LICENSE AGREEMENT
Exhibit
10.2
Execution
Version
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 Xxxxxx Xxxxxxxx
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.
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“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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3
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.
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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).
5
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,
prosecute or defend litigation in accordance with the provisions of this
Agreement or (c) comply with Applicable Law; provided, however, that if a Party
is required to make any such disclosure of the other Party’s Confidential
Information in connection with any of the foregoing, it will give reasonable
advance notice to the other Party of such disclosure requirement and will use
reasonable efforts to assist such other Party in efforts to secure confidential
treatment of such information required to be disclosed.
Section 3.02 Limited Disclosure And
Use. NexMed
and Warner each agree that any disclosure of the other Party’s Confidential
Information to any of its employees, consultants, Affiliates, agents,
subcontractors, or sublicensees shall be made only if and to the extent
necessary to carry out its rights and responsibilities under this Agreement,
shall be limited to the maximum extent possible consistent with such rights and
responsibilities, and shall only be made to the extent any such Persons are
bound by confidentiality obligations to maintain the confidentiality thereof and
not to use such Confidential Information except as expressly permitted by this
Agreement. Neither Party shall disclose or transfer the other Party’s
Confidential Information to any Third Parties under any circumstance without the
prior written approval from the other Party, except as otherwise required by
Applicable Law, and except as otherwise expressly permitted by this Agreement.
Each Party shall take such action, and shall cause its employees, consultants,
Affiliates, agents, subcontractors, and sublicensees to take such action, to
preserve the confidentiality of the other Party’s Confidential Information as it
would customarily take to preserve the confidentiality of its own Confidential
Information. In connection with the termination of this Agreement,
upon the request of the other Party, each Party will return all the Confidential
Information disclosed or transferred to it by the other Party pursuant to this
Agreement, including all copies and extracts of documents and all manifestations
of Confidential Information in any form, within sixty (60) days of such request;
provided however, that a Party may retain (a) any Confidential Information of
the other Party relating to any license which expressly survives such
termination and (b) one (1) copy of all other Confidential Information in
inactive archives solely for the purpose of maintaining a record of information
and materials deemed to be Confidential Information hereunder.
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Section 3.03 Publicity. Neither
Party may publicly disclose the existence or terms or any other matter of fact
regarding this Agreement without the prior written consent of the other Party;
provided, however, that either Party may make such a disclosure (a) to the
extent required by Applicable Law or by the requirements of any nationally
recognized securities exchange, quotation system or over-the-counter market on
which such Party has its securities listed or traded, or (b) to any actual or
prospective sublicensees, investors, lenders, other financing sources,
acquirors, or companies being acquired by such Party who are obligated to keep
such information confidential. The Party desiring to make any such
public announcement or disclosure shall inform the other Party of the proposed
announcement or disclosure in reasonably sufficient time prior to public release
and shall provide the other Party with a written copy thereof. Each
Party shall cooperate fully with the other with respect to all disclosures
regarding this Agreement to the Securities Exchange Commission and any other
Governmental Authority, including requests for confidential treatment of
proprietary information of either Party included in such
disclosure.
ARTICLE
4
Ownership
of Inventions, Enforcement and Defense of Claims
Section 4.01 Ownership of Permeation
Inventions. In the event that an invention, improvement,
discovery, data and/or other Technology is conceived solely by or on behalf of
Warner or made jointly by employees, agents and consultants of Warner and
NexMed, and is a discovery, invention, improvement or new use of the Licensed
Know-How or permeation enhancing excipient technology that is derived from the
Licensed Know-How (a “Permeation Invention”), such
Permeation Invention shall be the sole and exclusive property of NexMed, and
Warner agrees to assign, and hereby does assign, its entire right, title and
interest in and to such Permeation Invention to NexMed. Thereafter,
all assigned Permeation Inventions shall be part of the “Licensed Know-How”
under this Agreement.
