EXHIBIT 10.20
LICENSE AGREEMENT
AMONG
EMORY UNIVERSITY
AND
UNIVERSITY OF GEORGIA RESEARCH FOUNDATION, INC.
AND
TRIANGLE PHARMACEUTICALS, INC.
* Certain confidential portions of this Exhibit were omitted by means of
marking such portions with an asterick (the "▇▇▇▇"). This Exhibit has been
filed separately with the Secretary of the Commission without the ▇▇▇▇
pursuant to the Company's Application Requesting Confidential Treatment under
Rule 406 under the Securities Act.
TABLE OF CONTENTS
ARTICLE 1. DEFINITIONS. . . . . . . . . . . . . . . . . . . . . . . . 2
ARTICLE 2. GRANT OF LICENSE . . . . . . . . . . . . . . . . . . . . . 9
ARTICLE 3. ROYALTIES AND OTHER PAYMENTS . . . . . . . . . . . . . . . 11
ARTICLE 4. REPORTS AND ACCOUNTING . . . . . . . . . . . . . . . . . . 21
ARTICLE 5. PAYMENTS . . . . . . . . . . . . . . . . . . . . . . . . . 24
ARTICLE 6. DEVELOPMENT AND MARKETING PROGRAM. . . . . . . . . . . . . 25
ARTICLE 7. PATENT PROSECUTION . . . . . . . . . . . . . . . . . . . . 29
ARTICLE 8. INFRINGEMENT . . . . . . . . . . . . . . . . . . . . . . . 32
ARTICLE 9. WARRANTIES; EXCLUSION OF WARRANTIES;
AND INDEMNIFICATION . . . . . . . . . 33
ARTICLE 10. CONFIDENTIALITY . . . . . . . . . . . . . . . . . . . . . 38
ARTICLE 11. TERM AND TERMINATION. . . . . . . . . . . . . . . . . . . 40
ARTICLE 12. ASSIGNMENT. . . . . . . . . . . . . . . . . . . . . . . . 44
ARTICLE 13. TRANSFER OF LICENSED TECHNOLOGY . . . . . . . . . . . . . 45
ARTICLE 14. REGISTRATION OF LICENSE . . . . . . . . . . . . . . . . . 45
ARTICLE 15. NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE
COMPETITION AND PATENT TERM RESTORATION ACT . . . 45
ARTICLE 16. MISCELLANEOUS . . . . . . . . . . . . . . . . . . . . . . 47
ARTICLE 17. NOTICES . . . . . . . . . . . . . . . . . . . . . . . . . 51
THIS LICENSE AGREEMENT is made and entered into as of this 31st day of
March 1996, by and among EMORY UNIVERSITY, a Georgia nonprofit corporation
with offices at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇.▇., ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇,
(hereinafter referred to as "EMORY"), the University of Georgia Research
Foundation, Inc., a Georgia nonprofit corporation with offices at ▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇ (hereinafter referred to as
"UGARF") (EMORY and UGARF are together referred to here as "LICENSORS") and
TRIANGLE PHARMACEUTICALS, INC., a for profit Delaware corporation with
principal offices located at ▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (hereinafter referred to as "COMPANY").
WITNESSETH
WHEREAS, LICENSORS are the assignees of all right, title, and interest in
certain inventions developed by employees of EMORY and the University of
Georgia and are responsible for the protection and commercial development of
such inventions; and WHEREAS, ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, an employee of EMORY,
and ▇. ▇. ▇▇▇, an employee of the University of Georgia, are named as
inventors in the patents and patent applications identified in APPENDIX "A"
to this Agreement and are hereafter referred to as the "Inventors"; and
WHEREAS, COMPANY represents that it has the necessary expertise and will, as
appropriate, acquire the resources reasonably necessary to fully develop,
obtain approval for, and market therapeutic products based upon the
inventions claimed in the above referenced patents and applications; and
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WHEREAS, LICENSORS want to have such inventions developed,
commercialized, and made available for use by the public;
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. DEFINITIONS
-----------------------
The following terms as used herein shall have the following meaning:
1.1 "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 [ * ] of the voting stock of the
other corporation, or (a) in the absence of the ownership of at least [ * ] of
the voting stock of a corporation or (b) 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.
1.2 "Agreement" or "License Agreement" shall mean this Agreement,
including all EXHIBITS and APPENDICES attached to this Agreement.
1.3 "Dollars" shall mean United States dollars.
1.4 "FDA" shall mean the United States Food and Drug Administration or
successor entity.
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1.5 "Field of Use" shall mean the prevention and treatment of human
immunodeficiency virus (HIV).
1.6 "IND" shall mean an Investigational New Drug application or its
equivalent.
1.7 "Indemnitees" shall mean (a) in the case of the indemnity set forth
in Subsection 9.5(a), the Inventors, LICENSORS, and their trustees,
directors, employees and students, and all of their heirs, executors,
administrators, successors and legal representatives; (b) in the case of the
indemnity set forth in Subsection 9.5(b), COMPANY, its affiliates,
sublicensees, their directors, officers, employees and their heirs,
successors, executors, administrators and legal representatives; and (c) in
the case of the Indemnitees referenced in Subsection 9.7(b), the parties
identified in Subsections 1.7(a) and 1.7(b) above.
1.8 "Licensed Compounds" shall mean the compound 3'-Azido-2',3'
-dideoxy-5-methylcytidine, and its N(4) and 5(1) alkylated, acylated or
phosphorylated derivatives, including all salts, esters and purified
enantiomers of the foregoing. Notwithstanding the scope of
this definition, neither LICENSOR represents that it shall obtain valid
patent claims to any such compositions and LICENSORS specifically disclaim
any warranties or representations as to whether the Licensed Patents cover
any [ * ].
1.9 "Licensed Patents" shall mean (a) the patents and patent applications
identified in APPENDIX "A,"together with any and all substitutions, extensions,
divisionals, continuations, continuations-in-part, renewals, supplementary
protection certificates or foreign counterparts of such patent applications and
patents which issue thereon, anywhere in the world, including reexamined and
reissued patents; and (b) all other patents and
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patent applications in which or to which either LICENSOR acquires rights during
the term hereof which contain claims covering the manufacture, use or sale of
any Licensed Product to the extent that such LICENSOR possesses the right to
license such patents and patent applications to COMPANY for commercial purposes
without incurring financial or other non-contingent, material obligations to any
third parties.
1.10 "Licensed Product(s)" shall mean any Licensed Compound or any
pharmaceutical product containing one or more Licensed Compounds as active
ingredients, alone or in combination with other active ingredients, within the
Field of Use, the manufacture, use, importation, offer for sale or sale of which
is covered by any Valid Claim or which is made using Licensed Technology.
1.11 "Licensed Technology" shall mean all technical information and data,
whether or not patented, known or learned, invented, or developed by the
Inventors or any employees of LICENSORS working under the Inventors' direct or
indirect supervision, prior to or during the term hereof and while they are
under a duty to assign intellectual property rights to the LICENSORS, to the
extent that (a) such technical information and data are useful for the
manufacture, use, importation, offer for sale or sale of any Licensed Product;
and (b) LICENSORS possess the right to license the use of such information to
COMPANY for commercial purposes without incurring financial or other
non-contingent, material obligations to any third parties and without breaching
any obligations of confidentiality with such parties.
1.12 "Licensed Territory" shall mean the world.
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1.13 "LICENSORS" means Emory University and the University of Georgia
Research Foundation, Inc. "LICENSOR" shall mean either Emory University or the
University of Georgia Research Foundation, Inc.
1.14 "NDA" shall mean a New Drug Application or its equivalent.
1.15 "Net Selling Price" of Licensed Products which contain as their active
ingredients only Licensed Compounds shall mean the gross selling price paid by a
purchaser of such Licensed Product to COMPANY, an Affiliate or sublicensee of
COMPANY, or any other party authorized by COMPANY to sell Licensed Products
plus, if applicable, the value of all properties and services received in
consideration of a Sale of a Licensed Product, less only (a) discounts, rebates,
sales, use, or other similar taxes, transportation and handling charges and
allowances; and (b) returns which are accepted by COMPANY from independent
customers in accordance with COMPANY's normal practice and for which COMPANY
gives credit to such purchasers or retroactive price reductions in lieu of
returns, whether during the specific royalty period or not. 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 gross selling price billed by COMPANY in consideration of
the cash Sales of comparable Licensed Products during the then current royalty
period, less only reductions permitted in subsections (a) and (b) above and such
other reductions, if any, as LICENSORS agree are appropriate, which agreement
will not be unreasonably withheld or delayed.
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1. 16 "Net Selling Price" of Licensed Products which contain as their
active ingredients both Licensed Compounds and compounds other than Licensed
Compounds (a "Combination Product") shall be negotiated in good faith by the
parties with the intention of agreeing upon a fair and equitable formula;
provided, however, that if the parties are unable to agree upon such formula
within a reasonable period of time, the Net Selling Price with respect to such
Combination Product shall mean the gross sales price of such Combination Product
billed to independent customers, less all the allowances, adjustments,
reductions, discounts, taxes, duties, rebates or other charges referred to in
Section 1.15 multiplied by a fraction, the numerator of which shall be the
average invoice price per gram of Licensed Compound contained in the most
comparable stock keeping unit of any product having the Licensed Compound as the
sole active ingredient during the applicable royalty period in the applicable
country of the Licensed Territory, when such comparable product is sold for the
same indication as such Combination Product and the denominator of which shall
be the average invoice price per gram of the Licensed Compound sold alone as
described immediately above plus the average invoice price(s) per gram of the
other active ingredient(s) contained in such Combination Product in such country
during the applicable royalty period when such active ingredients are sold alone
for the same indication as such Combination Product. If there is no average
invoice price per gram in a given country for one or more of the active
ingredients comprising a Combination Product, the Net Selling Price with respect
to such Combination Product shall be deemed to be the gross sales of such
Combination Product billed to independent customers, less all the allowances,
adjustments, reductions, discounts, taxes, duties, rebates or other charges
referred to in Section 1.15, times a fraction, the numerator of which is the
number of Licensed Compounds in such Combination Product and the denominator of
which is the number of all active ingredients in such Combination Product.
