EXHIBIT 10.8
LICENSE AGREEMENT
between
EMORY UNIVERSITY
and
PHARMASSET, LTD.
(License of
D-D4FC)
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets and asterisks [***], have
been separately filed with the Commission.
TABLE OF CONTENTS
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Page
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ARTICLE 1. DEFINITIONS
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3
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ARTICLE 2. GRANT OF LICENSE
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8
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ARTICLE 3. DILIGENCE AND
COMMERCIALIZATION
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13
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ARTICLE 4. CONSIDERATION FOR LICENSE
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14
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ARTICLE 5. REPORTS AND PAYMENTS
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16
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ARTICLE 6. RECORDS
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18
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ARTICLE 7. PATENT PROSECUTION
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19
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ARTICLE 8. ABATEMENT OF INFRINGEMENT
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23
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ARTICLE 9. CONFIDENTIALITY
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ARTICLE 10. LIMITED WARRANTY, MERCHANTABILITY
AND EXCLUSION OF WARRANTIES
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ARTICLE 11. DAMAGES, INDEMNIFICATION, AND
INSURANCE
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26
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ARTICLE 12. TERM AND TERMINATION
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28
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ARTICLE 13. ASSIGNMENT
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31
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ARTICLE 14. ARBITRATION
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31
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ARTICLE 15. MISCELLANEOUS
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32
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ARTICLE 16. NOTICES
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34
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EXHIBIT A LICENSED PATENTS (D-D4FC)
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EXHIBIT B LICENSEE’S DEVELOPMENT
PLAN
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EXHIBIT C U.S. GOVERNMENT LICENSES
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EXHIBIT D STOCK PURCHASE AGREEMENT
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THIS LICENSE AGREEMENT is made and
entered into as of this 30th day of December, 1998, by and between
EMORY UNIVERSITY, a Georgia non-profit corporation with principal
offices located at 1380 South Oxford Road, Atlanta, Georgia 30322
(hereinafter “EMORY”), and PHARMASSET, LTD., a Barbados
corporation with corporate headquarters located at 1795 Peachtree
Road, N.E., Suite 350, Atlanta, Georgia 30309-2339 (hereinafter
“LICENSEE”).
WITNESSETH
:
WHEREAS, EMORY, subject to any
rights held by the United States Government, is the assignee of all
right, title, and interest in inventions developed by employees of
EMORY and is responsible for the protection and commercial
development of such inventions; and
WHEREAS, Raymond F. Schinazi, Ph.D.
and Dennis Liotta, Ph.D. did, during their course of employment
with Emory University, develop certain inventions claimed in the
issued patents and patent applications identified in Exhibit A of
this Agreement; and
WHEREAS, LICENSEE represents that
it, either directly or through its Affiliates or sublicensees, has
the necessary expertise and resources to fully develop and
commercialize the inventions; and
WHEREAS, LICENSEE wishes to obtain
certain rights to pursue the development and commercialization of
the inventions; and
WHEREAS, EMORY wishes to grant
LICENSEE such rights in accordance with the terms and conditions of
this Agreement.
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, partnership or other business entity which is
directly or indirectly controlled by LICENSEE or any entity which
directly or indirectly controls LICENSEE. “Controls” as
used herein means owns directly or indirectly at least thirty
percent (30%) of the outstanding voting shares or, in the
absence of such ownership or in the case of a non-corporate entity
or a non-profit corporation, possession, directly or indirectly, of
the power to materially influence the direction of the management
and policies of such corporation or non-corporate
entity.
3
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets and asterisks [***], have
been separately filed with the Commission.
1.2 “Agreement” or
“License Agreement” shall mean this Agreement,
including all Exhibits attached to this Agreement.
1.3 “Effective Date”
shall mean the later of (i) the date on which EMORY executes
this Agreement, or (ii) the date on which LICENSEE executes
this Agreement.
1.4 “EMORY Inventors”
shall mean Raymond F. Schinazi, Ph.D., and Dennis Liotta,
Ph.D.
