration of the Sale
of comparable Licensed Products during the three (3) months immediately
proceeding such Sale.
2.16 "Passthrough Royalties" shall mean Sublicensee Royalties
received by AtheroGenics from sublicensees wherein AtheroGenics does not develop
or manufacture the technology being sublicensed.
2.17 "Registration" shall mean in relation to any Licensed
Product, such approvals by United States authorities such as the FDA, as may be
legally required before such Licensed Product may be commercialized or Sold in
the United States.
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2.18 "Sale" or "Sold" shall mean the transfer or disposition by
AtheroGenics, its Affiliates, sublicensees, joint venture partners or any third
party authorized by AtheroGenics to make such transfer or disposition, of a
Licensed Product, for a selling price or other consideration to a party other
than AtheroGenics, its Affiliates, sublicensees or joint venture partners. A
Sale shall occur upon transfer of funds for a Licensed Product. A Sale shall not
include transfer of product for research, development, clinical or promotional
purposes.
2.19 "Sublicensee Royalties" shall mean the Net Selling Price paid
by a purchaser of a Licensed Product to AtheroGenics, an Affiliate or
sublicensee of AtheroGenics, or any other party (other than a joint venture in
which AtheroGenics or an Affiliate of AtheroGenics is a participant) authorized
by AtheroGenics to sell Licensed Products.
2.20 "Valid Claim" shall mean an issued claim of any unexpired
patent which is a Licensed Patent or claim of any pending patent application
which is a Licensed Patent, which claim has not been held unenforceable,
unpatentable or invalid by a court or governmental body of competent
jurisdiction, unappealable or unappealed within the time allowed for appeal, or
which has not been rendered unenforceable through disclaimer or otherwise and
which has not been lost through an interference proceeding.
ARTICLE 3. GRANT OF LICENSE
3.1 License. Emory hereby grants AtheroGenics and its Affiliates
an exclusive right and license to make, use, sell and have sold Licensed
Products utilizing inventions claimed in Licensed Patents in Subgroup (i) , (ii)
or (iii) and to practice Licensed Technology in the Licensed Territory during
the term of this Agreement.
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3.2 Future Option. Emory hereby grants AtheroGenics and its
Affiliates an option for an exclusive license to all of Emory's rights to
Licensed Patents of Subgroup (iv) . AtheroGenics shall pay for and prosecute
patent applications for inventions in Subgroup (iv) in a manner consistent with
its obligations under Section 9.2 of this Agreement. AtheroGenics shall have
ninety (90) days after issuance of any Valid Claim for such a Licensed Patent
within which to exercise its option for that patent. Any license of a Subgroup
(iv) Licensed Patent shall contain terms substantially similar to those
contained in this Agreement, and shall bear a running royalty rate of [*] and a
sublicense royalty rate comparable to the applicable rate for Licensed Patents
in Subgroup (iii).
3.3 Government Rights. The license granted in Section 3.1 above is
conditional upon and subject to a nonexclusive, nontransferable, royalty free
license to the United States and other rights retained by the United States in
inventions developed by nonprofit institutions with the support of federal
funds. These rights are set forth in 35 U.S.C. ss. 201 et seq. and 37 C.F.R. ss.
401 et seq. which may be amended from time to time by the Congress of the United
States or through administrative procedures.
3.4 Retained Licenses. The license granted in Section 3.1 and any
license to be granted under Section 3.2 above are further conditional upon and
subject to a right and license retained by Emory on behalf of itself and Emory
research collaborators to make, use and transfer (not for value) Licensed
Products and practice Licensed Technology for research and educational purposes
only. Emory shall not undertake to make, use or transfer Licensed Products or
practice Licensed Technology under the sponsorship of any for profit entity,
other than AtheroGenics, without the express written approval of AtheroGenics.
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Emory shall have the right to publish the general scientific
findings from research related to Licensed Patents and Licensed Technology
subject to thirty (30) days prior review by AtheroGenics. Emory shall, upon
AtheroGenics' request, delete any AtheroGenics' confidential information
disclosed in such proposed publication. Emory shall also, upon the request of
AtheroGenics made within that thirty (30) day period, refrain from making such
publication for a period of time not to exceed ninety (90) days from the date of
the request, in order to afford Emory, or AtheroGenics, as applicable, an
opportunity to file a United States patent application to protect patentable
subject matter disclosed in such proposed publication.
3.5 Sublicenses. AtheroGenics may grant sublicenses under this
license. AtheroGenics shall provide Emory with copies of all sublicense
agreements within thirty (30) days of their execution date. AtheroGenics shall
remain responsible to Emory for the payment of all fees and royalties due under
this Agreement, whether or not such payments are made to AtheroGenics by its
sublicensees. AtheroGenics shall include in any sublicense granted pursuant to
this Agreement, a provision requiring the sublicensee to indemnify Emory and
maintain liability coverage to the same extent that AtheroGenics is so required
pursuant to Section 11.3 of this Agreement.
ARTICLE 4. OBLIGATIONS OF EMORY EMPLOYEES
AtheroGenics acknowledges that the founders of AtheroGenics, Drs.
