CONFIDENTIAL DOCOSANOL DATA TRANSFER & PATENT LICENSE AGREEMENT
Exhibit 10.21
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “***”. A COMPLETE
VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE
EXCHANGE ACT OF 1934.
CONFIDENTIAL
DOCOSANOL DATA TRANSFER & PATENT LICENSE AGREEMENT
THIS DOCOSANOL DATA TRANSFER & PATENT LICENSE AGREEMENT is made and entered into as of July
6, 2006 (“Effective Date”) between Avanir Pharmaceuticals, a California corporation
(“Avanir”) and Healthcare Brands International Limited of 00 Xxxxx Xxxx Xxxxxx, Xxxxxx
X0X 0XX (“HBI”).
BACKGROUND
Avanir is the owner of certain data, know-how, trade secrets, confidential information,
inventions, technology, and patent rights and that (i) pertain to Docosanol, (ii) relate to use of
Docosanol in the treatment of viral infections and inflammations of skin and mucous membranes in
humans, and other medicinal uses, and (iii) include certain medicinal formulations and
manufacturing methods of products containing Docosanol.
The United States Food and Drug Administration (“FDA”) has approved Avanir’s New
Drug Application in the United States of America (“USA”) and Avanir received approval of
its Marketing Authorization Application (“MAA”) from the Swedish Medical Products Agency
(“MPA”) under a Mutual Recognition Process (“MRP”) relating to products incorporating
Docosanol for topical, human use for the treatment of herpes labialis.
HBI is interested in obtaining access to certain of Avanir’s proprietary data and know-how,
and Avanir is willing to grant such access on the terms and conditions of this Agreement.
HBI is interested in obtaining from Avanir a license to Avanir’s patent rights relating to
the use of Docosanol and Avanir is willing to grant such license and access on the terms and
conditions of this Agreement.
NOW, THEREFORE, in consideration of the monetary consideration set forth in this Agreement
and of the terms, conditions and agreements contained in this Agreement, and for other good and
valuable consideration, the receipt and adequacy of which are acknowledged, Avanir and HBI agree
as follows:
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Article I. DEFINITIONS
Words and phrases used in this Agreement which are not otherwise defined will be interpreted in
accordance with the common usage for such term in English in the USA. Technical terms unless
otherwise defined will be interpreted consistent with their common usage in the relevant
scientific field. Some terms are defined in this Agreement parenthetically, and such terms will
have the meanings apparent from the context in which such terms are parenthetically defined. When
used in this Agreement, each of the following defined terms will have the meanings set forth in
this Section.
Section 1.01 “Additional Territories” means Italy, Greece, Cyprus, Turkey, Romania,
Sweden, Denmark, Norway and/or Finland.
Section 1.02 “Additional Rights” means Avanir’s Know-how and/or Intellectual Property in
so far as it relates to any of the Additional Territories, including without limitation those
rights set out in Schedule 1.12.
Section 1.03 “Affiliate(s)” means, with respect to each party, any organization,
corporation, company, firm, or other entity that controls, is controlled by, or is under common
control with such party. In this context “control” shall mean the ability to control the
management of a company, whether through ownership of voting rights, contract, ability to control
or appoint the board or otherwise.
Section 1.04 “Approval Date” has the meaning specified in Section 5.01.
Section 1.05 “Business Day” means any day other than a Saturday, Sunday or any other day
which is a public holiday in England.
Section 1.06 “Data” means any data, results, know-how, and information which Avanir owns,
controls or has a license (with a right to sublicense) and relating to Docosanol or that is
necessary or useful to the manufacture, use or sale of Products, including, without limitation,
data or information incorporated either in Avanir’s approved New Drug Application in the USA or
the MAA, chemical compositions of monomers, derivatives, designs, polymers, solvents, catalysts,
formulae, specifications, designs, chemical and physical data, clinical data, information
concerning concentrations, combinations, indications, dosage strengths and sizes or packaging,
preparations, synthesis, processes, formulations, administrations, applications, toxicity,
operations, regulatory affairs and marketing.
Section 1.07 “Docosanol” means docosanol ***and any other *** ***.
Section 1.08 “European Rights” means all of Avanir’s Know-how and Intellectual Property in
so far as it relates to the Territory, including without limitation those rights set out in
Schedule 1.13.
Section 1.09 “First Commercial Sale” means, in the Territory the first commercial sale,
where sale means ***, whichever comes first, of a Product by HBI, its Affiliates or sublicensees
to any person or entity other than HBI, its Affiliates or sublicensees following Territory
Registration.
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Section 1.10 “Improvements” means any and all improvements, developments, alterations or
modifications to the Product made or developed by Avanir or HBI from time to time, solely to the
extent that the composition, manufacture or use of any such item would be dominated by the
Licensed Patents at the time when discovered or made or would require use of Know-how.
Section 1.11 “Intellectual Property” means all patents and patent applications (including
the Licensed Patents), registered and unregistered designs, design rights, copyright works or
other intellectual property rights from time to time owned by Avanir in relation to the creation,
manufacture, Registration, marketing, promotion, distribution and/or sale of the Products and/or
Docosanol, including any Improvements.
Section 1.12 “Know-how” means all of the Data, drawings, designs, specifications,
processes, knowledge, correspondence, technical information and expertise from time to time owned
or controlled by Avanir in relation to the creation, manufacture, Registration, marketing,
promotion, distribution and/or sale of the Products and/or Docosanol and its packaging, including
any Improvements.
Section 1.13 “Licensed Patents” means all (i) patents and patent applications in the
Territory which generally or specifically claim a Product, a process for manufacturing or
formulating a Product, an intermediate contained in a Product, or use of a Product and which are
owned or controlled by Avanir, including without limitation those listed in Schedule 1.13
and those owned by Avanir under Section 3.06; (ii) any divisionals, continuations, refilings, and
extensions of any of the foregoing patents and patent applications; and (iii) all substitutions,
reissues, renewals, reexaminations, patents of addition, and inventors’ certificates thereof,
patent term extensions, supplementary protection certificates and exclusivity extensions of the
foregoing patents.
Section 1.14 “Product(s)” means any finished or semi-finished product that contains
Docosanol (either as the sole ingredient or in combination with any other ingredient, substance or
compound, regardless of whether any other such ingredient, substance or compound is claimed as or
considered to be an “active ingredient” or not) in any and all concentrations, formulations,
preparations, administrations, combinations or dosage strengths and sizes thereof, together with
all expansions and Improvements thereon, the manufacturing, use or sale of which would, but for
the licenses granted hereunder, infringe any Licensed Patent or employ any Know-how.
Section 1.15 “Registration” means satisfaction of registration (including any duplicate
marketing authorizations) or notification requirements and receipt of approvals, licenses,
registrations or authorizations of any appropriate regulatory agency, department, bureau or other
government entity, necessary for the commercialization of the Product, including any manufacture,
use, storage, import, transport or sale of Products or the equivalent from the appropriate
governmental agency in any relevant country of the Territory or Additional Territory.
Section 1.16 “Territory” means Russia, the Ukraine and the nations of the European Union
as of the Effective Date, but not any of the following countries: Italy, Greece, Cyprus, Turkey,
Romania, Sweden, Denmark, Norway or Finland; provided, however, that if HBI has been granted a
license pursuant to Section 2.07 in respect of any Additional Territory, such Additional Territory
shall become part of the Territory and references to Territory shall thereafter be construed
accordingly. Other countries may be added to the Territory by the parties from time to time upon
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the mutual execution of an amendment to this Agreement adding such countries and upon the payment
of mutually agreed consideration therefor.
