Exhibit 10.4
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Confidential Treatment has been requested for the marked portions
of this exhibit pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.
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CONFIDENTIAL
UNIVERSITY OF
PENNSYLVANIA
AMENDED AND RESTATED LICENSE
AGREEMENT
This Amended and Restated License
Agreement (“ Agreement ”), effective
January 29, 2009 ( the “Restatement Date”) is made
by and between The Trustees of the University of Pennsylvania, a
Pennsylvania nonprofit corporation, with offices located at 3160
Chestnut Street, Suite 200, Philadelphia, Pennsylvania 19104-6283
(“ Penn ”) and Targeted Genetics Corporation, a
corporation organized and existing under the laws of Washington
(“ Targeted ”), having a place of business at
1100 Olive Way, Suite 100, Seattle, Washington 98101 and is an
amendment to and restatement of the original License Agreement
between Targeted and Penn (the “ Original Agreement
”) which became effective on June 1, 2002 (the
“Effective Date”).
RECITALS
WHEREAS, Genovo, Inc., a corporation
organized and existing under the laws of Delaware (“
Genovo ”), having a place of business at 512 Elmwood
Avenue, Sharon Hill, PA 19079 and Penn are parties to the following
three agreements, each dated as of June 30, 1995, and each as
amended through the Effective Date (collectively sometimes called
the “ Existing Agreements ”): that certain
Sponsored Research Agreement, pursuant to which Genovo funded
certain research at Penn relating to new strategies for gene
therapy (“ Sponsored Research Agreement ”); that
certain License Agreement Lung and Liver Fields pursuant to which
Penn has granted certain licenses and other rights to Genovo
relating to certain liver and lung fields (“ Liver/Lung
License ”); and that certain License Agreement Additional
Fields pursuant to which Penn has granted certain licenses and
other rights to Genovo relating to certain other fields (“
Additional Fields License ”); and
WHEREAS, the Sponsored Research
Agreement was terminated in accordance with that certain letter
agreement between the parties dated February 27, 2001;
and
WHEREAS, Penn owns and is a
proprietor of certain intellectual property, including items
developed under the Sponsored Research Agreement and items
discovered or developed prior thereto and agreed to be subject to
one or more of the Existing Agreements; and
WHEREAS, Genovo has become an
Affiliate of Targeted in a transaction in which former shareholders
of Genovo have become shareholders of Targeted; and
WHEREAS, Genovo and Targeted intend
to pursue further research directed toward the development and
improvement of gene therapy products and potential
commercialization thereof in one or more applications, and Penn
desires that they do so; and
WHEREAS, Penn has determined that
the exploitation of such intellectual property and improvements
thereto as described herein is in the best interests of Penn, is
consistent with its educational and research missions and goals,
and is likely to facilitate the accomplishment of the goals that
originally supported the Existing Agreements and the Original
Agreement;
WHEREAS, Penn and Targeted have had
certain disagreements concerning interpretation of the language of
the Original Agreement and after lengthy negotiation, Penn and
Targeted have reached an agreement on certain amendments and
modifications to the Original Agreement, including the return to
Penn of certain patent dockets licensed to Targeted under the
Original Agreement; and
WHEREAS, the parties now desire to
amend and restate the Original Agreement in its entirety with this
Agreement to reflect various matters contemplated by the parties as
hereinafter set forth;
NOW, THEREFORE, in consideration of
the premises and of the promises and covenants contained herein and
intending to be legally bound hereby, the parties, agree as
follows:
ARTICLE 1 -
DEFINITIONS
For the purposes of this Agreement,
in addition to the other terms defined above or elsewhere in this
Agreement, the following words and phrases shall have the meanings
set forth herein.