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1.17 "Phase II Commencement Date" shall mean the date of commencement of
the initial well-controlled clinical trial of a Licensed Product sponsored by
COMPANY, the primary objective of which (as reasonably determined by COMPANY)
is to ascertain additional data regarding the safety and tolerance of such
Licensed Product and preliminary data regarding such Licensed Product's [ * ],
is commenced. For purposes of the preceding sentence, such clinical trial
shall be deemed to have commenced when such Licensed Product is first
administered to any patient enrolled in such clinical trial. For purposes of
this definition, the term "COMPANY" shall include Triangle Pharmaceuticals,
Inc., its Affiliates and sublicensees or any party in a co-promotion or
co-marketing relationship with Triangle Pharmaceuticals, Inc pertaining to
such Licensed Product.
1.18 "Phase II Completion Date" shall mean the earlier of (a) [ * ] after
completion of the statistical analyses of those Phase II clinical studies
which COMPANY considers reasonably necessary for purposes of inclusion in an
NDA; or (b) [ * ] after the last administration of a Licensed Product to all
patients enrolled in the Phase II clinical studies; or (c) [ * ] after the
first public disclosure of the final results of all such Phase II clinical
studies. For purposes of this definition, the term "COMPANY" shall include
Triangle Pharmaceuticals, Inc., its Affiliates and sublicensees or any party
in a co-promotion or co-marketing relationship with Triangle Pharmaceuticals,
Inc. pertaining to any Licensed Product.
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1.19 "Registration" shall mean, in relation to any Licensed Product, such
approvals by the regulatory authorities in a given country (including pricing
approvals) as may be legally required before such Licensed Product may be
commercialized or Sold in such country.
1.20 "Sale" or "Sold" shall mean the sale, transfer, exchange, or other
disposition of Licensed Products whether by gift or otherwise, subsequent to
Registration in a given country (if such Registration is required) by COMPANY,
its Affiliates, sublicensees or any third party authorized by COMPANY to make
such sale, transfer, exchange or disposition. Sales of Licensed Products shall
be deemed consummated upon the first to occur of: (a) receipt of payment from
the purchaser; (b) delivery of Licensed Products to the purchaser or a common
carrier; (c) release of Licensed Products from consignment; or (d) if otherwise
transferred, exchanged, or disposed of, whether by gift or otherwise, when such
transfer, exchange, gift, or other disposition occurs. Notwithstanding the
foregoing definition of Sale, to the extent COMPANY distributes any Licensed
Product under a Treatment IND or other expanded access program at a sales price
which exceeds its fully absorbed cost therefor, such excess shall be deemed to
be a Sale for which royalties are payable in accordance with the other terms
hereof; provided, however, that such distribution shall not be deemed to be
Registration of such Licensed Product.
1.21 "U.S. Government Licenses" shall mean the non-exclusive licenses to
the U.S. Government or agencies thereof pursuant to [ * ]copies of which
licenses are attached hereto as APPENDIX "B."
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1.22 "Valid Claim" shall mean (a) an issued claim of any unexpired patent
included among the Licensed Patents, or (b) a pending claim of any pending
patent application included among the Licensed Patents, which has not been held
unenforceable, unpatentable or invalid by a decision of a court or governmental
body of competent jurisdiction, unappealable or unappealed within the time
allowed for appeal, which has not been rendered unenforceable through disclaimer
or otherwise or which has not been lost through an interference proceeding.
ARTICLE 2. GRANT OF LICENSE
----------------------------
2.1 LICENSE. LICENSORS hereby grant COMPANY and its Affiliates the
exclusive right and license to practice the Licensed Patents and the Licensed
Technology to make, have made, use, import, offer for sale and sell Licensed
Products in the Licensed Territory during the term of this Agreement.
2.2 GOVERNMENT RIGHTS. The license granted in Section 2.1 above is
conditional upon and subject to the U.S. Government Licenses 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 USCA
Sections 201 et seq. and 37 CFR 401 et seq., which may be amended from time to
time by the Congress of the United States or through administrative procedures.
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2.3 RETAINED LICENSE. The license granted in Section 2.1 above is further
conditional upon and subject to a right and license retained by LICENSORS on
behalf of themselves and LICENSORS' academic research collaborators to make and
use Licensed Products and practice Licensed Technology for research and
educational purposes only. LICENSORS shall promptly verify the names of any
research collaborators practicing the license retained in this Section 2.3 upon
COMPANY's written request.
2.4 SUBLICENSES. COMPANY may grant sublicenses upon LICENSORS' written
approval (which approval shall not be unreasonably withheld or delayed). In the
event LICENSORS do not respond to a request for approval to sublicense within
fifteen (15) days from receiving a copy of the proposed sublicense agreement
from COMPANY, such request shall be deemed to be approved. COMPANY shall
provide LICENSORS with complete copies of all sublicense agreements within
thirty (30) days of their execution. COMPANY shall remain responsible to
LICENSORS for the payment of all fees and royalties due under this Agreement,
whether or not such payments are made to COMPANY by its sublicensees. COMPANY
shall include in any sublicense granted pursuant to this Agreement a provision
requiring the sublicensee to indemnify LICENSORS and maintain liability
insurance coverage to the same extent that COMPANY is so required pursuant to
Article 9 of this Agreement.
2.5 NO IMPLIED LICENSE. The license and rights granted in this
Agreement shall not be construed to confer any rights upon COMPANY by
implication, estoppel, or otherwise as to any technology not specifically
identified in this Agreement, except as otherwise implied by law to the
extent necessary to practice the Licensed Patents or Licensed Technology.
2.6 THIRD PARTY LICENSES. In the event LICENSORS acquire a license from a
third party relating to intellectual property which would be deemed to be
Licensed Patents or Licensed Technology but for the inability to sublicense such
intellectual property to COMPANY without incurring financial or other
non-contingent, material obligations, LICENSORS shall give prompt
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notice and a copy thereof to COMPANY. Such notice shall be accompanied by
such data and information in LICENSORS' possession, which LICENSORS are
authorized to transfer to COMPANY, or which can be obtained from such third
party in order to assist COMPANY in determining whether to sublicense such
third party license. COMPANY shall have [ * ] to elect whether to obtain a
sublicense under such third party license pursuant to the terms thereof, but
with no additional obligations of any type other than as prescribed therein.
If COMPANY fails to notify LICENSORS of its decision regarding the
acquisition of such sublicense within such [ * ] period, this Section 2.6 shall
no longer apply to such third party license.
ARTICLE 3. ROYALTIES AND OTHER PAYMENTS
----------------------------------------
3.1 LICENSE INITIATION FEE. COMPANY shall pay LICENSORS a license
initiation fee in the form of an aggregate amount of Fifty Thousand (50,000)
shares of COMPANY common stock upon the execution of this Agreement. Such
shares shall be issued directly to LICENSORS or to certain Inventors, as
directed by LICENSORS. Each recipient of any shares shall sign the
Restricted Stock Purchase Agreement and Investors' Rights Agreement dated as
of even date herewith.
3.2 MILESTONE PAYMENTS. COMPANY shall pay LICENSORS a milestone payment
("Milestone Payments") in the amount specified below no later than [ * ] after
the occurrence of the corresponding event designated below, unless COMPANY has
given LICENSORS notice of termination prior to such due date.
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Event Milestone Payment
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[ * ] [ * ]
3.3 LICENSE MAINTENANCE FEES. In the event no [ * ] has been paid
pursuant to Subsection 3.2(a), COMPANY shall pay to LICENSORS, on the
anniversary of the date of this Agreement set forth below, the amount set forth
below opposite such date unless COMPANY has given notice of termination prior to
such due date:
Anniversary License Maintenance Fee
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[ * ] [ * ]
3.4 (a) RUNNING ROYALTIES. COMPANY shall pay LICENSORS a royalty equal
to the following percentages of the Net Selling Price of Licensed Products Sold
in the Licensed Territory by COMPANY and its Affiliates and sublicensees:
PERCENTAGE OF NET SELLING PRICE CUMULATIVE NET SELLING PRICE OF LICENSED
PRODUCTS FOR [ * ]
[ * ] [ * ]
(b) DURATION; REDUCTION. Royalties (at the rates set forth in this
Section 3.4, subject to reduction or modification only as prescribed herein)
shall be paid in respect of a given Licensed Product for a period of [ * ]
after commercial introduction of such Licensed Product in a given country.
