Exhibit 10.3
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UNC/NIIGATA/PANACOS LICENSE
AGREEMENT
UNC/NIIGATA/PANACOS LICENSE
AGREEMENT (this “Agreement”), effective as of
January 20, 2009 (the “Effective Date”), 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”), NIIGATA UNIVERSITY OF PHARMACY AND
APPLIED LIFE SCIENCES having an address at 5-13-2
Kamishin’Ei-cho Niigata 950-2081, Japan
(“Niigata”) 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
(together with its Affiliates 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 attached hereto
(“University Inventions”), developed jointly by
University and Licensee pursuant to the Sponsored Research
Agreement, and Niigata owns and controls its share of the ownership
interest in the inventions covered by the Patent listed on Appendix
B attached hereto (“Niigata Inventions”) (University
Inventions and Niigata Inventions hereinafter collectively referred
to as “Inventions”); and
WHEREAS substantially concurrently
with the execution and delivery of this Agreement,
(i) Licensee and Myriad Genetics, Inc. (“Myriad”)
are entering into, and effecting a closing under, an Asset Purchase
Agreement and related agreements whereby Panacos is assigning to
Myriad Panacos’s share of the ownership interest in certain
inventions covered by certain Patents (not including the
Inventions) jointly owned by Panacos and University (the
“Bevirimat Patents”), and (ii) University and
Myriad are entering into a License Agreement dated as of the date
hereof whereby University is granting to Myriad a worldwide license
to the Bevirimat Patents; 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 and Niigata
desire to facilitate a timely transfer of their 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 and Niigata, this transfer can best be accomplished
consistent with their mission by affiliation with
Licensee;
WHEREAS, University, Niigata, and
Licensee entered into that certain License Agreement dated as of
February 28, 2003 (as amended) pursuant to which Licensee
obtained an exclusive license to certain Inventions (the “
Original Agreement ”);
WHEREAS, University, Niigata, and
Licensee now wish to amend and restate the Original Agreement in
its entirety;
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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:
I. DEFINITIONS
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 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. “N IIGATA I NVENTIONS ” has the meaning set forth in the first
Whereas clause above.
1.4. “U NIVERSITY I NVENTIONS ” has the meaning set forth in the first
Whereas clause above.
1.5. “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 Niigata
Technology or by one or more Valid Claims of the Patents, or
(ii) any product containing at least one Licensed
Compound.
1.6. “L ICENSED C OMPOUNDS ” means any individual compounds whose
manufacture, use, sale, offer for sale or importation is covered by
any University Technology or Niigata Technology or by one or more
Valid Claims of the Patents.
1.7. “P ATENTS ” means any US patents and/or patent
applications owned or controlled in whole or in part by University
or Niigata prior to or during the Term of this Agreement and which
University and/or Niigata has the right to provide its share to
Licensee and which are included in and limited to those listed in
Appendix A and Appendix B, 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.
1.8. “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.
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1.9. “L ICENSED T ERRITORY ” means the world, subject to any
restrictions in Article XI herein.
1.10. “L ICENSED F IELD ” means any and all human therapeutic and
prophylactic uses.
1.11. “S UBLICENSEE ” means any person or organization to
which Licensee has granted a sublicense to the University
Technology or Niigata Technology or Patents for the purpose of
development and/or commercialization of Licensed Products in the
Licensed Field.
1.12. “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.
1.13. “S UBLICENSE I NCOME ” means all royalties, all other payments,
and any equity Licensee receives from Sublicensees, of which
University and/or Niigata is owed a percentage; provided, however,
that Sublicense Income shall specifically exclude (i) payments
made in consideration for the issuance of equity or debt securities
of Licensee at fair market value (but shall specifically include
any payments received by Licensee from the issuance of securities
of Licensee to the extent such payments are in excess of fair
market value), (ii) equity or debt securities of a Sublicensee
issued to Licensee if acquired by Licensee at fair market value,
and (iii) payments specifically committed to research funding
or development activities, or reimbursements 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 Niigata Technology or Patents.
1.14. “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.
1.15. “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 40% or more of the voting stock or other voting
interest of the corporation or other business entity.
1.16. “ 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.