1.5 “Field of Use” shall
mean all medical applications and uses, including all
pharmaceutical, therapeutic and diagnostic imaging applications and
uses, of the Licensed Compounds.
1.6 “Indemnitees” shall
mean EMORY, its trustees, employees, students, and their heirs,
executors, administrators, successors and legal
representatives.
1.7 “License Agreement
Year” shall mean the period from the Effective Date of this
Agreement through the following one-year period of each year during
the term of this Agreement.
1.8 “Licensed Compounds”
shall mean B-D-2’, 3’-DIDEOXY-2’,
3’-DIDEHYDRO-5-FLUOROCYTIDINE sometimes referred to as D-D4FC
or D5FC and the [***] of D-D4FC, and any salts, esters and [***]
derivatives thereof and [***] pro-drugs.
1.9 “Licensed Patents”
shall mean the patent applications and patents identified in
EXHIBIT A hereof, together with all divisionals, continuations,
reissues, reexaminations and foreign counterparts of such
applications or patents.
1.10 “Licensed
Product(s)” shall mean any process, service, or product, the
manufacture, use, or sale of which is covered by a Valid Claim or
incorporates or uses any Licensed Technology.
4
1.11 “Licensed
Technology” shall mean all Licensed Compounds, designs,
technical information, know-how, knowledge, data, specifications,
test results and other information, whether or not patented, which
is known to the EMORY Inventors on the date of this Agreement and
is useful for the manufacture, use or sale of any Licensed
Product.
1.12 “Licensed
Territory” shall mean the world.
1.13 “LICENSEE’s
Development Plan” shall mean EXHIBIT B of this
Agreement.
1.14 “Net Selling Price”
of Licensed Products shall mean the gross invoiced price paid to
LICENSEE, its Affiliates, or sublicensees by a purchaser of a
Licensed Product less the following discounts: a) customary trade,
quantity and cash discounts actually allowed and taken; b) credits
actually given for rejected or returned Licensed Products; c)
freight and insurance costs, if separately itemized on the invoice
paid by the customer; d) custom and excise taxes included in the
invoiced amount, and e) to the extent separately stated on purchase
orders, invoices or other documents of Sale, all taxes including
VAT, and sales or similar taxes. 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 paid to
LICENSEE in consideration of Sales of the same quantity of Licensed
Products during the six (6) month period immediately preceding
such Sale, without reduction of any kind (other than as provided
for in a) - d) above). If no Sales of Licensed Products have
occurred in the preceding six (6) months, then sales of
comparable products shall be used in such determination.
5
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets and asterisks [***], have
been separately filed with the Commission.
“Net Selling Price” with
respect to any Combination Product (a Licensed Product
incorporating additional active ingredients) 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 definition within a reasonable period
of time, Net Selling Price with respect to such Combination Product
shall mean the gross selling price of such Product paid by
independent customers, less all the allowances, adjustments,
reductions, discounts, taxes, duties, rebates or other charges
referred to in the above definition of Net Selling Price multiplied
by a fraction, the numerator of which shall be the average invoice
price per gram of compound contained in the most comparable stock
keeping unit of a Licensed Product having the compound as the sole
active ingredient during the applicable royalty period in a country
of the Licensed Territory, when such comparable Licensed 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 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 a
compound or for one or more of the active ingredients comprising a
Combination Product, Net Selling Price with respect to such
Combination Product shall be deemed to be [***] Percent ([***]%) of
the gross Sales price of such Combination Product paid by
independent customers, less all the allowances, adjustments,
reductions, discounts, taxes, duties, rebates or other charges
referred to in the above definition of Net Selling
Price.
1.15 “Major Market”
shall mean the following countries: United States, Great Britain,
France, Spain, Italy, Germany and Japan.
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1.16 “NDA” shall mean
new drug application relating to Licensed Patents and Licensed
Technology.
1.17 “IND” shall mean
investigational new drug application relating to Licensed Patents
and Licensed Technology.
1.18 “Registration”
shall mean the approval to market or sell any Licensed Compound by
the United States Food and Drug Administration (FDA) or any
successor, agency or authority with similar approval
powers.
