Exhibit 10.2
Execution
Version
LICENSE AGREEMENT
This License Agreement (this “
Agreement ”) is made effective as of February 3, 2009
(the “ Effective Date ”) by and between NexMed
Inc., a Nevada corporation (“ NexMed ”), and
Warner Chilcott Company, Inc., a Puerto Rico corporation (“
Warner ”). NexMed and Warner are each
hereinafter referred to individually as a “ Party
” and together as the “ Parties .”
Capitalized terms that are used and not defined in this Agreement
shall have their respective meanings set forth in the Purchase
Agreement (as defined below).
WHEREAS, the Parties have entered into an Asset
Purchase Agreement dated as of February 3, 2009 (the “
Purchase Agreement ”) pursuant to which Warner will
purchase the Purchased Assets (as defined in the Purchase
Agreement) from NexMed;
WHEREAS, NexMed is retaining certain Licensed
Patents (as defined below) and Licensed Know-How (as defined below)
that is necessary to or useful for exploiting the Purchased Assets;
and
WHEREAS, the Purchase Agreement contemplates
that the Parties shall enter into this Agreement simultaneously
with the Closing.
NOW, THEREFORE, in consideration of the mutual
covenants contained herein, and for other good and valuable
consideration, the receipt and adequacy of which are hereby
acknowledged, the Parties hereby agree as follows:
ARTICLE 1
Definitions
Section 1.01 Definitions . The
following initially capitalized terms, as used herein, have the
following meanings:
“ Affiliate ” means any
corporation, firm, limited liability company, partnership or other
entity that controls or is controlled by or is under common control
with a Party to this Agreement. For purposes of this
Section, “control” means ownership, directly or
indirectly through one or more Affiliates, of fifty percent (50%)
or more of the shares of stock entitled to vote for the election of
directors, in the case of a corporation, or fifty percent (50%) or
more of the equity interests in the case of any other type of legal
entity, status as a general partner in any partnership, or any
other arrangement whereby a person or entity controls or has the
right to control the board of directors or equivalent governing
body of a corporation or other entity, or otherwise has the ability
to direct the affairs or operations of such person.
“ ANDA Product ” means a
product that is the subject of an Abbreviated New Drug Application,
as defined under 21 U.S.C. § 355(j), filed by a Third Party
with the FDA, for which the Licensed Product is the reference
listed drug.
“ API ” means
alprostadil.
“ Approval ” means, with
respect to any Licensed Product, approval from the FDA (as
hereafter defined) for the marketing, use and sale of the Licensed
Product in the Territory.
“ Competing Product ” means
any Third Party pharmaceutical product for use in the Field,
including any ANDA Product.
“ Confidential Information ”
means with respect to a Party all trade secrets, processes,
formulae, data, know-how, improvements, inventions, chemical
materials, assays, techniques, marketing plans, strategies,
customer lists, or other information that has been created,
discovered, or developed by such Party, or has otherwise become
known to such Party, or to which rights have been assigned or
licensed to such Party, as well as any other information and
materials that are deemed confidential or proprietary to or by such
Party (including all information and materials of such
Party’s customers and any other Third Party and their
consultants), in each case that are disclosed by such Party to the
receiving Party, whether orally, visually, in writing or by way of
any other media, whether before or after the Effective Date of this
Agreement, that if disclosed in tangible form is marked
“confidential,” or if disclosure is not in tangible
form, the disclosing Party has notified the receiving Party at the
time of disclosure that such disclosure is confidential and
summarized such disclosure in writing, marking the summary
“confidential” and submitting it to the receiving Party
(or, if applicable, to such of the receiving Party’s
Affiliates or sublicensees to whom disclosure has been made) within
thirty (30) days of the disclosure. Confidential
Information shall not include any such information, data or
materials to the extent that the receiving Party can demonstrate
that such information, (a) as of the date of disclosure is known to
the receiving Party or its Affiliates other than by virtue of a
prior confidential disclosure to the receiving Party or its
Affiliates; (b) as of the date of disclosure is, or subsequently
becomes, publicly known, through no fault or omission of the
receiving Party or its Affiliates; (c) is obtained from a Third
Party having a lawful right to make such disclosure free from any
obligation of confidentiality to the disclosing Party; or (d) is
independently developed by or for the receiving Party or its
Affiliates without reference to or reliance upon any Confidential
Information of the disclosing Party.
“ Control ” or “
Controlled ” means, with respect to any Technology or
Patents, the ownership thereof or the possession by a Party of
rights under such Technology or Patents sufficient to permit it to
grant licenses or sublicenses to such Technology or Patents as
provided for herein, in each case without violating the terms of
any legally binding agreements between a Party and any Third Party
in existence as of the Effective Date.
“ Development ” or “
Develop ” means, with respect to a Licensed Product,
all clinical and other development activities undertaken to obtain
Approval of such Licensed Product in accordance with this
Agreement. When used as a verb, “Developing”
means to engage in Development and “Developed” shall
have a corresponding meaning.