1.1 “ [*]
,” as to a product (and as to the point in time when this
definition is referenced in this Agreement as to such product),
means that such product [*] achieved the milestone in
[*] and has since the achievement of such milestone
progressed as applicable [*] set forth below:
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(a)
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[*] on
such product with the appropriate health regulatory authority(ies)
in at least one Major Nation, and Targeted, a Covered Affiliate, or
their collaborators or sublicensees [*] ;
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(b)
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[*] clinical trials of such product have been
[*] within [*] year [*] for such product
[*] , and Targeted, a Covered Affiliate, or their
collaborators or sublicensees exert commercially reasonable efforts
to conduct and complete [*] ;
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(c)
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where [*] trials were
[*] for such product, [*] clinical trials of such
product have been [*] within [*] years after the
[*] of such [*] clinical trials, and
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Targeted, a Covered Affiliate, or
their collaborators or sublicensees exert commercially reasonable
efforts to conduct and complete [*] ;
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(d)
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[*] clinical trials of such product have been
[*] within [*] years after the [*] (or
[*] years after the [*] where [*] trials were
[*] for such product) clinical trials for such product, and
Targeted, a Covered Affiliate, or their collaborators or
sublicensees exert commercially reasonable efforts to conduct and
complete such [*] clinical trials of such product, including
the [*] ;
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(e)
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[*] for such product has been [*] with the
appropriate health regulatory authority(ies) in at least one Major
Nation within [*] years after the [*] for such
product, and Targeted, a Covered Affiliate, or their collaborators
or sublicensees exert commercially reasonable efforts to [*]
of such [*] until at least one such [*] or until all
[*] (it being understood that the product will no longer be
in [*] if all such [*] in all Major Nations have been
[*] ); and
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(f)
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such product
[*] in at least one Major Nation within [*] such
product by the appropriate health regulatory authority(ies) in that
Major Nation (including [*] in such Major
Nation);
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provided, however, that (1) if
Targeted (or, as applicable, a Covered Affiliate, or their
collaborators or sublicensees) [*] (even if, in
Targeted’s or such other entity’s [*] , it is
prudent for Targeted or such entity to do so), Targeted will not be
considered to be exerting commercially reasonable efforts as to the
conduct of such clinical trial; (2) the time periods specified
in this Section as applied to a product shall be tolled during any
period or periods in which Targeted (or, as applicable, a Covered
Affiliate, or their collaborators or sublicensees) is, beyond its
reasonable control, prevented from developing such product by
government-imposed moratoriums, laws or rulings that prevent others
generally from developing similar products, it being understood
that if a clinical trial is halted or suspended because of
[*] to Targeted’s (or such other entity’s)
conduct of the trial, such action will not toll the time periods
specified in this Section as applied to the product involved in
such trial; and (3) if at any time or times Targeted (or, as
applicable, a Covered Affiliate, or their collaborators or
sublicensees) believes that it may not be able to advance a
particular product through one or more of the above stages of
development within any of the specific time periods specified in
this Section (whether or not due to factors described in clause
(2) above), Targeted may so notify Penn, together with a
reasonably detailed description of the factors or reasons why
Targeted believes it should nevertheless continue to be considered
to have such product under [*] whereupon Penn and Targeted
will over a period of at least [*] to reach agreement on
extension(s) to such time period(s) as shall be reasonable in the
circumstances; and
further provided, that Penn will not
unreasonably withhold its consent to extensions of the forgoing
timeframe requirements to the extent that Targeted can demonstrate
that delays are due to the time required to enroll patients in
clinical trials and conduct the protocol for such trials, so long
as such enrollment and conduct of the protocol has proceeded and is
proceeding continuously in accordance with the protocol (and
applicable laws, regulations
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and good clinical practices) and the protocol
has not been interrupted or suspended (unless such interruption or
suspension is due to the action of regulatory authorities or is
required to comply with applicable laws, regulations or good
clinical practices, in which case, Penn would still not
unreasonably withhold its consent to such an extension so long as
Targeted or its sublicensees/Affiliates/collaborators are working
diligently to address the issues and restart such
trials).
1.2 “ Affiliate ”
of an entity means and includes the entities that, directly or
indirectly, own or control more than 50% of the voting interests
(or equivalent control) of such entity (“ Parent
”), or more than 50% of the voting interests (or equivalent
control) of which is, directly or indirectly, owned or controlled
by such entity or its Parent. “ Affiliated ”
refers to Affiliates. “ Covered Affiliate ”
refers to an affiliate of Targeted that has agreed in writing to be
bound by Targeted’s rights and obligations under this
Agreement; Penn acknowledges that Genovo, by its signature agreeing
to be bound by all the terms and obligations of Targeted below, is
a Covered Affiliate.