Thereafter, royalties shall be paid only so long as the manufacture, use,
offer for sale, sale or importation of such Licensed Product in such country
would, in the absence of a license, infringe a Valid Claim of an issued and
unexpired patent within the
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Licensed Patents. If, during such [ * ] period, a third party or third
parties commence selling a therapeutic product in a country in which there
are no Valid Claims or are Valid Claims only of the type described in Section
1.22(b) and (i) such product contains any Licensed Compound ("unlicensed unit
sales") and (ii) such unlicensed unit sales for any royalty period amount to
[ * ] or more of the COMPANY's unit sales of such Licensed Product in such
country in such royalty period, determined in accordance with Subsection
3.4(d) below, then COMPANY's royalty obligation in such country with respect
to such Licensed Product shall be suspended commencing with the royalty
period next succeeding the royalty period in which such [ * ] threshold was
initially exceeded and shall resume with the royalty period next succeeding
the first royalty period in which such [ * ] threshold is no longer exceeded.
COMPANY's royalty obligations with respect to such Licensed Product shall
resume in such country if and when such Valid Claim per Subsection 1.22(b)
becomes a Valid Claim per Subsection 1.22(a).
(c) UNIT SALES. For purposes of this Section 3.4, (i) "unlicensed
unit sales" and "COMPANY unit sales" shall be deemed to mean the grams of
Licensed Compound in third party product (irrespective of dosage form) or the
Licensed Product (irrespective of dosage form), respectively, as reflected on
the label of each such unit; and (ii) unlicensed unit sales shall be determined
by the sales reports of IMS America Ltd. of Plymouth Meeting, Pennsylvania
("IMS") or any successor to IMS or any other independent marketing auditing firm
selected by COMPANY or its sublicensees and reasonably acceptable to LICENSORS.
If COMPANY is entitled to a royalty suspension based on unlicensed unit sales
pursuant to Subsection 3.4(b) for
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any royalty period, it or its sublicensees shall submit the sales report of
IMS or such other independent firm, as applicable, for the relevant royalty
period to LICENSORS, together with COMPANY's or its sublicensees' sales
report for the relevant royalty period. Such sales reports for each royalty
period in which COMPANY is entitled to such royalty suspension shall be
submitted with the royalty report for such royalty period submitted pursuant
to Section 4.1.
3.5 ANNUAL MINIMUM ROYALTIES.
(a) Subject to Subsection 3.5 (b), in the event that COMPANY's
total annual royalty payment to LICENSORS pursuant to Section 3.4 above
during the [ * ] calendar year following the year during which the first FDA
Registration is granted for a Licensed Product covered by Subsection 3.4(a)
above and each calendar year thereafter for so long as there exist Valid
Claims in the U.S. is less than the annual minimum royalty set forth opposite
such year below (the "Annual Minimum"), COMPANY shall make a payment to
LICENSORS together with the report for the fourth quarter of such year
required in Section 4.1 of this Agreement equal to the difference between
such Annual Minimum and the total royalties paid to LICENSORS for the
preceding year pursuant to Section 3.4 above:
Calendar Year Annual Minimum
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[ * ] [ * ]
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(b) For any year in which Valid Claims do not exist in the United
States for the entire year or this Agreement is not in effect for the entire
year, the Annual Minimum shall be prorated accordingly.
(c) Commencing upon FDA Registration for a Licensed Product and
ending upon expiration of the [ * ] calendar year following the year in which
such FDA Registration is granted, COMPANY may credit solely against running
royalties (paid pursuant to Section 3.4), all reasonable costs incurred by
COMPANY after the date hereof (including any reimbursements to LICENSORS
pursuant to Section 7.1 for INTER PARTES Patent Prosecution Activities, as
defined therein) in connection with any litigation, interference, opposition
or other action pertaining to the validity, enforceability, allowability or
subsistence of the Licensed Patents or whether COMPANY's practice of the
Licensed Patents infringes a third party patent. Until the end of such [ * ]
calendar year, the amount of such credits shall not exceed in any year [ * ]
of the royalty payments due hereunder in such year. Commencing upon the [ * ]
calendar year following the year in which such FDA Registration is granted,
such credits shall not exceed in any year [ * ] of the Annual Minimum
payments due in such year. Such costs shall not be credited against any
other payments due to LICENSORS under this Agreement.
3.6 REIMBURSEMENTS. COMPANY shall reimburse to LICENSORS, within [ * ]
after submission to COMPANY of invoices and reasonable substantiation thereof:
(a) Expenses heretofore incurred by LICENSORS in connection with the
preparation, filing and prosecution of the Licensed Patents (approximating
[ * ]), and
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(b) Expenses incurred by LICENSORS in preparing this Agreement, not
to exceed [ * ].
3.7 ADDITIONAL PAYMENTS IN RESPECT OF SUBLICENSE AND OTHER AGREEMENTS.
In the event COMPANY grants sublicenses, sales or other rights with respect
to the Licensed Products pursuant to which COMPANY receives remuneration
other than royalties, then COMPANY shall pay to LICENSORS a percentage (the
"Applicable Percentage") as set forth below of all payments that COMPANY
receives from such sublicensees or other parties, including, without
limitation, (a) [ * ]; (b) [ * ]; (c) [ * ]; (d) [ * ]; and (e) [ * ]. As
used in this Section 3.7, the term [ * ] means [ * ] and all other [ * ] to
COMPANY in connection with a [ * ]; [ * ] means payments to COMPANY equal to
[ * ], where "A" is the [ * ] of COMPANY [ * ] purchased by the [ * ], "B" is
the [ * ] by the [ * ], and "C" is the [ * ] of the equity which, for
purposes hereof, shall be equal to [ * ] of the per share price obtained by
the COMPANY in its most recent round of preferred equity financing, unless
COMPANY's Board of Directors has established a new per share price in good
faith, in which case, such Board determined price shall apply; provided,
however, that in the event such shares or other units of equity are publicly
traded on a recognized securities market, the publicly traded price shall
apply; [ * ] means [ * ] COMPANY upon the fulfillment by COMPANY or the [ * ]
of [ * ]
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[ * ] or [ * ] in excess of those set forth in Section 3.2; [ * ] means [ * ]
(such as [ * ]) made by [ * ] to COMPANY to preserve, or to avoid a
forfeiture of rights under, the [ * ] in excess of those set forth in Section
3.5; and [ * ] means the amount by which actual payments made by a [ * ] to
COMPANY for Licensed Products or components of Licensed Products exceeds
COMPANY's standard costs for manufacture and shipment of such products plus
[ * ] of such costs, "standard costs" being determined in accordance with
Generally Accepted Accounting Principles. LICENSORS acknowledge that they
shall not be entitled to share in any payment made by a [ * ], regardless of
how such payment is denominated, that represents reimbursement or advance
payment of costs incurred by COMPANY for research, development or other
purposes (as agreed by LICENSORS and COMPANY) in COMPANY's pursuit of
regulatory or marketing approval for any Licensed Product. With respect to a
[ * ] or [ * ] concluded prior to Registration in [ * ] of the first Licensed
Product, the Applicable Percentage shall be [ * ]. With respect to a
sublicense or other contractual arrangement which is concluded after
Registration in [ * ] of the first Licensed Product, the Applicable
Percentage shall be [ * ]. With respect to any sublicensing or other
transaction to which this Section 3.7 applies but which relates to products
or compounds in addition to Licensed Products and for which an allocation
would be necessary, the parties shall meet and attempt to agree on which
portion of the total payments received by COMPANY pursuant to such
transaction should be subject to this Section 3.7. In the event the parties
cannot agree upon such allocation within a
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reasonable period of time, COMPANY shall select an independent certified
public accountant, to which LICENSORS have no reasonable objection, to
determine such allocation. Such allocation shall be determined in accordance
with generally accepted accounting principles in the United States.
3.8 ACCRUAL OF ROYALTIES. No royalty shall be payable on a Licensed
Product made, sold, or used for tests or development purposes or distributed
as samples. No royalties shall be payable on sales among COMPANY, its
Affiliates and sublicensees, but royalties shall be payable on subsequent
sales by COMPANY, its Affiliates or sublicensees to a third party. No
multiple royalty shall be payable because the manufacture, use or sale of a
Licensed Product is covered by more than one Valid Claim or at least one
Valid Claim and the Licensed Technology.
3.9 THIRD PARTY ROYALTIES. If COMPANY, its Affiliates or sublicensees
determine after consultation with LICENSORS, but at COMPANY's discretion,
that it or they are required to pay royalties or other fees to any third
party (including under any third party license to which Section 2.6 applies)
because the manufacture, use, offer for sale, importation, or sale of a
Licensed Product infringes any patent or other intellectual property rights
of such third party in a given country, and as a result of such third party
royalty payments or any other fees paid to such third party, the total
royalties payable by COMPANY to LICENSORS and such third parties exceeds [ * ]
of COMPANY's Net Selling Price for such Licensed Product during any royalty
period (such excess being referred to as "Excess Royalties"), COMPANY, its
Affiliates or sublicensees may deduct from running royalties thereafter due
to LICENSORS (per Section 3.4 of this Agreement) with respect to the Net
Selling Price of such
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Licensed Product in such country up to [ * ] of the Excess Royalties. In no
event shall the royalties due on such Sales of such Licensed Product in such
country on account of any reduction pursuant to this Section 3.9 thereby be
reduced to less than [ * ] of the royalties which would have been due
thereunder on such Sales of such Licensed Product in such country.
