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LICENSE AGREEMENT

License Agreement

LICENSE AGREEMENT | Document Parties: Aegera Therapeutics Inc | Neurologix, Inc You are currently viewing:
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Aegera Therapeutics Inc | Neurologix, Inc

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Title: LICENSE AGREEMENT
Governing Law: New York     Date: 9/4/2008
Industry: Biotechnology and Drugs     Law Firm: Katten Muchin     Sector: Healthcare

LICENSE AGREEMENT, Parties: aegera therapeutics inc , neurologix  inc
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Exhibit 10.1

LICENSE AGREEMENT

 

THIS LICENSE AGREEMENT (the “ Agreement ”) is made and entered into this 28th day of August 2008 (the “ Effective Date ”), by and between Aegera Therapeutics Inc., a company organized and existing under the laws of Canada (“ Licensor ”), having a principal place of business located at 810 chemin du Golf, Ile des Soeurs, Québec H3E 1A8, Canada, and Neurologix, Inc., a Delaware corporation (“ Licensee ”), having a principal place of business located at One Bridge Plaza, Fort Lee, NJ 07024, USA.

 

RECITALS

 

WHEREAS, Licensor is the owner of certain patents and other intellectual property relating to the X-linked Inhibitor of Apoptosis Protein (“ XIAP ”);

 

WHEREAS, Licensee desires to obtain an exclusive license in the Field (as hereinafter defined) to develop and commercialize products by using and practicing the Licensed Methods (as hereinafter defined) and Licensed Patent Rights (as hereinafter defined); and

 

WHEREAS , Licensor is willing to grant such a license to Licensee on the terms set forth herein.

 

NOW THEREFORE , the parties agree as follows:

 

ARTICLE I

 

DEFINITIONS

 

1.1

Accounting Standards ” shall mean United States Generally Accepted Accounting Principles, as generally and consistently applied throughout the applicable Person’s organization.

 

1.2

Affiliate ” means, with respect to a specified Person, any other Person, (i) which is controlling, controlled by or under common control with, such specified Person or (ii) in which such specified Person owns 20% or more of the equity or other ownership interests. For purposes of this Section 1.2, the term “control” means possession, direct or indirect, of the powers to direct, cause or direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, by contract or otherwise.

 

1.3

Confidential Information ” shall mean all technical and scientific know-how and information, non-clinical and clinical trial results, computer programs, knowledge, technology, means, methods, processes, practices, formulas, techniques, procedures, technical assistance, designs, drawings, apparatus, written and oral representations of data, specifications, assembly procedures, schematics and other valuable information of whatever nature and all other scientific, clinical, regulatory, marketing, financial and commercial information or data, whether communicated in writing, verbally or electronically, which is provided by a party to the other party in connection with this Agreement. For the avoidance of doubt, the terms and conditions of this Agreement shall be deemed the Confidential Information of both Licensor and Licensee.

 


 

1.4

Field ” means therapeutic or prophylactic use in the treatment of Huntington’s Disease by Gene Therapy.

 

1.5

First Commercial Sale ” means the first sale of any Licensed Product (as hereinafter defined) by Licensee or any of its Affiliates or Sublicensees following approval of its marketing to the general public by the appropriate governmental agency for the country in which the sale was made, and, where governmental approval is not required, the first sale in that country.

 

1.6

Gene Therapy ” means the treatment of certain disorders, including, but not limited to those caused by genetic anomalies or deficiencies, by introducing specific engineered genes into a patient’s body.

 

1.7

Improvements ” means any and all additions, alterations, modifications, design changes and other improvements to the Licensed Patent Rights, including subject art thereof, and the Technology which are individually developed by Licensor, Licensee, any Sublicensee or any Third Party during the Term.

 

1.8

License ” has the meaning set forth in Section 2.2.

 

1.9

Licensed Method ” means any process or method that is covered by a Valid Claim.

 

1.10

Licensed Patent Rights ” means the patents and patent applications listed in Schedule A hereto, including divisionals, continuations and, to the extent entirely supported by such patents and patent applications, continuation-in-part applications, any patents issuing on said applications, including reissues and reexaminations thereof, and any foreign counterparts thereto.