1.3 “ Bankruptcy Event
” means voluntary or involuntary proceedings by or against
Targeted are instituted in bankruptcy or under any insolvency law,
or a receiver or custodian is appointed for Targeted, or
proceedings are instituted by or against Targeted for corporate
reorganization or the dissolution of Targeted, which proceedings,
if involuntary, shall not have been dismissed within sixty
(60) days after the date of filing, or Targeted makes an
assignment for the benefit of creditors, or substantially all of
the assets of Targeted are seized or attached and not released
within sixty (60) days thereafter.
1.4 “ [*]
” includes [*] .
1.5 “ Calendar Quarter
” means each three-month period, or any portion thereof,
beginning on January 1, April 1, July 1
and October 1.
1.6 “ Calendar Year
” means a period of twelve (12) months beginning on
January 1 and ending on December 31.
1.7 “ [*]
Field ” means the prevention, treatment or cure of
[*] whether by in vivo or ex vivo means
(together with preparation, research, development, and attempts to
do the foregoing).
1.8 “ Confidential
Information ” means and includes all technical
information, inventions, developments, discoveries, software,
know-how, methods, techniques, formulae, data, processes and other
proprietary ideas, whether or not patentable or copyrightable, that
Penn identifies as confidential or proprietary at the time it is
delivered or communicated to Targeted.
1.9 “ [*] ”
means, with respect to a Penn Licensed Product: (a) the
[*] filed on such Penn Licensed Product in any Major Nation;
and (b) up to [*] additional [*] each of which
is [*] , and for which [*] within the next [*]
years for a Penn Licensed Product incorporating the
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same [*] as such Penn Licensed Product
and/or [*] of up to [*] additional [*] in such
Penn Licensed Product. Targeted shall designate the additional
[*] and additional [*] referred to in clause
(b) within [*] following the [*] on such Penn
Licensed Product in any Major Nation; provided, however, that as to
Penn Licensed Products covered by Group 2 Patents, Targeted may
designate such additional [*] and additional [*] at
an earlier time as described in Section 4.2.3. If, within such
[*] following the [*] referred to in clause (a), none
of Targeted or its Affiliates or licensees has actually [*]
in at least one Major Nation for a Penn Licensed Product directed
to a [*] that was so designated, then that [*] shall
from that time forward no longer be among the [*] with
respect to the Penn Licensed Product that was the subject
[*] referred to in clause (a).
1.10 “ Fair Market
Value ” means:
1.10.1 in the case of a Sale, the
cash consideration which Targeted or its Covered Affiliate or
sublicensee would realize from an unaffiliated, unrelated buyer
under no obligation to buy in an arm’s length sale of an
identical item sold in the same quantity and at the same time and
place of the transaction; or
1.10.2 in the case of a transaction
other than a Sale, the cash consideration which a willing party
would realize from an unaffiliated, unrelated third party under no
obligation to transact in an arm’s length transaction of the
same type and at the same time and place of transaction; provided,
however, that where Sales or other transactions are made in
connection with patient assistance programs or other charitable
purposes or to physicians or hospitals for promotional purposes,
“Fair Market Value” for purposes hereof shall mean the
actual consideration received, if any.
1.11 “ Federal Government
Interest ” means the rights of the United States
Government under Public Laws 96-517, 97-256 and 98-620, codified at
35 U.S.C. 200-212, and any regulations issued thereunder, as such
statute or regulations may be amended from time to time
hereafter.
1.12 “ [*]
” means [*] .
1.13 “ [*]
Letter Agreement ” means that certain letter agreement
among [*] dated as of August 27, 1999, as amended
through the Effective Date.
1.14 “ [*]
Field ” means the prevention, treatment, or cure of
[*] whether by in vivo or ex vivo means
(together with preparation, research, development, and attempts to
do the foregoing).
1.15 “ Major Nation(s)
” means any one or more of Canada, France, Germany, Japan,
the United Kingdom, or the United States. It is agreed for the
avoidance of doubt that any filings or other actions or proceedings
with or in the European Agency for the Evaluation of Medicinal
Products or its successor will be considered to be with or in the
health regulatory agency in at least one Major Nation.