R. Xxxxx Xxxxxxxxx and Xxxxxxx Xxxxxxx are full time employees of Emory and
their primary professional responsibilities are to Emory. Any contractual or
other relationship between AtheroGenics and Xx. Xxxxxxxxx and/or Xx. Xxxxxxx,
for as long as they remain employees of Emory, or between,
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AtheroGenics and any other employee of Emory, whether said relationship is
created prior to or during the term of this Agreement, shall be subject to all
relevant policies of Emory, including, but not limited to, the Emory and Emory
School of Medicine Consulting Policies and the Emory Procedures for Faculty
Members involved in Sponsored Scientific Research and Technology Transfer, and
the Emory Patent and Copyright Policies as now exist, or as may be amended or
established from time to time.
ARTICLE 5. ROYALTIES AND OTHER PAYMENTS
AtheroGenics shall receive income under this license as well as
Passthrough Royalties. Running royalties on Net Revenue and on Passthrough
Royalties shall be calculated in the following manner:
5.1 Net Revenue.
AtheroGenics shall pay Emory the following running
royalties on Net Revenue:
(a) [*] of the Net Revenue for Licensed Products utilizing
Inventions claimed in any Valid Claim of Licensed Patents in Subgroup (i) Sold
in the Licensed Territory; or
(b) [*] of the Net Revenue for Licensed Products utilizing
Inventions claimed in any Valid Claim of Licensed Patents in Subgroup (ii) or
Subgroup (iii) Sold in the Licensed Territory.
(c) In the event that a Licensed Product utilizes Inventions
claimed by Valid Claims contained in more than one Licensed Patent subgroup,
AtheroGenics shall pay the higher
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of the applicable running royalty rate, but in no case shall pay Emory or its
assigns more than [*] of the Net Selling Price for any Licensed Product.
5.2 AtheroGenics shall pay Emory the following running royalties
on Passthrough Royalties:
(a) [*] of the Passthrough Royalties paid to AtheroGenics, up to a
maximum of [*] of Net Selling Price, and [*] of lump sum licensing fees paid to
AtheroGenics, by a Sublicensee for Licensed Products utilizing Inventions
claimed in any Valid Claim of Licensed Patents in Subgroup (i) Sold in the
Licensed Territory; or
(b) [*] of the Passthrough Royalties paid to AtheroGenics, up to a
maximum of [*] of Net Selling Price, and [*] of lump sum licensing fees paid to
AtheroGenics, by a Sublicensee for Licensed Products utilizing Inventions
claimed in any Valid Claim of Licensed Patents in Subgroup (ii) or Subgroup
(iii) Sold in the Licensed Territory.
(c) In the event that a Licensed Product subject to Passthrough
Royalties utilizes Inventions claimed by Valid Claims contained in more than one
Licensed Patent subgroup, AtheroGenics shall pay the higher of the applicable
running royalty rate, but in no case shall pay Emory or its assigns more than
[*] of the Net Selling Price for any Licensed Product.
(d) Emory shall have the right to approve any sublicense
arrangement, which approval shall not be unreasonably withheld, which
AtheroGenics or Emory reasonably anticipates will result in Passthrough
Royalties of less than [*] of the Net Selling Price for 5.2(a) or [*] of the Net
Selling Price for 5.2 (b).
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5.3 Signing Fee. AtheroGenics shall pay Emory a signing fee in the
amount of [*] upon the execution of this Agreement.
5.4 Milestone Payments. AtheroGenics shall pay Emory a Milestone
Payment in the amount specified below no later than thirty (30) days after the
occurrence of the corresponding event designated below.
Event Milestone Payment
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(a) The date of the first IND for a Licensed [*]
Product filed by AtheroGenics, its Affiliate, or
sublicensee becomes effective.
(b) Commencement Date of a Phase III Trial for [*]
any Licensed Product.
(c) Registration of any Licensed Product. [*]
ARTICLE 6. REPORTS AND ACCOUNTING
6.1 Royalty Reports and Records. During the term of this
Agreement, AtheroGenics shall furnish, or cause to be furnished to Emory,
written reports governing each of AtheroGenics', AtheroGenics' Affiliates and
sublicensees fiscal quarters showing:
(a) the gross selling price of all Licensed Products Sold by
AtheroGenics, its Affiliates and sublicensees, in each country of the Licensed
Territory during the reporting period, together with the calculations of Net
Selling Price in accordance with Section 2.15; and
(b) the royalties payable in Dollars, which shall have accrued
hereunder in respect to such Sales; and
(c) the exchange rates, if any, used in determining the amount of
Dollars; and
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(d) the amount of any consideration received by AtheroGenics from
sublicensees and an explanation of the contractual obligation satisfied by such
consideration; and
(e) the occurrence of any event triggering a Milestone Payment
obligation in accordance with Section 5.4.
Reports shall be made semiannually after the first Sale of a
Licensed Product. These royalty reports shall be due within ninety (90) days of
the close of every second and fourth AtheroGenics fiscal quarter. AtheroGenics
shall keep accurate records in sufficient detail to enable royalties and other
payments payable hereunder to be determined.
6.2 Right to Audit. Emory shall have the right, upon prior notice
to AtheroGenics, not more than once in each AtheroGenics fiscal year, for the
period not exceeding the previous twenty four (24) months, through an
independent public accountant selected by Emory and acceptable to AtheroGenics,
which acceptance shall not be unreasonably refused, to have access during normal
business hours of AtheroGenics as may be reasonably necessary to verify the
accuracy of the royalty reports required to be furnished by AtheroGenics
pursuant to Section 6.1 of the Agreement. AtheroGenics shall include in any
sublicenses granted pursuant to this Agreement, a provision requiring the
sublicensee to keep and maintain records of Sales made pursuant to such
sublicense and to grant reasonable access to such records by Emory's independent
public accountant for the purpose of verifying the accuracy of royalty reports.
