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EXHIBIT 10.19
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 "Xxxx"). This Exhibit has been
filed separately with the Secretary of the Commission without the Xxxx
pursuant to the Company's Application Requesting Confidential Treatment under
Rule 406 under the Securities Act.
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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 . . . . . . . . . . . . . . . . . . . . . 23
ARTICLE 5. PAYMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
ARTICLE 6. DEVELOPMENT AND MARKETING PROGRAM. . . . . . . . . . . . . . . . 27
ARTICLE 7. PATENT PROSECUTION . . . . . . . . . . . . . . . . . . . . . . . 31
ARTICLE 8. INFRINGEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . 34
ARTICLE 9. WARRANTIES; EXCLUSION OF WARRANTIES;
AND INDEMNIFICATION . . . . . . . . . . . . . 36
ARTICLE 10. CONFIDENTIALITY . . . . . . . . . . . . . . . . . . . . . . . . 41
ARTICLE 11. TERM AND TERMINATION. . . . . . . . . . . . . . . . . . . . . . 43
ARTICLE 12. ASSIGNMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . 47
ARTICLE 13. TRANSFER OF LICENSED TECHNOLOGY . . . . . . . . . . . . . . . . 48
ARTICLE 14. REGISTRATION OF LICENSE . . . . . . . . . . . . . . . . . . . . 48
ARTICLE 15. NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE
COMPETITION AND PATENT TERM RESTORATION ACT . . . . . . . 48
ARTICLE 16. MISCELLANEOUS . . . . . . . . . . . . . . . . . . . . . . . . . 50
ARTICLE 17. NOTICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
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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 0000 Xxxxx Xxxxxx Xxxx, X.X., Xxxxxxx, Xxxxxxx 00000, (hereinafter
referred to as "EMORY"), the University of Georgia Research Foundation, Inc., a
Georgia nonprofit corporation with offices at 000 Xxxx Xxxxxxxx Xxxxxxx
Xxxxxxxx, Xxxxxx, XX 00000-0000 (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 0 Xxxxxxxxxx Xxxxx, 0000 Xxxxxxxxxx Xxxxx, Xxxxxx, XX 00000
(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, Xxxxxxx X. Xxxxxxxx, an employee of EMORY, and X. X. Xxx, 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) and hepatitis B virus (HBV).
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 B-D-Dioxolanyl purines
of the formula [CHART] wherein R is OH, CI, NH(2), or H, and X is
H, alkyl, acyl, monophosphate, diphosphate or triphosphate,
including all 5(1) and N(6) acylated and alkylated derivatives,
salts, esters, racernic mixtures and purified enantiomers thereof.
Notwithstanding the scope of this definition, neither LICENSOR
represents that it shall obtain valid patent claims to any such
compositions and
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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 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
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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.
1.13 "LICENSORS" shall mean Emory University and the University of
Georgia Research Foundation, Inc. "LICENSOR" means 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.
1.16 "Net Selling Price" of Licensed Products which contain as their
active ingredients both Licensed Compounds and compounds other than Licensed
Compounds (a
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"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
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Compounds in such Combination Product and the denominator of which is the number
of all active ingredients in such Combination Product.
1.17 "Phase II Commencement Date" shall mean the date of commencement
of the initial well-controlled clinical trial of a Licensed Product for HIV
or HBV, as applicable, 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" in respect of [HIV] shall mean the
earlier of (a) [ * ] days after completion of the statistical analyses of
those Phase II clinical studies which COMPANY considers reasonably necessary
for purposes of inclusion in an NDA for the applicable indication; or (b)
[ * ] after the last administration of a
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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. "Phase II Completion Date" in respect of
[ * ] means the first to occur of the periods specified in clauses (a) or (c)
above. 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.
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;
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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."
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.
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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
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 One Hundred
Fifty Thousand (150,000) 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.
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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.
Event Milestone Payment
----- -----------------
[ * ] [ * ]
3.3 LICENSE MAINTENANCE FEES.
(a) 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
----------- -----------------------
[ * ] [ * ]
(b) In the event no [ * ] has been paid pursuant to Subsection
3.2(c), 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:
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Anniversary License Maintenance Fee
----------- -----------------------
[ * ] [ * ]
The total amount of License Maintenance Fee payments made by COMPANY to
LICENSORS for the [ * ] indication shall be credited against the first
Milestone Payment for such indication.
3.4 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
for [ * ] indications:
(a) PERCENTAGE OF NET SELLING PRICE CUMULATIVE NET SELLING PRICE OF LICENSED
PRODUCTS FOR [ * ]
[ * ] [ * ]
(b) PERCENTAGE OF NET SELLING PRICE CUMULATIVE NET SELLING PRICE OF LICENSED
PRODUCTS FOR [ * ]
[ * ] [ * ]
(c) DURATION; REDUCTION. Royalties (at the rates set forth in 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 Licensed Patents. If, during
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such [ * ], 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).