1.19 “Sale” or
“Sold” shall mean the sale, transfer, exchange, or
other disposition of Licensed Products whether by gift or
otherwise, including, but not limited to, the use of Licensed
Products by any person authorized by LICENSEE other than LICENSEE.
None of: (a) the provision of Licensed Products, prior to the
approval of Licensed Products in a country and pursuant to a
requirement issued by the appropriate governmental agency in that
country, for consumption by or administration to persons for
humanitarian purposes or compassionate use, (b) the provision
of Licensed Products for use in clinical trials, nor (c) the
provision of samples in reasonable quantities without charge for
promotional purposes shall be deemed Sales for the purposes of this
Agreement. 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; (d) if deemed Sold by use, when first put to such
use; or (e) if otherwise transferred, exchanged, or disposed
of whether by gift or otherwise when such transfer, exchange, gift,
or other disposition occurs.
7
1.20 “U.S. Government
Licenses” shall mean the non-exclusive licenses to the U.S.
Government or agencies thereof, copies of which licenses are
attached hereto as EXHIBIT “C”.
1.21 “Valid Claim” shall
mean a claim included among the Licensed Patents so long as such
claim shall not have been irrevocably abandoned or held invalid in
an unappealable decision of a court or other authority of competent
jurisdiction.
ARTICLE 2. GRANT OF
LICENSE
2.1 License . EMORY hereby
grants LICENSEE an exclusive right and license under the Licensed
Patents to make, have made, use, import, offer for Sale, and Sell
Licensed Products and to practice Licensed Technology for the Field
of Use in the Licensed Territory during the term of this Agreement.
If any Affiliate exercises any rights granted by EMORY hereunder,
LICENSEE shall remain primarily liable to EMORY for the duties and
obligations of any Affiliate hereunder, and any breach hereof by an
Affiliate is deemed to be a breach by LICENSEE of this Agreement.
Except for the right to grant sublicenses under Article 2.3 (as
qualified by Articles 2.4 through 2.9), no other rights or licenses
are granted.
2.2 Retained License . EMORY
retains on behalf of itself, and any research collaborators, a
royalty-free right and license to make and use Licensed Products
and to practice Licensed Technology for research and educational
purposes only.
2.3 Sublicenses . Provided
that written approval of EMORY is obtained in advance, which
approval shall not be unreasonably withheld, (provided that if the
approval of EMORY is withheld solely on the basis of the fact that
the financial obligations of the sublicensee under the sublicense
would be materially less favorable to EMORY than those of LICENSEE
hereunder, such withholding of approval shall not be deemed to be
unreasonable), LICENSEE shall have the right to grant sublicenses
(including further sublicenses thereunder), consistent with this
Agreement (the parties acknowledging that such sublicenses may,
subject to EMORY’s right to
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consent, contain provisions which differ from
this Agreement (e.g. the definition of “Net Selling
Price” in respect of Combination Products may be cast in
terms of selling price per unit other than weight). If EMORY has
not responded to LICENSEE within ten (10) business days after
receipt of a proposed sublicense agreement, it will be assumed to
be approved.
2.4 Sublicensee Performance .
EMORY agrees that any sublicensee’s performance of its
diligence obligations as set forth in the sublicense agreement
shall be deemed to be performance by LICENSEE of any of its
diligence obligations under the License Agreement, including, but
not limited to, those set forth in Article 3 hereof. LICENSEE
further agrees to attach redacted copies of pertinent portions of
this Agreement to sublicense agreements.
2.5 Sublicense Restrictions .
The right to sublicense granted to LICENSEE under Article 2.3 is
subject to the following conditions:
2.5.1 Within thirty (30) days
after LICENSEE enters into any sublicense, LICENSEE must deliver to
EMORY a complete copy of the sublicense written in the English
language.
2.5.2 In the event of a termination
hereof under Article 12.2, all payments then or thereafter due to
LICENSEE from each of its sublicensees shall, upon notice from
EMORY to any such sublicensee, become owed directly to EMORY for
the account of LICENSEE; provided that EMORY shall remit to
LICENSEE the amount by which such payments in the aggregate exceed
the total amount owed by LICENSEE to EMORY.