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1.16 “ Net Sales
” means the gross sales amounts or, if such consideration is
in a form other than cash or cash equivalents, the Fair Market
Value, received by Targeted or its Covered Affiliates or their
sublicensees from the Sale of any Penn Licensed Product(s), less
qualifying costs directly attributable to such Sale borne by
Targeted, its Covered Affiliate or their sublicensees. Such
qualifying costs shall be limited to the following:
1.16.1 Discounts, in amounts
customary in the trade, for quantity purchases, prompt payments and
for wholesalers and distributors;
1.16.2 Credits or refunds, not
exceeding the original invoice amount, for claims or
returns;
1.16.3 Prepaid outbound packing,
transportation expenses and transportation insurance
premiums;
1.16.4 Sales and use taxes and other
fees imposed by a governmental agency; and
1.16.5 Retroactive price reductions
or rebates as required by law, all in accordance with U.S.
generally accepted accounting principles consistently
applied.
1.17 “ Non-Targeted
Party ” means any person or entity that is not Penn,
Targeted, an Affiliate of Penn, a Covered Affiliate, a sublicensee
of Targeted or of a Covered Affiliate (which term refers to persons
or entities to the extent acting under an express sublicense of
rights of Targeted or a Covered Affiliate under this Agreement), or
another collaborator or distributor of Targeted, a Covered
Affiliate, or their sublicensees.
1.18 “ Penn Licensed
Product(s) ” means
1.18.1 products that in the absence
of this Agreement would, where and when made, used, sold, or
imported, infringe at least one issued claim or pending claim of
Penn Patent Rights; and
1.18.2 products that are made using
a process or machine that in the absence of this Agreement would,
where and when used, infringe at least one issued claim or pending
claim of Penn Patent Rights.
All Penn Licensed Products intended
to [*] shall be considered [*] Penn Licensed Product
for purposes of Sections 4.1 and 4.3.
1.19 “ [*]
” means [*] .
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1.20 “ Penn Patent
Rights ” means those patents and patent applications
listed in Attachment 1 to this Agreement and all foreign
counterparts thereof, as well as continuation,
continuation-in-part, provided that such continuation-in-part
relates directly to existing patents or patent applications and not
to any new matter, divisional and re-issue applications thereof,
together with any and all patents issuing thereupon or upon any
foreign counterparts thereof; provided, however, that Targeted and
Genovo acknowledge that the invention relating to [*] , was
made at Penn following [*] . Targeted and Genovo hereby
acknowledge that they have no rights in this invention relating to
[*] , as defined in these applications and divisionals,
continuations, re-examinations, re-issues, and any foreign
counterparts thereof, and any patents issuing therefrom. Targeted
and Genovo agree that they will not make or pursue any claims that
this invention as so defined is or should have been part of the
Penn Patent Rights.
1.20.1 “ Group 1
Patents ” means those Penn Patent Rights that are so
designated in Attachment 1.
1.20.2 “ Group 2
Patents ” means those Penn Patent Rights that are so
designated in Attachment 1.
1.20.3 “ Group 3
Patents ” means those Penn Patent Rights that are so
Designated in Attachment 1.
1.20.4 “ Group 4
Patents ” means those Penn Patent Rights that were
designated as Group 4 Patents in the Original Agreement.
1.20.5 “ Group 5
Patents ” means those Penn Patent Rights that were
designated as Group 5 Patents in the Original Agreement.
1.21 “ Penn Technical
Information ” means research and development information,
unpatented inventions, know-how, and technical data developed by
Dr. James Wilson, or other employees of Penn with a duty to
assign their rights to Penn, under the Sponsored Research Agreement
designated in Attachment 2 or described in the Penn Patent Rights,
and not otherwise covered by Penn Patent Rights.
1.22 “ Phase I Trials
” “ Phase II Trials ” and “ Phase
III Trials ” mean, respectively, human clinical trials
designated by the U.S. Food and Drug Administration (FDA) as Phase
I, Phase II (or Phase I/II), or Phase III trials.
1.23 “ Returned Patents
” means the Group 4 Patents, the Group 5 Patents and the
portions of the Group 1, Group 2 and Group 3 Patents that were
licensed to Targeted under the Original License but that are not
included in the Penn Patent Rights licensed to Targeted under this
Agreement.
