EXHIBIT 10.5
NON-EXCLUSIVE SUBLICENSE
AGREEMENT
Between
Apath, L.L.C.
And
Pharmasset, Inc.
For
HCV REPLICON
And
RELATED INTELLECTUAL
PROPERTY
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.
NON-EXCLUSIVE SUBLICENSE
AGREEMENT
THIS NON-EXCLUSIVE SUBLICENSE
AGREEMENT (“ Agreement ”) is made and entered
into August 26, 2005 (the “ Effective Date
”) by and between Apath, L.L.C., a limited liability company
of the State of Missouri, with a business address at 893 N. Warson
Road, St. Louis, Missouri 63141 (“ Apath ”); and
Pharmasset, Inc., a Delaware company, with a business address at
303A College Road East, Princeton, New Jersey 08540 (“
Pharmasset ”). Apath and Pharmasset are hereinafter
referred to individually as a “ Party ” or
collectively as “ Parties .”
WHEREAS, Apath has obtained from
Washington University in St. Louis (“ WU ”)
exclusive commercial license rights, with the right to grant
sublicenses, to certain Intellectual Property and Tangible Property
(as those terms are subsequently defined in this Agreement)
relating to the Hepatitis C virus (“HCV”) under a
license agreement dated October 31, 1997, as amended pursuant
to amendments with effective dates of January 15, 2003 and
August 11, 2003 (collectively, the “Primary WU License
Agreement”);
WHEREAS, the Parties had entered
into a License Agreement dated October 18, 2000 and
subsequently amended on January 30, 2004 (collectively, the
“10/18/2000 License Agreement”) whereby non-exclusive
sublicense rights to the Intellectual Property and Tangible
Property had originally been granted by Apath to
Pharmasset;
WHEREAS, Apath wishes to allow
Pharmasset to continue laboratory research and screening using the
Intellectual Property and Tangible Property, and for other drug
discovery and development purposes, upon the revised terms and
conditions hereinafter set forth in this Agreement (and with the
resulting termination of the 10/18/2000 License Agreement), and is
willing to grant a sublicense for such use; and
WHEREAS, Pharmasset desires to
maintain its sublicense for continued use the Intellectual Property
and Tangible Property for its own laboratory research and screening
use, and for other drug discovery and development purposes upon the
revised terms and conditions hereinafter set forth in this
Agreement (and with the resulting termination of the 10/18/2000
License Agreement).
NOW THEREFORE, in consideration of
the above premises, the mutual promises and covenants contained
herein, and other good and valuable consideration, the receipt and
legal sufficiency of which is acknowledged by both Parties, the
Parties hereto agree as follows:
1. Termination of the
10/18/2000 License Agreement.
(a) Upon the full execution of this
Agreement by the Parties hereto, the 10/18/2000 License Agreement
shall terminate in favor of this Agreement and shall be of no
further force or effect. The Parties expressly agree that the
termination of the 10/18/2000 License Agreement shall be
comprehensive and, notwithstanding any provision contained therein,
shall not result in the survival of any rights or obligations of
either Party. Further, the Parties expressly waive the provisions
of Section 10.5 of the 10/18/2000 License Agreement requiring
three (3) month’s written notice prior to
termination.
(b) The Parties agree that, as of
the Effective Date, (i) each Party is in full compliance with
the terms and conditions of the 10/18/2000 License Agreement, (ii)
neither Party is aware of any claim it may have against the other
for breach of any provision of the 10/18/2000 License Agreement,
and (iii) each Party hereby waives any right to bring suit or
other action against the other under the 10/18/2000 License
Agreement.
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Apath/PHARMASSET
Non-Exclusive Sublicense
Agreement
(TP/IP)
|
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. Definitions . For
the purposes of this Agreement, the following words and phrases
shall have the following meanings:
(a) “ Affiliate ”
of a Party means any person, organization, or entity that is,
directly or indirectly, controlling, controlled by, or under common
control with the Party. The term “control” (including,
with correlative meaning, the terms “controlled by” and
“under common control with”), as used with respect to
any person, organization, or entity, means the possession, directly
or indirectly, of the power to direct, or cause the direction of,
the management and policies of such person, organization, or
entity, whether through the ownership of voting securities, or by
contract or court order, or otherwise. The ownership of voting
securities of a person, organization, or entity shall not, in and
of itself, constitute “control” for purposes of this
definition, unless said ownership is of a majority of the
outstanding securities entitled to vote of such a person,
organization, or entity.