Section 1.17 “Third Party” or “Third Parties” means any person, organization,
corporation, company, firm, or other entity that is not a party hereto or an Affiliate of either
party.
Article II. DATA TRANSFER & PATENT LICENSE
Section 2.01 Data Transfer. In consideration for the fee paid by HBI and in order to
support HBI’s direct pursuit of applications for Registrations for marketing approval of Products
in the Territory, Avanir (A) hereby grants HBI the right to access and reference the Data, (B)
will execute such letters of authorization or consents as reasonably requested by HBI in
connection with the foregoing, (C) will make available the Data which is the entire contents of
the approved Swedish MAA regulatory submission for 10% docosanol cream in the treatment of herpes
labialis, and pre-clinical data relating to any Product, including, without limitation, copies of
all existing clinical data, documents, papers, protocols, results and analyses and all
correspondence relating to the Swedish approval, and (D) will transfer, or cause to be
transferred, to HBI all regulatory licenses for Products in the Territory existing as of the
Effective Date. This Data represents a significant investment on the part of Avanir, and is
considered proprietary to Avanir. HBI, therefore, agrees to retain control over this Data and not
to transfer Data to Third Parties other than to regulatory authorities in the Territory or to
regulatory consultants of HBI who are obligated in writing to maintain its confidentiality without
advance written approval of Avanir.
Section 2.02 Patent License Grant. Subject to all the terms, payments and limitations of
this Agreement, Avanir hereby grants to HBI an exclusive license under the European Rights to
make, have made, use, have used, offer to sell, sell, have sold through distributors and import
Products in the Territory, and to subcontract such rights as reasonably required to exercise the
rights granted hereunder and to grant sub-licenses of such rights upon approval by Avanir, not to
be unreasonably withheld or delayed, and subject to the terms set forth in Schedule 2.
For clarity, as a consequence of the exclusive license granted herein, Avanir will not carry on or
procure any Third Party to carry on any activities within the scope of such license. Accordingly,
Avanir shall not seek customers in the Territory and will not maintain a distribution depot in the
Territory for sales of Product to customers in the Territory. Notwithstanding the foregoing,
Avanir shall be entitled to manufacture Product in the Territory for the sole purpose of exporting
Product outside the Territory provided that Avanir shall not sell or supply Product to any Third
Party in the event Avanir believes or has reasonable cause to believe that such Third Party
intends to sell such Product into the Territory. HBI shall not seek customers outside the
Territory and will not maintain a distribution depot outside the Territory for sales of Product to
customers outside the Territory. Notwithstanding the foregoing, HBI shall be entitled to
manufacture Product outside the Territory for the sole purpose of exporting Product into the
Territory provided that HBI shall not sell or supply Product to any Third Party in the event that
HBI believes or has reasonable cause to believe that such Third Party intends to sell such Product
outside the Territory.
Section 2.03 Duty to Supplement the Data. Subject to any contractual prohibitions by
which Avanir is bound as of the Effective Date, in the event that Avanir receives any supplemental
Data or other Know-how or copies of correspondence with regulatory authorities outside the
Territory from any other licensees or any other source that relates to the Products, Avanir will
promptly
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provide such updates of Data and/or Know-how to HBI. Upon request of HBI, Avanir shall request
permission from other licensees of Products to share any such information which Avanir receives
with HBI, solely for use by HBI under the terms of this Agreement. Avanir will also make
available, upon request, content from the US NDA 20-941 to HBI for use in seeking and supporting
Product Registrations in the Territory. HBI shall be permitted to reference such US NDA and any
other regulatory filings made by Avanir or its licensees in the Additional Territories to the
extent reasonably necessary to obtain Registrations in the Territory.
Section 2.04 Data Transfer Fees. In consideration for the transfer of the Data as a
know-how and data transfer fee, HBI will pay to Avanir, (a) the sum of £750,000 within ten (10)
business days of the execution of this Agreement and (b) the sum of £750,000 within 30 days of
receipt of each of the first two grants in the Territory by the appropriate regulatory authorities
of the regulatory approvals necessary to commence sales, including Registration and pricing
approvals if required, in each case with respect to approvals which are received after the
Effective Date.
Section 2.05 Taxes. HBI will pay and bear the expense of local, state and/or federal
government license, sales and use, property and ad valorem taxes and any custom duties, fees or
charges which may be imposed or assessed on it with respect to manufacture or sales of Products in
the Territory under this Agreement.
Section 2.06 Deferred Compensation. In accordance with Schedule 2 and in further
consideration for the licenses granted pursuant to Section 2.02, for (a) sales or
sublicenses of Product rights, (b) sales of HBI and (c) initial public offerings, Licensee will
pay Avanir non-refundable amounts as calculated on Schedule 2. For clarity, no royalties
shall be due on sales of Products hereunder.
Section 2.07 “Additional Territories License”. Avanir grants HBI a right of first offer
to obtain a license under the terms set out in Section 2.02 of the relevant Additional Rights in
respect of each of the Additional Territories. This shall mean that before making any offer to
any Third Party of, or making direct use by Avanir following expiration, termination or
renegotiation of any existing license agreement relating to, any of the Additional Rights (or any
interest in any of them), directly or indirectly, Avanir shall first notify HBI in writing of the
of its offer of such Additional Rights and shall give HBI *** Business Days in which to
decide whether it wishes to acquire the rights which are the subject of such written offer. If
HBI wishes to acquire such Additional Rights, HBI and Avanir shall then negotiate terms to extend
the licenses hereunder to include such rights in good faith for a period of no more than 60 days
from the end of the first *** Business Day period. If such terms are agreed within such period,
and Avanir has as of such date obtained by reversion from an existing licensee, rights to any
Registrations relevant to the Product in such part of the Additional Territory as has become part
of the Territory pursuant to this Section 2.07, Avanir shall transfer such rights to HBI upon the
execution of the amendment adding such Additional Territory. If HBI and Avanir are not able to
agree on such terms within such additional 60 day period then Avanir may thereafter offer such
Additional Rights to any Third Party on financial terms which are substantially equivalent to the
terms that were last offered to HBI.
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Article III. INTELLECTUAL PROPERTY
Section 3.01 Patent Prosecution and Maintenance.
(a) Discretionary Duty to Prosecute and Maintain: Avanir shall, at Avanir’s expense,
use all commercially reasonable efforts to prosecute or cause to be prosecuted or continue to
prosecute to allowance or final rejection in the Territory the patent applications included in the
Licensed Patents. Avanir shall, at Avanir’s expense use all commercially reasonable efforts to
maintain any issued patents described within the Licensed Patents. Avanir shall promptly provide
HBI with copies of all correspondence with patent offices relevant to the foregoing efforts. If,
subject to Avanir’s obligation to use all commercially reasonable efforts as provided herein,
Avanir fails to so file, prosecute, cause to be prosecuted, or maintain the Licensed Patents, HBI
may elect to do so.
(b) HBI’s Right to Consult: Avanir shall furnish HBI with copies of all
correspondence relating to the Licensed Patents to and from patent offices in the Territory and
shall provide HBI a reasonable time to offer its comments thereon, provided that in the event that
delay would jeopardize any potential patent right, Avanir shall use all commercially reasonable
efforts to proceed without awaiting HBI’s comments on any patent application or correspondence.