If such independent public accountant's report shows any underpayment of
royalties by AtheroGenics, its Affiliates or sublicensees, within ninety (90)
days after AtheroGenics' receipt of such report, AtheroGenics shall remit or
shall cause its sublicensees to remit to Emory:
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(a) the amount of such underpayment; and
(b) if such underpayment exceeds [*] of the total royalties owed
for the fiscal year then being reviewed, the reasonably necessary fees and
expenses of such independent public accountant performing the audit. Otherwise,
Emory's accountant's fees and expenses shall be borne by Emory. Any overpayment
of royalties shall be fully refunded within ninety (90) days by Emory.
6.3 Confidentiality of Records. All information subject to review
under this Article 6 shall be confidential. Except where provided by law, Emory
and its accountant shall retain all such information in confidence.
ARTICLE 7. PAYMENTS
7.1 Payment Due Dates. Royalties and sublicense fees payable to
Emory as a result of activities occurring during the period covered 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. Payments of royalties in whole
or in part may be made in advance of such due date. Any payment in excess of [*]
shall be made by wire or transferred to an account of Emory designated by Emory
from time to time; provided, however, that in the event that Emory fails to
designate such account, AtheroGenics or its Affiliates and sublicensees may
remit payment to Emory to the address applicable for the receipt of notices
hereunder; providing, further, that any notice by Emory of such account or
change in such account, shall not be effective until fifteen (15) days after
receipt thereof by AtheroGenics.
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7.2 Currency Restrictions. Except as hereinafter provided in this
Section 7.2, all royalties shall be paid in Dollars. If, at any time, legal
restrictions prevent the prompt remittance of part of or all royalties with
respect to any country in the Licensed Territory where Licensed Products are
Sold, AtheroGenics or its sublicensee shall have the right and option to make
such payments by depositing the amount thereof in local currency to Emory's
account in a bank or depository in such country.
7.3 Interest. Royalties and other payments required to be paid by
AtheroGenics pursuant to this Agreement shall, if overdue, bear interest at the
lesser of the maximum applicable legal rate of interest on overdue commercial
accounts, or the LIBOR rate, calculated on an average daily basis over the
period of the delinquency. The payment of such interest shall not foreclose
Emory from exercising any other rights it may have because any payment is
overdue.
ARTICLE 8. DEVELOPMENT AND MARKETING PROGRAM
8.1 Diligence Obligations. AtheroGenics shall directly, or in
collaboration with Affiliates and sublicensees, use its best efforts:
(a) to conduct a research and development program relating to the
use of Licensed Products in the Field; and
(b) to promptly register Licensed Products with the FDA as
required by law.
For purposes of this Agreement, "best efforts" shall mean that
AtheroGenics shall use reasonable efforts consistent with those used by
comparable biotechnology companies in the United States, at the same stage of
corporate and scientific development, in research and
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development projects for diagnostic methods or kits and therapeutic methods or
compositions deemed to have commercial value comparable to the Licensed
Products.
8.2 Fulfillment; Conversion. AtheroGenics' best efforts
obligations set forth in this Article 8 shall be deemed to have been fulfilled
if AtheroGenics (a) files an IND for Registration of a Licensed Product in the
United States within three (3) years after the effective date of this Agreement;
and (b) diligently pursues such Registration by complying with all FDA
requirements and appealing, to the extent permissible by law, any decisions
taken by the FDA which would prohibit Registration; and (c) commences marketing
at least one Licensed Product within six (6) months following Registration.
If AtheroGenics fails to meet any deadline set forth in this
Section 8.2 or use best efforts as defined in Section 8.1 of this Agreement,
Emory may, upon at least ninety (90) days' prior written notice, convert this
license from an exclusive to non-exclusive license and grant third parties
rights in Licensed Patents and/or Licensed Technology equal to or lesser rights
than rights granted to AtheroGenics for the same Licensed Patents and/or
Licensed Technology, unless within such ninety (90) day period AtheroGenics
meets such deadline or demonstrates to the reasonable satisfaction of Emory that
it has resumed and will continue to use best efforts.
8.3 Progress Reports. AtheroGenics shall, no less frequently than
once every twelve (12) months until a Licensed Product has been Registered,
provide Emory with a written report detailing AtheroGenics', its Affiliates' and
sublicensees, activities related to developing Licensed Products and pursuing
Registration of Licensed Products.
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8.4 Development Outside United States. No later than AtheroGenics'
filing of an NDA for a Licensed Product in the United States, AtheroGenics shall
directly, or in collaboration with Affiliates and sublicensees, use its best
efforts:
(a) to obtain Registration for a Licensed Product in such other
countries of the Licensed Territory as AtheroGenics or AtheroGenics' Affiliates
and sublicensees deem appropriate; and
(b) upon Registration of a Licensed Product in a particular
country proceed with due diligence to market such Licensed Product in such
country.
8.5 Development of Indications.
(a) AtheroGenics and Emory acknowledge that the compositions and
methods claimed in the Licensed Patents may be useful for a myriad of
indications. AtheroGenics shall, in accordance with its diligence obligations,
attempt to develop the Licensed Patents and Licensed Technology for all such
indications. However, because of the burdens, both financial and practical,
which may be accompanied by this requirement, such development is intended to be
staggered. Accordingly, AtheroGenics shall begin diligence requirements for its
second indication within [*] of the date of this Agreement, and thereafter for
one new indication at least once every [*]. Dates wherein diligence requirements
commence for a new indication shall be termed "Diligence Commencement Dates."