“ FDA ” means the United
States Food and Drug Administration and any successor agency or
authority thereto.
“ Field ” means the topical
treatment of male erectile dysfunction.
“ Licensed Know-How ” means
all Technology that is Controlled by NexMed that is necessary or
useful for Warner to Develop, make, use or sell the Licensed
Product in the Territory other than the Transferred
Technology.
“ Licensed Patents ” means
the Patents that are Controlled by NexMed that are necessary or
useful for Warner to Develop, make, use or sell the Licensed
Product in the Territory other than the Transferred Technology,
including the Patents set forth on Schedule A
.
“ Licensed Product ” means
any form or dosage of a pharmaceutical product for use in the Field
that contains API as an active ingredient.
“ Licensed Trademark ” means
the trademark set forth on Schedule B .
“ OTC Product ” shall mean a
Licensed Product for sale over-the-counter.
“ Patents ” means all rights
arising under patents or patent applications (including any patents
issuing therefrom), as well as any substitutions, continuations,
continuations-in-part, divisionals and all reissues, renewals,
reexaminations, extensions, supplementary protection certificates,
confirmations, revalidations, registrations or patents of addition
in connection with any of the foregoing.
“ Sublicensee ” means any
Third Party or Affiliate of Warner to whom Warner grants a
Sublicense of the rights granted to Warner under this Agreement, as
provided under Section 2.02.
“ Technology ” means, whether
or not patentable, any and all proprietary ideas, inventions,
discoveries, trade secrets, processes, formulae, data, know-how,
improvements, inventions, chemical materials, assays, techniques,
marketing plans, strategies, customer lists, biologic materials,
results, designs, specifications, methods, formulations, ideas,
technical information (including structural and functional
information), process information, pre-clinical information,
clinical information, any and all proprietary biological, chemical,
pharmacological, toxicological, pre-clinical, clinical, assay,
control and manufacturing data and materials or other
information.
“ Territory ” means the
United States of America, including its possessions and
territories.
“ Third Party ” means any
Person other than Warner, NexMed and their respective
Affiliates.
Section 1.02 Additional Definitions
. Each of the following terms is defined in the Section
set forth opposite such term:
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Term
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Section
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Agreement
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Preamble
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Controlling
Party
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Section
4.03
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Effective
Date
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Preamble
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NexMed
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Preamble
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OTC
Commercialization Notice
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2.05
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Party
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Preamble
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Parties
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Preamble
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Patent
Challenge
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6.04
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Purchase
Agreement
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Recitals
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Permeation
Invention
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Section
4.01
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Term
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6.01
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Terminating
Party
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6.03
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Warner
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Preamble
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Section 1.03
Other Definitional and
Interpretative Provisions . The words
“hereof”, “herein” and
“hereunder” and words of like import used in this
Agreement shall refer to this Agreement as a whole and not to any
particular provision of this Agreement. The captions
herein are included for convenience of reference only and shall be
ignored in the construction or interpretation
hereof. References to Articles and Sections are to
Articles and Sections of this Agreement unless otherwise
specified. Any singular term in this Agreement shall be
deemed to include the plural, and any plural term the
singular. Whenever the words “include”,
“includes” or “including” are used in this
Agreement, they shall be deemed to be followed by the words
“without limitation”, whether or not they are in fact
followed by those words or words of like import. When
the words “not to be unreasonably withheld” are used in
this Agreement, they shall be deemed to be followed by the phrase
“, conditioned or delayed”, whether or not they
are in fact followed by that phrase or a phrase of like
import. “Writing”, “written” and
comparable terms refer to printing, typing and other means of
reproducing words (including electronic media) in a visible
form. References to any agreement or contract are to
that agreement or contract as amended, modified or supplemented
from time to time in accordance with the terms hereof and
thereof. References to any Person include the successors
and permitted assigns of that Person. References from or
through any date mean, unless otherwise specified, from and
including or through and including,
respectively. References to “law” or
“laws” shall be deemed to include any and all
Applicable Law.
ARTICLE 2
Grant Of
Rights
Section 2.01 License To Warner
. Subject to the terms and conditions of this Agreement,
NexMed, on behalf of itself and its Affiliates, hereby grants to
Warner:
(a) a
perpetual, exclusive (even as to NexMed and its Affiliates but
subject to Section 5.03 of the Purchase Agreement), fully
transferable, fully sublicensable, royalty-free, fully paid-up
license under the Licensed Patents and Licensed Know-How to
Develop, have Developed, make, have made, use, have used, sell,
distribute for sale, have distributed for sale, offer for sale,
have sold, import or have imported Licensed Products in the Field
in the Territory; and
(b) a
perpetual, exclusive (even as to NexMed and its Affiliates but
subject to Section 5.03 of the Purchase Agreement), fully
transferable, fully sublicensable, royalty-free, fully paid-up
license under the Licensed Trademark solely in connection with the
Development, manufacture and commercialization the Licensed Product
in the Field in the Territory.