3.10 COMPULSORY LICENSES. Should a compulsory license be granted to any
third party in any country of the Licensed Territory to make, have made, use,
import, offer for sale or sell Licensed Products, the royalty rate payable
thereunder for sales of the Licensed Products by COMPANY in such country shall
be adjusted to match any lower royalty rate granted to the third party for such
country. COMPANY shall provide LICENSORS with prompt written notice of any
governmental or judicial procedures initiated in any country to impose a
compulsory license. COMPANY shall take all reasonable and legal steps as
COMPANY deems appropriate which are available to oppose such compulsory license
and shall, at LICENSORS' request, cooperate reasonably with LICENSORS in any
legal action which LICENSORS may wish to take to oppose such compulsory license,
which action shall be at LICENSORS' sole expense and may not be taken by
LICENSORS if such action would materially jeopardize the validity of any
Licensed Patents in such country.
3.11 REDUCTION IN ROYALTY DUE TO INVALID CLAIMS. In the event that all
applicable claims of a patent or patent application included within the Licensed
Patents under which COMPANY is selling or actively developing a Licensed Product
shall be held invalid or not infringed by the Licensed Products COMPANY is
selling or actively developing by a court of
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competent jurisdiction in a given country of the Licensed Territory, whether
or not there is a conflicting decision by another court of competent
jurisdiction in such country, COMPANY may cease all royalty payments on its,
its Affiliates' or its sublicensees' sales of such Licensed Product covered
by such claims and, if it does so, shall deposit such royalty payments in an
interest-bearing escrow account until such judgment is finally reversed by an
unappealed or unappealable decree of a court of competent jurisdiction of
higher dignity in such country or is otherwise unappealable or is unappealed
within the time allowed therefor; provided, however, that if such judgment is
finally reversed by an unappealed or unappealable decree of a court of
competent jurisdiction of higher dignity in such country, the former royalty
payments shall be resumed and the royalty payments not theretofore made and
interest earned thereon shall become due and payable to LICENSORS.
3.12 MOST FAVORED LICENSEE. Should COMPANY's exclusive license
hereunder become nonexclusive in any country of the Licensed Territory due to
LICENSORS' exercise of their conversion remedy and should LICENSORS
thereafter grant to a third party a license for any Licensed Product in such
country containing more favorable terms than those granted to COMPANY, then
in such an event, LICENSORS promptly shall notify COMPANY and or its
Affiliates or sublicensees, as applicable, and COMPANY and such Affiliates or
sublicensees shall have the benefit of such more favorable terms provided
they accept any less favorable terms contained in such license.
ARTICLE 4. REPORTS AND ACCOUNTING
4.1 ROYALTY REPORTS AND RECORDS. During the term of this Agreement,
COMPANY shall furnish, or cause to be furnished to LICENSORS, written reports
governing each of COMPANY's, COMPANY's Affiliates' and COMPANY's
sublicensees' fiscal quarters showing:
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(a) the gross selling price of all Licensed Products Sold by COMPANY,
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 Sections 1.15 and 1.16; and
(b) the royalties payable in Dollars, which shall have accrued
hereunder in respect to such Sales; and
(c) the exchange rates used, if any, in determining the amount of
Dollars; and
(d) a summary of all reports provided to COMPANY by COMPANY's
sublicensees; and
(e) the amount of any consideration received by COMPANY from
sublicensees, an explanation of the contractual obligation satisfied by such
consideration and calculation of any payments due LICENSORS pursuant to Section
3.7 of this Agreement;
(f) the occurrence of any event triggering a Milestone Payment
obligation in accordance with Section 3.2; and
(g) the basis for any credits taken against Annual Minimum payments
in accordance with Subsection 3.5(c), including documentation of costs incurred
by COMPANY in any litigation, infringement, interference, or other action
pertaining to the Licensed Patents, and any deductions from running royalty
payments taken pursuant to Section 3.9, including documentation of any royalties
or other fees paid to third parties.
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Reports shall be made semi-annually until the first Sale of a Licensed
Product and quarterly thereafter. Semi-annual reports shall be due within
thirty (30) days of the close of every second and fourth COMPANY fiscal quarter.
Quarterly reports shall be due within sixty (60) days of the close of every
COMPANY fiscal quarter. COMPANY shall keep accurate records in sufficient
detail to enable royalties and other payments payable hereunder to be
determined. COMPANY shall be responsible for all royalties and late payments
that are due to LICENSORS that have not been paid by COMPANY's Affiliates and
sublicensees. COMPANY's sublicensees shall have, and shall be notified by
COMPANY that they have, the option of making any royalty payment directly to
LICENSORS.
4.2 RIGHT TO AUDIT. LICENSORS shall have the right, upon prior notice to
COMPANY, not more than once in each COMPANY fiscal year nor more than once in
respect of any fiscal year, through an independent certified public accountant
selected by LICENSORS and acceptable to COMPANY, which acceptance shall not be
unreasonably refused, to have access during normal business hours to those
records of COMPANY as may be reasonably necessary to verify the accuracy of the
royalty reports required to be furnished by COMPANY pursuant to Section 4.1 of
the Agreement. COMPANY 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 access to such
records by LICENSORS' independent certified public accountant. If such
independent certified public accountant's report
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shows any underpayment of royalties by COMPANY, its Affiliates or
sublicensees, within thirty (30) days after COMPANY's receipt of such report,
COMPANY shall remit or shall cause its sublicensees to remit to LICENSORS:
(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 certified public accountant performing the
audit. Otherwise, LICENSORS' accountant's fees and expenses shall be borne by
LICENSORS. Any overpayment of royalties shall be fully creditable against
future royalties payable in any subsequent royalty periods. Upon the expiration
of [ * ] following the end of any fiscal year, the calculation of royalties
payable with respect to such fiscal year shall be binding and conclusive on
LICENSORS and COMPANY, unless an audit is initiated before expiration of such
[ * ].
4.3 CONFIDENTIALITY OF RECORDS. All information subject to review under
this Article 4 shall be confidential. Except where provided by law, LICENSORS
and its accountant shall retain all such information in confidence.
ARTICLE 5. PAYMENTS
5.1 PAYMENTS AND DUE DATES. Except as otherwise provided herein,
royalties and sublicense and other fees payable to LICENSORS as a result of
activities occurring during the period covered by each royalty report provided
for under Article 4 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 [ * ]
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[ * ] shall be made by wire transfer to an account or accounts of LICENSORS
designated by LICENSORS from time to time; provided, however, that in the
event that LICENSORS fail to designate such account, COMPANY or its
Affiliates and sublicensees may remit payment to LICENSORS to the address
applicable for the receipt of notices hereunder; providing, further, that any
notice by LICENSORS of such account or change in such account, shall not be
effective until fifteen (15) days after receipt thereof by COMPANY. One
hundred percent (100%) of each payment due hereunder shall be paid by COMPANY
to EMORY. UGARF acknowledges and agrees that COMPANY shall have no liability
to UGARF with respect to any payment due hereunder after such payment is made
by COMPANY to EMORY.
5.2 CURRENCY RESTRICTIONS. Except as hereinafter provided in this Section
5.2, 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, COMPANY or its sublicensee shall have the right and option to make such
payments by depositing the amount thereof in local currency to LICENSORS'
accounts in a bank or depository in such country.
5.3 INTEREST. Royalties and other payments required to be paid by
COMPANY pursuant to this Agreement shall, if overdue, bear interest at the
lesser of [ * ]or a per annum rate of [ * ] until paid. The payment of such
interest shall not foreclose LICENSORS from exercising any other rights they
may have because any payment is overdue.
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ARTICLE 6. DEVELOPMENT AND MARKETING PROGRAM
6.1 DUE DILIGENCE OBLIGATIONS. COMPANY shall directly, or through 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 of Use; and
(b) to diligently pursue Registration of the Licensed Products; and
(c) to effectively market the Licensed Products.
6.2 FULFILLMENT; CONVERSION.
(a) For purposes of this Agreement, "best efforts" shall mean that
COMPANY shall use reasonable efforts including, to the extent appropriate,
pursuing sublicenses or corporate alliances, consistent with those used by
comparable pharmaceutical companies in the United States in research and
development projects for therapeutic methods or compositions deemed to have
commercial value comparable to the Licensed Products. COMPANY's best efforts
obligations set forth in this Article 6 and implied by law shall be deemed to
have been fulfilled if COMPANY: (i) causes the Phase II Commencement Date
with respect to a first Licensed Product to occur by the [ * ] anniversary of
the date of this Agreement; and (ii) files an NDA for a Licensed Product by
the [ * ] anniversary of the date of this Agreement; and (iii) diligently
pursues such Registration; and (iv) commences marketing at least one Licensed
Product within [ * ] following such Registration. COMPANY shall be entitled
to obtain a maximum of three consecutive extensions of time for meeting each
of its obligations to commence Phase II clinical studies or file an NDA, by
paying to LICENSORS [ * ]
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for a first extension of [ * ] duration, [ * ] for a second extension of [ * ]
duration, and [ * ] for a third extension of [ * ] duration. Payment for
any such extension must be received by LICENSORS within [ * ] business days
following the expiration of the period during which any diligence obligation
was required to be met. COMPANY shall provide reports to LICENSORS every
[ * ] days following its NDA filing(s) concerning the status of such
filing(s) until final approval thereof. Each such report shall describe the
status of the COMPANY's NDA and disclose any request for additional
information or data received by COMPANY from the FDA during the reporting
period and COMPANY's plans for complying with such request. COMPANY shall
immediately notify LICENSORS if COMPANY determines that it is unwilling to
comply with any FDA requirement the failure with which to comply would result
in the given Licensed Product being unapprovable by the FDA (which notice is
hereinafter referred to as a "Failure of Diligence Notice"). Upon receipt of
such a Failure of Diligence Notice, COMPANY shall be deemed to have failed to
meet its diligence obligations, and LICENSORS may thereafter invoke any
remedy provided for in this Article without any further notice to COMPANY.