HBI shall have the right to consult with Avanir regarding the content of the patent applications
included in the Licensed Patents in the Territory and to comment on any prosecution thereof.
Avanir shall consider all such comments offered by HBI in good faith, it being agreed, however,
that all final decisions respecting conduct of the prosecution of said patent applications shall
rest solely in the discretion of Avanir. Any legal fees or expenses incurred by HBI under this
Section 3.01 shall be the sole responsibility of HBI.
(c) Abandonment of Prosecution: Avanir shall notify HBI in the event Avanir decides
at any time, subject to Avanir’s obligation to use all commercially reasonable efforts as provided
herein, to abandon or discontinue prosecution of any one or more of the patent applications
included in the Licensed Patents in the Territory, including any decisions to discontinue pursuit
of applications which have been finally rejected. Such notification will be given as early as
possible which in no event will be less than *** days prior to the date on which said
application(s) will become abandoned. HBI shall have the option, exercisable upon written
notification to Avanir, to assume full responsibility, at its discretion and expense, for the
prosecution of the affected patent application(s). Under no circumstances shall any such expense
paid by HBI be refundable to HBI by Avanir. Under no circumstance shall any such assumption of
responsibility on the part of HBI affect ownership of any such patent application or any patent
issuing thereon.
(d) Abandonment of Opposition Contest: Should a priority or opposition contest
develop in any patent office or other forum within the Territory relating to a patent or patent
application within the Licensed Patents which Avanir does not believe it would be commercially
reasonable to defend, then HBI shall be given *** days notice in which to elect to continue
prosecuting and defending such patent or patent applications at HBI’s own expense. Otherwise, HBI
shall pursue and bear the cost of any such contest and shall have control of such contest. Avanir
shall provide HBI with all cooperation and available documents required by HBI to prosecute any
such priority
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or opposition contest not pursued by HBI, including cooperation of any licensor or
consultants of Avanir, at HBI’s expense. Avanir shall have the right to participate in any such
contest, or designate its own counsel to so participate, at Avanir’s own expense, throughout each
step of such priority or opposition contest. Under no circumstance shall any such expenses or fees
paid by HBI
be refundable to HBI by Avanir. Under no circumstances shall any such election on the part of HBI
affect ownership of any such patent or patent application, including any patent issuing thereon.
(e) Patent Term Extension: In the event that applicable law in any country in the
Territory provides for the extension of the term of any patent included among Licensed Patents,
Avanir shall, upon request of HBI, apply for and use all commercially reasonable efforts to obtain
such an extension or, should the law require HBI to so apply, Avanir hereby gives permission to
HBI to do so. HBI and Avanir agree to cooperate with one another in obtaining such extension.
Avanir agrees to cooperate with HBI in the exercise of the authorization granted herein and will
execute such documents and take such additional action as HBI may reasonably request in connection
therewith.
Section 3.02 Enforcement of Patent Rights Against Third Parties. If either party becomes
aware of any product or activity of any Third Party that involves infringement or violation of any
of Avanir’s proprietary rights licensed to HBI hereunder, then such party will promptly notify the
other party in writing of such infringement or violation. Subject to Section 3.03, Avanir may in
its sole discretion take or not take whatever action it believes is appropriate in connection
with, and will have the right to initiate an infringement or other appropriate suit against, any
Third Party who is suspected of infringing or misappropriating any Licensed Patents, invention or
technology included in any Products or the Data in the Territory. If Avanir elects to take
action, HBI will fully cooperate therewith at Avanir’s expense. If Avanir initiates and
prosecutes any such action under this section, all legal expenses (including court costs and
attorneys’ fees) will be for Avanir’s account. All amounts awarded by way of judgment, settlement
or compromise and any such damages, royalties, settlement fees or other consideration received by
Avanir will be shared by the parties in proportion to the damages that each has suffered in
relation to such infringement. Avanir will have the sole and exclusive right to select counsel
for any such suit but shall consult with HBI in that regard. If necessary, HBI may be joined as a
party to the suit and will cooperate fully with respect to such suit and will offer such
assistance to Avanir as Avanir reasonably requests in connection therewith at no charge except for
reimbursement of reasonable out-of-pocket expenses (including attorneys’ fees) incurred in
rendering such assistance.
Section 3.03 Enforcement of Patent Rights Against Third Parties by HBI. If Avanir
declines to (or does not agree to) enforce or initiate an infringement or other appropriate suit
against an infringing Third Party in the Territory within *** Business Days of HBI
informing it of a claim, or, notwithstanding Section 3.02, to the extent such infringement relates
to the Territory, HBI will have the right to xxx in respect of any such infringement in the
Territory and shall be entitled to all amounts awarded by way of judgment, settlement or
compromise, provided, however, that Avanir will be entitled to a *** percent (***%) share of any
damages or payments (other than for reimbursement of costs or expenses, including attorneys’ fees)
received by HBI from such Third Party(s). If HBI elects to take such action, Avanir will fully
cooperate therewith at HBI’s expense
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and will not itself take any conflicting action under
Section 3.02 (though it may take action in respect of countries which are not within the
Territory). HBI may in any event seek injunctive relief in appropriate cases without notice to or
consent from Avanir.
The parties shall keep one another informed of the status of and of their respective activities
regarding any litigation or settlement thereof concerning Product pursuant to this Section 3.03 or
Section 3.02, provided, however, that no settlement or consent judgment or other voluntary final
disposition of any suit defended or action brought by a party pursuant to this Article 3
may be entered into without the consent of the other party if such settlement would require the
other party to be subject to an injunction or to make a monetary payment or would otherwise
adversely affect the other party’s rights under this Agreement or the validity, scope or
enforceability of the Licensed Patents.
Section 3.04 Confidential Information. Each party to this Agreement acknowledges that in
order for Avanir and HBI to carry out their respective obligations under this Agreement, it may be
necessary for Avanir and HBI to disclose to each other certain non-public and valuable business
information (“Confidential Information”), which shall include without limitation
information exchanged or provided under Sections 2.01, 2.03 and 4.02 hereof. Each party to this
Agreement agrees: (a) not to reveal or make available any Confidential Information of the other to
any Third Party, (except (i) to agents engaged to obtain Registrations in the Territory who have
entered into confidentiality agreements in a form acceptable to Avanir or (ii) as such disclosure
may be specifically approved in writing by the party against whom such disclosure is sought and
except as such disclosure may be required by the receiving party’s compliance with legal
requirements and in any such case such party will promptly notify the other party of any such
legally required disclosure) and to ensure that it will treat such Confidential Information of the
other party in the same manner as it treats its own Confidential Information, such treatment to be
at least the degree that a reasonable person would perform under similar circumstances; (b) to
ensure that Affiliates, sublicensees, employees, agents, associates or other persons to whom such
disclosure may be made or who may otherwise have access to such Confidential Information of the
other have, directly or indirectly, agreed in writing to safeguard and maintain such Confidential
Information of the other and not to disclose or use such Confidential Information of the other
except as expressly provided herein; (c) to ensure that Confidential Information of the other is
not used for the receiving party’s benefit except as such benefits are expressly contemplated in
this Agreement; (d) to prohibit the Confidential Information of the other from being duplicated in
any manner; except as is reasonably necessary to perform the tasks and obligations contemplated
under this Agreement; and (e) to prohibit the Confidential Information of the other from being
published in any form without the express written consent from the disclosing party. The
obligations of this Section with respect to Confidential Information of the other Party will
continue during the term of this Agreement and for 10 years thereafter. For clarity, this
Section 3.04 shall not be deemed to prevent HBI from subcontracting or sublicensing under
Section 2.02 or either Party from making any permitted assignment under Section
7.03.