 

1.11

Licensed Product ” means a product, the manufacture, use, offer for sale, sale or importation of which employs a Licensed Method or the manufacture, use, offer for sale, sale or importation of which is covered by a Valid Claim.  Once a product becomes a Licensed Product, such product shall remain a Licensed Product for all purposes under this Agreement.

 

1.12

Net Sales ” means the total amount invoiced by Licensee or its Affiliates or Sublicensees from the sale or distribution of Licensed Products in the Territory, less the sum of the following deductions where applicable, determined in accordance with the Accounting Standards: sales, use, tariff, import/export duties or other excise taxes imposed upon particular sales, transportation charges, allowances or credits to customers because of rejections or returns and actual amounts credited for uncollectible amounts on previously sold Licensed Products.  Sales between or among Licensee and its Affiliates or Sublicensees shall be excluded from the computation of Net Sales, except where such Affiliates or Sublicensees are end users (i.e., where such sale is the last sale to the consumer), but Net Sales shall include the subsequent final sales to Third Parties by such Affiliates or Sublicensees.

 

2


 

To the extent that any amount that would otherwise qualify as a deduction in the calculation of Net Sales is paid by a Third Party pursuant to a separate charge or invoice, such amount shall not be deducted in the calculation of Net Sales.  In the case of any sale or other disposal of a Licensed Product between or among a party and its Affiliates, or Sublicensees, for resale, Net Sales shall be calculated as above only on the value charged or invoiced on the first arm’s-length sale thereafter to a Third Party.  In the case of any sale or other disposal for value, such as barter or counter-trade, of any Licensed Product, or part thereof, other than in an arm’s length transaction exclusively for money, Net Sales shall be calculated as above on the value of the non-cash consideration received or the fair market price (if higher) of the Licensed Product in the country of sale or disposal.

 

Transfers of samples of the Licensed Product, such as for physician samples and indigent patient and similar programs (including registration samples), will not be included for purposes of determining Net Sales; provided that no compensation beyond the cost of goods of any such transferred Licensed Product is received, such sampling and other programs are conducted in a manner consistent with Licensee’s, its Affiliate’s or it Sublicensee’s normal practices applied across all of its products and no non-cash consideration or other benefits (e.g., concessions or agreements with respect to products other than the Licensed Product) is obtained in exchange for such transferred Licensed Product.

 

1.13

Ottawa License Agreement ” means the License Agreement between University of Ottawa and Aegera (as successor to Apoptogen Inc.), made as of November 30, 1995, as amended as of October 10, 2000.

 

1.14

Person ” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including without limitation, a government or political subdivision, department or agency of a government.

 

1.15

Royalty Term ” means the period that commences on the Effective Date and terminates, on a country-by-country basis, with respect to each Licensed Product, on the later to occur of (a) the expiration of the last to expire Valid Claim within the Licensed Patent Rights covering such Licensed Product, (b) ten (10) years after the First Commercial Sale of such Licensed Product in such country or (c) the full prosecution of any claims under a properly filed patent application.

 

1.16

Sublicensee ” means any Third Party sublicensed by Licensee to make, have made, use, offer for sale, sell, have sold, import or have imported Licensed Products.

 

1.17

Territory ” means the entire world except for the People’s Republic of China.

 

1.18

Third Party ” means any Person other than Licensee, Licensor or any of their respective Affiliates.

 

1.19

Third Party License ” means any agreement under which a license to the Licensed Patent Rights or Technology is granted by a Third Party to Licensor.

 

3


 

1.20

Technology ” means any and all proprietary processes, trade secrets, technical information and know-how claimed in or relating to the Licensed Patent Rights, that is necessary or useful to make, use, offer for sale, sell or import Licensed Products in the Field and that is owned or controlled by Licensor as of the Effective Date.

 

1.21

Valid Claim ” means (a) any claim of an issued, unexpired patent included in the Licensed Patent Rights, which claim has not lapsed, been abandoned, been revoked or been held to be invalid or unenforceable by a final judgment of a court of competent jurisdiction or other governmental agency from which no appeal can be or is taken within the time allowed for appeal and which has not been admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise; or (b) any claim of a patent application included in the Licensed Patent Rights that has been pending for less than seven (7) years and which has not been withdrawn, cancelled, abandoned, or finally held to be unallowable.