Section 4.02 Notice Of
Infringement. If, during the Term, either Party learns of any
actual, alleged or threatened infringement by a Third Party of any Licensed
Patents in the Field in the Territory, such Party shall notify the other Party
within fifteen (15) days of becoming aware of such infringement and shall
provide such other Party with available evidence of such
infringement.
7
Section 4.03 Infringement Of Licensed Patents or
Licensed Know-How. In the event any actual, alleged or
threatened infringement, misappropriation or violation of the Licensed Patents
or the Licensed Know-How in the Territory relating to any Competing Product
including ancillary invalidity claims that occurs at such time that there is no
product approved for sale in the Territory covered by a claim in a Licensed
Patent or that uses Licensed Know-How, other than the Product marketed by
Warner, its Affiliates or Sublicensees pursuant to Section 2.01; then Warner
shall be deemed to be the “Controlling Party” for purposes of this Section
4.03. Otherwise, NexMed shall be deemed to be the “Controlling
Party”. The Controlling Party shall have the first right (but
not the obligation), at its own expense and with legal counsel of its own
choice, to institute, prosecute and control any action, suit or proceeding (or
take other appropriate legal action) against any actual, alleged or threatened
infringement, misappropriation or violation of the Licensed Patents or the
Licensed Know-How in the Territory relating to any Competing Product including
ancillary invalidity claims. The non-Controlling Party shall have the right, at
its own expense, to be represented in any such action, suit or proceeding
brought by the Controlling Party by counsel of the non-Controlling Party’s own
choice; provided, however, that under no circumstances shall the foregoing
affect the right of the Controlling Party to control the action, suit or
proceeding as described in the third sentence of this Section
4.03. Notwithstanding the foregoing, neither Party shall settle,
compromise or otherwise resolve any such action, suit or proceeding that (i) in
the case of a settlement by NexMed, materially restricts or waives rights under
the Licensed Patents or Licensed Know-How granted to Warner hereunder and (ii)
in the case of a settlement by Warner, materially restricts or waives any rights
under the Licensed Patents or Licensed Know-How, in each case without the prior
written consent of the other Party which consent shall not be unreasonably
withheld, conditioned or delayed. If the Controlling Party does not
file any action, suit or proceeding against any such infringement,
misappropriation or violation within six (6) months after the earliest of notice
under Section 4.02, or a written request from the non-Controlling Party to take
action with respect to such infringement, misappropriation or violation, then
the non-Controlling Party shall have the right (but not the obligation), at its
own expense, to bring an action, suit or proceeding (or take other appropriate
legal action) against such actual, alleged or threatened infringement,
misappropriation or violation with legal counsel of its own choice, but shall
not be permitted to settle, compromise or otherwise resolve any such suit
without the prior written consent of the Controlling Party, which consent shall
not be unreasonably withheld, conditioned or delayed. Any damages,
monetary awards or other amounts recovered by a Party, whether by judgment or
settlement, pursuant to any suit, proceeding or other legal action taken under
this Section 4.03, shall be applied as follows:
(a) first,
to reimburse the Parties for their respective out-of- pocket costs and expenses
(including reasonable attorneys’ fees and costs) incurred in prosecuting such
enforcement action; and
(b) second,
any remaining balance shall be retained by or paid to the Party bringing such
suit, proceeding or action; provided that in all cases Warner shall be entitled
to any portion of such remaining balance that represent compensation for lost
sales, royalty or profits with respect to the Product.
Section 4.04 Joinder; Cooperation. If a Party brings any
such action, suit or proceeding hereunder, the other Party hereby consents to be
joined as a plaintiff if necessary to prosecute such action, suit or proceeding,
and to give the Party bringing such action, suit or proceeding reasonable
assistance and authority to file and prosecute the action, suit or proceeding;
provided, however, that
neither Party shall be required to transfer any right, title or interest in or
to any property to the other Party or any Third Party to confer standing on such
other Party hereunder.