(b) In the event COMPANY fails to meet any diligence requirement set
forth herein in respect of the Licensed Products, LICENSORS shall have the
option in their sole discretion to (i) terminate the Agreement within the entire
Licensed Territory or any portion of the Licensed Territory, (ii) convert the
license granted in this Agreement into a non-exclusive license within the entire
Licensed Territory or any portion of the Licensed Territory, or (iii)
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terminate the Agreement within a portion of the Licensed Territory and
convert the license granted in this Agreement into a non-exclusive license
within a portion of the Licensed Territory.
(c) Upon exercise by LICENSORS of any portion of their rights under
the preceding Subsection, COMPANY shall deliver to LICENSORS all data, and shall
grant to LICENSORS and their sublicensees a non-exclusive, royalty free license
under all intellectual property rights in COMPANY's or COMPANY's sublicensees'
control and required for regulatory or commercial reasons in order to market any
Licensed Product in the country or countries in which termination has occurred.
COMPANY shall further provide LICENSORS, promptly upon request, copies of the
IND, NDA or other documents required for regulatory approvals for Sale in the
United States and any foreign countries provided that such termination has
occurred with respect to such countries. COMPANY shall, further permit
LICENSORS and any licensee of LICENSORS to cross-reference such filings for such
indication and shall sell LICENSORS or LICENSORS' licensees any Licensed
Compounds or intermediates used in the synthesis of such Licensed Compounds
(and not being used by COMPANY for the synthesis of other compounds) at
COMPANY's cost.
(d) Prior to exercising any rights under this Section, LICENSORS
shall give COMPANY [ * ] notice and shall meet with COMPANY, at COMPANY's
request and expense, during such [ * ] period, to discuss any disagreements
about whether COMPANY has complied with the requirements of this Section.
Upon expiration of such [ * ] period, LICENSORS shall have the right in their
sole discretion to proceed with the
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exercise of all rights and remedies provided for herein unless the applicable
diligence obligation is met during such [ * ] period.
6.3 PROGRESS REPORTS. COMPANY shall, no less frequently than once every
[ * ] until a Licensed Product has been Registered, provide LICENSORS
with a written report detailing all activities of COMPANY, its Affiliates and
sublicensees related to developing Licensed Products, except to the extent
required to do so more frequently pursuant to Section 6.2.
6.4 DEVELOPMENT OUTSIDE UNITED STATES. No later than COMPANY's filing of
an NDA for a Licensed Product in the United States, COMPANY shall directly, or
through or in collaboration with Affiliates and sublicensees, commence its best
efforts:
(a) to obtain Registration for a Licensed Product in such other
countries of the Licensed Territory as COMPANY or COMPANY's 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.
ARTICLE 7. PATENT PROSECUTION
7.1 LICENSED PATENTS ASSIGNED TO LICENSORS.
(a) LICENSORS shall be primarily responsible for all patent
prosecution activities pertaining to Licensed Patents assigned solely to
LICENSORS. LICENSORS shall select patent counsel, acceptable to COMPANY, to
prosecute, acquire from the relevant patent offices, defend and maintain and
handle any litigation, interference, opposition or other action pertaining to
the validity, enforceability, allowability or subsistence (all of the foregoing
activities
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being referred to as "Patent Prosectution Activities") of all such Licensed
Patents and shall provide COMPANY with copies of all filings and
correspondence pertaining to such Patent Prosecution Activities (pre and post
the date hereof), in a timely manner, so as to give COMPANY an opportunity to
comment thereon. To the extent reasonably possible, LICENSORS shall pursue
Patent Prosecution Activities in respect of such Licensed Patents in at least
the following countries: [ * ], and [ * ]. LICENSORS shall, upon COMPANY's
request, pursue Patent Prosecution Activities in respect of such Licensed
Patents in additional countries. If LICENSORS decide to abandon or allow to
lapse any patent application or patent within the Licensed Patents or
discontinue any other Patent Prosecution Activities in respect thereof in any
country of the Licensed Territory, LICENSORS shall inform COMPANY and COMPANY
shall be given the opportunity to assume Patent Prosecution Activities in
respect thereof.
(b) COMPANY shall reimburse LICENSORS, not later than thirty (30)
days after receiving an invoice from LICENSORS (and reasonable substantiation
thereof if requested by COMPANY), for all reasonable out-of-pocket expenses
incurred by LICENSORS after the date of this Agreement for all such Patent
Prosecution Activities. Invoices shall be submitted once in respect of each
calendar quarter as promptly as practicable after the end of such quarter. If
COMPANY fails to promptly reimburse LICENSORS for any undisputed expenses for
Patent Prosecution Activities respecting any patent application or issued patent
assigned solely to LICENSORS within the time allowed therefor, upon at least
thirty (30) days' prior notice to COMPANY, such patent application or issued
patent shall not be considered a Licensed Patent
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and LICENSORS shall be free, at their election, to continue or discontinue
any or all of the Patent Prosecution Activities in respect of such patent
application or issued patent or grant rights to such patent application or
issued patent to third parties.
(c) COMPANY reserves the right to terminate its obligations
pursuant to Section 7.1 with respect to any patent application or patent
included in the Licensed Patents in any country or countries upon at least
thirty (30) days' prior written notice to LICENSORS. After the date
specified in such notice on which COMPANY's obligation to pay further
expenses for Patent Prosecution Activities terminates, such patent
application or patent, as the case may be, shall no longer be included in the
Licensed Patents in those countries in which COMPANY has exercised its rights
to terminate such obligations.
7.2 LICENSED PATENTS JOINTLY ASSIGNED TO COMPANY AND LICENSORS. Any
invention relating to a Licensed Compound, the invention of which under
applicable patent law is attributed jointly to at least one employee of either
LICENSOR and at least one employee of COMPANY, shall be assigned by such
employees to such LICENSOR and COMPANY. Any such jointly assigned patent, or
patent application which includes claims to any Licensed Products shall be
considered a Licensed Patent and subject to the terms of this Agreement.
COMPANY shall be primarily responsible for all Patent Prosecution Activities
pertaining to Licensed Patents jointly assigned to LICENSORS and COMPANY.
COMPANY shall select patent counsel, acceptable to LICENSORS, to pursue Patent
Prosecution Activities in respect of all such Licensed Patents and shall provide
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LICENSORS with copies of all filings and correspondence pertaining to such
Patent Prosecution Activities, in a timely manner, so as to give LICENSORS an
opportunity to comment thereon. COMPANY shall advise such patent counsel in
writing that for purposes of such Patent Prosecution Activities, such counsel
represents both COMPANY and any LICENSOR which is a joint assignee of such
patent application or issued patent. COMPANY shall further inform LICENSORS
of any decision by COMPANY to discontinue any Patent Prosecution Activities
in respect of any pending patent application or issued patent promptly upon
reaching such decision and in any case, no less than thirty (30) days before
the discontinuance thereof. COMPANY shall be solely responsible for all
expenses incurred by COMPANY in connection with Patent Prosecution Activities
for patent applications and patents to which this Section 7.2 applies.
COMPANY shall pursue Patent Prosecution Activities in respect of such
Licensed Patents in those countries it deems reasonably appropriate after
consultation with LICENSORS. If COMPANY fails to timely pursue Patent
Prosecution Activities in respect of any patent application or issued patent
jointly assigned to COMPANY and LICENSORS in any country in which LICENSORS
wish to pursue Patent Prosecution Activities, LICENSORS shall be free at
their sole expense, to continue or discontinue any or all of the Patent
Prosecution Activities in respect of such patent application or issued patent
in such country or grant their rights to such patent application or issued
patent to third parties. Thereafter, LICENSORS' rights to such patent
application and issued patent shall no longer be included in the license
granted pursuant to Section 2.1 and COMPANY shall further, upon LICENSORS'
request, license COMPANY's rights under such jointly assigned patents to
LICENSORS or any licensees of LICENSORS, non-exclusively on a royalty free
basis.
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ARTICLE 8. INFRINGEMENT
------------------------
8.1 THIRD PARTY INFRINGEMENT. If COMPANY or either LICENSOR becomes
aware of any activity that it believes infringes a Valid Claim, the party
obtaining such knowledge shall promptly advise the others of all relevant
facts and circumstances pertaining to the potential infringement. COMPANY
shall have the right to enforce any rights within the Licensed Patents or the
Licensed Technology against such infringement, at its own expense. LICENSORS
shall cooperate with COMPANY in such effort, at COMPANY's expense, including
being joined as a party or parties to such action if necessary. COMPANY may
deposit up to [ * ] of any running royalties and Milestone Payments which are
otherwise payable to LICENSOR during the pendency of any such infringement
action in an interest-bearing escrow account (bearing interest at rates
comparable to other COMPANY deposits of immediately available funds).
COMPANY shall, upon the final resolution or settlement of such infringement
action, provide LICENSORS with an accounting of the total royalty payments
and Milestone Payments escrowed (and interest thereon) and COMPANY's expenses
incurred in such infringement action. COMPANY shall be entitled to offset
any expenses which COMPANY fails to recoup from any damage award or
settlement payments arising from such infringement action against such
escrowed royalties. Any escrowed payments (and interest thereon) in excess
of COMPANY's unrecouped expenses shall be immediately paid to LICENSORS. Any
damage award or settlement payments made to COMPANY in excess of COMPANY's
expenses shall be treated as royalty bearing Sales of Licensed Products and
COMPANY shall make royalty payments on such revenues in accordance with
Article 3 of this Agreement.