(b) If AtheroGenics fails to begin using diligence to develop a
new potential indication an any Diligence Commencement Date in accordance with
Section 8.5 (a) of this Agreement, Emory may, commencing ninety (90) days after
that Diligence Commencement Date, request in writing that AtheroGenics enter
into good faith negotiations with prospective
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sublicensees which Emory believes are interested in developing an indication
which AtheroGenics is not developing, for the purpose of sublicensing one new
potential indication. Within sixty (60) days of receipt of such written
request, AtheroGenics shall (i) commence and diligently pursue good faith
negotiations with such prospective sublicensee or (ii) provide Emory with a
detailed development plan, including milestones, for such indication in
accordance with diligence requirements of this Agreement.
ARTICLE 9. PATENT PROSECUTION
9.1 Licensed Patents Assigned Solely to Emory. AtheroGenics shall
be primarily responsible for all patent prosecution activities pertaining to
Licensed Patents assigned solely to Emory. AtheroGenics, with the agreement of
Emory, which agreement shall not be unreasonably withheld, shall select patent
counsel to prosecute all such Licensed Patents and shall provide Emory with
copies of all communications from patent offices, filings and correspondence
pertaining to such patent prosecution activities, in a timely manner, so as to
give Emory an opportunity to comment thereon prior to any responsive filing.
Emory shall have the right to have claims which are supported by the
specification added to an application.
AtheroGenics shall pursue prosecution of such Licensed Patents in
at least the following countries: United States, EPO countries, Japan and
Canada. AtheroGenics shall, upon Emory's request, pursue prosecution of such
Licensed Patents in additional countries at Emory's expense.
If AtheroGenics chooses not to timely file or pursue patent
protection or patent maintenance for any patent application or issued patent
assigned solely to Emory, AtheroGenics
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shall notify Emory prior to abandonment in such a manner as would allow Emory a
reasonable period of time to take over prosecution or maintenance of said patent
application or issued patent. Such patent application or issued patent shall
then not be considered a Licensed Patent and Emory shall be free, at its
election, to abandon or maintain the prosecution of such patent application or
issued patent or grant rights to such patent application or issued patent to
third parties.
9.2 Licensed Patents Jointly Assigned to AtheroGenics and Emory.
AtheroGenics shall be primarily responsible for all patent prosecution
activities pertaining to Licensed Patents assigned jointly to AtheroGenics and
Emory. AtheroGenics shall select patent counsel to prosecute all such Licensed
Patents and shall provide Emory with copies of all communications from patent
offices, filings and correspondence pertaining to such patent prosecution
activities, in a timely manner, so as to give Emory an opportunity to comment
thereon prior to any responsive filing. Emory shall have the right to have
claims which are supported by the specification added to an application.
AtheroGenics shall pursue prosecution of such Licensed Patents in
at least the following countries: United States, EPO countries, Japan and
Canada. AtheroGenics shall, upon Emory's request, pursue prosecution of such
Licensed Patents in additional countries at Emory's expense.
If AtheroGenics chooses not to timely file or pursue patent
protection or patent maintenance for any patent application or issued patent
assigned jointly to AtheroGenics and Emory, AtheroGenics shall, upon Emory's
request, assign its interests in such patent application or issued patent to
Emory. After such assignment, such patent application or issued patent shall
then not be considered a Licensed Patent and Emory shall be free, at its
election, to abandon or
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maintain the prosecution of such patent application or issued patent or grant
rights to such patent application or issued patent to third parties.
ARTICLE 10. INFRINGEMENT
10.1 If either AtheroGenics or Emory becomes aware of a product
made, used or sold in the Licensed Territory, which it believes infringes a
Valid Claim, the party obtaining such knowledge shall promptly advise the other
party of all relevant facts and circumstances pertaining to the potential
infringement. AtheroGenics shall have the right to enforce any issued Licensed
Patent against such infringement, at its own expense. Emory shall cooperate with
AtheroGenics in such effort, including being joined as a party to such action,
if necessary. During the pendency of such an action, royalty rates owed by
AtheroGenics to Emory shall be reduced by [*] from those listed in Article 5 of
this Agreement.
10.2 Any damages or costs recovered by AtheroGenics in connection
with any action filed by AtheroGenics hereunder shall be applied first to
reimbursing AtheroGenics for costs and expenses of such litigation. Any damages
or costs recovered by AtheroGenics in excess of costs and expenses credited
shall be the sole property of AtheroGenics. Any such excess damages or costs
shall be treated as proceeds of Sales of Licensed Products in the fiscal quarter
received by AtheroGenics, and royalties shall be payable by AtheroGenics to
Emory thereon in accordance with the terms of this Agreement.
10.3 Any multiplication of damages for punitive purposes shall be
treated as proceeds of Sales of Licensed Products in the fiscal quarter received
by AtheroGenics, and
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royalties shall be payable by AtheroGenics to Emory thereon in accordance with
the terms of this Agreement, and AtheroGenics shall retain all attorney fees
awarded.
