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LICENSE AGREEMENT

License Agreement

LICENSE AGREEMENT | Document Parties: VALENTIS INC | Juvaris BioTherapeutics, Inc You are currently viewing:
This License Agreement involves

VALENTIS INC | Juvaris BioTherapeutics, Inc

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Title: LICENSE AGREEMENT
Governing Law: California     Date: 11/1/2006
Industry: Biotechnology and Drugs     Law Firm: Liner Yankelevitz Sunshine & Regenstreif LLP;Wilson Sonsini Goodrich & Rosati P.C.    

LICENSE AGREEMENT, Parties: valentis inc , juvaris biotherapeutics  inc
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Exhibit 10.1

LICENSE AGREEMENT

This License Agreement (the “Agreement”), effective as of October 27, 2006 (the “Effective Date”), is entered into by and between Valentis, Inc., a Delaware corporation having offices at 863A Mitten Road, Burlingame, California 94010 (“Valentis”) and Juvaris BioTherapeutics, Inc., a Delaware corporation having offices at 6200 Stoneridge Mall Road, Suite 3F, Pleasanton, CA 94588 (“Juvaris”).  All references to Valentis and Juvaris in this Agreement shall include their Affiliates (as defined below).

BACKGROUND

A.            Valentis is the owner or exclusive licensee of certain Patent Rights and Know-How (as such terms are defined below), and Juvaris wishes to acquire a license under the Patent Rights and Know-How; and

B.            Valentis is willing to grant Juvaris such a license, on the terms and conditions set forth below.

NOW, THEREFORE, in consideration of the promises and the mutual covenants hereinafter recited, the parties agree as follows:

ARTICLE 1.

DEFINITIONS

In this Agreement, the following terms shall have the meanings set forth in this Article.

1.1           “ Affiliate ” means any company, corporation, division or other entity which is directly or indirectly controlling, controlled by or under common control with a party hereto.  For the purpose of this Agreement, with respect to any company, corporation, division or other entity, “control” shall mean the direct or indirect ownership of at least fifty percent (50%) of the outstanding shares or other voting rights of the subject company, corporation or other entity to elect directors.

1.2           “ Confidential Information ” means (a) any proprietary or confidential information or material in tangible form disclosed hereunder that is marked as “Confidential” at the time it is delivered to the receiving party, or (b) proprietary or confidential information disclosed orally hereunder which is identified as confidential or proprietary when disclosed and such disclosure of confidential information is confirmed in writing within thirty (30) days by the disclosing party.

1.3           “ Know-How ” means unpatented and/or unpatentable technical information, including ideas, concepts, inventions, discoveries, data, designs, formulas, specifications, procedures for experiments and tests and other protocols, results of experimentation and testing, fermentation and purification techniques, and assay protocols owned by Valentis as of the Effective Date which may be necessary for the practice of the Patent

 



 

Rights solely as contemplated hereunder.  Know-How shall not include the Patent Rights.  All Know-How shall be Confidential Information of Valentis.

1.4           “ Juvaris Customer ” means any person or entity (a) for whom Juvaris, pursuant to a written agreement, undertakes Process Development and (b) who otherwise abides by the requirements of Section 2.3.

1.5           “ Juvaris Partner ” means an entity with whom Juvaris, pursuant to a written agreement and a bona fide collaboration or license of rights, shares substantial cost and economic risk of the development, commercialization or marketing of a Juvaris Product.

1.6           “ Juvaris Expression Materials ” means those compositions of matter or articles of manufacture created by Juvaris that are suitable for the manufacture of a polynucleotide.

1.7           “ Juvaris Products ” means any product or material resulting from the use of the Licensed Technology by or on behalf of: (i) Juvaris; or (ii) Juvaris Customers or Juvaris Partners that are sublicensees of Juvaris under such Licensed Technology pursuant to the terms of Article 2.

1.8           “ Licensed Technology ” means the Patent Rights and the Know-How.

1.9           “ Patent Rights ” means the patent applications and patents listed on Schedule 1.9 hereto and, to the extent covered by the transfer of rights pursuant to this Agreement, patent applications and patents owned or controlled by Valentis covering improvements made by Juvaris to the technology disclosed in the patent applications and patents listed on Schedule 1.9 , and all divisions, continuations, continuations-in-part, and substitutions thereof, all foreign patent applications corresponding to the preceding applications; and all U.S. and foreign patents issuing on any of the preceding applications, including extensions, reissues, and reexaminations.

1.10         “ Process Development ” means, when undertaken by Juvaris on behalf of a Juvaris Customer, as applicable, using, making, having made or importing the methods, compositions of matter or articles of manufacture embodied by the Patent Rights or the Know-How, but only as it directly relates to those activities customarily associated with or reasonably necessary for the development of manufacturing or scale-up processes reasonably required for the commercial or clinical production of a plasmid DNA product, including for example preclinical studies, GLP toxicology studies and other activities to support an IND filing, and clinical trials; provided, however, that, notwithstanding anything to the contrary, production of material for use in a clinical study, such as, for example, a Phase IIb clinical trial, that was not intended to be a pivotal trial but is determined later to be suitable to qualify as a pivotal trial will be deemed to be Process Development.