2.5.3 Even if LICENSEE enters into
sublicenses, LICENSEE shall remain primarily liable to EMORY for
all of LICENSEE’s duties and obligations contained in this
Agreement, and in the event of any act or omission of a sublicensee
that would be a breach of its sublicense, LICENSEE shall be liable
for the performance of its duties and obligations under this
Agreement in respect of those matters as to which such breach by
sublicensee has occurred.
9
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets and asterisks [***], have
been separately filed with the Commission.
2.6 Form of Sublicensee
Payments . Except as provided for in Article 2.8, LICENSEE
shall not receive from sublicensees anything of value in lieu of
cash payments in consideration for any sublicense under this
Agreement without the prior written permission of EMORY.
2.7 Delivery of Sublicense
Agreements . LICENSEE agrees to forward to EMORY a copy of any
and all sublicense agreements promptly upon execution by the
parties, which disclosure shall be subject to Section 9.1
hereof.
2.8 Sharing of Sublicensee
Payments . LICENSEE and EMORY agree to share cash actually
received from sublicensing Licensed Patents and Licensed Technology
in the following manner:
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EMORY
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LICENSEE
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Running royalties received from
sublicensee(s)
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[***]
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%
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[***]
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%
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Cash or the
cash value of other valuable consideration received from sublicense
issue fees, milestone payments, or other fees other than royalties
[excluding only (i) funds actually received for use by LICENSEE
solely for the pre-clinical or clinical development of any Licensed
Compound and (ii) additional equity investments in LICENSEE up
to [***]].
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[***]
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%
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[***]
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%
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10
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets and asterisks [***], have
been separately filed with the Commission.
2.9 Taxes . LICENSEE further
agrees that all sublicenses shall contain an agreement
substantially similar to Article 5.2 of this Agreement. If a
sublicensee shall fail to comply with such provision (or the
sublicense does not provide for such provision), then EMORY’s
percentage, as determined in Article 2.8, shall be adjusted so that
EMORY shall receive an amount equal to [***] Percent ([***]%) of
the royalty, as calculated without reduction for Taxes withheld or
due to be withheld on the payment.
2.10 Sublicense Royalty Floor
. LICENSEE agrees that payments to EMORY in respect of royalties
received by LICENSEE from any sublicensee shall not be less than
[***] percent ([***]%) of the Net Selling Price of all Licensed
Products Sold by the sublicensee.
2.11 Milestone Payment .
LICENSEE shall pay EMORY as additional partial consideration, a
Marketing Milestone of [***] ($[***]) Dollars provided that
notwithstanding anything to the contrary contained herein, such
Marketing Milestone shall be payable only if Licensee performs all
development, commercialization, marketing and sales activities
itself and not through any sublicensee. Subject to the foregoing
sentence, the Marketing Milestone shall be payable as follows: on
each [***] ($[***]) Dollars in Net Sales (up to a cumulative total
of [***] ($[***]) Dollars) in Net Sales within the Licensed
Territory, a Marketing Milestone Payment of [***] ($[***]) Dollars
will be due (up to an aggregate of [***] ($[***]) Dollars). Upon
payment of the final [***] ($[***]) Dollars in respect of the first
[***] ($[***]) Dollars in cumulative Net Sales within the Licensed
Territory, the Marketing Milestone Payment obligation shall
terminate. Each Marketing Milestone Payment shall be due at the
same time the royalty report covering the royalty period in which
such incremental [***] ($[***]) Dollars in Net Sales has been
achieved, is due.
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2.12 No Implied License . The
license and right granted in this Agreement shall not be construed
to confer any rights upon LICENSEE by implication, estoppel, or
otherwise as to any technology not specifically identified in this
Agreement as Licensed Patents or Licensed Technology.