10.4 If AtheroGenics shall fail, within one hundred twenty (120)
days after receiving notice from Emory of a potential infringement, or providing
Emory with notice of such infringement, to either (a) terminate such
infringement, (b) institute sub-licensing negotiations, to be completed within a
reasonable period of time, or (c) institute an action to prevent continuation
thereof and, thereafter to prosecute such action diligently, or if AtheroGenics
notifies Emory that it does not plan to terminate the infringement, negotiate a
sub-license or institute such action, then Emory shall have the right to do so
at its own expense. AtheroGenics shall cooperate with Emory in such effort,
including being joined as a party to such action if necessary. Emory shall be
entitled to retain all damages or costs awarded to Emory in such action.
ARTICLE 11. REPRESENTATIONS AND WARRANTIES
11.1 Warranty of Ownership and Right to License. Emory represents
and warrants to AtheroGenics as follows:
(a) Right to Grant. Subject to Section 3.3 hereof, and certain
rights held by Isis Pharmaceuticals in patent application number [*], Emory
hereby represents that it has not granted to any third party, and no third party
holds, any option, license, sublicense or similar right relating to the use of
the Licensed Subject Matter within the Field. Emory further represents that it
has the right to grant the license granted hereunder to the Licensed Patents and
Licensed Technology.
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(b) Adversary Proceedings. There are no claims, disputes, actions,
proceedings, suits or appeals pending against Emory with respect to the Licensed
Subject Matter (other than those, if any, with respect to which service of
process or similar notice has not yet been made on Emory), and to the knowledge
of Emory, none has been threatened against Emory. To the knowledge of Emory, no
third party has infringed any of Emory's rights to use the Licensed Subject
matter in the Field.
11.2 Exclusion of Other Warranties. Emory disclaims any warranties
of merchantability or fitness for a particular purpose and any other implied
warranties with respect to the capabilities, safety, utility, or commercial
application of the Licensed Patents, Licensed Technology or Licensed Products.
ARTICLE 12. INDEMNIFICATION AND INSURANCE
12.1 No Liability. Emory shall not be liable to AtheroGenics or
AtheroGenics' Affiliates, customers or sublicensees for compensatory, special,
incidental, indirect, consequential or exemplary damages resulting from the
manufacture, testing, design, labeling, use or sale of Licensed Products.
12.2 Indemnification. AtheroGenics shall defend, indemnify, and
hold harmless the Indemnitees, from and against any and all claims, demands,
loss, liability, expense, or damage (including investigative costs, court costs
and attorneys, fees) Indemnitees may suffer, pay, or incur as a result of
claims, demands or actions against any of the Indemnitees arising or alleged to
arise by reason of, or in connection with, any and all personal injury
(including death) and property damage caused or contributed to, in whole or in
part, by
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AtheroGenics or AtheroGenics' Affiliates, contractors, agents, or sublicensees
manufacture, testing, design, use, Sale or labeling of any Licensed Product.
AtheroGenics' obligations under this Article shall survive the expiration or
termination of this Agreement for any reason. However, this section 12.2 shall
not obligate AtheroGenics to indemnify Emory for any claims, demands or actions
against any of the Indemnitees arising or alleged to arise by reason or, or in
connection with, any and all personal injury (including death) and property
damage caused or contributed to, in whole or in part, by Emory during any
participation by Emory in clinical testing of any Licensed Product.
12.3 Insurance. Without limiting AtheroGenics' indemnity
obligations under the preceding paragraph, AtheroGenics shall, prior to any
clinical trial or Sale of any Licensed Product, cause to be in force, an
"occurrence based type" liability insurance policy which:
(a) insures Indemnitees for all claims, damages, and actions
mentioned in Section 12.2 of this Agreement; and
(b) includes a contractual endorsement providing coverage for all
liability which may be incurred by Indemnitees in connection with this
Agreement; and
(c) requires the insurance carrier to provide Emory with no less
than thirty (30) days' written notice of any change in the terms or coverage of
the policy or its cancellation; and
(d) provides Indemnitees product liability coverage in an amount
appropriate and customary in the industry for bodily injury and for property
damage, subject to a reasonable aggregate amount.
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12.4 Occurrence Based Coverage Not Available. If AtheroGenics is
unable to obtain "occurrence based type" liability insurance for a reasonable
fee, AtheroGenics shall procure "claims made type" liability coverage to be
effective prior to any clinical trial or Sale of any Licensed Patent, and
throughout the term of this Agreement and "tail coverage," extending at least
ten (10) years after termination of this Agreement. AtheroGenics shall notify
Emory prior to its first clinical trial or commercial Sale of any Licensed
Product, or all insurance coverage AtheroGenics possesses to meet AtheroGenics'
obligations under Sections 12.2 and 12.3 of this Agreement.
12.5 Notice of claims. AtheroGenics shall promptly notify Emory of
all claims made to AtheroGenics involving the Indemnitees and shall advise Emory
of the policy amounts that might be needed to defend and pay any such claims.
ARTICLE 13. CONFIDENTIALITY
13.1 Treatment of Confidential Information. During the term of
this Agreement, AtheroGenics and Emory each may disclose certain information
which the disclosing party deems to be of a confidential, proprietary and trade
secret nature. For the term of this Agreement and for a period of seven (7)
years following termination of this Agreement, AtheroGenics and Emory each
agrees that it shall regard, maintain and preserve the secrecy and
confidentiality of any and all information and data, whether in oral or written
form, including but not limited to, products, processes, methods, concepts,
ideas, programs, formulas, apparatuses, chemicals, organisms, molecules,
prototypes, techniques, know-how, marketing plans, business plans, financial
information, data, strategies, forecasts, customer lists or technical
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requirements of customers, or other trade secrets (collectively referred to
herein as the "Proprietary Information") of the other party which may be
disclosed to or obtained by it pursuant to this Agreement.