1.24 “ Sale ”
means any bona fide transaction for which consideration is received
or expected for the sale, use, lease, transfer, or other
disposition of Penn Licensed Product(s);
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provided, however, that the sale, lease,
transfer, or other disposition of any Penn Licensed Product between
Targeted, its Covered Affiliates, or their sublicensees, and
another entity in such group, other than to a non-Covered-Affiliate
distributor or to an end user, shall not be considered a Sale. In
such cases, “Net Sales” hereunder shall be determined
using the invoiced or otherwise recognized sales price by the
transferee party, Covered Affiliate, or sublicensee to the
non-Covered-Affiliate distributor or the end user, less the
qualifying costs allowed under Section 1.16. A Sale of Penn
Licensed Product(s) shall be deemed completed at the time Targeted,
its Covered Affiliate or their sublicensee invoices, ships, or
receives payment for such Penn Licensed Product(s), whichever
occurs first. Sale shall not include any use of Penn Licensed
Products in preclinical work, clinical trials, or internal research
by Targeted, its Covered Affiliates, or their sublicensees or other
collaborators, distributors, or contractors, or [*]
.
1.25 “ Senior
Officer(s) ” means, as to Targeted at any relevant time,
the then-incumbent Chief Executive Officer of Targeted, and as to
Penn at any relevant time, the Managing Director, Center for
Technology Transfer.
1.26 “ [*]
Field ” means the prevention, treatment, or cure of
any disease or diseases in whole or in part through [*] ,
whether by in vivo or ex vivo means (together with
preparation, research, development, and attempts to do the
foregoing). For purposes hereof, the [*] are more fully
described in Attachment 3.
ARTICLE 2 - LICENSE GRANTS AND
DILIGENCE
2.1 Group 1 Patents
.
2.1.1 Group 1 License Grant .
Penn hereby grants to Targeted and the Covered Affiliates for the
term of this Agreement the worldwide right and license, with the
right to grant sublicenses, to develop, have developed, make, have
made, use, have used, import, have imported, sell, offer for sale
and have sold Penn Licensed Products under the Group 1 Patents
[*] . Such right and license shall be [*]
.
2.2 Group 2 Patents
.
2.2.1 Group 2 License Grant .
Penn hereby grants to Targeted and the Covered Affiliates for the
term of this Agreement the worldwide right and license, with the
right to grant sublicenses, to develop, have developed, make, have
made, use, have used, import, have imported, sell, offer for sale
and have sold Penn Licensed Products under the Group 2 Patents
[*] . Such right and license shall be [*]
.
2.2.2 Group 2 Licenses to
[*] . Penn retains the right to license [*]
(“ [*] ”) non-exclusively to develop,
have developed, make, have made, use, have used, import, have
imported, sell, offer for sale and have sold Penn Licensed Products
under the Group 2 Patents solely [*] , and solely in
conjunction with [*] proprietary [*] technology that
exists as of the Effective Date, including any improvements and
modifications thereof, (currently referred to as [*] “
[*] ” and “ [*] ” technologies,
including any modifications and improvements of the
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foregoing, and inclusive of
subsequent improvements thereto, provided that the technology
remains a [*] operably linked to some [*] proprietary
[*] technology) and that is substantial and necessary to be
used for such development, making, use, importation or sale of such
Penn Licensed Products; provided, however, that:
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(a)
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[*] may be permitted to grant sublicenses under such
license, provided that the sublicensee is similarly bound to use
such Penn Licensed Patents solely in conjunction with such
[*] proprietary [*] technology; and
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(b)
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Notwithstanding
the foregoing in any transaction or transactions between [*]
or its sublicensees on the one hand and either Targeted or
[*] on the other, in any such transaction(s), rights to the
Group 2 Patents will be obtained from Targeted based upon its
rights under this Agreement and/or [*] based upon its
sublicense from Targeted.
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2.2.3 Intentionally
Omitted.
2.2.4 Group 2 Specified
[*] Sublicenses after Year [*] . [*] ,
Targeted shall make non-exclusive, commercial-use [*] under
the Group 2 Patents available to third parties on commercially
reasonable terms, provided that (unless Targeted [*] in its
discretion): (a) each such sublicense is restricted to
[*] identified in such sublicense; (b) such [*]
is(are) not the subject of any sublicense previously granted by
Targeted or its Affiliates on an exclusive basis, nor is any such
exclusive sublicense with respect to such [*] then in active
negotiation; (c) such sublicense does not permit use in or
application to the [*] Field or in or to the [*]
Field or in or to the [*] Field; and (d) such
sublicense does not permit use or application to an [*]
applicable to any Penn Licensed Product that is then in [*]
by Targeted, its Affiliates or their licensees. Where Targeted has
[*] and [*] within [*] thereafter, Targeted
shall either inform Penn [*] , together with a statement of
the terms on which [*] , or else Targeted shall [*] ,
then Penn shall have the right to [*] , provided that
[*] under clauses (a) - (d) above (reading references to
[*] to refer [*] , and recognizing that Penn will
[*] .