Section 3.05 Trademarks. HBI will have no right to use the Avanir trade name or any Avanir
trademark. HBI will solely own any trademark or trademarks selected by HBI for use in connection
with the sale of the Products in the Territory, together with any registrations or pending
registration applications or intent to use filings therefor, and HBI will be solely responsible
for use and registration of such trademarks and all related costs and expenses.
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Section 3.06 Improvements. Each party will solely own any and all Improvements that each
such party invents, develops, discovers or creates, without any obligation to the other party with
respect thereto other than as expressly provided herein. Subject to mutual agreement on
applicable terms
and conditions, HBI will grant to Avanir a non-exclusive license outside the Territory to any
HBI-owned Improvements.
Article IV. REGULATORY MATTERS
Section 4.01 Additional Studies. HBI will be responsible for (a) conducting any
additional pre-clinical, clinical or non-clinical studies reasonably necessary or required to be
conducted in order to obtain or to maintain in effect Registrations of the Products in the
Territory and (b) all costs and expenses associated therewith.
Section 4.02 Registrations. Avanir hereby grants to HBI the right to communicate directly
with applicable government agencies. HBI will be solely responsible for, will manage, direct and
control the application process and will directly communicate with each applicable agency required
in order to prepare and submit an application for Registration with health care authorities in at
least *** countries in the Territory within *** months from the Effective Date. HBI
will directly bear all costs and expenses of, and will own, all applications for Registrations.
Avanir will assist HBI in the regulatory matters as appropriate, and HBI will compensate Avanir
for its personnel’s reasonable time and expenses *** man hours will be provided with Avanir’s
executive hours and non-executive hours to be charged to HBI at $***/hour and $***/hour
respectively, plus expenses). Each party will notify the other immediately by telephone (with
prompt, written follow-up) of any inquiry, contact or communication received from any governmental
regulatory agency or other official body which adversely relates to or impacts upon the Products
or any component or ingredient thereof (including, without limitation, any issuance of any
Registration administrative decree relating to a recall of the Products or the imposition of any
post marketing surveillance period), and will promptly furnish the other party with copies of all
written communications relating thereto sent to or received from such regulatory agency. HBI will
keep Avanir informed of the status of the Registration efforts on a current basis and will furnish
Avanir, upon Avanir’s reasonable request, copies of all of the documents, data and other
information supplied to or received from the government in the Territory or other any approval
authority in connection with the Registration. Avanir will have the right to be informed of, and
upon HBI’s request, will participate in and attend discussions regarding any Registration in the
Territory or any administrative decree. Upon receipt of the Registrations, HBI will promptly
furnish Avanir copies or other evidence thereof.
Section 4.03 Adverse Event Data Exchange. In the event that either party or its
Affiliates or licensees (or, in HBI’s case, sub-licensees) obtains, directly or indirectly,
information, data, inquiries complaints or reports on any Adverse Events (as defined in accordance
with ICH Guidelines) relevant to a Product during the development, marketing and distribution of
any of the Products, such party will disclose, as soon as reasonably practicable and, in
accordance with applicable laws, such information and data to the other party. In any event, each
party shall inform the other party of any Adverse Event of which it becomes aware in a timely
manner commensurate with the seriousness of the Adverse Event and in compliance with ICH
Guidelines. HBI will be
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responsible for reporting all Adverse Events to the appropriate
regulatory authorities in the countries in the Territory in accordance with the appropriate laws
and regulations of the relevant countries and authorities and Avanir or its other licensees will
be responsible for reporting all
Adverse Events to the appropriate regulatory authorities in the countries outside the Territory.
HBI will ensure that its Affiliates and sublicensees comply with all such reporting obligations,
and Avanir will use commercially reasonable efforts to ensure that its Affiliates and other
licensees comply with all such reporting obligations.
Section 4.04 Labeling. HBI agrees that (a) in any part of the Territory, the Product’s
packaging and all Product labeling will only be in the primary languages of the country(ies) where
the Product is being sold, and (b) in any country of the Territory where there is a Licensed
Patent, the word “patented” will appear on the Product’s packaging in a place determined by HBI in
its sole discretion, in each case to the extent practicable and permissible under any applicable
law.
Article V. ALLOCATIONS OF RESPONSIBILITIES AND RISKS.
Section 5.01 Commercialization & Manufacturing of Products. HBI will use all
commercially reasonable efforts to apply its marketing and sales expertise to maximize the sale of
the Products in the Territory as soon as is reasonably practical. Such efforts shall include that
the First Commercial Sale will occur no later than *** months after the receipt of all
regulatory approvals required to commence sales, including Registration and pricing approvals if
required, in each country, which approvals are received after the Effective Date (each such date,
an “Approval Date”). As between Avanir and HBI, throughout the term of this Agreement,
HBI will be solely responsible for and entitled to (and Avanir shall refrain from and shall not
assist or procure any Affiliate or Third Party unless at the request of HBI to): (a) manufacture
or have manufactured the Products for distribution and sale in the Territory and any related
packaging, (b) acquire or cause to be acquired all manufacturing equipment and licenses,
including, without limitation, plant, equipment and facilities licenses and approvals, necessary
to enable the manufacture and testing of the Products, (c) obtaining any required importation
licenses or approvals for importation of bulk Docosanol or fully manufactured Products into the
Territory, (d) report matters regarding the manufacture of Products to relevant regulatory
authorities and handle and respond to any appropriate governmental agency inspections with respect
to manufacturing of Products, all in accordance with applicable laws and regulations.
Section 5.02 WARRANTIES.
(a) Avanir represents that it owns the Know-How and the Licensed Patents and has all power
and authority necessary to grant the licenses and rights to HBI under this Agreement.
(b) Avanir further warrants and represents that there is nothing in any Third Party agreement
Avanir has entered into as of the Effective Date which, in any way, will limit Avanir’s ability to
perform all of the obligations undertaken by Avanir hereunder, and that it will not enter into any
Agreement after the Effective Date under which Avanir would incur any such limitations.
*** | Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. |
10
(c) Nothing in this Agreement shall be construed as a warranty that Licensed Patents are
valid or enforceable as of the Effective Date, or that they will be so during the term of this
Agreement; provided, however, that Avanir hereby warrants and represents that it has no present
knowledge from which it can be inferred that Licensed Patents are invalid or that their exercise
would infringe patent rights of Third Parties, and that the Licensed Patents have been filed,
prosecuted and maintained in good faith to date. Avanir further warrants and represents that it
has no present knowledge from which it can be inferred that the use of or the process of
manufacturing Product, and all intermediates of such process, will infringe patent rights of Third
Parties in any country in the Territory.
(d) Avanir warrants and represents that, it has furnished to HBI, or will, pursuant to
Article 2 hereof, furnish to HBI, copies of all clinical information and correspondence with
regulatory authorities in the Territory relevant to Products that are in the possession of Avanir
as of the Effective Date.
(e) Avanir warrants and represents that the officers of Avanir have no present knowledge of
the existence of any pre-clinical or clinical results or findings concerning the Product which it
has not provided to HBI prior to the Effective Date and which results or findings in Avanir’s
reasonable opinion, evidences any issue of quality, toxicity, safety and/or efficacy that would
materially impair marketing and sale of the Product.