1.11         “ Third Party ” means any person or entity other than Juvaris or Valentis.

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ARTICLE 2.

LICENSE

2.1           Grant to Juvaris .  Subject to the terms and conditions of this Agreement, Valentis hereby grants to Juvaris for the sum of two hundred thousand dollars ($200,000) payable on or before the one year anniversary of the Effective Date, a non-exclusive, non-transferable (except as provided for in this Article 2 and Section 9.2 below), worldwide, royalty-free, fully paid up license under the Licensed Technology, with the right to grant sublicenses to Juvaris Customers and Juvaris Partners, to:

(a)           make, have made, use, sell, offer for sale, export and import Juvaris Products;

(b)           engage in Process Development for Juvaris Customers;

(c)           transfer to a Juvaris Customer in exchange for consideration any Juvaris Expression Materials encoding such Juvaris Customer’s product; and

(d)           make, have made, use, sell, offer for sale, export and import any Juvaris Product for the benefit of a Customer, in exchange for consideration, at a facility designated by Juvaris.

2.2           Grant to Juvaris Customers .  Subject to the terms and conditions of this Agreement, Valentis hereby grants to Juvaris a right to grant to each Juvaris Customer who abides by the conditions of Section 2.3, a non-exclusive, non-transferable, worldwide license under the Licensed Technology, with the right to grant sublicenses to contract manufacturers solely for the production of the Juvaris Customer’s products, to:

(a)           have Juvaris, on behalf of and for the benefit of such Juvaris Customer, make, have made, use, export and import Juvaris Expression Materials encoding any such Juvaris Customer’s product;

(b)           have Juvaris, on behalf of and for the benefit of such Juvaris Customer, undertake Process Development with respect to any such Juvaris Customer’s product;

(c)           have Juvaris make, on behalf of and for the benefit of such Juvaris Customer and at a facility designated by Juvaris any Juvaris Product using Juvaris Expression Materials;

(d)           have a contract manufacturer who is otherwise licensed by Valentis, under the terms of the applicable license agreement, make any Juvaris Product using Juvaris Expression Materials; and

(e)           use, export and import, and sell, any Juvaris Product made by Juvaris or a contract manufacturer in accordance with the license grants of this Agreement.

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(f)            Juvaris agrees to generate and maintain a comprehensive list (“Customer Contact List”) containing the name and address (and individual to contact, if appropriate) of each Juvaris Customer or entity or person on whose behalf it engages in Process Development.  As additional Juvaris Customers are identified and when activities are initiated by Juvaris on behalf of any such Juvaris Customer, Juvaris shall update the Customer Contact List.  Juvaris shall use reasonable commercial efforts to obtain the right in each and every agreement entered into with a Juvaris Customer to disclose to Valentis such Juvaris Customer’s name and address (and individual to contact, if appropriate).  To the full extent that Juvaris is able without violating the terms of an agreement between Juvaris and a Juvaris Customer, Juvaris shall provide the Customer Contact List to Valentis within forty-five (45) days after the end of each calendar year.  The Customer Contact List shall be Confidential Information of Juvaris, and Valentis shall keep such list, and information contained in such list, strictly confidential; provided, however, that Valentis’s obligations of confidentiality shall not prohibit Valentis’s use of the information contained in the Customer Contact List for purposes of identifying and prosecuting potential infringement of the Patent Rights or misappropriation of the Know-How.  Except as otherwise set forth in the previous sentence, Valentis’s obligations of confidentiality with respect to the Customer Contact List shall be subject to the terms of Article 5 of this Agreement.

2.3           No Implied Rights .  Only the licenses granted pursuant to the express terms of this Agreement shall be of any legal force or effect.  No other license rights shall be granted or created by implication, estoppel or otherwise.  For the avoidance of doubt, by example only and without expanding or narrowing the license grants of Sections 2.1 and 2.2, the grants of rights made pursuant to Sections 2.1 and 2.2 do not include, and expressly exclude, any right or license (a) to engage in any activities on behalf of or in collaboration with any Third Party (other than as expressly set forth herein), or (b) to release or waive any claim of infringement under any patent or patent application owned or controlled by Valentis or its Affiliates, including, without limitation, the Patent Rights.

2.4           Ownership; Enforcement; No Challenge .

(a)           At all times, Valentis will retain ownership of the Licensed Technology, including all embodiments of the Patent Rights or the Know-How, that in each case is owned by Valentis as of the Effective Date, and any improvements made by Valentis thereof, and nothing herein shall be construed to limit Valentis’ right to freely use and commercialize such Licensed Technology itself or with Third Parties.  Valentis retains the right, at its sole discretion, to enforce, maintain and otherwise protect the Licensed Technology.  Juvaris shall give Valentis notice of any infringement by a Third Party of any Patent Rights owned or controlled by Valentis or misappropriation of the Know-How which comes to Juvaris’ actual knowledge during the term of this Agreement.  Juvaris will cooperate on a commercially reasonable basis with Valentis with respect to any actions Valentis may choose to take pursuant to this Section 2.4, and Valentis will reimburse Juvaris for its reasonable costs in this regard.