8.2 LICENSORS' RIGHTS TO PURSUE THIRD PARTY INFRINGERS. If COMPANY
shall fail, within one hundred twenty (120) days after receiving notice from
LICENSORS of a potential infringement, or providing LICENSORS with notice of
such infringement, to either (a) terminate such infringement or (b) institute
an action to prevent continuation thereof and, thereafter, to prosecute such
action diligently, or if COMPANY notifies LICENSORS that it does not plan to
terminate the infringement or institute such action, then LICENSORS shall
have the right to do so at their own expense. COMPANY shall cooperate with
LICENSORS in such effort, including being joined as a party to such action if
necessary. LICENSORS shall be entitled to retain all damages or costs
awarded to LICENSORS in such action.
* Confidential Treatment Requested
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ARTICLE 9. WARRANTIES; EXCLUSION OF WARRANTIES;
-----------------------------------------------
AND INDEMNIFICATION
-------------------
9.1 WARRANTIES OF LICENSORS.
(a) LICENSORS represent and warrant that, to the best of their
knowledge:
(i) LICENSORS have disclosed to COMPANY all potential patent
rights in the control of third parties known to LICENSORS which may be needed to
commercialize any Licensed Products ; and
(ii) APPENDIX "A" is a complete list of all patents and patent
applications included in the Licensed Patents as of the date hereof. LICENSORS
will, from time to time during the term of this Agreement, promptly provide
COMPANY, upon request, with an updated version of APPENDIX "A."
(b) LICENSORS further represent and warrant that they are the
exclusive owners of all right, title and interest in the patents and patent
applications identified in APPENDIX "A" as of the date hereof, subject to the
rights of the U.S. Government, as described in the U.S. Government Licenses.
For purposes of the representation and warranty set forth in clause (i) of
Subsection 9.1(a), "LICENSORS" shall mean the Inventors and any employees of
EMORY or UGARF who work in the technology transfer area. COMPANY
acknowledges that LICENSORS have not undertaken any investigation with
respect to the potential patent rights of any third party.
9.2 WARRANTIES OF EACH PARTY. Each party hereto represents to the others
that it is free to enter into this Agreement and to carry out all of the
provisions hereof, including, in the case of LICENSORS, their grant to COMPANY
of the license described in Section 2. 1.
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9.3 MERCHANTABILITY AND EXCLUSION OF WARRANTIES. COMPANY possesses the
necessary expertise and skill in the technical areas pertaining to the
Licensed Patents, Licensed Products and Licensed Technology to make, and has
made, its own evaluation of the capabilities, safety, utility and commercial
application of the Licensed Patents, Licensed Products and Licensed
Technology. ACCORDINGLY, EXCEPT AS SET FORTH IN SECTIONS 9.1 AND 9.2,
LICENSORS DO NOT MAKE ANY REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT
TO THE VALIDITY OF LICENSED PATENTS, LICENSED TECHNOLOGY OR LICENSED PRODUCTS
AND EXPRESSLY DISCLAIM 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.
9.4 NO LIABILITY FOR CONSEQUENTIAL DAMAGES AND LIMITATION OF LIABILITY.
LICENSORS shall not be liable to COMPANY or COMPANY's 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 by or through COMPANY, its Affiliates or
sublicensees. This Section shall not affect COMPANY's rights hereunder to any
credit or royalty reduction explicitly permitted elsewhere herein.
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9.5 INDEMNIFICATION.
(a) COMPANY 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 reasonable
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
manufacture, testing, design, use, Sale, or labeling of any Licensed Products by
COMPANY or COMPANY's Affiliates, contractors, agents or sublicensees. COMPANY's
obligations under this Article shall survive the expiration or termination of
this Agreement for any reason.
(b) LICENSORS shall indemnify and hold Indemnitees harmless from and
against any and all claims, demands, loss, liability, expense or damage
(including investigative costs, court costs and reasonable attorneys' fees)
Indemnitees may suffer, pay or incur as a result of claims, demands or actions
against any of the Indemnitees arising by reason of, or in
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connection with, the breach by LICENSORS of any of their representations and
warranties set forth in this Agreement.
9.6 INSURANCE. Without limiting COMPANY's indemnity obligations under the
preceding Section, COMPANY shall, to the extent available at commercially
reasonable rates and prior to any clinical trial or Sale of any Licensed
Product, cause to be in force, an [ * ] insurance policy which:
(a) insures LICENSORS and their Indemnitees for all claims, damages,
and actions mentioned in Section 9.5(a) of this Agreement; and
(b) requires the insurance carrier to provide LICENSORS with no less
than [ * ] written notice of any change in the terms or coverage of the policy
or its cancellation; and
(c) provides Indemnitees product liability coverage in an amount no
less than [ * ] per occurrence for bodily injury and [ * ] per occurrence for
property damage, subject to a reasonable aggregate amount, as determined by
COMPANY.
9.7 NOTICE OF CLAIMS; INDEMNIFICATION PROCEDURES.
(a) COMPANY shall promptly notify LICENSORS of all claims involving
the Indemnitees for which indemnification is or may be provided in Section
9.5(a) and shall advise LICENSORS of the policy amounts that might be needed to
defend and pay any such claims.
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(b) An Indemnitee which intends to claim indemnification under this
Article shall promptly notify the other party (the "Indemnitor") in writing of
any matter in respect of which the Indemnitee or any of its employees or agents
intend to claim such indemnification. The Indemnitee shall permit, and shall
cause its employees and agents to permit, the Indemnitor, at its discretion, to
settle any such matter and agrees to the complete control of such defense or
settlement by the Indemnitor; provided, however, that such settlement does not
adversely affect the Indemnitee's rights hereunder or impose any obligations on
the Indemnitee in addition to those set forth herein in order for it to exercise
such rights. No such matter shall be settled without the prior written consent
of the Indemnitor and the Indemnitor shall not be responsible for any legal fees
or other costs incurred other than as provided herein. The Indemnitee, its
employees and agents shall cooperate fully with the Indemnitor and its legal
representatives in the investigation and defense of any matter covered by the
applicable indemnification. The Indemnitee shall have the right, but not the
obligation, to be represented by counsel of its own selection and expense.
ARTICLE 10. CONFIDENTIALITY
10.1 TREATMENT OF CONFIDENTIAL INFORMATION. Except as otherwise provided
hereunder, during the term of this Agreement and for a period of [ * ]
thereafter:
(a) COMPANY and its Affiliates and sublicensees shall retain in
confidence and use only for purposes of this Agreement, any written information
and data supplied by LICENSORS to COMPANY under this Agreement; and
* CONFIDENTIAL TREATMENT REQUESTED
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(b) LICENSORS shall retain in confidence and use only for purposes of
this Agreement any written information and data supplied by COMPANY or on behalf
of COMPANY to LICENSORS under this Agreement.
For purposes of this Agreement, all such information and data which a party
is obligated to retain in confidence shall be called "Information."
10.2 RIGHT TO DISCLOSE. To the extent that it is reasonably necessary to
fulfill its obligations or exercise its rights under this Agreement, or any
rights which survive termination or expiration hereof, each party may disclose
Information to its Affiliates, sublicensees, consultants, outside contractors,
actual or prospective investors, governmental regulatory authorities and
clinical investigators on condition that such entities or persons agree:
(a) to keep the Information confidential for a [ * ] time period and
to the same extent as each party is required to keep the Information
confidential; and
(b) to use the Information only for such purposes as such parties are
authorized to use the Information.
Each party or its Affiliates or sublicensees may disclose Information to
the government or other regulatory authorities to the extent that such
disclosure (i) is necessary for the prosecution and enforcement of patents, or
authorizations to conduct clinical trials or commercially market Licensed
Products, provided such party is then otherwise entitled to engage in such
activities during the term of this Agreement or thereafter in accordance with
the provisions of this Agreement, or (ii) is legally required.
* CONFIDENTIAL TREATMENT REQUESTED
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10.3 RELEASE FROM RESTRICTIONS. The obligation not to disclose Information
shall not apply to any part of such Information that:
(a) is or becomes patented, published or otherwise part of the public
domain, other than by unauthorized acts of the party obligated not to disclose
such Information (for purposes of this Article 10 the "receiving party") or its
Affiliates or sublicensees in contravention of this Agreement; or
(b) is disclosed to the receiving party or its Affiliates or
sublicensees by a third party provided that such Information was not obtained by
such third party directly or indirectly from the other party to this Agreement;
or
(c) prior to disclosure under this Agreement, was already in the
possession of the receiving party, its Affiliates or sublicensees, provided that
such Information was not obtained directly or indirectly from the other party to
this Agreement; or
(d) results from research and development by the receiving party or
its Affiliates or sublicensees, independent of disclosures from the other
party to this Agreement, provided that the persons developing such
information have not had exposure to the information received from the other
party to this Agreement; or
(e) is required by law to be disclosed by the receiving party,
provided that the receiving party uses reasonable efforts to notify the other
party immediately upon learning of such requirement in order to give the other
party reasonable opportunity to oppose such requirement; or
(f) COMPANY and LICENSORS agree in writing may be disclosed.
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ARTICLE 11. TERM AND TERMINATION
11.1 TERM. Unless sooner terminated as otherwise provided in this
Agreement, the term of this Agreement shall commence on the date of this
Agreement and shall continue in full force and effect until the expiration of
the last to expire Valid Claim.