2.13 Government Rights . The
Licensed Patents, Licensed Technology, or portions thereof were
developed with financial or other assistance through grants or
contracts funded by the United States government. LICENSEE
acknowledges that in accordance with Public Law 96-517 and other
statutes, regulations, and Executive Orders as now exist or may be
amended or enacted and the U.S. Government Licenses, the United
States government has certain rights in the Licensed Patents and
Licensed Technology. LICENSEE shall take all action necessary to
enable EMORY to satisfy its obligations under any federal law
relating to the Licensed Patents or Licensed Technology. If the
United States government should take action which renders it
impossible or impractical for EMORY to grant the rights and license
granted herein to LICENSEE under this Agreement or otherwise
perform EMORY’s obligations under this Agreement, EMORY or
LICENSEE may terminate this Agreement immediately by notice to the
other party. LICENSEE shall not have any right to the return of any
payments of any kind made by it to EMORY prior to the date of
termination.
2.14 Cooperation . During the
term of this License Agreement, EMORY shall, at LICENSEE’s
expense, fully cooperate with LICENSEE in dealing with any persons
or entities who may have been previously granted any rights,
including manufacturing rights, in respect to any Licensed Patents,
Licensed Products or Licensed Technology (all as defined in this
License Agreement) including visits to the facilities of any such
persons and entities if deemed advisable by EMORY.
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2.15 Access to Materials .
During the term of this License Agreement, EMORY shall provide
LICENSEE with full access upon reasonable notice to all documents
and samples, including reagents, which may be in the possession or
control of EMORY relating to both the Licensed Patents and Licensed
Technology provided to LICENSEE hereunder and shall, within a
reasonable period, provide LICENSEE with a true and complete list
thereof.
2.16 Cooperation in Regulatory
Activities . During the term of this License Agreement, EMORY
shall cooperate fully with LICENSEE in respect of LICENSEE’s
pursuit of all regulatory approvals to market and sell any Licensed
Compound, provided that all such activities shall be undertaken at
the sole expense of LICENSEE.
2.17 U.S. Manufacture .
LICENSEE, either directly or through Affiliates or sublicensees,
agrees to use its best efforts to manufacture Licensed Products for
United States Sales substantially in the United States.
ARTICLE 3. DILIGENCE AND
COMMERCIALIZATION
3.1 Diligence and
Commercialization . LICENSEE shall use its reasonable best
efforts, either directly or through Affiliates or sublicensees,
throughout the term of this Agreement to comply with
LICENSEE’s Development Plan and to bring Licensed Products to
market in accordance with LICENSEE-Development Plan through a
thorough, vigorous, and diligent program for exploitation of the
right and license granted in this Agreement to LICENSEE and to
create, supply, and service in the Licensed Territory as extensive
a market as possible. In no instance shall LICENSEE’s
reasonable best efforts be less than efforts customary in
LICENSEE’s industry.
3.2 Lack of Diligence . If
EMORY concludes that LICENSEE is not diligent in development or
Sales of Licensed Products pursuant to Article 3.1 for any reason
other than a) the withholding by a regulatory agency of marketing
approval despite LICENSEE’s diligent
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Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets and asterisks [***], have
been separately filed with the Commission.
effort to obtain such approval; or b)
unanticipated technical or scientific problems which have been
promptly reported to EMORY in writing; or c) other causes beyond
the reasonable control of LICENSEE which have been promptly
reported to EMORY in writing; then EMORY may give notice to
LICENSEE stating the basis for its conclusion and, upon the request
of EMORY, LICENSEE shall show cause why the license granted
hereunder should not be terminated. If within ninety (90) days
after LICENSEE’s receipt of said notice, the parties have not
resolved the matter through good faith negotiations in a mutually
acceptable manner, the parties shall submit the dispute to
arbitration under the provisions of Article 14 of this
Agreement.