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Section 4.05 Trademark Maintenance and
Enforcement. From the Effective Date and during the Term, Warner shall
establish, maintain and enforce the Licensed Trademark in the
Territory. In the event that either Party becomes aware of any
infringement of the Licensed Trademark by a Third Party in the Territory, such
Party shall promptly notify the other Party and the Parties shall consult with
each other in good faith with respect thereto and shall jointly determine how to
proceed with respect to such infringement, including by the institution of legal
proceedings against such Third Party.
Section 4.06 Defense of
Claims. In the event that any action, suit or proceeding is
brought against NexMed or Warner or any Affiliate or Sublicensee of either Party
alleging the infringement of the Patents, Know-How or intellectual property
rights of a Third Party by reason of the Development, manufacture, use, sale,
importation or offer for sale of a Licensed Product in the Territory then Warner
shall indemnify, defend and hold NexMed, its Affiliates and their respective
directors, officers, employees, stockholders and agents and their respective
successors, heirs and assigns harmless in accordance with the indemnification
provisions of the Purchase Agreement.
ARTICLE
5
Disclaimer
Of Warranties; Claims
Section 5.01 Disclaimer Of
Warranties. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THE
PURCHASE AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY
WARRANTY, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE
OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES,
WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF
QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY
WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY
INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
Section 5.02 Claims. Any and
all direct claims between the Parties or brought by a Third Party against either
Party arising out of, based upon or relating to this Agreement, including any
breaches hereunder, shall be handled in accordance with and subject to Article 6
of the Purchase Agreement.
ARTICLE
6
Term
And Termination
Section 6.01 Term; Expiration. This Agreement shall
commence on the Effective Date and shall continue unless terminated as provided
herein (the “Term”).
Section 6.02 Termination for Breach. Other
than as provided in Section 6.03 or Section 6.04, Nexmed may terminate this
Agreement only if (i) Warner breaches ARTICLE 3, (ii) Warner fails to
cure such breach within sixty (60) days written notice by Nexmed; and (iii) such
breach causes or is likely to cause a material adverse impact on Nexmed’s patent
rights or business; and (iv) termination of this Agreement is the only
appropriate remedy for such breach.
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Section 6.03 Termination for Other
Causes. Either Party (the
“Terminating
Party”)
shall have the right to terminate this Agreement immediately upon
written notice, (i) if the other Party shall file a petition in bankruptcy, or
if an involuntary petition in bankruptcy shall be filed against the other Party
and such petition shall not be dismissed within sixty (60) days, or if a
receiver or guardian has been appointed for the other Party, or (ii) upon the
dissolution, termination of existence or insolvency of the other
Party.
Section 6.04 Patent
Challenge. NexMed will be permitted to terminate this
Agreement by written notice effective upon receipt if Warner or its Affiliates
directly, or indirectly through assistance granted to a Third Party, commence
any interference or opposition proceeding, challenge the validity or
enforceability of (other than in defense of an action for infringement of a
Patent Controlled by Warner), or oppose any extension of or the grant of a
supplementary protection certificate with respect to, any Licensed Patent (each
such action, a “Patent
Challenge”). Warner will include provisions in all agreements
granting sublicenses of Warner’s rights hereunder providing that if the
Sublicensee or its Affiliates undertake a Patent Challenge with respect to any
Licensed Patent under which the sublicensee is sublicensed, Warner will be
permitted to terminate such sublicense agreement. If a sublicensee of
Warner (or an Affiliate of such sublicensee) undertakes a Patent Challenge of
any such Licensed Patent under which such Sublicensee is sublicensed, then
Warner upon receipt of notice from NexMed of such Patent Challenge will
terminate the applicable sublicense agreement. If Warner fails to so
terminate such sublicense agreement, NexMed may terminate Warner’s right to
sublicense and any sublicenses previously granted to such sublicensee shall
automatically terminate. In connection with such sublicense
termination, Warner shall cooperate with NexMed’s reasonable requests to cause
such a terminated sublicensee to discontinue activities with respect to the
Licensed Product.