11.2 TERMINATION. LICENSORS shall have the right to terminate this
Agreement upon the occurrence of any one or more of the following events,
provided that LICENSORS have given COMPANY the notice required in Section 11.3
and COMPANY has failed to cure the breach described in such notice:
(a) failure of COMPANY to make any payment required pursuant to this
Agreement when due; or
(b) failure of COMPANY to timely issue COMPANY stock to LICENSORS or
certain Inventors as designated by LICENSORS in accordance with the certain
Restricted Stock Purchase Agreement among LICENSORS and such Inventors and
COMPANY of even date herewith; or
(c) failure of COMPANY to render reports to LICENSORS as required by
this Agreement; or
(d) the institution of any proceeding by COMPANY under any
bankruptcy, insolvency, or moratorium law; or
(e) any assignment by COMPANY of substantially all of its assets for
the benefit of creditors; or
40
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(f) placement of COMPANY's 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 in the case of in involuntary bankruptcy
proceeding, which is contested by COMPANY, such termination shall not become
effective until the bankruptcy court of jurisdiction has entered an order
upholding the petition; or
(g) a decision by COMPANY or COMPANY's permitted assignee of rights
under this Agreement to quit the business of developing or selling Licensed
Products; or
(h) the breach by COMPANY of any other material term of this
Agreement.
11.3 EXERCISE. LICENSORS may exercise their right of termination by giving
COMPANY, its trustees, receivers or assigns, thirty (30) days' prior written
notice of LICENSORS' election to terminate. Such notice shall include the basis
for such termination. Upon the expiration of such period, this Agreement shall
automatically terminate unless COMPANY has cured the breach. Such notice and
termination shall not
41
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prejudice LICENSORS' right to receive royalties or other sums due hereunder and
shall not prejudice any cause of action or claim of LICENSORS.
11.4 FAILURE TO ENFORCE. The failure of LICENSORS, 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
LICENSORS thereafter to enforce each and every such provision of this Agreement.
11.5 TERMINATION BY COMPANY. COMPANY 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 LICENSORS; or
(b) upon COMPANY's convenience and written notice of such termination
given to LICENSORS at least ninety (90) days prior to the date of such
termination. The termination right set forth in this Subsection 11.5(b) may be
exercised by COMPANY in respect of the entire Licensed Territory or one or more
countries (excluding the United States) of the Licensed Territory without
affecting this Agreement in the remaining countries of the Licensed Territory.
11.6 EXERCISE. COMPANY may exercise its right of termination pursuant to
Section 11.5(a) by giving LICENSORS thirty (30) days' prior written notice of
COMPANY's election to terminate. The notice shall include the basis for such
termination. Upon the expiration of such period, this Agreement shall
automatically terminate unless LICENSORS have cured the breach. Such notice of
termination shall not
42
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prejudice any cause of action or claim of COMPANY accrued or to accrue on
account of any breach or default by LICENSORS.
11.7 EFFECT. If this Agreement is terminated as a result of COMPANY's
breach pursuant to Section 11.2, or in accordance with Section 11.5(b): (a)
COMPANY shall use its best efforts to return, or at LICENSORS' direction,
destroy, all data, writings and other documents and tangible materials supplied
to COMPANY by LICENSORS; and (b) COMPANY shall further, upon LICENSORS' request
and with no need for additional consideration, grant LICENSORS a non-exclusive,
royalty free license (with the right to sublicense) to all of COMPANY's rights
in any Licensed Patents and other patents owned by, licensed to (to the extent
sublicensing is permissible and subject to the terms thereof, including any
royalty obligations) or controlled by COMPANY which include claims covering or
potentially covering the manufacture, use or sale of any Licensed Products, or
derivatives or analogues thereof. COMPANY shall further provide LICENSORS with
full and complete copies of all toxicity, efficacy, and other data generated by
COMPANY or COMPANY's Affiliates, sublicensees, contractors or agents in the
course of COMPANY's efforts to develop Licensed Products or obtain governmental
approval for the Sale of Licensed Products, including but not limited to any
IND, NDA or other documents filed with any government agency. LICENSORS and
their licensees shall be authorized to cross-reference any such IND, NDA or
other filings made in the United States or foreign countries where permitted by
law. LICENSORS shall be authorized to provide data pertaining to the Licensed
Patents and Licensed Technology to any third party with a bona
43
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fide interest in licensing such technology. Such data shall be provided on a
confidential basis; provided, however, that if such third party enters into a
license with LICENSORS, such third party shall be free to use such data for all
purposes, including to obtain government approvals to sell products containing
any Licensed Compound. COMPANY shall cooperate reasonably (at no unreimbursed
expense to COMPANY) with any third party licensee of LICENSORS in pursuing
governmental approval to sell any product containing any Licensed Compound,
including but not limited to, permitting such third parties to cross-reference
any NDA filed with the FDA or Registration obtained from the FDA or analogous
documents filed or obtained in any foreign countries.
ARTICLE 12. ASSIGNMENT
COMPANY shall not assign this Agreement or any part thereof without the
prior written consent of LICENSORS, which consent shall not be unreasonably
withheld or delayed. COMPANY may, however, without consent, assign or sell its
rights under this Agreement (a) in connection with the transfer or sale of
substantially its entire business to which this Agreement pertains, (b) in the
event of its merger or consolidation with another company, or (c) to an
Affiliate. Any permitted assignee shall assume all obligations of its assignor
under this Agreement. No assignment shall relieve any party of responsibility
for the performance of any accrued obligation which such party has under this
Agreement. Any assignee of this Agreement shall assume all accrued and
prospective obligations including, but not limited to, those set forth in
Articles 6 and 7. Any such assignee shall further, within sixty (60) days of
becoming the assignee of rights hereunder, meet with LICENSORS'
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representatives to discuss such assignee's plans for the future development of
the Licensed Products. If such assignee determines that it does not wish to
continue the development or marketing obligations required under this Agreement
or otherwise attempt to sublicense its rights, then such assignee shall
immediately terminate this Agreement. Any such termination shall be treated as
a termination under Subsection 11.5(b).
ARTICLE 13. TRANSFER OF LICENSED TECHNOLOGY
Within sixty (60) days following the date hereof and as far as they have
not previously done so, LICENSORS shall supply COMPANY with all available
Licensed Technology. With respect to any Licensed Technology which becomes
known to LICENSORS during the term of this Agreement, such disclosure will be
made at least semi-annually or sooner, if practicable.
ARTICLE 14. REGISTRATION OF LICENSE
COMPANY, at its expense, may register the license granted under this
Agreement in any country of the Licensed Territory where the use, sale or
manufacture of a Licensed Product in such country would be covered by a Valid
Claim. Upon request by COMPANY, LICENSORS agree promptly to execute any "short
form" licenses submitted to it by COMPANY in order to effect the foregoing
registration in such country.
ARTICLE 15. NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE
COMPETITION AND PATENT TERM RESTORATION ACT
15.1 NOTICES RELATING TO THE ACT. LICENSORS shall use their best efforts
to notify COMPANY of (a) the issuance of each U.S. patent included among the
Licensed Patents, giving the date of issue and patent number for each such
patent; and (b) each notice pertaining to any patent included among the Licensed
Patents which LICENSORS
45
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receive as patent owner pursuant to the Drug Price Competition and Patent Term
Restoration Act of 1984 (hereinafter the "Act"), including, but not necessarily
limited to, notices pursuant to Sections 101 and 103 of the Act from persons who
have filed an abbreviated NDA ("ANDA") of a "paper" NDA. Such notices shall be
given promptly, but in any event within ten (10) days of LICENSORS' notice of
each such patent's date of issue or receipt of each such notice pursuant to the
Act, whichever is applicable.
15.2 AUTHORIZATION RELATING TO PATENT TERM EXTENSION. LICENSORS hereby
authorize COMPANY (a) to include in any NDA for a Licensed Product, as COMPANY
may deem appropriate under the Act, a list of patents included among the
Licensed Patents that relate to such Licensed Product and such other information
as COMPANY, in its reasonable discretion, believes is appropriate to be filed
pursuant to the Act; (b) to commence suit for any infringement of the Licensed
Patents under Section 271(e) (2) of Title 35 of the United States Code
occasioned by the submission by a third party of an IND or a paper NDA for a
Licensed Product pursuant to Sections 101 or 103 of the Act; and (c) subject to
LICENSORS' consent (which consent will not be unreasonably withheld or delayed),
to exercise any rights that may be exercisable by LICENSORS as patent owners
under the Act to apply for an extension of the term of any patent included among
the Licensed Patents. In the event that applicable law in any other country of
the Licensed Territory hereafter provides for the extension of the term of any
patent included among the Licensed Patents in such country, upon request by
COMPANY, LICENSORS shall use their best efforts to obtain such extension or, in
lieu thereof, shall authorize COMPANY or, if requested by
46
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COMPANY or its sublicensees to apply for such extension, in consultation with
LICENSORS. LICENSORS agree to cooperate with COMPANY or its sublicensees, as
applicable, in the exercise of the authorization granted herein or which may be
granted pursuant to this Section 15.2 and will execute such documents and take
such additional action as COMPANY may reasonably request in connection
therewith, including, if necessary, permitting themselves to be joined as proper
parties in any suit for infringement brought by COMPANY under subsection (b)
above. The provisions of Article 8 shall apply to any suit for infringement
brought by COMPANY under subsection (b) above. In the event COMPANY decides not
to commence suit for infringement under subsection (b) above, COMPANY will
notify LICENSORS of its decision within thirty (30) days so that LICENSORS may
institute such litigation themselves, if they wish, at their own cost and
expense.