(d) 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(c) for any royalty period, it or its
sublicensees shall submit the sales report of IMS or such other independent
firm, as
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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 (c), in the event that COMPANY's
total annual royalty payment to LICENSORS pursuant to Subsection 3.4(a) 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 Subsection 3.4(a)
above:
Calendar Year Annual Minimum
------------- --------------
[ * ] [ * ]
(b) Subject to Subsection 3.5 (c), in the event that COMPANY's
total annual royalty payment to LICENSORS pursuant to Subsection 3.4(b) above
during the [ * ] calendar
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year following the year during which the first FDA Registration is granted
for a Licensed Product covered by Subsection 3.4(b) 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
Subsection 3.4(b) above:
Calendar Year Annual Minimum
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[ * ] [ * ]
(c) If during a given year, the sum of royalty payments paid
hereunder for all Licensed Products described in Subsections 3.4(a) and
3.4(b) of this Agreement exceed the sum of the applicable Annual Minimums
which are required to be paid for such year pursuant to Subsections 3.5(a)
and 3.5(b), COMPANY shall be deemed to have satisfied the requirements of
each of Subsections 3.5(a) and 3.5(b) for such year. 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.
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(d) 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 (whether paid pursuant to Section 3.4 or 3.5). 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
(b) Expenses incurred by LICENSORS in preparing this Agreement,
not to exceed [ * ].
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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 [ * ] or [ * ] in excess of those set forth in Section 3.2; [ * ] means
[ * ] (such as [ * ]) made by [ * ] to COMPANY
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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 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 reasonable period of time,
COMPANY shall select an independent certified public accountant, to which
LICENSORS have
* CONFIDENTIAL TREATMENT REQUESTED
19
DAPD
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 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
* CONFIDENTIAL TREATMENT REQUESTED
20
DAPD
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 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
* CONFIDENTIAL TREATMENT REQUESTED
21
DAPD
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
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DAPD
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:
(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
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DAPD
(g) the basis for any credits taken against Annual Minimum
payments in accordance with Subsection 3.5 (d), 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.
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 shows any underpayment of royalties by COMPANY, its
Affiliates or sublicensees, within thirty
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DAPD
(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 [ * ]
shall be made by wire transfer to an account or accounts of LICENSORS
* CONFIDENTIAL TREATMENT REQUESTED
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DAPD
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.
* CONFIDENTIAL TREATMENT REQUESTED
26
DAPD
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 for
[ * ] (the "First Indication") to occur by the [ * ] anniversary of the date
of this Agreement; and (ii) files an NDA for a Licensed Product for
the First Indication by the [ * ] anniversary of the date of this Agreement;
and (iii) causes the Phase II Commencement Date with respect to [ * ] (the
"Second Indication") to occur by the [ * ] anniversary of the date of this
Agreement; and (iv) files the NDA for a Licensed Product for the Second
Indication by the
* CONFIDENTIAL TREATMENT REQUESTED
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DAPD
[ * ] anniversary of the date of this Agreement; and (v) diligently pursues
such Registrations for both indications; and (vi) 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 for [ * ] by paying to LICENSORS [ * ] 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 [ * ] 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.
* CONFIDENTIAL TREATMENT REQUESTED
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DAPD
(b) In the event COMPANY fails to meet any diligence requirement
set forth herein in respect of a Licensed Product for a given indication,
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 for such indication, (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 for such indication, or (iii) 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 for such indication.
(c) Upon exercise by LICENSORS of any portion of their rights
under the preceding Subsection with respect to a given indication, 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 for such
indication. 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 for such indication
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
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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 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.
* CONFIDENTIAL TREATMENT REQUESTED
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DAPD
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 being referred to as "Patent Prosecution 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
* CONFIDENTIAL TREATMENT REQUESTED
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DAPD
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 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
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DAPD
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 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 such Patent Prosecution Activities, LICENSORS
shall be free at their sole expense, to continue or discontinue any or all
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DAPD
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.
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
* CONFIDENTIAL TREATMENT REQUESTED
34
DAPD
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' RIGHT 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.
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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.
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DAPD
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.
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
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DAPD
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.
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.
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DAPD
(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 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.
* CONFIDENTIAL TREATMENT REQUESTED
39
DAPD
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.
(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.
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DAPD
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
(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.
* CONFIDENTIAL TREATMENT REQUESTED
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DAPD
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.
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 of this Agreement,
41
DAPD
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.
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
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DAPD
(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
(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
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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 either or both indications in 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
45
DAPD
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 fide interest in
licensing such technology. Such data shall be provided on a confidential
46
DAPD
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' 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
47
DAPD
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 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,
48
DAPD
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 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
49
DAPD
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.
