Exhibit 10.16
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this
“Agreement”), effective as of February 28, 2003
(the “Effective Date”), is between THE UNIVERSITY OF
NORTH CAROLINA AT CHAPEL HILL having an address at CB #4105, 308
Bynum Hall, Chapel Hill, NC (hereinafter referred to as
“University”) and PANACOS PHARMACEUTICALS, INC., a
corporation organized and existing under the laws of Delaware and
having an address at 209 Perry Parkway, Gaithersburg, MD 20877
(hereinafter referred to as “Licensee”).
WITNESSETH
WHEREAS, University owns and
controls its share of the ownership interest in the inventions
covered by the Patents listed in Appendix A (hereinafter
“Inventions”) hereto, developed jointly by the parties
pursuant to the Sponsored Research Agreement; and
WHEREAS, Licensee is desirous of
producing, using and selling products which include the use of
Inventions and is willing to expend its commercially reasonable
efforts and resources to do so if it can obtain an exclusive
license to use the Inventions under the terms and conditions set
forth herein; and
WHEREAS, University desires to
facilitate a timely transfer of its information and technology
concerning the Inventions for the ultimate benefit of the public
and this transfer is best accomplished by the grant of this
license; and
WHEREAS, in the opinion of the
University, this transfer can best be accomplished consistent with
its mission by affiliation with Licensee;
WHEREAS, University and Licensee
entered into that certain License Agreement dated as of
April 28, 1999 pursuant to which Licensee obtained an
exclusive license to certain Inventions (the “ Original
Agreement ”);
WHEREAS, University and Licensee now
wish to amend and restate the Original Agreement in its entirety
and University desires to provide Licensee with, and License
desires to obtain, an exclusive license to certain additional
Inventions;
NOW, THEREFORE, for and in
consideration of the covenants, conditions, and undertakings
hereinafter set forth, it is agreed by and between the parties as
follows:
1.1. “U NIVERSITY T ECHNOLOGY ” means any unpublished (a) research
and development information, (b) unpatented inventions, and
(c) technical data, owned by or in the control of University
prior to the Effective Date or during the Term of this
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Agreement, which relates to and is
necessary for: (i) the practice of the Inventions, or
(ii) the manufacture, use, sale, offer for sale or importation
of any compounds disclosed in the Patents or any analogs,
derivatives, modifications or improvements thereof, and which
University has the right to provide Licensee under this Agreement,
and which Licensee does not otherwise own or control.
1.2. “I NVENTIONS ” has the meaning set forth in the first
Whereas clause above.
1.3. “L ICENSED P RODUCTS ” means (i) any method, procedure, or
component part thereof whose manufacture, use, sale, offer for sale
or importation is covered by any University Technology or by one or
more Valid Claims of the Patents, or (ii) any product
containing at least one Licensed Compound.
1.4. “L ICENSED C OMPOUNDS ” means any individual compounds whose
manufacture, use, sale, offer for sale or importation is covered by
any University Technology or by one or more Valid Claims of the
Patents.
1.5. “P ATENTS ” means any US patents and/or patent
applications owned or controlled in whole or in part by University
prior to or during the Term of this Agreement and which University
has the right to provide its share to Licensee and which are
included in and limited to those listed in Appendix A attached
hereto, as well as any continuations, continuations in part,
divisionals, provisionals, continued prosecution applications,
extensions, or reissues thereof, and any foreign counterpart of any
of the foregoing.
1.6. “N ET S ALES ” means, subject to Article 3.4, the
invoiced sales price of Licensed Products sold by Licensee, less
(a) any charges for sales taxes or other taxes separately
stated on the invoice, (b) shipping and insurance charges,
(c) actual credits and allowances for returned, rejected,
recalled, or defective goods, (d) trade discounts, but before
cash discounts and (e) government mandated rebates. Licensed
Products will be considered sold when billed out, or when delivered
or paid for before delivery, whichever first occurs. As used
herein, “cash discounts” means discounts given on
account of payments made in cash or payments made early.
1.7. “L ICENSED T ERRITORY ” means the world, subject to any
restrictions in Article XI herein.
1.8. “L ICENSED F IELD ” means any and all human therapeutic and
prophylactic uses.
1.9. “S UBLICENSEE ” means any person or organization to
which Licensee has granted a sublicense to the University
Technology or Patents for the purpose of development and/or
commercialization of Licensed Products in the Licensed
Field.