2.2.5 Group 2 Diligence outside
the [*] Field . Penn shall have the right, at its
option, to [*] the right and license under this
Section 2.2 [*] outside of the [*] Field, if
Targeted and/or its Affiliates and/or sublicensees [*] , at
any time after the [*] anniversary of the Effective Date, to
have [*] at least [*] under the Group 2 Patents
outside of the [*] Field, provided that Penn gives Targeted
at least [*] prior notice of Penn’s intention to
exercise such right (unless Targeted [*] prior to the end of
such [*] period in which case no such [*] shall
occur). The Parties acknowledge and agree that, as of the
Restatement Date, [*] (the products developed under the
agreements with [*] described in Sections 4.1.8 and 4.1.9
below) are in [*] and, therefore, diligence for the Group 2
Patents has been satisfied as of the Restatement Date.
2.3 Group 3 Patents
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2.3.1 Group 3 License Grant .
Penn hereby grants to Targeted and the Covered Affiliates for the
term of this Agreement the worldwide right and license, with the
right to grant sublicenses, to develop, have developed, make, have
made, use, have used, import, have imported, sell, offer for sale
and have sold Penn Licensed Products under the Group 3 Patents in
[*] .
2.3.2 Group 3 Specified
[*] Sublicenses after Year [*] . [*] ,
Targeted shall make non-exclusive, commercial-use [*] under
the Group 3 Patents available to third parties on commercially
reasonable terms, provided that (unless Targeted [*] in its
discretion): (a) each such sublicense is restricted to
[*] identified in such sublicense; (b) such [*]
is(are) not the subject of any sublicense previously granted by
Targeted or its Affiliates on an exclusive basis, nor is any such
exclusive sublicense with respect to such [*] then in active
negotiation; (c) such sublicense does not permit use in or
application to the [*] Field or in or to the [*]
Field or in or to the [*] Field; and (d) such
sublicense does not permit use or application to any product in an
[*] applicable to any Penn Licensed Product that is then in
[*] by Targeted, its Affiliates or their licensees. Where
Targeted has [*] and [*] within [*]
thereafter, Targeted shall either inform Penn [*] , together
with a statement of the terms on which [*] , or else
Targeted shall [*] under the Group 3 Patents, provided that
[*] under clauses (a) – (d) above (reading
references therein to [*] to refer [*] and
recognizing that Penn will [*] .
2.3.3 Group 3 Diligence outside
the [*] Field . Penn shall have the right, at its
option, to [*] the right and license under this
Section 2.3 [*] outside of the [*] Field, if
Targeted and/or its Affiliates and sublicensees [*] , at any
time after the [*] anniversary after the Effective Date, to
have at least [*] under the Group 3 Patents [*] , or
at any time after the [*] anniversary of the Effective Date,
to have [*] at least [*] under the Group 3 Patents
for used outside of the [*] Field, provided that Penn gives
Targeted at least [*] prior notice of Penn’s intention
to exercise such right (unless Targeted [*] prior to the end
of such [*] period in which case no such [*] shall
occur). Targeted shall have the right, at its option and by notice
to Penn given at any time, to [*] the right and license
under this Section 2.3 (or with respect to one or more of the
Penn Patent Rights included in Group 3) [*] from the date of
such notice forward.
2.3.4 Group 3 Diligence in the
[*] Field . Penn shall have the right, at its option, to
[*] the right and license under this Section 2.3
[*] in the [*] Field if Targeted and its Affiliates
and sublicensees [*] , at any time after the [*]
anniversary after the Effective Date, to have [*] , or at
any time after the [*] anniversary of the Effective Date, to
have [*] at least [*] under the Group 3 Patents for
use in the [*] Field, provided that Penn gives Targeted at
least [*] prior notice of Penn’s intention to exercise
such right. Targeted shall have the right, at its option and by
notice to Penn given at any time on or before the [*]
anniversary of the Effective Date, to [*] the right and
license under this Section 2.3 (or with respect to one or more
of the Penn Patent Rights included in Group 3) [*] in the
[*] Field from the date of such notice forward.
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2.4 No Implied Diligence.
