Exhibit
10.1


 


NON-EXCLUSIVE
LICENSE AGREEMENT


THIS NON-EXCLUSIVE LICENSE
AGREEMENT (the “Agreement”)
is entered into as of January 8, 2007 (the “Effective Date”),
by and between ALTHEA TECHNOLOGIES,
INC., a Delaware corporation, having offices at 11040 Roselle
Street, San Diego, CA 92121 (“Althea”),
and VALENTIS, INC., a
Delaware corporation, having offices at 863A Mitten Road, Burlingame, CA 94010
(“Valentis”).


WHEREAS,
Valentis is the owner, or is the exclusive licensee of, the Licensed Technology
(as defined below); and


WHEREAS, Althea
wishes to obtain, and Valentis is willing to grant, a non-exclusive,
worldwide license under the Licensed Technology on the terms and subject to the
conditions set forth herein.


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


1.             DEFINITIONS. 
As used in this Agreement, the following terms
have the meanings set forth below:


1.1          “Affiliate” shall
mean any corporation or other entity which controls, is controlled by, or is
under common control with, a party.  For
the purposes of this definition, a corporation or other entity shall be
regarded as in control of another corporation or entity if it owns or directly
or indirectly controls more than 50% of the voting securities or other
ownership interest of the other corporation or entity, or if it possesses,
directly or indirectly, the power to direct or cause the direction of the
management and policies of the corporation or other entity.


1.2          “Confidential Information”
shall mean all data and information, tangible or intangible, whether in
written, graphic, verbal or electronic form, developed by or disclosed or made
available by one party to the other party, its employees or representatives
under this Agreement and that is marked as “Confidential” at the time it is
delivered to the receiving pary or when disclosed orally is confirmed in
writing within thirty (30) days by the disclosing party.  Notwithstanding the foregoing, Confidential
Information shall not include any information which the receiving party can
prove by competent evidence:


(a)           is now, or
hereafter becomes, through no act or failure to act on the part of the
receiving party, generally publicly known or available;


(b)           is known by the
receiving party at the time of receiving such information, as evidenced by its
records;


(c)           is hereafter
furnished to the receiving party by a Third Party, as a matter of right and
without restriction on disclosure; or


(d)           is independently
developed by the receiving party, as evidenced by its records, without
knowledge of, and without the aid, application or use of, the Confidential
Information of the disclosing party.



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1.3          “Control” shall mean
possession of the ability to grant a license or sublicense as provided for
herein without violating the terms of any agreement or other arrangement with
any Third Party.


1.4          “Customer” shall
mean any Third Party for whom Althea provides contract manufacturing services.


1.5          “Know-How” shall
mean know-how, trade secrets, data, processes, techniques, procedures,
compositions, devices, methods, formulas, protocols and information, whether or
not patentable specifically related to the Licensed Technology.


1.6          “Licensed Patents”
shall mean the patents and patent applications listed in Appendix I hereto
and (a) any and all corresponding foreign patents and patent applications,
whether now existing or hereafter filed, (b) any provisionals,
continuations, continuation-in-part, substitutions, divisionals, reissues, renewals,
substitute applications and inventors’ certificates arising from, or based
upon, any of the foregoing patents or patent applications, and (c) any
patents issuing from any of the foregoing patent applications.


1.7          “Licensed Technology”
shall mean:


(a)           the Licensed Patents;
and


(b)           Know-How that is
(i) in the possession and control of Valentis on the Effective Date,
(ii) necessary or useful for the practice of the inventions claimed in the
Licensed Patents, and (iii) not generally publicly known.


1.8          “Product” shall mean
plasmid DNA for use in research, preclinical development, clinical development
or commercialization activities.


1.9          “Term” shall have
the meaning provided in Section 6.1.


1.10        “Third Party” shall
mean any entity other than Althea or Valentis or an Affiliate of Althea or
Valentis.


2.             LICENSE.


2.1          License Grant.  Subject to the terms and conditions of this
Agreement, Valentis hereby grants to Althea a non-exclusive, worldwide,
fully-paid, royalty-free license, with the right to grant sublicenses as set forth
in Section 2.2, under the Licensed Technology to make, have made, use,
sell, have sold, offer to sell and import Products.  Without limiting or expanding the generality
of the foregoing, Althea shall have the right to practice the license granted
under this Section 2.1 for the purpose of providing contract manufacturing
services on behalf of Third Parties.