ARTICLE 4. CONSIDERATION FOR
LICENSE
4.1 Purchased Shares . In
partial consideration for the license granted to LICENSEE under
this Agreement, LICENSEE shall issue to EMORY such number of shares
(the “Purchased Shares”) of LICENSEE’s Common
Stock, no par value (“Common Stock”), as will cause
EMORY to own shares of Common Stock representing [***] percent
([***]%) (in addition to any percentage owned at the date hereof by
virtue of any other extant license agreement between EMORY and
LICENSEE) of the outstanding shares of the capital stock of
LICENSEE on a fully diluted basis, assuming the exercise,
conversion and/or exchange of all outstanding securities of
LICENSEE for or into shares of Common Stock, all on the terms and
conditions as set forth in the stock purchase agreement between
LICENSEE and EMORY (“Stock Purchase Agreement”), a copy
of which is attached as Exhibit D.
4.2 Antidilution . In partial
consideration for the license granted to LICENSEE under this
Agreement, and until LICENSEE has received [***] ($[***]) cash in
equity financing, prior to (and excluding) the initial underwritten
public offering for cash of LICENSEE’s equity securities.
LICENSEE shall issue to EMORY, for no additional consideration,
from time to time, such number of additional shares of Common Stock
(collectively, the “Additional
14
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets and asterisks [***], have
been separately filed with the Commission.
Purchased Shares”) as will cause EMORY to
continue to hold shares of Common Stock representing such
additional [***] percent ([***]%) of the outstanding capital stock
of LICENSEE (referenced in Section 4.1 hereof) on a fully
diluted basis, assuming the exercise, conversion and/or exchange of
all outstanding securities of LICENSEE for or into shares of Common
Stock.
4.3 Royalties . As partial
consideration for the license granted to LICENSEE under this
Agreement, LICENSEE or Affiliates which are not also sublicensees,
shall pay EMORY a royalty equal to [***] percent ([***]%) of the
Net Selling Price of all Licensed Products Sold by LICENSEE or such
Affiliates during the term of this Agreement. Royalties shall be
due and payable on a semi-annual basis on December 31 and
June 30 of each year.
4.4 Minimum Royalties .
LICENSEE shall pay annual minimum royalties to EMORY in accordance
with the following schedule:
Year after NDA Registration in
the First Major Market
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2
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$
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[***]
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3
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$
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[***]
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4
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$
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[***]
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5
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$
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[***]
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6 and thereafter
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$
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[***]
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If the actual royalties due under
Article 4.3 in any year are greater than the minimum royalty
payment due for that year, the minimum royalty will be credited
against actual royalties due in that year.
If the minimum royalties due in any
year are greater than the actual royalties due for that year, the
difference shall become a future credit against [***] percent
([***]%) of each earned royalty payment which LICENSEE would be
required to pay pursuant to Article 4.3 hereof until the entire
credit is exhausted. In no event shall LICENSEE make a payment less
than the minimum royalty due in that year.
15
Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets and asterisks [***], have
been separately filed with the Commission.
Minimum royalties shall be paid for
a period of [***] ([***]) years after NDA registration in the first
Major Market. After such [***] ([***]) year period, minimum
royalties shall be paid only so long as the manufacture, use, offer
for Sale, Sale or importation of Licensed Products in the Licensed
Territory would, in the absence of this license, infringe a Valid
Claim.
4.5 Reimbursement for Patent
Expenses . LICENSEE shall reimburse EMORY for all reasonable
external out-of-pocket fees, costs, and expenses heretofore and
hereafter during the term of this Agreement paid or incurred by
EMORY in filing, prosecuting, and maintaining the Licensed Patents
in the Licensed Territory (excluding any currently pending legal
proceedings), which expenses are not required to be reimbursed by
any other licensee. LICENSEE shall deliver such reimbursement to
EMORY within ninety (90) days after EMORY notifies LICENSEE of
out-of-pocket fees, costs and expenses and provides LICENSEE with
documentation, including copies of invoices, from time to time of
the amount of such fees, costs, and expenses which have been paid
or incurred by EMORY.