1.10. “C ONFIDENTIAL I NFORMATION ” means information considered proprietary
to the party disclosing the information, and may include
information relating to: research, development, patent prosecution
and maintenance, manufacturing, purchasing, accounting,
engineering, marketing, merchandising or selling.
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1.11. “S UBLICENSE I NCOME ” means all royalties, all other payments,
and any equity Licensee receives from Sublicensees, of which
University is owed a percentage; provided, however, that Sublicense
Income shall specifically exclude (i) [***](but shall
specifically [***] to the extent such [***], (ii) [***], and
(iii) [***] of the same. In the event of a sublicense as
contemplated herein, such sublicense shall state explicitly the
consideration provided in exchange for University Technology or
Patents.
1.12. “IND” means an
Investigational New Drug Application filed with the Food and Drug
Administration for authorization to initiate human clinical trials
in the United States, or any foreign equivalent document for
authorization to initiate human clinical trials outside the United
States.
1.13. “A FFILIATE ” means any corporation or other business
entity which, directly or indirectly, controls, is controlled by,
or is under common control with, a party. For purposes of this
definition, “control” means ownership or beneficial
interest in [***]% or more of the voting stock or other voting
interest of the corporation or other business entity.
1.14. “ ANDA ” means an Abbreviated New Drug
Application, made in the form of a Food and Drug Administration
submission or package to the Food and Drug Administration, for
approval to market a Licensed Product in the United States, or any
foreign equivalent document for approval to market a Licensed
Product outside the United States.
1.15. “ CLASS OF LICENSED COMPOUNDS ” means each subset of Licensed Compounds
as described in the Patents and identified in Appendix A as
(i) Class 1, (ii) Class 2, or (iii) Class
3.
1.16. “ FIRST COMMERCIAL SALE ” means the first sale of Licensed Product
for use in the Field by Licensee or its Sublicensee to any third
party in a country.
1.17. “ NDA ” means an original New Drug Application,
made in the form of a Food and Drug Administration submission or
package to the Food and Drug Administration, for approval to market
a Licensed Product in the United States, or any foreign equivalent
document.
1.18. “P ERFORMANCE M ILESTONE ” means any milestone listed on Appendix B
attached hereto.
1.19. “P HASE II C LINICAL T RIAL ” means a dosing range trial to evaluate
efficacy and safety in the targeted patient population and/or to
define optimal dosing regimen of Licensed Product, or any other
trial required to be designated as a Phase II clinical trial by the
Food and Drug Administration.
1.20. “R OYALTY Q UARTER ” has the meaning set forth in Article
3.5.
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1.21. “S PONSORED R ESEARCH A GREEMENT ” means that certain sponsored research
agreement by and between the parties effective April 28, 1999,
including any amendments thereto.
1.22. “T ERM ” shall commence on the Effective Date
and shall expire upon the expiration of the last Valid Claim of the
Patents, unless earlier terminated pursuant to Article
VII.
1.23. “V ALID C LAIM ” means either (a) a claim of an
issued and unexpired patent included within the Patents which has
not been held permanently revoked, unenforceable or invalid by a
decision of a court or other governmental agency of competent
jurisdiction, unappealable or unappealed within the time allowed
for appeal, and which has not been admitted to be invalid or
unenforceable through reissue or disclaimer or otherwise or
(b) a claim of a pending patent application included within
the Patents, which claim was filed in good faith and has not been
abandoned or finally disallowed without the possibility of appeal
or refiling of said application. Notwithstanding the foregoing (and
subject to Article 3.3(iii)), if a claim of a pending patent
application has not issued as a claim of an issued patent within
ten (10) years after the filing date from which such claim
takes priority, such pending claim shall cease to be a Valid Claim
for purposes of this Agreement unless and until such claim becomes
an issued claim of an issued patent.
1.24. “P ATENT C OUNSEL ” has the meaning set forth in Article
11.1.
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II.
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TERMINATION OF
ORIGINAL AGREEMENT; GRANT OF LICENSE; UNIVERSITY
RESTRICTIONS
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2.1. University and Licensee hereby
acknowledge and agree that the Original Agreement is terminated and
superseded by this Agreement as of the Effective Date of this
Agreement. Notwithstanding any provision to the contrary in the
Original Agreement, no provision contained therein shall survive
termination of the Original Agreement. Notwithstanding the
foregoing, each party hereby agrees that all actions, suits,
damages, claims and demands, in law or in equity, which either of
them has against the other under the terms of the Original
Agreement, upon, or by reason of any breach of the Original
Agreement, shall be enforceable under this Agreement.