2.2          Sublicenses.  Subject to the terms and
conditions of this Agreement, Althea shall have the right to grant sublicenses
under the license granted to Althea pursuant to Section 2.1 as follows:



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(a)           to any Customer, to
the extent necessary for such Customer to manufacture, or to have manufactured
on such Customer’s behalf, a Product that Althea previously manufactured for
such Customer;


(b)           to any Third Party
designated by a Customer, to the extent necessary for such Third Party to
manufacture on such Customer’s behalf a Product that Althea previously
manufactured for such Customer;


(c)           to any Third Party
selected by Althea, to the extent necessary for such Third Party to manufacture
on Althea’s behalf a Product that Althea previously manufactured for its own
account; and/or


(d)           to any Affiliate of
Althea.


Upon Valentis’ written request from time to time, Althea shall disclose
to Valentis the identities of all then-existing sublicensees, which disclosure
shall be considered Confidential Information of Althea.


2.3          Disclosure of Know-How.  Promptly after the Effective Date, Valentis
shall disclose to Althea the Know-How included the Licensed Technology the acceptance
of which shall be deemed to have occurred on the delivery of same.


2.4          No implied rights.  Except as expressly granted above, all rights
not granted are expressly reserved.


3.             PAYMENT OBLIGATIONS.


3.1          License Fee.  As full and complete payment for the license
granted hereunder, Althea shall pay to Valentis a license fee of $185,000.  Such fee shall be payable in U.S. dollars and
shall be made by wire transfer to a bank and account designated in writing by
Valentis within 10 days after the Effective Date.


3.2          Taxes.  All taxes levied on account of the payment
accruing to Valentis under this Agreement shall be paid by Valentis for its own
account, including taxes levied thereon as income to Valentis.  If provision is made in law or regulation for
withholding, such tax shall be deducted by Althea from the amount otherwise
payable by it hereunder for payment to the proper taxing authority on behalf of
Valentis and a receipt of payment of the tax secured and promptly delivered to
Valentis.   Althea shall be responsible
for all other taxes that arise from this Agreement.


4.             PROTECTION OF CONFIDENTIAL INFORMATION.


4.1          Confidentiality. 
During the Term and for a period of five (5) years thereafter, each
party agrees, with respect to any Confidential Information disclosed to such
party (the “Receiving
Party”) by the other party (the “Disclosing Party”) under this
Agreement:


(a)           To use such
Confidential Information only for the purposes set forth in this Agreement;



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(b)           To receive,
maintain and hold the Confidential Information in strict confidence and to use
the same methods and degree of care (but at least reasonable care) to prevent
disclosure of such Confidential Information as it uses to prevent disclosure of
its own proprietary and Confidential Information and to protect against its
dissemination to unauthorized parties;


(c)           Not to disclose, or
authorize or permit the disclosure of any Confidential Information to any third
party without the prior written consent of the Disclosing Party; and


(d)           Except as needed to
fulfill its obligations under this Agreement, to return any Confidential
Information to the Disclosing Party at the request of the Disclosing Party and
to retain no copies or reproductions thereof.


4.2          Authorized Disclosure. 
Notwithstanding Section 4.1, the Receiving Party may disclose
Confidential Information, without violating the obligations of this Agreement,
to the extent the disclosure is required by a valid order of a court or other
governmental body having jurisdiction; provided,
that, the Receiving Party gives reasonable prior written notice to
the Disclosing Party of such required disclosure and makes a reasonable effort
to obtain, or to assist the Disclosing Party in obtaining, a protective order
preventing or limiting the disclosure and/or requiring that the Confidential
Information so disclosed be used only for the purposes for which the law or
regulation requires, or for which the order was issued.


4.3          Use of Name/Publicity. 
Neither party shall use the other party’s name in connection with any
publication or promotion without the other party’s written consent, except as
required by federal, state or local laws, rules and regulations.


5.             REPRESENTATIONS AND WARRANTIES.


5.1          Mutual Representations and Warranties.  Each party represents and warrants to the
other that, as of the Effective Date: (a) it is duly organized and validly
existing under the laws of its jurisdiction of incorporation or formation, and
has full corporate or other power and authority to enter into this Agreement and
to carry out the provisions thereof; (b) it is duly authorized to execute
and deliver this Agreement and to perform its obligations thereunder, and the
person or persons executing this Agreement on its behalf has been duly
authorized to do so by all requisite corporate or partnership action; and
(c) this Agreement is legally binding upon it, enforceable in accordance
with its terms, and does not conflict with any agreement, instrument or
understanding, oral or written, to which it is a party or by which it may be
bound, nor violate any material law or regulation of any court, governmental
body or administrative or other agency having jurisdiction over it.


