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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