(f) AVANIR EXPRESSLY DISCLAIMS ANY OTHER WARRANTY AND ESPECIALLY WITH RESPECT TO (A) THE
QUALITY, EFFICACY OR EFFICIENCY OF THE PRODUCTS, DATA OR OTHER INFORMATION TO BE DELIVERED UNDER
THIS AGREEMENT; AND (B) MERCHANTABILITY OF ANY DATA, PRODUCTS OR KNOW-HOW, OR FITNESS FOR A
PARTICULAR PURPOSE WITH RESPECT TO ANY AND ALL OF THE FOREGOING.
Section 5.03 Limitation of Liability. TO THE EXTENT PERMITTED BY APPLICABLE LAW, NEITHER
HBI NOR AVANIR WILL BE LIABLE WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT UNDER ANY
CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER THEORY FOR COST OF PROCUREMENT OF SUBSTITUTE
GOODS, SERVICES, TECHNOLOGY OR RIGHTS OR FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES. NEITHER
AVANIR NOR HBI WILL BE LIABLE FOR ANY AMOUNTS AGGREGATING IN EXCESS OF THE AMOUNTS PAID TO IT (FOR
AVANIR) OR BY IT (FOR HBI) HEREUNDER, PROVIDED THAT THIS LIMITATION SHALL NOT APPLY TO THE
INDEMNITIES SET OUT IN SECTION 5.04.
Section 5.04 Indemnification.
(a) Notice of Indemnified Claims. If during the term of this Agreement, either party
receives notice of or becomes aware of any Third Party claim against such party or its Affiliates
or sublicensees, which claim is subject to indemnification by the other party under this
Section 5.04 (an “Indemnified Claim”), such party seeking indemnification will
promptly inform the other party of such claim and all relevant and applicable facts relating
thereto in writing.
11
(b) Defense of Indemnified Claims. Upon receiving a notification of an Indemnified
Claim, the indemnifying party will have sole discretion with respect to and will solely control,
at the indemnifying party’s expense, the defense of any such Indemnified Claim. The indemnifying
party will keep the indemnified party fully informed regarding the status of any negotiations or
suits relating to such Indemnified Claim. The indemnified party will cooperate fully with the
indemnifying party and will offer such assistance to the indemnifying party as the indemnifying
party requests in connection with the defense of any such Indemnified Claim at no charge to the
indemnifying party, except for reimbursement of reasonable out-of-pocket expenses incurred in
rendering such assistance. The indemnifying party will have the right to join the indemnified
party as a party to any lawsuit relating to such Indemnified Claim at the indemnifying party’s
expense and the indemnified party will have the right to be represented therein by legal counsel
of its own choice at the indemnified party’s expense. The indemnifying party will not settle any
such suit if such settlement would have an affect on the rights of the indemnified party without
obtaining the prior written consent of the indemnified party, which consent will not be
unreasonably withheld. The indemnifying party’s obligation to indemnify under this Section
5.04 will not apply to the extent that the party seeking indemnification (i) failed to comply
with the obligations under this Section 5.04; or (ii) contributed to such loss, damage,
injury, liability or claim by any act, or by an omission to perform some duty imposed by law, this
Agreement or other contract between the parties, on the indemnified party. The indemnification
rights of either party under this Section 5.04 will be the sole remedy for any claims for
which either such party seeks indemnification under this Section 5.04.
(c) Indemnification of Avanir by HBI. HBI will defend, indemnify and hold harmless
Avanir, its successors, assigns, officers, directors, employees and agents from any and all
claims, causes of action, losses, liabilities and expenses (including, but not limited to,
reasonable attorneys’ fees) to Third Parties (including Avanir’s employees and any sublicensee)
arising out of any personal injury, death, environmental damage or property damage resulting from
HBI’s creation, manufacture, Registration, marketing, promotion, distribution and/or sale of
Docosanol or Products or any other of HBI’s acts or omissions in relation to (i) any defects in
design, materials or workmanship of any kind or (ii) failure to comply with any applicable laws or
misappropriation of any Third Party rights related to the manufacture, labeling, marketing,
advertising, distribution, transportation, sale and use of the Docosanol or Products by HBI or its
Affiliates or sublicensees or by any Third Party acting under any contract with HBI or with HBI’s
knowledge, consent or approval, or (c) claims that any HBI trademark used by it in relation to the
Products infringes any trademark rights owned by a Third Party.
(d) Indemnification of HBI by Avanir. Avanir will defend, indemnify and hold
harmless HBI, its successors, assigns, officers, directors, employees and agents from any and all
claims, causes of action, losses, liabilities and expenses (including, but not limited to,
reasonable attorneys’ fees) to Third Parties (including HBI’s employees and any sublicensee)
arising out of any personal injury, death, environmental damage or property damage resulting from
Avanir’s failure to comply with any applicable laws, or claims that HBI’s approved use or sale of
Products infringes any patent or similar right owned by a Third Party in the Territory. If an
action is commenced by a Third Party against HBI seeking a preliminary or permanent injunction
with respect to the use of the Products by HBI and Avanir is unable to either obtain a written
opinion of patent counsel that HBI is not infringing the third-party’s patent, or that such patent
is invalid, or a license to such Third Party’s patent, despite use of best efforts, then HBI will
cease any such infringement or misappropriation unless it will release Avanir from any
indemnification
12
obligations arising out of subsequent infringement by HBI. Avanir shall further
defend, indemnify and hold harmless HBI, its successors, assigns, officers, directors, employees
and agents from any and all claims, causes of action, losses, liabilities and expenses (including,
but not limited to, reasonable attorneys’ fees) to Third Parties (including Avanir’s employees and
any sublicensee) arising out of any personal injury, death, environmental damage or property
damage resulting from Avanir’s creation, manufacture, Registration, marketing, promotion,
distribution and/or sale of Docosanol or Products outside of the Territory, including in relation
to (i) any defects in design,
materials or workmanship of any kind or (ii) failure to comply with any applicable laws or
misappropriation of any Third Party rights, related to the manufacture, labeling, marketing,
advertising, distribution, transportation, sale and use of the Products by Avanir or its
Affiliates or sublicensees or by any Third Party acting under any contract with Avanir or with
Avanir’s knowledge, consent or approval, or (c) claims that any Avanir trademark infringes any
trademark rights owned by a Third Party.
Section 5.05 Insurance. To provide each indemnified party under this Agreement with
adequate assurance of indemnification, for the term of this Agreement and for a period of five
years after the expiration of this Agreement or its earlier termination, each party will obtain
and maintain, at its sole cost and expense, product liability insurance in amounts, which are
reasonable and customary in the local pharmaceutical industry considering the respective size and
activities of the two parties. Such product liability insurance will insure against all
liability, including liability for personal injury, physical injury and property damage. Each
party will provide written proof of the existence of such insurance to the other party upon
request.
Section 5.06 Compliance with Export and Other Laws. Each party to this Agreement hereby
covenants to comply with, and the performance of the terms of this Agreement will be subject to
all applicable treaties, laws, statutes, rules and regulations of any federal, state or local
governmental entity or instrumentality, including without limitation, the provisions of the USA
Export Administration Act of 1969, as amended.