5.2          Valentis Representations and
Warranties.  Valentis
represents and warrants to Althea that, as of the Effective Date: (a) the
patents and patent applications listed on Appendix I hereto are the only
patent rights known by Valentis that are Controlled by Valentis that claim the
inventions described in the patents and patent applications listed on said
Appendix I; (b) Valentis has the right to grant to Althea the license
under the Licensed Technology that Valentis purports to grant hereunder;
(c) Valentis has not received written notice from any Third Party claiming
that the practice of the Licensed Technology infringes the intellectual property rights of such



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Third Party; (d) Valentis is not a party to any legal action, suit
or proceeding relating to the Licensed Technology; (e) to Valentis’
knowledge, the issued patents in the Licensed Patents are valid and enforceable;
and (f) the Licensed Patents are not the subject of any pending or
threatened claim, challenge, opposition, interference or other proceeding
questioning their validity or enforceability.


5.3          Disclaimer of Warranties.  EXCEPT AS EXPRESSLY SET FORTH
IN THE TRANSACTION AGREEMENTS, NEITHER PARTY MAKES ANY REPRESENTATION OR
WARRANTY TO THE OTHER PARTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, ANY WARRANTY OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE.


5.4          Limitation of Liability.  EXCEPT FOR PAYMENTS UNDER ARTICLE 3 OR
LIABILITY FOR BREACH OF ARTICLE 4, NEITHER PARTY SHALL BE ENTITLED TO
RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE
DAMAGES IN CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER; provided, however, that this
Section 5.4 shall not be construed to limit either party’s indemnification
obligations under Article 7.


6.             TERM; TERMINATION.


6.1          Term.  The term of this Agreement (the “Term”) shall commence as of the
Effective Date and, unless terminated earlier as provided herein, shall
continue until the expiration of the last to expire of the Licensed Patents,
whereupon the license granted hereunder shall become irrevocable and perpetual.


6.2          Termination by Valentis.  If Althea materially breaches its obligations
under this Agreement and fails to cure such breach within 30 days
following its receipt of written notice from Valentis, then Valentis shall have
the right to terminate this Agreement.


6.3          Termination by Althea. 
Althea shall have the right to terminate this Agreement at any time upon
written notice to Valentis.


6.4          Effect
of Expiration or Termination.


(a)           Within 30 days
following the expiration or termination of this Agreement, each party shall
return to the other party, or destroy, upon the written request of the other
party, any and all Confidential Information of the other party in its
possession.


(b)           Expiration or
termination of this Agreement shall not relieve the parties of any obligation
accruing prior to such expiration or termination.  The provisions of Sections 3.2, 5.3,
5.4, 6.4 and 6.5 and Articles 4, 7 and 8 shall survive termination or
expiration of this Agreement.


6.5          Rights in Bankruptcy.  All rights and licenses
granted under or pursuant to this Agreement are, and will otherwise be deemed
to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code,
licenses of right to “intellectual property” as defined under Section 101
of the



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U.S. Bankruptcy Code.  Valentis
agrees that Althea, as licensee of such rights under this Agreement, will
retain and may fully exercise all of its rights and elections under the U.S.
Bankruptcy Code.


7.             INDEMNIFICATION.


7.1          Althea Indemnification.  Althea
hereby agrees to save, defend, indemnify and hold harmless Valentis and its
officers, directors, employees, consultants and agents (each, an “Valentis Indemnitee”) from and
against any and all losses, damages, liabilities, expenses and costs, including
reasonable legal expense and attorneys’ fees (“Indemnified Losses”), to which any such
Valentis Indemnitee may become subject as a result of any claim, demand, action
or other proceeding by any Third Party to the extent such Indemnified Losses
arise directly out of: (i) the material breach by Althea of any
representation, warranty, covenant or agreement made by it under this
Agreement; or (ii) the development, manufacture, use, handling, storage,
sale or other disposition of any Product by Althea or any of its Affiliates or
sublicensees


7.2          Control of Defense. 
In the event a Valentis Indemnitee seeks indemnification under
Section 7.1, it shall inform Althea of a claim as soon as reasonably
practicable after it receives notice of the claim, shall permit Althea to assume
direction and control of the defense of the claim (including the right to
settle the claim solely for monetary consideration), and shall cooperate as
requested (at the expense of Althea) in the defense of the claim.  If Althea defends the suit or claim, Valentis
may participate in (but not control) the defense thereof at its sole cost and
expense.