Each party hereto shall take the same measures to preserve the
secrecy and confidentiality and avoid the unauthorized use or disclosure of the
other party's Proprietary Information as such party takes to protect its own
Proprietary Information.
13.2 Access. Each party hereto shall limit access to the
Proprietary Information to those of its employees and agents, Affiliates,
sublicensees, consultants, outside contractors, governmental regulatory
authorities and clinical investigators who have a reasonable need for access to
such information in connection with the operation of this Agreement. Further,
each party or its Affiliates or sublicensees may disclose Proprietary
Information to the United States government or other regulatory authorities to
the extent that such disclosure is necessary for the prosecution and/or
enforcement of patents or for authorizations to conduct clinical trials or
commercially market Licensed Products, provided that such party is otherwise
entitled to engage in such activities under this Agreement, or may disclose
Proprietary Information as is necessary to exercise any rights which survive
termination or expiration of this Agreement. All persons or entities to whom
Proprietary Information is disclosed under this Section 13.2 shall be subject to
the non-disclosure covenants contained herein.
Each party shall use its best efforts to disclose Proprietary
information to the other in writing and marked as proprietary. If it is
necessary to first disclose such information other than in written form, the
disclosing party shall, within thirty (30) days of such first disclosure,
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reduce the information to writing and provide the receiving party with a copy of
such information marked as proprietary.
13.3 Covenant Not to Use or Disclose. AtheroGenics and Emory each
agrees that it will not, at any time without the prior written consent of the
other party, use or disclose the Proprietary Information belonging to the other
party for any reason or in any manner whatsoever except as may be necessary for
the operation of this Agreement, as explicitly authorized under this Agreement,
or as required by law.
13.4 Return of Confidential Documents. Upon termination of this
Agreement, or forthwith upon the request of the other party, AtheroGenics and
Emory shall promptly return to the other party all such documents, drawings,
samples, specimens or reproductions thereof which may have come into its
possession.
13.5 Proprietary Rights. AtheroGenics and Emory each acknowledges
that the disclosure of Proprietary Information under this Agreement confers no
rights in the receiving party other than the right to use the Proprietary
Information of the disclosing party for the operation of this Agreement.
13.6 Exceptions. The obligations undertaken by AtheroGenics and
Emory hereunder shall not apply to any portion of the Proprietary Information
disclosed hereunder which:
(a) was known to the non-disclosing party prior to disclosure of
such Proprietary Information by the disclosing party;
(b) is, or shall become, other than by an act or omission of the
non-disclosing party, generally available to the public; or
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(c) shall, by lawful means, be made available to the
non-disclosing party by a third party with the right to disclose; or
(d) is required by law to be disclosed by the non-disclosing
party, provided the non-disclosing party uses its best efforts to notify the
disclosing party immediately upon learning of such requirement in order to give
the disclosing party reasonable opportunity to oppose such requirement; or
(e) results from research and development by the receiving party
or its Affiliates or sublicensees, independent of disclosures from the other
party of this Agreement, provided that the persons developing such information
have not had any exposure to the information received from the disclosing party;
or
(f) AtheroGenics and Emory agree in writing may be disclosed.
In claiming the benefit of any of the exceptions set forth in this
Section 13.5, the non-disclosing party shall have the burden of establishing
that a portion of the Proprietary Information is subject to such exception.
ARTICLE 14. TERM AND TERMINATION
14.1 Term. The term of this Agreement shall Commence on the
Effective Date and, unless sooner terminated as otherwise provided for in this
Agreement, shall continue in full force and effect until the expiration of the
last to expire Valid Claim. If no Valid Claim should issue within ten (10) years
of the date of this Agreement, this Agreement shall terminate on the tenth
(l0th) anniversary of its Effective Date. If such early termination occurs for
failure of a
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Valid Claim to issue, AtheroGenics shall be entitled to continue to utilize
within the Field all inventions, data or other information described and/or
claimed in Licensed Patents and all technical information and data comprising
Licensed Technology.
14.2 Termination. Emory shall have the right to terminate this
Agreement upon the occurrence of any one or more of the following events and
provided that Emory has given AtheroGenics the notice required in Section 14.3
of this Agreement and AtheroGenics has failed to cure the breach described in
such notice within the allotted time:
(a) failure of AtheroGenics to make any payment required pursuant
to this Agreement within five (5) days after receipt of notice that payment is
past due; or
(b) failure of AtheroGenics to timely issue AtheroGenics stock to
Emory in accordance with that certain Stock Purchase Agreement between Emory and
AtheroGenics of even date herewith, provided, however, that any regulatory
requirements that would prevent or delay such issuance of stock shall not be
grounds for termination; or
(c) failure of AtheroGenics to render royalty or progress reports
to Emory as required by this Agreement within ten (10) days after receipt of
notice that the report is past due or
(d) the institution of any proceeding by AtheroGenics under any
bankruptcy, insolvency, or moratorium law wherein AtheroGenics is the subject of
that proceeding; or
(e) any assignment by AtheroGenics of substantially all of its
assets for the benefit of creditors; or
(f) placement of AtheroGenics' assets in the hands of a trustee or
a receiver unless the receivership or trust is dissolved within thirty (30) days
thereafter and provided that
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in the case of an involuntary bankruptcy proceeding, which is contested by
AtheroGenics, such termination shall not become effective until the bankruptcy
court of jurisdiction has entered an order upholding the petition; or
(g) a decision by AtheroGenics or AtheroGenics' assignee of rights
under this Agreement to quit the business of developing or selling Licensed
Products; or
(h) the breach by AtheroGenics of any other material term of this
Agreement.