Section 6.05 Additional Termination Right of
Warner. Warner shall also have the right to terminate this
Agreement, for
any reason and without cause upon not less than sixty (60) days prior written
notice to Nexmed.
Section 6.06 Effect of
Termination. Upon termination of this Agreement or any right
or license pursuant to Section 6.02 through Section 6.05, the rights and
obligations of the Parties hereunder, and all licenses granted to Warner
hereunder shall immediately cease.
Section 6.07 Surviving
Provisions. Notwithstanding any provision herein to the
contrary, the rights and obligations of the Parties set forth in Section 6.06,
and Section 7.04 and ARTICLE 3 as well as any rights or obligations otherwise
accrued hereunder, shall survive the expiration or termination of the Term for
any reason.
ARTICLE
7
Miscellaneous
Section 7.01 Jurisdiction. The Parties
agree that any suit, action or proceeding seeking to enforce any provision of,
or based on any matter arising out of or in connection with, this Agreement or
the transactions contemplated hereby shall be brought in the United States
District Court for the District of New Jersey or any New Jersey State court, so
long as one of such courts shall have subject matter jurisdiction over such
suit, action or proceeding, and that any cause of action arising out of this
Agreement shall be deemed to have arisen from a transaction of business in the
State of New Jersey, and each of the Parties hereby irrevocably consents to the
jurisdiction of such courts (and of the appropriate appellate courts therefrom)
in any such suit, action or proceeding and irrevocably waives, to the fullest
extent permitted by law, any objection that it may now or hereafter have to the
laying of the venue of any such suit, action or proceeding in any such court or
that any such suit, action or proceeding brought in any such court has been
brought in an inconvenient forum. Process in any such suit, action or
proceeding may be served on any Party anywhere in the world, whether within or
without the jurisdiction of any such court.
10
Section 7.02 Notification. All notices,
requests and other communications hereunder shall be in writing, shall be
addressed to the receiving Party’s address set forth below or to such other
address as a Party may designate by notice hereunder, and shall be either (i)
delivered by hand, (ii) made by facsimile transmission (to be followed with
written confirmation by the delivering Party), (iii) sent by private courier
service providing evidence of receipt, or (iv) sent by registered or certified
mail, return receipt requested, postage prepaid. The addresses and
other contact information for the Parties are as follows:
|
If
to NexMed:
|
NexMed,
Inc.
00
Xxxx Xxxxxx Xxxxx
Xxxx
Xxxxxxx, XX 00000
Attn:
Chief Financial Officer
Fax: (000)
000-0000
|
|
With
a copy to:
|
Xxxxxx,
Xxxxx & Xxxxxxx LLP
000
Xxxxxxxx Xxxxxx
Xxxxxxxxx,
Xxx Xxxxxx 00000
Attn:
Xxxxx X. Xxxxxx
Fax: (000)
000-0000
|
|
If
to Warner:
|
Xxxxxx
Xxxxxxxx Company, Inc.
XX
Xxx 0000
Xxxxxxx,
Xxxxxx Xxxx 00000
Attn: Director,
Business Management
Fax: (000)
000 0000
|
|
With
a copy to:
|
Xxxxxx
Xxxxxxxx (US), LLC
000
Xxxxxxxxxx Xxxxx
Xxxxxxxx,
Xxx Xxxxxx 00000
Attn:
General Counsel
Fax:
(000)
000-0000
|
11
All
notices, requests and other communications hereunder shall be deemed to have
been given either (i) if by hand, at the time of the delivery thereof to the
receiving Party at the address of such Party set forth above, (ii) if made by
facsimile transmission, at the time that receipt thereof has been acknowledged
by the recipient, (iii) if sent by private courier, on the day such notice is
delivered to the recipient, or (iv) if sent by registered or certified mail, on
the fifth (5th)
business day following the day such mailing is made.