 

ARTICLE II

 

GRANT

 

2.1

Subject to the terms and conditions of this Agreement and the Ottawa License Agreement, Licensor hereby grants to Licensee and its Affiliates in the Territory an exclusive license, under the Licensed Patent Rights to make, have made, use, offer for sale, sell, have sold, import and have imported Licensed Products in the Field in the Territory (the “ Product License ”) during the Term.

 

2.2

Subject to the terms and conditions of this Agreement and the Ottawa License Agreement, Licensor hereby grants to Licensee and its Affiliates an exclusive license to use and have used the Technology in connection with the manufacture, use, offer for sale, sale and importation of Licensed Products in the Field in the Territory (the “ Technology License ” and, together with the Product License, the “ License ”) during the Term.

 

2.3

Licensor shall retain ownership of any Improvements to the inventions claimed in the Licensed Patent Rights and to the Technology that are developed or invented by or on behalf of it, its Affiliates or Third Parties (“ Licensor Improvements ”).  Licensor shall promptly notify Licensee, in writing, of any Licensor Improvements in the Field in the Territory.  In the event that Licensor, its Affiliates or Third Parties, makes any such Improvements, and Licensor and Licensee are able to determine commercially reasonable terms for a license of such Improvements, Licensor, shall grant to Licensee an exclusive license, with the right to grant sublicenses, to make, have made, use, offer for sale, sell, have sold, import and have imported the Licensor Improvements in the Field in the Territory.

 

2.4

Licensee shall retain ownership of any improvements to the inventions claimed in the Licensed Patent Rights and to the Technology that are developed or invented by or on behalf of Licensee, its Affiliates and Sublicensees (“ Licensee Improvements ”).  Licensee shall promptly notify Licensor, in writing, of any Licensee Improvements.  In the event that Licensee, or its Affiliates, makes any Improvements to the inventions claimed in the Licensed Patent Rights or to the Technology, and Licensor and Licensee, or its Affiliates, are able to determine commercially reasonable terms for a license of such Improvements, Licensee, or its Affiliates, shall grant to Licensor a non-exclusive license, with the right to grant sublicenses, to make, have made, use, offer for sale, sell, have sold, import and have imported the Licensee Improvements; provided that, during the Term, such license shall not permit the manufacture, use, offer for sale, sale or importation of Licensed Products in the Field in the Territory.

 

4


 

ARTICLE III

 

SUBLICENSES

 

3.1

Licensee shall have the right to grant exclusive and/or non-exclusive sublicenses (each a “ Sublicense ”) of the License to Third Parties.  The granting by Licensee of a Sublicense shall not relieve Licensee of any of its obligations hereunder.

 

3.2

Licensee shall furnish Licensor with an unredacted copy of any Sublicense within 15 days after the execution thereof; provided that the existence and terms of any such Sublicense shall constitute Confidential Information of Licensee.

 

3.3

Licensee shall provide to Licensor a copy of all information submitted to Licensee by Sublicensees that is relevant to the computation of the payments due from Licensee to Licensor under this Agreement.

 

3.4

Licensee shall obtain from its Affiliates and Sublicensees all licenses and access to information and documents necessary for Licensee to grant to Licensor the rights and licenses set forth in Section 2.4.

 

3.5

The Sublicense shall be consistent with all the relevant terms of this Agreement, including Section 2.4, this Article III and Articles VI, IX, X, XI, XV and XVI.

 

3.6

In the event of a material default of a Sublicense by any Sublicensee, Licensee will promptly inform Licensor of such default.  Notwithstanding any such material default, Licensee shall remain responsible for the satisfaction of all obligations of Licensee, its Affiliates and Sublicensees under this Agreement.

 

ARTICLE IV

 

INITIATION and MAINTENANCE FEES

 

4.1

On the Effective Date, Licensee shall pay to Licensor a non-refundable initiation fee of ########.* This fee is not intended to be, and shall not be construed as, an advance against Royalties (as hereinafter defined).

 


* ######## = Material omitted pursuant to a request for Confidential Treatment and filed separately with the Commission on the date of filing of this Form 8-K.