7.3          Settlements. 
Neither party may settle a claim or action related to any Indemnified
Losses subject to indemnification under this Article 7 without the consent
of the other party, if such settlement would impose any monetary obligation on
the other party or require the other party to submit to an injunction or
otherwise limit the other party, its Affiliates, employees, agents, officers
and directors.


8.             MISCELLANEOUS.


8.1          Assignment.  Except as expressly provided hereunder,
neither this Agreement nor any rights or obligations hereunder may be assigned
or otherwise transferred by Althea without the prior written consent of
Valentis (which consent shall not be unreasonably withheld); provided, however, that either party may assign this
Agreement and its rights and obligations hereunder without the other party’s
consent (a) in connection with the transfer or sale of all or
substantially all of the business of such party to which this Agreement relates
to a Third Party, whether by merger, sale of stock, sale of assets or
otherwise, or (b) to any Affiliate. 
Notwithstanding the foregoing, any such assignment to an Affiliate shall
not relieve the assigning party of its responsibilities for performance of its
obligations under this Agreement. The rights and obligations of the parties
under this Agreement shall be binding upon and inure to the benefit of the
successors and permitted assigns of the parties.  Any assignment not in accordance with this Agreement
shall be null and void.


8.2          Governing Law.  This Agreement will be governed and construed
in accordance with the laws of the State of California, excluding its conflicts
of laws provisions.



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8.3          Severability.  If
any provision of this Agreement should be held invalid or unenforceable, the
remaining provisions shall be unaffected and shall remain in full force and
effect, to the extent consistent with the intent of the parties as evidenced by
this Agreement as a whole.


8.4          Independent Contractor Relationship.  The parties’ relationship hereunder is that
of independent contractors, and nothing in this Agreement should be construed
to create a partnership, joint venture, or employer-employee relationship
between the parties.  Neither party is an
agent of the other party or is authorized to make any representation, contract,
or commitment on behalf of the other party.


8.5          Entire Agreement; Amendment.  This Agreement (including Appendix I
attached hereto) sets forth all of the agreements and understandings between
the parties hereto with respect to the subject matter hereof, and supersedes
and terminates all prior agreements and understandings between the parties with
respect to the subject matter hereof. 
There are no agreements or understandings with respect to the subject
matter hereof, either oral or written, between the parties other than as set
forth herein.  Except as expressly set
forth in this Agreement, no subsequent amendment, modification or addition to
this Agreement shall be binding upon the parties hereto unless reduced to
writing and signed by the respective authorized officers of the parties.


8.6          Waiver.  Except as specifically provided for herein,
the waiver from time to time by either party of any right or failure to
exercise any remedy shall not operate or be construed as a continuing waiver of
the same right or remedy or of any other of such party’s rights or remedies
provided under this Agreement.


8.7          Notices.  All notices and other communications provided
for hereunder shall be in writing and shall be mailed by first-class,
registered or certified mail, postage paid, or delivered personally, by
overnight delivery service or by facsimile, with confirmation of receipt,
addressed as follows:




	
   If to Althea:

  	
   

  	
  Althea Technologies, Inc.

  	
   

  	
   

  
	
   

  	
   

  	
  11040 Roselle Street

  	
   

  	
   

  
	
   

  	
   

  	
  San Diego, CA 92121

  	
   

  	
   

  
	
   

  	
   

  	
  Attention: Chief Financial Officer

  	
   

  	
   

  
	
   

  	
   

  	
  Facsimile: (858) 882-0133

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   If to Valentis:

  	
   

  	
  Valentis, Inc.

  	
   

  	
   

  
	
   

  	
   

  	
  363A Mitten Road

  	
   

  	
   

  
	
   

  	
   

  	
  Burlingame, CA 94010

  	
   

  	
   

  
	
   

  	
   

  	
  Attention: Benjamin F. McGraw, III

  	
   

  	
   

  
	
   

  	
   

  	
   President
  and Chief Executive Officer

  	
   

  	
   

  
	
   

  	
   

  	
  Facsimile: 650.652.1990

  	
   

  	
   

  






 


Either party may by like notice specify or change an
address to which notices and communications shall thereafter be sent.  Notices sent by facsimile shall be effective
upon



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confirmation of receipt, notices sent by mail or
overnight delivery service shall be effective upon receipt, and notices given
personally shall be effective when delivered.


8.8          Headings. 
Section headings are for convenience of reference only and shall
not be considered in the interpretation of this Agreement.