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
50
DAPD
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.
16.5 PATENT MARKING. COMPANY shall xxxx 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
51
DAPD
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.
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
52
DAPD
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 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.
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DAPD
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
0000 Xxxxxxxxx Xxxxx
Xxxxxxx, Xxxxxxx 00000
Attention: Xxxxxxx Xx Xxxxx
University of Georgia Research Foundation, Inc.
000 Xxxx Xxxxxxxx Xxxxxxx Xxxxxxxx
Xxxxxx, XX 00000-0000
Attention: Xxxx Xxxxx
To COMPANY: TRIANGLE PHARMACEUTICALS INC.
0 Xxxxxxxxxx Xxxxx
0000 Xxxxxxxxxx Xxxxx
Xxxxxx, XX 00000
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
54
DAPD
manner shall be deemed to have been given when such acknowledgment has been
transmitted.
[REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK]
55
DAPD
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/Xxxx Xxxxxx
-----------------------------------------------
Xxxx Xxxxxx
Executive Vice President
UNIVERSITY OF GEORGIA RESEARCH
FOUNDATION, INC.
By:/s/Xxx X. Key
-----------------------------------------------
Xxx X. Key
Executive Vice President
COMPANY:
TRIANGLE PHARMACEUTICALS, INC.
By:/s/Xxxxx X. Xxxxx
-----------------------------------------------
Name:
Title:
[SIGNATURE PAGE TO DAPD LICENSE AGREEMENT]
125-194472 (3/22/96)
56
DAPD PATENT PORTFOLIO
--------------------------------------------------------------------------------
Docket No. Country Serial No. Filed Patent No. Grant Date
EMU113 U.S. 07/967,460 10/28/92 5,444,063 08/22/95
Taiwan 82108587 10/16/93
China 93120708.8 10/28/93
Europe 94900424.6 10/28/93
Japan 511314/1994 10/28/93
Canada 2147893 10/28/93
Australia 55419/94 10/28/93
Vietnam S-1202/95 10/28/93
Korea 95-701648 10/28/93
Russia 95110698.14 10/28/93
EMU113DIV [ * ] [ * ] [ * ]
UGA390 U.S. 07/622,762 12/5/90 5,179,104 01/12/93
Australia 91475/91 12/5/91
Canada 2099589 12/5/91
Europe 92902800.9 00/0/00
Xxxxx 4-502956 12/5/91
UGA390CIP [ * ] [ * ] [ * ]
(UGA447) Australia 50933/93 08/25/93
Canada 2143107 08/25/93
Europe 93920366.7 08/25/93
Japan 506616/1994 08/25/93
UGA447DIV [ * ] [ * ] [ * ]
--------------------------------------------------------------------------------
* CONFIDENTIAL TREATMENT REQUESTED
APPENDIX "B"
(Page 1 of 3)
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 divisionals or continuations of the patent application and all patents or
reissues which may be granted thereon.
Invention Title: [ * ]
Inventors: Xx. Xxxxxxx Xxxxxxxx
Patent Application
Serial No.: [ * ]
Filing Date: [ * ]
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/Xxx X. Xxxxxxx Date: 6/2/93
------------------------------------- -----------------
Typed Name: Xxx X. Xxxxxxx, Ph.D.
Title: Associate Vice President for Research
Accepted on behalf of Government:
____________________________________________ Date: _________________
* CONFIDENTIAL TREATMENT REQUESTED
APPENDIX "B"
page 2 of 3
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 divisionals or continuations of the patent application and all patents or
reissues which may be granted thereon:
Invention Title: [ * ]
Inventors: Xx. Xxxxx X. Xxx
Xx. Xxxxxxx Xxxxxxxx
Patent Application
Serial No.: [ * ]
Filing Date: [ * ]
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, Xxxxx University, subject to the provisions of 37 CFR
401 and 45 CFR 8.
Signed: /s/Xxx X. Xxxxxxx Date: 6/2/93
-------------------------------------- --------------
Typed Name: Xxx X. Xxxxxxx, Ph.D.
Title: Associate Vice President for Research
Accepted on behalf of Government:
______________________________________________ Date: ______________
APPENDIX "B"
page 3 of 3
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 divisionals or continuations of the patent application and all patents or
reissues which may be granted thereon:
Invention Title: [ * ]
Inventors: Xx. Xxxxx X. Xxx
Xx. Xxxxxxx Xxxxxxxx
Patent Application
Serial No.: [ * ]
Filing Date: [ * ]
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/Xxx X. Xxxxxxx Date: 6/4/93
------------------------------------------- -------------
Typed Name: Xxx X. Xxxxxxx, Ph.D.
Title: Associate Vice President for Research
Accepted on behalf of Government:
___________________________________________________ Date: _____________