14.3 Exercise. Before Emory may exercise its right of termination
as defined in Section 14.2 of this Agreement, it must first provide
AtheroGenics, its trustees, receivers or assigns ("Recipients") with written
notice of default and of Emory's intent to terminate. Such notice shall include
the basis for such termination. Recipients shall have thirty (30) days after
actual receipt of such notice Within which to undertake to cure the default or
dispute the grounds for termination.
(a) If Recipients do not dispute the grounds for termination and
undertake to cure the default within that thirty (30) day period and (a) default
is cured within that thirty (30) day period, or (b) in the instance that the
breach cannot p reasonably be cured within thirty days, if default is cured
within a reasonable period of time, Emory's notice of intent to terminate shall
cease to be effective.
(b) If Recipients have a good faith dispute as to the grounds for
termination put forth by Emory in its notice, Recipients shall, within the
thirty (30) day period after actual receipt of notice, notify Emory that they
intend to demonstrate lack of grounds for termination. In such case, Recipients
shall have ninety (90) days following the date on which notice of breach is
actually received to either
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demonstrate such lack of grounds to Emory's satisfaction, and optionally to file
a petition for arbitration in accordance with Article 17 of this Agreement.
During this ninety (90) day period, cure of the deficiency shall render Emory's
notice of intent to terminate ineffective.
14.4 Termination by AtheroGenics. AtheroGenics shall have the
right to terminate this Agreement upon the occurrence of either of the following
events:
(a) the breach of a material term of this Agreement by Emory; or
(b) ninety (90) days after actual delivery by AtheroGenics to
Emory of written notice of AtheroGenics intent to terminate.
14.5 Exercise. Before AtheroGenics may exercise its right of
termination pursuant to Section 14.4(a) of this Agreement it must first provide
Emory with written notice of AtheroGenics' election to terminate. Such notice
shall include the basis for such termination. Emory shall have thirty (30) days
after actual receipt of such notice within which to undertake to cure the
default or dispute the grounds for termination.
(a) If Emory does not dispute the grounds for termination and
undertakes to cure the default within that thirty (30) day period and (a)
default is cured within that thirty (30) day period, or (b) in the instance that
the breach cannot reasonably be cured within thirty days, if default is cured
within a reasonable period of time, AtheroGenics' notice of intent to terminate
shall cease to be effective.
(b) If Emory has a good faith dispute to the grounds for
termination put forth by AtheroGenics in its notice, Emory shall, within the
thirty (30) day period after actual receipt of notice, notify AtheroGenics that
it intends to demonstrate lack of grounds for termination. In such case, Emory
shall have ninety (90) days following the date on which notice of breach is
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actually received to either demonstrate such lack of grounds to AtheroGenics'
satisfaction, and optionally to file a petition for arbitration in accordance
with Article i7 of this Agreement. During this ninety (90) day period, cure of
the deficiency shall render AtheroGenics' notice of intent to terminate
ineffective.
14.6 Failure to Enforce. The failure of Emory or AtheroGenics At
any time, or for any period of time, to enforce any of the provisions of this
Agreement, shall not be construed as a waiver of such provisions or as a waiver
of the right of Emory or AtheroGenics thereafter to enforce each and every such
provision of this Agreement.
14.7 Effect.If this Agreement is terminated as a result of
AtheroGenics' breach pursuant to Section 14.2 or in accordance with Section 14.4
(b) , AtheroGenics shall return, or at Emory's direction, destroy, all data,
writings and other documents and tangible materials supplied to AtheroGenics by
Emory.
ARTICLE 15. ASSIGNMENT
AtheroGenics may grant, transfer, convey, or otherwise assign any
or all of its rights and obligations under this Agreement in conjunction with
the transfer of all, or substantially all, of the business interest of
AtheroGenics to which this Agreement relates. Emory's written consent, which
shall not be unreasonably withheld, shall be required prior to any other
assignment of AtheroGenics' rights or obligations under this Agreement.
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ARTICLE 16. MISCELLANEOUS
16.1 Legal Compliance. AtheroGenics shall comply with all
applicable federal, state and local laws and regulations relating to its
manufacture, use, Sale, labelling or distribution of Licensed Products.
16.2 Independent Contractor. AtheroGenics' relationship to Emory
shall be that of a licensee only. AtheroGenics shall not be the agent of Emory
and shall have no authority to act for, or on behalf of, Emory in any matter for
which AtheroGenics does not have express written permission. Persons retained by
AtheroGenics as employees or agents shall not, by reason thereof, be deemed to
be employees or agents of Emory. Emory's relationship to AtheroGenics shall be
that of a licensor only. Emory shall not be the agent of AtheroGenics and shall
have no authority to act for, or an behalf of, AtheroGenics in any matter for
which Emory does not have express written permission. Persons retained by Emory
as employees or agents shall not, by reason thereof, be deemed to be employees
or agents of AtheroGenics.
16.3 Patent Marking. AtheroGenics shall xxxx Licensed Products
Sold in the United States with United States patent numbers in compliance with
35 U.S.C. S 287. Licensed Products manufactured or Sold in other countries shall
be marked in compliance with the intellectual property laws in force in such
foreign countries.