(b) “ Compound ”
means any inhibitor of HCV viral function made by or for Pharmasset
in the course of a research and/or development program for the
purpose of finding a therapeutic or prophylactic agent for the
treatment of HCV, and which inhibitor or any precursor thereto is
identified or validated by means of the Covered
Technology.
(c) “ Field of Use
” means, subject to the exclusion which follows,
Pharmasset’s own drug discovery, screening, research and
development programs undertaken with respect to any Compound.
Without in any way limiting the foregoing, “Field of
Use” shall include (i) developmental activities such as
use in conjunction with research on a Compound before its
commercial launch, and (ii) laboratory research and screening
intended to identify or validate a Compound.
“Field of Use” does not
include any laboratory testing and/or research services of the type
set out above or otherwise, the primary purpose of which is
intended to or reasonably appears to be intended to identify or
develop information to support any regulatory filings needed to
make, use or sell a [***] Inhibitor.
(d) “ Insurance Minimum
Amounts ” means minimum annual limits of USD $2,000,000
per claim and USD $5,000,000 in the aggregate.
(e) “ Intellectual
Property ” means all know-how (including laboratory
methodology), research or technical data and Licensed Patent Rights
that are licensed (with right to grant sublicenses) to Apath from
WU under the Primary WU License Agreement.
(f) “ Licensed Patent
Rights ” means (i) U.S. Patent Application Serial
Nos. [***], all U.S. and ex-U.S. patent applications based or
claiming priority thereon or relating thereto, and all patents
issuing therefrom, including, but not limited to, U.S. Patent Nos.
[***]; and (ii) any other Patent Rights claiming or
encompassing manufacture, use, sale, distribution and/or practice
within the Field of Use that are licensed from WU to Apath under
the Primary WU License Agreement or any amendments
thereto.
(g) “ Patent Rights
” means all patent applications filed anywhere in the world,
and continuation-in-part, continuation, divisional, and
continued-prosecution applications of such patent applications, any
patents granted on any aforesaid applications, and any renewals,
extensions, patents of addition, revivals, re-examinations, and
reissues thereof, and any patents which may issue
therefrom.
(h) “ [***] Inhibitor
” means a HCV viral inhibitor with a primary mechanism of
action derived from interfering with the function of the [***]
element of the HCV genome.
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Apath/PHARMASSET
Non-Exclusive Sublicense
Agreement
(TP/IP)
|
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.
(i) “ Covered
Technology ” means any Intellectual Property used by
Pharmasset (including Tangible Property and Tangible Property
Improvements) within the Field of Use that (i) in the absence
of a license from Apath, would infringe a Valid Claim of Licensed
Patent Rights and/or (ii) involves a use thereof permitted to
Pharmasset under this Agreement. For the purpose of this Agreement,
“ Valid Claim ” means a patent claim in an
issued patent included within the Licensed Patent Rights which has
not been disclaimed or canceled; provided, however, that in the
event any claim of a patent that falls within the Licensed Patent
Rights hereunder shall be held invalid or not infringed by a court
of competent jurisdiction in a final decision from which an appeal
cannot be or is not taken, or certiorari cannot be granted, then,
for the purposes of this Agreement, effective as of the date of
such final decision, such claim held invalid shall be considered
canceled from such patent and any such claim held not infringed
shall be considered limited in scope in accordance with such final
decision.
(j) “ Tangible Property
” means:
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(i)
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Cell lines that
express [***] (including the [***]) and the HCV replicon cell lines
(including [***]), reagents used to make the cell lines (including
[***]), and the [***] ([***]).
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(ii)
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Any other
biological materials (whether or not patented) provided by Apath to
Pharmasset which have been or are presently being utilized by
Pharmasset or others authorized hereunder as a causative factor in
identifying, isolating, or validating a Compound, except such
biological materials which are not proprietary to Apath or are
generally available to the public.