2.2. (i) University grants to
Licensee, to the extent of the Licensed Territory, a non-exclusive
right and license (with the right to grant sublicenses pursuant to
Article 2.3) to use University Technology in the Licensed Field,
subject to all the terms and conditions of this
Agreement.
(ii) University grants to Licensee,
to the extent of the Licensed Territory, an exclusive right and
license (with the right to grant sublicenses pursuant to Article
2.3) under the Patents to make, have made, use, sell, offer for
sale, and import Licensed Products and Licensed Compounds embodying
the Invention(s) in the Licensed Field, upon the terms and
conditions set forth herein.
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2.3. University grants to Licensee,
to the extent of the Licensed Territory, the right to sublicense.
Sublicensees shall be subject to provisions substantially similar
to the following provisions of this Agreement: Articles 2.5, 2.6,
2.7, 2.8, VI, IX, 11.6, XII, XIV, XV, XVI, XIX, XXI, and XXII and
this Article 2.3 Sublicensees may not further sublicense any rights
they obtain herein without the written consent of University. In
the event of early termination of this Agreement, any sublicense
agreement with any Sublicensee shall provide for the termination of
the sublicense, or the conversion to a license directly between
such Sublicensee and University on substantially the same terms as
the sublicense agreement, at the option of the Sublicensee,
provided, however, that in no event shall University have greater
obligations to such Sublicensee as it has to Licensee
hereunder.
2.4. Any license granted herein
(excluding the grant in Article 2.2(i) above) is exclusive for the
Term of this Agreement.
2.5. Licensee shall not disclose any
University Technology pursuant to Article 2.2(i) above to third
parties during the Term or any time thereafter, provided, however,
that disclosure of University Technology may be made at any time
(1) with the prior written consent of University, or
(2) pursuant to the provisions of this Agreement, including
Article 6 herein.
2.6. Licensee is further granted the
right to disclose and use any University Technology, or other
Confidential Information of University pertaining to the Patents,
Licensed Products, or Licensed Compounds in any submission to
local, state, federal or foreign governmental agency, including,
but not limited to, the US Food and Drug Administration and the US
Patent and Trademark Office, notwithstanding any provisions to the
contrary in Article VI.
2.7. Notwithstanding the foregoing,
any and all licenses granted hereunder are subject to the rights of
the United States Government which may arise out of its sponsorship
of the research which led to the Inventions.
2.8. Subject to the licenses granted
to Licensee pursuant to the foregoing provisions of this Article
II, each party retains all right, title, and interest in such
party’s inventions and intellectual property, including,
without limitation, its share of any joint inventions and jointly
owned Patents.
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III.
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LICENSE FEE AND
ROYALTIES
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3.1. In consideration for the
licenses granted hereunder, Licensee shall issue a total of [***]
([***]) shares of Common Stock of Licensee $.01 par value per
share, in the name of University within [***] ([***]) days of the
Effective Date of this Agreement, provided that University enters
into a restricted stock agreement in the form attached hereto as
Appendix C.
3.2. The parties acknowledge that
Licensee has paid University for all past costs (including
reasonable attorney’s fees) arising out of the filing,
prosecution, or
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maintenance of the Patents. Licensee
will pay a further license fee in the form of payment of future
costs (including attorney’s fees) arising out of the filing
and prosecution of the Patents covering the Inventions pursuant to
Article XI of this Agreement. Payment of such costs shall be
non-refundable and shall not be a credit against any other amounts
due hereunder.
3.3. (i) Beginning on the Effective
Date of this Agreement and continuing, on a country-by-country
basis, until the last to expire Valid Claim of Patents covering
such Licensed Products, Licensee will pay University a running
patent royalty on all Net Sales of Licensed Products in the
Licensed Field covered by a Valid Claim of the Patents, in
accordance with the chart below:
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NET SALES OF
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ROYALTY RATE
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[***]
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[***]
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[***]
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[***]
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(ii) During the Term of this
Agreement, Licensee will pay University a running technology
royalty on all Net Sales of Licensed Products in the Licensed Field
not covered by a Valid Claim of the Patents but whose manufacture,
use, sale, offer for sale or importation is covered by University
Technology, in accordance with the chart below:
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NET SALES OF
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ROYALTY RATE
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[***]
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[***]
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[***]
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[***]
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(iii) In addition to the foregoing,
the parties acknowledge and agree that in the event a claim of a
pending patent application ceases to be a Valid Claim pursuant to
the last sentence of Article 1.23, and such pending patent
application later issues during the Term of this Agreement,
Licensee shall pay University [***] if such claim of the pending
patent application had not ceased to be a Valid Claim in the first
instance pursuant to Article 1.23, and [***].