16.4 Use of Names. AtheroGenics shall obtain the written approval
of Emory prior to making use of the name of any Emory employee not also employed
by AtheroGenics, or the name Emory, for any commercial purpose. This section
16.5 shall not be construed to prevent AtheroGenics from identifying
AtheroGenics employees also employed by Emory as being affiliated with Emory.
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Emory shall obtain the written approval of AtheroGenics prior to
making use of the name AtheroGenics.
16.5 Place of Execution. This Agreement and any subsequent
modifications or amendments hereto shall be deemed to have been executed in the
State of Georgia, U.S.A. This Agreement shall not become effective or binding
upon Emory until signed by its Executive Vice President in the State of Georgia,
U.S.A.
16.6 Governing Law. This Agreement and all amendments,
modifications, alterations, or supplements hereto, and the rights of the parties
hereunder, shall be construed under and governed by the laws of the State of
Georgia and the United States of America.
16.7 Entire Agreement. This Agreement constitutes the entire
agreement between Emory and AtheroGenics with respect to the subject matter
hereof and shall not be modified, amended or terminated except as herein
provided or except by another agreement in writing executed by the parties
hereto.
16.8 Survival. Any promises, duties and/or obligations herein
contained, such as Articles 12 and 13, which expressly or by implication subsist
after the termination of this Agreement, shall survive such termination.
16.9 Severability. All rights and restrictions contained herein
may be exercised and shall be binding only to the extent that they do not
violate any applicable laws and are intended to be limited to the extent
necessary so that they will not render this Agreement illegal, invalid or
unenforceable. If any provision or portion of any provision of this Agreement
shall be held to be illegal, invalid or unenforceable by a court of competent
jurisdiction, the same shall
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be reformed to comply with applicable law or stricken if not so conformable, so
as not to affect the validity or enforceability of the remainder of this
Agreement.
16.10 Force Majeure. Any delays in or failure of performance of
any party to this Agreement shall not constitute a default hereunder, or give
rise to any claim for damages, if and to the extent caused by occurrences beyond
the control of the party affected, including, but not limited to, acts of God,
strikes or other concerted acts of workers, civil disturbances, fires, floods,
explosions, riots, war, rebellion, sabotage, acts of governmental authority or
failure of governmental authority to issue licenses or approvals which may be
required.
ARTICLE 17. ARBITRATION
Any and all disputes arising with respect to the interpretation of
this Agreement, or the parties' respective performance under or breach of the
Agreement, shall be resolved by binding arbitration at the request of either
party in Atlanta, Georgia before a panel of three (3) arbitrators in accordance
with the rules and procedures of the American Arbitration Association. The panel
shall provide the parties, in writing, findings of fact and conclusions of law
in support of any decision reached. Either party shall have the right to appeal
the decision on the grounds of gross error of law or absence of evidence to
support the facts. The foregoing arbitration provision shall not preclude either
AtheroGenics or Emory from seeking equitable relief from a court of competent
jurisdiction to protect its intellectual property from unlawful use or
disclosure.
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ARTICLE 18. NOTICES
All notices, statements and reports required to be given by one
party to the other shall be in writing and shall be deemed to have been given
upon delivery in person or, upon the expiration of five (5) days after deposit
in a lawful mail depositary in the country of residence of the party giving the
notice, registered or certified postage prepaid, and addressed as follows:
To Emory: Emory University
Attn: Xxxxxxx Xx Xxxxx
Director of Licensing and Patent Counsel
0000 Xxxxxxx Xxxx, X.X.
RM 116 WHSCAB
Xxxxxxx, XX 00000
To AtheroGenics: AtheroGenics, Inc.
Attn: Xxxxxxx Xxxxx
0000 Xxxxxxxxx Xxxx, X.X.
Xxxxx 0000, Xxxx Xxxxx
Xxxxxxx Financial Tower
Xxxxxxx, XX 00000
with copies to: Lyon & Lyon
Attn: Xxxxx X. Xxxxxxxxx, Ph.D.
First Interstate World Center
000 Xxxx Xxxxx Xxxxxx, Xxxxx 0000
Xxx Xxxxxxx, XX 00000-0000
Either party hereto may change the address to which notices to such party are to
be sent by giving notice to the other party at the address and in the manner
provided above. Any notice may be given, in addition to the manner set forth
above, by telex, facsimile or cable, provided that the party giving such notice
obtains acknowledgment by telex, facsimile or cable that such notice has been
received by the party to be notified. Notice made in this manner shall be deemed
to have been given when such acknowledgment has been transmitted.
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IN WITNESS WHEREOF, Emory and AtheroGenics have caused this
Agreement to be signed by their duly authorized representatives as of the day
and year indicated below.
EMORY UNIVERSITY: ATHEROGENICS:
By: Xxxx X. Xxxxxx By: Xxxxxxx Xxxxx
------------------------------------ ------------------------------
Name: Xxxx Xxxxxx Name: Xxxxxxx Xxxxx
Title: Executive Vice President Title: Chairman of the Board
Date: 1/13/95 Date: 1-23-95
---------------------------------- ----------------------------
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EXHIBIT A
[*]
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EXHIBIT B
SECTION 1 - - PENDING APPLICATIONS
1. [*]
SECTION 2 - - INVENTIONS AND CONCEPTS
1. [*]
2. [*]
3. [*]
4. [*]
37
