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CONFIDENTIAL DOCOSANOL DATA TRANSFER & PATENT LICENSE AGREEMENT

Patent License Agreement

CONFIDENTIAL 

DOCOSANOL DATA TRANSFER & PATENT LICENSE AGREEMENT 

 | Document Parties: AVANIR PHARMACEUTICALS | Healthcare Brands International Limited of You are currently viewing:
This Patent License Agreement involves

AVANIR PHARMACEUTICALS | Healthcare Brands International Limited of

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Title: CONFIDENTIAL DOCOSANOL DATA TRANSFER & PATENT LICENSE AGREEMENT
Date: 12/18/2006
Industry: Biotechnology and Drugs    

CONFIDENTIAL 

DOCOSANOL DATA TRANSFER & PATENT LICENSE AGREEMENT 

, Parties: avanir pharmaceuticals , healthcare brands international limited of
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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 56 Queen Anne Street, London W1G 8LA (“ 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.

 

 

 

 

***

 

Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

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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.

 

 

 

 

***

 

Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

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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

 

 

 

 

***

 

Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

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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 sue 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

 

 

 

 

***

 

Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

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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 regi


 
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