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3. Grant . Subject to
the terms and conditions of this Agreement, Apath hereby grants to
Pharmasset, and Pharmasset hereby accepts, a non-exclusive,
non-transferable sublicense (without the right to sublicense
others) under the Intellectual Property to make (i.e., replicate),
use (but not sell or for any other commercial purpose) and practice
Covered Technology encompassed by the Intellectual Property. This
grant shall be retroactive to Pharmasset’s first use of
Covered Technology that would require the grant of rights under the
Intellectual Property as contemplated herein. Notwithstanding the
foregoing, Apath grants Pharmasset no license or sublicense under
the Intellectual Property, and the sublicense granted hereunder
specifically excludes, any rights not included within the
definition of the term “Covered Technology”.
4. Restrictions on
Grant . The sublicense grant set forth in this Agreement is
subject to the following conditions and restrictions, in addition
to the other terms of this Agreement:
(a) The sublicense granted hereunder
shall not be construed to confer any rights upon Pharmasset by
implication, estoppel, or otherwise as to any other technology of
WU or of Apath, except as expressly set forth in this
Agreement;
(b) As between Pharmasset and Apath,
title to Intellectual Property and Tangible Property shall remain
in WU and/or Apath, and no rights are to be transferred to
Pharmasset hereunder other than as specifically set forth herein;
additionally, the transfer of Tangible Property to Pharmasset by
Apath is not to be considered a conditional or unconditional sale
of goods; provided, however, that Pharmasset will own all rights,
including all intellectual property rights, inventions, ideas,
know-how, trade secrets, discoveries and other subject
matter
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- 4 -
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Apath/PHARMASSET
Non-Exclusive Sublicense
Agreement
(TP/IP)
|
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.
conceived and reduced to practice solely by
Pharmasset’s employees, by third parties retained by
Pharmasset or by such Pharmasset employees and third parties
working together;
(c) Pharmasset shall not distribute
Intellectual Property and/or Tangible Property and Tangible
Property Improvements (as defined in Section 5 below) to any
third party (including any Affiliate) without obtaining the prior
written consent of Apath. Once the consent of Apath is granted
(which consent shall not be unreasonably withheld or delayed),
Pharmasset shall be entitled to distribute the Intellectual
Property and/or Tangible Property and Tangible Property
Improvements to its Affiliates, who shall be bound by the terms of
this Agreement by accepting such Intellectual Property and/or
Tangible Property or Tangible Property Improvements. Prior to
providing the Tangible Property or Tangible Property Improvement to
any Affiliate, Pharmasset shall notify Apath of the identity of
such Affiliate, and Pharmasset shall provide such Affiliate with
the terms and conditions of this Agreement and take reasonable
measures to ensure that the terms are understood by such Affiliate.
Pharmasset shall guarantee the full and complete performance of all
duties and obligations hereunder by any such Affiliate.
(d) If through the course of
research within the Field of Use conducted by Pharmasset, a
candidate for pharmaceutical products for treatment or prophylaxis
of HCV is discovered to act as a [***] Inhibitor, such research on
such a [***] Inhibitor must immediately cease unless Pharmasset
obtains a further grant of rights therefor.
(e) Use of the Tangible Property and
Tangible Property Improvements is subject to United States laws
governing the export of technical data, computer software,
laboratory prototypes and other commodities. Pharmasset shall be
responsible for complying with all applicable laws and regulations
regarding its use of the Tangible Property and Tangible Property
Improvements.
5. Rights to
Improvements . Apath agrees that use by Pharmasset of the
licensed Tangible Property as provided herein within the Field of
Use shall not give rise to any claim by Apath against Pharmasset
with respect to Pharmasset’s intellectual property, including
Pharmasset’s pharmaceutical product candidates and products,
subject to the following: (i) so long as such pharmaceutical
product candidates and products do not include any biological
material containing, in whole or in part, Tangible Property or
Tangible Property Improvements, as defined below; (ii) so long
as such candidates and products do not include a [***] Inhibitor;
and (iii) except for Tangible Property Improvements. The
parties acknowledge that Pharmasset may discover or develop
progeny, derivatives and modifications to the licensed Tangible
Property (“ Tangible Property Improvements ”).
In the event that Pharmasset wishes to commercialize such Tangible
Property Improvements, then Pharmasset shall notify Apath in a
timely way, under the Confidentiality provisions agreed to herein,
of the discovery or development thereof specifying the biological
nature and composition thereof as well as the process for making
such Tangible Property Improvements. (In the preceding sentence,
“commercialize” shall include the sale or license of
the Tangible Property Improvement to a third party, or other
com