ARTICLE 16. MISCELLANEOUS
16.1 ARBITRATION. Any controversy, claim or dispute regarding COMPANY's
failure to meet its diligence obligations in accordance with Article 6 of this
Agreement, including, without limitation, any dispute concerning the scope of
this arbitration clause, shall be resolved through arbitration conducted under
the auspices of the American Arbitration Association pursuant to that
organization's rules for commercial arbitration. Any hearings requested by
COMPANY shall be held in Atlanta, Georgia. Any hearings requested by LICENSORS
shall be held in Durham, North Carolina.
47
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16.2 EXPORT CONTROLS. COMPANY acknowledges that LICENSORS are subject to
United States laws and regulations controlling the export of technical data,
biological materials, chemical compositions and other commodities and that
LICENSORS' obligations under this Agreement are contingent upon compliance with
applicable United States export laws and regulations. The transfer of technical
data, biological materials, chemical compositions and commodities may require a
license from the cognizant agency of the United States government or written
assurances by COMPANY that COMPANY shall not export data or commodities to
certain foreign countries without the prior approval of certain United States
agencies, or as otherwise prescribed by applicable law or regulation. LICENSORS
neither represent that an export license shall not be required nor that, if
required, such export license shall issue.
16.3 LEGAL COMPLIANCE. COMPANY shall comply with all laws and regulations
relating to its manufacture, use, sale, labeling or distribution of Licensed
Products and shall not take any action which would cause LICENSORS or COMPANY to
violate any laws or regulations.
16.4 INDEPENDENT CONTRACTOR. COMPANY's relationship to LICENSORS shall be
that of a licensee only. COMPANY shall not be the agent of LICENSORS and shall
have no authority to act for, or on behalf of, LICENSORS in any matter. Persons
retained by COMPANY as employees or agents shall not, by reason thereof, be
deemed to be employees or agents of LICENSORS.
48
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16.5 PATENT MARKING. COMPANY shall ▇▇▇▇ Licensed Products Sold in the
United States with United States patent numbers. Licensed Products manufactured
or Sold in other countries shall be marked in compliance with the intellectual
property laws in force in such countries. The foregoing obligations shall be
subject to size and space limitations.
16.6 USE OF NAMES. COMPANY shall obtain the prior written approval of
LICENSORS prior to making use for any commercial purpose of the name of any of
the Inventors, any employee of either of the LICENSORS or of the LICENSORS,
except that COMPANY may identify LICENSORS to prospective investors and in
public announcements relating to consummation of this Agreement.
16.7 EFFECT. This Agreement shall not become effective or binding upon the
parties until signed by EMORY's Executive Vice President, UGARF's Vice President
for Research and the President or any other authorized officer of COMPANY.
16.8 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.
16.9 ENTIRE AGREEMENT. This Agreement constitutes the entire agreement
among LICENSORS and COMPANY 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.
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16.10 SURVIVAL. Articles 9 and 10 shall survive termination of this
Agreement for any reason. Section 11.7 shall survive termination pursuant to
Section 11.2 or 11.5(b). Upon expiration of this Agreement, COMPANY shall have
a fully paid up license to use the Licensed Technology.
16.11 SEVERABILITY. All rights and restrictions contained herein may
be exercised and shall be applicable and 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,
not essential to the commercial purpose of this Agreement, shall be held to be
illegal, invalid or unenforceable by a court of competent jurisdiction, it is
the intention of the parties that the remaining provisions or portions thereof
shall constitute their agreement with respect to the subject matter hereof, and
all such remaining provisions, or portions thereof, shall remain in full force
and effect. To the extent legally permissible, any illegal, invalid or
unenforceable provision of this Agreement shall be replaced by a valid provision
which shall implement the commercial purpose of the illegal, invalid, or
unenforceable provision. In the event that any provision essential to the
commercial purpose of this Agreement is held to be illegal, invalid or
unenforceable and cannot be replaced by a valid provision which will implement
the commercial purpose of this Agreement, this Agreement and the rights granted
herein shall terminate.
16.12 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
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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 workmen, 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.
16.13 ATTORNEYS' FEES. If any action at law, in equity or under
Section 16.1 of this Agreement is necessary to enforce or interpret the terms of
this Agreement, the prevailing party shall be entitled to reasonable attorneys'
fees, costs and necessary disbursements, in addition to any other relief to
which the party may be entitled.
16.14 COUNTERPARTS. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
ARTICLE 17. NOTICES
All notices, statements, and reports required to be given under this
Agreement shall be in writing and shall be deemed to have been given upon
delivery in person or when deposited in the mail in the country of residence of
the party giving the notice, registered or certified postage prepaid, and
addressed as follows:
To LICENSORS: Emory University
Director of Licensing and Patent Counsel
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇
University of Georgia Research Foundation, Inc.
631 ▇▇▇▇ Graduate Studies Building
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Athens, GA 30602-7411
Attention: ▇▇▇▇ ▇▇▇▇▇
To COMPANY: TRIANGLE PHARMACEUTICALS INC.
▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: Company Secretary
Any 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.
[REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK]
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IN WITNESS WHEREOF, LICENSORS and COMPANY have caused this Agreement to be
signed by their duly authorized representatives, as of the day and year
indicated below.
LICENSORS:
EMORY UNIVERSITY
By: /s/ ▇▇▇▇ ▇▇▇▇▇▇
--------------------------------------
▇▇▇▇ ▇▇▇▇▇▇
Executive Vice President
UNIVERSITY OF GEORGIA RESEARCH
FOUNDATION, INC.
By: /s/ ▇▇▇ ▇. Key
--------------------------------------
▇▇▇ ▇. Key
Executive Vice President
COMPANY:
TRIANGLE PHARMACEUTICALS, INC.
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇
--------------------------------------
Name:
Title:
[SIGNATURE PAGE TO CS-92 LICENSE AGREEMENT]
53
APPENDIX "A"
CS92 PATENT PORTFOLIO
--------------------------------------------------------------------------------
Docket No. Country Serial No. Filed Patent No. Grant Date
--------------------------------------------------------------------------------
UGA443 U.S. 07/362,756 06/07/89 5,084,445 01/28/92
--------------------------------------------------------------------------------
UGA443CIP U.S. 07/534,523 06/06/90 5,077,279 12/31/91
--------------------------------------------------------------------------------
Europe 90911253.4 06/06/90
--------------------------------------------------------------------------------
Japan 2-510715 06/06/90
--------------------------------------------------------------------------------
APPENDIX "B"
(page 1 of 2)
LICENSE TO THE UNITED STATES GOVERNMENT
This instrument confers to the United States Government, as represented by
the Department of Health and Human Services, a nonexclusive, nontransferable,
irrevocable, paid-up license to practice or have practiced on its behalf
throughout the world the following subject invention. This license will
extend to all divisions or continuations of the patent application and all
patents or reissues which may be granted thereon:
Invention Title: [ * ]
Inventors: ▇▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ (▇▇▇▇▇ University)
▇▇. ▇▇▇▇▇ ▇. ▇▇▇ (University of Georgia)
Patent Application
Serial No.: [ * ]
Filing Date: [ * ]
Title:
Country, if other than the United States:
This subject invention was conceived or first actually reduced to practice in
performance of a government-funded project, National Institutes of Health
Grant/Contract [ * ]. Principal rights to this subject invention have
been left with the Licensor, Emory University, subject to the provisions of 37
CFR 401 and 45 CFR 8.
Signed: /s/ ▇▇▇ ▇. ▇▇▇▇▇▇▇ Date: 5/18/92
---------------------------------- ---------------------
Typed Name: ▇▇▇ ▇. ▇▇▇▇▇▇▇, Ph.D.
Title: Associate Vice President for Research
Accepted on behalf of Government:
Date:
---------------------------------------- ---------------------
* CONFIDENTIAL TREATMENT REQUESTED
APPENDIX "B"
(page 2 of 2)
LICENSE TO THE UNITED STATES GOVERNMENT
This instrument confers to the United States Government, as represented by the
Department of Health and Human Services, a nonexclusive, nontransferable,
irrevocable, paid-up license to practice or have practiced on its behalf
throughout the world the following subject inventio. This license will extend
to all divisions or continuations of the patent application and all patents or
reissues which may be granted thereon:
Invention Title: [ * ]
Inventors: ▇▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ (▇▇▇▇▇ University)
▇▇. ▇▇▇▇▇ ▇. ▇▇▇ (University of Georgia)
Patent Application
Serial No.: [ * ]
Filing Date: [ * ]
Title:
Country, if other than the United States:
This subject invention was conceived or first actually reduced to practice in
performance of a government-funded project, Natioal Institutes of Health
Grant/Contract [ * ]. Principal rights to this subject invention have
been left with the Licensor, Emory University, subject to the provisions of 37
CFR 401 and 45 CFR 8.
Signed: /s/ ▇▇▇ ▇. ▇▇▇▇▇▇▇ Date: 5/18/92
---------------------------------- ---------------------
Typed Name: ▇▇▇ ▇. ▇▇▇▇▇▇▇, Ph.D.
Title: Associate Vice President for Research
Accepted on behalf of Government:
Date:
---------------------------------------- ---------------------
* CONFIDENTIAL TREATMENT REQUESTED