8.9          Force Majeure.  Neither party shall be held liable or
responsible to the other party nor be deemed to have defaulted under or
breached this Agreement for failure or delay in fulfilling or performing any
term of this Agreement when such failure or delay is caused by or results from
causes beyond the reasonable control of the affected party, including, without
limitation, fire, floods, earthquakes, natural disasters, embargoes, war, acts
of war (whether war be declared or not), insurrections, riots, civil
commotions, strikes, lockouts or other labor disturbances, acts of God or acts,
omissions or delays in acting by any governmental authority or the other party.


8.10        Counterparts.  This
Agreement may be executed in multiple counterparts, each of which shall be
deemed an original and all of which together shall constitute one and the same
instrument.  Delivery of an executed
counterpart by facsimile or other electronic transmission shall be as effective
as delivery of a manually signed counterpart.



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IN WITNESS WHEREOF,
the parties hereto have executed this NON-EXCLUSIVE LICENSE AGREEMENT on the Effective
Date.


	
  ALTHEA
  TECHNOLOGIES, INC.:

  	
   

  	
  VALENTIS, INC.:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By: 

  	
  /s/ Magda
  Marquet                                 

  	
   

  	
   

  	
  By:

  	
  /s/ Benjamin F. McGraw,
  III                     

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Printed Name:
  Magda Marquet, Ph.D.

  	
  Printed Name: Benjamin
  F. McGraw, III

  
	
   

  	
   

  	
   

  
	
  Title:
  Co-President & Co-CEO

  	
  Title: Chairman, President & CEO

  
								



 



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APPENDIX
I


LICENSED
PATENTS


	
  Family

  	
   

  	
  Title

  	
   

  	
  Number

  	
   

  	
  Filed/Priority Date

  
	
  1

  	
   

  	
  Methods for Purifying Nucleic Acids (Tangential Flow

  Ultrafiltration/Diafiltration

  [UF/DF] for plasmid

  purification)

  	
   

  	
  US6,011,148

  EP0923592B1

  AU717136B2

  CA2261150C

  JP3492702B2

  	
   

  	
  filed 1997-07-31 as

  PCT app. (publ.

  WO98/05673),

  claiming priority to

  1996-08-01

  
	
  2

  	
   

  	
  Methods for Purifying Nucleic Acids (Purification protocol

  including static mixing for lysis,

  TMAE anion exchange

  chromatography and UF/DF for

  plasmid purification)

  	
   

  	
  US Pub. No.

  2002/0198372A1

  EP1098966A1

  AU4863899A1

  CA2338397AA

  JP2002521029T2

  	
   

  	
  filed 1999-07-07,

  including as PCT

  app. (publ.

  WO00/05358)

  claiming priority to

  1998-07-23

  
	
  3

  	
   

  	
  Process and Equipment for Plasmid Purification  (TMAE

  anion exchange and/or

  hydrophobic interaction

  chromatography (HIC) for

  plasmid purification)

  	
   

  	
  US Pub. No.

  2001/034435A1

  	
   

  	
  filed 1997-07-03,

  claiming priority to

  1996-07-19

  provisional, issue fee

  paid in TMAE

  claims

  
	
  4

  	
   

  	
  Apparatus and Method for Preparative Scale
  Purification of Nucleic Acids  (flotation of alkaline precipitate for large scale plasmid
  purification)

  	
   

  	
  WO04/024283

  US10/527,618

  EP1554398A2

  CA2498518AA

  AU3267175AA

  JP2004000536251

  	
   

  	
  filed 2003-09-12 as

  PCT app., claiming

  priority to 2002-09-

  13 (US Provisional)

  
	
  Methods for Purifying Nucleic Acids (Purification protocol including static

  mixing for lysis, TMAE anion exchange

  chromatography and UF/DF for plasmid

  purification)

  	
   

  	
  WO00/05358

  US09/121,798 (US Pub.

  No. 2002/0198372A1)

  EP1098966A1

  AU48638/99A1

  CA2338397AA

  JP2002-521029,A

  (unexamined publication

  no.)

  	
   

  	
  PCT filed 1999-07-07,

  claiming priority to

  1998-07-23

  



 



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  Family

  	
   

  	
  Title

  	
   

  	
  Number

  	
   

  	
  Filed/Priority Date

  
	
  Process and Equipment for Plasmid

  Purification (TMAE anion exchange

  and/or hydrophobic interaction

  chromatography (HIC) for plasmid

  purification)

  	
   

  	
  US7,026,468 (issuing

  from 09/774,284,

  published as

  2001/034435A1)-

  US 11/327,987 (US Pub.

  No. 2006/0106208A1)-

  pending

   

  	
   

  	
  filed 1997-07-03,

  claiming priority to

  1996-07-19 provisional

   

  



 


 



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