Targeted’s diligence obligations with respect to this
Agreement and the licenses granted hereunder are as explicitly
stated in this Article 2, and no other or additional diligence or
efforts obligations are implied, nor shall any be
inferred.
2.5 Retained Research Rights
. For all exclusive licenses granted under this Article 2: Penn
retains the reserved right to use, and to permit third parties to
use, the Penn Patent Rights strictly for educational and for
research purposes (“Research”) and to use or
commercialize the results of the Research, provided that any and
all such commercialization of results, does not fall within the
scope of any exclusive rights of Targeted or the Covered Affiliates
hereunder, and that such limitation is incorporated into a written
agreement with such third party.
2.6 Government Interest .
Targeted acknowledges that in accordance with the Federal
Government Interest, the United States government retains certain
rights in intellectual property funded in whole or part under any
contract, grant or similar agreement with a Federal agency,
including but not limited to the requirement that Penn Licensed
Products subject to Sale in the United States must be substantially
manufactured in the United States. The license grant of this
Article 2 is expressly subject to all of such rights.
2.7 Penn Technical
Information . Penn, to the extent it has rights in the Penn
Technical Information, hereby irrevocably grants Targeted and the
Covered Affiliates a non-exclusive, royalty-free, paid-up right and
license to make, use, sell, import, reproduce, disclose and
otherwise exploit the same during and after the term of this
Agreement, such license to Penn Technical Information shall not
include the right to sublicense, except in conjunction with a
sublicense of Penn Patent Rights under Article 3, and to the extent
necessary to exercise the sublicense of Penn Patent
Rights.
2.8 No Implied Licenses . No
other rights or licenses are granted by implication hereunder.
Targeted acknowledges that Penn shall have the right, in its sole
discretion and without obligation to Targeted, to grant other
parties licenses under the Penn Patent Rights so long as the same
do not conflict with, and are not within the scope of, any of the
exclusive rights or licenses granted hereunder to Targeted and the
Covered Affiliates.
ARTICLE 3 -
SUBLICENSES
3.1 The right to sublicense
conferred upon Targeted and the Covered Affiliates under this
Agreement shall be subject to the following conditions:
3.1.1 Any sublicenses shall be
subject to the terms and conditions granted to Targeted and the
Covered Affiliates under this Agreement.
3.1.2 No sublicensee (excluding, for
this purpose, [*] under that certain [*] , among
[*] , as amended, and [*] under the [*] Letter
Agreement, but including, for this purpose, any sub-sublicensee of
[*] under such agreement(s)) shall have the power to grant
further sublicenses without the express approval of Penn, which
approval shall not be
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unreasonably withheld, except that
Targeted may permit a sublicensee to further sublicense its rights
to a downstream sublicensee (“sub-sublicensee”) that is
an Affiliate of such sublicensee; or to a third party collaborator
solely for purposes of research, development or other
non-commercial purposes, or as reasonably necessary, to
manufacturers or distributors for the account of such sublicensees,
but only on condition that any such downstream sublicense agreement
(“sub-sublicense”) requires the sub-sublicensee to
comply with the applicable terms of this Agreement and prohibits
further sublicensing. For clarity, the sub-sublicensee shall
be prohibited from further sublicensing. Except when used in
this Section 3.1.2, the term sublicense includes any
sub-sublicense and the term sublicensee includes any
sub-sublicensee.
3.1.3 Targeted shall forward to
Penn, within thirty (30) days of execution, a complete and
accurate copy written in the English language of each sublicense
granted hereunder, including options to sublicense and research or
collaboration agreements granting any subset of rights under the
Patent Rights, and including rights granted by sublicensees
pursuant to 3.1.2. Penn’s receipt of such sublicense shall
not constitute an approval of such sublicense or a waiver of any of
Penn’s rights or Targeted’s obligations
hereunder.
3.1.4 Targeted shall not grant any
sublicense under any Penn Patent Rights in fields where Targeted
has non-exclusive license rights hereunder unless:
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(a)
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with respect to
Group 1 Patents, such sublicenses are (i) [*] ,
(ii) are provided in connection with the grant of bona fide
rights to material Targeted intellectual property or technology and
(iii) the grant of rights is limited to use of Group 1 Patents
in connection with such material Targeted intellectual property or
technology; or
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(b)
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such license to
Targeted hereunder was initially non-exclusive or became
non-exclusive due to an election by Targeted as provided herein
(rather than due to [*] ), and such sublicense is not a
[*] ; or
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(c)
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the conditions
in provision (b) apply except that the sublicense is a
[*] and Targeted has obtained Penn’s prior written
approval of such sublicense, which approval shall not be reasonably
withheld or delayed; or
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(d)
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if the license
to Targeted [*] , Targeted has obtained Penn’s prior
written approval of such sublicense.