 

5


 

4.2

Commencing on January 1, 2009, and on each subsequent January 1 during the Term, Licensee shall pay an annual maintenance fee (the “ Maintenance Fee ”) of ########* to Licensor. The Maintenance Fee for each calendar year shall be offset against Royalties (as hereinafter defined) payable to Licensor based on Net Sales occurring in the same calendar year.

 

ARTICLE V

 

ROYALTIES

 

5.1

Within sixty (60) days after the end of each calendar quarter during an applicable Royalty Term in which Net Sales occur, Licensee shall pay to Licensor earned royalties on the Net Sales during such calendar quarter (“ Royalties ”).  The Royalties due for any calendar quarter shall be determined as follows:

 

 

5.1.1

On the first ######## during such calendar year, Licensee shall pay Royalties in an amount equal to ########;

 

 

5.1.2

On the next ######## during such calendar year, Licensee shall pay Royalties in an amount equal to ########;

 

 

5.1.3

On Net Sales during such calendar year in excess of ########, Licensee shall pay Royalties in an amount equal to ########;

 

 

5.1.4

Royalties shall be payable only once with respect to Net Sales regardless of the number of Licensed Patent Rights which cover the Licensed Product;

 

 

5.1.5

On a Licensed Product-by-Licensed Product and country-by-country basis, for Net Sales of a Licensed Product in a country made during any portion of the applicable Royalty Term in which no Valid Claim covers such Licensed Product in such country, the royalty rates set forth in Sections 5.1.1 through 5.1.3 above applicable to such Net Sales shall be reduced to ########.

 

 

5.1.6

To the extent that Licensee or any of its Affiliates or Sublicensees determines that it is required to obtain in any jurisdiction a license from a Third Party to patent rights covering XIAP (excluding, for the avoidance of doubt, patent rights covering any delivery vector that may be incorporated into a Licensed Product) in order to make, use, offer for sale, sell or import a Licensed Product in the Field in such jurisdiction, then ######## in such jurisdiction may be deducted from royalties otherwise payable to Licensor; provided that in no event shall the aggregate royalties payable to Licensor in any calendar quarter based on Net Sales in such jurisdiction be reduced by ######## as a result of any such deduction; provided further that any excess deduction remaining as a result of such limitation may be carried forward to subsequent periods.

 


* ######## = Material omitted pursuant to a request for Confidential Treatment and filed separately with the Commission on the date of filing of this Form 8-K.

 

6


 

5.2

In addition to the Royalties payable pursuant to Section 5.1, Licensee shall pay Licensor the following milestone payments for each Licensed Product (collectively, “ Milestone Payments ”), each of which shall be paid only once for each Licensed Product: ########*

 

5.3

Royalties shall be payable on a Licensed Product-by-Licensed Product and country-by-country basis during the applicable Royalty Term.

 

5.4

All monies due to Licensor under this Agreement shall be payable in United States dollars by wire transfer to an account to be established by Licensor. Licensee shall be responsible for all bank transfer charges.  When Licensed Products are sold for monies other than United States dollars, the Royalties will first be determined in the foreign currency of the country in which such Licensed Products were sold and then converted into United States dollars at the exchange rate established by Capital One Bank on the last day of the applicable calendar quarter.

 

5.5

Any tax for the account of Licensor required to be withheld by Licensee under the laws of any foreign country shall be promptly paid by Licensee for and on behalf of Licensor to the appropriate governmental authority, provided that Licensee and Licensor shall use reasonably and legal efforts to cooperate to minimize such withholding taxes (e.g., by taking advantage of applicable tax treaties) and Licensee shall use reasonable commercial efforts to furnish Licensor with proof of payment of any such tax.  Nothing herein shall require Licensee to be responsible for or pay any taxes payable by Licensor, including taxes on the income of Licensor.

 

5.6

If at any time legal restrictions prevent the prompt remittance to Licensor of part or all Royalties by Licensee with respect to any country where a Licensed Product is sold, Licensee shall have the right and option to make such payments by depositing the amount thereof in local currency in Licensor ‘s bank account or other depository in such country.

 


* ######## = Material omitted pursuant to a request for Confidential Treatment and filed separately with the Commission on the date of filing of this Form 8-K.