Section 2.02 Right to Sublicense
. Warner shall have the right to grant sublicenses under
the exclusive licenses granted pursuant to Section
2.01. In connection with the grant of any permitted
sublicense hereunder, Warner shall ensure that each of its
Affiliates and Sublicensees accepts and complies with all of the
terms and conditions of this Agreement as if such Affiliates or
Sublicensees were a party to this Agreement and Warner shall
guarantee and remain obligated for the performance (or failure of
performance) of any Affiliate or Sublicensee hereunder.
Section 2.03 Retained Rights
. Except as expressly provided hereunder, NexMed and its
Affiliates reserve all other rights in and to the Licensed
Know-How, Licensed Patents and Licensed Trademark, including
retaining all rights to the Licensed Trademark outside the
Territory. Notwithstanding anything else contained
herein to the contrary, NexMed and its Affiliates at all times
reserve such rights under the Licensed Know-How and Licensed
Patents as is necessary to allow NexMed and its Affiliates to
Develop, manufacture and supply Licensed Products outside the
Territory.
Section 2.04 Right of Reference.
Each Party and its Affiliates will, upon reasonable
request, provide the other Party and its Affiliates, its licensees
and sublicensees with access to and a right to reference and use
any filings with the FDA related to the Licensed Product including
drug master files.
Section 2.05 OTC Product . If
at any time during the Term, Warner determines in good faith that
it is reasonably likely that an OTC Product could be (i)
manufactured under a commercially viable manufacturing process and
(ii) sold in compliance with Applicable Law, then Warner shall
notify NexMed within ninety (90) days of such determination whether
it intends to Develop and commercialize such OTC Product (such
notice, the “ OTC Commercialization Notice
”). Following delivery of an OTC Commercialization
Notice reflecting Warner’s intent to Develop and
commercialize an OTC Product, the parties shall promptly determine
in good faith the fair market value of such OTC Product and Warner
shall promptly pay to NexMed an amount equal to such fair market
value; provided that if the Parties cannot agree on such fair
market value, an independent valuation expert reasonably acceptable
to both Parties shall be retained to determine such
value. Notwithstanding the foregoing, if Warner fails to
provide the OTC Commercialization Notice within the period
described in this Section 2.05 or such notice reflects a
determination not to Develop and Commercialize the OTC Product, the
rights granted to Warner to Develop and commercialize the OTC
Product in the Field and in the Territory under this Agreement
shall revert to NexMed and NexMed shall thereafter have the
unencumbered right to grant one or more Third Parties the right to
Develop and commercialize the OTC Product (it being understood that
nothing in this Section 2.05 shall in any way limit the rights
granted to Warner pursuant to Section 2.01 with respect to any
prescription pharmaceutical product included in the Licensed
Products).
Section 2.06 Licensed Trademark
. The Licensed Trademark shall be used by Warner only
pursuant to the terms of this Agreement to identify and in
connection with the marketing and sale of Licensed Product in the
Field in the Territory, and shall not be used by Warner to identify
or in connection with the marketing of any other
products. Warner shall comply with NexMed’s
trademark guidelines and specifications as provided to Warner on
the Effective Date as may be reasonably amended from time to time
by NexMed upon reasonable prior written notice to Warner (it being
understood Warner shall be free to utilize any existing inventories
containing the Licensed Trademark prior to the amendment of such
guidelines or specifications) in connection with its use of the
Licensed Trademark in all promotional materials, advertisements,
packaging, labeling and trade dress. Warner agrees to
use the Licensed Trademark with the necessary trademark
designations, and shall use the Licensed Trademark in a manner that
does not derogate from NexMed’s and its Affiliates’
rights in the Licensed Trademark. Warner agrees that it
will take no action that will interfere or diminish NexMed’s
or its Affiliates’ rights in the Licensed
Trademark. Warner agrees that all use of the Licensed
Trademark will inure to the benefit of NexMed and its
Affiliates. The Licensed Trademark shall be owned by
NexMed or its Affiliates and, upon the request of NexMed, Warner
agrees to assign any rights (other than the rights granted
hereunder) it may have in the Licensed Trademark to
NexMed. Warner shall have no rights under this Agreement
in or to the Licensed Trademark or the goodwill pertaining thereto
except as specifically provided herein.
ARTICLE 3
Treatment
Of Confidential Information
Section 3.01 Confidentiality Obligations
. Each of NexMed and Warner agree that during the Term
and for ten (10) years thereafter, it will keep confidential, and
will cause its employees, consultants, Affiliates, agents,
subcontractors, and Sublicensees to keep confidential, all
Confidential Information of the other Party. Neither
NexMed nor Warner nor any of their employees, consultants,
Affiliates, agents, subcontractors, or Sublicensees shall use
Confidential Information of the other Party for any purpose
whatsoever other than exercising any rights granted to it or
reserved by it hereunder. Without limiting the
foregoing, each Party may disclose information to the extent such
disclosure is reasonably necessary to (a) file and prosecute patent
applications and/or maintain patents which are filed or prosecuted
in accordance with the provisions of this Agreement, or (b)
file,
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