Article VI. TERM & TERMINATION
Section 6.01 Term. Unless otherwise terminated as set forth below, the term of this
Agreement will commence on the date of this Agreement and will continue until and automatically
expire, on a country by country basis upon the later to occur of (a) the 15th anniversary of the
First Commercial Sale in each respective country of the Territory or (b) the date the last claim
of any Licensed Patent licensed under this Agreement expires or is invalidated that covers sales
of Products in each such country of the Territory. Upon expiration of the term of this Agreement
in each such country of the Territory, HBI will thereafter retain a fully paid-up perpetual,
irrevocable, royalty-free, exclusive license under the Intellectual Property and Know-how in such
country.
Section 6.02 Material Breach by HBI. If HBI materially breaches, materially defaults or
otherwise materially fails to perform under the terms of this Agreement, Avanir may terminate this
Agreement by giving *** days advanced written notice, unless HBI will cure such breach,
default or failure of performance within such *** day period or (where it is not reasonably
possible to cure within such period) within such longer period as may be reasonable in all the
circumstances
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13
provided that HBI is continuing to use its reasonable endeavors to cure such breach.
For the avoidance of doubt, a failure of HBI to (i) prepare and file the application for
Registration in at least *** countries of the Territory within *** months after the Effective Date
or (ii) complete the First Commercial Sale of Products in each country by the *** month
anniversary of the relevant Approval Date will each be considered a breach of this Agreement,
entitling Avanir to terminate the Agreement as provided herein but, in the case of (ii), only with
respect to the relevant country. For clarity, the parties agree that in the event that HBI in
good faith disputes the existence of a
material breach by HBI, the dispute shall be resolved pursuant to Section 7.06 prior to any
termination pursuant to this Section 6.02 becoming effective, and that during the pendency of any
such proceedings, the parties shall remain bound by the terms and conditions of this Agreement.
Section 6.03 Lack of Funding. Notwithstanding anything else in this Agreement to the
contrary, in the event that HBI fails to close a transaction providing funding to HBI in at least
the amount of *** million within *** days of the Effective Date, Avanir will have the
right to terminate this Agreement and the licenses granted herein upon *** days notice, unless HBI
closes such financing within such second ***-day period.
Section 6.04 Material Breach by Avanir. If Avanir materially breaches, materially
defaults or otherwise materially fails to perform under the terms of this Agreement, HBI may
terminate this Agreement by giving *** days advanced written notice to Avanir, unless Avanir cures
such breach, default or failure of performance within such *** day period.
Section 6.05 Continuing Obligations. Termination of this Agreement by either party for any
reason under the terms and conditions of this Agreement will not affect obligations of either
party incurred prior to termination or the right of either party to recover damages from any
breach thereof or affect HBI’s obligations to pay Avanir any fees, milestones, or other payments
that have accrued as of the date of such termination. In the event Avanir terminates this
Agreement for non-payment of fees under Section 5 by HBI, all amounts then owing by HBI
will immediately become due and payable.
Section 6.06 Remedies. Upon termination of this Agreement by either party for any reason
under the terms and conditions of this Agreement, neither party will incur any liability
whatsoever for any damage, loss or expenses of any kind suffered or incurred by the other arising
directly and solely from or incident to any termination of this Agreement (or any part thereof) by
such party (whether or not such party is aware of any such damage, loss or expenses) so long as
such party’s termination complies with the terms of the Agreement. Termination is not the sole
remedy under this Agreement and, whether or not termination is effected, all other remedies will
remain available.
Section 6.07 Consequences of Termination. Upon termination of this Agreement by either
party prior to the expiration of this Agreement set forth in Section 6.01:
(a) Licenses. The licenses granted under Section 2.02 will terminate, and
HBI will permanently discontinue all advertising with respect to Products, although HBI may, to
the extent permitted by applicable law, continue to sell Products which it has in inventory at the
time of
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14
termination; provided, however, that any such sale will (i) be made at prices and under
terms generally consistent with previous sales of the Products by HBI and (ii) be conducted in a
manner so as not to be harmful to Avanir or the market for the Products. Notwithstanding the
above, HBI may not sell the Products more than *** days after the effective date of termination.
At Avanir’s option, remaining stocks of Products may be bought by Avanir at HBI’s standard sale
price. HBI will deliver such stocks at Avanir’s direction and expense.
(b) Confidential Information. HBI will return all copies of all of Avanir’s
Confidential Information and any other Data relating to the Products.
Article VII. MISCELLANEOUS
Section 7.01 Publicity. The parties to this Agreement understand that Avanir is a public
company and agree that Avanir may disclose certain matters pertaining to this Agreement as to
enable it to fully comply with USA or Territory securities laws or regulations, which disclosure
may be in the form of public statements, whether oral or written, including, but not limited to,
shareholder reports, communications with stock market analysts, press releases or other
communications with the media. Notwithstanding the foregoing, any press release or other
announcement pertaining to this Agreement by either party will be provided to the other party in
advance for review and approval with such approval not to be unreasonably withheld or delayed.
Section 7.02 Publications. Neither HBI nor its agents, collaborators or subcontractors
will publish the results of any clinical studies of any Products without the prior approval of
Avanir, which approval of Avanir may not be unreasonably withheld or delayed.
Section 7.03 Rights to Assign. Neither party will have the right to assign or delegate
this Agreement, or any of its rights or obligations under this Agreement (except for Avanir’s
rights to payments pursuant to this Agreement) without the other’s express written consent, and
such assignment or delegation without such consent will be null and void for all purposes. Avanir
shall not unreasonably withhold its consent to any partial assignment of HBI’s rights hereunder
for which payment would accrue in accordance with Section 2.06. Notwithstanding anything to the
contrary in this Agreement, either Avanir or HBI may assign its entire interest in this Agreement
without any prior consent provided that such assignment is to a wholly-owned Affiliate or part of
the sale or transfer of substantially all of Avanir’s or HBI’s business related to the Product, or
pursuant to a merger, corporate division, corporate separation or de-merger, as the case may be,
and subject only to HBI’s compliance with Section 2.06.
Section 7.04 Notices/Reports. Any reports, notices or other communications required or
permitted to be given by either party to this Agreement will be given in writing by personal
delivery, overnight courier service or facsimile, or by registered or certified air mail, postage
prepaid, return receipt requested, addressed to each respective party at the address shown below.
If to Avanir:
Avanir Pharmaceuticals, Inc.
00000 Xxxxxxxx Xxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attention: Chief Financial Officer
Facsimile No: (000)-000-0000
00000 Xxxxxxxx Xxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attention: Chief Financial Officer
Facsimile No: (000)-000-0000
15
If to HBI:
Healthcare Brands International Limited
0 Xxxxx Xxxx Xxxxxx
Xxxxxx X0X 0XX
Xxxxxxx.
Attention: CEO
Facsimile No.: 000-00-0000000000
0 Xxxxx Xxxx Xxxxxx
Xxxxxx X0X 0XX
Xxxxxxx.
Attention: CEO
Facsimile No.: 000-00-0000000000
or to such other address as either party may indicate by proper notice to the other in the same
manner as provided in this Agreement. All notices are deemed effective on the date of receipt or,
if delivery is not accepted, five days after placement with the addressee, an overnight courier
service or a post office, as applicable.
Section 7.05 Severability. If any provision of this Agreement is determined to be
invalid, void, or unenforceable, then any such provision will be ineffective to the extent
invalid, void or unenforceable, and the remaining provisions of this Agreement will continue in
full force and effect without being impaired or invalidated in any way.