(b)           Except as required under applicable law, Juvaris shall not participate, directly or indirectly, in any opposition or challenge to the validity or enforceability of any Patent Right in any forum and Juvaris shall not assist any Third Party in any such participation.  Any breach by Juvaris of this Section 2.4(b) shall constitute a material breach of

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this Agreement and any licenses or rights granted hereunder may, at Valentis’s option, be terminable.

2.5           Reports, Records and Audits .

(a)           Juvaris shall use reasonable commercial efforts to obtain the right in each and every agreement entered into with a Juvaris Customer to disclose to Valentis the activities, compositions of matter or articles of manufacture made or undertaken by Juvaris for the benefit of such Juvaris Customer.  Within forty-five (45) days after the end of each calendar year, commencing with the first calendar year after the Effective Date, Juvaris, unless in violation of the terms of an agreement between Juvaris and a Juvaris Customer, shall deliver to Valentis a written report which specifies with reasonable detail the activities, compositions of matter or articles of manufacture made or undertaken by Juvaris that are subject to this Agreement, including, without limitation, any Process Development as to which Juvaris claims the benefit of the license grant of Section 2.1.  The reports delivered by Juvaris to Valentis pursuant to this Section 2.5(a) shall be Confidential Information of Juvaris.

(b)           Juvaris shall maintain records fully and properly reflecting those activities to be reported to Valentis pursuant to Section 2.5(a) (the “Records”) in sufficient detail and in good scientific manner appropriate for patent, regulatory and manufacturing purposes for at least three (3) years after the date of delivery of the report containing such information.  Upon the written request of Valentis and not more than once in each calendar year, Juvaris shall permit an independent third party, selected by Valentis and reasonably acceptable to Juvaris, at Valentis’ expense, to have access during normal business hours to such of the Records of Juvaris as may be reasonably necessary to verify compliance with the terms of this Agreement, as well as the accuracy of the reports hereunder; provided, however, that Juvaris shall not be obligated to disclose any information in such Records to the extent such disclosure would violate the terms of an agreement between Juvaris and a Juvaris Customer.  Juvaris shall certify any statements by Juvaris personnel as to their accuracy and correctness.

ARTICLE 3.

IMPROVEMENTS

Valentis shall be free to research, develop and patent any improvements made by Valentis to the Licensed Technology and, except as expressly set forth herein, no rights shall be or are to be construed as granted under this Agreement to Juvaris to any patents or patent applications (other than the Patent Rights) arising from such activities.

ARTICLE 4.

REPORTS AND RECORDS

4.1           Reports .  Juvaris shall make a written report to Valentis within thirty (30) days after each anniversary of the Effective Date describing Juvaris’ activities under the rights granted to Juvaris pursuant to Section 2.1.  Each such report shall also contain a written

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certification that Juvaris is in material compliance with all relevant terms and conditions of this Agreement.  Valentis shall treat all such reports as Confidential Information of Juvaris.

4.2           Records .  Juvaris shall, and shall cause any Juvaris Customer to use reasonable efforts to, keep complete, true and accurate books of account and records for the purpose of determining compliance with this Agreement.

ARTICLE 5.

CONFIDENTIALITY

5.1           Confidential Information .  Except as expressly provided herein, the parties agree that, for the term of this Agreement and for five (5) years thereafter, the receiving party shall keep confidential and shall not publish or otherwise disclose, and shall not use for any purpose except for the purposes contemplated by this Agreement, any Confidential Information furnished to such receiving party by a disclosing party hereto, except to the extent that it can be established by the receiving party by written proof that such Confidential Information:

(a)           was already known to the receiving party, other than under an obligation of confidentiality to the disclosing party, at the time of disclosure;

(b)           was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving party;

(c)           became generally available to the public or otherwise part of the public domain after its disclosure other than through any act or omission of the receiving party in breach of this Agreement; or

(d)           was subsequently disclosed to the receiving party by a person or entity with no obligation to the disclosing party with respect to such information.

5.2           Permitted Use and Disclosures .  Each party hereto may use or disclose information disclosed to it by the other party to the extent such use or disclosure is reasonably necessary for the purposes contemplated by this Agreement, and in such case pursuant to a confidentiality agreement no less restrictive than the terms set forth in this Article 5, or in complying with applicable law or government regulations; provided, however , that if a party is required to make any such disclosure of the other party’s Confidential Information, other than pursuant to such a confidentiality agreement, it will give reasonable advance notice to such other party of such disclosure.  Notwithstanding anything herein to the contrary, Juvaris shall be free to disclose the Licensed Technology to the extent such disclosure is required in its filings with regulatory and patent authorities.

5.3           Confidential Terms .  Except as expressly provided herein, each party agrees that the terms of this Agreement and the transaction and relationship with each other constitute Confidential Information and are not to be disclosed to any Third Party without the consent of the other party; provided that disclosures may be made as required by securities or

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