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1.17. “ CLASS OF LICENSED COMPOUNDS ” means each subset of Licensed Compounds
as described in the Patents and identified in Appendix A and
Appendix B as (i) Class 1, (ii) Class 2, or
(iii) Class 3.
1.18. “ 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.
1.19. “ 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.
1.20. “P ERFORMANCE M ILESTONE ” means any milestone listed on Appendix C
attached hereto.
1.21. “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.
1.22. “R OYALTY Q UARTER ” has the meaning set forth in Article
3.5.
1.23. “S PONSORED R ESEARCH A GREEMENT ” means that certain sponsored research
agreement by and between University and Licensee effective
April 28, 1999, including any amendments thereto.
1.24. “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.
1.25. “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.
1.26. “P ATENT C OUNSEL ” has the meaning set forth in Article
11.1.
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1.27. “N IIGATA T ECHNOLOGY ” means any unpublished (a) research
and development information, (b) unpatented inventions, and
(c) technical data, owned by or in the control of Niigata
prior to the Effective Date or thereafter during the Term, which
relates to and is necessary for: (i) the practice of the
Niigata Inventions, or (ii) the manufacture, use, sale, offer
for sale or importation of any compounds disclosed in the Niigata
Patents or any analogs, derivatives, modifications or improvements
thereof, and which Niigata has the right to provide Licensee under
this Agreement, and which Licensee does not otherwise own or
control.
II. TERMINATION OF ORIGINAL
AGREEMENT; GRANT OF LICENSE; UNIVERSITY RESTRICTIONS
2.1. University, Niigata, 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.
(iii) Niigata 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 Niigata Technology in the Licensed Field, subject to
all the terms and conditions of this Agreement.
(iv) Niigata 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 Niigata Patents to make, have made, use, sell, offer
for sale, and import Licensed Products and Licensed Compounds
embodying the Niigata Inventions in the Licensed Field, upon the
terms and conditions set forth herein.
2.3. University and Niigata each
grant 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, 2.9, VI, IX, 11.6, XIV, XV,
XVI, XIX, XXI, and XXII and this Article 2.3. Sublicensees may not
further sublicense
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any rights they obtain herein
without the written consent of University as to the University
Inventions and Niigata as to the Niigata Inventions. 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 and/or Niigata (as the case may be) on
substantially the same terms as the sublicense agreement, at the
option of the Sublicensee, provided, however, that in no event
shall University or Niigata 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 shall not disclose any
Niigata Technology pursuant to Article 2.2(iii) above to third
parties during the Term or any time thereafter, provided, however,
that disclosure of Niigata Technology may be made at any time
(1) with the prior written consent of Niigata, or
(2) pursuant to the provisions of this Agreement, including
Article 6 herein.
2.7. Licensee is further granted the
right to disclose and use any University Technology, or other
Confidential Information of University or Niigata Technology, or
other Confidential Information of Niigata 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.
2.8. 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.
2.9. 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.
III. LICENSE FEE AND
ROYALTIES
3.1. [RESERVED].
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 maintenance of the Patents. Licensee will pay a
further license fee in the form of
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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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<$100 million
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2.5
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%
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>$100 million
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3
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%
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Notwithstanding the
foregoing provisions of this Article 3.3(i), (a) in the event
that the Licensed Product for which royalties are payable hereunder
is covered by a Valid Claim of the Niigata Patents but no other
Patents, then Licensee shall pay University one-half (
1 / 2 ) of the royalties
otherwise payable to University under this Article 3.3(i), and
Licensee shall pay Niigata the remaining one-half (
1 / 2 ) of such royalties; and
(b) in the event that the Licensed Product for which royalties
are payable hereunder is covered by Valid Claims of both the
Niigata Patents and at least one other Patent, then Licensee shall
pay University two-third ( 2 / 3 ) of the royalties
otherwise payable to University under this Article 3.3(i), and
Licensee shall pay Niigata the remaining one-third (
1 / 3 ) of such
royalties.