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3.1.5 If Targeted becomes subject to
a Bankruptcy Event, all payments then or thereafter due and owing
to Targeted from its sublicensees shall upon notice from Penn to
any such sublicensee become payable directly to Penn for the
account of Targeted; provided however, that Penn shall remit to
Targeted the amount by which such payments exceed the amounts owed
by Targeted to Penn.
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3.1.6 Notwithstanding any such
sublicense, Targeted shall remain primarily liable to Penn for all
of Targeted’s duties and obligations contained in this
Agreement, and any act or omission of a Covered Affiliate or
sublicensee of Targeted which would be a breach of this Agreement
if performed by Targeted shall be deemed to be a breach by Targeted
of this Agreement.
3.2 Targeted and Penn acknowledge
that (i) for purposes of the [*] Letter Agreement,
[*] by this Agreement, but, rather, shall only have been
amended hereby, and (ii) [*] shall not be bound by any
amendment or alteration of the Existing Agreements, or any of them,
to the extent the same may bear on the rights or obligations of
[*] under the [*] Letter Agreement. Accordingly,
Targeted and Penn agree that this Agreement is intended to be, and
shall be construed to be, consistent with the [*] Letter
Agreement, [*] Letter Agreement shall remain in full force
and effect.
3.3. Targeted and Penn shall work
together to facilitate the process for approval of sublicenses, for
example, by having a pre-approved template for use with such
[*] .
ARTICLE 4 - ROYALTIES AND
MILESTONES
4.1 Royalties .
4.1.1 In further consideration of
the licenses granted pursuant to Article 2, but subject to
Section 4.1.4, Targeted shall pay to Penn a royalty in
accordance with the following table for the Net Sales received by
Targeted, the Covered Affiliates, or their sublicensees with
respect to each particular Penn Licensed Product that has been, or
that later is, in whole or in part developed by [*] under a
right or sublicense granted by Targeted or a Covered Affiliate or
otherwise collaboratively by [*] on the one hand and by
Targeted and/or Covered Affiliates on the other:
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For the portion of Net Sales of such Penn
Licensed Product in a Calendar Year:
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The royalty rate for
such Net Sales will be:
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Less than or equal to [*]
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[
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*]
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Greater than [*] and less than or equal
to [*]
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*]
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Greater than [*] and less than or equal
to [*]
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*]
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4.1.2 In further consideration of
the licenses granted pursuant to Article 2, but subject to
Section 4.1.4, Targeted shall pay to Penn a royalty in
accordance with the following table for the Net Sales received by
Targeted, the Covered Affiliates, or their sublicensees with
respect to each particular Penn Licensed Product to which
Section 4.1.1 above is not applicable:
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For the portion of Net Sales of such
Penn Licensed Product in a Calendar
Year:
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The royalty rate for
such Net Sales will be:
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Less than or equal to [*]
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[
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*]
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Greater than [*] and less than or equal
to [*]
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[
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*]
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Greater than [*] and less than or equal
to [*]
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[
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*]
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Greater than [*]
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[
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*]
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4.1.3 For purposes of each of
Section 4.1.1 and Section 4.1.2: (i) no additional
or multiple royalties shall be payable with respect to the Net
Sales of any Penn Licensed Product, regardless of the number of
Penn Patent Rights, or claims of Penn Patent Rights, that would in
the absence of this Agreement be infringed by such Penn Licensed
Product or processes or machines used to make it, even if such Penn
Patent Rights include those from more than one of the patent groups
defined in Section 1.20; (ii) the Net Sales thresholds in
such sections will be [*] , but where the same Penn Licensed
Product is [*] , or otherwise to accommodate the same to
[*] , the Net Sales thereof [*] shall be [*]
for purposes of Section 4.1.2; and (iii) all Net Sales of
any particular Penn Licensed Product received by any of Targeted,
Covered Affiliates, or their sublicensees will be [*] for
purposes of Section 4.1.2.