Section 7.03 Language. This
Agreement has been prepared in the English language and the English language
shall control its interpretation.
Section 7.04 Governing
Law. This Agreement will be construed, interpreted and applied
in accordance with the laws of the State of New Jersey, excluding its body of
law controlling conflicts of law.
Section 7.05 Entire
Agreement. This Agreement, together with the Purchase
Agreement and the Ancillary Agreements, is the entire Agreement between the
Parties with respect to the subject matter hereof and supersedes all prior
representations, understandings and agreements between the Parties with respect
to the subject matter hereof.
Section 7.06 Amendment. No
modification to this Agreement shall be effective unless in writing with
specific reference to this Agreement and signed by the Parties.
Section 7.07 Waiver. The terms
or conditions of this Agreement may be waived only by a written instrument
executed by the Party waiving compliance. The failure of either Party
at any time or times to require performance of any provision hereof shall in no
manner affect its rights at a later time to enforce the same. No
waiver by either Party of any condition or term shall be deemed as a continuing
waiver of such condition or term or of another condition or term.
Section 7.08 Headings. Section
and subsection headings are inserted for convenience of reference only and do
not form part of this Agreement.
Section 7.09 Assignment. Warner
may transfer or assign this Agreement to an Affiliate or a Third Party without
the consent of NexMed. NexMed may not transfer or assign this
Agreement or any of the Licensed Patents to any Third Party without the written
consent of Warner; except that NexMed may transfer or assign this Agreement or
any of the Licensed Patents without such consent to an entity that (i) agrees in
writing that it will not market in the Field a product that is covered by a
claim in a Licensed Patent or (ii) acquires all or substantially all of the
capital stock, business or assets of NexMed (whether by merger, reorganization,
acquisition, sale or otherwise) and which entity agrees in writing to be bound
by the terms and conditions of this Agreement. The provisions of this
Agreement shall be binding upon and inure to the benefit of the Parties and
their respective successors and assigns.
Section 7.10 Construction. The
Parties hereto acknowledge and agree that: (i) each Party and its
counsel reviewed and negotiated the terms and provisions of this Agreement and
have contributed to its revision; (ii) the rule of construction to the effect
that any ambiguities are resolved against the drafting Party shall not be
employed in the interpretation of this Agreement; and (iii) the terms and
provisions of this Agreement shall be construed fairly as to all Parties hereto
and not in favor of or against any Party, regardless of which Party was
generally responsible for the preparation of this Agreement. Neither
Party shall challenge the validity or enforceability of the terms, conditions,
obligations and covenants hereunder.
12
Section 7.11 Severability. If
any provision(s) of this Agreement are or become invalid, are ruled illegal by
any court of competent jurisdiction or are deemed unenforceable under Applicable
Law from time to time in effect, it is the intention of the Parties that the
remainder of this Agreement shall not be affected thereby provided that a
Party’s rights under this Agreement are not materially affected. The
Parties hereto covenant and agree to renegotiate any such term, covenant or
application thereof in good faith in order to provide a reasonably acceptable
alternative to the term, covenant or condition of this Agreement or the
application thereof that is invalid, illegal or unenforceable, it being the
intent of the Parties that the basic purposes of this Agreement are to be
effectuated.
Section 7.12 Status. Nothing in
this Agreement is intended or shall be deemed to constitute a partner, agency,
employer-employee, or joint venture relationship between the
Parties.
Section 7.13 Section
365(n). All licenses granted under this Agreement are deemed
to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of
right to “intellectual property” as defined in Section 101 of such
Code.