Section 7.06 Dispute Resolution. As a required precondition to terminating the Agreement
or any license granted pursuant to this Agreement or to initiating any legal action, any dispute,
controversy, or claim arising out of this Agreement or its interpretation, performance, breach,
enforcement or termination, or any other claim arising out of the respective rights and duties of
the parties (hereinafter, a “Dispute”), will be resolved, to the exclusion of a court of
law, by binding arbitration conducted in accordance with the Arbitration Rules of the United
Nations Commission on International Trade Law (UNCITRAL), in effect as of the date hereof. Unless
the parties agree in writing on the appointment of a single arbitrator, the matter will be
referred to three arbitrators; one to be appointed by each party, and the third, who will act as
Chairman, being nominated by the two so selected by the parties. The arbitration decision or
award will be final and binding on the parties, and the parties agree to be bound thereby and to
act accordingly. The arbitration award is to be given by a majority decision; however, if there
be no majority in favor of a single decision or award, the award will be made by the Chairman
alone. The arbitrators will be empowered to award relief which is legal and/or equitable in
nature, as appropriate. The expenses of the proceeding will initially be borne equally by the
parties to the dispute, but the prevailing party in such proceeding will be entitled to recover,
in addition to reasonable attorneys’ fees and all other expenses, its contribution for the
reasonable fees and expenses of the arbitrator as an item of damage and/or recoverable expenses.
The place of arbitration will be London. The language of such arbitration will be English.
Judgment on the award rendered by the arbitrators may be entered in any court of competent
jurisdiction, or application may be made to such court for judicial acceptance of the award and/or
an order of enforcement as the case may be. The arbitration will be conducted confidentially and
any award may be made public only with the prior written consent of the parties.
16
Section 7.07 Governing Law. This Agreement will be construed in accordance with the laws
of New York, USA, without giving any effect to the principles of conflict of laws thereof and
without regard to the United Nations Convention on Contracts for the International Sale of Goods.
Section 7.08 Entire Agreement. This Agreement (together with its Exhibits and Schedules)
contains the entire agreement of the parties regarding the subject matter of this Agreement and
supersedes all prior agreements, understandings and negotiations regarding the same. This
Agreement may not be changed, modified, amended or supplemented except by a written instrument
signed by both parties.
Section 7.09 Waiver. The waiver by either party of a breach of any provisions contained
in this Agreement will be in writing and will in no way be construed as a waiver of any succeeding
breach of such provision of the waiver of the provision itself.
Section 7.10 Relationship of the Parties. The relationship between Avanir and HBI under
this Agreement is that of parties to an arms-length negotiated contract. Nothing in this
Agreement is intended or is to be construed so as to create between Avanir and HBI, respectively,
the relationship of partners, or joint venturers, or to establish either party to this Agreement
as the employee or agent of the other party to this Agreement. Neither party to this Agreement
has an express or implied right or authority under this Agreement to make any statement or
commitments of any kind or to assume or to create any obligations on behalf of or in the name of
the other party to this Agreement, or to bind the other party to any contract, agreement or
undertaking with any Third Party.
Section 7.11 Certain Construction Rules. The Article and Section headings used in this
Agreement are for convenience of reference only and in no way define, limit, extend or describe
the scope or intent of any provisions hereof. In addition, as used in this Agreement, unless
otherwise expressly stated to the contrary, (a) all references to days, months or years are
references to calendar days, months or years and (b) any reference to a “Section,” “Article,”
“Exhibit,” or “Schedule” is a reference to a Section or Article of this Agreement or an Exhibit or
Schedule attached to this Agreement. Any reference to a “person” means any individual,
corporation, partnership, joint venture, association, trust or any other entity or organization of
any kind or character, including a governmental agency.
Section 7.12 Counterparts. This Agreement may be executed in several counterparts, each
of which will be an original, but all of which, when taken together, will constitute one and the
same instrument.
Section 7.13 Further Assurances. Each party agrees to execute, acknowledge and deliver
such further instruments, and do such other acts, as may be necessary and appropriate in order to
carry out the purposes and intent of this Agreement.
[REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK]
17
IN WITNESS WHEREOF, the parties to this Agreement have executed this Agreement as of the day and
year first written above.
HEALTHCARE BRANDS | AVANIR PHARMACEUTICALS | |||||||||
INTERNATIONAL LIMITED | ||||||||||
By:
|
By: | |||||||||
Name: |
||||||||||
Title: |
||||||||||
Date:
|
Date: | |||||||||
[SIGNATURE PAGE TO DOCOSANOL DATA TRANSFER &
PATENT LICENSE AGREEMENT]
18
SCHEDULE 1.13
Licensed Patents [table follows]
19
Patent / | |||||||||||
Filing | Application | Issue | |||||||||
Patent title | Territory | Status | date | Number | date | ||||||
Use of C-20 to C-26
Aliphatic Alcohols
in the Treatment of
Viral Infections
|
EP | Issued | 4/16/90 | 0469064 | 9/29/93 | ||||||
Use of C-27 to C-32
Aliphatic Alcohols
in Antiviral
Treatment
|
EP | Issued | 4/16/90 | 0428642 | 9/29/93 | ||||||
***
|
*** | *** | *** | *** | *** | ||||||
***
|
*** | *** | *** | *** | *** | ||||||
Viral inhibition by
long-chain
alcohols, alkanes,
fatty acids and
amides
|
EP | Issued | 09/10/97 | 1001759 | 7/20/05 | ||||||
Viral inhibition by
long-chain
alcohols, alkanes,
fatty acids and
amides
|
Poland | Issued | 9/10/97 | 189618 | 1/5/05 | ||||||
***
|
*** | *** | *** | *** | *** | ||||||
***
|
*** | *** | *** | *** | *** | ||||||
***
|
*** | *** | *** | *** | *** | ||||||
***
|
*** | *** | *** | *** | *** | ||||||
***
|
*** | *** | *** | *** | *** | ||||||
Synergistic
inhibition of viral
replication by
long-chain
hydrocarbons and
nucleoside analogs
|
Russian Federation | Issued | 3/8/2000 | 2251415 | 5/10/05 | ||||||
***
|
*** | *** | *** | *** | *** | ||||||
***
|
*** | *** | *** | *** | *** | ||||||
***
|
*** | *** | *** | *** | *** |
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1
Patent / | ||||||||||
Filing | Application | Issue | ||||||||
Patent title | Territory | Status | date | Number | date | |||||
***
|
*** | *** | *** | *** | *** | |||||
***
|
*** | *** | *** | *** | *** | |||||
***
|
*** | *** | *** | *** | *** | |||||
***
|
*** | *** | *** | *** | *** | |||||
***
|
*** | *** | *** | *** | *** |
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2
SCHEDULE 2
DEFERRED COMPENSATION
With respect to any transaction resulting in an Event listed in the table below which commences
during the term of this Agreement (a “Transaction”), HBI shall pay to Avanir compensation
according to the formula set forth below.
After the first such Event of the kind listed in 3 or 4 below, or of the kind listed in 1 or 2
below if all rights to the Product in all countries in the Territory then controlled by HBI are
sold, no subsequent Event of any kind shall be deemed to trigger any such payment obligation to
Avanir. If Event 1 or 2 occurs in part, but not all of the Territory, or with respect to some,
but not all of HBI’s rights to the Product hereunder, and after such sale HBI retains any rights
to the Product in any part of the Territory, any subsequent Event 1 or 2, either in another
country or countries in the Territory, or with respect to other rights to a Product, shall trigger
a payment obligation but only with respect to such other country(ies) and rights, and only if it
occurs prior to an Event listed in 3 or 4 below.