ARTICLE 5. REPORTS AND
PAYMENTS
5.1 Payments . Unless
otherwise specified, all payments required under this Agreement
shall be payable within thirty (30) days of the due date for
each payment. All payments due under this Agreement shall be made
in person or via the United States mail or private courier to the
following address:
Director, Office of Technology
Transfer
Emory University
2009 Ridgewood Drive
Atlanta, Georgia 30322
5.2 Tax Matters . All
payments made to EMORY under the terms of this Agreement (without
limitation including the delivery of the Purchased Stock and the
Additional Purchased Stock, the royalties, the minimum royalties
and the amounts due under Articles 2.8 and 2.11) shall be made free
and clear of any tax, withholding or other governmental charge or
levy (other
16
than taxes imposed on the net income of EMORY),
all such non-excluded amounts being “Taxes.” Should the
LICENSEE be obligated by law to withhold any Taxes, the payment due
hereunder shall be increased such that after the withholding of the
appropriate amount EMORY receives the amount that would have been
paid but for the Taxes withheld. Should EMORY be obligated to pay
such Taxes, and such Taxes were not satisfied by way of
withholding, LICENSEE shall promptly reimburse EMORY for such
payment, in an amount such that after the payment of the Taxes,
EMORY has received the same amount that it would have received had
such Taxes not been payable.
5.3 Progress Reports .
LICENSEE will provide EMORY with semi-annual progress reports
detailing the activities of LICENSEE relevant to LICENSEE’s
Development Plan.
5.4 Royalty Reports . Once
royalties are due, within thirty (30) days of December 31
and June 30 of each year, throughout the term of this
Agreement and of the year following the termination or expiration
of this Agreement, LICENSEE shall render a written report setting
forth for the preceding period in question, the following as may be
applicable:
(a) all Sales (including Net Selling
Price of each product sold) of Licensed Products or Combination
Products by LICENSEE, its sublicensees, and its Affiliates on a
country-by-country basis throughout the Licensed Territory;
and
(b) the amount of royalty payable
hereunder; and
(c) any other information reasonably
necessary to show the basis on which such royalty has been
computed, and
(d) any payments due EMORY pursuant
to Article 4.4; and
(e) other income received by
LICENSEE from sublicensees and the amounts thereof due to EMORY
pursuant to Article 2.7, accompanied by an explanation of the basis
of said income and the amount of such income due EMORY;
and
(f) in case no payment is due,
LICENSEE shall so report.
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Certain portions of this Exhibit have been
omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets and asterisks [***], have
been separately filed with the Commission.
Each royalty report shall be
accompanied by the payment of all royalties due for the period in
question. Any minimum royalty payment due under Article 4.4 shall
accompany the report for the period ending on December 31 of
the applicable License Agreement Year.
5.5 Currency Conversion . If
any Licensed Products are Sold for monies other than United States
dollars, the Net Selling Price of such Licensed Products shall
first be determined in the foreign currency of the country in which
such Licensed Products are Sold and then converted to United States
dollars at the spot rate published by the Wall Street
Journal (U.S. edition) for conversion of that foreign currency
into United States dollars on the last day of the six month period
for which such payment is due.
5.6 Interest . Payments
required under this Agreement shall, if overdue, bear interest
until payment at a per annum rate [***] percent ([***] %) above the
prime rate in effect as published in the Wall Street Journal
on the due date. The payment of such interest shall not foreclose
EMORY from exercising any other rights it may have because any
payment is late.
ARTICLE 6. RECORDS
6.1 Records of Sales . During
the term of this Agreement and for a period of three (3) years
thereafter, LICENSEE shall keep at its principal place of business
true and accurate records of all Sales in accordance with generally
accepted accounting principles in the respective country where such
Sales occur and in such form and manner so that all royalties and
other payments owed to EMORY may be readily and accurately
determined. LICENSEE shall furnish EMORY copies of such records
upon EMORY’s request, which shall not be made more often than
once per License Agreement Year.
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6.2 Audit of Records . EMORY
shall have the right, from time to time at reasonable times during
normal business hours through an independent certified public
accountant, to examine the records of LICENSEE in order to verify
the calculation of any royalties payable under this Agreement. Such
examination and verification shall not occur more than once each
License Agreement Year and the calendar year immediately following
termination of this Agreement. Unless otherwise agreed in writing
by LICENSEE, the fees and expenses of performing such examination
and verification shall be borne by EMORY. LICENSEE shall, subject
to Article 14 hereof, immediately pay EMORY any underpayment
identified by such independent certified public account. In
addition, if such examination reveals an underpayment by LICENSEE
of more than five percent (5%) for any period examined,
LICENSEE shall reimburse EMORY for all expenses of the accountant
reasonably incurred in performing the examination.