 

7


 

5.7

In the event that any patent or any claim thereof included within the Licensed Patent Rights shall be held invalid or unenforceable in a final decision by a court of competent jurisdiction from which no appeal has or can be taken, any such claim so adjudicated shall thereupon cease to constitute a Valid Claim.  Licensee shall not, however, be relieved from paying any Royalties that accrued before such decision or that are based on another patent or claim not involved in such decision.

 

ARTICLE VI

 

DUE DILIGENCE

 

Licensee shall use, or shall cause its Affiliates or Sublicensees to use, commercially reasonable efforts to develop and commercialize the Licensed Products throughout the Territory, including, without limitation, in accordance with the milestones set forth in Schedule B attached hereto.

 

ARTICLE VII

 

PATENT FILING, PROSECUTION AND MAINTENANCE

 

7.1

Licensor shall have the first right to prepare, file, prosecute and maintain the Licensed Patent Rights in the United States and in all foreign countries within the Territory with counsel selected by Licensor at Licensor’s expense.  Licensor shall (i) promptly provide Licensee and its counsel with copies of any official communications from the United States and any foreign patent office relating to the Licensed Patent Rights, and (ii) provide Licensee and its counsel with advance copies of all written communications addressed to the United States or any foreign patent office relating to the Licensed Patent Rights.  In the event that Licensor determines not to prepare, file, prosecute or maintain any patent rights constituting Licensed Patent Rights, Licensor shall promptly notify Licensee in writing, and, subject to Licensor’s pre-existing contractual obligations to Third Parties, Licensee shall have the right to prepare, prosecute and maintain any such application or right that is relevant to the Field in Licensor’s name and at Licensee’s expense; provided that , Licensor’s abandonment of a particular patent application in favor of a continuation, divisional or other substitute application shall not give rise to the foregoing Licensee step-in right.  Licensee shall have reasonable opportunities to participate in decisions with respect to the filing, prosecution and maintenance of patents and patent applications in the Licensed Patent Rights, to the extent such decisions are material to the protection of Licensed Products in the Field.  Licensor shall consider in good faith any comments timely provided by Licensee with respect to the filing, prosecution and maintenance of patents and patent applications in the Licensed Patent Rights, to the extent such comments are relevant to Licensed Products in the Field.

 

7.2

In the event that Licensor advises Licensee in writing that it has determined to abandon, any patent application or issued patent licensed under this Agreement, and Licensee thereafter exercises its step-in rights with respect to the preparation, prosecution and maintenance thereof as set forth in Section 7.1 above, Licensee’s license under such abandoned Licensed Patent Rights set forth in Section 2.1 shall convert to, and thereafter be, a fully paid-up, non-royalty-bearing license.

 

8


 

ARTICLE VIII

 

PATENT INFRINGEMENT

 

8.1

In the event that Licensee learns of the substantial infringement in the Field of any patent in the Licensed Patent Rights, Licensee shall so notify Licensor, in writing, and shall provide Licensor with evidence of such infringement to the extent reasonably available to Licensee (such notice is hereinafter referred to as an “ Infringement Notice ”).   Licensor shall have the right, but not the obligation, to prosecute at its own expense the alleged infringement described in an Infringement Notice; provided that, within thirty (30) days after receipt by Licensor of an Infringement Notice, Licensor shall notify Licensee, in writing, whether it intends to prosecute the alleged infringement described in the Infringement Notice (such notice is hereinafter referred to as an “ Infringement Reply Notice ”).

 

8.2

Licensee shall have the right to prosecute at its own expense any substantial infringement in the Field described in an Infringement Notice, and Licensee shall be entitled to retain any recovery obtained by such prosecution, including any portion of such recovery to which Licensor might otherwise be entitled pursuant to this Agreement,  in the event that:

 

 

8.2.1

Licensor fails timely to deliver an Infringement Reply Notice to Licensee in response to such Infringement Notice;

 

 

8.2.2

Licensor’s Infringement Reply Notice indicates Licensor’s intention not to take reasonable actions to eliminate any substantial infringement in the Field described in such Infringement Notice; or

 

 

8.2.3

for


 
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