Section 7.14 Further
Assurances. Each Party agrees to execute, acknowledge and
deliver such further instructions, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
Section 7.15 Counterparts. This
Agreement may be executed simultaneously in one or more counterparts (including
by facsimile), each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument. This Agreement
shall become effective when each Party shall have received a counterpart hereof
signed by the other Party. Until and unless each Party has received a
counterpart hereof signed by the other Party, this Agreement shall have no
effect and no Party shall have any right or obligation hereunder (whether by
virtue of any other oral or written agreement or other
communication). No provision of this Agreement is intended to confer
any rights, benefits, remedies, obligations or liabilities hereunder upon any
Person other than the Parties and their respective successors and
assigns.
Section 7.16 Expenses. Except as otherwise
provided herein, all costs and expenses incurred in connection with this
Agreement shall be paid by the Party incurring such cost or
expense. All excise, sales, use, value added, registration stamp,
recording, documentary, conveyancing, franchise, property, transfer, gains and
similar taxes, levies, charges and fees incurred in connection with the
transactions contemplated by this Agreement shall be borne by
Warner.
Section 7.17 WAIVER OF JURY TRIAL. EACH OF THE PARTIES
HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL
PROCEEDING ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE TRANSACTIONS
CONTEMPLATED HEREBY.
13
Section 7.18 Specific
Performance. The Parties agree that irreparable damage would
occur if any provision of this Agreement were not performed in accordance with
the terms hereof and that the Parties shall be entitled to an injunction or
injunctions to prevent breaches of this Agreement or to enforce specifically the
performance of the terms and provisions hereof in the courts referred to in
Section 7.01, in addition to any other remedy to which they are entitled under
Applicable Law or in equity.
Section 7.19 Fulfillment of
Obligations. Any obligation of any party to any other party
under this Agreement, which obligation is performed, satisfied or fulfilled by
an Affiliate of such party, shall be deemed to have been performed, satisfied or
fulfilled by such Party.
[Signature
Page Follows]
14
IN
WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their
duly authorized representative.
|
By:
|
/s/ Xxx
Xxxxxx
|
|
Name:
|
Xxx
Xxxxxx
|
|
Title:
|
Senior
Director
|
|
By:
|
/s/
Xxxxxx Xxx
|
|
Xxxxxx
Xxx
|
|
|
Title:
|
President
&
CEO
|
SIGNATURE
PAGE TO THE LICENSE AGREEMENT
SCHEDULE
A
Licensed
Patents
|
Patent No.
|
Appln. No.
|
Filed
|
Granted
|
Nominal Expiration Date
(Without Term Extension, If
Any Applicable)
|
Title
|
|||||||
|
5,082,866
|
07/566,758
|
14-Aug-1990
|
21-Jan-1992
|
21-Jan-2009
|
Biodegradable
Absorption Enhancers
|
|||||||
|
NMD-102
|
6,046,244
|
08/964,509
|
5-Nov-1997
|
April
4, 2000
|
5-Nov-2017
|
Topical
Compositions For Prostaglandin E1
Delivery
|
||||||
|
NMD-107
|
6,118,020
|
09/314,571
|
19-May-1999
|
12-Sep-2000
|
19-May-2019
|
Cystalline
Salts Of Dodecyl 2-(N, X-Xxxxxxxxxxxxx)-Xxxxxxxxxx
|
||||||
|
XXX-000
|
6,224,573
|
09/232,360
|
15-Jan-1999
|
May
1, 2001
|
15-Jan-2019
|
Medicament
Dispenser
|
||||||
|
NMD-113
|
6,414,028
|
09/542,668
|
4-Apr-2000
|
July
2, 2002
|
5-Nov-2017
|
Topical Compositions
Containing Prostaglandin X0
|
||||||
|
XXX-000
|
6,841,574
|
10/336,481
|
3-Jan-2003
|
11-Jan-2005
|
3-Jan-2023
|
Topical
Stabilized Prostaglandin E Compound Dosage
Forms
|
SCHEDULE
B
Licensed
Trademark
U.S.
Registration No. 2,801,021 ACCUDOSE, for medical devices, namely, single-use
dispensers for semi-solid pharmaceuticals.