(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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<$100 million
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1.25
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%
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>$100 million
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1.5
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%
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Notwithstanding the foregoing
provisions of this Article 3.3(ii), (a) in the event that the
Licensed Product for which royalties are payable hereunder is
covered by both University Technology and Niigata Technology, then
Licensee shall pay University
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one-half (
1 / 2 ) of the royalties
otherwise payable to University under this Article 3.3(ii), and
Licensee shall pay Niigata the remaining one-half (
1 / 2 ) of such royalties; and
(b) in the event that the Licensed Product for which royalties
are payable hereunder is not covered by University Technology but
is covered by Niigata Technology, then Licensee shall pay Niigata
one hundred percent (100%) of the royalties otherwise payable
to University under this Article 3.3(ii).
(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 and/or Niigata the difference between
any patent royalties that would have been payable by Licensee under
Article 3.3(i) 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 the technology royalty actually paid pursuant to
Article 3.3(ii).
(iv) No later than thirty
(30) days before the First Commercial Sale of a particular
Licensed Product, Licensee retains the right to notify University
and Niigata in writing of its determination of the allocation of
payments between University and Niigata hereunder (if any). In such
an event, University and Niigata shall have thirty (30) days
to respond in writing if they disagree with Licensee’s
determination. In the event Licensee does not receive written
notice of a disagreement within such 30 day period, then
Licensee’s determination shall be deemed acceptable to the
parties. In the event Licensee receives written notice of a
disagreement within such 30 day period, Licensee retains the right
to make royalty payments into an escrow account until such time as
University and Niigata provide Licensee with written confirmation
of their resolution of such disagreement. In no event shall
Licensee owe University and Niigata, in the aggregate, royalties
greater than the royalty rates set forth in this Article
3.3.
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 multiplying the
net sales (i.e., the invoiced sales price of the combination
less the deductions set forth in Article 1.6) by the fraction
A/(A+B) in which “A” is the total of the gross selling
prices of the Licensed Compounds, and “B” is the total
of the gross selling prices of the other active
ingredients.
(ii) In the event that it is not
possible to determine the gross selling price for each ingredient,
Net Sales shall be calculated by multiplying the net sales
(i.e., the invoiced sales price of the combination less the
deductions set forth in Article 1.6) of the combination by the
fraction C/(C+D), in which “C” is the total of the
direct costs plus the direct overhead of the Licensed Compounds and
“D” that of the other active ingredients. The direct
costs plus the direct overhead of a component shall be determined
in accordance with generally acceptable cost accounting
principles.
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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 and Niigata (with respect to Licensed Products covered
by a Valid Claim of the Niigata Patents or by Niigata Technology)
within thirty (30) 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 three
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 first 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 fifty percent (50%) 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 and/or Niigata
hereunder, provided that in no event shall the royalty payments or
percentage of Sublicense Income otherwise due University and/or
Niigata be reduced by more than fifty percent (50%) 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 and/or Niigata hereunder if such third party payments
relate solely to other active ingredients to which the combination
Product calculations in Article 3.4 have been applied.
3.7. Concurrently with the making of
each report pursuant to Article 3.5 above, Licensee shall pay to
the University and/or Niigata all payments due University and/or
Niigata 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.
Notwithstanding the
foregoing, (a) in the event that the Licensed Product for
which milestone payments are due hereunder is covered by a Valid
Claim of the Niigata Patents but no other Patents, or is not
covered by a Valid Claim of any Patents but is covered by the
University Technology and Niigata Technology, then Licensee shall
pay University one-half ( 1 / 2 ) of the compensation
otherwise payable to University under this Article 3.8 (or Article
IV as the case may be), and Licensee shall pay Niigata the
remaining one-half ( 1 / 2 ) of such compensation; and
(b) in the event that the Licensed Product for which milestone
payments are due hereunder is covered by Valid Claims of both the
Niigata Patents and at least one other Patent, then Licensee shall
pay University two-thirds ( 2
/
3 ) of the compensation
otherwise payable to University under this Article 3.8 (or Article
IV as
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the case may be),
and Licensee shall pay Niigata the remaining one-third (
1
/
3 ) of such compensation; and
(c) in the event that the Licensed Product for which milestone
payments are due hereunder is not covered by a Valid Claim of any
Patents but is covered by the Niigata Technology but not the
University Technology, then Licensee shall pay Niigata one hundred
percent (100%) of the compensation otherwise payable to
Uni