3.4. (i) In the event any Licensed
Product in the Licensed Field is a combination of one or more
Licensed Compounds with one or more other active ingredients not
licensed hereunder, Net Sales for purposes of determining royalty
payments on such combination shall be calculated by
[***].
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(ii) In the event that it is not
possible to determine the gross selling price for each ingredient,
Net Sales shall be calculated by [***].
3.5. Beginning with the date of
First Commercial Sale of any Licensed Product in the Licensed
Field, Licensee agrees to make quarterly written reports to
University within [***] ([***]) days after the first
(1st) days of each January, April, July, and October during
the Term of this Agreement and as of such dates, stating in each
such report the number, description, and aggregate Net Sales of
Licensed Products sold, used, or otherwise disposed of during the
preceding [***] calendar months (each such three calendar months a
“Royalty Quarter”) and upon which a royalty or
percentage of Sublicense Income is payable as provided in Articles
3.3 or IV hereof, as appropriate. The [***] such report shall
include all Net Sales of Licensed Products made prior to the date
of such report. Until Licensee has achieved the First Commercial
Sale of Licensed Product, a report shall be submitted by Licensee
at the end of each January after the Effective Date of this
Agreement and will include a full written report summarizing
Licensee’s technical and other efforts made towards such
First Commercial Sale of a Licensed Product.
3.6. In the event that it is
necessary or required for Licensee to make royalty or other
payments to one or more third parties in order for Licensee or any
Sublicensee to make, use, or sell Licensed Products, Licensee may
offset a total of [***] percent ([***]%) of such third-party
payments against any royalty payments and/or percentage of
Sublicense Income, as appropriate and in the Royalty Quarter they
are due, that are otherwise due University hereunder, provided that
in no event shall the royalty payments or percentage of Sublicense
Income otherwise due University be reduced by more than [***]
percent ([***]%) in any Royalty Quarter. Notwithstanding the
foregoing, in no event shall Licensee offset third-party payments
against any royalty payments and/or percentage of Sublicense Income
that are otherwise due University hereunder [***].
3.7. Concurrently with the making of
each report pursuant to Article 3.5 above, Licensee shall pay to
the University all payments due University under Articles 3.3, 3.8
or IV, as appropriate.
3.8. Licensee will make milestone
payments upon the first of either Licensee or a Sublicensee
reaching the designated stages of development listed in the table
below, for each Licensed Product. Payment shall be the greater of
the compensation due University pursuant to Article IV (if
applicable), or the amount listed in the table below.
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MINIMUM
PAYMENT DUE
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[***]
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$
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[***]
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[***]
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$
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[***]
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[***]
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$
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[***]
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[***]
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$
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[***]
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For the avoidance of doubt, the
parties acknowledge and agree that in no event shall Licensee owe
University payments under both this Article 3.8 and Article IV with
respect to milestone payments received by Licensee from
Sublicensees for the milestones listed hereunder.
In the event of default of any
payment owing to University under the terms of this Agreement, and
if it becomes necessary for University to undertake legal action to
collect said payment, Licensee shall pay [***] legal fees and costs
incurred by University in connection therewith.
3.9. The parties recognize that
different Licensed Products may contain the same Licensed Compound.
However, the parties agree that [***] [***] shall be payable
pursuant to Section 3.8 or IV (as applicable) for each
individual Licensed Compound, regardless of the number of Licensed
Products containing such Licensed Compound. For purposes of this
Agreement, [***] shall not be considered distinct Licensed
Compounds.
3.10. Nothing in this Agreement
shall be construed to require the payment of more than [***] of
Sublicense Income with regard to the Net Sale of an individual
Licensed Product in the Licensed Field. No [***] of Sublicense
Income shall be payable because any Licensed Product, or its
manufacture, use, sale, offer for sale or importation is covered by
more than one Valid Claim in a given country.
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In the case of income derived by
Licensee from Sublicensees, Licensee shall pay University a share
of Sublicense Income, whose share shall be in accordance with the
following table, on a Sublicensee by Sublicensee ba