No. | Event | Formula | ||
1
|
The sale to a Third Party of HBI’s rights to Products only | ***% x *** | ||
2
|
The sale to a Third Party of HBI’s rights to multiple products, including the Product, | ***% X *** X (*** /***) | ||
3
|
First Sale or Merger of HBI with a Third Party | ***% X *** X (*** /***) | ||
4
|
IPO of HBI | Issuance of Shares of HBI to Avanir in a Dollar value = ***% of the ***-money valuation (i.e., post-IPO) x (*** /***) |
Notwithstanding the foregoing, in the event that HBI grants a sublicense of, but does not assign/
sell outright, rights to the Products in all or part of the Territory, HBI shall pay to Avanir
***% of all relevant *** received The payment by HBI of the compensation provided in the table
above resulting from any subsequent assignment of all rights to the Product in the relevant
country, or the sale, merger or IPO of HBI under any of the Events above will terminate HBI’s
obligation under this paragraph to pay Avanir any subsequent portion of the ***.
For the avoidance of doubt, the parties acknowledge and agree that HBI’s use of distributors or
sales or marketing agents shall be neither a sublicense nor a sale of Product rights for purposes
hereof, and thus does not constitute any of the Events described in the table above.
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1
Examples:
Case 1:
• | HBI sells all rights to Product alone in France, Germany and Spain. HBI pays ***% of *** to Avanir. | ||
• | HBI is then acquired. HBI pays ***% of *** X (***/***) to Avanir. | ||
• | No further payment obligations to Avanir. |
Case 2:
• | HBI sells all rights to Product in Germany and France. HBI pays ***% of *** to Avanir. | ||
• | HBI then sells all remaining rights to Product in rest of Territory in subsequent transaction. HBI pays ***% of *** to Avanir. | ||
• | No further payment obligation to Avanir, even upon Sale of HBI or IPO of HBI. |
Case 3:
• | HBI sublicenses rights to Product in Germany and France but retains rights in rest of the Territory. HBI pays ***% of *** to Avanir. | ||
• | HBI then sells all remaining rights to Product (but not the Germany and France rights). HBI pays ***% of *** to Avanir. HBI continues to pay ***% of *** to Avanir. |
Case 4:
• | HBI sublicenses rights to Product in Germany and France but retains rights in rest of the Territory. HBI pays ***% of *** to Avanir. | ||
• | HBI then is sold or merged (as an Event 3) or goes public (as an Event 4) HBI pays Avanir as shown on the table for Events 3 or 4, as relevant. HBI (including any successor to HBI) is no longer required to pay ***% of *** to Avanir. |
Case 5:
• | HBI sublicenses rights to Product in Germany and France but retains rights in rest of the Territory. HBI pays ***% of *** to Avanir. |
*** | Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. |
2
• | HBI then sells all remaining rights (including Germany and France rights) to Product. HBI pays ***% of *** Proceeds to Avanir. HBI (including any assignee of HBI) is no longer required to pay ***% of *** to Avanir. |
Definitions:
“Net Product Sales” means gross revenues from sales by or on behalf of HBI of Products to third
parties in the relevant Territory, less ***, *** and *** and ***, in the twelve
calendar months ended prior to the closing of the relevant Transaction.
“License Receipts” means the total of any ***, *** or *** received from a sublicensee as
consideration for the grant of a sublicense to the Product.
“Net Total Sales” means Net Product Sales *** sales by or on behalf of HBI of *** not licensed
under this Agreement, in the twelve calendar months ended prior to the closing of the relevant
Transaction.
“M&A Proceeds” means the gross amount of any consideration, in any form or kind, received by HBI
or HBI’s shareholders in connection with the sale, merger or change of control of HBI, net of
reasonable out-of-pocket legal fees, finders fees and broker fees paid (but not in any event to
exceed ***% of such gross amount of consideration), as evidenced by HBI in reasonable detail;
provided that the compensation paid to Avanir shall be comprised of the same cash or
non-cash type and ratio of consideration payable to HBI or HBI’s shareholders generally, and shall
be paid at the same time or times as received. In the event that the M&A Proceeds is not in the
form of cash or publicly traded securities, then if the parties cannot agree on the value of M&A
Proceeds, they will engage a mutually agreeable Third Party to determine such valuation.
“Sale Proceeds” means the gross amount of any consideration, in any form or kind, received by HBI
as consideration for the sale of the Product rights to a Third Party, net of reasonable
out-of-pocket legal fees, finders fees and broker fees (but not in any event to exceed ***% of
such gross amount of consideration), as evidenced by HBI in reasonable detail; provided
that the compensation paid to Avanir shall be comprised of the same cash or non-cash type and
ratio of consideration payable to HBI generally, and shall be paid at the same time or times as
received. .
PROCESS
1.1 | HBI shall submit its draft determination of the amount payable pursuant to the above formula to Avanir within *** Business Days of completion of the relevant Transaction, following which Avanir shall have *** Business Days within which to submit a written notification of its acceptance or non-acceptance of the amount. If Avanir does not so notify HBI within *** Business Days of delivery of the draft determination, or if Avanir notifies HBI that it accepts the draft determination, then Avanir will be deemed to have accepted the draft determination with respect to such Transaction. |
*** | Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. |
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1.2 | If Avanir notifies HBI of any objection then: | |
1.2.1 | Avanir will set out in reasonable detail their reasons for such non-acceptance and specify the adjustments that in its opinion should be made to the draft determination and provide supporting evidence for each such adjustment; | |
1.2.2 | Avanir will provide the HBI with access to all such documents and working papers relating to its preparation of the reasons for non-acceptance and proposed adjustments to the draft determination; and | |
1.2.3 | HBI and Avanir will respectively use all reasonable endeavors to reach agreement upon the adjustments needed to meet the objections of Avanir. | |
1.3 | If Avanir and HBI do not reach agreement within *** Business Days after service of the notice to HBI of non-acceptance, then the matter(s) in dispute will be referred to the decision of a single independent chartered accountant or an independent firm of chartered accountants (in either case, the “Independent Accountant”) that is mutually agreeable to both parties. The Independent Accountant (whose costs will be shared equally by the parties) will act as expert (and not as arbitrator) and the decision of the Independent Accountant shall (in the absence of manifest error) be final and binding on the parties. It is the parties’ intention that the Independent Accountant will perform his task within *** Business Days if practicable and they shall encourage him to do so. | |
1.4 | Avanir and HBI will use all reasonable endeavors to provide all such working papers, documents and other information as is requested by the Independent Accountant and will procure that the Independent Accountant is requested to state, when giving his decision on the matter(s) referred to him, what adjustments (if any) need to be made to the draft determination. | |
1.5 | If Avanir and HBI reach agreement on (or Avanir is deemed to have accepted) the draft determination or if a revised determination is finally determined at any stage in the procedure, the determination as so agreed or determined will provide the amount payable to Avanir (as applicable) within *** Business Days upon reaching agreement and shall be final and binding on Avanir and HBI. | |
1.6 | Avanir and HBI will pay their own costs and expenses in connection with the preparation and agreement of the draft determination or any objections thereto including, where applicable, any costs associated with presentation of their cases to the Independent Accountant. |
*** | Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. |
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