ARTICLE 7. PATENT
PROSECUTION
7.1 Prosecution and Maintenance
of Licensed Patents Assigned Solely to EMORY .
(a) EMORY shall be primarily
responsible for all patent prosecution activities pertaining to
Licensed Patents assigned solely to EMORY. LICENSEE shall be
afforded reasonable opportunities to advise EMORY and cooperate
with EMORY in such Patent Prosecution Activities pertaining to such
Licensed Patents. EMORY shall select counsel, reasonably acceptable
to LICENSEE, 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 subsistance (all of the
foregoing activities being referred to as “Patent Prosecution
Activities”) of all such Licensed Patents and shall provide
LICENSEE with copies of all filings and correspondence pertaining
to such Patent Prosecution
19
Activities (pre and post the date
hereof), in a timely manner, so as to give LICENSEE an opportunity
to comment thereon. To the extent reasonably possible, EMORY shall
pursue Patent Prosecution Activities in respect of such Licensed
Patents in at least the following countries: United States, EPO
countries, Japan, Canada and Australia. EMORY shall, upon
LICENSEE’s request, pursue Patent Prosecution Activities for
Licensed Patents in additional countries. If EMORY decides 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, EMORY shall promptly so inform LICENSEE and LICENSEE
shall be given the opportunity, with patent attorneys selected by
it, to assume Patent Prosecution Activities in respect thereof. In
all cases, each party hereto shall give due consideration to the
other party’s or its sublicensees’ position with
respect to Patent Prosecution Activities and provide the other
party with copies of all domestic and foreign patent office
correspondence with respect to such Licensed patents as well as
such additional documentation as a party hereto may reasonably
request relating to such Licensed Patents.
(b) LICENSEE 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 EMORY. After the date
specified in such notice on which LICENSEE’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 LICENSEE has exercised its rights to terminate such
obligations.
7.2 Licensed Patents Jointly
Assigned to LICENSEE and EMORY . Any invention relating to a
Licensed Compound, the invention of which under applicable patent
law is attributable jointly to at least one employee of EMORY and
at least one employee of LICENSEE
20
(who is not also an employee of EMORY) shall be
assigned by such employees jointly to LICENSEE and EMORY. Any such
jointly assigned patents or patent application which includes
claims to any Licensed Product shall be considered a Licensed
Patent and subject to the terms of this Agreement Licensee shall be
primarily responsible for all Patent Prosecution Activities
pertaining to Licensed Patents jointly assigned to EMORY and
LICENSEE. LICENSEE shall select counsel, acceptable to EMORY, to
pursue Patent Prosecution Activities in respect of all such
Licensed Patents and shall provide EMORY with copies of all filings
and correspondence pertaining to such Patent Prosecution
Activities, in a timely manner, so as to give EMORY an opportunity
to comment thereon. LICENSEE shall advise such counsel in writing
that for purposes of such Patent Prosecution Activities, such
counsel represents both EMORY and LICENSEE. LICENSEE shall further
inform EMORY of any decision by LICENSEE 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. LICENSEE shall be solely responsible for all expenses
incurred by LICENSEE and prosecuting and maintaining such patents.
LICENSEE shall pursue Patent Prosecution Activities of such
Licensed Products in those countries it deems reasonably
appropriate after consultation with EMORY. If LICENSEE fails to
timely pursue Patent Prosecution Activities in respect of any
patent application or issued patent jointly assigned to LICENSEE
and EMORY in any country in which EMORY wishes to pursue such
Patent Prosecution Activities, EMORY shall be free at its sole
expense, to continue or discontinue any or all the Patent
Prosecution Activities in respect of such patent application or
issued patent in such country or grant its rights to such patent
application or issued patent to third parties. Thereafter
EMORY’s rights to such patent application and issued patent
shall no longer be in